On August 9, 2021, the Phase IIa clinical trial evaluating the efficacy and safety of our company’s independently developed recombinant human thymosin β4 for injection (project code: NL005) in patients with acute myocardial infarction completed enrollment of the last patient, successfully completing the entire enrollment task according to the pre-scheduled plan.

The Phase IIa trial, now completed with patient enrollment, is led by Professor Dou Kefei from Fuwai Hospital of the Chinese Academy of Medical Sciences. A total of six centers are participating in this study. The trial adopts a multicenter, randomized, double-blind, multi-dose, placebo-controlled parallel-group design, with a total of 62 subjects enrolled. According to the established trial protocol, subjects will undergo a 3-month follow-up period. The company will carry out data cleaning, statistical analysis, and trial summarization in accordance with the trial procedures. Meanwhile, the company is concurrently conducting research and developing subsequent trial protocols.

Recombinant human thymosin β4 (abbreviated as Tβ4) is a small-molecule protein naturally present in the human body, composed of 43 amino acids. Scientific research has shown that Tβ4 exhibits a variety of biological activities, including anti-inflammatory, pro-angiogenic, anti-apoptotic, and anti-fibrotic effects, making it well-suited for tissue repair in various organs. Therefore, the primary indication for Tβ4 is acute myocardial infarction–reperfusion injury (abbreviated as MIRI). This drug can also be used in the treatment of conditions such as dry eye syndrome and acute lung injury.

Currently, there are no approved drugs available worldwide for the treatment of MIRI. According to a forecast by Yaodu Consulting, by 2025, the theoretical market size for MIRI treatment drugs in China could reach 6.34 billion yuan. If this drug is successfully developed, it will provide a new therapeutic solution for MIRI, playing a crucial role in preserving cardiac function and improving patients' quality of life.

NL005 is an innovative Class 1 drug with independent intellectual property rights owned by our company. It has been successively selected for the national “11th Five-Year Plan,” “12th Five-Year Plan,” and “13th Five-Year Plan” special programs for “Major New Drug Development,” and has received the “China Patent Excellence Award.” Previously, Phase I clinical trials involving healthy volunteers have been completed, preliminarily confirming its safety and pharmacokinetic characteristics in humans, thereby further supporting the drug’s development potential. The results of this study were recently officially published in the “Journal of Cellular and Molecular Medicine.” ( Wang X, Liu L, Qi L, et al. A first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin β4 in healthy Chinese volunteers. J Cell Mol Med. 2021; 00:1-7. ).

Xu Songshan, Chairman of the company, stated: “We are delighted to see that the Phase IIa study of NL005 has successfully completed patient enrollment as scheduled. We would like to extend our heartfelt gratitude to all participating research institutions, investigators, and clinical research teams for their hard work and dedication. Together with the broader community of clinical researchers, our company will continue to drive forward the subsequent stages of this research. We look forward to the successful completion of this drug’s development and its early availability on the market, providing an effective and safe treatment option for myocardial infarction and benefiting patients worldwide.”