Domestic IP-based cap analogues help Chinese-developed self-replicating RNA drugs secure FDA IND approval

Recently, CD-GA-102 Injection—originally developed by Professor Xie Weifen’s team at the Second Affiliated Hospital of Naval Medical University (Shanghai Changzheng Hospital) and commercialized by Shanghai Cell Diff Pharmaceuticals—officially received an Investigational New Drug (IND) approval from the U.S. FDA. This project holds two “world’s first” distinctions: First, it is the world’s first drug to treat liver cancer based on the mechanism of transcription factor-induced differentiation; second, it is the world’s first systemically administered self-replicating RNA (srRNA) anticancer drug to enter the clinical phase. This approval marks a new breakthrough for China in the cutting-edge field of “induced differentiation” for solid tumors.

For this project, Synthgene supplied the complete set of mRNA synthesis materials, including its proprietary cap analogs!