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21
2023-09
Vitalgen completed the enrollment in the Phase I/II clinical trial of the world's first BCD gene therapy
On September 21, 2023, the surgical administration of all subjects was successfully completed in the Phase I/II clinical trial of VGR-R01, marking another critical step toward the marketing of this world-first therapeutic product.
13
2023-07
Vitalgen received CTA approval for its proprietary new drug VGM-R02b, a dedicated new drug for rare pediatric diseases
On July 13, 2023, the proprietary VGM-R02b of Shanghai Vitalgen BioPharma Co., Ltd. was granted CTA approval for the treatment of glutaric acidemia type I from the National Medical Products Administration (NMPA).
04
2023-05
Six independent innovation and R&D achievements of Vitalgen will be presented at ASGCT
The 26th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) will be held in Los Angeles on May 16 to 20, 2023. Vitalgen will present its following development covering the latest advances of the AAV gene therapy for CNS and ophthalmic diseases, CRISPR gene editing and lipid nanoparticle technology platforms on schedule at the meeting in Los Angeles on May 17-18, 2023.
27
2023-04
Clinical trial for Vitalgen's self-developed VGM-R02b accepted
On April 27, 2023, Shanghai Vitalgen BioPharma Co., Ltd. received the notification of clinical trial acceptance from the National Medical Products Administration for its self-developed VGM-R02b. VGM-R02b is used for the treatment of glutaric acidemia type I (GA-I) and is an innovative drug for children. It was previously granted Rare Pediatric Disease Designation (RPDD) status by the U.S. Food and Drug Administration (FDA) for the treatment of glutaric acidemia type I (GA-I).
01
2023-03
Launch of an investigator-initiated trial of VGN-R08b for treating type II Gaucher disease (GDII)
The 1st 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.
30
2023-01
Launch of an investigator-initiated trial of VGN-R09b for treating aromatic L-amino acid decarboxylase deficiency (AADCD)
The 1st 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.
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