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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2024-05-24
ASCO 2024| Two Abstracts of the Study Results of Kelun-Biotech’s TROP2-ADC SKB2...
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(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/.
2024-01-11
CEO of Kelun-Biotech Dr. Micheal Ge delivered a presentation on The 42nd JPM Ann...
MoreThe 42nd J.P. Morgan Annual Healthcare Conference（“JPMHC”）2024 is taking place on January 8-11 at San Fracisco, USA, members of Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK, Kelun-Biotech) senior management team participated in the conference. Dr. Micheal Ge, CEO of Kelun-Biotech, delivered a presentation about innovation strength and business progress of Kelun-Biotech.
Presentation Title: Dedicated to human health with a caring heart
Presentation Time: Pacific Standard Time (PST) Tuesday 8:00 AM, January 9, 2024
As one of the pioneers in the antibody-drug conjugates (ADC) development company, Kelun-Biotech has established world leading ADC platform “OptiDC?”, as well as a rich and differentiated ADC R&D pipeline covers unmet clinical needs in the field of oncology. Our core product Trops-ADC and Her2 ADC are expected to be approved for NDA in China this year. Meanwhile, Kelun-Biotech is accelerating the development progress of over 10 clinical and pre-clinical ADC and ADC-derivative products. With the support of the Kelun Group, Kelun-Biotech has built mature R&D, manufacturing and quality control system, the company is now building a commercialization team to form the marketing system. Kelun-Biotech’s innovation capability has gained high recognition from global partners, including MSD, and the capital market. Kelun-Biotech is rapidly developing a unique growth curve as an ADC R&D pharmaceutical enterprise.
Dr.Michael Ge said: “It’s our pleasure to meet again with global industry leaders, innovative technology creators and members of the investment community here at JPMHC. Our top priority is to rapidly advance our differentiated pipeline programs into and through the clinic for disease conditions with significant medical needs. We will continue to innovate and optimize our ADC platform, discover novel payloads, linkers, engineer novel ADC designs, and expand clinical application of antibody drug conjugates to non-oncology disease areas. Build upon our end-to-end drug development capabilities, infrastructure, and commercialization readiness. Furthermore, we plan to extend our global footprints through strategic partnerships and maximize our pipeline and portfolio value. We look forward to achieving and updating you on the 2024 milestones in the coming year”.
Presentation Slides is available on the investor relations page of Kelun-Biotech website at: 投资者关系 - 四川科伦博泰生物医药股份有限公司 (kelun-biotech.com)
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/.
2023-12-11
First TROP2-ADC in China! CDE Accepted the New Drug Application for SKB264 (MK-2...
MoreSichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, 6990.HK) announced that the new drug application (the “NDA”) for SKB264 (MK-2870, Brand name: 佳泰莱) in adult patients with unrespectable locally advanced, 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) was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). SKB264 (MK-2870) is expected to be the first domestic TROP2-ADC to be approved for marketing in China. This SKB264 New Drug Application is based on a multi-center, randomized, controlled phase 3 clinical study of SKB264 (MK-2870) monotherapy for second line or above locally advanced or metastatic
SKB264 new drug application has been included in the priority review and approval process by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). For drugs that included in the priority review, CDE will prioritize the review and verification procedures to effectively shorten the approval timeframe for launching clinical-valuable new drugs to the market. The Company plans to publish the Phase III clinical trial data at the Academic Conference 2024 and promote the early launch of SKB264, to enrich the clinical treatments for patients with second-line and above TNBC.
Breast cancer is the number one malignant tumor that seriously threatens women's health all over the world, and its incidence is increasing year by year. TNBC is a subtype of breast cancer with specific molecular expression characteristics, invasive behavior and metastatic patterns, and has a poorer prognosis than other subtypes of breast cancer, with higher rates of local recurrence and distant metastasis, and the 5-year survival rate is only 13% for advanced TNBC patients (National Cancer Institute 2022). Due to the lack of therapeutic targets such as endocrine and HER2, TNBC is insensitive to both hormonal and targeted therapies, and the current treatment is still based on chemotherapeutic agents. For patients with second-line and above TNBC, the progression-free survival of current clinically available chemotherapy regimens is less than 3 months, and overall survival is about 5-8 months (Kazmi et al. 2020, O'Shaughnessy et al. 2021), and there is a large and urgent unmet clinical need for more effective therapeutic agents
On December 2023, Kelun-Biotech updated efficacy and safety results from a phase II expansion cohort in patients with previously treated metastatic TNBC for SKB264 (MK-2870) have been presented at the 46th San Antonio Breast Cancer Symposium (SABCS). (SABCS 2023 news link here)
About SKB264 (MK-2870)
SKB264 is a representative innovative ADC targeting TROP2, developed by Kelun-Biotech 's internationally renowned ADC research and development platform—OptiDC. It consists of a humanized anti-TROP2 monoclonal antibody with high affinity and targeting, combined with the self-developed small toxin molecule T030 (a topoisomerase I inhibitor) through a stability-optimized CL2A linker. The drug-to-antibody ratio (DAR) averages as high as 7.4. The stability of SKB264 has been enhanced in two main ways, allowing more ADC to effectively reach tumor cells. Firstly, the antibody end of the linker uses a sulfonamide pyrimidine connector, which allows for irreversible coupling with the antibody. Secondly, T030 contains a methyl sulfone structure, which can securely bind with the toxin end of the linker. The linker of SKB264 is affected by both extracellular pH-sensitive cleavage and intracellular enzymatic cleavage within tumor cells, which leads to efficient release of the small toxin molecule to exert its anti-tumor effects. T030 activity is similar to that of DXd and also shows a “bystander effect”. In summary, SKB264 exerts its anti-tumor effect in three ways. Firstly, the pH-sensitive linker can cleave and release T030 in the acidic tumor microenvironment. Secondly, after being engulfed by tumor cells, SKB264 releases T030 via enzymatic cleavage. Thirdly, T030 can also penetrate the cell membrane to exert a "bystander effect" to kill surrounding tumor cells. With a high-affinity monoclonal antibody, highly active toxin molecule, good stability, and high DAR value, the overall design of SKB264 contributes to its robust anti-tumor activity which has been preliminarily demonstrated in clinical studies to date.
