Glenmark Secures Global Rights for Next-Gen HER2-Targeted Therapy

Glenmark Specialty S.A. (GSSA), a wholly owned subsidiary of Glenmark Pharmaceuticals (NSE: GLENMARK), has signed an exclusive license and collaboration agreement with Hengrui Pharma for Trastuzumab Rezetecan (SHR-A1811).

This next-generation HER2-targeting antibody drug conjugate (ADC) represents a significant step in Glenmark’s oncology strategy, particularly in the development of complex biologics.

Under the agreement, Glenmark secures exclusive rights to develop and commercialise Trastuzumab Rezetecan globally, excluding China, Hong Kong, Macao, Taiwan, USA, Canada, Europe, Japan, Russia, and several other countries.

The deal involves an upfront payment of US$18 million, with Hengrui eligible for regulatory and commercial milestone payments of up to US$1.093 billion. Additionally, Glenmark will pay royalties on net sales within the licensed territories.

Trastuzumab Rezetecan: A Promising ADC

Trastuzumab Rezetecan is Hengrui’s self-developed HER2-targeted ADC. In May 2025, it was approved in China for adult patients with HER2-mutated non-small cell lung cancer (NSCLC) who had received prior systemic therapy, marking it as the first China-developed ADC for HER2-mutated NSCLC.

The therapy is also under priority review in China for breast cancer and has received Breakthrough Therapy Designation for nine indications, including NSCLC, breast, gastric, colorectal, biliary tract, and gynecologic cancers.

Clinical and Regulatory Milestones

The drug continues to advance in multiple clinical trials globally. In August 2025, Trastuzumab Rezetecan combined with adebrelimab and chemotherapy received Orphan Drug Designation from the US FDA for gastric or gastroesophageal junction adenocarcinoma, reflecting its potential in addressing high-burden cancers.

Also Read: Glenmark Pharma Gets DCGI Nod for Phase 3 Trial of Envafolimab!

Conclusion

This collaboration reinforces Glenmark’s long-term commitment to delivering next-generation oncology therapies across underserved markets. By acquiring global development rights, Glenmark strengthens its oncology portfolio and positions itself as a key player in complex biologics, aligning with its strategic focus on innovative cancer treatments.

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