Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. and its subsidiary Shanghai Hengrui Medicine Co., Ltd. have announced that their injectable SHR-A1904 has been included in the list of breakthrough therapies by the National Medical Products Administration (NMPA) of China [1] Group 1: Drug Information - Drug Name: Injectable SHR-A1904 [1] - Acceptance Number: CXSL2100034 [1] - Drug Type: Therapeutic biological product [1] - Registration Category: Class 1 [1] - Application Date: November 1, 2025 [1] - Proposed Indication: Locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma positive for CLDN18.2, previously treated with at least one line of systemic therapy [1] Group 2: Regulatory Approval - The application has been reviewed and meets the requirements of the "Drug Registration Management Measures" and the announcement regarding the "Breakthrough Therapy Drug Review Work Procedures (Trial)" issued by the NMPA [1] - The inclusion in the breakthrough therapy program has been approved [1]