The 1^st in-human trial of VGN-R08b, a gene therapy product independently developed by Shanghai Vitalgen BioPharma Co., Ltd. has been initiated in collaboration with Xinhua Hospital, affiliated with the Shanghai JiaoTong University School of Medicine. This trial will evaluate the tolerability, safety and efficacy of intracerebroventricular administration of VGN-R08b for treating GDII patients.

The 1^st in-human trial of VGN-R09b, a gene therapy product independently developed by Shanghai Vitalgen BioPharma Co., Ltd. has been initiated in collaboration with the Shanghai Children's Medical Center, Shanghai JiaoTong University School of Medicine. This trial will evaluate the tolerability, safety and efficacy of intrastriatal administration of VGN-R09b for treating AADCD patients.

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”.