我们决定向甘孜泸定、雅安石棉捐赠300万元现金、300万元物资，目前已成功对接甘孜州红十字会、雅安市红十字会，今天下午已经完成打款，物资根据当地所需正在紧急集结。对于灾区需要的其他支持，我们也当全力以赴。”
9月6日下午，四川科伦药业股份有限公司相关负责人告诉记者，针对四川泸定6.8级地震中受灾严重的泸定县和石棉县，他们紧急启动灾害应急处理方案，并进行现金和物资捐赠。
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2025-10-20
The New England Journal of Medicine Publishes Results of Phase III OptiTROP-Lung...
MoreAfter a median follow-up of 18.9 months, the median PFS was 8.3 months in the sac-TMT group and 4.3 months in the chemotherapy group (hazard ratio (HR), 0.49; 95% confidence interval (CI), 0.39 to 0.62; two-sided P<0.0001).
OS was significantly longer with sac-TMT than with chemotherapy (HR, 0.60; 95% CI, 0.44 to 0.82; two-sided P=0.001); 18-month OS rate was 65.8% and 48.0%, respectively. In the supplementary analysis, in which data were censored at the start date of subsequent ADC, the HR was 0.56 (95% CI, 0.41 to 0.77).
Sac-TMT was associated with a higher incidence of stomatitis with most cases being mild and with grade 3 or higher cases reported in very few patients (4.8%; all were grade 3). Low incidence of ocular-surface toxic effects, no ILD or pneumonitis, and one infusion-related reaction (grade 2) was reported in the sac-TMT group.
On October 20, results from the Phase III registrational clinical study OptiTROP-Lung04—led by Professor Zhang Li's team from Sun Yat-sen University Cancer Center—were published in the New England Journal of Medicine (Impact Factor = 78.5). The study evaluated the efficacy and safety of the TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) monotherapy versus pemetrexed plus platinum chemotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed failed after treatment with EGFR-tyrosine kinase inhibitor (TKI) therapy. The study was also selected as a Late-Breaking Abstract (LBA) at the 2025 European Society for Medical Oncology (ESMO) Congress and was presented as an oral report in the Presidential Symposium (Presentation # LBA5).
OptiTROP-Lung04 is a randomized, open-label, multicenter Phase III study designed to evaluate the efficacy and safety of sac-TMT monotherapy versus pemetrexed plus platinum in patients with EGFR-mutated locally advanced or metastatic NSCLC who had progressed on prior EGFR-TKI therapy. Eligible patients were those with histologically and/or cytologically confirmed disease. The primary endpoint was Progression-Free Survival (PFS) assessed by a Blinded Independent Review Committee (BIRC) per RECIST v1.1, and the key secondary endpoint was overall survival (OS). Results showed that compared with platinum-based doublet chemotherapy, sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in both PFS and OS. Consistent PFS and OS benefits were observed across all prespecified subgroups, including prior EGFR-TKI therapy, presence of liver or brain metastases, and EGFR mutation subtype.
Based on the positive results of the OptiTROP-Lung04 study, sac-TMT has been approved by the National Medical Products Administration (NMPA) in China for the treatment of adult patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who have progressed after EGFR-TKI therapy. To date, sac-TMT monotherapy remains the only approved treatment option for advanced EGFR-mutant NSCLC patients who have progressed after prior TKI therapy, as well as those who have progressed after prior TKI and platinum-based chemotherapy (either concurrently or sequentially). This achievement provides comprehensive coverage for the entire population of TKI-resistant patients.
Dr. Michael Ge, Chief Ｅxecutive Officer of Kelun-Biotech, commented: “OptiTROP-Lung04 is a key study that propels sac-TMT from late-line to an earlier-line treatment-setting in lung cancer, achieving a significant improvement in overall survival. We are thrilled that the results have been published in The New England Journal of Medicine, allowing this important finding to be shared widely among medical professionals and providing a reference for future lung cancer research. Together with our partner MSD, we will continue to advance sac-TMT’s clinical development and regulatory approvals, covering broader lung cancer and other indications, with the goal of making sac-TMT a cornerstone therapy for the benefit of patients.”
Professor Shengxiang Ren from the Department of Oncology at Shanghai Pulmonary Hospital, Tongji University, stated: “The application of third-generation EGFR-TKIs has significantly improved the overall prognosis for patients with advanced EGFR-mutant NSCLC. However, drug resistance is almost inevitable. Traditional treatment after resistance involves platinum-based doublet chemotherapy, which offers limited overall benefit. In recent years, regimens of chemotherapy plus immune checkpoint inhibitors+anti-angiogenic agents, or EGFR/c-Met bsAb, or PD-1/VEGF bsAb, have been successively approved for this indication. However, all these approaches are chemotherapy-based, highlighting an urgent need to explore novel treatment regimens. The OptiTROP-Lung04 study confirms sac-TMT as the first treatment option as a monotherapy to deliver clear dual benefits in both PFS and OS following EGFR-TKI progression. The sequential application of sac-TMT prior to chemotherapy demonstrates strong competence, establishing itself as a new standard of care for patients with advanced EGFR-mutant lung cancer after TKI resistance.”
About Sac-TMT
Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.
In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan).
To date, three indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting), EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy and EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy. Sac-TMT is the first TROP2 ADC drug approved for marketing in lung cancer globally. In addition, the new indication application for sac-TMT for the treatment of adult patients with unresectable locally advanced, metastatic hormone receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting was accepted by the Center for Drug Evaluation of the NMPA, and was included in the priority review and approval process.
As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 15 ongoing Phase Ⅲ global clinical studies of sac-TMT as a monotherapy or with pembrolizumab1 or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.
About Kelun-Biotech
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
References:
1. Pembrolizumab (KEYTRUDA®) is a registered trademark of Merck Sharp & Dohme LLC (MSD), a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
2025-10-19
Kelun-Biotech Presents Positive Phase 3 Data for Trastuzumab Botidotin Compared ...
MoreCHENGDU, China, Oct, 18 , 2025——Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) announced that at the 2025 European Society for Medical Oncology (ESMO) Congress held in Berlin, Germany, Results from a Phase 3 study of the Company’s human epidermal growth factor receptor 2 (HER2)-directed ADC trastuzumab botidotin (also known as A166) trastuzumab botidotin versus trastuzumab emtansine (T-DM1) in HER2-positive unresectable or metastatic BC was presented as an oral report by Professor Xichun Hu from Fudan University Shanghai Cancer Center (Presentation # LBA24, Proffered paper session 1: Breast cancer, metastatic).
Trastuzumab botidotin is a HER2-targeted ADC composed of a cytotoxic drug (Duostatin-5, anti-microtubule agent) with site-specific conjugation to trastuzumab via a stable protease-cleavable valine-citrulline linker. The unique linker is stable in plasma and selectively cleaved by lysosomal cathepsin B that is up-regulated in cancer cells.
In this study, a total of 365 patients with HER2+ unresectable or metastatic BC who had received at least one prior anti-HER2 therapy were randomized (1:1) to receive trastuzumab botidotin or T-DM1. 53% of patients had received ≥2 lines of anti-HER2 therapy, 61% of patients had HER2 Immunohistochemistry (IHC) 3+, and 60% of patients had been treated with TKIs, particularly pyrotinib (56%). As of April 26, 2025, median follow-up was 14.9 months.
Median PFS was significantly longer in trastuzumab botidotin than in T-DM1 (11.1 months vs 4.4 months; HR: 0.39, 95% CI, 0.30-0.51, p<0.0001). PFS benefit with trastuzumab botidotin was consistently observed regardless of prior lines of anti-HER2 therapy (HR 0.36, 95% CI, 0.25-0.53, for 1 prior line; HR 0.39, 95% CI, 0.28-0.56, for ≥2 prior lines).
ORR by blinded independent central review (BICR) was 76.9% vs 53.0%.
A trend toward benefit in OS was observed in trastuzumab botidotin (HR 0.62; 95% CI, 0.38-1.03).
Grade ≥3 treatment emergent adverse events (TEAEs) occurred in 69.8% of patients in trastuzumab botidotin and 63.7% in T-DM1. The most common TEAEs associated with dose reduction were ocular AEs for trastuzumab botidotin, and were platelet count decreased for trastuzumab emtansine. Only two patients permanently discontinued trastuzumab botidotin due to TEAE. No on-treatment deaths were observed in trastuzumab botidotin, compared with 1.6% in T-DM1, all of which were considered unrelated to treatment.
As a conclusion, this second head-to-head trial comparing T-DM1 with other anti-HER2 regimens demonstrated that trastuzumab botidotin statistically improved PFS with an ORR of 76.9% vs 53.0%. PFS benefit with trastuzumab botidotin was consistently observed regardless of prior lines of anti-HER2 therapy. Ocular AEs were also manageable.
