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 SHRA1811, a drug targeting HER2-positive breast cancer [1][2]. Group 1: Clinical Trial Approval - The clinical trial application for injectable SHRA1811 was accepted on July 31, 2025, and meets the requirements for drug registration, allowing the initiation of clinical trials [1]. - The trial will be a randomized, open-label, multi-center Phase III study comparing SHRA1811 with Docetaxel + Carboplatin + Trastuzumab + Pertuzumab for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer [1]. Group 2: Product Mechanism and Market Context - Injectable SHRA1811 binds to HER2-expressing tumor cells, inducing apoptosis through the release of toxins in the lysosomes of tumor cells, which enhances anti-tumor efficacy [2]. - Similar products currently available in the market include Roche's Ado-trastuzumab emtansine and AstraZeneca's Fam-trastuzumab deruxtecan, both of which are already marketed in China [2]. - The global sales of similar products are projected to reach approximately $6.557 billion in 2024, with a cumulative R&D investment of about 141.475 million yuan for injectable SHRA1811 [2].