Intas launches Hetronifly as first PD one therapy for ESSCLC

Intas Pharmaceuticals, a prominent multinational company specializing in pharmaceutical formulation development, manufacturing, and marketing, has introduced Hetronifly (serplulimab) in the Indian market.

This product is the first PD-1 inhibitor to receive global approval for the treatment of extensive-stage small cell lung cancer (ES-SCLC). This launch represents a significant achievement, following its successful introduction in Europe.

The launch is a result of a strategic licensing agreement between Intas Pharmaceuticals Limited and Shanghai Henlius Biotech, Inc. which further enhances Intas’ oncology portfolio and reaffirms its dedication to providing advanced therapies to patients in India. Serplulimab is the first PD-1 inhibitor to gain approval for ES-SCLC worldwide and is currently available in over 40 countries, including major European markets.

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Its effectiveness is backed by the landmark ASTRUM-005 trial, which showed a 40% decrease in the risk of death and a significantly improved overall survival rate compared to the existing standard chemotherapy regimen. Importantly, serplulimab received an ESMO-MCBS score of 4/5, the highest among current immunotherapies, indicating the greatest clinical benefits for this condition.

This innovative humanized monoclonal antibody features a unique dual blockade mechanism targeting PD-L1 and PD-L2, along with the highest PD-1 internalization, establishing a new standard for deep immune engagement in solid tumors. Globally, serplulimab has been administered to over 100,000 patients across various malignancies, including SCLC, NSCLC, ESCC, and MSI-high cancers.

Despite the potential of immuno-oncology, cost remains a significant obstacle in India. Hetronifly, priced approximately 75% lower than currently available immunotherapies for this indication, highlights Intas’ commitment to delivering high-quality innovative therapies at affordable prices for cancer patients in India.