Core Viewpoint - Lepu Biopharma-B (02157) saw a significant stock increase of over 4%, currently trading at 7.34 HKD, with a transaction volume of 30.16 million HKD, following the announcement of its drug MRG003 being considered for breakthrough therapy designation [1] Group 1: Drug Development and Regulatory Status - MRG003, an EGFR-targeted ADC drug developed by Lepu Biopharma, is proposed for breakthrough therapy designation for treating recurrent or metastatic nasopharyngeal carcinoma in patients who have previously failed platinum-based and PD-1/PD-L1 inhibitor treatments [1] - MRG003 is currently the leading EGFR ADC drug in global development, having previously received breakthrough therapy designation and priority review qualification from CDE, as well as orphan drug status, fast track designation, and breakthrough therapy designation from the FDA [1] - The company initially submitted the marketing application for MRG003 for nasopharyngeal carcinoma in September 2024 but withdrew it to provide additional information, and resubmitted it in March of this year, now included in the priority review process for specific recurrent/metastatic nasopharyngeal carcinoma patients [1]
港股异动 | 乐普生物-B(02157)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