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 SKB264 (MK-2870) in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).
SKB264 has received 3 BTDs from the CDE of China’s NMPA for the treatment of locally advanced or metastatic 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.
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 Phase III or NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.
References:
1. National Cancer Institute (2022) Cancer Stat Facts: Female Breast Cancer Subtypes.
2.[Kazmi S, Chatterjee D, Raju D, et al. (2020)] Overall survival analysis in patients with metastatic breast cancer and liver or lung metastases treated with eribulin, gemcitabine, or capecitabine. Breast Cancer Research and Treatment; 184(2):559-565.
3.[O'Shaughnessy J, Punie K, Oliveira M, et al. (2021)] 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. https://meetinglibrary.asco.org/record/198258/abstract
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.
2023-11-27
Kelun-Biotech announced that A400/EP0031 has been granted Orphan Drug Designatio...
MoreKelun-Biotech announces that KL590586 (EP0031) (small molecule RET kinase inhibitor, also named A400) program, licensed to global ex-China partner Ellipses Pharma, has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) for the treatment of RET fusion-positive solid tumors.
Orphan drugs are drugs used for the prevention, treatment and diagnosis of rare diseases. The FDA grants ODD for investigational treatments for rare diseases, such as RET fusion-positive solid tumours, defined as affecting fewer than 200,000 people in the United States. The designation is an important milestone in the development of innovative drugs, it is expected to accelerate the progress of clinical trials in the United States. ODD qualifies the developer for certain incentives with the goal of accelerating drug development for patients, including tax credits and seven years of market exclusivity in the US upon approval by the FDA.
A400 (EP0031) is a next generation selective RET inhibitor (SRI) with broad activity against common RET fusions and mutations. Therefore, A400 (EP0031) may overcome resistance mechanisms to first generation SRIs. 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. At present, Kelun-Biotech is conducting A400 (EP0031) pivotal clinical study in China for RET-positive non-small cell lung cancer.
In March 2021, Kelun-Biotech granted Ellipses an exclusive license for A400 (EP0031) in certain territories including the US and Europe, with Kelun-Biotech retaining certain rights in Greater China and parts of the Asia-Pacific region such as Korea, Singapore, Malaysia.
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.
About RET altered malignancies
RET fusions and mutations are present in a wide range of tumors, including non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancer, as well as colorectal cancer, so targeting RET gene changes is promising as a treatment for all types of cancer. However, for patients with RET gene alteration, the effect of traditional chemotherapy and immunotherapy is limited, especially for patients with drug resistance after first-generation SRI treatment, the acceptable treatment options are limited, and the prognosis is poor, and there are still unmet clinical needs.
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 establishing an globalized drug development and industrialization platform for the unmet medical needs in China and worldwide. The Company is committed to becoming an leading global enterprise in the field of innovation drugs.
At the 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 multiple global trials conducted simultaneously in several regions including China, Europe, and the United States. The company has established one of the world’s leading in-house developed ADC platform, OptiDC, and has four ADC projects in the clinical stage (two of which are in the phase III or NDA stage, respectively) and several projects in the preclinical stage.
For more information, please visit https://kelun-biotech.com/.
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. For more information, please visit www.ellipses.life
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2025-10-11
Third Indication for Kelun-Biotech’s TROP2 ADC Sac-TMT Approved for Marketing by NMPA in EGFRm NSCLC Following Progression on EGFR-TKI Therapy
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CHENGDU, China, October, 11, 2025—Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) announced that the Company’s trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) was approved for marketing by the National Medical Products Administration (NMPA) for its third indication, the treatment of adult patients with epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed after treatment with EGFR-tyrosine kinase inhibitor (TKI) therapy.
