Shenzhen NewDEL Biotech Co., Ltd.  ("NewDEL Biotech") and Guangdong Innovation Center For Small Molecule Drug Discovery ("Small Molecule Center") announced today that their first Class I new drug project, ND-003, has been granted clinical trial approval (IND) by the U.S. Food and Drug Administration (FDA).

ND-003, a highly selective kinase inhibitor jointly developed by NewDEL Biotech and Small Molecule Center, exhibits inhibition activity against a few kinases such as TRK and RET at a concentration of 1 uM, with higher inhibitory activity against related mutated proteins. Preclinical studies have demonstrated that ND-003 possesses an exceptionally wide therapeutic window. In a 14-day dose range study conducted in rats and dogs, the animals tolerated doses exceeding 2000 mg/kg/day and 500 mg/kg/day, respectively. Moreover, in efficacy studies on transplant tumor animals with TRK/RET gene fusions/mutations, ND-003 demonstrated effective doses of less than 2 mg/kg. These findings suggest promising clinical applications for ND-003 in the treatment of TRK/RET gene fusion/mutation-related tumors.

In addition to oncology indications, research data indicate potential development value for ND-003 in various therapeutic areas such as atopic dermatitis, pulmonary fibrosis, and renal fibrosis. Preclinical research in these areas is currently underway, and it is anticipated that the fibrosis indications of ND-003 will enter the clinical trial stage by the end of this year.

Mr. He Xun, Chairman of NewDEL Biotech, stated, "NewDEL Biotech has experienced rapid development over the past two years. The FDA's approval of the clinical trial for the ND-003 project marks a significant milestone for the company, transitioning from the preclinical stage to clinical development. Leveraging our proprietary DEL3.0 technology platform (DEL live cell screening technology integrated with AI), NewDEL Biotech is actively advancing its pipeline of research and development. We have already screened and plan to screen over 100 new targets, with a conservative estimate of obtaining IND clinical approval for three innovative drugs in both China and the United States by the end of 2023, and for another four by the end of 2024. In the future, NewDEL Biotech will adhere to its independent research and development path for new drugs, continuously innovate technologies, and ultimately bring more novel therapies to patients worldwide."

【About NewDEL Biotech】

Founded in April 2021, Shenzhen NewDEL Biotech Co., Ltd.  is an industrial company incubated and controlled by the Guangdong Innovation Center For Small Molecule Drug Discovery. With its proprietary DEL3.0 library and unique live cell screening technology, NewDEL Biotech focuses on FIC innovative drug design, research and development, and industrialization, aiming to become a leading international biopharmaceutical company with distinct characteristics.

【About Small Molecule Center】

As a provincial-level manufacturing innovation center, the Small Molecule Center continuously explores sustainable development models that balance social and economic benefits. With the goal of completing technology development, diffusion, and initial commercialization to meet clinical needs, the center focuses on breaking through industry "bottlenecks" and empowering upstream and downstream resources in the industry chain. The progression of ND-003 from laboratory technology to clinical stage exemplifies the typical case of technology diffusion and commercial application by the Small Molecule Center. The center will join forces with NewDEL Biotech to accelerate research and development, continue to overcome challenges, and promote high-quality development of the industry.

【Forward-looking Statements】

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