四川科伦药业股份有限公司 关于子公司在2025年欧洲肿瘤内科学会大会上 公布多项创新药物研究成果的公告

Core Viewpoint - Sichuan Kelun Pharmaceutical Co., Ltd. announced significant clinical research results from its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., at the 2025 European Society for Medical Oncology (ESMO) conference, highlighting advancements in targeted antibody-drug conjugates (ADCs) for various cancers [1]. Group 1: Clinical Research Results Overview - Two studies on sac-TMT (LKB5) were selected for Late Breaking Abstract (LBA) oral presentations, demonstrating its efficacy in treating EGFR mutation-positive non-small cell lung cancer (NSCLC) and hormone receptor-positive, HER2-negative breast cancer (BC) [2][3]. - In the OptiTROP-Lung04 study, sac-TMT showed a median progression-free survival (PFS) of 8.3 months compared to 4.3 months for chemotherapy, reducing the risk of disease progression or death by 51% [2][3]. - The OptiTROP-Breast02 study reported a median PFS of 8.3 months for sac-TMT versus 4.1 months for investigator's choice chemotherapy, with a hazard ratio (HR) of 0.35 [4][5]. Group 2: Safety and Efficacy - Both studies indicated similar rates of treatment-related adverse events (TRAEs) between sac-TMT and chemotherapy, with no TRAEs leading to treatment discontinuation in the sac-TMT group [3][5]. - The objective response rate (ORR) for sac-TMT was 60.6% in NSCLC and 41.5% in BC, significantly higher than the chemotherapy groups [2][5]. - The studies support the approval of sac-TMT by the National Medical Products Administration (NMPA) for specific cancer treatments [3][5]. Group 3: Additional Research and Drug Information - The study on SKB315, targeting Claudin18.2 in advanced solid tumors, showed an ORR of 37.5% and a median PFS of 8.2 months [6]. - The innovative drugs sac-TMT and botu-tuzumab (舒泰莱) are designed to target specific cancer types, with sac-TMT being the first TROP2 ADC approved for lung cancer indications [8][10]. - Kelun Botai has initiated multiple clinical studies for these drugs, indicating a robust pipeline for cancer treatment [9][11].