Policy & Regulation
Shanghai Henlius Biotech's EMA application for HANSIZHUANG (serplulimab) in combination with chemotherapy receives validation
24 March 2023 -

Shanghai Henlius Biotech, Inc. (2696.HK), a subsidiary of China-based Shanghai Fosun Pharmaceutical (Group) Co Ltd, announced on Thursday that the European Medicines Agency (EMA) has validated the application for the company's self-developed anti-PD-1 mAb HANSIZHUANG (serplulimab), in combination with chemotherapy (carboplatin and etoposide), intended for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

The European Commission (EC) has earlier granted Orphan Drug Designation (ODD) to the product for the treatment of small cell lung cancer (SCLC).

The company submitted the regulatory application based on data from ASTRUM-005, a randomised, double-blind, placebo-controlled international multi-centre phase three clinical study that assessed the efficacy and adverse event profile of the PD-1 inhibitor serplulimab plus chemotherapy compared with placebo plus chemotherapy as first-line treatment in patients with ES-SCLC.

The study has set up 128 sites in various countries, including China, Poland, Turkey, and Georgia, and enrolled 585 subjects, among whom 31.5% were white. The results were presented orally at the 2022 ASCO annual meeting and were then published in the JAMA (impact factor of 157.3), demonstrating the high level of academic acclaim on a global scale.