Core Viewpoint - Lepu Biopharma-B (02157) saw a significant increase in stock price, rising over 4% following the announcement of its drug MRG003 being considered for breakthrough therapy designation for treating recurrent or metastatic nasopharyngeal carcinoma [1] Group 1: Stock Performance - Lepu Biopharma-B's stock rose by 4.11%, reaching HKD 7.34, with a trading volume of HKD 30.16 million [1] Group 2: Drug Development - The drug MRG003, an EGFR-targeted ADC, is proposed for breakthrough therapy designation, aimed at patients who have failed previous treatments with platinum-based drugs and PD-1/PD-L1 inhibitors [1] - MRG003 is currently the leading EGFR ADC drug in global development, having previously received breakthrough therapy designation and priority review from CDE, as well as orphan drug status and fast track designation from the FDA [1] - The company initially submitted a marketing application for MRG003 for nasopharyngeal carcinoma in September 2024, but withdrew it to provide additional information, and has since resubmitted it in March of this year, now included in the priority review process for specific recurrent/metastatic nasopharyngeal carcinoma patients [1]
乐普生物-B早盘涨超4% MRG003拟被纳入突破性疗法认定 瞄准难治性鼻咽癌