Intas Pharmaceuticals has launched HETRONIFLY (Serplulimab), the first PD-1 inhibitor globally approved for the treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC), in the Indian market.
This launch follows a strategic licensing agreement between Intas Pharmaceuticals Ltd. and Shanghai Henlius Biotech, Inc., further strengthening Intas' oncology portfolio.
Serplulimab is the first PD-1 inhibitor worldwide to receive approval for ES-SCLC, and is currently present in over 40 countries, including key European markets. Its efficacy is supported by the ASTRUM-005 trial, which demonstrated a 40 percent reduction in the risk of death and remarkably higher overall survival rate versus the current standard-of-care Chemotherapy regimen. Notably, Serplulimab achieved an ESMO-MCBS score of 4/5—the highest among current immunotherapies, signifying highest clinical benefit in this indication.
The novel humanized mAb has a unique dual-blockade mechanism of PD-L1 and PD-L2, along with the highest PD-1 internalization, which sets a new benchmark in deep immune engagement for solid tumors. Globally, Serplulimab has been administered to over a lakh patients across a range of malignancies including SCLC, NSCLC, ESCC, and MSI-high cancers.
Commenting on the launch, Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals said, “The launch of HETRONIFLY reinforces our strategic position in oncology and reflects Intas' commitment to accelerating access to globally validated therapies. It aligns with our operating model of delivering high-impact innovations to the Indian market with speed and cost-efficiency.”
Despite the promise of immuno-oncology, cost remains a significant barrier in India. HETRONIFLY, introduced at approximately 75 percent lower cost than the currently available immunotherapies for this indication, underscores Intas' commitment to providing high-quality innovative therapies at affordable prices to cancer patients in India.
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