On August 11, 2022 Cullgen Inc., a leading biotechnology company developing targeted protein degraders based on its proprietary uSMITE platform technology, reported that the Chinese National Medical Products Administration (NMPA) has allowed the Investigational New Drug (IND) application for CG001419, a TRK degrader for the treatment of solid tumors (Press release, Cullgen, AUG 11, 2022, View Source [SID1234618176]). CG001419 is a first-in-class, selective, potent oral targeted protein degrader for the treatment of neurotrophic tyrosine receptor kinase (NTRK) fusion-positive cancers, which have been identified in numerous solid tumors including non-small cell lung, breast, and pancreatic cancers.

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Cullgen will commence a Phase I clinical trial program in humans for CG001419 in China promptly.

"NMPA’s allowance of this IND application for CG001419 represents an important milestone for Cullgen," said Dr. Yue Xiong, Cullgen’s co-founder and Chief Scientific Officer. "Our TRK degrader program was one of the first programs pursued by Cullgen, and this IND allowance by NMPA demonstrates that we are able to successfully advance a program from discovery phase into clinical development. In addition to cancer, we are also exploring other potential clinical indications of our TRK degraders."