Since the Phase III clinical trial of “Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection,” initiated by our company, was officially launched in July, a total of nine research centers have been activated by year-end. Among them, 17 cases have been screened, and 15 have been enrolled. Currently, the trial is proceeding smoothly according to plan.

　　This trial is jointly conducted by our company in collaboration with Kun Tuo Xin Cheng Pharmaceutical R&D (Beijing) Co., Ltd. (CRO) and Beijing Lianshida Pharmaceutical Technology Development Co., Ltd. (SMO). The leading coordinating institution is Peking Union Medical College Hospital, with Professor Changwei Liu from the Department of Vascular Surgery serving as the principal investigator. The trial is planned to be carried out at 20 centers nationwide.

　　After meticulous planning and careful preparation in the earlier stages, the project team has completed all necessary tasks, including bidding for collaborating institutions, screening of research centers, obtaining PSV approval, securing approval from the Genetic Office, institutional project initiation, ethical review, and contract signing. At the beginning of July, Peking Union Medical College Hospital in Beijing officially launched the study and enrolled its first subject. Currently, a total of nine centers—Chifeng City Hospital, Shanxi Provincial People’s Hospital, Zhangzhou Hospital in Fujian Province, Beijing Hospital, Chongqing No. 9 People’s Hospital, Shanghai Seventh People’s Hospital, Xiangya Third Hospital of Central South University, and the First Affiliated Hospital of Xi’an Jiaotong University—have officially commenced the study. Other centers have also entered the stage of institutional ethics review and are set to launch one after another soon.

　　Since the initiation of the Phase III trial, our company has promptly refined our clinical trial quality management system in accordance with GCP guidelines and diligently organized all parties involved in the trial to provide robust support for the clinical research. Meanwhile, the project team has promptly conducted collaborative monitoring and auditing to ensure the quality of the trial.

　　In 2019, due to factors such as adjustments in industry regulations and changes in institutional qualifications, the pace of launching new centers was somewhat slowed down. In 2020, our company will accelerate the launch process for the remaining centers, meticulously manage projects, and thoroughly study the feasibility of obtaining conditional approval for market launch, striving to complete Phase III trials by 2021.