科伦博泰生物-B：核心产品TROP2ADC芦康沙妥珠单抗(sac-TMT)获国家药品监督管理局批准第四项适应症上市，用于治疗2L+HR+/HER2-乳腺癌

Core Viewpoint - The approval of the antibody-drug conjugate sac-TMT (also known as SKB264/MK-2870) for a new indication in treating HR+/HER2- breast cancer in China represents a significant advancement for the company and the industry, particularly for patients who have undergone prior endocrine therapy and at least one line of chemotherapy [1] Group 1: Regulatory Approval - The National Medical Products Administration (NMPA) of China has approved sac-TMT for treating adult patients with unresectable or metastatic HR+/HER2- breast cancer who have previously received endocrine therapy and at least one line of chemotherapy [1] - This approval marks the fourth indication for sac-TMT in China [1] Group 2: Clinical Study Results - The approval is based on positive results from the OptiTROP-Breast023 phase II clinical study, which was presented at the 2025 European Society for Medical Oncology (ESMO) conference [1] - The OptiTROP-Breast02 study evaluated the efficacy and safety of sac-TMT compared to physician's choice of chemotherapy in patients with unresectable or metastatic HR+/HER2- breast cancer, with 95.7% of patients having visceral metastases and 75.9% having liver metastases at enrollment [2] - The study showed a significant improvement in progression-free survival (PFS) for the sac-TMT group compared to the chemotherapy group (8.3 months vs. 4.1 months; hazard ratio (HR), 0.35; 95% confidence interval (CI): 0.26-0.48; p<0.0001) [2] - Consistent PFS benefits were observed across predefined subgroups, including those with HER2 expression of 0 and low expression [2] - The overall survival (OS) benefit trend and objective response rate (ORR) were also significantly higher in the sac-TMT group (41.5% vs. 24.1%) [2] Group 3: Ongoing Research - Ongoing phase III clinical studies are evaluating sac-TMT, with or without pembrolizumab, for treating HR+/HER2- breast cancer patients who have previously received endocrine therapy but not chemotherapy, both globally and in China [3]