Glenmark Pharmaceuticals on Friday (September 5, 2025) stated it has initiated a multi-country Phase 3 clinical trial for Envafolimab, a novel drug for third-stage non-small cell lung cancer.
The firm stated it has acquired approval from the Drugs Controller General of India to start affected person enrolment and dosing within the nation.
In parallel, the drug agency has submitted a clinical trial utility in Russia and is making ready to open extra clinical trial websites in Brazil and Mexico, Glenmark stated in a press release.
The randomised, multi-centre, Phase 3 trial will assess the efficacy, security, pharmacokinetics, and immunogenicity of Envafolimab in sufferers with third-stage non-small cell lung cancer (NSCLC).
Lung cancer stays the main explanation for cancer-related deaths worldwide, with NSCLC comprising round 80-85% of circumstances.
“By advancing this trial across multiple geographies, we are reinforcing our commitment to transforming the standard of care in Stage III NSCLC and addressing one of the greatest unmet needs in cancer treatment today,” Glenmark Pharmaceuticals Global Head of Clinical Development Monika Tandon stated.
Shares of Glenmark settled 3.3% up at ₹2,056.35 apiece on the BSE.