"Professor Xichun Hu, National Lead Principal Investigator from Fudan University Shanghai Cancer Center:“Trastuzumab botidotin effectively balances safety and efficacy through its unique molecular design, reducing the incidence of interstitial lung disease and hematologic toxicity. According to research data, trastuzumab botidotin demonstrated significant survival benefits in the pivotal Phase III trial, with an overall manageable safety profile, providing a new important treatment option for pretreated HER2+ BC patients. These positive results also offer robust evidence-based support for personalized treatment and updates to clinical practice guidelines.”
About Trastuzumab botidotin
Trastuzumab botidotin is a differentiated HER2 ADC to treat advanced HER2+ solid tumors. As an innovative HER2 ADC developed by the Company, it conjugates a novel, monomethyl auristatin F (MMAF) derivative (a highly cytotoxic tubulin inhibitor, Duo-5) via a stable, enzyme-cleavable linker to a HER2 monoclonal antibody with a DAR of 2. Trastuzumab botidotin specifically binds to HER2 on the surface of tumor cells and is internalized by tumor cells, releasing the toxin molecule Duo-5 inside the cell. Duo-5 induces tumor cell cycle arrest in the G2/M phase, leading to tumor cell apoptosis. After targeting HER2, trastuzumab botidotin can also inhibit the HER2 signaling pathway; it has antibody-dependent cell-mediated cytotoxicity (ADCC) activity.
Based on the results of a multi-center, randomized, open-label, controlled, Phase 3 KL166-III-06 study, trastuzumab botidotin was approved for marketing by the NMPA in for adult patients with unresectable or metastatic HER2 positive BC who have received one or more prior anti-HER2 therapy. At a pre-specified interim analysis, trastuzumab botidotin demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS as assessed by the BICR compared with T-DM1[; the beneficial trend for OS of trastuzumab botidotin was also observed.
Currently, the Company has initiated an open, multi-center Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase inhibitor ADC.
About Kelun-Biotech
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 projects are in the NDA stage and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 1 ADC project approved for marketing and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
2025-10-18
Positive Results from Phase 3 OptiTROP-Lung04 Trial of Sacituzumab Tirumotecan P...
MoreCHENGDU, China, Oct, 19, 2025——Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) announced that at the 2025 European Society for Medical Oncology (ESMO) Congress held in Berlin, Germany, results from a Phase 3 OptiTROP-Lung04 trial of the Company’s trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) in EGFR-mutated non-small cell lung cancer (NSCLC) following progression on epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) was presented as an oral report by Professor Li Zhang from Sun Yat-sen University Cancer Center (Presentation # LBA5, Presidential Symposium II) and were simultaneously published in the New England Journal of Medicine (Impact Factor = 78.5).
In the OptiTROP-Lung04 trial, a total of 376 patients were randomized (1:1) to receive sac-TMT monotherapy or chemotherapy.
As at the data cut-off date July 06, 2025, the median follow-up is 18.9 months. the median Progression-Free Survival (PFS) was 8.3 months in the sac-TMT group and 4.3 months in the chemotherapy group. Sac-TMT significantly improved PFS over chemotherapy with 51% lower risk of disease progression or death (hazard ratio (HR) 0.49; 95% confidence interval (CI), 0.39-0.62; P<0.0001).
At the preplanned interim analysis of overall survival (OS), the OS was not reached (NR) in the sac-TMT group and 17.4 months in the chemotherapy group. sac-TMT significantly improved OS over chemotherapy with 40% lower risk of death (hazard ratio (HR) 0.6; 95% CI: 0.44-0.82; two-sided P=0.001). In the supplemental analysis, when censoring patients at the date of initiation of subsequent ADCs, sac-TMT significantly improved OS over chemotherapy with 44% lower risk of death (HR, 0.56; 95% CI, 0.41 - 0.77).
Sac-TMT significantly improved ORR as compared to chemotherapy (60.6% vs 43.1%)
A consistent PFS and OS benefit of sac-TMT over chemotherapy was observed across all predefined subgroups, including prior EGFR-TKI therapy, presence of liver or brain metastases, and EGFR mutation subtype.
The incidence of any grade treatment-related adverse events (TRAEs) and grade ≥3 TRAEs was similar between the two groups. The most common TRAEs for both sac-TMT and chemotherapy were hematologic toxicities. No TRAEs led to discontinuation or death, and no cases of interstitial lung disease/pneumonitis were reported in the sac-TMT group. Ocular surface toxicity: occurred in 9.6% of patients in the sac-TMT group, all of which were grade 1 - 2.
As a conclusion, sac-TMT demonstrates highly statistically significant and clinically meaningful improvements in PFS and OS compared to platinum-based chemotherapy and showed a manageable safety profile, with no unexpected safety signals identified. Several global phase 3 studies of sac-TMT monotherapy (NCT06305754, NCT06074588) and combination study with osimertinib in China (NCT06670196) in EGFR-mutant NSCLC are ongoing.
Professor Zhang Li, National Lead Principal Investigator from Sun Yat-sen University Cancer Center, commented: "Compared to platinum-based doublet chemotherapy, sac-TMT not only significantly prolonged PFS but also demonstrated a statistically significant and clinically meaningful improvement in OS within this patient population. This achievement marks a major breakthrough in global lung cancer treatment—sac-TMT, as a monotherapy, demonstrated statistically significant and clinically meaningful improvements in both PFS and OS in the Phase III trial for patients with EGFR-TKI-resistant NSCLC. This study provides highly valuable, new evidence-based guidance for lung cancer management worldwide and has the potential to reshape the therapeutic landscape for EGFR-TKI-resistant NSCLC "
About sac-TMT
Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, GC, gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.
In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).
To date, three indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting), EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy and EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy. Sac-TMT is the first TROP2 ADC drug approved for marketing in lung cancer globally. In addition, the new indication applications for sac-TMT for the treatment of adult patients with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), and was included in the priority review and approval process.
As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 15 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.
About Kelun-Biotech
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC project approved for marketing and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
2024-05-24
ASCO 2024| Two Abstracts of the Study Results of Kelun-Biotech’s TROP2-ADC SKB2...
More
(May 24th, Chengdu and New Jersey) The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago, Illinois, the United States of America from May 31 to June 4, 2024, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) will present two clinical stage study results at ASCO.
1.The Phase 3 OptiTROP-Breast01 study of its anti-TROP2 ADC sacituzumab tirumotecan (sac-TMT) (formerly SKB264/MK-2870) in patients with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC).
? Session: Special clinical science symposium (Abstract #104; Next-Generation Antibody–Drug Conjugates: The Revolution Continues),
? Time: June 2, 2024, 9:45 AM to 11:15 AM local time
2. The Phase 2 OptiTROP-Lung01 study of sac-TMT in combination with KL-A167 (an anti-PD-L1 mAb) as 1L treatment for patients with advanced non-small cell lung cancer (NSCLC)
? Session: oral (Abstract #8502; Lung Cancer—Non-Small Cell Metastatic Oral)
? Time: May 31, 2024, 2:45 PM to 5:45 PM local time.
Sac-TMT is jointly developed by Kelun-Biotech and MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) at clinical stage.
The abstracts for the above studies were published on ASCO’s official website on [May 23, 2024], local time. The study results are summarized as follows:
TNBC
Patients were randomly assigned (1:1) to receive sac-TMT (n = 130) or chemotherapy (n = 133). The median age was 51 years; 87% had visceral metastases; 26% received prior PD-1/PD-L1 inhibitors; 48% received three or more prior lines of chemotherapy for advanced disease. The primary endpoint of progression free survival (PFS) was met based on interim analysis (data cut-off: Jun 21, 2023) with a 69% reduction in risk of progression or death (HR 0.31; 95% CI, 0.22 to 0.45; P <0.00001).
The median PFS, as assessed by BICR, was 5.7 months (95% CI, 4.3 to 7.2) with sac-TMT and 2.3 months (95% CI, 1.6 to 2.7) with chemotherapy; PFS rate at 6 months was 43.4% vs 11.1%. In the subset of patients with trophoblast cell-surface antigen 2 (TROP2) H-score > 200, the median PFS was 5.8 months with sac-TMT and 1.9 months with chemotherapy (HR 0.28; 95% CI, 0.17 to 0.48). At the first planned interim analysis for overall survival (OS) (data cut-off: Nov 30, 2023) with median follow-up of 10.4 months, OS was statistically significant in favor of sac-TMT (HR 0.53; 95% CI, 0.36 to 0.78; P =0.0005); the median OS was not reached (95% CI, 11.2 to NE) with sac-TMT and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. The objective response rate (ORR) assessed by BICR was 43.8% with sac-TMT and 12.8% with chemotherapy.
Most common grade ≥ 3 treatment-related adverse events (TRAEs) (sac-TMT vs. chemotherapy) were neutrophil count decreased (32.3% vs. 47.0%), anemia (27.7% vs. 6.1%) and white blood cell count (WBC) decreased (25.4% vs. 36.4%).
A Phase 3 global study led by MSD of sac-TMT plus pembrolizumab versus treatment of physician's choice (TPC) in TNBC who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery (NCT06393374) and a Phase 3 study led by the Company of sac-TMT in China for 1L treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC (NCT06279364) are ongoing.
