On 10 May 2026, Shanghai Henlius Biotech announced that the European Commission (EC) has approved two new indications for Hetronifly® (serplulimab) including combination use for (a) certain metastatic oesophageal squamous cell carcinomas; and (b) certain non-squamous non-small cell lung carcinomas.
This follows positive opinions for these indications from the EMA’s Committee for Medicinal Products for Human Use (CHMP) in March 2026.
Henlius’ Hetronifly® is the first and only anti-PD-1 mAb approved in the EU for extensive-stage small cell lung cancer (ES-SCLC). Hetronifly® received a positive opinion from the European Medicines Agency’s CHMP for 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).
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 nsqNSCL. Henlius launched serplulimab as Hansizhuang® in certain Asian countries, including China, in August 2024.
Shanghai Henlius is pursuing regulatory approval of serplulimab for the perioperative treatment of gastric cancer. In December 2025, its New Drug Application for Hansizhuang®, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by adjuvant treatment after surgery, for gastric cancer was accepted by China’s National Medical Products Administration (NMPA) and granted Priority Review.