康方生物早盘涨超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

Core Viewpoint - Kangfang Biopharma (09926) has seen a significant stock price increase following the announcement that its innovative bispecific antibody drug, Yiwosi (PD-1/VEGF dual antibody), has been included in the Breakthrough Therapy Designation (BTD) list for first-line treatment of triple-negative breast cancer (TNBC) by the National Medical Products Administration (NMPA) [1] Group 1 - 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] - The inclusion of Yiwosi in the BTD list is expected to accelerate its clinical development and market launch [1] - Yiwosi has previously received three BTD recognitions from the CDE, with two indications already approved for market and one ongoing Phase III clinical study [1] Group 2 - Currently, Yiwosi has initiated 14 Phase III clinical studies globally, including four international multicenter trials, which will enhance its clinical value release worldwide [1]