Sac-TMT is the first and only ADC globally to show an overall survival (OS) benefit compared with platinum doublet chemotherapy and be approved for advanced NSCLC that has progressed after only TKI therapy (second line). Currently sac-TMT monotherapy is the only regimen approved for advanced EGFR-mutant NSCLC following progression on TKI therapy or TKI therapy and platinum-based chemotherapy (used sequentially or in combination)—achieving comprehensive coverage across the TKI-resistant population.
In a pre-specified interim analysis of OS, compared with the current standard of care of platinum-based doublet chemotherapy, sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and OS, and significantly extends survival outcomes for these patients. More importantly, it remains the only monotherapy regimen not based on platinum-based doublet chemotherapy approved for NSCLC following progression after TKI therapy.
The approval is based on a randomized, open-label, multi-center Phase III study (OptiTROP-Lung04) which has been selected as a late-breaking abstract (LBA) at the 2025 European Society for Medical Oncology (ESMO) Congress and will be presented as an oral report in the Presidential Symposium session (Presentation # LBA5). The OptiTROP-Lung04 study evaluates the efficacy and safety profile of sac-TMT monotherapy at 5mg/kg every other week (Q2W) as an intravenous injection versus pemetrexed plus platinum chemotherapy for the treatment of patients with EGFR-mutant locally advanced or metastatic non-squamous NSCLC who have failed after treatment with EGFR-TKI therapy. This is the first Phase III trial globally in a Chinese population demonstrating significant OS improvement with an ADC compared to platinum-based doublet chemotherapy in EGFR-mutant NSCLC following TKI-resistance. Sac-TMT demonstrated statistically significant and clinically meaningful improvement in both OS and PFS.
In March 2025, sac-TMT was approved for EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Compared with current standard of care of docetaxel, sac-TMT monotherapy significantly extends the PFS and OS for these patients. Additionally, the patient enrollment for a Phase III registrational study in China of sac-TMT combined with osimertinib as first-line treatment of locally advanced or metastatic non-squamous EGFR-mutant NSCLC has been completed.
Dr. Michael Ge, CEO of Kelun-Biotech said, “We are delighted to announce the approval of the third indication for our core product, sac-TMT, marking another major milestone in lung cancer treatment. EGFR mutations are the most common oncogenic driver in lung cancer, accounting for approximately 40–50% of non-squamous NSCLC cases in China. Third-generation EGFR-TKIs are the standard first-line therapy for these patients, yet resistance inevitably develops, leaving few effective treatment options. The approval of this new indication highlights sac-TMT’s broad coverage across TKI-treated NSCLC, offering a more precise and effective treatment with a proven survival benefit for a larger patient population. Looking ahead, we are advancing the clinical development of sac-TMT in combination with osimertinib for first-line EGFR-mutant NSCLC.”
About NSCLC
Lung cancer is the leading malignant tumor in China. According to statistics from the National Cancer Center, approximately 1.06 million1 new lung cancer cases are diagnosed annually in the country. Pathological classification of lung cancer primarily includes non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with NSCLC being the most common pathological type, accounting for about 80–85% of all lung cancer patients. According to the 2025 Chinese Society of Clinical Oncology (CSCO) Guidelines for Diagnosis and Treatment of Non-Small Cell Lung Cancer and the Chinese Medical Association Guidelines for Clinical Diagnosis and Treatment of Lung Cancer (2025 Edition), EGFR-TKI therapy is the first-line treatment for advanced NSCLC with EGFR mutations2,3. Following resistance to EGFR-TKIs, platinum-based doublet chemotherapy remains the primary standard treatment regimen. Current treatment options demonstrate suboptimal efficacy, particularly in extending overall survival, leaving significant unmet clinical needs where there’s urgent requirement for new drugs to improve patient survival outcomes.
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 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab4 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 3 projects have been approved for marketing, 2 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, 1 ADC project in NDA stage and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
References:
[1]. Analysis of the Epidemiology of Malignant Tumors in China in 2022 [J]. Chinese Journal of Oncology, 2024, 46(3):221-231.
[2]. Chinese Society of Clinical Oncology (CSCO) (2025). Diagnosis and Treatment Guidelines for Non-Small Cell Lung Cancer.
[3]. Chinese Medical Association Clinical Diagnosis and Treatment Guidelines for Lung Cancer (2025 Edition) [J]. Chinese Journal of Cancer, 2025, 47(9): 769-810.
