Glenmark Specialty has received DCGI approval to initiate a Phase 3 trial of trastuzumab rezetecan in HER2-expressing platinum-resistant ovarian cancer, marking India as the first enrollment country in its multinational program.
Written By: Mayuresh Salvi, PharmD
Reviewed By: Pharmacally Editorial Team
Glenmark has received approval from the Drugs Controller General of India (DCGI) to initiate a Phase 3 clinical trial of trastuzumab rezetecan (SHR-A1811) in patients with HER2-expressing platinum-resistant ovarian cancer (PROC). India will be the first country across Glenmark’s licensed markets to begin patient enrollment, with expansion planned in Australia and South Korea following regulatory approvals.
The multinational study aligns with Jiangsu Hengrui Pharmaceuticals’ ongoing parent Phase 3 trial in China and broadens the clinical development program into more diverse patient populations. The trial supports Glenmark’s rights to develop and commercialize the HER2-targeted antibody-drug conjugate (ADC) across multiple global territories under its licensing agreement with Hengrui Pharma.
HER2-targeted ADC addresses a major treatment gap
Trastuzumab rezetecan is a HER2-directed antibody-drug conjugate developed to treat HER2-overexpressing tumors. The therapy combines trastuzumab with a cytotoxic payload, allowing targeted delivery of chemotherapy to HER2-positive cancer cells while limiting exposure to healthy tissue.
The current Phase 3 trial focuses on platinum-resistant ovarian cancer, one of the most difficult forms of recurrent ovarian cancer. Many patients initially respond to platinum-based chemotherapy but later develop resistance, leaving few effective treatment options and poor long-term outcomes.
Ovarian cancer remains the eighth most common cancer among women worldwide, and India accounts for a substantial share of global cases and deaths, highlighting the need for more effective targeted therapies.
Global Phase 3 program expands beyond China
The randomized, controlled, multicenter Phase 3 study will evaluate the efficacy, safety, and pharmacokinetics of trastuzumab rezetecan in patients with HER2-expressing platinum-resistant ovarian cancer. By enrolling patients across multiple countries, the study will generate evidence from broader patient populations to strengthen the therapy’s clinical data package across Glenmark’s licensed markets.
Dr. Monika Tandon, Global Head of Clinical Development at Glenmark Pharmaceuticals, said the trial represents an important milestone in expanding the company’s oncology pipeline. She noted that platinum-resistant ovarian cancer continues to have significant unmet medical needs and emphasized that multinational enrollment will help generate clinically relevant evidence across diverse populations while supporting the development of new targeted treatment options.
Growing clinical and regulatory momentum for trastuzumab rezetecan
Glenmark secured exclusive commercialization and development rights for trastuzumab rezetecan outside several major markets through a licensing agreement with Hengrui Pharma signed in September 2025.
The ADC has continued to gain regulatory momentum in China. It received conditional approval in May 2025 for previously treated HER2-mutated advanced non-small cell lung cancer, becoming the first China-developed ADC approved for this indication. In March 2026, Chinese regulators approved the therapy for second-line HER2-positive breast cancer after granting priority review. Hengrui also submitted a biologics license application in February 2026 for HER2-positive advanced colorectal cancer.
To date, China’s National Medical Products Administration has granted Breakthrough Therapy designation to trastuzumab rezetecan across nine oncology indications, including lung, breast, gastric, colorectal, biliary tract, and gynaecologic cancers.
Regulatory Path Forward
Patient enrollment is now set to begin in India, with Australia and South Korea expected to join the Phase 3 program after obtaining regulatory approvals. The expanded multinational study is expected to strengthen the global evidence base for trastuzumab rezetecan and support future regulatory submissions across Glenmark’s licensed territories.
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About the Writer
Mayuresh Sunil Salvi (Linkedin) is a PharmD professional and healthcare writer with a strong interest in pharmacovigilance, drug safety, and emerging medical research. He is passionate about exploring new drug discoveries, clinical research, and advances in evidence-based medicine. His interests also include ward rounds, prescription audits, and treatment analysis to support rational pharmacotherapy and improved patient care.