Fosun International's Serplulimab Gains Regulatory Approval in the UK and India for First-Line Treatment of Extensive-Stage Small Cell Lung Cancer

Reuters
25 Jun
Fosun International's Serplulimab Gains Regulatory Approval in the UK and India for First-Line Treatment of Extensive-Stage Small Cell Lung Cancer

Fosun International Limited's self-developed anti-PD-1 monoclonal antibody, serplulimab, has received regulatory approval in the United Kingdom and India for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). This marks the world's first approval of an anti-PD-1 mAb for ES-SCLC and expands its reach to nearly 40 countries, including China, Europe, and multiple Southeast Asian nations. The drug, commercially known in Europe as Hetronifly®, will be marketed in these regions by Fosun's partners, Intas and its subsidiary Accord Healthcare. The approval is based on results from the global phase 3 clinical study ASTRUM-005, demonstrating a significant long-term survival benefit. Henlius, a Fosun subsidiary, continues to pursue further global regulatory filings and partnerships to enhance accessibility to this innovative treatment.

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