Core Viewpoint - InnoCare Pharma-B (09606) shares rose by 10.19% to HKD 339.40, with a trading volume of HKD 135 million, following the announcement of Fast Track Designation (FTD) by the FDA for its new generation HER3-targeted antibody-drug conjugate DB-1310 for specific breast cancer patients [1] Group 1 - The FDA granted Fast Track Designation to DB-1310 for the treatment of adult patients with HR-positive, HER2-negative breast cancer who have previously undergone endocrine therapy and CDK4/6 inhibitor treatment, and are in the stage of unresectable or metastatic disease [1] - DB-1310 is the first HER3-ADC drug to receive FTD for this indication globally, indicating a significant milestone for the company [1] - The broad FTD indication for DB-1310 will facilitate its clinical development in both chemotherapy-naive and chemotherapy-resistant settings for HR+/HER2- breast cancer [1]
映恩生物-B早盘涨超10% DB-1310获美国FDA授予快速通道资格