On 9 June 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration has approved a new indication of Hansizhuang® (serplulimab, marketed as Hetronifly® in EU), in combination with Oxaliplatin and S-1. The new indication is the neoadjuvant treatment of resectable gastric cancer with tumour PD-L1 expression CPS ≥ 5, followed by adjuvant monotherapy after surgery.
Henlius says the approval means that serplulimab is the first and only anti-PD-1 mAB in the world that has been approved for perioperative treatment of gastric cancer.
Henlius’ serplulimab received its first approval from China’s National Medical Products Administration (NMPA) in November 2022, for the first-line treatment (in combination with carboplatin and paclitaxel) of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC). It has also been approved in China for ES-SCLC, ESCC and nsqNSCLC. Henlius launched serplulimab as Hansizhuang® in certain Asian countries, including China, in August 2024.
Hetronifly® received a positive opinion from the European Medicines Agency’s CHMP for extensive-stage small cell lung cancer (ES-SCLC) in September 2024. In February 2025, it was approved by the EC for use in combination with carboplatin and etoposide as a first-line treatment for adult patients with ES-SCLC. It has since been approved in other countries for this indication, including the UK and India (June 2025). In May 2026, Hetronifly® was also approved in the EU for combination use in treating (a) certain metastatic oesophageal squamous cell carcinomas; and (b) certain non-squamous non-small cell lung carcinomas.