30 March 2026 - Shanghai Henlius Biotech today announced that its self-developed anti-PD-1 monoclonal antibody, serplulimab (trade name in Europe: Hetronifly), has received two positive opinions from the EMA’s CHMP. 

The CHMP recommends approval of serplulimab in combination with chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung carcinoma and with unresectable locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma (whose tumours express PD-L1 with a CPS ≥ 5.).

Read Henlius press release