Mumbai: Glenmark Specialty S.A. (GSSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark), today announced that it 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 terms of the agreement, Glenmark obtains 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 an upfront payment of US$18 million. 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.
“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 the treatment of 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. 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 for review and was included in the priority review program. To date, Trastuzumab Rezetecan has been included in the NMPA’s Breakthrough Therapy Designation list for nine indications, covering NSCLC, breast cancer, gastric or gastroesophageal junction adenocarcinoma, colorectal cancer, biliary tract cancer, and gynecologic malignancies.
Currently, Trastuzumab Rezetecan is actively advancing multiple clinical trials. In August 2025, Trastuzumab Rezetecan in combination with adebrelimab and chemotherapy obtained Orphan Drug Designation from the US FDA for gastric or gastroesophageal junction adenocarcinoma.
This collaboration marks a significant step forward in Glenmark’s focused oncology strategy, particularly in complex biologics. It reinforces Glenmark’s long-term commitment to delivering next-generation therapies across high-burden, underserved geographies.