[4]. Pembrolizumab (KEYTRUDA®) is a registered trademark of Merck Sharp & Dohme LLC (MSD), a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
2025-09-28
Kelun-Biotech to Present Results from Multiple Clinical Studies at the 2025 ESMO Congress
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CHENGDU, China, Sept. 23, 2025 /PRNewswire/ -- The 2025 European Society for Medical Oncology (ESMO) Congress will take place in Berlin, Germany, from October 17 to 21. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990) will present results from multiple clinical studies at the congress, including data from its TROP2 ADC sacituzumab tirumotecan (sac-TMT), HER2 ADC A166 (trastuzumab botidotin), and CLDN18.2 ADC SKB315. Among these, two Phase III clinical studies of sac-TMT were selected for the Latest Breakthrough Abstracts (LBA) and presented as oral reports, including one featured in the Presidential Symposium; one Phase III clinical study of A166 was selected for LBA and presented as oral report.
Abstract titles of these studies have been published on the official website of ESMO. The study results to be presented include:
Title: Sacituzumab tirumotecan (sac-TMT) vs platinum-based chemotherapy in EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) following progression on EGFR-TKIs: results from the randomized, multi-center phase 3 OptiTROP-Lung04 study
Presentation Type: Presidential Symposium
Presentation #: LBA5
Date and Lecture Time: October 19, 4：52 PM to 5:04 PM local time
Title: Sacituzumab tirumotecan (sac-TMT) vs investigator's choice of chemotherapy (ICC) in previously treated locally advanced or metastatic hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer (BC): results from the randomized, multi-center phase 3 OptiTROP-Breast02 study
Presentation Type: Proffered Paper
presentation #: LBA23
Date and Lecture Time: October 18, 10:45 AM to 10:55 AM local time
Title: Trastuzumab botidotin vs trastuzumab emtansine (T-DM1) in HER2-positive unresectable or metastatic breast cancer: results from a randomized phase 3 study
Presentation Type: Proffered Paper
presentation #: LBA24
Date and Lecture Time: October 18, 10:55 AM to 11:05AM local time
Title: SKB315, a novel Claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC), in patients (pts) with advanced solid tumors including gastric/ gastroesophageal junction cancer (GC/GEJC): a phase 1 study
Presentation Type: Poster
Presentation #: 2139P
Date and Session Time: October 19, 9:00 AM to 5:00 PM local time
Title: Sacituzumab tirumotecan (sac-TMT) in Participants (pts) with Previously Treated, Advanced KRAS-Mutant NSCLC: Results from Cohort 5d of the SKB264-II-08 Study
Presentation Type: Poster
Presentation #: 1945P
Date and Session Time: October 18, 9:00 AM to 5:00 PM local time
Title: Sacituzumab tirumotecan (sac-TMT) + pembrolizumab[1] (pembro) for treatment-naïve advanced PD-L1 positive NSCLC: results from the Phase 2 MK-2870-003/SKB264-II-04 study
Presentation Type: Poster
Presentation #: 1949P
Date and Session Time: October 18, 9:00 AM to 5:00 PM local time
Title: Sacituzumab tirumotecan (sac-TMT) + Pembrolizumab in Metastatic Castration-Resistant Prostate Cancer (mCRPC): Results from Phase 2 MK-2870-002/SKB264-II-06 Study
Presentation Type: Poster
Presentation #: 2421P
Date and Session Time: October 18, 9:00 AM to 5:00 PM local time
Title: Sacituzumab tirumotecan (Sac-TMT) Monotherapy in Advanced/Metastatic Endometrial Carcinoma (EC): Results from a Phase 1/2 Study (MK-2870-001/KL264-01)
Presentation Type: Poster
Presentation #: 1111P
Date and Session Time: October 18, 9:00 AM to 5:00 PM local time
Title: Efficacy and Safety of sacituzumab tirumotecan (Sac-TMT) Monotherapy in Advanced/Metastatic Cervical Cancer: Results from a Phase 1/2 Study (MK-2870-001/KL264-01)
Presentation Type: Poster
Presentation #: 1168P
Date and Session Time: October 18, 9:00 AM to 5:00 PM local time
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, 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, 2 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. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and 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 were accepted by the Center for Drug Evaluation of NMPA, and were included in the priority review and approval process. As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 14 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 Trastuzumab Botidotin (A166)
Trastuzumab botidotin is a differentiated HER2 ADC in new drug application (NDA) registration stage to treat advanced HER2+ solid tumors. As an innovative HER2 ADC developed by the Company, it conjugates a novel, 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 randomized, controlled, open-label Phase III study, the New Drug Application (NDA) for trastuzumab botidotin was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in January 2025 for the treatment of adult patients with HER2+ unresectable or metastatic BC who have received at least one prior anti-HER2 therapy was accepted by the CDE of the NMPA. At a pre-specified interim analysis, trastuzumab botidotin monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by the Blinded Independent Central Review (BICR) compared with T-DM1.
Currently, Kelun-Biotech has initiated an open, multi-center Phase II clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase inhibitor ADC.
