Glenmark Specialty S.A., a subsidiary of Glenmark Pharmaceuticals, has entered into an exclusive license and collaboration agreement with Hengrui Pharma for Trastuzumab Rezetecan (SHR-A1811), a next-generation HER2-targeting antibody drug conjugate (ADC). Glenmark gains exclusive rights to develop and commercialize Trastuzumab Rezetecan worldwide, excluding specific regions. Glenmark will pay an upfront payment of US$18 million, and Hengrui is eligible for up to US$1.093 billion in milestone payments.
Strategic Oncology Collaboration
Glenmark Specialty S.A. (GSSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd., announced a strategic collaboration with Hengrui Pharma on September 24, 2025. The agreement involves an exclusive license for Trastuzumab Rezetecan (SHR-A1811), a HER2-targeting ADC, to bolster Glenmark’s oncology offerings.
Deal Terms and Territory
Under the terms of the agreement, Glenmark secures exclusive rights to develop and commercialize Trastuzumab Rezetecan (SHR-A1811) globally, with exceptions that include Mainland China, Hong Kong SAR, Macao SAR, Taiwan Region, USA, Canada, Europe, Japan, Russia, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, and Uzbekistan.
The financial details include an upfront payment of US$18 million from Glenmark. Furthermore, Hengrui is eligible for potential regulatory and commercial milestone payments up to US$1.093 billion. Glenmark will also pay royalties to Hengrui based on net sales within the licensed territory.
Drug Overview
Trastuzumab Rezetecan is Hengrui’s self-developed HER2-targeted ADC. In May 2025, it was approved in China for treating adult patients with HER2 (ERBB2) activating mutations in unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. It marks the first China-developed ADC approved for HER2-mutated NSCLC. As of September 2025, its application in breast cancer has been accepted by China’s NMPA and included in the priority review program.
Hengrui’s Breakthrough Therapy Designation
Trastuzumab Rezetecan has received NMPA’s Breakthrough Therapy Designation for nine indications, which include NSCLC, breast cancer, gastric or gastroesophageal junction adenocarcinoma, colorectal cancer, biliary tract cancer, and gynecologic malignancies.
Clinical Trials
Trastuzumab Rezetecan is actively advancing in several clinical trials. In August 2025, the combination of Trastuzumab Rezetecan with adebrelimab and chemotherapy received Orphan Drug Designation from the US FDA for treating gastric or gastroesophageal junction adenocarcinoma.
Source: BSE
