Core Viewpoint - Heng Rui Medicine (01276) has seen a stock price increase of over 5% following the announcement that its self-developed antibody-drug conjugate (ADC) SHR-A1904 has been officially included in the breakthrough therapy list by the National Medical Products Administration (NMPA) [1] Group 1: Company Developments - The ADC SHR-A1904 targets Claudin18.2 (CLDN18.2) and is intended for the treatment of locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma in patients who have previously received at least one line of systemic therapy [1] - The inclusion in the breakthrough therapy program is based on the potential clinical value of the drug for specific indications, which will allow for prioritized review resources and enhanced R&D guidance from the drug review center [1] Group 2: Industry Context - Gastric cancer is a highly prevalent malignancy in China, with new cases and deaths in 2020 accounting for approximately 44% and 48.6% of global totals, respectively, indicating a significant unmet clinical need [1] - The CLDN18.2 target is highly expressed in various gastrointestinal tumors and is currently a hot target in tumor drug development, with no similar ADC products approved globally [1]
恒瑞医药(01276)午后涨超5% CLDN18.2 ADC胃癌适应症纳入突破性治疗品种名单