About SKB315
SKB315 is a novel CLDN18.2 ADC targeting advanced solid tumors configured with a proprietary, in-house developed humanized CLDN18.2 mAb and a differentiated payload-linker design. Currently, Kelun-Biotech has initiated the exploration in combination with immunotherapy for gastric/gastroesophageal junction cancer (GC/GEJC) while advancing monotherapy studies for tumors expressing CLDN18.2, such as GC/GEJC and pancreatic cancer.
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 3 projects have been approved for marketing, 2 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,1 ADC project in NDA stage and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
[1] Pembrolizumab (KEYTRUDA®) is a registered trademark of Merck Sharp & Dohme LLC (MSD), a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. |
2025-09-28
Kelun-Biotech's New Drug Application for Its Novel Next-generation Selective RET Inhibitor A400/EP0031 Accepted for Review by the NMPA for the Treatment of RET-fusion positive NSCLC
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CHENGDU, China, Sept. 23, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that a new drug application (NDA) for the Company's small molecule rearranged during transfection (RET) kinase inhibitor A400 (also known as EP0031) was accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of adult patients with RET-fusion positive locally advanced, or metastatic non-small cell lung cancer (NSCLC). This acceptance for review is based on the positive results from the two pivotal Phase 2 cohorts of the KL400-I/II-01 study for both 1L and 2L+ advanced RET-fusion positive NSCLC.
Cohort 1 and 2, the Phase 2 stage of the KL400-I/II-01 study, evaluate the efficacy and safety of A400/EP0031 90mg orally once daily (QD) for the treatment of patients with pre-treated and treatment-naïve RET-fusion positive locally advanced, or metastatic NSCLC, respectively. Primary efficacy endpoints of the two pivotal cohorts were reached, where A400/EP0031 demonstrated favorable efficacy in pretreated and treatment-naïve NSCLC including patients with prior immunotherapy or brain metastases. A400/EP0031 also demonstrated an encouraging, manageable tolerability and safety profile.
Dr. Michael Ge, CEO of Kelun-Biotech said, "We are pleased to report positive results from the clinical study of A400/EP0031 in treating RET-fusion positive NSCLC, which gives us confidence in its future clinical potential. As a tumor agnostic precision therapy, A400/EP0031 represents our significant strategic positioning in the solid tumor field. We look forward to working closely with regulatory authorities to expedite the review process for A400/EP0031, bringing this innovative therapy to patients with RET-fusion positive NSCLC as soon as possible."
About RET-fusion positive NSCLC
RET gene fusions represent one of the rare yet significant driver mutation types in NSCLC. In Chinese NSCLC patients, the incidence of RET gene fusions ranges from 1.4% to 2.5%[1]. Patients with RET fusions derive limited benefit from conventional treatments. In recent years, the emergence of novel highly selective inhibitors has led to breakthroughs in the clinical management of advanced RET-fusion positive NSCLC patients. However, their therapeutic benefits are limited, in part, by acquired RET drug-resistant mutations and safety issues such as hypertension and hematological toxicity, underscoring the need for novel selective RET inhibitors with improved safety and better efficacy against drug-resistant mutations.
About A400/EP0031
A400/EP0031 is a novel next-generation selective RET inhibitor for NSCLC, medullary thyroid cancer (MTC) and other solid tumors with a high prevalence of RET alterations. The Company is currently conducting a phase 1b/2 clinical study for RET+ MTC and solid tumor in China. The results from the Phase 1 study of A400/EP0031 in patients with advanced RET-mutant MTC were presented at the 2025 ASCO Annual Meeting.
In March 2021, the Company granted Ellipses Pharma Limited, a U.K.-based international oncology drug development company, an exclusive license to develop, manufacture and commercialize this agent outside Greater China and certain Asian countries under the code EP0031.
In March 2024, it was announced that EP0031/A400 was granted Fast Track designation by the Food and Drug Administration (FDA) for the treatment of RET-fusion positive NSCLC. In April 2024, EP0031/A400 was cleared by the FDA to progress into Phase 2 clinical development and is now open in the United States, United Kingdom, Europe and United Arab Emirates.
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 3 projects have been approved for marketing, 2 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, 1 ADC project in NDA stage and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/
Reference: |
[1].Chinese Anti-Cancer Association Professional Committee of Cancer Pathology Molecular Pathology Collaborative Group, et al. Chinese Journal of Pathology, 2021, 50(6): 583-591. |
2025-08-19
Nature Medicine Publishes Results of Phase II Study of Sacituzumab Tirumotecan Plus Tagitanlimab as First-Line Therapy for NSCLC
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990) announced that clinical data from a Phase II study evaluating novel TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) in combination with PD-L1 monoclonal antibody (mAb) tagitanlimab for the first-line treatment of advanced or metastatic non-small cell lung cancer (NSCLC) have been published in Nature Medicine (Impact Factor: 58.7).
