The clinical trial applications for ND-003, a Class I new drug jointly developed by Shenzhen NewDEL Biotech Co., Ltd. ("NewDEL Biotech"）and the Guangdong Innovation Center For Small Molecule Drug Discovery("Small Molecule Center") , for the indications of pulmonary fibrosis and renal fibrosis, have recently received approval letters from the FDA. Previously, the indications for these two conditions for ND-003 were respectively granted clinical trial approval by the Chinese NMPA on December 13th and December 18th, 2023. With this recent development, within a short span of approximately two and a half years since its establishment, NewDEL Biotech has obtained clinical trial approvals for ND-003 in three indications, including tumors, pulmonary fibrosis, and renal fibrosis, in both China and the United States.

AboutND-003

ND-003 is a highly selective kinase inhibitor jointly developed by NewDEL Biotech and the Small Molecule Center. At a concentration of 1 uM, it selectively inhibits only a few kinases and exhibits higher inhibitory activity against relevant mutated proteins. Preclinical studies have shown that ND-003 has an extremely wide therapeutic window. In 14-day dose range determination studies in rats and dogs, rats tolerated doses of >2000 mg/kg/day and dogs tolerated doses of >500 mg/kg/day. Furthermore, in efficacy trials on corresponding mutated xenograft animals and fibrosis animals, ND-003 demonstrated significant therapeutic effects, indicating its promising clinical prospects in the fields of tumors and fibrosis treatment.

About NewDEL Biotech

Shenzhen NewDEL Biotech Co., Ltd. was established in April 2021 and is an industrial company incubated and majority-owned by the Guangdong Innovation Center For Small Molecule Drug Discovery . NewDEL Biotech relies on its proprietary DEL 3.0 library and unique live cell screening technology to address unmet clinical needs. It aims to establish an innovative drug lifecycle system focused on FIC (Focused Innovation Cluster) drug design, development, and industrialization. The company is committed to becoming a leading international biopharmaceutical company with distinctive characteristics focused on new drug research and development.

About Small Molecule Center

Guangdong Innovation Center For Small Molecule Drug Discovery  is a provincial-level manufacturing innovation center with the goal of completing technology development and achieving initial commercial applications. Focused on the needs and common key technologies of biomedical innovation, it conducts independent research and parallel collaborative research to address industry bottlenecks. Additionally, it continuously explores sustainable development models that balance social and economic benefits. By co-building innovation consortia with industry entities and integrating capital funds, innovative carriers, expert talents, and other resources, it empowers industry upstream and downstream resources to promote high-quality industry development.