Hengrui Pharma(SH:600276) Shang Hai Zheng Quan Bao·2025-12-24 18:15Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has announced that its drug SHR-A1904 has been included in the list of breakthrough therapeutic drugs by the National Medical Products Administration (NMPA) of China, which is a significant milestone for the company in the oncology sector [1][2]. Group 1: Drug Information - Drug Name: SHR-A1904, a targeted antibody-drug conjugate (ADC) aimed at Claudin18.2, with a registration classification of Class 1 [1][2]. - Indication: It 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]. - Development Investment: The cumulative R&D investment for SHR-A1904 has reached approximately 174 million yuan [2]. Group 2: Market Context - Gastric cancer is a significant health issue globally, ranking fifth in incidence and fourth in mortality, with about 60% of cases occurring in East Asia. In China alone, there were 479,000 new cases and 374,000 deaths in 2020, accounting for 44% and 48.6% of global gastric cancer cases, respectively [2]. - SHR-A1904 is the first of its kind targeting Claudin18.2, with no similar products approved globally to date [2]. Group 3: Clinical Trial Approval - The company has also received approval for clinical trials of another drug, SHR-A2102, which is a targeted ADC against Nectin-4. This drug will undergo trials in combination with other therapies for advanced solid tumors and esophageal cancer [5][6]. - The cumulative R&D investment for SHR-A2102 has reached approximately 248 million yuan [6].