The publication highlighted initial findings from the Phase II OptiTROP-Lung01 study, evaluating the efficacy and safety results of sac-TMT in combination with tagitanlimab as a first-line treatment of advanced or metastatic NSCLC patients without actionable genomic alterations. The study was led by Prof. Zhang Li's team at the Center for Cancer Prevention and Control, Sun Yat-sen University, China. Patients in Cohort 1A received sac-TMT (5 mg/kg, Q3W) plus tagitanlimab (1200 mg, Q3W) in a three-week cycle, while patients in Cohort 1B were treated with sac-TMT (5 mg/kg, Q2W) plus tagitanlimab (900 mg, Q2W) in a four-week cycle. Patients received sac-TMT in combination with tagitanlimab in a non-randomized manner until disease progression or unacceptable toxicity. Median follow-ups for Cohort 1A and Cohort 1B were 19.3 months and 13.0 months, respectively (Data cutoff date: May 27, 2024).
The study results demonstrated promising anti-tumor activity, and manageable safety of sac-TMT in combination with tagitanlimab as a first-line treatment for advanced or metastatic NSCLC patients. A total of 40 patients in Cohort 1A and 63 patients in Cohort 1B were included in the full analysis set (FAS) for efficacy assessment. In Cohort 1A and Cohort 1B, respectively, the confirmed objective response rates (ORRs) were 40.0% (95% CI: 24.9–56.7) and 66.7% (95% CI: 53.7–78.0), and the ORRs were:
44.4% and 64.7% among patients with non-squamous carcinoma, 36.4% and 69.0% with squamous carcinoma;
41.7% and 57.1% among patients with PD-L1 tumor proportion score (TPS) <1%;
38.5% and 63.2% for TPS 1–49%;
40.0% and 78.3% for TPS ≥50%.
The median progression-free survival (mPFS) for Cohort 1A was 15.4 months (95% CI: 6.7–17.9) and not reached (95% CI: 9.6–NE) for Cohort 1B.
The most common grade ≥3 treatment-related adverse events (TRAEs) for both Cohorts 1A and 1B were decreased neutrophil count, decreased white blood cell count and anemia. No treatment-related deaths were observed.
Subgroup analyses showed consistent efficacy across PD-L1 and TROP2 expression levels, as well as in both squamous and non-squamous histological subtypes.
Dr. Michael Ge, CEO of Kelun-Biotech, commented: "The OptiTROP-Lung01 study supports the promising efficacy and safety of sacituzumab tirumotecan in combination with tagitanlimab as a first-line treatment for patients with advanced NSCLC. The results were observed across PD-L1/TROP2 expression levels and histological subtypes and support the advancement potential of sac-TMT from later-line to front-line therapy. The publication of results from several studies in top-tier international journals reflects the recognition of our innovation-driven development strategy. We will continue to work to address critical clinical challenges and unmet medical needs, striving to deliver more therapeutic options and improve quality of life for patients."
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 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, Macao, and Taiwan).
To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the CDE, and were included in the priority review and approval process. As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 14 ongoing Phase III global clinical studies of sac-TMT as a monotherapy or with pembrolizumab[1] or other agents for several types of cancer. These studies are sponsored and led by MSD.
About Tagitanlimab
Tagitanlimab is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC. Previously, the NMPA has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively.
[1] Pembrolizumab (KEYTRUDA®) is a registered trademark of Merck Sharp & Dohme LLC (MSD), a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. |
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 3 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 platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
2025-05-22
Fourth NDA for Kelun-Biotech’s TROP2 ADC sacituzumab tirumotecan (sac-TMT) Accepted by the Center for Drug Evaluation
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CHENGDU, China, May , 22, 2025—Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) announced that a new indication application (the “Application”) for the Company’s trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870)(佳泰莱®) was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of adult patients with unresectable locally advanced, metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting. This acceptance is based on the positive results from the registrational phase 3 OptiTROP-Breast02 study, and the Application is the fourth indication application for sac-TMT that has been accepted by the NMPA.
OptiTROP-Breast02 is a randomized, open-label, multi-center, Phase 3 clinical study that evaluates the efficacy and safety results of sac-TMT monotherapy 5mg/kg every other week (Q2W) versus chemotherapy treatment of physician’s choice for the treatment of patients with unresectable locally advanced or metastatic HR+/HER2- (Immunohistochemistry [IHC] 0, IHC 1+ or IHC 2+/ In Situ Hybridization [ISH]-) BC. Primary efficacy endpoint of this Phase 3 clinical study was reached according to a pre-specified interim analysis, where sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by the blinded independent review committee (BIRC) compared with chemotherapy treatment of physician’s choice and the risk of disease progression or death was significantly reduced. Sac-TMT also demonstrated the beneficial trend for overall survival (OS).
On May 16, 2024, the CDE’s official website announced that the Application would be reviewed via the priority review and approval process. This marks the fourth sac-TMT indication to go through the CDE’s priority review and approval process, with three previous sat-TMT indications approved following priority review.