NSCLC
Patients with treatment naive advanced NSCLC without actionable genomic alterations were enrolled to receive sac-TMT 5 mg/kg Q3W plus KL-A167 1200 mg Q3W (cohort 1A) or sac-TMT 5 mg/kg Q2W plus KL-A167 900 mg Q2W (cohort 1B) in a non-randomized manner until disease progression or unacceptable toxicity. As of January 02, 2024, 40 and 63 patients have been enrolled in cohort 1A and 1B, respectively. Median ages were 63/63 years (cohort 1A/1B); 97.5%/85.7% had Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 1; 30.0%/33.3%, 32.5%/30.2% and 37.5%/36.5% of patients had programmed death ligand 1 (PD-L1) expression < 1%, 1%-49% and ≥ 50% of tumor cells by IHC 22C3 pharmDx assay, respectively.
After median follow up of 14.0 months for cohort 1A, the ORR was 48.6% (18/37, 2 pending confirmation), disease control rate (DCR) was 94.6% and median PFS was 15.4 months (95% CI: 6.7, NE) with a 6-month PFS rate of 69.2%. After median follow-up of 6.9 months for cohort 1B, the ORR was 77.6% (45/58, 5 pending confirmation), DCR was 100% and median PFS was not reached with a 6-month PFS rate of 84.6%. Additional subgroup analyses of cohort 1B are shown in the following table:
*Including confirmed or unconfirmed response. ORR was calculated based on response evaluable population defined as patients with ≥ 1 on-study scans.
In cohorts 1A and 1B, the most common Grade ≥ 3 TRAEs were neutrophil count decreased (30.0%/30.2%), WBC decreased (5.0%/17.5%), anemia (5.0%/15.9%), rash (5.0%/6.3%) and drug eruption (7.5%/0). Treatment-related adverse events leading to discontinuation of sac-TMT occurred in 1 patient of cohort 1B due to drug hypersensitivity, and there were no treatment-related deaths.
Two Phase 3 global studies led by MSD of sac-TMT in patients with 3L+ EGFR mutant NSCLC (NCT06074588), and 2L EGFR mutant NSCLC (NCT06305754) and a Phase 3 study led by the Company of sac-TMT in China in patients with 2L EGFR mutant NSCLC (NCT05870319) are ongoing. Additionally, Three Phase 3 global studies led by MSD of sac-TMT plus pembrolizumab are ongoing: One in patients with 1L Metastatic Squamous NSCLC (NCT06422143) , a second in patients with metastatic NSCLC expressing PD-L1 ≥ 50% (NCT06170788), and the third in patients with resectable NSCLC not achieving a pathological complete response (NCT06312137) .
2024-04-08
AACR 2024| Two Abstracts of the Study Results of Kelun-Biotech’s TROP2-ADC SKB2...
More2024 American Association for Cancer Research (AACR) Annual Meeting is being held in San Diego, California, the United States of America from April 5th to 10th, 2024, local time.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK, the “Company”) will present two study results of anti-TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) during the AACR meeting scheduled below. The abstracts for the studies have been published on the official website of the AACR on April 5th, 2024, local time (See link below).
1. The updated efficacy and safety results for its anti-TROP2 ADCSKB264/sac-TMT in patients with previously treated advanced non-small cell lung cancer (NSCLC) from a phase 2 study in a poster session scheduled on April 9 2024, 1:30 PM - 5:00 PM local time (Abstract Presentation Number: CT247).
2.The preliminary efficacy and safety results for its anti-TROP2 ADC SKB264/sac-TMT in patients with previously treated advanced gastric or gastroesophageal junction (GEJ) cancer from a phase 2 study as an oral presentation, which is scheduled in a session on April 9 2024, 2:30 PM - 4:30 PM local time (Abstract Presentation Number: CT038).
The study results are summarized as follows:
NSCLC
Patients with previously treated advanced NSCLC were enrolled to receive SKB264/sac-TMT at 5 mg/kg Q2W until disease progression or unacceptable toxicity (KL264-01, NCT04152499). The data cut-off date was November 22, 2023.
Five Phase 3 global studies of SKB264/sac-TMT in patients with NSCLC are ongoing. Including two Phase 3 global studies of SKB264/sac-TMT in patients with 3L+ EGFR mutant NSCLC (NCT06074588), and 2L EGFR mutant NSCLC (NCT06305754) and a Phase 3 study ofSKB264/sac-TMT in China in patients with 2L EGFR mutant NSCLC (NCT05870319). Additionally two Phase 3 global studies of SKB264/sac-TMT plus pembrolizumab in patients with metastatic NSCLC expressing programmed death ligand 1 (PD-L1)≥ 50% (NCT06170788) and resectable NSCLC not achieving pathological complete response (NCT06312137) are ongoing.
As of the Data Cut-off date, 43 NSCLC patients had been enrolled and the median follow-up was 17.2 months. 21 patients with EGFR wild type had received a median of 3 prior regimens of therapy including anti-PD-1/L1 inhibitors. 22 patients with EGFR mutant had progressed on or after TKI therapy, 50% of whom also failed at least one line of chemotherapy. Updated efficacy results are shown in the following:
*Including confirmed or unconfirmed response. Based on response evaluable patients (≥1 on-study scans) with 4 patients (2 EGFR mutant patients with non-squamous histology and 2 EGFR wild type patients with squamous histology) excluded.
The most common Grade ≥3 treatment-related adverse events (TRAEs) were neutrophil count decreased (34.9%), anemia (30.2%), white blood cell (WBC) count decreased (25.6%), stomatitis (9.3%), and rash (7.0%). No TRAEs leading to treatment discontinuation or deaths occurred. No drug-related interstitial lung disease (ILD)/pneumonitis was reported.
Gastric/GEJ cancer
Patients with previously treated inoperable advanced gastric/GEJ adenocarcinoma were enrolled to receive SKB264/sac-TMT monotherapy at 5 mg/kg Q2W until disease progression or unacceptable toxicity in Phase 2 expansion cohort of KL264-01 study (NCT04152499). Patients with heavily pre-treated gastric/GEJ cancer were enrolled first, and then the cohort was amended to enroll patients with only one prior therapy of chemotherapy and anti-PD-1/L1 therapy. The data cut-off date was Nov 22, 2023.
As of the data cut-off date, a total of 48 patients were enrolled and followed up for at least 9 weeks. 24 patients (50.0%) had received one prior line of therapy (2L), while 24 patients (50.0%) had received ≥ 2 prior lines of therapy (3L+). 40 patients (83.3%) had received prior anti-PD-1/L1 inhibitors. Of 41 response-evaluable patients (defined as ≥ 1 on-study scans), the objective response rate (ORR) was 22.0% (9 partial responses, 2 pending confirmation) and disease control rate (DCR) was 80.5%. The ORRs in the 2L and 3L+ setting were 27.3% (including 2 pending confirmation) and 15.8%, respectively. Median duration of response (DoR) was 7.5 months. In the subset of 3L+ patients (n=24 including 54.2% of patients with ≥ 4 prior lines of therapy) with more mature follow-up (median follow up of 14.6 months), the median progression free survival (mPFS) was 3.7 months (95% CI: 2.6, 5.4) and median overall survival (mOS) was 7.6 months (95% CI: 5.3, 15.5).
The most common ≥ Grade 3 TRAEs were anemia (20.8%), neutrophil count decreased (18.8%), WBC decreased (12.5%) and neutropenia (6.3%). No TRAEs leading to treatment discontinuation or deaths occurred. No neuropathy or drug-related ILD/pneumonitis was reported.
A Phase 3 global study of SKB264/sac-TMT monotherapy versus standard of care (SOC) chemotherapy in 3L+ gastric/GEJ adenocarcinoma is being planned.
Press Contact: Xinwei Li, klbio_pr@kelun.com
2024-03-13
The FOURTH BTD! TROP2-ADC SKB264 (MK-2870) Granted Breakthrough Therapy designat...
MoreOn 8th March 2024, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK, Kelun-Biotech)’s innovative core product TROP2-ADC SKB264 (also known as MK-2870) was granted Breakthrough Therapy Designation（BTD） by the Center for Drug Evaluation（ CDE） of the National Medical Products Administration (NMPA) of China for first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative triple negative breast cancer (TNBC). SKB264 (MK-2870) is jointly developed by Kelun-Biotech and MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA).
This is the fourth Breakthrough Therapy Designation for SKB264 (MK-2870) granted by the NMPA. Previously, SKB264 (MK-2870) was granted BTD for:
July 2022, locally advanced or metastatic TNBC.
January 2023, EGFR-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) after progression on EGFR tyrosine kinase inhibitor (TKI) therapy.
June 2023, locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer in patients who have previously received at least two lines of systematic chemotherapy.
