Glenmark Pharmaceuticals Ltd., through its wholly-owned subsidiary Glenmark Specialty S.A. (GSSA), has entered into a landmark exclusive license and collaboration agreement with Hengrui Pharma for Trastuzumab Rezetecan (SHR-A1811), a next-generation HER2-targeting antibody drug conjugate (ADC).
Under the terms of the agreement, Glenmark obtains exclusive rights to develop and commercialize Trastuzumab Rezetecan worldwide, except for select territories including Mainland China, Hong Kong, Macao, Taiwan, the USA, Canada, Europe, Japan, and several countries in Eastern Europe and Central Asia. Glenmark will make an upfront payment of USD 18 million, with Hengrui Pharma eligible for regulatory and commercial milestone payments totaling up to USD 1.093 billion, along with royalties based on net sales within the licensed territories.
About Trastuzumab Rezetecan
Trastuzumab Rezetecan is a self-developed HER2-targeted ADC by Hengrui Pharma. It was approved in May 2025 in China for the treatment of adult patients with HER2 (ERBB2) activating mutations in unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who had received at least one prior systemic therapy. Notably, it is the first China-developed ADC approved for HER2-mutated NSCLC.
In September 2025, the drug received a priority review designation from China’s NMPA for a new breast cancer indication. To date, Trastuzumab Rezetecan has been granted Breakthrough Therapy Designation by the NMPA for nine indications, covering NSCLC, breast cancer, gastric or gastroesophageal junction adenocarcinoma, colorectal cancer, biliary tract cancer, and gynecologic malignancies.
The ADC is also progressing through multiple global clinical trials, including a combination therapy with adebrelimab and chemotherapy, which received Orphan Drug Designation from the US FDA for gastric or gastroesophageal junction adenocarcinoma in August 2025.
