Shanghai Henlius Pharmaceutical Co., Ltd (HKG: 2696) has announced receiving regulatory clearance in Australia to conduct a Phase III clinical study evaluating the efficacy and safety of its programmed death-1 (PD-1) inhibitor, Serplulimab (HaiSiZhuang). The study will assess the drug in combination with chemotherapy (carboplatin/cisplatin-etoposide) in patients with limited stage small cell lung cancer (LS-SCLC) alongside concurrent radiotherapy.
Serplulimab’s Regulatory Milestones
Serplulimab has recently been approved for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) solid tumors that have failed standard therapy in March this year. Additionally, supplementary New Drug Applications (sNDAs) for Serplulimab in combination with chemotherapy in first-line squamous non-small cell lung cancer (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.
Orphan Drug Designation and Global Development
In April this year, Serplulimab was granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) for the treatment of small cell lung cancer (SCLC). The drug is currently the subject of multiple ongoing clinical studies worldwide, including as a component of 11 combination therapies. This global development program underscores Henlius’ commitment to advancing innovative treatments for patients with challenging cancers.-Fineline Info & Tech