Breast cancer is one of the most common malignant tumors in women, with its incidence showing an increasing trend year by year. The International Agency for Research on Cancer (IARC) and the World Health Organization (WHO) estimated that in 2020, there were over 2.26 million new cases of breast cancer globally, accounting for 11.7% of all tumors, making it the most prevalent cancer [1]. Triple-negative breast cancer (TNBC) is a clinical subtype that is negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2), comprising 10.0% to 20.8% of all breast cancer types. Triple-negative breast cancer is characterized by high heterogeneity, a high rate of recurrence and metastasis, and a poorer prognosis compared to other types of breast cancer. It lacks effective and specific treatment methods [2]. Currently, the primary treatment for PD-L1 negative TNBC is chemotherapy, which offers limited survival benefits, highlighting the urgent need for new treatment plans. For patients with inoperable locally advanced, recurrent, or metastatic PD-L1 negative triple-negative breast cancer, the first-line standard treatment in China still involves chemotherapy, including single-agent or combination chemotherapy [3]. Compared to single-agent chemotherapy, combination chemotherapy has greater toxicity and offers limited survival benefits.
BTD is designed to expedite the development of new drugs for serious diseases that have shown significant efficacy or safety over existing therapies in preliminary clinical trials. For new drugs included in the Breakthrough Therapy List, CDE will prioritize the allocation of resources for communication, enhanced guidance, and promotion of drug development. If the relevant conditions have been assessed to be met, an application for conditional approval and an application for priority review and approval may also be submitted at the time of the application for drug marketing authorization. This will help accelerate the SKB264 (MK-2870) development process and address the unmet clinical needs of Chinese patients as soon as possible.
参考文献：
[1] Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J(Engl).2022 Feb 9; 135(5):584-590.
[2] 三阴性乳腺癌含铂方案临床应用专家共识（2021版）.中华肿瘤防治杂志2021年6月第28卷第12期.
[3] 《中国临床肿瘤学会（CSCO）乳腺癌诊疗指南2023版》.
2024-03-13
Kelun Biotech and Ellipses corporate pipeline A400(EP0031) has been granted Fast...
MoreOur key product A400(EP0031), a small molecule rearranged during transfection (RET) kinase inhibitor program, has been granted Fast Track designation by the United States Food and Drug Administration (FDA) for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC).
A400 (EP0031) is a second-generation selective RET inhibitor (SRI) with broad activity against common RET fusions and mutations.
In March 2021, the Company granted Ellipses Pharma Limited, a U.K.-based international drug development company, an exclusive, royalty-bearing, sub licensable license to develop, manufacture and commercialize A400 (EP0031) in all countries excluding Greater China, North Korea, South Korea, Singapore, Malaysia and Thailand.
In June 2022, the FDA approved an investigational new drug application for A400 (EP0031), and a phase 1/2 trial is ongoing in patients with malignant tumors with RET gene alteration.
In November 2023, A400 was granted Orphan Drug Designation by the FDA for the treatment of RET fusion-positive solid tumors.
In preclinical studies, A400 (EP0031) demonstrated favourable inhibitory activity against key RET kinases in-vitro and in-vivo. A400 (EP0031) also demonstrated good penetration of the blood brain barrier in animal models. Data shared at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting on A400 (EP0031) showed promising anti-tumor efficacy in patients with advanced RET+ solid tumors, highlighted by ORR of 80.8% and 69.7% for 1L and 2L+ advanced RET+ NSCLC, respectively, based on results from its ongoing phase 1/2 trial. In both cases, DCR of over 96% were reported.
At present, the Company is conducting A400 (EP0031) pivotal clinical study in China for RET- positive NSCLC.
About Ellipses Pharma Limited
Ellipses Pharma is a global drug development company based in London, focused on accelerating the development of cancer treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection with an uninterrupted funding flow to minimise the time it takes to advance lead products through clinical trials and reach patients.
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has 33 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC, and has four ADC projects in the clinical stage (two of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.
2024-03-04
INCLUSION IN STOCK LIST OF STOCK CONNECT SOUTHBOUND TRADING LINK
Morepursuant to the Notice of Adjustment of Stock List of Southbound Trading Link of the Shanghai-Hong Kong Stock Connect ( 关于沪港通下港股通目标调整的通知) made by the Shanghai StockExchange on March 1, 2024, the Company will be included in the list of eligible shares of the Southbound Trading Link of the Shanghai-Hong Kong Stock Connect with effect from March 4, 2024.
2024-02-26
Kelun-Biotech (6990.HK) attended the FinanceAsia 2023 Annual Awards celebration ...
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On February 21, 2024, the prestigious international finance magazine, FinanceAsia, held its 2023 annual achievement awards ceremony in Hong Kong. Kelun-Biotech (6990.HK) was invited to attend the celebration dinner and was awarded the "Best IPO in Asia and Hong Kong for 2023" honor.
FinanceAsia is regarded as one of the most representative professional monthly magazine in Asia's capital market and has significant influence in the investment industry. Founded in 1996, its sponsored "FinanceAsia Achievement Awards" is one of the most influential and credible industry award selections in the Asia-Pacific region, the award ceremony is an significant annual gathering in the investment industry.
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has 33 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC, and has four ADC projects in the clinical stage (two of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.
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2023-09-14
Tapping into a new filed | The signing ceremony of the cooperation between Kelun-Biotech and the Affiliated Hospital of Southwest Medical University was successfully completed!
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On September 14, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. reached an exclusive license agreement with the Affiliated Hospital of Southwest Medical University on the bone-targeting radiolabeled drug TBM-001. Kelun-Biotech will obtain the global exclusive rights to the TBM-001 project, including worldwide research, development, production, and commercial promotion, and global sublicensing rights. Kelun-Biotech will pay the Affiliated Hospital of Southwest Medical University a total of 38.5 million yuan for the initial contract payment and development milestones, as well as royalties from foreign re-licensing and net sales after product launch.
The signing ceremony was held at Nanyuan Hotel in Luzhou City, Sichuan Province. The Deputy Mayor of Luzhou City Suping Luo, the Vice President of Southwest Medical University Minhai Nie, the Party Secretary of the Affiliated Hospital of Southwest Medical University Yong Xu, the Dean Yong Jiang, the Chairman of Kelun-Biotech Gexin Liu, and the General Manager of Kelun-Biotech Junyou Ge, etc. attended the signing ceremony.
The radionuclide-drug conjugate (RDC) drug is an emerging tumor precision diagnostic and therapeutic drug developed based on radionuclide-targeting ligand molecular coupling technology. RDC uses tumor target-specific molecules as carriers to guide radionuclides to accurately target tumors and achieve brachytherapy, which has unique advantages in early diagnosis of tumors and therapeutic evaluation.TBM-001 is an innovative RDC drug independently developed by Professor CY's team from the Department of Nuclear Medicine of the Affiliated Hospital of Southwest Medical University, and intended to be used for early diagnosis of bone tumor metastasis and precision targeted therapy. According to data from clinical researches initiated by the investigators, TBM-001 has shown effectiveness and safety superior to existing radioactive drug for bone metastasis in imaging diagnosis and treatment of late-stage prostate cancer, breast cancer, lung cancer and other bone metastases of malignant tumor, and significantly improved the quality of life of patients.
Regarding this cooperation, Gexin Liu, the chairman of Kelun-Biotech, stated that radioactive drug is an industry that require high investment with a high barrier of entry. The strong alliance between a regional leading university and high-level technology company is an important measure to break through key technologies and resource links in the industry, and an effective way to promote independent innovation and achievement transformation in the field of nuclear medicine in our country. Both parties are leaders in their respective fields. We all boasts distinct advantages in nuclear medicine discovery, clinical transformation, and conjugated drugs represented by ADC, and we all have industry-leading innovative achievements. This signing marks a new stage in the strategic cooperation between the two parties, highlighting our pragmatic development philosophy and our will and belief in working together for a win-win outcome and benefiting patients in the field of targeting radionuclide-drug conjugate.
Regarding this cooperation, Junyou Ge, the general manager of Kelun-Biotech, stated that RDC has become a new hot topic for anti-tumor drug research and development following Antibody-Drug Conjugates (ADC) at present. TBM-001 is a bone-targeting RDC with differentiated advantages. The innovative technology of Affiliated Hospital of Southwest Medical University and its philosophy are very consistent with Kelun-Biotech's strategy to strengthen the innovative advantages in the field of targeted drug conjugates, so we are pleased to cooperate with the Affiliated Hospital of Southwest Medical University. The Department of Nuclear Medicine has mature platform resources in the discovery of radioactive drugs and the clinical transformation of diagnosis and treatment. Combined with Kelun-Biotech's technical advantages in the ADC field and a complete new drug research and development system, both parties shall be benefited to jointly enter the RDC frontier field with high resource and technical barriers.
Minhai Nie, the Vice President of Southwest Medical University, stated that the Department of Nuclear Medicine has deep technical experience in clinical diagnosis, treatment, research and development of radiopharmaceuticals and clinical transformation. It possesses a Class IV "Radiopharmaceuticals Use Permit" and obtained National Drug Clinical Trial Accreditation. We look forward to our cooperation based on complementary advantages and efficient collaboration to realize the commercial value of TBM-001 as soon as possible, allowing patients with bone metastases from tumors to use more effective drugs at an earlier date.
