Glenmark Specialty SA, a wholly owned subsidiary of Glenmark Pharmaceuticals has announced the advancement of its multi-country phase 3 clinical trial for Trastuzumab rezetecan (SHR-A1811), a HER2-targeted Antibody Drug Conjugate (ADC), for patients with Platinum-Resistant Ovarian Cancer (PROC).

India will serve as the first country in Glenmark’s licensed markets to initiate patient enrollment for the phase 3 clinical trial, following the approval of Drugs Controller General of India (DCGI). The company also plans to enroll patients in Australia and South Korea, subject to regulatory approvals.

The study is aligned with Jiangsu Hengrui Pharmaceuticals' ongoing parent phase 3 trial in China. Glenmark aims to generate clinically relevant data across broader and more diverse patient populations, supporting the development of Trastuzumab rezetecan across the company’s licensed markets. The randomised, controlled, multi-center, phase 3 trial is designed to evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab rezetecan in patients with HER2-expressing PROC, a difficult-to-treat disease where treatment options remain limited, and outcomes continue to be poor. Conducting the trial across multiple geographies is expected to support the generation of evidence from diverse patient groups and strengthen the clinical data package for the therapy across Glenmark’s licensed markets.

Commenting on the announcement, Dr. Monika Tandon, Global Head—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. PROC remains an area of significant unmet need, and the initiation of patient enrollment in India, with additional countries planned, reflects our commitment to developing novel targeted therapies for patients with hard-to-treat cancers and limited treatment options. This study also strengthens our ability to generate clinically relevant evidence across diverse populations.”

Many patients with advanced ovarian cancer treated with available platinum-based therapies develop recurrence and subsequently platinum resistance. This underscores the need for continued clinical development of targeted therapies that may improve treatment options for patients with advanced and resistant disease.

In September 2025, Glenmark entered into an exclusive collaboration and license agreement with Jiangsu Hengrui Pharmaceuticals for Trastuzumab rezetecan (SHR-A1811), securing rights to develop and commercialise the asset across multiple markets. Under the agreement, Glenmark holds exclusive rights 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.