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The 43rd J.P. Morgan Annual Healthcare Conference (“JPMHC”) 2025 will take place January 13-16 in San Fracisco, USA, local time. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech” or “The Company”, 6990.HK) was invited to the conference. Dr. Michael Ge, President and CEO of Kelun-Biotech, will deliver a presentation on updated business progresses and development plan of Kelun-Biotech.

Presentation Time: Pacific Time (PT) Thursday 9:30 AM, January 16, 2025

Presentation Location: San Fracisco, USA (Westin St. Francis)

JPMHC is honored as the “benchmark for the development and investment of global healthcare area”. This conference would attract more than 400 healthcare companies and 3,000 industrial investors globally for discussion of the new trends and development directions of the healthcare industry. During this JPMHC, Kelun-biotech would work together with those massive senior experts and talents of healthcare area, by focusing on the cutting-edge industrial topics, to discuss the future development and collaboration opportunities of healthcare industry.

You can visit Investor Relations page of Kelun-Biotech’s official website for participation of live webcast of presentation session, and watch replay within 30 days after the conference

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/.

Jan. 10. 2025

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) announced that the Company and HBM Holdings Limited  (“Harbour BioMed”) (together with the Company, the “Licensors”), have entered into an exclusive license agreement (the “License Agreement”) with Windward Bio AG (“Windward Bio”) for SKB378/HBM9378[1], an anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody (mAb) jointly developed by the Licensors.

Subject to the terms and conditions of the License Agreement, Windward Bio is granted an exclusive license for the research, development, manufacturing and commercialization of SKB378/HBM9378 globally (excluding Greater China and several Southeast and West Asian countries). In return, the Licensors are eligible to receive a total of up to US$970 million upfront and milestone payments as well as single to double-digit tiered royalties on net sales of SKB378/HBM9378. The US$45 million upfront and near-term payments include both cash consideration and equity in the parent company of Windward Bio. Subject to the terms and conditions of the License Agreement, the Licensors are also eligible to receive additional payment from Windward Bio if Windward Bio undergoes a near-term change of control or enters into a sublicense agreement with a third party. The payments to be made by Windward Bio to the Licensors under the License Agreement shall be paid in equal amounts to the Company and Harbour BioMed.

Windward Bio is a clinical-stage, drug development company committed to improving outcomes for people living with advanced immunological conditions with an initial focus on severe respiratory conditions. It is led by a highly experienced team of biopharmaceutical Ｅxecutives with deep discovery, development, and commercialization expertise, and is advancing a potential best-in-class TSLP monoclonal antibody into phase 2 development and creating novel, long-acting bispecific programs for immunological diseases. Collectively, they have contributed to more than 15 product launches and Ｅxecuted two Nasdaq IPOs and two sales.

In connection with the License Agreement, Windward Bio announced a US$200 million Series A financing round led by OrbiMed, Novo Holdings and Blue Owl Healthcare Opportunities with the co-investment of SR One, Omega Funds, RTW Investments, Qiming Venture Partners, Quan Capital, and Pivotal bioVenture Partners. 

Dr. Micheal Ge, CEO of Kelun-Biotech said, “We are pleased to have entered into a partnership with Windward Bio for the SKB378/HBM9378, one of our pioneering pipelines in immunology area, which is not only a proof of its potential market value globally, but also a practice of our active exploration of global cooperation. SKB378/HBM9378 is our first immunology product candidate out licensed with a NewCo model. In the future, we will continue to expand our global presence and strategic partnerships to maximize the value of our pipelines.”

ABOUT SKB378/HBM9378

SKB378/HBM9378 is a co-development project jointly conducted by the Company and Harbour BioMed, with both parties equally sharing global rights. SKB378/HBM9378 is a novel, recombinant fully human monoclonal antibody (mAb) that potently binds to the TSLP ligand and inhibits the TSLP mediated signaling pathway by blocking the interaction between TSLP and TSLP receptor. This is a well-validated cytokine that plays a key role in the development and progression of a wide array of immunological conditions, including asthma and COPD where inhibition has demonstrated benefit in a wide array of inflammatory phenotypes. SKB378/HBM9378 has been engineered to achieve an extended half-life and effector silencing and is subcutaneously administered.

