Glenmark Pharmaceuticals Limited announced the advancement of its multi-country Phase 3 clinical trial for Trastuzumab rezetecan (SHR-A1811), a HER2-targeted antibody drug conjugate, in patients with platinum-resistant ovarian cancer. Glenmark Specialty S.A, a wholly owned subsidiary, is conducting the trial.
India will be the first country in Glenmark's licensed markets to begin patient enrollment following approval from the Drugs Controller General of India. Glenmark also plans to enroll patients in Australia and South Korea, subject to regulatory approvals. The randomized, controlled, multi-centre Phase 3 trial will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab rezetecan in patients with HER2-expressing platinum-resistant ovarian cancer.
The study is aligned with Jiangsu Hengrui Pharmaceuticals Co. Ltd.'s ongoing parent Phase 3 trial in China. In September 2025, Glenmark entered an exclusive collaboration and license agreement with Hengrui Pharma for Trastuzumab rezetecan, securing rights to develop and commercialize the asset across multiple markets. Glenmark holds exclusive rights worldwide excluding Mainland China, Hong Kong SAR, Macao SAR, Taiwan Region, USA, Canada, Europe, Japan, Russia, and other specified territories.
Trastuzumab rezetecan received conditional approval in China in May 2025 for HER2-mutated non-small cell lung cancer. In March 2026, the drug was approved in China for HER2-positive second-line breast cancer. A biologics license application was also filed in China in February 2026 for HER2-positive advanced colorectal cancer. The therapy has received nine Breakthrough Therapy Designations from China's National Medical Products Administration across multiple cancer types.
Ovarian cancer is the eighth most common cancer among women globally. India ranks among the countries with the highest number of ovarian cancer cases and deaths. Many patients with advanced ovarian cancer who receive platinum-based therapies develop recurrence and platinum resistance over time.
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