On February 21, 2022, the second interim investigator’s online meeting for the Phase III clinical trial of “Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection in the Treatment of Severe Lower Limb Ischemic Disease” was successfully held. The meeting was chaired by Professor Changwei Liu from the Department of Vascular Surgery at Peking Union Medical College Hospital. More than 50 investigators from 24 research centers across China were invited to participate online. Also attending the meeting were Mr. Songshan Xu, Chairman of the company, along with other senior executives; Lu Rong, Deputy General Manager of Kuntuo Xincheng (CRO); Liu Yang, General Manager of Lianshida (SMO); and all members of the NL003 project team.

        Project Manager Sun Yinjian of NL003 first provided an update on the overall progress of the Phase III clinical trial. From 2020 to 2021, due to the outbreak of the COVID-19 pandemic, regional outbreaks have continued to occur, significantly impacting the initiation and enrollment processes of the clinical trial. The company has implemented a variety of measures to push forward the trial vigorously. Currently, the NL003 clinical trial has been expanded to 24 centers, located in 18 cities across 14 provinces nationwide. Through collaborative recruitment efforts and frequent monitoring and quality control activities, the company has not only accelerated the enrollment rate but also ensured the high quality of the trial. All cases that have completed enrollment meet the required quality standards, and no serious adverse events have been reported.

        After hearing the briefing, the participating researchers put forward constructive suggestions and response measures regarding center management, patient recruitment, regional collaboration, and other aspects. They will accelerate patient enrollment by adopting a trial strategy that prioritizes the ulcer indication while simultaneously advancing the study on resting pain. Senior representatives from the CRO and SMO companies also expressed their commitment to providing greater support for this project, strengthening project personnel management, and working closely with the sponsor and investigators to achieve the established goals.

        Xu Songshan, Chairman of the company, expressed his gratitude for the researchers’ hard work over the past two years. He noted that NL003 is currently the company’s flagship R&D project, but due to recurring COVID-19 outbreaks, the trial’s progress has fallen short of expectations. To make up for the delays caused by the pandemic, the company has implemented a series of measures, including increasing investment, establishing a collaborative hospital model, engaging third-party recruitment agencies, and optimizing development strategies, all aimed at accelerating the trial’s advancement. Currently, all 24 centers nationwide have been fully activated, and senior company executives are managing the trial hospitals on a regional basis, conducting regular visits and providing full support to ensure steady progress. We are confident that, through the joint efforts of all team members, we will successfully complete the trial according to the established goals and strive to become the first domestically approved naked plasmid gene therapy drug, thereby providing better treatment options for patients with lower-limb ischemic disease at an early date.

        Professor Liu Changwei summarized the conference. He praised the efforts made by all the researchers involved in this trial under the pandemic conditions. He noted that although COVID-19 is still occurring sporadically, as the pandemic has now entered a state of routine management, hospitals have developed effective response measures and are now well-equipped to carry out research activities. He called on all researchers to work together with a scientific and rigorous attitude, advancing the trial at a high quality and completing the entire Phase III study ahead of schedule, thus making a positive contribution to bringing the new drug to market and benefiting patients suffering from lower-limb ischemic disease.