Hengrui subsidiary gets clinical trial nod for innovative HER2 drug

Jiangsu Hengrui Medicine's subsidiary, Suzhou Sinovant Biosciences, has received approval from the National Medical Products Administration for the clinical trial of "Recombinant Trastuzumab Deruxtecan for Injection." This approval allows the company to proceed with clinical trials for the drug as a monotherapy in patients with HER2-amplified solid tumors. The drug binds to HER2-expressing tumor cells and releases toxins to induce cell apoptosis. It has already been approved for sale in China in May 2025 for treating unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) activating mutations that have previously received at least one systemic therapy.

The company has invested approximately 141,475,000 yuan in the Recombinant Trastuzumab Deruxtecan for Injection project to date. Similar products globally generated approximately $6.557 bn in sales in 2024. However, the company advises investors to be cautious, as drug development and market launch are subject to various uncertainties and a lengthy, multi-stage process of research, clinical trials, and regulatory approvals.