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Intas Pharmaceuticals, one of the leading multinational pharmaceutical formulation development, manufacturing and marketing companies in the world, 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 marks another major milestone, following the successful Launch in Europe.
This launch follows a strategic licensing agreement between Intas Pharmaceuticals Limited and Shanghai Henlius Biotech, Inc., further strengthening Intas’ oncology portfolio and reinforcing its commitment to delivering cutting-edge therapies to patients in India.
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 landmark ASTRUM-005 trial, which demonstrated a 40% 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 unique dual blockade mechanism of PD-L1 and PD-L2, along with highest PD-1 internalization, which sets a new benchmark in deep immune engagement for solid tumours. Globally, serplulimab has been administered to over a lakh patients across a range of malignancies including SCLC, NSCLC, ESCC, and MSI-high cancers.
Despite the promise of immuno-oncology, cost remains a significant barrier in India. Hetronifly, introduced at approximately 75% lower cost than the current available immunotherapies for this indication, underscores Intas’ commitment to providing high quality innovative therapies at affordable prices to the cancer patients in India.
Commenting on the launch, Binish Chudgar, chairman & 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.”
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