(Professor Dou Kefei, Fuwai Hospital, Chinese Academy of Medical Sciences; Principal Investigator of the NL005 Phase IIb Clinical Study)

On December 22, 2022, the interim investigator meeting for the Phase IIb clinical study of Recombinant Human Thymosin β4 Injection (NL005), hosted by NORTHLAND and led by Professor Dou Kefei from Fuwai Hospital, Chinese Academy of Medical Sciences, was successfully held. More than 30 investigators from 14 hospitals across the country, along with project leaders and members from the sponsor, CRO, and SMO companies, gathered virtually to attend the meeting.

The meeting was chaired by Professor Dou Kefei from Fuwai Hospital, Chinese Academy of Medical Sciences. Professor Dou began by expressing gratitude to the chief experts and research teams from the 14 participating research centers for their support and efforts. He also praised the centers for overcoming numerous challenges and successfully achieving their phased enrollment targets as planned, despite the severe impact of the pandemic. He expressed his hope that everyone would continue to work together and looked forward to the successful completion of the NL005 Phase IIb clinical study.

In his speech, Han Chengquan, Vice President of the company, expressed gratitude to all researchers, as well as to the teams from Haijingge Pharma (CRO) and PharmEngine Jinshi (SMO), for their full support of the project during this special period. He also highlighted the company’s key business developments. He noted that the company has long been committed to the research and development of new drugs in the cardiovascular field and has already accumulated substantial data on the safety and efficacy of the NL005 project. Currently, ischemia-reperfusion injury following acute myocardial infarction remains a global challenge, and there is still a significant unmet need for clinical drug treatments in this area worldwide. If the NL005 project is successfully developed, it will play a crucial role in improving patients’ quality of life. Under the leadership of Director Dou, the remarkable achievements made within just six months are truly commendable. The company is confident and eager to work together with all researchers to further advance this project and looks forward to achieving the anticipated outcomes.

At the meeting, project managers from CRO and SMO companies respectively reported on the project progress and clinical coordination efforts. Director He Yi from Beijing You'an Hospital and Teacher Zhang Lijun from Beijing Anzhen Hospital summarized the work related to cardiac MRI scanning and image reading. Teacher Dong Qiuting from Fuwai Hospital of the Chinese Academy of Medical Sciences provided an interpretation of the inclusion and exclusion criteria. Director Guo Jincheng from Beijing Luhe Hospital affiliated with Capital Medical University and Director Wang Jingping from Shanxi Provincial Cardiovascular Hospital shared their clinical experiences and insights into informed consent techniques, respectively. The attending experts offered numerous valuable comments and suggestions on the trial procedures and reached a consensus on the principles and methods for implementing the clinical trial protocol and addressing specific issues. Professor Dou Kefei emphasized that subsequent research efforts must continue to strictly adhere to the protocol and GCP guidelines, ensuring that the clinical study remains authentic, objective, and scientifically sound.

Finally, Mr. Xu Songshan, Chairman of the company, summarized the discussion. He stated that NL005 is classified as a Class 1 therapeutic biological product. According to predictions by Yaodu Consulting, the market size for drugs treating ischemia-reperfusion injury in acute myocardial infarction will reach 5.07 billion yuan by 2025. If this drug is successfully developed, it will not only enrich clinical treatment options for ischemia-reperfusion injury in acute myocardial infarction and improve patients’ quality of life, but also generate significant economic benefits. Although the R&D of this project poses enormous challenges, the company remains fully confident and is already at the forefront of research in this field. It is precisely through the joint efforts of everyone that the scientific rigor of the clinical trial protocol, the standardization of its implementation, and the smooth enrollment of participants have been ensured. Moving forward, the company will continue to allocate resources efficiently and work closely with all experts to strive for the early completion of the clinical study, bringing good news to patients.