India Pharma Outlook Team | Wednesday, 24 September 2025
Intas Pharmaceuticals launches HETRONIFLY (Serplulimab) in the Indian market, the world's first PD-1 inhibitor to be approved for use in Extensive-Stage Small Cell Lung Cancer (ES-SCLC).
This launch is a significant step following its previous launch in Europe and is enabled by a licensing agreement with Shanghai Henlius Biotech, Inc.
Serplulimab is the only PD-1 inhibitor to be approved for ES-SCLC and is currently available in over 40 countries worldwide, including certain European countries. Supported by the pivotal ASTRUM-005 trial, Serplulimab showed a 40% reduction in the risk of death along with superior outcomes in survival as compared to standard chemotherapy.
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It also received a new ESMO-MCBS score of 4/5, the maximum score of any current immunotherapy in this indication. Serplulimab's unique dual blockade of PD-L1 and PD-L2 along with highest PD-1 internalization leads in establishing a new bar of immune engagement of solid tumors. Clearly demonstrated in multiple cancers, including SCLC, NSCLC, ESCC, and MSI-high tumors, Serplulimab has been administered to over 100,000 patients worldwide.
In India, Intas has priced HETRONIFLY about 75% less than other immunotherapies, addressing one of the largest barriers to receiving cancer care: costs. The Chairman & Managing Director of Intas, Binish Chudgar stated that the therapy's development enhances the company's leadership position in oncology while ensuring more rapid and affordable access to innovative therapies for patients in India.
