Core Viewpoint - InnoCare Pharma-B (09606) experienced a morning increase of over 3%, currently up 3.25% at HKD 318, with a trading volume of HKD 23.3955 million. The company announced that the FDA has granted Fast Track Designation (FTD) for its next-generation HER3-targeted antibody-drug conjugate DB-1310, aimed at treating adult patients with advanced or unresectable metastatic hormone receptor-positive (HR+), HER2-negative breast cancer who have previously undergone endocrine therapy and CDK4/6 inhibitor treatment, or have experienced disease recurrence within six months after completing adjuvant chemotherapy [1]. Group 1 - The FDA has granted Fast Track Designation to DB-1310, making it the first HER3-ADC drug to receive this designation for the specified indication [1]. - The FTD designation for DB-1310 covers a broad range of indications in HR+/HER2- breast cancer, including patients who have received or not received chemotherapy during the stage of unresectable or metastatic disease [1]. - This broad indication will facilitate the critical clinical development of DB-1310 in both pre-chemotherapy frontline scenarios and post-chemotherapy resistant scenarios [1].
映恩生物-B早盘涨超3% DB-1310获美国FDA授予快速通道资格