23 May 2026 - Henlius Biotech announced that serplulimab (Hetronifly), the company’s self-developed anti-PD-1 mAb, has received a positive opinion from the CHMP of the EMA, recommending its approval in combination with chemotherapy for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer.

The positive CHMP opinion was primarily based on ASTRUM-004, a randomised, double-blind, international multi-centre phase 3 clinical trial. Led by Dr. Caicun Zhou of Shanghai East Hospital, Tongji University School of Medicine, the study was designed to evaluate the efficacy and safety of serplulimab versus placebo, each in combination with chemotherapy, in patients with previously untreated advanced squamous non-small cell lung cancer.

Read Henlius press release