Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has issued updates on the development statuses of two of its key products. The company’s Programmed-death 1 (PD-1) inhibitor, HaiSiZhuang (serplulimab), has been approved for a new indication in the treatment of first-line PD-L1 positive unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in combination with chemotherapy. Additionally, Grafalon (anti-human T lymphocyte rabbit immunoglobulin) has received clearance for a clinical study aimed at preventing graft versus host disease (GvHD) following hematopoietic stem cell transplantation.
Serplulimab’s New Indication and Clinical Efficacy
Serplulimab has been approved in China for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) solid tumors that have failed standard therapy, squamous non-small cell lung cancer (sqNSCLC), and extensive stage small cell lung cancer (ES-SCLC). The latest approval is based on the results of the ASTRUM-007 study, a randomized, double-blind, multi-center Phase III clinical trial that assessed the efficacy and safety of the serplulimab/chemotherapy combination against a placebo/chemotherapy combination in advanced ESCC. The study demonstrated comprehensive survival benefits in terms of overall survival (OS) and progression-free survival (PFS), with good safety profiles. Notably, the survival benefits for the population with PD-L1 CPS ≥ 10 were more significant, with a median OS of 18.6 months versus 13.9 months and a 41% reduction in mortality risk.
Grafalon’s Clinical Study Clearance
Fosun Pharma secured a licensing deal with Swiss firm Neovii Pharmaceuticals AG in September last year, obtaining exclusive rights to Grafalon in China. The drug has received its first market approval to prevent rejection in solid organ transplantation (SOT) and to treat acute rejection crisis in cases where the effectiveness of corticosteroid therapy is not satisfactory. The clearance for a clinical study in preventing GvHD after hematopoietic stem cell transplantation marks another step in expanding the application of Grafalon in the field of transplantation medicine.-Fineline Info & Tech