Suping Luo, the Deputy Mayor of Luzhou City, congratulates both parties on reaching a cooperation on the TBM-001 project. She mentioned that the municipal party committee and the municipal government will fully support our cooperation, and they will provide corresponding services to support the strong alliance between Kelun-Biotech and the Affiliated Hospital of Southwest Medical University to help them grow and develop. She hopes that both parties will leverage their own advantages to achieve a perfect combination of conjugate and nuclear medicine, provide new treatment techniques to ensure the health of the people, and promote the high-quality development of the bio-nuclear medicine industry in Luzhou, Sichuan, and even the whole country.
In December 2022, the Affiliated Hospital of Southwest Medical University reached an cooperation with the "National Engineering Research Center for Bio-targeted Drugs" of Kelun-Biotech. The cooperation have started in the field of radioactive drugs. In addition to TBM-001, the Company and the Affiliated Hospital of Southwest Medical University have also initiated the co-development of other RDC drugs targeting unmet clinical needs. Kelun-Biotech will work together with partners in the industry to integrate superior resources, fully utilize the technical advantages of the OptiDC platform, and accelerate the pace in tapping into the new filed of RDC.
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About the Affiliated Hospital of Southwest Medical University
The affiliated hospital of Southwest Medical University was established in August 1950, located in Luzhou City, Sichuan Province. It is a tertiary general hospital directly under the Health Commission of Sichuan Provincial. It serves nearly 60 million people in the combined region of Sichuan, Chongqing, Yunnan, and Guizhou provinces. The hospital currently has two campuses, Zhongshan and Kangjian Center, and is a comprehensive clinical teaching hospital integrating medical treatment, teaching, and scientific research.
About the Nuclear Medicine Department of the Affiliated Hospital of Southwest Medical University
The Department of Nuclear Medicine at the Affiliated Hospital of Southwest Medical University is a top-tier nuclear medicine department in China. According to the big data analysis of SCI papers of nuclear medicine published worldwide in 2022 released by the authoritative organization Healsan Consulting LLC, the Affiliated Hospital of Southwest Medical University ranks third in the world and first in China in terms of the impact of its SCI papers of nuclear medicine.
About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) (hereinafter referred to as "Kelun-Biotech") is a holding subsidiary of Kelun Pharmaceutical. It is committed to the R&D, manufacturing, commercialization, and international cooperation of biotechnological drugs and innovative small molecule drugs. Kelun-Biotech has been committed to addressing medical needs in China and globally. With a key focus on major disease areas such as cancer, autoimmunity, inflammation, and metabolism, it aims to build an international drug R&D and industrialization platform, striving to become a leading innovative enterprise. Kelun-Biotech has made significant progress in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and innovative small molecule drugs with new targets. Kelun-Biotech has successfully established the internationally renowned ADC R&D platform OptiDC, with 4 ADCs investigated in clinical studies (2 of which are in the registration Phase III or NDA stage, respectively), and several ADCs in preclinical studies. Kelun-Biotech currently has 33 innovative projects for the treatment of major diseases such as cancer, autoimmunity, inflammation, and metabolism, including 14 in clinical stage. Several clinical trials are multi-center studies conducted simultaneously in multiple countries including China, Europe and America.
2023-09-11
The first of its kind in China! Kelun-Biotech's Cetuximab Solution for Infusion Accepted for market registration application by the National Medical Products Administration.
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On September 11, 2023, Kelun-Biotech announced that the major product A140 solution for infusion (Cetuximab Solution for Infusion, trade name: Datalai?) was recently accepted for marketing application by the Center for Drug Evaluation of the National Medical Products Administration (acceptance number: CXSS2300075).
A140 solution for infusion is the first cetuximab solution for infusion that filed an application for marketing in China. It is intended for the treatment of metastatic colorectal cancer with wild-type RAS genes: used in combination with FOLFOX or FOLFIRI regimens for first-line treatment; and in combination with irinotecan for patients who have failed treatment containing irinotecan. At the same time, it is also intended for the treatment of head and neck squamous cell carcinoma (HNSCC): used in combination with platinum and fluorouracil chemotherapy for first-line treatment of recurrent and/or metastatic diseases; and in combination with radiotherapy for the treatment of locally advanced diseases.
This product is a recombinant epidermal growth factor receptor (EGFR) human-mouse chimeric monoclonal antibody (mAb), which inhibits the growth and survival of tumor cells expressing EGFR. The A140 solution for infusion is firstly developed in China to be filed for production in accordance with the “Guidelines for Design of Clinical Trials of Injectable Cetuximab Biosimilar (for Trial Implementation)” using the original cetuximab as a reference drug. The reference drug ctuximab (trade name: Erbitux?) was approved for import into China in 2007. The approved indications in China include metastatic colorectal cancer and HNSCC. As of 2022, the global market size of cetuximab has reached 1.73 billion US dollars, and the sales in China have reached 2.253 billion yuan. Due to reasons such as drug accessibility, the clinical demand for cetuximab has not been met. A140 solution for infusion has the same amino acid sequence and mechanism of action as cetuximab, and its proposed indications are consistent with Erbitux?. The A140 solution for infusion will provide significantly increased accessibility once the Application is approved, and will bring compliant, safe, and effective treatment options to more patients.
In recent years, due to factors such as population aging and unhealthy lifestyles caused by improved living standards (such as sedentary lifestyle, high-fat and high-protein diets, etc.), the incidence of colorectal cancer in China has been on the rise. According to the epidemiological data of cancer released by the National Cancer Center of China in 2022, there were 408,000 new cases of colorectal cancer and 196,000 deaths in China. The incidence and mortality rates of colorectal cancer ranked second and fourth among all malignant tumors, respectively. Currently, cetuximab is one of the main treatment options for metastatic colorectal cancer with the primary tumor located in the left half of the colon and expressing wild-type RAS EGFR.
Head and neck squamous cell carcinoma (HNSCC) is the most common malignant tumor in the head and neck area. In 2022, there were about 78,000 new cases of HNSCC and over 40,000 deaths in China. The incidence and mortality rates of HNSCC ranks seventh and sixth among all malignant tumors in Chinese men, respectively. Since cetuximab was approved globally for first-line treatment of recurrent or metastatic HNSCC and used in combination with radiotherapy for locally advanced HNSCC, it has allowed many HNSCC patients worldwide to receive treatment plans containing cetuximab, which improved their quality of life and extended their life expectancy.
The application for registration of A140 solution for infusion is based on information from a series of studies, including pharmacologic comparative study, non-clinical comparative study, and clinical comparative study. The Phase III clinical safety and efficacy study of A140 is a randomized, double-blinded, parallel-controlled, multi-centered Phase III clinical study comparing the efficacy, safety and immunogenicity of A140 and the original cetuximab combination chemotherapy regimen (mFOLFOX6 regimen) for first-line treatment of RAS wild-type metastatic colorectal cancer.
About Kelun-Biotech
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) (hereinafter referred to as "Kelun-Biotech") is a holding subsidiary of Kelun Pharmaceutical. It is committed to the R&D, manufacturing, commercialization, and international cooperation of biotechnological drugs and innovative small molecule drugs. Kelun-Biotech has been committed to addressing medical needs in China and globally. With a key focus on major disease areas such as cancer, autoimmunity, inflammation, and metabolism, it aims to build an international drug R&D and industrialization platform, striving to become a leading innovative enterprise. Kelun-Biotech has made significant progress in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and innovative small molecule drugs with new targets. Kelun-Biotech has successfully established the internationally renowned ADC R&D platform OptiDC, with 4 ADCs investigated in clinical studies (2 of which are in the registration Phase III or NDA stage, respectively), and several ADCs in preclinical studies. Kelun-Biotech currently has 33 innovative projects for the treatment of major diseases such as cancer, autoimmunity, inflammation, and metabolism, including 14 in clinical stage. Several clinical trials are multi-center studies conducted simultaneously in multiple countries including China, Europe and America. For more information, please visit https://kelun-biotech.com/.
2023-09-07
Passionate Competition for Championship in Badminton The seventh Kelun-Biotech Badminton Match was successfully concluded.
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To enrich the leisure life of employees, improve their physical fitness, and enhance team cohesion, the labor union of Kelun-Biotech held the seventh badminton match on September 2, 2023. There were 7 participating teams, with nearly 90 employees, at this match. Regular team matches and fun games (juggling, serving, and drawing) were arranged. The participating players fought hard on the court, showcasing the charm of sports competition. The entire event was full of exciting moments.
The match was conducted under the following principle, i.e., " It’s not winning that matters, but friendship and safety". Before the competition, each team took their spare time for serious training to continuously improving their skills in order to get prepared to achieve excellent results. During the competition, they strove hard and sweat on the court. Off the court, each team communicated with one another and made progress together. Meanwhile, the members of the organizing committee and the chief referee took their responsibilities and made fair judgments. Their heart-devoted contrition ensured the smooth running of this badminton match.
Intense battles have unfolded between the teams since the beginning of the match. The players fought for every point with full vigor and vitality, and participated in the competition with full passion, high morale, and a spirit of unity. Although the team members were randomly grouped without good rapport, this does not affect their performance on the field. During the break, the team leaders timely arranged tactics and mobilized their team members to ensure that they sprint on the court in the best condition.
After intense competition, the first, second, and third places were finally determined, and the Excellent Team Award was bestowed. Each team received rewards such as sports backpacks, fascia guns, and badminton strings.
The badminton match is not just a competitive event, but also an opportunity to promote employee communication and cooperation. Through the match, employees not only exercised their bodies and improved their technical skills, but also enhanced friendship and cooperation between departments. Meanwhile, this match fully demonstrates the spirit of our employees who unite as one to make positive and striving efforts, and further highlights the cultural charm of "health, happiness, and confidence" in the company.
2023-09-06
Kelun-Biotech Appears at the 2023 CIFTIS Selected for the Ten-Year Achievement Exhibition and as Demonstration Case for Science & Technology Innovation Service .
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From September 2 to 6, 2023, the 2023 China International Fair for Trade in Services (abbreviated as "CIFTIS"), with the annual theme of "Opening up Leads to Development, Cooperation Delivers the Future", was held in Beijing. Only two companies from Sichuan Province were selected, one of which was Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (abbreviated as " Kelun-Biotech "). Kelun-Biotech was successfully selected for the 2023 CIFTIS Ten-Year Achievement Exhibition and as "Demonstration Case for Science & Technology Innovation Service".
This year's CIFTIS has set up a special area for the China Service Trade Achievement Exhibition, presenting the achievements of China's service trade development over the past 10 years. The Sichuan Comprehensive Exhibition Hall covers an area of 100 square meters. Its main thread of display is Chengdu, the innovative demonstration city, and the seven national service export bases. Based on a concentrated display of high-quality physical objects, it showcases the innovative development achievements and characteristic highlights of Sichuan's service trade.
(Kelun-Biotech's large molecular model displayed at the ten-year achievement exhibition of CIFTIS)
Kelun-Biotech reached a cooperation with the international pharmaceutical giant Merck, with upfront and milestone payments totaling up to 11.8 billion US dollars, thereby setting a new record for the amount of foreign authorization transactions for innovative drugs in China. Therefore, it was successfully included in the ten-year achievement exhibition for its historic breakthrough from a basically "importer of services" to "exporter of services".
Kelun-Biotech's "OptiDC" innovative Antibody Drug Conjugate (ADC) platform is one of the only two service demonstration cases selected in Sichuan. Kelun-Biotech's "OptiDC" innovative Antibody Drug Conjugate (ADC) platform has developed a complete ADC core component library, which can design the best combination and make effective optimization according to the biological characteristics of the target, thereby proposing the optimal ADC to meet the medical needs in various indications. With its strong R&D strength and the synergistic effect of multi-platform technology, Kelun-Biotech has become a technology exporter among the world's top biopharmaceutical companies, thus opening a new paradigm of service trade.
2023-08-28
Kelun-Biotech Announces Interim Results for 2023
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Kelun-Biotech Announces Interim Results for 2023:
Global Strategic Partnership and Rich Pipeline Boost Significant Revenue Growth in the First Half of the Year
Chengdu, China, August 28, 2023 – Today, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, HKEX: 6990.HK), an innovative biopharmaceutical company focusing on the R&D, manufacturing, commercialization, and international cooperation of biotechnology drugs and innovative small molecule drugs, announced its interim results for the six months ended June 30, 2023.
The announcement shows that Kelun-Biotech’s revenue for the first half of 2023 amounts to approximately RMB 1,046 million, an increase of 203.3% compared to the same period last year. The increase is mainly attributable to the receipt of the non-refundable upfront payment of USD175.0 million from Merck Sharp & Dohme LLC (together with its affiliates, “MSD”) in March 2023 pursuant to the license and collaboration agreement we entered into with MSD to develop up to seven preclinical ADC (antibody drug conjugate) assets for the treatment of cancer. Thanks to the revenue from license and collaboration agreements, and provision of research and development service, Loss for the period are RMB 31.13 million ，the loss for the period has significantly narrowed by 88.5% year-on-year.
R&D and commercialization work together to contribute to the long-term value accumulation
Kelun-Biotech’s core product, SKB264, was granted a Breakthrough Therapy Designation (BTD) in January, 2023 by the National Medical Products Administration (NMPA) for EGFR-TKI failed EGFR-mutant locally advanced or metastatic NSCLC and another BTD in June for locally advanced or metastatic hormone receptor positive (HR)+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) which has previously received at least 2L systemic chemotherapy. In addition, the clinical development of SKB264 made significant progress in the first half of 2023: In June, the company released the data of phase II study of SKB264 in patients with locally advanced or metastatic NSCLC at the 2023 ASCO Annual Meeting, demonstrating promising efficacy and controlled safety of SKB264; In July, achieved first-patient-in for a pivotal phase III trial of SKB264 for EGFR-mutant locally advanced or metastatic non-squamous NSCLC (TKI failure) in China; In August, the phase III clinical trial of SKB264 in patients with unresectable locally advanced, recurrent or metastatic triple negative breast cancer (TNBC) who have failed second-line or above prior standard of care met the primary endpoint.
In May 2023, Kelun-Biotech submitted an NDA to the NMPA for another core product, A166 (HER2 ADC), targeting 3L+ advanced HER2+ BC. The company is also conducting a confirmatory phase III trial in China for 2L+ advanced HER2+ BC and multiple phase Ib clinical trials in China to explore the therapeutic potential of A166 for other advanced HER2+ solid tumors, including gastric cancer and colorectal cancer.
In addition, Kelun-Biotech is making significant progress with other key products. SKB315 (Claudin 18.2 ADC) is undergoing the phase Ia clinical trial in China for patients with advanced solid tumors; The phase Ia clinical trials of SKB410 for advanced solid tumors, which also received IND approval from the NMPA, successfully enrolled the first patient in July 2023; We have completed patient enrollment of the phase III trial of A167 in combination with chemotherapy as a 1L treatment for RM-NPC; We have completed patient enrollment of the phase III trial of A167 in combination with chemotherapy as a 1L treatment for RM-NPC; We have completed patient enrolment of A140 (Cetuximab biosimilar) in November 2022 with an anticipated NDA filing with NMPA for RAS wild-type mCRC in the second half of 2023. In July, the company commenced pivotal trial of A400 (RET inhibitor) for advanced RET+ NSCLC, a trial of A400 for advanced RET+ medullary thyroid carcinoma received IND approval from the NMPA.
Considering the research and development progress of its drug pipelines, Kelun-Biotech is setting up a fully-fledged commercialization team to prepare and implement the marketing and commercialization of its strategic products. Currently, Kelun-Biotech has established a department structure within the company, consisting of various departments such as Marketing, Access and Commerce, Medical Affairs, Sales, and Strategic Planning and Commercial Excellence.
Stable global strategic partnership, Kelun-Biotech has achieved a significant revenue growth
In January 2023, MSD subscribed for the Shares in Kelun-Biotech at a consideration of
approximately USD 1 million as part of the Series B Financing. In March, the receipt of the non-refundable upfront payment of USD 175.0 million from Merck Sharp & Dohme LLC (together with its affiliates, “MSD”) in March 2023 pursuant to the license and collaboration agreement we entered into with MSD to develop up to seven preclinical ADC (antibody drug conjugate) assets for the treatment of cancer. In the first half year of 2023, we had various exchanges and visits with MSD management, and we made concerted efforts to promote the progress of the project and continued to deepen the results of strategic cooperation. Currently, clinical-stage products such as SKB264, SKB315, A410 as well as other preclinical-stage products developed in collaboration with MSD are being advanced and developed in an orderly manner as planned.
Kelun-Biotech entered into a collaboration and license agreement with Ellipses, under which it granted Ellipses an exclusive, royalty-bearing, sublicensable license to develop, manufacture and commercialize A400 in all countries excluding Greater China, North Korea, South Korea, Singapore, Malaysia and Thailand. Kelun-Biotech has received certain milestone payments from Ellipses during the Reporting Period. A clinical trial application of A400 was approved by the Spanish Agency of Medicines and Medical Devices (AEMPS) in February 2023. As of July 26, 2023, seven and four clinical research centers in the United States and Europe, respectively, were in use for A400.
Strong capital operation promotes innovation strategy
In February, 2023, Kelun-Biotech completed Series B Financing and raised over USD 200 million.
In July, 2023, Kelun-Biotech was successfully listed on the Main Board of the Stock Exchange. The net proceeds arising from the Listing and the full exercise of the Over-Allotment Option amounted to approximately HK$1454.9 million.
