Intas Pharmaceuticals Launches HETRONIFLY (Serplulimab), India’s First Novel Immunotherapy for Advanced Small Cell Lung Cancer

AHMEDABAD, India, Aug. 5, 2025 /PRNewswire/ — 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 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 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.

Despite the promise of immuno-oncology, cost remains a significant barrier in India. HETRONIFLY™, introduced at approximately 75% 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.

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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