On July 5, 2024, the Phase 1/2 clinical study of the gene therapy drug VGN-R09b Injection for treatment of primary Parkinson's disease self-developed by Shanghai Vitalgen BioPharma Co., Ltd. (hereinafter referred to as “Vitalgen”) was initiated at Huashan Hospital, Fudan University.

A number of experts and teams attended the meeting, including Prof. Wang Jian from the Department of Neurology, Prof. Chen Liang from the Department of Neurosurgery at Huashan Hospital, Prof. Zhang Jing from the Phase 1 site, Prof. Zuo Chuantao from the PET Center and his department's clinical research team as well as the Vitalgen team from the sponsor. Together, they witnessed the successful initiation of the first registered clinical study of gene replacement therapy for Parkinson's disease in China. At the kick-off meeting, all parties had an in-depth discussion on the study protocol of VGN-R09b Injection, and fully communicated and exchanged views on the implementation process and corresponding details of the R&D protocol.

VGN-R09b Injection obtained the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration on April 2024, which granted consent to conduct a clinical trial for treating primary Parkinson's disease (PD) and aromatic L-amino acid decarboxylase deficiency (AADCD). On July 2, 2024, the first subject was dosed in the registered clinical study of this product for treatment of AADCD at the Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine.

This kick-off meeting was successfully held, and subsequent recruitment of subjects will be conducted nationwide. Vitalgen will work together with the research team at Huashan Hospital to get the product approved and marketed in China as soon as possible, and deliver the world-leading therapeutic solution to patients with Parkinson's disease.

Figure A photo taken at the kick-off meeting