Shares of Glenmark Pharmaceuticals Ltd soared 3% on Friday, 4 September, after the company announced securing approval from DCGI. 

Glenmark Pharmaceuticals’ shares surged after the Drugs Controller General of India (DCGI) approved a Phase 3 clinical trial of Envafolimab, a new subcutaneous PD-L1 inhibitor, in patients with resectable Stage III non-small cell lung cancer (NSCLC).

The multi-country research, which excludes China, will assess the drug’s efficacy, safety, pharmacokinetics, and immunogenicity. Patient recruitment and dosing will soon commence in India, and trial applications have been filed in Russia, with more sites planned for Brazil and Mexico.

Envafolimab is currently in Phase 3 testing in China, sponsored by 3D Medicines Inc.

Monika Tandon, global head of clinical development at Glenmark Pharmaceuticals, said, “The initiation of this pivotal Phase 3 study for Envafolimab marks an important milestone in Glenmark’s journey to reimagine possibilities in oncology. With its novel subcutaneous administration, Envafolimab has the potential to make cutting-edge immunotherapy more accessible and convenient for patients worldwide, especially in regions where healthcare resources are constrained.”
 
Monika added, 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.”

Lung cancer is the largest cause of cancer death globally, with NSCLC accounting for up to 85% of cases. Survival rates for Stage III patients remain poor, highlighting the need for novel treatments.

Glenmark is a research-led global pharmaceutical company that operates in the branded, generic, and over-the-counter markets, with a presence in over 80 countries and 11 manufacturing locations spread across four continents.

At 2:13 pm, the shares of Glenmark Pharmaceuticals were trading 3% higher at Rs 2,050.70 on NSE.

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