The Phase III clinical trial of “Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection” (code name NL003), intended for the treatment of rest pain associated with severe lower-limb ischemic disease, has completed enrollment of the last subject. The trial has now entered its final stages, including subsequent data cleaning, unblinding, and statistical analysis.

NL003 Phase III Clinical Trial The study is divided into two trial protocols: one for resting pain and the other for ulcers. The resting pain trial was originally planned to enroll 300 patients but ultimately enrolled 302. The ulcer trial was initially planned to enroll 240 patients but actually enrolled 242. The ulcer trial was the first to complete unblinding in February 2024, and its primary data have now been released. The results were consistent with expectations. The company is actively preparing the New Drug Application (NDA) documentation for the ulcer indication, aiming to complete the relevant submission as soon as possible.

This time, all subjects have been withdrawn from the resting pain trial, meaning that after nearly five years, the enrollment and follow-up of subjects in NL003’s two pivotal trials—resting pain and ulcer—have now been fully completed. If the results of the resting pain trial also meet expectations, we anticipate submitting an NDA for the resting pain indication in the second half of this year.

NL003 is a gene therapy drug independently developed by our company. It is classified as a Class 1 therapeutic biological product and is supported under the national “Major New Drug Development” special program. Our company will continue to adopt a scientific and rigorous approach, swiftly and efficiently completing the series of tasks following the completion of the clinical trial phase. We look forward to NL003 being approved for market launch at an early date, thereby addressing unmet medical needs in this field and providing patients with more and better treatment options for related diseases.