Positive CHMP opinion for Han Si Zhuang as first-line treatment for extensive-stage small cell lung cancer

Shanghai Henlius Biotech, Inc.  announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of Hansizhuang (serplulimab), Henlius’ independently developed anti-PD-1 monoclonal antibody (mAb), as a first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).In 2023, Henlius entered into an exclusive license agreement with Intas Pharmaceuticals Limited (“Intas”) for the development and commercialisation a total of more than 50 countries in Europe and India. This positive opinion from CHMP marks another step closer for both companies to providing serplulimab for patients in Europe. If approved, serplulimab will be marketed by Intas’ subsidiary, Accord Healthcare Ltd, in Europe.

”The positive opinion from CHMP is primarily based on ASTRUM-005, a randomized, double-blind, placebo-controlled international multi-centre clinical study, which evaluated 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 a total of 128 sites in various countries including China, Poland, Turkey, and Georgia, and enrolled 585 subjects, among whom 31.5% were Caucasians. The ASTRUM-005 clinical trial results were firstly presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of the American Medical Association (JAMA), making it the first study published on JAMA in SCLC immunotherapy. Based on the ASTRUM-005 study, Hansizhuang has been approved in China and Southeast Asian countries for first-line treatment of ES-SCLC, making it the world’s first anti-PD-1 mAb approved for first-line treatment of SCLC.

Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung CancerThe ASTRUM-005 Randomized Clinical Trial ;Ying Cheng, MD; Liang Han, MD; Lin Wu, PhD; et alJun Chen, PhD; Hongmei Sun, BS; Guilan Wen, MMed; Yi;. et  al., for the ASTRUM-005 Study GroupJAMA. 2022;328(12):1223-1232. doi:10.1001/jama.2022.16464.