Dr. Michael Ge, CEO of Kelun-Biotech said, “We are very pleased that the NDA application for the fourth indication of our core product, sac-TMT, has been accepted by the CDE of NMPA, which is another breakthrough for the breast cancer treatment field. This not only verifies the clinical value and innovative nature of sac-TMT, but also highlights the ‘patient-centered’ mission of Kelun-Biotech. We look forward to the OS results of sac-TMT with longer follow-up. In the future, we will continue to explore sac-TMT as an oncology therapeutic agent, aiming to address new indications with unmet clinical needs, so as to benefit more oncology patients globally.”
About HR+/HER2-BC
Breast cancer is one of the most common malignant tumors that seriously threaten women's health worldwide. In 2022, there were about 2,297,000 new cases of breast cancer and 666,000 deaths worldwide [1]. Among them, HR+/HER2- breast cancer is the most common subtype, accounting for about 70% of all breast cancer cases, and advanced HR+/HER2- breast cancer has a poor prognosis [2]. Patients with this subtype of breast cancer are often hormone-sensitive, so the preferred treatment option is endocrine therapy combined with CDK4/6 inhibitors. Rescue chemotherapy is preferred for patients with advanced HR+/HER2- breast cancer with visceral metastases who require rapid disease remission, who are previously resistant to endocrine therapy, or who do not have optimal endocrine therapy options. There is currently no standard treatment option for second- and third-line HR+/HER2-advanced breast cancer patients who have failed first-line chemotherapy. In summary, there is an unmet clinical need for patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have received prior endocrine therapy and have received other systemic therapies in the advanced or metastatic stages.
About sac-TMT (佳泰莱®)
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 non-small cell lung cancer (NSCLC), 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 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, Macao, and Taiwan).
To date, two 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) and epidermal growth factor receptor (EGFR) mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-tyrosine kinase inhibitor (TKI) therapy and platinum-based chemotherapy. Sac-TMT became the first domestically developed and fully approved for marketing ADC in China with global intellectual property rights . It is also the world's first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, the new indication application for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy was accepted by the NMPA, and was included in the priority review and approval process. As of today, the Company has initiated 8 registrational clinical studies in China. MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other 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 3 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 platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
Media: klbio_pr@kelun.com
Reference
[1] Globalcan 2022: China.
[2] [Wang Y et al (2024)] Current status of treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. Journal of Clinical Surgery; 32(7):780-782.
2025-02-13
Study Results Abstracts From Kelun-Biotech’s TROP2 ADC Sacituzumab Tirumotecan (sac-TMT) At 2025 ASCO Genitourinary Cancers Symposium
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At the American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium 2025, to be held in San Francisco, USA, from Feb. 13-15, 2025, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd （“Kelun-Biotech”） will present efficacy and safety results from the Phase 1/2 KL264-01/MK-2870-001 study (NCT04152499) of its anti-TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB-264/MK-2870) as monotherapy in patients with unresectable, locally advanced or metastatic urothelial carcinoma (UC) who progressed on or after prior anti-cancer therapies. These findings will be presented in a poster session on February 14, 2025, local time (Abstract #796).
The abstract for the above study was also published on the official website of the ASCO GU Cancers Symposium 2025 on February 10, 2025, local time.
UC
Eligible participants had histologically/cytologically confirmed locally advanced or metastatic UC, had experienced progression of disease on ≥1 prior line of platinum-based therapy and had received prior anti-PD-(L)1 therapy; platinum-ineligible patients were eligible if they received prior anti-PD-(L)1 therapy (prior neoadjuvant/adjuvant therapy counted as a line of therapy if patients progressed within 12 months). Patients had Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1 and measurable disease by CT/MRI. Patients received sac-TMT 5 mg/kg every two weeks (Q2W) until progression of disease, unacceptable toxicity or withdrawal of consent.
As of data cutoff on June 30, 2024, 49 treated patients had a minimum follow-up of ≥9 weeks. Eleven patients received sac-TMT as 2L treatment; 38 received sac-TMT as 3L+ treatment. Median age was 62 and 61 years old, respectively; most patients were Asian (82%; 100%). Median (range) follow-up was 9.5 (7.5-16.2) months and 11.7 (7.8-17.4) months, respectively. Among all patients, objective response rate (ORR) was 31%. Efficacy data are shown below:
Outcome | UC 2L sac-TMT 5 mg/kg (n=11) | UC 3L+ sac-TMT 5 mg/kg (n=38) |
Confirmed ORRa n (%) | 5 (45) | 10 (26) |
95% CI | 16.7-76.6 | 13.4-43.1 |
CR n (%) | 1 (9) | 0 |
PR n (%) | 4 (36) | 10 (26) |
SD n (%) | 3 (27) | 17 (45) |
PD n (%) | 2 (18) | 10 (26) |
Not evaluable n (%) | 1 (9) | 1 (3) |
Median DoRb, months (range) | NE (3.5+ to 13.9+) | NE (2.1 to 15.0+) |
Median PFSb, months (95% CI) | 5.8 (1.7-NE) | 5.0 (3.5-7.4) |
Median OSb, months (95% CI) | NE (2.0-NE) | 11.5 (8.9-NE) |
CI=Confidence interval, CR=Complete response, PR=Partial response, SD=Stable disease, PD=Progression of disease, DoR=Duration of response, PFS=Progression-free survival, OS=Overall survival, NE=Not evaluable.
