Cullgen Announces Chinese NMPA Allowance of Investigational New Drug Application of TRK Degrader to Begin Clinical Trials

SAN DIEGO--(BUSINESS WIRE)--Cullgen Inc., a leading biotechnology company developing targeted protein degraders based on its proprietary uSMITE™ platform technology, today announced 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. 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.

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.”

About Cullgen Inc.:

Cullgen is a privately held clinical-stage biopharmaceutical company dedicated to the development of first-in-class new chemical entities (NCEs) for the treatment of diseases lacking effective therapeutic approaches. The company applies its proprietary uSMITE™ (ubiquitin-mediated, small molecule-induced target elimination) platform to expand the drug design paradigm beyond functional site inhibition, enabling the targeting of historically “undruggable” proteins for selective destruction. Leveraging years of work by its founders on the proteasome system and key discoveries regarding its functionality, Cullgen has successfully generated multiple highly potent, selective, and bioavailable targeted protein degrader compounds. For more information, visit www.cullgen.com.