Hengrui Pharmaceutical (01276): Recon trastuzumab for injection obtained a notice of approval for clinical trials of the drug

Zhitong Finance App News, Hengrui Pharmaceutical (01276) issued an announcement. Recently, the company's subsidiary Suzhou Shengdia Biomedical Co., Ltd. received approval from the State Drug Administration to issue a “Drug Clinical Trial Approval Notice” for injectable Ruikang trastuzumab, which will conduct clinical trials in the near future.

The company's injectable Recon trastuzumab was approved for marketing in China in May 2025. It is suitable for treating adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) activation mutations and who have received at least one type of systematic treatment in the past.

Recon trastuzumab for injection can bind to HER2-expressed tumor cells and be internalized to release toxins through protease cleavage in tumor cytosomes, inducing cell cycle blockade and triggering tumor cell apoptosis. The toxins it releases have high membrane permeability, can exert a killing effect on bystanders, and further enhance anti-tumor efficacy. According to inquiries, 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, and they have all been marketed domestically. In addition, verdicitumab developed by Rongchang Biotech was approved for domestic marketing in 2021, and bodutrastuzumab developed by Colenbotai was approved for domestic marketing in 2025. According to the EvaluatePharma database, the total global sales volume of similar products over 2024 is approximately US$6.557 billion. Up to now, the total R&D investment for injectable Ruikang trastuzumab related projects is about 1414.75 million yuan.