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 injectable Rikan Trastuzumab, marking a significant step in the development of new cancer therapies [1][2]. Group 1: Clinical Trial Approval - The clinical trial application for injectable Rikan Trastuzumab (SHR-A1811) was approved, allowing for a Phase III study comparing it to a combination of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab for the treatment of early or locally advanced HER2-positive breast cancer [1][2]. - The approval was based on compliance with the requirements for drug registration as per the Drug Administration Law of the People's Republic of China [1]. Group 2: Product Mechanism and Market Context - Injectable Rikan Trastuzumab works by binding to HER2-expressing tumor cells, inducing apoptosis through the release of toxins within the cells [2]. - Similar products already on the market include Roche's Ado-trastuzumab emtansine and AstraZeneca's Fam-trastuzumab deruxtecan, both of which have been approved in China [2]. - The global sales of similar products are projected to reach approximately $6.557 billion in 2024, indicating a robust market for HER2-targeted therapies [2]. - The cumulative R&D investment for injectable Rikan Trastuzumab has reached approximately 141.475 million yuan [2].