Glenmark Specialty S.A. (GSSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark), has announced an exclusive license and collaboration agreement with Hengrui Pharma for Trastuzumab Rezetecan (SHR-A1811), a next-generation HER2-targeting antibody drug conjugate (ADC).
Under this agreement, Glenmark obtains exclusive rights to develop and commercialize Trastuzumab Rezetecan across multiple global regions, excluding Mainland China, Hong Kong SAR, Macao SAR, Taiwan, USA, Canada, Europe, Japan, Russia, and several CIS countries.
Glenmark will make an upfront payment of USD 18 million, while Hengrui will be eligible for regulatory and commercial milestone payments of up to USD 1.093 billion, along with tiered royalties based on net sales within the licensed territories.
Strategic Collaboration to Advance Oncology Innovation
“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,”
— Glenn Saldanha, Chairman & Managing Director, Glenmark Pharmaceuticals Ltd.
“Facing the major global challenge of cancer treatment, Hengrui has accelerated the research and development of cutting-edge innovative therapies such as ADCs. This collaboration with Glenmark is a significant step in deepening our presence in emerging markets and expanding patient access to breakthrough treatments,”
— Jo Feng, President, Hengrui Pharma.
About Trastuzumab Rezetecan (SHR-A1811)
Trastuzumab Rezetecan is Hengrui’s self-developed HER2-targeted ADC.
- May 2025: Approved in China for treating adult patients with HER2 (ERBB2) activating mutations in unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) after prior systemic therapy.
- September 2025: Breast cancer indication accepted for priority review by China’s NMPA.
- Breakthrough Therapy Designation: Granted by NMPA for nine indications including NSCLC, breast, gastric/gastroesophageal, colorectal, biliary tract, and gynecologic cancers.
- August 2025: Combination therapy of Trastuzumab Rezetecan + adebrelimab + chemotherapy received Orphan Drug Designation from the U.S. FDA for gastric or gastroesophageal junction adenocarcinoma.
Mechanism of Action
Trastuzumab Rezetecan is designed to selectively deliver a cytotoxic payload to tumor cells overexpressing or harboring mutations in the human epidermal growth factor receptor 2 (HER2) gene.
- The antibody component binds specifically to the HER2 receptor on cancer cells.
- Upon internalization, the linker technology releases the chemotherapeutic payload inside the tumor cell, inducing apoptosis and minimizing off-target toxicity.
- This targeted mechanism allows for higher potency against cancer cells while sparing normal tissues, improving the therapeutic index compared to conventional chemotherapy.
- Breakthrough Therapy Designation
Trastuzumab Rezetecan has received Breakthrough Therapy Designation from the NMPA for nine indications, covering a broad range of solid tumors including:- Non-small cell lung cancer (NSCLC)
- Breast cancer
- Gastric or gastroesophageal junction adenocarcinoma
- Colorectal cancer
- Biliary tract cancer
- Multiple gynecologic malignancies
- Orphan Drug Designation by US FDA
In August 2025, SHR-A1811 in combination with adebrelimab (anti-PD-L1 antibody) and chemotherapy received Orphan Drug Designation from the U.S. FDA for the treatment of gastric or gastroesophageal junction adenocarcinoma. This designation highlights the therapy’s potential benefit in rare, hard-to-treat cancers.
Clinical Development Landscape
Trastuzumab Rezetecan is currently being evaluated in multiple Phase II and Phase III global clinical trials targeting both first-line and later-line treatments. Key areas of investigation include:
- NSCLC with HER2 mutations or overexpression
- HER2-positive breast cancer (early and metastatic)
- Gastrointestinal malignancies (including gastric and colorectal cancers)
- Biliary tract and gynecologic cancers
Preliminary data from ongoing trials have demonstrated:
- Encouraging objective response rates (ORR)
- Durable responses in heavily pretreated patients
- A manageable safety profile, with most adverse events being low-grade and reversible
This evidence positions SHR-A1811 as a potential best-in-class ADC for HER2-driven cancers, complementing and potentially surpassing existing HER2 therapies in certain patient populations.
Therapeutic Potential
The broad therapeutic reach of Trastuzumab Rezetecan offers the possibility to:
- Expand treatment options beyond breast cancer to lung, gastrointestinal, and gynecologic cancers.
- Address HER2-mutated tumors, not just HER2-overexpressing cancers — a major advancement in targeted oncology.
- Provide a valuable treatment option in emerging markets where access to cutting-edge biologics remains limited.
Strengthening Glenmark’s Global Oncology Footprint
This partnership marks a significant step in Glenmark’s oncology strategy, particularly in complex biologics. It supports Glenmark’s long-term commitment to delivering next-generation therapies across high-burden and underserved geographies, leveraging its global development and commercial infrastructure.
About Glenmark Pharmaceuticals Ltd.
Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is a global, research-led pharmaceutical company with a focus on respiratory, dermatology, and oncology therapeutic areas.
- 11 world-class manufacturing facilities across 4 continents
- Operations in 80+ countries
- Ranked among Top 100 global biopharma companies (Scrip 100, 2023)
- Ranked among Top 50 Generics & Biosimilar companies (Generics Bulletin, 2024)
- Committed to sustainability with SBTi-approved GHG reduction targets (2023)
About Hengrui Pharma
Hengrui Pharma, founded in 1970, is a global pharmaceutical company focused on oncology, metabolic & cardiovascular, immunological & respiratory diseases, and neuroscience. The company is committed to advancing human health by accelerating research, development, and commercialization of innovative therapies.
