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).
Under the agreement, Glenmark secures exclusive rights to develop and commercialize Trastuzumab Rezetecan worldwide, excluding Mainland China, Hong Kong SAR, Macao SAR, Taiwan, USA, Canada, Europe, Japan, Russia, and select CIS countries. Glenmark will make an upfront payment of US$18 million, while Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion, in addition to royalties on net sales within the licensed territory.
“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,” said Glenn Saldanha, chairman and managing director, Glenmark Pharmaceuticals Limited.
“Facing the major global challenge of cancer treatment, Hengrui has over the years accelerated the research and development of cutting-edge innovative therapies such as ADCs and is committed to addressing clinical treatment challenges and meeting unmet medical needs. This collaboration with Glenmark is a significant step in Hengrui’s ongoing strategy to deepen its presence in emerging markets. We look forward to working together to enhance the accessibility of innovative therapies and to bring new hope to patients in more countries and regions,” said Jo Feng, president of Hengrui Pharma.
Trastuzumab Rezetecan is Hengrui’s self-developed HER2-targeted ADC. In May 2025, it was approved in China for 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—the first China-developed ADC approved for HER2-mutated NSCLC. In September 2025, its new indication for breast cancer was accepted by China’s NMPA for review under the priority review program. To date, Trastuzumab Rezetecan has received Breakthrough Therapy Designation from the NMPA for nine indications, covering NSCLC, breast, gastric or gastroesophageal junction adenocarcinoma, colorectal, biliary tract, and gynecologic cancers.
The drug is also advancing multiple clinical trials globally. In August 2025, Trastuzumab Rezetecan, in combination with adebrelimab and chemotherapy, received Orphan Drug Designation from the US FDA for gastric or gastroesophageal junction adenocarcinoma.
This collaboration represents a key milestone in Glenmark’s focused oncology strategy, particularly in complex biologics, and underscores its long-term commitment to delivering next-generation therapies across high-burden and underserved geographies.