China-based Shanghai Henlius Biotech (HKG: 2696) has announced that its global, multi-center Phase III clinical study (NCT05353257) for HaiSiZhuang (serplulimab) in limited stage small-cell lung cancer (LS-SCLC) has been approved in Spain, a member country of the European Union (EU). The study will assess the PD-1 inhibitor combined with chemotherapy and radiotherapy as a first-line treatment.
Serplulimab Profile
Serplulimab, a programmed death-1 (PD-1) inhibitor, was approved in March this year for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) solid tumors that have failed standard therapy. The drug is currently undergoing two other global, multi-center Phase III clinical studies in squamous non-small cell lung cancer (sqNSCLC) and extensive-stage SCLC (ES-SCLC) in China, Turkey, Poland, Georgia, and other countries, with over 30% of subjects being Caucasian.
Regulatory and Clinical Progress
Last month, serplulimab was approved in China for the treatment of sqNSCLC. The results of its ASTRUM-005 study in ES-SCLC were published online in JAMA, highlighting the drug’s potential as a first-line treatment for these challenging conditions. The approval in Spain marks a significant milestone in the global development of serplulimab, positioning Henlius to expand its presence in the EU market.-Fineline Info & Tech
