Early clinical trial of Vitalgen BioPharma self-developed VGN-R09b injection for the treatment of AADC deficiency started successfully

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. The project is also the clinical trial of gene therapy products conducted by the site as the leading unit for the first time.

2023-01-30

Vitalgen BCD Gene Therapy IND Approved

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. VGR-R01 is a gene replacement therapy drug for patients with Bietti crystalline dystrophy (BCD) caused by CYP4V2 gene mutation, and is the second clinically approved gene therapy product from Vitalgen after the approval of VGB-R04 injection in July this year.

2022-11-01

Shanghai Vitalgen BioPharma Co., Ltd. received Rare Pediatric Disease Designation (RPDD) from the U.S. FDA for its independently developed VGN-R08b

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. Food and Drug Administration (FDA) for its independently developed VGN-R08b. This product is our second gene therapy product to obtain FDA RPDD after VGM-R02b for the treatment of Glutaric Acidemia Type I received FDA RPDD in May 2022, and will have the opportunity to apply for U.S. Pediatric Orphan Drug Priority Review Voucher (PRV) as a rare pediatric disease product.

2022-10-24

Milestone of BCD gene therapy: Vitalgen VGR-R01 IND application accepted

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.

2022-08-19

Mr. Shou Ziqi, Vice Chairman of Shanghai Municipal CPPCC Committee, visited Vitalgen with his delegation

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”. The accompanying government officials included Mr. Zhou Weizhong, Director of the Study and History Commission of the Shanghai Municipal CPPCC Committee.

2022-07-01

VGM-R02b Obtained Rare Pediatric Disease Designation (RPDD) from FDA

On May 25, 2022 (Eastern Standard Time), Shanghai Vitalgen BioPharma Co., Ltd. was awarded Rare Pediatric Disease Designation (RPDD) for the drug candidate VGM-R02b in treating glutaric aciduria type I (GA-1) by the Food and Drug Administration (FDA) . This is the first gene therapy product for GA-I worldwide. The designation will qualify Vitalgen upon approval of VGM-R02b for an assignable and transferable priority review voucher (PRV) that can be used to speed up the approval process for any other drug.

2022-05-26

Recent Progresses in Gene Therapy Presented by Vitalgen BioPharma at the ASGCT Annual Meeting

The 25th Annual Meeting of American Society of Gene & Cell Therapy (ASGCT) will be held on May 16-19, 2022 in Washington, D.C., USA. Shanghai Vitalgen BioPharma Co., Ltd. have submitted two poster presentations describing recent research progresses in collaboration with the Institute of Zoology, Chinese Academy of Science, making its first appearance at the ASGCT Annual Meeting.

2022-05-16