Jiangsu Hengrui Pharmaceuticals (01276): The third indication for injectable rexinoid trastuzumab has been approved for market launch.

Jiangsu Hengrui Pharmaceuticals (01276) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., recently received notification from the National Medical Products Administration (NMPA) that the company's injectable Rykan Trastuzumab has been approved for a third indication, making it the first anti-HER2 product approved for use in colorectal cancer in China. The injectable Rykan Trastuzumab has already been approved in China for two indications: treatment of 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 therapy; and treatment of adult patients with locally advanced or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 therapies. Injectable Rykan Trastuzumab is an antibody-drug conjugate (ADC) independently developed by the company that targets HER2. It binds to tumor cells expressing HER2, facilitating endocytosis, and releases toxins through proteolytic cleavage in the tumor cell lysosome, inducing cell cycle arrest and triggering apoptosis in tumor cells. The released toxins have high membrane permeability and can exert a bystander killing effect, further enhancing anti-tumor efficacy. This approval is primarily based on a randomized, open-label, positive-controlled, multicenter, Phase III HORIZONCRC01 (SHR-A1811-III-309) study led by Professor Li Jin from Shanghai Gaobo Cancer Hospital, affiliated with China Pharmaceutical University, and Professor Yuan Ying from Zhejiang University School of Medicine. This study achieved its primary endpoint, and the significant data were presented as an oral report at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Currently, Rykan Trastuzumab has 11 indications included in the list of breakthrough therapies, covering non-small cell lung cancer, breast cancer, gastric or gastroesophageal junction adenocarcinoma, colorectal cancer, biliary tract cancer, and gynecological malignancies. In addition to the injectable Rykan Trastuzumab, similar products already on the market in China include Roche's Ado-trastuzumab emtansine, AstraZeneca and Daiichi Sankyo's Fam-trastuzumab deruxtecan, REMEGEN's Wedratuzumab, and Kelun-Bota's Botudab. According to the EvaluatePharma database, the total global sales of similar products are estimated to be approximately $8.157 billion by 2025. As of now, the cumulative research and development investment in the injectable Rykan Trastuzumab project is approximately 2.1442 billion yuan (unaudited).