Recombinant Human Thymosin β4 for Injection (NL005)

   　 ● Project Overview

　　Registration Category: Class 1 Therapeutic Biological Product

　　Indications: (1) Ischemia-reperfusion injury caused by acute myocardial infarction

　　(2) Acute Lung Injury and Acute Respiratory Distress Syndrome

　　(3) Dry Eye Syndrome

　　R&D Progress: Ischemia-Reperfusion Injury Caused by Acute Myocardial Infarction (Phase II Clinical Trial Study)

　　Government Projects: Continuously supported by the national major science and technology projects for the development of new drugs under the “11th Five-Year Plan,” “12th Five-Year Plan,” and “13th Five-Year Plan.”

　　Market Prospects: China has at least 2 million patients with myocardial infarction. Currently, there are no clinically available drugs that effectively promote myocardial tissue repair in patients suffering from ischemia-reperfusion injury induced by myocardial infarction. This product can inhibit apoptosis, promote angiogenesis, and enhance the ischemic resistance of cardiomyocytes, holding promise as a new therapeutic agent.

　　For detailed market forecasts, see https://mp.weixin.qq.com/s/sL_4p-dQm8n5AsOXPv2EVQ (Source: Yaodu Consulting)

　　 ● Mechanism of action

　　NL005 is administered via intravenous injection. Tβ4 can reach the reperfusion injury site in the heart through the bloodstream, and by modulating inflammation, inhibiting cardiomyocyte apoptosis, promoting neovascularization at ischemic sites, and facilitating tissue repair, it achieves the therapeutic goal of treating the disease.

　　 ●Research findings

　　This project has entered Phase II clinical trials and has systematically completed preclinical studies, including pharmaceutical studies, pharmacokinetic studies, and animal experiments. In addition, the Phase I clinical trial in humans has been successfully completed, demonstrating the safety of the drug and its high level of tolerability in humans.

　　Existing research results indicate that NL005 exhibits significant therapeutic effects in an MIRI animal model and outperforms the control drug in terms of treatment efficacy, while also requiring a lower clinical dosage.

　　The project has established a stable pilot-scale preparation process and comprehensive quality standards, and is capable of industrialization.