Core Viewpoint - The approval of the antibody-drug conjugate (ADC) A166 (also known as 博度曲妥珠单抗) by the National Medical Products Administration (NMPA) for treating HER2-positive adult breast cancer patients who have previously received one or more anti-HER2 therapies marks a significant advancement in the treatment landscape for this patient population [1]. Group 1: Drug Approval and Clinical Study - The NMPA has approved A166 for use in patients with unresectable or metastatic HER2-positive breast cancer who have previously undergone treatment with one or more anti-HER2 drugs [1]. - The approval is based on a multicenter, randomized, open-label, controlled Phase 3 study (KL166-III-06) that evaluated the efficacy and safety of A166 compared to T-DM1 in patients with HER2-positive unresectable or metastatic breast cancer [1]. - The interim analysis showed that A166 significantly improved progression-free survival (PFS) compared to T-DM1, with a notable trend towards improved overall survival (OS) [1]. Group 2: Future Research and Development - The company has initiated an open-label, multicenter Phase 2 clinical study of A166 for treating HER2-positive unresectable or metastatic breast cancer previously treated with topoisomerase inhibitor ADCs [2].
科伦博泰生物-B(06990.HK)：核心产品博度曲妥珠单抗治疗2L+ HER2+乳腺癌获批上市