March 17, 2022 In the evening, Professor Dou Kefei from Fuwai Hospital of the Chinese Academy of Medical Sciences chaired a special meeting to review and discuss the Phase IIa clinical trial results of NL005—the recombinant human thymosin β4 injection, a Class 1.1 new drug developed by our company—and to finalize the protocol design for the Phase IIb trial. More than 20 cardiovascular experts from 19 hospitals nationwide, along with company executives and project team members, participated in the meeting via online video conference.

        The meeting began with a summary and review of the results from the Phase IIa clinical trial, followed by a detailed presentation and in-depth discussion on the design of the Phase IIb clinical trial protocol. Each participating researcher, drawing on their clinical experience from previous trials and existing clinical operational procedures, offered valuable insights and suggestions for further refining the Phase IIb protocol—from the perspective of study objectives and GCP guidelines—and expressed their willingness to continue contributing to the project’s subsequent research efforts, working together to scientifically evaluate this new drug. The project manager of the NL005 program provided a briefing on the overall implementation plan for the Phase IIb clinical study, including the distribution and selection of research centers, the engagement of third-party institutions, the organizational management framework, and the quality assurance system.

        Finally, Mr. Xu Songsan, Chairman of the company, expressed his gratitude to the researchers who had undertaken the Phase IIa trial. He noted that NL005 is an innovative drug with significant clinical trial challenges. Thanks to the concerted efforts of all the researchers, the Phase IIa trial was successfully completed on schedule and achieved its intended objectives, providing a solid foundation for the smooth advancement of the Phase IIb clinical trial and the formulation of the study protocol. At the same time, he extended his appreciation to the researchers who will soon be joining the Phase IIb clinical trial. He said: “The company attaches great importance to this study and will carefully analyze and incorporate the recommendations from all experts to further refine the trial protocol, striving to launch the Phase IIb trial at the earliest possible date. We also hope that more researchers will join the Phase IIb trial. The company will actively coordinate resources and work closely with all experts to overcome the challenges posed by the pandemic and carry out the study in accordance with the project’s protocol and established schedule.”