Jiangsu Hengrui Pharmaceuticals (01276): Injection of \(derived\) single-antibody \(drug\) approved to conduct clinical trials.

Jiangsu Hengrui Pharmaceuticals (01276) announced recently that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received the approval notice for the clinical trial of injection of trastuzumab deruxtecan issued by the National Medical Products Administration ("NMPA"). The company will soon start the clinical trial. In accordance with the Drug Administration Law of the People's Republic of China and related regulations, the clinical trial application for injection of trastuzumab deruxtecan submitted on July 31, 2025 meets the requirements for drug registration. The approval allows the company to conduct a specific phase III clinical study comparing trastuzumab deruxtecan (SHR-A1811) as a monotherapy to a combination of docetaxel, carboplatin, trastuzumab deruxtecan, and pertuzumab as neoadjuvant therapy for HER2-positive early or locally advanced breast cancer. Trastuzumab deruxtecan injection can bind to tumor cells expressing HER2, enter the cells, release toxins by protease cleavage in the tumor cells' lysosomes, induce cell cycle arrest, and subsequently induce tumor cell apoptosis. The released toxin has high membrane permeability, allowing bystander killing effect and further enhancing the anti-tumor efficacy. Similar products currently on the market abroad include Ado-trastuzumab emtansine developed by Roche and Fam-trastuzumab deruxtecan developed by AstraZeneca in collaboration with Daiichi Sankyo, which are both already available in China. In addition, REMEGEN's Vedolizumab was approved for sale in China in 2021, and Kolon Life Science's Boduzumab deruxtecan was approved for sale in China in 2025. According to the EvaluatePharma database, the global sales of similar products in 2024 totaled approximately $6.57 billion. As of now, the total research and development investment in the trastuzumab deruxtecan injection project is approximately 1.41475 billion yuan.