Another Homegrown Class 1 New Drug Receives FDA IND Clearance: ND-003 by Small Molecule Innovation Center

ND-003The leading unit of Phase I clinical trial is the Sun Yat-sen University Cancer Center, with the renowned medical oncology expert Professor Zhang Li serving as the Leading Principal Investigator (Leading PI). More than 60 experts from approximately 25 research centers across China specializing in oncology and clinical trials gathered to contribute their insights and strategies, laying a solid foundation for the smooth conduct of the trial.

Previously, on July 13, 2023, Guangdong Small Molecule Innovation Center (hereinafter referred to as "Small Molecule Center") announced:

• Its first Class I new drug project (hereinafter referred to as "ND-003") has been approved by the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application! This project was jointly developed by the Small Molecule Center and its incubated and controlled enterprise, Shenzhen NewDEL Biotech Co., Ltd. (hereinafter referred to as "NewDEL Biotech").

• In addition to developing the aboveTumorIndications aside, research data shows,ND-003 inAtopic Dermatitis, pulmonary fibrosis, renal fibrosis and other indications have potential development value.Relevant preclinical research work is currently underway, and it is expected that the fibrosis indication of ND-003 can enter the clinical trial stage by the end of this year.