Glenmark Seals Multi-Billion Dollar Deal for Next-Gen HER2-Targeting Cancer Drug

Glenmark Pharmaceuticals Ltd., through its wholly-owned subsidiary Glenmark Specialty S.A. (GSSA), has entered a major exclusive licensing and collaboration agreement with China’s Hengrui Pharma for Trastuzumab Rezetecan (SHR-A1811), a cutting-edge, next-generation HER2-targeting antibody-drug conjugate (ADC).

This strategic partnership significantly bolsters Glenmark’s focus on complex biologics and its oncology pipeline, securing development and commercialization rights for the innovative therapy in a broad range of global territories.

Deal Structure and Financials

Upfront Payment: Glenmark will make an upfront payment of US$18 million to Hengrui Pharma.
Total Potential Value: Hengrui is eligible to receive up to US$1.093 billion in regulatory and commercial milestone payments.
Royalties: Glenmark will also pay corresponding royalties to Hengrui based on the net sales of Trastuzumab Rezetecan within the licensed territory.
Licensed Territory: Glenmark obtains exclusive rights worldwide, excluding Mainland China, Hong Kong SAR, Macao SAR, Taiwan Region, USA, Canada, Europe, Japan, Russia, and several other CIS (Commonwealth of Independent States) countries. This primarily focuses the therapy’s expansion into high-burden, underserved emerging markets.

Trastuzumab Rezetecan: A Promising ADC

Trastuzumab Rezetecan (SHR-A1811) is Hengrui’s self-developed HER2-targeted ADC, a class of drugs designed to selectively deliver a potent chemotherapy agent directly to cancer cells that overexpress the HER2 protein.

Approvals and Designations:
- Approved in China (May 2025): For the treatment of adult patients with HER2-mutated non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. It is the first China-developed ADC approved for this indication.
- Priority Review (China, September 2025): New indication for use in breast cancer was accepted and included in the priority review program by China’s NMPA.
- Breakthrough Therapy Designation (China): Included on the list for nine indications, spanning NSCLC, breast cancer, gastric/gastroesophageal junction adenocarcinoma, colorectal cancer, and others.
- Orphan Drug Designation (US FDA, August 2025): For its use in combination with adebrelimab and chemotherapy for gastric or gastroesophageal junction adenocarcinoma.

Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals Limited, emphasized the strategic fit: “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.”

The collaboration is a critical move in Glenmark’s long-term strategy to deliver next-generation therapies across high-burden, underserved geographies, enhancing the accessibility of innovative cancer treatments globally.