In November 2024, an IND application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) was submitted for SKB378/HBM9378 for the treatment of chronic obstructive pulmonary disease (COPD). The Company has also completed phase 1 clinical trial in healthy subjects in China under IND approval from the NMPA for the treatment of moderate-to-severe asthma.

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 visithttps://kelun-biotech.com/.

Dec. 31. Chengdu

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) has received marketing authorization in China from National Medical Products Administration (NMPA) for the programmed cell death ligand1(PD-L1)-directed innovative humanized monoclonal antibody (“mAb”) tagitanlimab (formerly KL-A167) (科泰莱®) for the treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC) who have failed after prior 2L+ chemotherapy. This is the world's first PD-L1 monoclonal antibody approved for the treatment of NPC.

The approval is based on a single-arm, multi-center, phase II clinical study in patients with recurrent or metastatic NPC who have failed after prior 2L+ systematic therapies, led by Professor Shi Yuankai of the Cancer Hospital Chinese Academy of Medical Sciences as the principal investigator, to evaluate the efficacy and safety profile of tagitanlimab monotherapy. As of the data cutoff date, the median follow-up time was 21.7 months, 132 patients entered full analysis set (FAS) totally, the independent review committee (IRC)-assessed objective recovery rate (ORR) was 26.5%, the duration of recovery (DoR) was 12.4 months and the median overall survival (OS) was 16.2 months. Meanwhile, tagitanlimab showed a manageable safety profile, where the incidence of grade 3 immune-related adverse event (irAEs) was 3.9% and no grade 3 above irAE was observed. Data from these clinical studies have been published in The Lancet Regional Health-Western Pacific^[1].

Dr. Micheal Ge, CEO of Kelun-Biotech said, “It is a great pleasure to share with you the significant moment of the successful approval of tagitanlimab for the domestic market, which is yet another proof of Kelun-Biotech's excellence in the field of innovative drug discovery and development. The excellent efficacy and safety results achieved by tagitanlimab mark a significant progress and breakthrough in our exploration of the frontiers of medical science and technology. At the same time, we are also actively advancing our multi-strategy clinical development blueprint, aiming to deeply explore the potential of tagitanlimab in combination with ADC assets as an early-line treatment and maximize the clinical value of our oncology pipeline, with a view to reaching a wider group of patients and providing highly effective and safe therapeutic options for Chinese patients”

About NPC

The 2022 GLOBOCAN data showed that there were more than 120,000 new cases of nasopharyngeal cancer globally^[2], 51,000 new cases of nasopharyngeal cancer and 28,400 deaths in China ^[3]. According to the 2021 CSCO guidelines, the 1L treatment regimen for non-locally treatable recurrent or metastatic nasopharyngeal cancer is based on platinum-containing combination chemotherapy, and the 2L treatment is based on monotherapy. The 5-year survival rate of patients with recurrent or metastatic nasopharyngeal cancer is 18.5%, with a median OS of 22.1 months^[4], and there is still an unmet clinical need to improve the clinical benefit of this group of patients, especially those who develop metastases after treatment. In recent years, immunotherapy has provided more therapeutic options for tumor patients and has become an effective way to treat patients with nasopharyngeal carcinoma.

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/.

Reference

[1]. Shi, Yuankai, et al. Lancet Reg Health West Pac. 2022 0ct 10:31:100617.

[2]. GLOBOCAN (2022).WHO, Global Cancer Observatory.

[3]. Journal of the National Cancer Center 4(2024)47-53.
[4].Hong S, Huang Y, Yang Y, et al. (2020)] GEM20110714: Final overall survival results of the phase III study of firstline gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma.

On Dec.4, the innovative drug SKB500 developed by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) received a clinical trial notice approving the investigational new drug application from the Center for Drug Evaluation of the National Medical Products Administration (NMPA).

SKB500 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 OptiDC^TM 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 1 project has been approved for marketing, 3 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/.

Nov.27, Chengdu

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 first domestically developed trophoblast cell-surface antigen 2 (TROP2)-directed antibody–drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) (佳泰莱®) for 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). This is the first domestically developed TROP2 ADC approved for marketing in China and the first domestically developed ADC fully approved for marketing in China.

