恒瑞医药：注射用瑞康曲妥珠单抗获得药物临床试验批准通知书

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of injection Rituximab, which is set to begin soon [1] Group 1: Product Approval and Clinical Trials - The injection Rituximab is approved for adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received at least one systemic treatment [1] - The product is expected to be launched in China by May 2025 [1] Group 2: Mechanism and Market Context - Injection Rituximab binds to HER2-expressing tumor cells, inducing apoptosis through a mechanism involving toxin release in the lysosomes of tumor cells [2] - Similar products already on the market include Roche's Ado-trastuzumab emtansine and AstraZeneca's Fam-trastuzumab deruxtecan, both of which are also available in China [2] - The global sales of similar products are projected to reach approximately $6.557 billion from 2024 onwards [2] - The cumulative R&D investment for injection Rituximab has reached approximately 141.475 million yuan [2]