June 18, 2021 Our company’s “Recombinant Human Thymosin β4 for Injection” (project code NL005) II The interim meeting of investigators for the Phase I clinical trial was successfully held in Beijing. This project is a Class 1 new drug in the category of therapeutic biological products, with an indication for ischemic reperfusion injury following acute myocardial infarction. The meeting was jointly attended by 12 investigators from the Chinese Academy of Medical Sciences Fuwai Hospital (the leading unit) and five other participating research centers. The meeting was chaired by Professor Dou Kefei from Fuwai Hospital, the principal investigator of this trial.

First, Han Chengquan, Vice President in charge of clinical operations at the company, reported on the overall status of the clinical trial for this project and the progress of each center. He also explained the issues identified during on-site monitoring and audits at various centers. Liu Yue, the company’s medical manager, provided an explanation of the mechanism of action of the investigational drug in treating ischemia-reperfusion injury associated with acute myocardial infarction, as well as the research findings already achieved. This helped the attendees gain a deeper understanding of the drug’s unique characteristics and the significance of its development.

Subsequently, Ms. Zhang Lijun, an expert from the Independent Imaging Assessment Committee, explained the consensus on imaging assessment for this trial and analyzed the MRI results of some subjects who have completed follow-up. Director Guo Jincheng from Beijing Luhe Hospital and Director Lin Wenhua from TEDA International Cardiovascular Hospital respectively introduced the procedures for subject recruitment and enrollment in the trial. Participants also discussed and examined several practical issues arising during the clinical trial, reaching further consensus on the implementation of the clinical trial protocol as well as on the principles and methods for handling specific issues.

Professor Dou Kefei (Principal Investigator) summarized the meeting. He stated that the study is progressing smoothly according to the requirements and timelines specified in the clinical trial protocol, and urged all investigators to strictly adhere to GCP guidelines and the clinical trial protocol, dedicating more time and effort to recruiting an adequate number of subjects for the trial. He emphasized the importance of completing the trial tasks as soon as possible and making a positive contribution to the development of innovative drugs in China.

Finally, Xu Songsan, Chairman of the company, delivered a closing thank-you speech. He stated that the NL005 project is one of the innovative drugs that the company has been developing for over a decade, and it has continuously received rolling support from the national “Major New Drug Creation” programs during the 11th, 12th, and 13th Five-Year Plans. As an innovative drug development endeavor, there are relatively few reference publications and case studies available, making the development process highly challenging and requiring close collaboration with researchers from various fields—especially those involved in clinical trials. Thanks to the strong support and dedicated efforts of researchers at all participating centers, the clinical trial for this project is currently progressing smoothly. On behalf of the company, he expressed heartfelt gratitude to all the researchers and expressed his hope for continued cooperation, so that together we can strive toward the development of innovative drugs with intellectual property rights in China and soon provide safe and effective treatments for patients suffering from acute myocardial infarction and ischemia-reperfusion injury in China.