HENLIUS (02696): Suluclizumab injection receives positive review from the Committee for Medicinal Products for Human Use of the European Medicines Agency.

HENLIUS (02696) announced that recently, the company's independently developed Slulumab injection (Chinese trade name: Hanszhuang; EU trade name: Hetronifly) (Slulumab) has received positive review from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending the approval of Slulumab in combination with carboplatin and albumin-bound paclitaxel for first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) in adult patients. The CHMP's review will be submitted to the European Commission (EC), and the EC will consider this opinion and make a final decision within the next two months. Once approved by the EC, the centralized marketing authorization for Slulumab will take effect in all European Union member states and European Economic Area (EEA) countries, including Iceland, Liechtenstein, and Norway. The positive opinion from CHMP was primarily based on a randomized, double-blind, international multicenter phase 3 clinical trial. The study results showed that the use of Slulumab in combination with carboplatin and albumin-bound paclitaxel for first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer significantly benefited patients, achieving the predefined primary endpoints, and demonstrating good safety and tolerability. In December 2023, the group received several Good Manufacturing Practice (GMP) certificates from the Health and Youth Care Inspectorate in the Netherlands, indicating that the production line related to Slulumab has met EU GMP standards.