The approval is based on the positive results from a randomized, controlled, phase 3 OptiTROP-Breast01 study in 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). Sac-TMT demonstrated statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) compared to chemotherapy. The results were presented at the special clinical science symposium for next-generation ADCs at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in May 2024.

Previously, NMPA has accepted two supplemental new drug applications (sNDA) seeking the approvals of sac-TMT monotherapy for the treatment of patients with locally advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC) following progression on EGFR-TKI therapy only, or both EGFR-TKI and platinum-based chemotherapy, respectively.

Dr. Micheal Ge, CEO of Kelun-Biotech said, “It is a great pleasure to share with you the important milestone moment of the successful approval and launch of sacituzumab tirumotecan (佳泰莱®) in China, which is a significant achievement of Kelun-Biotech's years of deep-rooted source innovation. As the company's first proprietary TROP2 ADC innovative drug, the successful launch of sacituzumab tirumotecan officially opens up a new pattern for the treatment of patients with 2L+ advanced TNBC. We expect that its excellent clinical efficacy and safety results will significantly enhance the clinical benefits and improve the quality of life of patients with advanced TNBC. In the future, we will continue to explore the clinical value of sacituzumab tirumotecan in other indications, maximize the market potential of sacituzumab tirumotecan, and satisfy the clinical needs of patients nationwide.”

ABOUT MARKET VALUE

Breast cancer is a threat to women's lives and health. Among them, triple-negative breast cancer has unique biological behavioral characteristics, and is also known as the “most toxic” breast cancer. 2022 analysis of China's malignant tumor epidemiology data shows that there are 357,000 new cases of breast cancer and 75,000 deaths in Chinese women annually ^[1]. In the absence of effective therapeutic targets for triple-negative breast cancer, chemotherapy is the most important systemic treatment in the clinic ^[2], but it often has poor efficacy and high toxicity and side effects, and the prognosis is different from other subtypes of breast cancer ^[3], it is vital to explore more therapeutic means to improve the clinical benefit.

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 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).

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 1 project has been approved for marketing, 3 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/.

Reference

[1].Han, Bingfeng, et al. "Cancer incidence and mortality in China, 2022." Journal of the National Cancer Center 4.1 (2024): 47-53.  

[2]. [Chinese Society of Clinical Oncology (CSCO) (2024)] Guidelines for the diagnosis and treatment of breast cancer.

[3]. https://seer.cancer.gov/statfacts/html/breast-subtypes.html .

Oct. 31 2024, the new drug application (NDA) (the “Application”) based on the positive results from the pivotal phase III OptiTROP-Lung04 study of sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) which developed by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China in adult patients with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) who progressed after treatment with EGFR-tyrosine kinase inhibitor (TKI) therapy.

OptiTROP-Lung04 is a multi-center, randomized, registrational phase III clinical study that evaluates the efficacy and safety results of sac-TMT monotherapy versus pemetrexed plus platinum chemotherapy for the treatment of patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR- TKI therapy. At a pre-specified interim analysis, 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 pemetrexed plus platinum chemotherapy. Sac-TMT also showed a manageable safety profile, with no unexpected safety signals identified.

The Application is the third NDA for sac-TMT that has been accepted by the NMPA. On October 25, 2024, it was announced on the official website of the CDE that the Application was planned to be included in the priority review and approval process of the CDE.

Previously, two NDAs for sac-TMT in patients with 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 for sac-TMT monotherapy in adult patients with locally advanced or metastatic EGFR-mutant NSCLC who experience progression following treatment with an EGFR-TKI and platinum-based chemotherapy, respectively, were accepted by the NMPA.

Sac-TMT, a core product of the Company, is a novel human trophoblast cell-surface antigen 2 (TROP2) antibody-drug conjugate (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).

Dr. Micheal Ge, CEO of Kelun-Biotech, said, “sac-TMT (sacituzumab govitecan) has received its third NDA. In response to unmet clinical needs, the company has always adhered to the spirit of hard work inherent in Kelun, focusing on original innovation and doing practical work to develop new drugs with differentiated advantages and international potential. We believe that sac-TMT will shine in the field of oncology and contribute Chinese strength to the global health cause.”

