Glenmark Advances Multi-Country Phase 3 Clinical Trial of Trastuzumab rezetecan in Platinum-Resistant Ovarian Cancer

Glenmark Advances Multi-Country Phase 3 Clinical Trial of Trastuzumab rezetecan in Platinum-Resistant Ovarian Cancer​

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). The HER2 targeted antibody drug conjugate (ADC) is being studied for patients battling platinum-resistant ovarian cancer (PROC).

India has been designated as the first country within Glenmark's licensed markets to begin patient enrollment for the Phase 3 clinical trial, following regulatory approval from the Drugs Controller General of India (DCGI). The company plans further patient enrollments in Australia and South Korea, subject to respective regulatory approvals.

The randomized, controlled, multi-centre Phase 3 trial is designed to evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab rezetecan in patients with HER2 expressing platinum-resistant ovarian cancer. This disease presents significant clinical challenges as treatment options remain limited, leading to poor outcomes for patients. Conducting the study across multiple geographies aims to generate evidence from diverse patient groups, thereby strengthening the clinical data package for this therapy across Glenmark's licensed markets.

The ongoing study aligns with the parent Phase 3 trial being conducted by Jiangsu Hengrui Pharmaceuticals Co. Ltd. in China.

The Drug and Collaboration Background​

Trastuzumab rezetecan (SHR-A1811) is a HER2 targeted first in class antibody drug conjugate (ADC). It was developed by Hengrui Pharma to address challenges associated with HER2 overexpressing tumors across various cancers, including breast, gastric, and colorectal types.

In September 2025, Glenmark entered into an exclusive collaboration and license agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) for Trastuzumab rezetecan. Under this agreement, Glenmark holds exclusive rights globally, 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.

Product Development Status​

Trastuzumab rezetecan has several noted indications through Hengrui Pharma in China:

• It was conditionally approved in May 2025 for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 activating mutations and have received at least one prior systemic therapy. This marked the first China developed ADC approved for HER2 mutated NSCLC.
• In March 2026, the application for a new breast cancer indication was approved by China's National Medical Products Administration (NMPA) for patients with HER2 positive secondline (2L) breast cancer.
• Hengrui Pharma also filed a biologics license application (BLA) in February 2026 for advanced colorectal cancer.

To date, Trastuzumab rezetecan has been included in the NMPA's Breakthrough Therapy Designation list across nine indications, including NSCLC, breast cancer, gastric or gastroesophageal junction adenocarcinoma, colorectal cancer, biliary tract cancer, and gynecologic malignancies.

GLENMARK Stock Price Movement​

Glenmark Pharmaceuticals Limited shares slipped on Wednesday, shedding 2.12% and settling at ₹2161.90 amid market volatility. The decline was supported by heavy institutional activity, with 455,357 shares traded during the session.