Pharma Focus Asia

NMPA Grants Approval for Sugemalimab as First-line Treatment for Esophageal Squamous Cell Carcinoma, as Announced by CStone

Monday, December 11, 2023

CStone Pharmaceuticals, a prominent biopharmaceutical company specializing in innovative immuno-oncology therapies, has received approval from the National Medical Products Administration (NMPA) in China for the supplemental biologics license application (sBLA) for sugemalimab (Cejemly®). The approval is specifically for the first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) when used in combination with fluorouracil and platinum-based chemotherapy. Notably, this approval positions sugemalimab as the world's inaugural anti-PD-L1 monoclonal antibody sanctioned for this indication.

Dr. Jason Yang, CEO of CStone, expressed enthusiasm about the approval, highlighting the clinical significance and potential of sugemalimab. He also conveyed ongoing efforts to secure additional approvals in China for indications such as the first-line treatment of gastric cancer. Furthermore, Dr. Yang emphasized collaborative efforts with regulatory bodies in the U.S., Europe, and other territories.

Professor Li Jin, Principal Investigator of the GEMSTONE-304 study, underscored the prevalence of esophageal cancer in China and its substantial impact on patients. The GEMSTONE-304 study demonstrated the significant improvement in progression-free survival (PFS) and overall survival (OS) with sugemalimab in combination with chemotherapy compared to first-line chemotherapy for ESCC, along with a manageable safety profile.

The approval is based on data from the GEMSTONE-304 study, a phase 3 registrational clinical trial. Results presented at the 2023 ESMO World Congress on Gastrointestinal Cancer revealed statistically significant and clinically meaningful improvements in PFS and OS with sugemalimab combined with chemotherapy. The safety profile remained consistent with previous findings in other diseases.

Esophageal cancer is a prevalent global malignancy, with ESCC being the predominant type in China. Sugemalimab, a fully human anti-PD-L1 monoclonal antibody, was developed using CStone's OmniRat® transgenic animal platform, enabling the creation of fully human antibodies in a single step. Notably, the NMPA has already granted approval for sugemalimab for other indications, and regulatory agencies in Europe and the UK are currently reviewing applications.

CStone Pharmaceuticals maintains a strategic collaboration agreement with Pfizer for the development and commercialization of sugemalimab in mainland China, with plans to introduce additional oncology medicines to the Greater China market.



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