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 innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including over 10 projects in the clinical stage and 4 projects in the NDA 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 5 ADC projects in the clinical stage (2 of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.

From September 25^th to 29^th, the 27th China Clinical Oncology Congress and the 2024 CSCO Annual Meeting were held in Xiamen. Experts and scholars in the field of oncology from all over China gathered together to discuss the hotspots at the forefront of clinical practice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, 6990.HK) presented multiple clinical research results and progress of TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) at the conference.

TNBC

                             【2024 CSCO：Oral report by Academician Binghe Xu 】

On the afternoon of September 27, Academician Binghe Xu from the Cancer Hospital of the Chinese Academy of Medical Sciences gave an oral presentation and paper discussion on the results of the Phase III OptiTROP-Breast01 study of sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC) in the Innovative Drugs Clinical Data Session.

The median PFS assessed by BICR was 6.7 months (95% CI, 5.5 to 8.0) with SKB264 and 2.5 months (95% CI, 1.7 to 2.7) with chemotherapy; The sac-TMT group had a 68% reduction in risk of disease progression or death compared to the chemotherapy group (HR 0.32; 95% CI, 0.22 to 0.44; P <0.00001). In the subset of pts with TROP2 H-score > 200, the median PFS was 8.3 months with SKB264 and 2.3 months with chemotherapy (HR 0.29; 95% CI, 0.19 to 0.46). The median OS was not reached (95% CI, 11.2 to NE) with SKB264 and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. The sac-TMT group had a 47% reduction in risk of death compared to the chemotherapy group (HR 0.53; 95% CI, 0.36 to 0.78; P =0.00005). Compared to the investigator's choice of chemotherapy, sac-TMT for metastatic TNBC patients showed statistically and clinically significant improvements in PFS and OS, with a manageable safety profile, and could be a new and effective therapeutic option for this group of patients.

Binghe Xu said, “Breast cancer is a highly prevalent malignant tumor in the world, threatening women's lives and health, among which, triple-negative breast cancer is also known as ‘the most toxic’ breast cancer due to its poor therapeutic effect. The future direction of advanced triple-negative breast cancer treatment is precise and stratified treatment. Sac-TMT can help to meet more treatment needs of patients, and may be expected to become the new standard of second-line treatment for advanced triple-negative breast cancer in the future. For the research and development of ADC, domestic enterprises have gone through the stages of catching up and running parallel to each other, and now they have become an important force in the global ADC innovation technology, and we believe that one day, patients with advanced triple-negative breast cancer can get more effective treatment through ADC innovative drugs.”

NSCLC

【2024 CSCO：Oral report by Prof.Wengfeng Fang】

On the afternoon of September 28, Prof. Wenfeng Fang from the Affiliated Cancer Hospital of Sun Yat-sen University orally reported the results of the Phase II OptiTROP-Lung01study, a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC) with sac-TMT in combination with KL-A167, an anti-PD-L1 monoclonal antibody, in the session of Clinical Data of Innovative Drugs, with a paper discussion.

Pts with treatment naive advanced NSCLC without actionable genomic alterations were enrolled to receive SKB264 5 mg/kg Q3W + KL-A167 1200 mg Q3W (cohort 1A，130 Pts) or SKB264 5 mg/kg Q2W + KL-A167 900 mg Q2W (cohort 1B,133 Pts) in a non-randomized manner. After median follow up of 14.0 mo and 6.9 mo for cohort 1A and 1B, the ORR was 48.6% (18/37, 2 pending confirmation), DCR was 94.6% and median PFS was 15.4 mo (95% CI: 6.7, NE) with 6-mo PFS rate of 69.2% for cohort 1A ; the ORR was 77.6% (45/58, 5 pending confirmation), DCR was 100% and median PFS was not reached with 6-mo PFS rate of 84.6% for cohort 1B.

