By Fineline Cube 
Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196) announced that its subsidiary Shanghai Henlius Biotech Inc.’s (HKG: 2696) self-developed anti-PD-1 monoclonal antibody (mAb) Hansizhuang (serplulimab, marketed as Hetronifly in Europe) has received approvals from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Indian Central Drugs Standard Control Organization (CDSCO) for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). The product will be commercialized in these regions by Henlius’ partner Intas Pharmaceuticals and its subsidiary Accord Healthcare under the brand name Hetronifly.
Clinical Trial Results
The approvals are based on results from the ASTRUM-005 study, conducted across 128 trial sites globally with 585 participants. At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, the final analysis of ASTRUM-005 demonstrated that with a median follow-up of 42.4 months, the 4-year overall survival (OS) rate in the serplulimab plus chemotherapy group reached 21.9% (95% CI: 17.6–26.6%). This confirms the long-term survival benefits of this immunotherapy regimen for ES-SCLC patients.
Global Impact
Hansizhuang is the world’s first anti-PD-1 mAb approved for first-line SCLC treatment. It has been approved in nearly 40 countries and regions, including China, Indonesia, Singapore, and Germany, benefiting over 110,000 patients worldwide.-Fineline Info & Tech