The National Medical Products Administration (NMPA) has recently approved the new drug application (NDA) for a new indication of HENLIUS' (02696) self-developed innovative anti-PD-1 monoclonal antibody, Serplulimab Injection (HANSIZHUANG®). The approval is for its use in combination with oxaliplatin and tegafur, gimeracil, and oteracil potassium (S-1) for neoadjuvant treatment, followed by monotherapy adjuvant treatment, in patients with resectable gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 with a combined positive score (CPS) ≥5.
This approval is primarily based on a randomized, double-blind, multicenter Phase 3 clinical study. The results demonstrated that neoadjuvant treatment with Serplulimab Injection combined with chemotherapy, followed by adjuvant monotherapy with Serplulimab Injection, significantly improved event-free survival (EFS) in patients compared to neoadjuvant treatment with placebo combined with chemotherapy followed by adjuvant chemotherapy. The treatment met the pre-specified superiority criteria and showed a better safety and tolerability profile compared to full-course chemotherapy.
HENLIUS' Serplulimab Injection is an innovative anti-PD-1 monoclonal antibody developed by the company. Its approved indications within mainland China now include, in combination with chemotherapy, first-line treatment for squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), non-squamous non-small cell lung cancer (nsNSCLC), and this new indication for neoadjuvant/adjuvant treatment of gastric cancer. Concurrently, Serplulimab Injection has also received marketing approvals in regions including the European Union, the United Kingdom, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India. It has been granted orphan drug designations by regulatory authorities in the United States, Switzerland, and South Korea.
Furthermore, HENLIUS is systematically advancing multiple global clinical trials for Serplulimab Injection and its related combination therapies, which broadly cover indications such as lung cancer, head and neck squamous cell carcinoma, and colorectal cancer.
According to data from IQVIA MIDASTM, the global sales of PD-1 targeted monoclonal antibody drugs are projected to be approximately $50.871 billion in 2025. This approval marks the world's first perioperative gastric cancer treatment regimen that replaces postoperative adjuvant chemotherapy with an immunotherapy monotherapy. This development is expected to significantly enhance the market competitiveness of Serplulimab Injection and provide more treatment options for gastric cancer patients in China.
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