Prof. Wenfeng Fang said, “The emergence of ADC drugs is epoch-making. The dual-drug regimen of sac-TMT combined with immunotherapy is leading a new direction in the exploration of first-line treatment for advanced NSCLC, with very stunning efficacy observed in the preliminary study data. In the future, the potential for the application of sac-TMT in the treatment of NSCLC is worth looking forward to, and sac-TMT is expected to provide diversified treatment options and better survival benefits for more patients, both in the driver-negative and EGFR-mutated patient populations.”

CC

【2024 CSCO：Oral report by Pro.Jing Wang】

On the morning of September 28, Professor Jing Wang from Hunan Cancer Hospital orally reported the results of Efficacy and Safety of sac-TMT Plus Pembrolizumab in patients with recurrent or metastatic cervical cancer. Pts with R/M CC who had progressed on or after platinum-doublet chemotherapy and received no more than 2 systemic therapies for R/M disease were enrolled.38 pts were treated and followed up for at least 17 weeks or 2 tumor assessments. The median follow-up was 6.2 mo, The ORR was 57.9% (22/38, 3 unconfirmed), with 3 complete responses. Responses were also observed in pts were pre-treated with anti-PD-1 based therapy. Median PFS was not reached and 6-mo PFS rate was 65.7%.

Professor Jing Wang said, “Cervical cancer highly expresses TROP2, and previous studies have suggested that the overexpression ratio is more than 90%. High TROP2 expression is closely related to the poor prognosis of tumor patients, and it may also be related to the sensitivity of some drug therapies, which makes it a good target to explore. It is believed that with these promising results, more studies will emerge in the field of gynecologic oncology in the future to further validate these findings and bring hope to a wider range of cancer patients.”

EC/OC

【2024 CSCO：Oral report by Dr.Zhuo Yang】

On the morning of September 28, Dr. Zhuo Yang from Liaoning Provincial Cancer Hospital shared the results of safety and efficacy of sac-TMT in pts with previously treated advanced endometrial carcinoma (EC) and ovarian cancer (OC) from a Phase 2 Study. In the endometrial cancer cohort, 44 EC pts were enrolled and median follow-up time was 7.2 mo. 52.3% of pts had received ≥ 2 prior lines of therapy. The ORR was 34.1% (15/44, 12 confirmed) and DCR was 75%. Median PFS was 5.7 mo (95% CI: 3.7, 9.4) with 6-mo PFS rate of 47.5%.

40 OC pts were enrolled and median follow-up time was 28.2 mo. All pts had received ≥ 2 prior lines of therapy (80% of pts ≥ 3 prior lines). 87.5% of pts were platinum-resistant. The ORR was 40% (16/40, 14 confirmed) and DCR was 75%. mPFS was 6.0 mo (95% CI: 3.9, 7.3); mo was 16.5 mo (95% CI: 10.7, NE). In the pts with TROP2 IHC H-score > 200 (n=13) or H-score ≤ 200 (n=22), the ORR was 61.5% (8/13, 7 confirmed) and 27.3% (6/22, 6 confirmed) respectively. In the pts with platinum-resistant (n=35), mPFS was 6.0 mo (95% CI: 5.3, 7.3) and mOS was 16.1 mo (95% CI: 10.5, NE).

Prof Danbo Wang said, “Ovarian cancer and endometrial cancer have their own epidemiological characteristics, and the incidence rate of endometrial cancer in developed cities in China is increasing year by year, and it may become the top gynecological malignant tumor in Chinese women in the future. In contrast, ovarian cancer is characterized by insidious onset, high late detection rate and high mortality rate. Exploring new therapeutic strategies to overcome platinum resistance and improve the survival rate of ovarian cancer patients is a key direction for future research. Sac-TMT shows great potential in the treatment of advanced endometrial and ovarian cancers. It has not only achieved remarkable results in terms of efficacy, but also well controlled safety. I believe that in the future research and application, it will become a leader in the field of ADC innovative drug development and bring new hope to more gynecological oncology patients.”

With a caring heart, Kelun-Biotech is committed to solving unmet clinical needs in China and around the world. By focusing on its own technological strengths, Kelun-Biotech is able to provide patients in China with novel ADC drugs with significant clinical value and excellent cost-effectiveness, and to enhance the benefits for clinical patients. In the future, we will continue to accelerate the R&D and clinical progress of our drug candidates, enhance our integrated drug development capabilities, and contribute to the realization of Healthy China 2030.

From September 25^th to 29^th, the 27th China Clinical Oncology Congress and the 2024 CSCO Annual Meeting were held in Xiamen. Experts and scholars in the field of oncology from all over China gathered together to discuss the hotspots at the forefront of clinical practice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, 6990.HK) presented multiple clinical research results and progress of TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) at the conference.

TNBC

                             【2024 CSCO：Oral report by Academician Binghe Xu 】

On the afternoon of September 27, Academician Binghe Xu from the Cancer Hospital of the Chinese Academy of Medical Sciences gave an oral presentation and paper discussion on the results of the Phase III OptiTROP-Breast01 study of sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC) in the Innovative Drugs Clinical Data Session.

The median PFS assessed by BICR was 6.7 months (95% CI, 5.5 to 8.0) with SKB264 and 2.5 months (95% CI, 1.7 to 2.7) with chemotherapy; The sac-TMT group had a 68% reduction in risk of disease progression or death compared to the chemotherapy group (HR 0.32; 95% CI, 0.22 to 0.44; P <0.00001). In the subset of pts with TROP2 H-score > 200, the median PFS was 8.3 months with SKB264 and 2.3 months with chemotherapy (HR 0.29; 95% CI, 0.19 to 0.46). The median OS was not reached (95% CI, 11.2 to NE) with SKB264 and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. The sac-TMT group had a 47% reduction in risk of death compared to the chemotherapy group (HR 0.53; 95% CI, 0.36 to 0.78; P =0.00005). Compared to the investigator's choice of chemotherapy, sac-TMT for metastatic TNBC patients showed statistically and clinically significant improvements in PFS and OS, with a manageable safety profile, and could be a new and effective therapeutic option for this group of patients.

Binghe Xu said, “Breast cancer is a highly prevalent malignant tumor in the world, threatening women's lives and health, among which, triple-negative breast cancer is also known as ‘the most toxic’ breast cancer due to its poor therapeutic effect. The future direction of advanced triple-negative breast cancer treatment is precise and stratified treatment. Sac-TMT can help to meet more treatment needs of patients, and may be expected to become the new standard of second-line treatment for advanced triple-negative breast cancer in the future. For the research and development of ADC, domestic enterprises have gone through the stages of catching up and running parallel to each other, and now they have become an important force in the global ADC innovation technology, and we believe that one day, patients with advanced triple-negative breast cancer can get more effective treatment through ADC innovative drugs.”

NSCLC

【2024 CSCO：Oral report by Prof.Wengfeng Fang】

On the afternoon of September 28, Prof. Wenfeng Fang from the Affiliated Cancer Hospital of Sun Yat-sen University orally reported the results of the Phase II OptiTROP-Lung01study, a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC) with sac-TMT in combination with KL-A167, an anti-PD-L1 monoclonal antibody, in the session of Clinical Data of Innovative Drugs, with a paper discussion.

Pts with treatment naive advanced NSCLC without actionable genomic alterations were enrolled to receive SKB264 5 mg/kg Q3W + KL-A167 1200 mg Q3W (cohort 1A，130 Pts) or SKB264 5 mg/kg Q2W + KL-A167 900 mg Q2W (cohort 1B,133 Pts) in a non-randomized manner. After median follow up of 14.0 mo and 6.9 mo for cohort 1A and 1B, the ORR was 48.6% (18/37, 2 pending confirmation), DCR was 94.6% and median PFS was 15.4 mo (95% CI: 6.7, NE) with 6-mo PFS rate of 69.2% for cohort 1A ; the ORR was 77.6% (45/58, 5 pending confirmation), DCR was 100% and median PFS was not reached with 6-mo PFS rate of 84.6% for cohort 1B.

Prof. Wenfeng Fang said, “The emergence of ADC drugs is epoch-making. The dual-drug regimen of sac-TMT combined with immunotherapy is leading a new direction in the exploration of first-line treatment for advanced NSCLC, with very stunning efficacy observed in the preliminary study data. In the future, the potential for the application of sac-TMT in the treatment of NSCLC is worth looking forward to, and sac-TMT is expected to provide diversified treatment options and better survival benefits for more patients, both in the driver-negative and EGFR-mutated patient populations.”