Dr. Ge Junyou, Ｅxecutive Director and General Manager of Kelun-Biotech, commented: “The significant revenue growth in the first half of 2023 is a strong testament to Kelun-Biotech’s continuous efforts to advance its clinical value-oriented and differentiated oncology and non-oncology pipeline, enhance its drug development capabilities, continue to seek strategic partners, and optimize its operation system, among other correct strategic tactics. Looking ahead to the second half of the year, Kelun-Biotech will further advance the research and development progress of various pipelines, refine the commercialization strategies for each late-stage drug candidate, and continue to pursue a flexible strategy to capture the commercial value in major international markets, through forging synergistic license and collaboration opportunities worldwide.”
About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”) is a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, which focuses on the R&D, manufacturing, commercialization, and international cooperation of biotechnology drugs and innovative small molecule drugs. The company focuses on serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease. Building an international drug R&D and industrialization platform to address the unmet clinical needs of the world and China, the Company is committed to becoming an international leading enterprise in the field of innovation. Significant progress has been made in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and sought-after technologies for innovative small molecule drugs. OptiDC, an internationally renowned ADC research and development platform, has been successfully constructed by Kelun-Biotech, and 4 ADCs are in clinical trials (including two in registrational Phase III or NDA filing stage), along with multiple projects in preclinical development. At present, the company has 33 innovative projects for the treatment of serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, and 14 programs are advancing in clinical studies, including multiple global multicenter clinical trials which are being conducted simultaneously in several countries and regions including China, Europe, and the United States. To learn more, please visit https://kelun-biotech.com/.
Forward-Looking Statements
This press release contains certain forward-looking statements. These statements are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used in this press release, the words “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “going forward,” “intend,” “may,” “might,” “ought to,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “will,” “would” and the negative forms of these words and other similar expressions are intended to identify forward-looking statements. Such statements reflect the current views of our management with respect to future events, operations, liquidity and capital resources, some of which may not materialize or may change.
It is advised not to place any undue reliance on any forward-looking statements contained herein. The Company can give no assurance that these forward-looking statements will prove to have been correct. Expectations reflected in these forward-looking statements are subject to change and the Company undertakes no obligation to update or revise any forward-looking statements herein.
2023-08-14
Kelun-Biotech announces that a Phase III clinical trial of SKB264 (MK-2870, TROP2-ADC) in unresectable locally advanced, recurrent or metastatic TNBC has met its primary endpoint
Chengdu, China, August 14, 2023 - Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. ("Kelun-Biotech", HKEX: 6990.HK) announced today that its innovative TROP2-AD...
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Chengdu, China, August 14, 2023 - Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. ("Kelun-Biotech", HKEX: 6990.HK) announced today that its innovative TROP2-ADC (SKB264, also known as MK-2870) met the primary endpoint in the randomized, controlled, open-label, multi-center Phase III clinical trial of SKB264 for injection versus investigator selected regimens in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC) who have failed second-line or above prior standard of care.
Kelun-Biotech recently held an Independent Data Monitoring Committee (IDMC) meeting to review the interim analysis data of the Phase III clinical trial of SKB264. The IDMC resolution indicated that the trial met the primary endpoint of progression-free survival (PFS) as assessed by the Independent Review Committee (IRC), and at a pre-specified interim analysis, SKB264 demonstrated a statistically significant improvement in PFS, compared with the control group receiving standardized chemotherapy. Based on the results from the interim analysis, Kelun-Biotech plans to communicate with the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) of China regarding the submission of a new drug application (NDA) of SKB264.
Dr. Ge Junyou, Ｅxecutive Director and General Manager of Kelun-Biotech, commented, "TNBC is one of the most aggressive and prevalent subtypes of breast cancer (BC) with huge unmet medical needs. Patients with TNBC who have received second-line or later treatment have an overall survival of 5.2 to 8.4 months [1]. SKB264 has been granted breakthrough therapy designation (BTD) for the treatment of locally advanced or metastatic TNBC. For drugs included in the list of BTD, the CDE will prioritize resource allocation for communication and guidance to facilitate drug development. This will help accelerate the development and commercialization of SKB264 to provide high-quality treatment options for patients with advanced TNBC."
SKB264 is one of the core products with independent intellectual property rights of Kelun-Biotech, and will be supported by an extensive development plan. This clinical trial, which met its primary endpoint, is the first registrational Phase III study of SKB264 (MK-2870) in China. In addition, Kelun-Biotech is also advancing a Phase II trial of SKB264 with or without KL-A167 (Kelun’s anti-PD-L1 monoclonal antibody) as a first-line treatment for advanced TNBC, and another randomized, open-label, multicenter Phase III clinical study of SKB264 versus investigator’s choice regimens in patients with unresectable locally advanced, recurrent or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who had failed at least one line of chemotherapy is expect to be launched in the second half of 2023.
About SKB264 (MK-2870)
SKB264 is an innovative TROP2-directed ADC which was developed by OptiDC, a well-known international ADC R&D platform of Kelun-Biotech, using a proprietary payload-linker strategy (Kthiol design strategy) that achieves an optimized balance of ADC safety and efficacy by combining novel irreversible antibody conjugation chemistry, pH-sensitive payload release mechanisms, and site-specific moderately potent toxin molecules with a DAR of 7.4 (novel topoisomerase I inhibitors) [2].
SKB264 has received 3 Breakthrough Therapy Designations (BTDs) from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC), locally advanced or metastatic EGFR-mutated non-small cell lung cancer which has failed EGFR-TKI therapy and locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer which has received at least second-line systemic therapy.
SKB264 is currently conducting Phase II and Phase III clinical trials of monotherapy/combination in multiple solid tumors. In China, the Phase III registrational clinical study of SKB264 monotherapy for patients with advanced or metastatic TNBC who have failed at least second-line therapy is progressing smoothly, and SKB264 is expected to become the first domestic TROP2-ADC approved for the Chinese market. Phase III clinical studies of SKB264 monotherapy in patients with TKI-resistant and EGFR-mutated non-small cell lung cancer (NSCLC) are also rapidly advancing. Several Phase II clinical studies of SKB264 in combination with pembrolizumab (KEYTRUDA?, MSD’s anti-PD-1 therapy) or KL-A167 (Kelun’s anti-PD-L1 monoclonal antibody) are ongoing. Kelun-Biotech has licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize SKB264 in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).
About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”) is a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, which focuses on the R&D, manufacturing, commercialization, and international cooperation of biotechnology drugs and innovative small molecule drugs. The company focuses on serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease. Building an international drug R&D and industrialization platform to address the unmet clinical needs of the world and China, the Company is committed to becoming an international leading enterprise in the field of innovation. Significant progress has been made in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and sought-after technologies for innovative small molecule drugs. OptiDC, an internationally renowned ADC research and development platform, has been successfully constructed by Kelun-Biotech, and 4 ADCs are in clinical trials (including two in registrational Phase III or NDA filing stage), along with multiple projects in preclinical development. At present, the company has 33 innovative projects for the treatment of serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, and 14 programs are advancing in clinical studies, including multiple global multicenter clinical trials which are being conducted simultaneously in several countries and regions including China, Europe, and the United States. To learn more, please visit https://kelun-biotech.com/.
References:
[1] O'Shaughnessy, Joyce, et al. Assessment of sacituzumab govitecan (SG) versus treatment of physician’s choice (TPC) cohort by agent in the phase 3 ASCENT study of patients (pts) with metastatic triple-negative breast cancer (mTNBC). (2021): 1077-1077.
[2] Cheng Yezhe, et al. Preclinical profiles of SKB264, a novel anti-TROP2 antibody conjugated to topoisomerase inhibitor, demonstrated promising antitumor efficacy compared to IMMU-132. Frontiers in Oncology, Vol 12, 2022
Forward-Looking Statements
This press release contains certain forward-looking statements. These statements are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used in this press release, the words “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “going forward,” “intend,” “may,” “might,” “ought to,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “will,” “would” and the negative forms of these words and other similar expressions are intended to identify forward-looking statements. Such statements reflect the current views of our management with respect to future events, operations, liquidity and capital resources, some of which may not materialize or may change.
It is advised not to place any undue reliance on any forward-looking statements contained herein. The Company can give no assurance that these forward-looking statements will prove to have been correct. Expectations reflected in these forward-looking statements are subject to change and the Company undertakes no obligation to update or revise any forward-looking statements herein.
2023-08-01
Selected for oral presentation! Kelun-Biotech to announce latest clinical study results of SKB264 (MK-2870, TROP2-ADC) for treatment of HR+/HER2- breast cancer at ESMO Congress 2023
Chengdu, China, August 1, 2023 - Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990.HK) announced that it will present the data from...
