Recently, the last subject has been withdrawn from the Phase III clinical trial of our company’s “Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection” (code name NL003), which is intended for the treatment of ischemic ulcers. This marks the completion of more than four years of subject enrollment and follow-up activities for the trial, officially ushering in the data cleaning and statistical analysis phase. The countdown to the release of the final results has now begun.

NL003 Phase III clinical trial, conducted by Beijing As the leading unit, Peking Union Medical College Hospital is conducting the study at 24 research centers nationwide. Adopt multiple The study employed a centralized, randomized, double-blind, placebo-controlled trial design, with two separate trial protocols—one for ulcers and the other for resting pain—conducted concurrently. The ulcer trial was planned to enroll 240 patients but ultimately enrolled 242; the resting pain trial was planned to enroll 300 patients but actually enrolled 302. Currently, the ulcer trial has completed all follow-up visits. The company is now expediting data cleaning and quality control at the participating centers in accordance with GCP guidelines, striving to promptly complete statistical analysis, prepare the summary report, close the centers, and initiate the next steps, including the early submission of the New Drug Application (NDA).

NL003 is my husband. The gene therapy drug independently developed by the company is a Class 1 therapeutic biological product and is supported under the nation’s “Major New Drug Development” special program. The company will, with a scientific and rigorous approach, swiftly and efficiently complete the series of tasks following the formation of the research team. We look forward to trial results that meet expectations, enabling early approval and market launch, thereby providing patients with related diseases with more and better treatment options.