Shanghai Henlius Biotech (HKG: 2696) has announced receiving orphan drug designation (ODD) status from the European Committee for its HanSiZhuang (serplulimab) for the treatment of small-cell lung cancer (SCLC). The programmed death-1 (PD-1) inhibitor, previously awarded ODD status in the US for the same indication, is expected to become the first drug of its type to gain approval as a first-line treatment of SCLC.
Serplulimab: Approved and Under Review in China
Serplulimab has been approved in China to treat unresectable or metastatic microsatellite highly unstable (MSI-H) solid tumors that have failed standard therapy, and combined with chemotherapy in first-line squamous non-small cell lung cancer (sqNSCLC). Supplementary New Drug Applications (sNDAs) for the drug combined with chemotherapy in first-line extensive-stage small cell lung cancer (ES-SCLC) and first-line esophageal squamous cell carcinoma (ESCC) were accepted for review in China in April and August of 2022, respectively.
Global Clinical Studies Underway
Multiple clinical studies for serplulimab are well underway around the globe, positioning the drug for potential approval and use in various indications, including SCLC, where there is a significant unmet medical need.-Fineline Info & Tech