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Chengdu, China, August 1, 2023 - Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990.HK) announced that it will present the data from a Phase I/II clinical trial of the innovative TROP2-ADC (SKB264, MK-2870) jointly developed by Kelun-Biotech and MSD (the tradename of Merck & Co., Inc Rahway NJ USA) at the European Society for Medical Oncology (ESMO) Congress 2023 to be held in Madrid, Spain from October 20 to 24, 2023. The data will be presented in the form of an oral presentation and will focus on the treatment of previously-treated patients with metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In June of this year, SKB264 was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic HR+/HER2- breast cancer which has received at least second-line systemic therapy.
The abstract of this oral presentation is titled "SKB264 (MK-2870) in previously treated hormone receptor-positive (HR+)/ HER2-negative metastatic breast cancer (mBC): results from a phase I/II, single-arm, basket trial", and the presentation number is 380MO. Details of the abstract are expected to be released on the official website of the ESMO Congress on October 16, 2023, local time.
The ESMO Congress is the most prestigious and influential oncology conference in Europe. It brings together clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all around the world each year. By sharing the latest cutting-edge data, it provides unparalleled networking opportunities and high quality education for oncologists and other stakeholders.
About SKB264 (MK-2870)
SKB264 is an innovative ADC targeting TROP2 which was developed by OptiDC, a well-known international ADC R&D platform of Kelun-Biotech, using a proprietary payload-linker strategy (Kthiol design strategy) that achieves an optimized balance of ADC safety and efficacy by combining novel irreversible antibody conjugation chemistry, pH-sensitive payload release mechanisms, and site-specific moderately potent toxin molecules with DAR of 7.4 (novel topoisomerase I inhibitors) [1].
SKB264 has received 3 Breakthrough Therapy Designations (BTDs) from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic triple-negative breast cancer, locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have failed EGFR-TKI therapy and the treatment of locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer which has received at least second-line systemic therapy.
SKB264 is currently conducting Phase II and Phase III clinical trials of monotherapy/combination in multiple solid tumors. In China, the Phase III registrational clinical study of SKB264 monotherapy for patients with advanced or metastatic triple-negative breast cancer (TNBC) who have failed at least second-line therapy is progressing smoothly, and it is expected to become the first domestic TROP2-ADC approved for the Chinese market. Phase III clinical studies of SKB264 monotherapy in patients with TKI-resistant and EGFR-mutated non-small cell lung cancer (NSCLC) are also rapidly advancing. Several Phase II clinical studies of SKB264 in combination with pembrolizumab (KEYTRUDA?, MSD’s anti-PD-1 therapy) or KL-A167 (Kelun’s anti-PD-L1 monoclonal antibody) are ongoing. Kelun-Biotech has licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to research, develop, produce and commercialize SKB264 in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).
About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”) is a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, which focuses on the R&D, manufacture, commercialization and international cooperation of biotechnology drugs and innovative small molecule drugs. The company focuses on serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease. Building an international drug R&D and industrialization platform to address the unmet clinical needs of the world and China, the Company is committed to becoming an international leading enterprise in the field of innovation. Significant progress has been made in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and sought-after technologies for innovative small molecule drugs. OptiDC, an internationally renowned ADC research and development platform, has been successfully constructed by Kelun-Biotech, and 4 ADCs are in clinical trials (including two in registrational Phase III or NDA filing stage), along with multiple projects in preclinical development. At present, the company has 33 innovative projects for the treatment of serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, and 14 programs are advancing in clinical studies, including multiple global multicenter clinical trials which are being conducted simultaneously in several countries and regions including China, Europe, and the United States. To learn more, visit
References:
[1] Cheng Yezhe, et al. Preclinical profiles of SKB264, a novel anti-TROP2 antibody conjugated to topoisomerase inhibitor, demonstrated promising antitumor efficacy compared to IMMU-132. Frontiers in Oncology, Vol 12, 2022
Forward-Looking Statements
This press release contains certain forward-looking statements. These statements are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used in this press release, the words “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “going forward,” “intend,” “may,” “might,” “ought to,” “plan,” “potential,” “predict,” “project,”“seek,” “should,” “will,” “would” and the negative of these words and other similar expressions are intended to identify forward-looking statements. Such statements reflect the current views of our management with respect to future events, operations, liquidity and capital resources, some of which may not materialize or may change.
You are cautioned not to place any undue reliance on any forward-looking statements contained herein. The Company can give no assurance that these forward-looking statements will prove to have been correct. Expectations reflected in these forward-looking statements are subject to change and the Company undertakes no obligation to update or revise any forward-looking statements herein.
2023-07-11
Kelun-Biotech successfully listed on the main board of HKEX
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”) announced its official listing on the main board of Hong Kong Exchanges and Clearing Limit...
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Hong Kong, China, July 11, 2023 - Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”) announced its official listing on the main board of Hong Kong Exchanges and Clearing Limited (HKEX), with the stock code: 6990.HK. Shares started trading at 60.60 Hong Kong dollars (“HKD”) in the morning. By midday close, Kelun-Biotech’s share price went up by 3.80%, with a total market value of HKD13.58 billion.
As the largest Initial Public Offering (IPO) in the medical and health sector of the Hong Kong stock market in the past two years and one of the most popular investment projects in the medical and health sector recently, Kelun-Biotech’s listing on HKEX has attracted high attention and great interest from both local and international investors.
As a global unicorn enterprise, Kelun-Biotech has established a strategic partnership with Merck Sharp & Dohme LLC (together with its affiliates, “MSD”), one of the top ten multinational pharmaceutical companies in the world, and has entered into nine out-license agreements with MSD to develop up to nine ADC assets with upfront and milestone payments totaling up to USD11.8 billion. In addition, Kelun-Biotech has also received support from blue chip healthcare investors such as IDG Capital, CMG-SDIC Capital, Lilly Asia Ventures, Hillhouse, Cinda, and Sherpa, and has introduced five cornerstone investors including RTW Funds, Laurion Capital Ｍaster Fund, TruMed, CUAM, and Kelun International in this IPO.
Mr. Liu Gexin, Chairman of the Board of Kelun-Biotech said: “As the core subsidiary carrying the innovation mission of Kelun Pharmaceutical, Kelun-Biotech’s successful entry into the international capital market today marks a significant stage victory for Kelun Pharmaceutical’s ‘innovation-driven’ development strategy. With this listing as an opportunity, Kelun-Biotech will continuously improve its corporate governance structure and undertake corporate social responsibilities; accelerate the clinical research of indication-oriented anti-tumor drugs, and expand differentiated non-oncology drug portfolio; focus on key areas, and build more competitive platforms and pipelines. Leveraging Kelun Pharmaceutical’s decades-long experience in the domestic market, and the continuously deepening strategic cooperation with MSD, we will promote the development and commercialization process of planned projects, and strive to become an innovation-oriented pharmaceutical company with a global vision and industry competitiveness, to reward investors and society with excellent performance!"
Since its incorporation in 2016, Kelun-Biotech has been dedicated to the R&D, manufacturing and commercialization of novel drugs in oncology, immunology and other therapeutic areas. Kelun-Biotech is one of the first movers in the development of antibody drug conjugates (ADCs), with over a decade of accumulated experience in ADC development and is one of the first biopharmaceutical companies in China, and one of the few globally, to establish an in-house developed ADC platform, OptiDC. Relying on the platform, Kelun-Biotech has built a strong asset portfolio with 33 highly differentiated and clinically valuable pipelines centered around two ADCs, SKB264 and A166. Among the pipelines, 14 are in clinical stage, five in pivotal trial- or NDA registration-stage, nine in phase 1-or phase 2-stage.
With the Gong ringing and stock market opening at 9:30, the shares of Kelun-Biotech began to trade officially, and received a warm market response. Looking forward, Dr. Ge Junyou, Ｅxecutive Director and General Manager of Kelun-Biotech said: "We will continue to advance and enhance our drug R&D capabilities. In addition to optimizing our R&D platforms and developing novel technologies to support the R&D of innovative drugs, we will strengthen the development of clinical-stage drugs in partnership with strategic partners such as MSD, in the fields of rapid indication expansion, monotherapy and combination therapy, late- and early-line. Furthermore, we will continue to expand cGMP manufacturing and quality control facilities, enhance commercialization system and capabilities, and promote the marketing of more excellent innovative drugs, to bring better treatment options for patients in China and around the world."
About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”) is a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, which focuses on the R&D, manufacture, commercialization and international cooperation of biotechnology drugs and innovative small molecule drugs. The company focuses on serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease. Building an international drug R&D and industrialization platform to address the unmet clinical needs of the world and China, the Company is committed to becoming an international leading enterprise in the field of innovation. Significant progress has been made in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and sought-after technologies for innovative small molecule drugs. OptiDC, an internationally renowned ADC research and development platform, has been successfully constructed by Kelun-Biotech, and 4 ADCs are in clinical trials (including two in registrational Phase III or NDA filing stage), along with multiple projects in preclinical development. At present, the company has 33 innovative projects for the treatment of serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, and 14 programs are advancing in clinical studies, including multiple global multicenter clinical trials which are being conducted simultaneously in several countries and regions including China, Europe, and the United States. To learn more, visit http://kelun-biotech.com/.