Glenmark Specialty S.A. (GSSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd., 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). This move strengthens Glenmark’s oncology portfolio and reinforces its commitment to advancing innovative cancer therapies across multiple regions.

Glenmark has obtained exclusive rights to develop and commercialize 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 Hengrui US$18 million upfront. Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion. Based on the net sales of Trastuzumab Rezetecan within the licensed territory, Glenmark will pay corresponding royalties to Hengrui.

Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals Limited, said, “We are delighted to collaborate with Hengrui and build on the scientific momentum of SHR-A1811 as we continue expanding our oncology pipeline and leadership. This partnership aligns strongly with our strategy to bring differentiated, high-value therapies to patients and reinforces our commitment to advancing innovation in areas of significant unmet need.”

Jo Feng, President of Hengrui Pharma, noted, “Cancer remains a major global challenge, and Hengrui has been at the forefront of developing cutting-edge therapies like ADCs to address clinical treatment challenges and unmet needs. Our partnership with Glenmark marks a significant step in deepening our presence in emerging markets. We look forward to working together to enhance accessibility to innovative therapies and offer new hope to patients across more countries and regions.”

Trastuzumab Rezetecan, developed in-house by Hengrui, received approval in China in May 2025 for the treatment of adults with HER2-activating mutations in unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) after at least one prior systemic therapy. This approval makes it the first China-developed ADC approved for HER2-mutated NSCLC. 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 (National Medical Products Administration) for review and was included in the priority review program. To date, Trastuzumab Rezetecan has been included in the NMPA’s for nine indications, including breast cancer, gastric or gastroesophageal junction adenocarcinoma, colorectal cancer, biliary tract cancer, and gynecologic malignancies.

Currently, Trastuzumab Rezetecan is progressing through multiple clinical trials. In August 2025, the combination of Trastuzumab Rezetecan with adebrelimab and chemotherapy received Orphan Drug Designation by the US FDA for gastric or gastroesophageal junction adenocarcinoma.

This collaboration embodies an important milestone in Glenmark’s focused oncology strategy, particularly in complex biologics.