On March 1, 2023, our company successfully completed the enrollment of all subjects in the Phase IIb clinical trial for NL005, our independently developed Class 1 innovative drug—recombinant human thymosin β4 injection—used for the treatment of ischemia-reperfusion injury in acute myocardial infarction.

The Phase IIb clinical trial, led by Professor Dou Kefei from Fuwai Hospital of the Chinese Academy of Medical Sciences, involves a total of 14 research centers nationwide and has enrolled 96 subjects. This trial adopts a multicenter, randomized, double-blind, placebo-controlled study design. Building on the procedures and results of the Phase IIa clinical study, the trial protocol has been optimized and the sample size further expanded for in-depth investigation. The primary objectives are to further evaluate the preliminary efficacy and safety across different dose groups and to determine the optimal dosage regimen. Compared with the Phase IIa trial, the Phase IIb trial features a more rigorous study design, more scientifically defined inclusion criteria, and more appropriately selected evaluation indicators.

Since the first patient was enrolled in July 2022, thanks to the concerted efforts of all research personnel, this trial has successfully overcome the impact of the COVID-19 pandemic and has essentially completed the enrollment of all subjects according to the original trial plan. Moving forward, the company will continue to carry out relevant tasks—including subject follow-up and exit, data cleaning, and statistical analysis—following the clinical trial procedures.

The NL005 project is an innovative recombinant protein drug independently developed by our company, classified as a Class 1 drug for registration purposes. Its intended indication is ischemia-reperfusion injury (MIRI) caused by acute myocardial infarction. In recent years, ischemic heart disease—primarily driven by acute myocardial infarction—has become the leading cause of death threatening human health and continues to rise year after year. Currently, clinical treatments for acute myocardial infarction mainly include PCI procedures and thrombolysis. However, after revascularization, further ischemia-reperfusion injury (MIRI) may occur. To date, no effective drug for treating MIRI has been approved and marketed worldwide. Our NL005 project has been designated as its primary indication for MIRI. The project has been selected three consecutive times for the national “Major New Drug Development” special program and holds invention patents in China, the United States, Japan, South Korea, and Europe. It has also been awarded the “Outstanding Patent Award” in China.

The completion of enrollment for all subjects in the Phase IIb clinical trial of NL005 represents a significant milestone for this research project. We look forward to achieving promising study results from this clinical trial, which will provide a solid scientific basis for the development of the Phase III clinical trial protocol. Meanwhile, the company will accelerate the formulation of the Phase III trial protocol and continue conducting follow-up research. We sincerely hope that NL005 will be successfully developed at an early date, offering a new therapeutic solution for ischemia-reperfusion injury in acute myocardial infarction and breaking the global shortage of effective treatments in this therapeutic area.