Glenmark Pharmaceuticals Gains Nearly 3% as Phase 3 Trial of Envafolimab Begins in India and Abroad

Mumbai, September 5, 2025: Glenmark Pharmaceuticals Ltd. (NSE: GLENMARK, BSE: 532296) stock rose more than 2.91% to ₹2,048 during Friday’s trading after the firm announced it has begun a multi-country Phase 3 clinical trial of Envafolimab, a new subcutaneous PD-L1 inhibitor, for patients with resectable Stage III non-small cell lung cancer (NSCLC).

The Drugs Controller General of India (DCGI) has issued a No Objection Certificate to start patient enrollment in India. At the same time, trial applications are ongoing in Russia, with additional sites planned in Brazil and Mexico.

52-Week High at ₹2,284.80 Shows Broad Trading Range and Momentum

By 1:04 PM IST, Glenmark Pharmaceuticals’ stock was trading at ₹2,048, up 2.91%. The stock opened at ₹1,990.90, reached an intraday high of ₹2,055.20, and a low matching the opening. Over the past year, the stock has gained 19%, with a 47% rise in the last six months and a 6.02% increase in the past five days. Glenmark has a market capitalisation of ₹57,820 crore and trades at a P/E ratio of 76.75. In the last 12 months, its shares have ranged from a 52-week low of ₹1,275.50 to a 52-week high of ₹2,284.80, reflecting significant volatility.

Phase 3 Trial Targets Stage III NSCLC Patients Across India and Abroad

The multi-center, Phase 3 randomised trial will evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of Envafolimab in patients with Stage IIIA and IIIB (N2) NSCLC. A parallel 3D Medicines Inc.-sponsored Phase 3 trial is already underway in China.

With its new subcutaneous administration, Envafolimab can potentially make state-of-the-art immunotherapy more convenient and readily available, particularly in areas with limited healthcare resources,” said Dr. Monika Tandon, Global Head of Clinical Development, Glenmark Pharmaceuticals.

Envafolimab’s Subcutaneous Administration Could Expand Immunotherapy Access Globally

In͏itially approved in China in 2021 for advan͏ce͏d unresectable or metas͏tatic solid tumors wit͏h MSI-H͏/dMMR, the t͏reatme͏nt͏ has alrea͏dy ͏he͏lped over͏ 40,000 patients in t͏he countr͏y. In 2024, ͏Alphamab Onco͏lo͏gy and 3D Medicines Inc. licen͏sed it to ͏G͏lenmar͏k͏ for͏ development and commercial͏iza͏tion across Indi͏a, the Asia Pacific (excludin͏g͏ Singapore, Thail͏and, an͏d M͏ala͏ysi͏a), ͏t͏he Midd͏le East, Africa, Russia͏, the CI͏S͏, and Latin America. The therap͏y is currentl͏y͏ undergoing multiple P͏hase 2 and 3 tri͏al͏s for ͏in͏di͏c͏ations including b͏ilia͏ry tract can͏ce͏r, endom͏etrial cancer͏, renal c͏ell carcinoma, and others.

Glenmark Pharmaceuticals’ initiation of the multi-country Phase 3 trial for Envafolimab highlights its expansion in oncology research. The trial’s design emphasizes efficacy, safety, and broader accessibility of subcutaneous immunotherapy. With approvals in multiple regions and ongoing trials for other cancer types, the company continues to advance its clinical pipeline while strengthening its global development footprint.

REF: https://nsearchives.nseindia.com/corporate/GLENMARK_05092025094537_PR_05092025_Signed.pdf

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