Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection (NL003)

● Project Overview

　　Registration Category: Class 1 Therapeutic Biological Product, Gene Therapy Drug

　　Indications: Lower limb ischemic disease (CLI): ischemic ulcers, rest pain, and intermittent claudication.

　　R&D Progress: Entering Phase III Clinical Trials (Ischemic Ulcers, Rest Pain)

　　Government Project: Selected for the National “11th Five-Year Plan” and “13th Five-Year Plan” Major Science and Technology Special Projects for the Creation of New Drugs

　　Market Prospects: China has at least 30 million patients suffering from lower-limb arterial ischemia, and currently, there are no effective clinical treatments available. This product can promote neovascularization in ischemic areas and is suitable for the treatment of arterial ischemic diseases. Once it enters production, it could generate significant economic and social benefits.

　　For detailed market forecasts, see https://mp.weixin.qq.com/s/KHqy72FJo_ac_2tMkN981w (Source: Yaodu Consulting)

　　 ● Mechanism of action

　　By locally injecting NL003 into the ischemic site, the plasmid transfects striated muscle cells, enabling them to continuously express and secrete hepatocyte growth factor (HGF), a protein with angiogenic properties. This promotes the regeneration of new blood vessels, establishes collateral circulation at the ischemic site, and creates a "molecular bypass" mechanism, thereby increasing blood flow to the ischemic area and achieving the goal of treating ischemic diseases.

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　　 ● Results of the Phase II Clinical Study for the Treatment of CLI

　　The results of the Phase II clinical trial indicate that this product demonstrates good efficacy in alleviating pain and ulcers in patients with critical limb ischemia (CLI). No serious adverse events related to the study drug were reported, suggesting that the product has a favorable safety profile. The findings of the Phase II clinical study were published in Volume 27, Issue 12 of Molecular Therapy (pages 2158–2165).