Core Viewpoint - Kangfang Biopharma's innovative bispecific antibody drug, Iwosimab (PD-1/VEGF bispecific), has been included in the Breakthrough Therapy Designation (BTD) list for first-line treatment of triple-negative breast cancer (TNBC), which is expected to accelerate its clinical development and market entry [1] Group 1: Stock Performance - Kangfang Biopharma's stock rose over 5% in early trading, currently up 4.94% at HKD 119, with a trading volume of HKD 748 million [1] Group 2: Clinical Development - The National Medical Products Administration's (NMPA) Center for Drug Evaluation (CDE) has publicly announced the inclusion of Iwosimab in the BTD list, which will expedite its clinical development and market approval [1] - Iwosimab has previously received three BTD recognitions from CDE, with two indications already approved for market and one ongoing Phase III clinical trial progressing rapidly [1] - Currently, Iwosimab has initiated 14 Phase III clinical studies globally, including four international multicenter trials, which will enhance its clinical value worldwide [1]
港股异动 | 康方生物(09926)早盘涨超5% 依沃西获得第四个突破性疗法认定 临床开发与上市进程有望加速