July 11, 2022 The kickoff meeting for the Shanxi Linfen Central Hospital—the participating institution in the Phase IIb clinical trial of recombinant human thymosin β4 for injection (NL005)—was held successfully. This marks the second center to launch the study, following the lead coordinating center. More than 40 participants attended the meeting, including the center’s investigators, research nurses, radiology staff, GCP pharmacy personnel, and staff from the clinical trial organization, as well as representatives from the sponsor, CRO, and SMO project teams.

The kickoff meeting was chaired by Dean Fan Jiamao, the principal investigator from the Shanxi Linfen Central Hospital. The meeting provided a comprehensive and detailed briefing on the R&D background of NL005, the design of the Phase IIb clinical study protocol, the study operational procedures, and GCP-related knowledge. Participants engaged in lively discussions on inclusion and exclusion criteria, drug management, and potential issues that might arise during the clinical study, reaching a consensus on these matters. Dean Fan encouraged all researchers to attach great importance to clinical research, actively participate in clinical trials, carefully learn from the experience gained in the Phase IIa trial, rigorously carry out screening procedures, proactively facilitate patient enrollment, and support the early market launch of domestically developed new drugs.

        Han Chengquan, Vice President of our company, expressed the company’s heartfelt gratitude to all researchers for their strong support. He highlighted the company’s background and development journey, and emphasized that the process of developing new drugs is both challenging and long-term. He expressed his hope that, together with all researchers, the company will continue to work hard to accelerate the development of domestically produced new drugs.

As of now, the NL005 project has completed the approval process for 14 centers, and 6 of them have already received ethical approval. As the centers gradually begin operations, the patient enrollment phase of the project will officially commence.