ND-003, a Highly Selective Kinase Inhibitor Developed by NewDel Biotech and Guangdong Small Molecule New Drug Innovation Center, Receives IND Approvals in Both the U.S. and China for Pulmonary and Renal Fibrosis

ND-003 is a highly selective kinase inhibitor jointly developed by NewDEL Biotech and the Small Molecule Center. At a concentration of 1 μM, it inhibits only a few kinases such as TRK and RET, demonstrating high selectivity and specificity, with even higher inhibitory activity against related mutant proteins.Preclinical studies show that ND-003 has an extremely high therapeutic window. In 14-day dose-range finding studies in rats and dogs, the animals tolerated doses exceeding 2000 mg/kg/day and 500 mg/kg/day, respectively. Additionally, in animal efficacy tests across multiple indications, the effective dose was less than 2 mg/kg, indicating significant potential for clinical application.

The Small Molecule Innovative Drug Innovation Center of Guangdong Province is a provincial-level manufacturing innovation center aimed at achieving the goal of technical development to first commercial application. Focused on the innovative development needs and key common technologies of the biopharmaceutical industry, it advances through both independent research and collaborative research, striving to overcome industry "bottleneck" challenges. At the same time, it continuously explores sustainable development models that balance social and economic benefits, forming an innovation consortium with industry partners, integrating resources such as capital, innovative platforms, expert talent, and more, empowering upstream and downstream industrial resources, and promoting high-quality development in the industry.