Recently, CSPC (1093.HK) announced that the application for marketing of enlonstobart for injection (brand name: Enshuxing) of CSPC Megalith Biopharmaceutical Co., Ltd., a subsidiary company of CSPC, has been accepted by the National Medical Products Administration (NMPA) of the People's Republic of China, with eligibility for the conditional approval pathway. Enlonstobart for injection was originally developed by Hangzhou Sumgen Biotech Co., Ltd. (referred to as "Sumgen Biotech"). Itsfirst clinical trial was approval on September 29, 2018, soon afterwards Sumgen Biotech entered into a strategic partnership with CSPC in November 2018.
Enlonstobart for injection is a recombinant fully human anti-PD-1 monoclonal antibody, belonging to the IgG4 monoclonal antibody drug. It is applied as a Class 1 therapeutic biological product for the treatment of relapsed or metastatic cervical cancer patients with positive PD-L1 expression who have failed to respond to first-line platinum-based chemotherapy. A phase III confirmatory clinical trial of the product for the first-line treatment of cervical cancer has also been initiated with approval granted by the NMPA. Multiple clinical trials for other indications are also progressing steadily.
Enlonstobart is the first innovative drug independently developed by Sumgen Biotech, and the company has achieved strategic cooperation with CSPC. The acceptance and conditional approval for the application of marketing is a significant milestone for this project, as well as a major achievement in Sumgen Biotech's development journey. It marks a new phase in Sumgen Biotech's innovative antibody research and development.
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