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14
2022-11
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.
21
2022-10
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.
09
2022-08
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.
30
2022-06
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”.
25
2022-05
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) .
16
2022-05
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.
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