Hengrui Medicine recently announced the signing of a licensing agreement with Glenmark Specialty SA for the Ruikang Trastuzumab project. The agreement provides for a paid license to Glenmark Specialty SA for the company's innovative Class 1 drug, Ruikang Trastuzumab (SHR-A1811), for which the company holds independent intellectual property rights.
Ruikang Trastuzumab is an antibody-drug conjugate (ADC) independently developed by Hengrui that targets HER2. It binds to and is internalized by HER2-expressing tumor cells. Within the tumor cell lysosome, trastuzumab releases a toxin through proteolytic cleavage, inducing cell cycle arrest and ultimately apoptosis. The released toxin is highly permeable, exerting a bystander effect and further enhancing anti-tumor efficacy.
The company's Ruikang Trastuzumab was approved for marketing in China in May 2025. It is indicated for the 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 treatment. This is also China's first independently developed antibody-drug conjugate approved for patients with HER2-mutated NSCLC.
In addition, multiple clinical studies of Ruikang Trastuzumab are actively progressing. In August 2025, Ruikang Trastuzumab received orphan drug designation from the US FDA for its combination with adebelimumab and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma. In September 2025, the National Medical Products Administration accepted Ruikang Trastuzumab's application for a new breast cancer-related indication for marketing authorization and placed it under priority review.
As of now, nine indications of Ruikang Trastuzumab have been included in the list of breakthrough therapeutics by the Drug Review Center of the National Medical Products Administration, covering diseases such as non-small cell lung cancer, breast cancer, gastric cancer or gastroesophageal junction adenocarcinoma, colorectal cancer, biliary tract cancer, and gynecological malignancies.
The announcement also stated that Glenmark Specialty will pay Hengrui an upfront payment of US$18 million. Hengrui is eligible to receive regulatory and sales-related milestone payments of up to US$1.093 billion. Glenmark Specialty will also pay Hengrui royalties based on sales of Ruikang Trastuzumab within the licensed scope.
The signing of this agreement will help expand Ruikang's trastuzumab's overseas market, providing high-quality treatment options for patients worldwide. It will also further enhance the company's innovative brand and overseas performance. The company prioritizes both independent research and development and open collaboration, strengthening international collaboration based on internal growth to achieve rapid translation of R&D results. Leveraging leading international partners to expand into overseas markets, the company accelerates its integration into the global drug innovation network, maximizes product value, and enables its innovative products to serve patients worldwide.

https://news.qq.com/rain/a/20250925A06SHK00