Jiangsu Hengrui Pharmaceuticals (01276): The approval notice for the clinical trial of the injection of Rekang Xianzhutuzumab has been obtained.

Jiangsu Hengrui Pharmaceuticals (01276) announced that its subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. recently received the drug clinical trial approval notice issued by the National Medical Products Administration for the injection of Rekankutuzumab Monoclonal Antibody, and will soon begin clinical trials. The injection of Rekankutuzumab Monoclonal Antibody was approved for domestic market in May 2025, and is suitable for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) activating mutations who have previously received at least one systemic therapy. Rekankutuzumab Monoclonal Antibody for injection can bind to HER2-expressing tumor cells and be internalized, releasing toxins through protease cleavage in the tumor cell lysosome, inducing cell cycle arrest and triggering tumor cell apoptosis. The released toxin has high membrane permeability, which can exert bystander killing effects and further enhance the anti-tumor efficacy. As of now, similar products on the market abroad include Ado-trastuzumab emtansine developed by Roche and Fam-trastuzumab deruxtecan, developed by AstraZeneca in collaboration with Daiichi Sankyo, both of which are already on the market in China. In addition, REMEGEN's Vidicizumab Monoclonal Antibody was approved for domestic market in 2021, and the Bokutuzumab Monoclonal Antibody, developed by KOLON Life Science, was approved for domestic market in 2025. According to the EvaluatePharma database, the global sales of similar products in 2024 amounted to approximately $6.57 billion. As of now, the cumulative research and development investment in the Rekankutuzumab Monoclonal Antibody injection project is approximately RMB 141.475 million.