HENLIUS (02696): The injection solution of surlitumab (Chinese brand name: Hanszhuang) has received a positive review opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency.

HENLIUS (02696) announces that recently, the monoclonal antibody injection Salulirab (Chinese product name: Hanzhuang) has received positive evaluation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending approval for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in adult patients in combination with carboplatin and etoposide. The evaluation opinion of CHMP will be submitted to the European Commission (EC), which will consider the opinion and make a final review decision in the next 2-3 months. Once approved by the EC, the centralized marketing authorization for Hanzhuang will be effective in all European Union Member States and European Economic Area (EEA) countries including Iceland, Liechtenstein, and Norway. This positive opinion from CHMP is based on a randomized, double-blind, international multicenter Phase 3 clinical study. The study results show that Hanzhuang in combination with chemotherapy (carboplatin-etoposide) significantly benefits previously untreated ES-SCLC patients compared to chemotherapy alone, meeting the pre-specified primary endpoint criteria, and demonstrating good safety and tolerability. In December 2023, the group received several GMP certificates from the Health and Youth Care Inspectorate of the Netherlands, indicating that the production line related to Hanzhuang complies with the EU GMP standards.