Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the National Medical Products Administration (NMPA) has accepted a supplementary Biologic License Application (BLA) for its PD-1 inhibitor Serplulimab (HaiSiZhuang) in combination with cisplatin and fluorouracil (5-FU) for first-line treatment of locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). Additionally, Henlius received approval in Australia to conduct a Phase I trial of HLX60 combined with Serplulimab for advanced/metastatic solid tumors.
Serplulimab Development
- ESCC Indication: The NMPA’s acceptance marks progress in Henlius’s efforts to expand Serplulimab’s indications. The drug was approved in March 2023 for microsatellite highly unstable (MSI-H) solid tumors.
- Global Trials: Serplulimab is being studied in 11 combination therapies worldwide, with two indication filings under review. The U.S. FDA granted Orphan Drug Designation (ODD) for small-cell lung cancer (SCLC) in April 2023.
HLX60 Program
- Australia Approval: Henlius received approval to test HLX60, a GARP-targeted monoclonal antibody, in combination with Serplulimab for solid tumors and lymphomas. GARP is a target expressed on regulatory T cells (Treg), platelets, and tumor cells.
- Mechanism: HLX60 blocks TGF-β1 release mediated by GARP, enhancing anti-tumor immune responses. A Phase I filing for HLX60 was accepted by the NMPA earlier this month.-Fineline Info & Tech
