Glenmark Specialty S.A., a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd., has announced the advancement of its multi-country Phase 3 clinical trial for Trastuzumab rezetecan (SHR-A1811), a HER2-targeted antibody-drug conjugate (ADC) being developed for patients with platinum-resistant ovarian cancer (PROC).

India will become the first country within Glenmark's licensed markets to begin patient enrollment after receiving approval from the Drugs Controller General of India (DCGI). The company also plans to expand enrollment to Australia and South Korea, subject to regulatory approvals.

The randomized, controlled, multi-centre Phase 3 study is aligned with Jiangsu Hengrui Pharmaceuticals' ongoing parent trial in China and is designed to evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab rezetecan in patients with HER2-expressing platinum-resistant ovarian cancer—a disease with limited treatment options and poor clinical outcomes.

Dr. Monika Tandon, Global Head of Clinical Development, Glenmark Pharmaceuticals, said, "Advancing this pivotal Phase 3 trial marks an important step in Glenmark's journey to build a differentiated oncology pipeline for global markets. The initiation of patient enrollment in India reflects our commitment to developing novel targeted therapies for patients with hard-to-treat cancers while generating clinically relevant evidence across diverse populations."

Ovarian cancer remains the eighth most common cancer among women globally, with India accounting for a significant share of cases and deaths. Many patients eventually develop resistance to platinum-based chemotherapy, highlighting the need for innovative targeted therapies.

The Phase 3 programme builds on Glenmark's September 2025 exclusive licensing agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. for Trastuzumab rezetecan, under which Glenmark secured rights to develop and commercialize the therapy across multiple international markets outside China and several other excluded territories.