June 27, 2022 The kick-off meeting for the Phase IIb clinical trial of recombinant human thymosin β4 for injection (code-named NL005)—led by the Fuwai Hospital of the Chinese Academy of Medical Sciences—was successfully held. More than 30 participants from Fuwai Hospital, including researchers, research nurses, physicians from the laboratory and imaging departments as well as the clinical trial institution, along with representatives from the sponsor, CRO, and SMO project teams, attended the meeting via Tencent Meeting.

        The meeting was chaired by Professor Dou Kefei, the principal investigator, who provided an overview of the NL005 project, outlined the design of the Phase IIb clinical study protocol, and presented detailed operational guidelines for the trial. During the meeting, participants received targeted training on topics such as informed consent and GCP-related knowledge. Director Dou noted that the Phase IIb trial is planned to be conducted at 15 centers nationwide, and so far, approval has been obtained for 11 centers, with ethical review already completed for three of these centers. Compared to the Phase IIa design, this Phase IIb trial features a more rigorous protocol; however, it also presents greater challenges in patient enrollment. He urged all research personnel to thoroughly understand the inclusion and exclusion criteria, carefully screen patients, and ensure that no eligible case is overlooked. He expressed hope that the enrollment target would be met as soon as possible and looked forward to the early market launch of this domestically developed new drug, which holds significant clinical value.

        Han Chengquan, Vice President in charge of clinical operations at the company, stated that the recently concluded Phase IIa clinical trial marked NL005’s first-ever human clinical trial. The results of this study provide valuable guidance for the design of subsequent research efforts. Given the complex mechanisms underlying ischemic reperfusion injury, the company will increase its investment and conduct more in-depth research. We look forward to collaborating closely with all participating parties to successfully complete the Phase IIb clinical trial as planned and eagerly anticipate the ultimate scientific findings.

        The successful convening of this kickoff meeting for the leading unit marks the official and comprehensive launch of the NL005 Phase IIb clinical trial. Our company will perform project management duties diligently to ensure that the trial is conducted in a scientific, rigorous, standardized manner and is completed according to schedule.