The first clinical study on the gene therapy product named VGN-R08b injection independently developed by Shanghai Vitalgen Biomedical Co., Ltd. (hereinafter referred to as "Vitalgen"), titled an exploratory clinical study to evaluate the tolerability and safety of VGN-R08b by intracerebroventricular injection in patients with type II Gaucher disease, was successfully initiated in Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine on March 1, 2023.

On January 30, 2023, the first clinical study of VGN-R09b injection, a gene therapy drug developed by Shanghai Vitalgen BioPharma Co., Ltd. (“Vitalgen BioPharma”) - “an open, dose-escalation early clinical study to evaluate the tolerability, safety and efficacy of intra-striatal injection of VGN-R09b in patients with AADC deficiency” was successfully started at Shanghai Children's Medical Center (SCMC) affiliated to Shanghai Jiao Tong University School of Medcine.

On November 1, 2022, the clinical trial (IND) application for VGR-R01 injection developed independently by Shanghai Vitalgen BioPharma Co., Ltd. (hereinafter referred to as “Vitalgen”) received the implied permission from the Center for Drug Evaluation (CDE) National Medical Products Administration.

On October 21, 2022 (EDT), Shanghai Vitalgen BioPharma Co., Ltd. was granted the Rare Pediatric Disease Designation (RPDD) for the treatment of Neuronopathic Gaucher Disease (nGD) by the U.S.

On August 9, 2022, Shanghai Vitalgen BioPharma Co., Ltd. (hereinafter referred to as “Vitalgen”) announced that the IND application of its self-developed VGR-R01 injection (rAAV2/8-CYP4V2) was accepted by Center for Drug Evaluation (CDE), National Medical Products Administration. VGR-R01 is a gene therapy product independently developed by Vitalgen for patients with Bietti crystalline dystrophy (BCD) caused by CYP4V2 gene mutation. It is also the first therapeutic drug for BCD with IND application. Its mechanism of action is gene replacement.

On June 30, 2022, Mr. Shou Ziqi, Vice Chairman of Shanghai Municipal Committee of the Chinese People's Political Consultative Conference (CPPCC), visited Shanghai Vitalgen BioPharma Co., Ltd. (hereinafter referred to as “Vitalgen”) as part of his major inspection tours to “prevent the epidemic, stabilize economy and ensure security”.