FOSUN PHARMA (600196.SH) announced that its subsidiary Shanghai Henlius Biotech, Inc. and its controlled subsidiaries recently had the supplemental new drug application for Serplulimab Injection (branded as HANSIZHUANG® in China) accepted by the National Medical Products Administration (NMPA). The application seeks approval for a new indication—combined with platinum-based chemotherapy as neoadjuvant therapy followed by adjuvant therapy for PD-L1-positive, resectable gastric cancer patients—and has been included in the priority review process.

Serplulimab is an innovative anti-PD-1 monoclonal antibody independently developed by the group. As of the announcement date (December 12, 2025), the drug has been approved in China, the EU, the UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India. In China, its approved indications include first-line combination therapy for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC).

Additionally, Serplulimab has received orphan drug designation from regulatory authorities in the US, EU, Switzerland, and South Korea for related indications. In November 2025, the NMPA’s Center for Drug Evaluation included the drug in the breakthrough therapy program for its use in neoadjuvant/adjuvant gastric cancer treatment. Multiple combination therapies centered on Serplulimab are undergoing global clinical trials, covering indications such as lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer.