February 4, 2024, by Shenzhen NewDEL Biotech Co., Ltd.(Small Molecule Center)Its incubated company Shenzhen NewDEL Biotech Co., Ltd.(abbreviation "NewDEL Biotech")Jointly Developed byClass 1 New Drug ND-003Completion of First Participant Dosing（FIH）。
The Study（CTR20233737）Is a project inSolid TumorA Phase I dose-escalation and expansion clinical trial involving single and multiple dosing in patients was conducted to explore the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of ND003 in cancer patients, providing support for subsequent clinical studies.
According to the Small Molecule Center, ND-003 has recently been approved for 4 indications in both China and the United States, coveringTumors, Pulmonary Fibrosis, Renal Fibrosis, and Atopic Dermatitis, The specific R&D progress is as follows:
February 4, 2024, Tumor IndicationsCompletedFirst Subject Dosed;
On February 2, 2024, the atopic dermatitis indication received clinical trial authorization from the U.S. FDA;
On January 17, 2024, the IND (Investigational New Drug) application for atopic dermatitis indication was approved by China NMPA (Notice No.: 2024LP000160 and 2024LP000161).
On January 8, 2024, the clinical trial application for pulmonary fibrosis and renal fibrosis indications received an approval letter from the FDA.
On December 19, 2023, the drug clinical trial application (IND) for renal fibrosis indication was approved by China NMPA (Notice No.: 2023LP02592 and 2023LP02593).
On December 14, 2023, the drug clinical trial application (IND) for pulmonary fibrosis indications was approved by China's NMPA (Notice Numbers: 2023LP02509 and 2023LP02510).
On October 17, 2023, the oncology indication received clinical trial approval (IND) from China's NMPA (Notice Numbers: 2023LP02037, 2023LP02038);
On July 13, 2023, ND-003 for tumor indications received FDA IND approval in the United States.
September 23, 2023, byGuangdong Small Molecule New Drug Innovation Center(hereinafter referred to as "Small Molecule Center") and the first incubated company of the Small Molecule Center—Shenzhen NewDEL Biotech Co., Ltd. (hereinafter referred to as "NewDEL Biotech") held "EvaluationND-003A Single-Arm, Non-Randomized, Open-Label, Dose-Escalation and Dose-Expansion, Multicenter Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy in Patients with Advanced Solid Tumors"The Investigator Meeting was Successfully Held in Guangzhou."
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 expertise and advice, laying a solid foundation for the smooth progress of the trial.
The meeting was first opened with a speech by Professor Zhang Li. Professor Zhang Li stated: "ND-003 is a highly selective kinase inhibitor, and the preclinical data shows a very good therapeutic window. We look forward to ND-003’s clinical research achieving excellent results through everyone's cooperation. As a domestically developed drug in China, it will bring good news to more cancer patients."About Small Molecule Center
Small Molecule Center asProvincial Manufacturing Innovation Center, continuously exploring a sustainable development model that balances social and economic benefits, always focusing on completing technology development to...Technology DiffusionTargeting the first commercial application, with a focus on meeting patients' clinical needs as the starting point, efforts will be made to overcome the industry's "bottleneck" technical challenges and empower upstream and downstream resources in the industry. The advancement of ND-003 from laboratory technology to the clinical stage is a typical case of the diffusion and commercial application of Small Molecule Center technology. The Small Molecule Center will collaborate with NewDEL Biotech to accelerate the R&D process, continue to "tackle difficult problems," and contribute to promoting high-quality development in the industry.Shenzhen NewDEL Biotech Co., Ltd. was established in April 2021. It is an industrial company incubated and controlled by the Guangdong Provincial Small Molecule Innovative Drug Innovation Center. Relying on its proprietary DEL3.0 library construction and unique live-cell screening technology, NewDEL Biotech focuses on unmet clinical needs to build a full life-cycle system for FIC innovative drug design, research, development, and industrialization. The company is committed to becoming an internationally leading biopharmaceutical enterprise with distinctive characteristics in new drug research and development.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 only inhibits 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 wide therapeutic window. In 14-day dose-ranging studies in rats and dogs, the animals tolerated doses exceeding 2000 mg/kg/day in rats and >500 mg/kg/day in dogs. Additionally, in multiple animal efficacy studies for various indications,Effective Dose<2 mg/kg, with extremely high clinical application prospects.Source: Official Account of Guangdong Small Molecule Innovative Drug Innovation Center
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