The discussion meeting on the Phase II clinical trial protocol for Recombinant Human Thymosin β4 for Injection (NL005) was successfully held.

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2019-11-19


  On November 18, 2019, our company successfully held a workshop on the Phase IIa clinical trial protocol for recombinant human thymosin β4 injection (NL005) at the Beijing Guobin Hotel. The meeting aimed to develop a scientifically sound and reasonable clinical trial protocol and achieved the expected results.

  The meeting was chaired by Professor Dou Kefei, Deputy Director of the Coronary Heart Disease Center at Fuwai Hospital, Chinese Academy of Medical Sciences. The meeting invited Professor Li Jing, Chief Physician of the Department of Cardiology and PCI Team Leader at Xuanwu Hospital, Capital Medical University; Professor Guo Jincheng, Director of the Cardiovascular Center and CCU Director at Beijing Luhe Hospital, Affiliated to Capital Medical University; Professor Wu Yuan, CCU Director at the Coronary Heart Disease Center, Fuwai Hospital, Chinese Academy of Medical Sciences; Professor Zhao Shihua, Director of the Magnetic Resonance Imaging Department at Fuwai Hospital, Chinese Academy of Medical Sciences; Professor Yang Minfu, Deputy Director of the Nuclear Medicine Department at Chaoyang Hospital, Affiliated to Capital Medical University; and Professor Zhang Jian, Director of the Heart Failure Center at Fuwai Hospital, Chinese Academy of Medical Sciences. In addition, more than ten experts were invited to attend, including representatives from the Clinical Trial Institutions of Fuwai Hospital, Chinese Academy of Medical Sciences, and Beijing Luhe Hospital, Affiliated to Capital Medical University, as well as IQVIA’s China Medical Regulatory Strategy Consultant.

  The attending experts listened to a briefing on the previous research findings of the recombinant human thymosin β4 project and reviewed the Phase IIa trial protocol. They conducted a detailed discussion—addressing issues such as subject selection, evaluation criteria, dosing regimen, duration of administration, and trial duration—and reached a consensus. This provided our company with specific guidance for refining the trial protocol.

  Xu Songshan, Chairman of the company, expressed his gratitude for the experts’ visit and their professional advice. He stated that the company will carefully summarize the outcomes of this meeting, further refine the trial protocol, and strive to launch the Phase IIa clinical trial at an early date. He also looks forward to continued, in-depth collaboration with the experts.

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