China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its HER2 monoclonal antibody (mAb) injection FS-1502 in HER2-expressing advanced gastric cancer patients. The study will evaluate the efficacy of FS-1502 in combination with the company’s programmed-death 1 (PD-1) monoclonal antibody (mAb) HanSiZhuang (serplulimab) and/or chemotherapy.
Drug Profile
FS-1502 is an innovative HER2-targeted antibody-drug conjugate (ADC) being developed exclusively by Fosun Pharma in Greater China under an August 2015 licensing deal with South Korea-based firm LegoChem Biosciences Inc. The drug is designed to target HER2-expressing cancer cells, delivering a cytotoxic payload to the tumor site.
Study Details
The Phase II study will assess the safety and efficacy of FS-1502 in combination with serplulimab and/or chemotherapy. The trial aims to evaluate the potential benefits of this combination therapy in improving patient outcomes for advanced gastric cancer.
Background on Serplulimab
Serplulimab was approved to treat unresectable or metastatic microsatellite highly unstable (MSI-H) solid tumors that have failed standard therapy in March this year. The drug is currently the subject of multiple ongoing clinical studies globally, including as a component of 10 combination therapies. Additionally, two indication approval filings are under review. Serplulimab obtained Orphan Drug Designation (ODD) status from the US FDA for the treatment of small-cell lung cancer (SCLC) in April this year.-Fineline Info & Tech
