Glenmark Pharma arm enters $1.1 billion agreement with Hengrui for oncology drug

Drugmaker Glenmark Pharmaceuticals Ltd on Wednesday (September 24) said its wholly owned subsidiary Glenmark Specialty S.A. (GSSA) 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).

As part of the agreement, Glenmark will make an upfront payment of $18 million to Hengrui. The latter is also eligible to receive regulatory and commercial milestone payments of up to $1.093 billion. Additionally, Glenmark will pay royalties to Hengrui based on the net sales of Trastuzumab Rezetecan within the licensed territory.

Under the terms of the pact, Glenmark obtains exclusive rights to develop and commercialise Trastuzumab Rezetecan (SHR-A1811) across multiple regions 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.

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Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals Limited, said, "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."

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) patients 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.

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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.

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