The National Medical Products Administration (NMPA) has granted a second marketing approval to HaiSiZhuang (serplulimab), a programmed death-1 (PD-1) inhibitor developed by Shanghai Henlius Biotech (HKG: 2696). The drug is now approved for the treatment of first-line squamous non-small cell lung cancer (sqNSCLC).
Previous Approvals and Clinical Progress
Serplulimab was initially approved in March of this year for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) solid tumors that have failed standard therapy. Supplementary New Drug Applications (sNDAs) for the drug in combination with chemotherapy for first-line sqNSCLC, first-line extensive stage small-cell lung cancer (SCLC), and first-line esophageal squamous cell carcinoma (ESCC) were accepted for review in China in September 2021, April 2022, and August 2022, respectively.
Global Development and Regulatory Milestones
In April of this year, serplulimab received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of small-cell lung cancer (SCLC). The drug is currently subject to multiple ongoing clinical studies globally, including as a component of 11 combination therapies. Additionally, serplulimab has passed the National Reimbursement Drug List (NRDL) negotiation formality review for its MSI-H solid tumor indication in China.-Fineline Info & Tech
