On May 14, 2021, the interim meeting for investigators of the Phase III clinical trial of “Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection” (hereinafter referred to as “NL003”), organized by Beijing Northland Biotechnology Co., Ltd., was successfully held in Hangzhou. The meeting invited over 20 participants, including investigators from already activated and newly added research centers, as well as representatives from CRO and SMO companies. The meeting was chaired by Professor Changwei Liu, the principal investigator of this trial from the Department of Vascular Surgery at Peking Union Medical College Hospital.

Sun Yinjian, Manager of the Company’s Clinical Research Department, presented an overview of the progress of the Phase III clinical trial for the NL003 project, analyzed the clinical data from currently enrolled patients, and released the monthly enrollment plans for each center. Since March of this year, the clinical trial has resumed normal operations, free from the impact of the pandemic, and is expected to be completed as scheduled.

From the perspective of trial management, Hou Shujian, Project Manager at the CRO company, summarized the issues currently arising in the trial process and proposed recommendations for subsequent improvement plans.

Han Chengquan, Vice President in charge of clinical operations at the company, provided a detailed overview of the domestic and international R&D progress in gene therapy drugs, as well as the mechanism of action and clinical research findings of the NL003 project. He also explained the overall trial schedule and the key measures the company has taken. To accelerate the trial’s progress, the company has now increased the number of participating research centers from 18 to 25. Additionally, the company will collaborate with specialized subject recruitment agencies to broaden the scope of subject enrollment. Furthermore, the company will regularly organize regional and national project workshops to enhance communication and collaboration among all participating institutions. At the same time, the company has formulated policies to encourage researchers to conduct scientific research related to this project, supporting them in carrying out basic studies on mechanisms of action, expanding indications, and exploring clinical applications. The company is committed to ensuring that clinical and basic research advance in parallel, thereby accumulating more robust and high-quality scientific data for future regulatory submissions and clinical use of NL003.

The participating researchers engaged in a lively discussion on specific issues encountered during the conduct of this clinical trial and listened to shared experiences from leading centers regarding subject recruitment. The researchers further reached a consensus on scientific requirements such as trial inclusion criteria, study methodology, and evaluation metrics, and offered constructive suggestions for the subsequent implementation of the trial.

Professor Liu Changwei summarized this investigator meeting and put forward requirements for all participating research centers. He expressed the hope that all participating institutions and researchers would further clarify the quality standards for the study, arrange and implement specific tasks at each center, and actively advance the trial with a scientific and rigorous attitude. While ensuring high-quality results, they should strive to accelerate the trial’s progress and aim to complete the trial as soon as possible.

Mr. Xu Songshan, Chairman and President of the company, delivered the closing remarks. He expressed his gratitude to the attending experts for taking time out of their busy schedules to participate in this mid-term meeting. He also extended sincere appreciation to all centers and third-party collaborating institutions for their proactive efforts and remarkable achievements in advancing this trial following the pandemic. Currently, all aspects of the trial have gotten on track and are progressing smoothly. The company will step up its investment in human resources, material resources, and financial support to provide full backing for this trial, and looks forward to the clinical trial being completed with high quality and according to schedule.

Through this meeting, the participating research centers gained a clearer understanding of the investigational drug NL003 and its clinical significance, and reached a consensus on the overall project plan as well as the enrollment targets for each center. The researchers attending the meeting expressed their commitment to fully advancing the trial in accordance with clinical research standards, working together to develop innovative drugs that are both scientifically sound and possess intellectual property rights in China—drugs that are safer and more effective. They also look forward to seeing the clinical research findings soon translated into clinical practice, thereby enriching treatment options for lower-limb ischemic diseases and alleviating patients’ suffering.