Another Kinase Inhibitor, ND-003, Secures Chinese IND Approval for Oncology Indication; Small Molecule Innovation Center Files Prospectus

Oct 18, 2023 06:30 CST Updated 06:30

NewDEL Biotech

Antitumor New Drug R&D Company

Small Molecule Innovation Center of Guangdong Province (referred to as "Small Molecule Center") announced today that itsShenzhen NewDEL Biotech Co., Ltd. (referred to as "NewDEL Biotech")The first Class I new drug jointly developed – ND-003 for tumor indications – has received clinical trial approval (IND) from China's NMPA (Approval Notice Numbers: 2023LP02037, 2023LP02038). Previously, ND-003 had already obtained clinical trial authorization (IND) from the U.S. FDA on July 13, 2023. Thus, ND-003 for tumor indications has now been approved to conduct clinical trials in both China and the United States.Achieving Dual Filing in China and the US！

Notice Number: 2023LP02037

Notice Number: 2023LP02038

This project was launched in Guangzhou on September 23.Phase I Clinical Trial Investigator Meeting，Clinical trials are proceeding intensively. Apart from oncology indications, research data shows,ND-003 in Atopic Dermatitis,Pulmonary Fibrosis, renal fibrosis and other indications have potential development value.Among them, IND applications for pulmonary fibrosis and renal fibrosis have been submitted and officially accepted by the CDE. It is expected that ND-003 will bring more good news to patients in the future!

ND-003

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, while demonstrating higher inhibitory activity against related mutant proteins. Preclinical studies have shown that ND-003 has an exceptionally wide therapeutic window. In 14-day dose-ranging studies in rats and dogs, rats tolerated doses exceeding 2000 mg/kg/day, and dogs tolerated doses over 500 mg/kg/day. Additionally, in xenograft efficacy tests involving multiple TRK/RET fusions or mutations, the effective dose was less than 2 mg/kg. ND-003 shows great promise for clinical application in treating tumors associated with TRK/RET gene fusions or mutations.

Small Molecule Center

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. Focusing on the innovation and development needs of the biopharmaceutical industry and key common technologies, it conducts both independent research and collaborative research, striving to overcome industry "bottleneck" issues. At the same time, it continuously explores sustainable development models that balance social and economic benefits, forming innovative consortia with industry partners, integrating resources such as capital, innovative platforms, expert talent, and more to empower upstream and downstream industrial resources, promoting high-quality development within the industry.

NewDEL Biotech

Shenzhen NewDEL Biotech Co., Ltd. was established in April 2021. It is an industrial company incubated and controlled by the Guangdong Province Small Molecule Innovative Drug Innovation Center. Relying on its proprietary DEL3.0 library construction and unique live cell screening technology, NewDEL Biotech has built an innovative drug lifecycle system focused on the design, research, development, and industrialization of FIC drugs to address unmet clinical needs. The company is committed to becoming a world-leading biopharmaceutical company with distinctive characteristics in new drug research and development.

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