October 8, 2024

SAN DIEGO, California, USA, October 8, 2024 -- 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 CG009301, a highly selective GSPT1 degrader for the treatment of relapsed or refractory hematological malignancies (including but not limited to AML, ALL, and high-risk MDS). Cullgen will soon initiate the Phase I clinical trial of CG009301 in humans in China.

"The allowance of the CG009301 IND application by the National Medical Products Administration marks another significant milestone for Cullgen," said Dr. Ying Luo, Chairman and CEO of Cullgen. "Our GSPT1 degrader is now our second active clinical trial program in humans. The allowance of this IND application demonstrates our ability to successfully advance projects from the early research and discovery stage to the clinical development stage. In addition to CG009301, we are also exploring additional applications of our GSPT1 degrader program for use in other modalities.”

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 that utilize proprietary novel E3 ligands. Cullgen is also actively advancing several of its highly potent degraders as payloads for use in degrader-antibody conjugates (DACs). For more information, visit www.cullgen.com.

Contacts for inquiries or additional information:

Cullgen Inc.

Thomas Eastling, CFO

inquiries@cullgen.com