科伦药业：子公司核心产品博度曲妥珠单抗获NMPA批准上市

Core Viewpoint - The approval of the antibody-drug conjugate (ADC) by the National Medical Products Administration (NMPA) for treating HER2-positive breast cancer represents a significant advancement in targeted therapy for patients who have previously received one or more anti-HER2 treatments [1] Group 1: Company Developments - Kolun Pharmaceutical's subsidiary, Kolun Botai, received NMPA approval for the ADC, Bodu Trastuzumab, aimed at treating unresectable or metastatic HER2-positive adult breast cancer patients [1] - The approval is based on the results of a multicenter, randomized, open-label, controlled Phase III study (KL166-III-06), which demonstrated significant statistical and clinical improvement in progression-free survival (PFS) compared to T-DM1 [1] Group 2: Industry Implications - The approval of Bodu Trastuzumab highlights the growing importance of targeted therapies in oncology, particularly for patients with specific genetic markers such as HER2 [1] - This development may enhance competition in the market for HER2-targeted therapies, potentially impacting pricing and accessibility for patients [1]