Intas Pharmaceuticals has announced the launch of HETRONIFLY™ (Serplulimab) in India, marking a significant milestone as it becomes the first PD-1 inhibitor globally approved for the treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). This follows its successful introduction in European markets and further expands Intas’ innovative oncology portfolio.
The launch is part of a strategic licensing agreement with Shanghai Henlius Biotech, Inc., reflecting Intas’ ongoing commitment to delivering breakthrough cancer therapies in India.
Serplulimab is the only PD-1 inhibitor to receive regulatory approval worldwide for ES-SCLC. It is now available in over 40 countries, including key European regions. The therapy’s efficacy is backed by the pivotal ASTRUM-005 trial, which demonstrated a 40% reduction in the risk of death and significantly improved overall survival compared to the current standard chemotherapy regimen. It also earned an ESMO-MCBS score of 4 out of 5, the highest rating among current immunotherapies for this indication, highlighting its strong clinical benefit.
A humanized monoclonal antibody (mAb), Serplulimab features a unique dual-blockade mechanism targeting PD-L1 and PD-L2, and exhibits the highest PD-1 internalization in its class, offering deeper immune engagement in solid tumors. Globally, Serplulimab has been used by over 1 lakh patients across multiple cancer types, including SCLC, NSCLC, ESCC, and MSI-high cancers.
Addressing the affordability challenge in immuno-oncology, HETRONIFLY™ is priced approximately 75% lower than existing immunotherapies for ES-SCLC in India. This pricing strategy aims to increase accessibility to high-quality cancer care for Indian patients.
Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals, stated:
“The launch of HETRONIFLY™ reinforces our leadership in oncology and demonstrates our unwavering commitment to making globally validated innovations accessible to Indian patients. It aligns with our core strategy of introducing high-impact therapies with speed, scale, and affordability.”