Jiangsu Hengrui Pharmaceuticals (600276.SH): Type 1 innovative drug injection Rukancituximab (SHR-A1811) has obtained approval for new indications for drug registration.

Jiangsu Hengrui Pharmaceuticals (600276.SH) announced recently that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received a notification from the National Medical Products Administration (NMPA) approving the addition of a new indication for its independently developed Class 1 innovative drug injection, Rituximab Derucutinab (SHR-A1811). The approved indication is for the treatment of locally advanced or metastatic HER2-positive adult breast cancer patients who have previously received one or more anti-HER2 drugs. Rituximab Derucutinab injection can bind to tumor cells expressing HER2 and be internalized, releasing toxins through protease cleavage in the tumor cells' lysosomes, inducing cell cycle arrest and triggering tumor cell apoptosis. The released toxin has high membrane permeability, leading to bystander killing effects and further enhancing the anti-tumor efficacy. Similar products already on the market in China include Ado-trastuzumab emtansine developed by Roche, Fam-trastuzumab deruxtecan developed by AstraZeneca in collaboration with Daiichi Sankyo, Vedixytrastuzumab developed by REMEGEN, and BCD-127 trastuzumab deruxtecan developed by Junshi Biosciences. According to EvaluatePharma database, the total global sales of similar products is estimated to be around $8.157 billion USD in 2025. As of now, the cumulative research and development investment in Rituximab Derucutinab injection related projects is approximately 1.8883 billion RMB (unaudited).