Hengrui Pharma and Glenmark Pharmaceuticals Enter Exclusive License Agreement for HER2 ADC Trastuzumab Rezetecan (SHR-A1811)

SHANGHAI, Sept. 24, 2025 /PRNewswire/ -- Hengrui Pharma (600276.SH; 01276.HK), a leading innovative global pharmaceutical company focused on scientific and technological innovation, announced today that it has entered into an exclusive license agreement with Glenmark Specialty S.A. (GSSA), a wholly-owned subsidiary of Glenmark Pharmaceuticals Ltd., which is a research-led, global pharmaceutical company, for Hengrui's independently developed HER2-targeting ADC, Trastuzumab Rezetecan (SHR-A1811).

Under the terms of the agreement, Hengrui has granted Glenmark exclusive rights to develop and commercialize Trastuzumab Rezetecan 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 Hengrui 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.

Jo Feng, President of Hengrui Pharma, said:

"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."

Glenn Saldanha, Chairman and Managing Director of Glenmark, said:

"We are delighted to collaborate with Hengrui and build on the scientific momentum of Trastuzumab Rezetecan (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."

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.

Notably, based on its proprietary modular ADC platform (HRMAP®) and over 10 years of experience in ADC research and development, Hengrui Pharma has become a leading domestic enterprise in the layout of popular targets, with a number of differentiated ADC products. At present, more than 10 differentiated ADC molecules, including Trastuzumab Rezetecan, have been successfully approved for clinical trials. As of June 2025, 6 of Hengrui's ADC products are in Phase III clinical trials or beyond, and a number of innovative drug products are deployed in various solid tumor treatment fields.

About Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is a research‐led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. Glenmark Pharmaceuticals has 11 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries. Scrip 100 positions Glenmark Pharmaceuticals amongst the Top 100 biopharmaceutical companies ranked by Pharmaceutical Sales in 2023. For more information, please visit the following website of Glenmark Pharmaceuticals: www.glenmarkpharma.com.

About Hengrui Pharma

Hengrui Pharma is an innovative, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. Its therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. Founded in 1970 with the core principle of putting patients first, Hengrui Pharma remains committed to advancing human health by striving to conquer diseases, improve health, and extend lives through the power of science and technology.

SOURCE Hengrui Pharma