“+” No progressive disease or death as of last disease assessment.
a Includes all patients as-treated.
b Kaplan-Meier method for censored data.
By safety data cutoff (May 21, 2024), grade ≥3 treatment-related adverse events (TRAEs) occurred in 59% of patients. The most common Grade 3-4 TRAEs were anemia (39%), neutrophil count decreased (29%), white blood cells count decreased (16%), stomatitis (12%), and platelet count decreased (8%), which were generally reversible with dose modifications and/or supportive care. No Grade 5 TRAEs occurred; TRAEs led to sac-TMT discontinuation in one patient.
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 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.
Previously, the National Medical Products Administration (NMPA) has approved the marketing of sac-TMT in China for 2L+ advanced triple negative breast cancer (TNBC), and accepted two supplemental new drug applications (sNDA) seeking the approvals of sac-TMT monotherapy for 2L/3L EGFR-mutant non-small cell lung cancer (NSCLC).
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).
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 3 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 platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
2025-01-21
Kelun-Biotech’s Product Tagitanlimab Approved for Marketing in Second Indication in Combination with Cisplatin and Gemcitabine For the First-line Treatment of Patients with recurrent or metastatic NPC
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Jan. 21 2025
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) announced that the Company received marketing authorization in China from National Medical Products Administration (NMPA) for the programmed cell death ligand 1(PD-L1)-directed innovative humanized monoclonal antibody (“mAb”) tagitanlimab (formerly KL-A167) used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC).
The approval is based on a randomized, double-blinded, placebo controlled, multi-center, phase III clinical study evaluates the efficacy and safety results of tagitanlimab in combination with cisplatin and gemcitabine versus placebo in combination with cisplatin and gemcitabine for the treatment of recurrent or metastatic NPC, which was led by Professor Shi Yuankai of the Cancer Hospital Chinese Academy of Medical Sciences as the principal investigator.
According to the study results, tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment for recurrent or metastatic NPC could have better progression-free survival (PFS), higher objective response rate (ORR) and extended duration of response (DoR) compared with chemotherapy, where all the patients could benefit regardless of the PD-L1 expression. The median PFS for tagitanlimab in combination with chemotherapy is not reached compared to 7.9 months for placebo in combination with chemotherapy (HR=0.47, 95% CI: 0.33-0.66, p<0.0001), and the risk of disease progression and death is reduced by 53%; ORR is 81.7% vs 74.5%; median DoR is 11.7 vs 5.8 months(HR=0.48, 95% CI: 0.32-0.70), which has nearly doubled compared to placebo arm; currently the median overall survival (OS) is still not mature, however the beneficial trend for OS of tagitanlimab in combination with chemotherapy has already been observed (HR=0.62, 95％CI: 0.32-1.22), and its risk of death is reduced by 38%[1]. Tagitanlimab also showed a manageable safety profile.
This is the second indication approved for tagitanlimab. Previously, NMPA has approved the marketing in China of tagitanlimab monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy.
Dr. Micheal Ge, CEO of Kelun-Biotech said, “We are pleased that the second indication of our self-developed PD-L1 monoclonal antibody was successfully approved for marketing and demonstrated statistically significant and clinically meaningful improvements in PFS. For domestic NPC patients, Tagitanlimab has realized a breakthrough in therapeutic coverage and innovation from the backline to the frontline, which once again strongly validates the excellent strength of Kelun-Biotech's new drug research and development. In the future, the company will always be based on unmet clinical needs, source innovation, and explore more and more excellent clinical therapeutic solutions to benefit more 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 more than 30 ongoing key innovative drug projects, of which 2 projects have been approved for marketing, 2 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 platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
2025-01-21
Kelun-Biotech’s Novel ADC Drug SKB445 Receives NMPA Approval For the treatment of advanced solid tumors
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Jan. 21, 2025.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) announced that the Company has received a clinical trial notice approving the investigational new drug application for the innovative drug SKB445 developed by the Company from the Center for Drug Evaluation of the National Medical Products Administration.
SKB445 is a novel ADC drug with proprietary intellectual property rights developed by the Company based on the biological characteristics of the target and using the technology of the OptiDCTM platform, which has demonstrated promising efficacy and safety window in preclinical studies and is intended to be used for the treatment of advanced solid tumors.
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 2 projects have been approved for marketing, 2 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 platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.