Glenmark Pharmaceuticals has commenced its multi-country Phase 3 clinical trial for Trastuzumab rezetecan (SHR-A1811) in India, marking a significant milestone in the country's biologics development. Following the approval from the Drugs Controller General of India (DCGI), India becomes the first country in Glenmark's licensed markets to initiate patient enrollment for this trial. This development represents the first-in-market clinical progression for this molecule globally, validating Glenmark's strategic shift toward complex biologics and high-value oncology segments. The estimated R&D intensity for this program is 8-10% of annual revenue, highlighting the significant investment required for advanced drug development.
The randomized, controlled, multi-centre trial 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 outcomes. According to Glenmark Pharmaceuticals, the company plans to enroll patients in Australia and South Korea, subject to regulatory approvals, as part of its broader effort to gather clinically relevant data across diverse patient populations. The study is aligned with Jiangsu Hengrui Pharmaceuticals Co.'s ongoing parent Phase 3 trial in China, with Glenmark aiming to develop novel targeted therapies for patients with hard-to-treat cancers and limited treatment options. Dr. Monika Tandon, Global Head of Clinical Development at Glenmark Pharmaceuticals, stated that advancing this pivotal Phase 3 trial marks an important step in building a differentiated oncology pipeline for global markets.
Securing India as the first site for Phase 3 trials suggests a streamlined regulatory pathway and domestic cost-efficiencies for clinical development. This strategic choice demonstrates a sophisticated approach to clinical development and market entry, as Glenmark is aggressively pivoting toward the ADC platform, a high-growth segment in global oncology. The first-mover advantage in the ₹2,500 crore domestic cancer segment provides a cushion against generic volatility and could significantly expand Glenmark's oncology portfolio, which currently faces competitive pricing pressures in generic segments. In September 2025, Glenmark entered into an exclusive collaboration and license agreement with Jiangsu Hengrui Pharmaceuticals for Trastuzumab rezetecan, securing rights to develop and commercialise the asset across multiple markets, excluding certain regions.
The global Antibody-Drug Conjugate market is projected to reach $15 billion by 2028, with the ADC market representing one of the most lucrative and technically challenging areas of drug development. Trastuzumab rezetecan has achieved significant regulatory milestones, including conditional approval in China for NSCLC in May 2025, priority review designation in September 2025, and breast cancer approval in March 2026. The drug has been granted NMPA Breakthrough Therapy Designation for nine indications, covering NSCLC, breast cancer, gastric or gastroesophageal junction adenocarcinoma, colorectal cancer, biliary tract cancer, and gynecologic malignancies. Ovarian cancer ranks as the eighth most common cancer among women worldwide, with India facing a significant burden due to high numbers of cases and deaths. Many patients with advanced ovarian cancer develop resistance to available platinum-based therapies, creating a massive commercial whitespace for effective ADCs.