CC

【2024 CSCO：Oral report by Pro.Jing Wang】

On the morning of September 28, Professor Jing Wang from Hunan Cancer Hospital orally reported the results of Efficacy and Safety of sac-TMT Plus Pembrolizumab in patients with recurrent or metastatic cervical cancer. Pts with R/M CC who had progressed on or after platinum-doublet chemotherapy and received no more than 2 systemic therapies for R/M disease were enrolled.38 pts were treated and followed up for at least 17 weeks or 2 tumor assessments. The median follow-up was 6.2 mo, The ORR was 57.9% (22/38, 3 unconfirmed), with 3 complete responses. Responses were also observed in pts were pre-treated with anti-PD-1 based therapy. Median PFS was not reached and 6-mo PFS rate was 65.7%.

Professor Jing Wang said, “Cervical cancer highly expresses TROP2, and previous studies have suggested that the overexpression ratio is more than 90%. High TROP2 expression is closely related to the poor prognosis of tumor patients, and it may also be related to the sensitivity of some drug therapies, which makes it a good target to explore. It is believed that with these promising results, more studies will emerge in the field of gynecologic oncology in the future to further validate these findings and bring hope to a wider range of cancer patients.”

EC/OC

【2024 CSCO：Oral report by Dr.Zhuo Yang】

On the morning of September 28, Dr. Zhuo Yang from Liaoning Provincial Cancer Hospital shared the results of safety and efficacy of sac-TMT in pts with previously treated advanced endometrial carcinoma (EC) and ovarian cancer (OC) from a Phase 2 Study. In the endometrial cancer cohort, 44 EC pts were enrolled and median follow-up time was 7.2 mo. 52.3% of pts had received ≥ 2 prior lines of therapy. The ORR was 34.1% (15/44, 12 confirmed) and DCR was 75%. Median PFS was 5.7 mo (95% CI: 3.7, 9.4) with 6-mo PFS rate of 47.5%.

40 OC pts were enrolled and median follow-up time was 28.2 mo. All pts had received ≥ 2 prior lines of therapy (80% of pts ≥ 3 prior lines). 87.5% of pts were platinum-resistant. The ORR was 40% (16/40, 14 confirmed) and DCR was 75%. mPFS was 6.0 mo (95% CI: 3.9, 7.3); mo was 16.5 mo (95% CI: 10.7, NE). In the pts with TROP2 IHC H-score > 200 (n=13) or H-score ≤ 200 (n=22), the ORR was 61.5% (8/13, 7 confirmed) and 27.3% (6/22, 6 confirmed) respectively. In the pts with platinum-resistant (n=35), mPFS was 6.0 mo (95% CI: 5.3, 7.3) and mOS was 16.1 mo (95% CI: 10.5, NE).

Prof Danbo Wang said, “Ovarian cancer and endometrial cancer have their own epidemiological characteristics, and the incidence rate of endometrial cancer in developed cities in China is increasing year by year, and it may become the top gynecological malignant tumor in Chinese women in the future. In contrast, ovarian cancer is characterized by insidious onset, high late detection rate and high mortality rate. Exploring new therapeutic strategies to overcome platinum resistance and improve the survival rate of ovarian cancer patients is a key direction for future research. Sac-TMT shows great potential in the treatment of advanced endometrial and ovarian cancers. It has not only achieved remarkable results in terms of efficacy, but also well controlled safety. I believe that in the future research and application, it will become a leader in the field of ADC innovative drug development and bring new hope to more gynecological oncology patients.”

With a caring heart, Kelun-Biotech is committed to solving unmet clinical needs in China and around the world. By focusing on its own technological strengths, Kelun-Biotech is able to provide patients in China with novel ADC drugs with significant clinical value and excellent cost-effectiveness, and to enhance the benefits for clinical patients. In the future, we will continue to accelerate the R&D and clinical progress of our drug candidates, enhance our integrated drug development capabilities, and contribute to the realization of Healthy China 2030.