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Glenmark Specialty S.A. (GSSA), a wholly owned subsidiary of India-based Glenmark Pharmaceuticals, has entered into an exclusive license and collaboration agreement with China's 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 commercialise Trastuzumab Rezetecan (SHR-A1811) worldwide, excluding Mainland China, the Hong Kong SAR, the Macao SAR, Taiwan Region, USA, Canada, Europe, Japan, Russia, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan and Uzbekistan.
Glenmark will pay an upfront payment of $18 million. Hengrui is eligible to receive regulatory and commercial milestone payments of up to $1.093 billion. Based on the net sales of Trastuzumab Rezetecan within the licensed territory, Glenmark will pay corresponding royalties to Hengrui.
Trastuzumab Rezetecan is Hengrui’s self-developed HER2-targeted ADC. In May 2025, it was approved 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 have received at least one prior systemic therapy. This is the first China-developed ADC approved for HER2-mutated NSCLC.
In September 2025, the new indication for Trastuzumab Rezetecan in breast cancer was accepted by China’s NMPA for review and was included in the priority review program. To date, Trastuzumab Rezetecan has been included in the NMPA’s Breakthrough Therapy Designation list for nine indications, covering NSCLC, breast cancer, gastric or gastroesophageal junction adenocarcinoma, colorectal cancer, biliary tract cancer, and gynecologic malignancies.
Currently, Trastuzumab Rezetecan is actively advancing multiple clinical trials. In August 2025, Trastuzumab Rezetecan in combination with adebrelimab and chemotherapy obtained Orphan Drug Designation from the US FDA for gastric or gastroesophageal junction adenocarcinoma.
