Glenmark Specialty S.A., a wholly owned subsidiary of Glenmark Pharmaceuticals, has advanced the global clinical development of trastuzumab rezetecan (SHR-A1811), a HER2-targeted Antibody-Drug Conjugate (ADC), by initiating a multi-country Phase 3 clinical trial for patients with Platinum-Resistant Ovarian Cancer (PROC).

India has become the first country within Glenmark’s licensed territories to commence patient enrolment for the pivotal study after receiving approval from the Drugs Controller General of India (DCGI). The company also plans to expand enrolment to Australia and South Korea, subject to obtaining the necessary regulatory approvals.

The Phase 3 trial is aligned with Jiangsu Hengrui Pharmaceuticals’ ongoing parent study in China and is intended to generate clinical evidence across broader and more diverse patient populations. The data will support the development and regulatory strategy for trastuzumab rezetecan across Glenmark’s licensed markets.

The randomized, controlled, multi-centre study will 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. Conducting the trial across multiple countries is expected to strengthen the clinical evidence package by incorporating data from diverse patient populations.

Commenting on the development, Dr. Monika Tandon, Global Head of Clinical Development at Glenmark Pharmaceuticals, said the advancement of the pivotal Phase 3 study marks a significant milestone in the company’s strategy to build a differentiated oncology portfolio for global markets. She noted that platinum-resistant ovarian cancer remains an area of high unmet medical need and initiating patient enrolment in India reflects Glenmark’s commitment to developing innovative targeted therapies for difficult-to-treat cancers while generating clinically relevant evidence across diverse populations.

Ovarian cancer continues to be one of the most challenging gynaecological cancers worldwide and ranks as the eighth most common cancer among women globally. India remains one of the countries with the highest burden of ovarian cancer cases and deaths, highlighting the need for more effective treatment options.

Trastuzumab rezetecan became part of Glenmark’s oncology pipeline following an exclusive collaboration and licensing agreement signed with Jiangsu Hengrui Pharmaceuticals. in September 2025. Under the agreement, Glenmark secured exclusive rights to develop and commercialise the therapy across multiple international markets, excluding Mainland China, Hong Kong SAR, Macao SAR, Taiwan Region, the United States, Canada, Europe, Japan, Russia and select Commonwealth of Independent States (CIS) countries.

The Phase 3 trial represents a key step in expanding the clinical development of trastuzumab rezetecan and advancing a potential new treatment option for patients with HER2-expressing platinum-resistant ovarian cancer in Glenmark’s licensed markets.