Vitalgen Announces Completion of Patient Enrollment in The Phase III Clinical Trial of VGR-R01 for the Treatment of Bietti Crystalline Dystrophy

SHANGHAI, CHINA, March 19, 2025--Shanghai Vitalgen Biopharma Co., Ltd. announces the successful completion of patient enrollment in its Phase III pivotal clinical trial (VGR-R01-301) of VGR-R01, an investigational gene therapy for the treatment of Bietti crystalline dystrophy (BCD).

2025-03-19

Inclusion of VGR-R01, a Vitalgen gene therapy for treating Bietti Crystalline Dystrophy in the CDE "Care Plan" pilot project

The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced on December 16, 2024 that VGR-R01, a gene therapy developed by Shanghai Vitalgen BioPharma Co., Ltd. for treating Bietti Crystalline Dystrophy (BCD) has been incorporated in the pilot project of Patient-Centered Drug Research and Development Pilot Work Plan for Rare Diseases (“Care Plan”).

2024-12-17

Shanghai Vitalgen BioPharma entered an agreement with GRIT Biotechnology for the use of Vitalgen's proprietary CRISPR-AaCas12bMax tool and technology in GRIT's cell therapy programs

Shanghai Vitalgen BioPharma Co. Ltd. and GRIT Biotechnology Co. Ltd. jointly announced today that an agreement has been reached for GRIT to use Vitalgen's AaCas12bMax gene editing tool and its related technologies to develop, manufacture and commercialize GRIT's cell therapy products.

2024-11-05

VGR-R01, a gene therapy exclusively developed by Vitalgen, was granted the Orphan Drug Designation by the U.S. FDA

VGR-R01, a gene therapy developed by Shanghai Vitalgen BioPharma Co., Ltd. for the treatment of Bietti crystalline dystrophy (BCD), was granted the Orphan Drug Designation (ODD) by the United States Food and Drug Administration on October 29, 2024 (EST).

2024-10-30

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.

2024-09-21

Vitalgen's VGR-R01 is included in the China's list of breakthrough therapeutic varieties

Recently, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that VGR-R01 independently developed by Shanghai Vitalgen BioPharma Co., Ltd. (hereinafter referred to as Vitalgen) was formally included in the list of breakthrough therapeutic varieties for the treatment of bietti crystalline dystrophy (BCD).

2024-08-30

VGN-R09b, China's first domestically developed gene therapy drug for the treatment of aromatic L-amino acid decarboxylase deficiency, completed the first subject administration in a registered study

At present, the first registered investigational drug of VGN-R09b independently developed and produced by Shanghai Vitalgen BioPharma Co., Ltd. and its wholly-owned subsidiary Shanghai TaiChang Biotechnology Co., Ltd. (hereinafter referred to as “the company”) in children with aromatic L-amino acid decarboxylase deficiency (AADCD) has completed the 28-day post-dose follow-up.

2024-08-12

VGN-R09b, China's First Domestically Developed Gene Therapy Drug for the Treatment of Primary Parkinson's Disease, Approved for Clinical Trials in the United States

On July 26, 2024, VGN-R09b self-developed by Shanghai Vitalgen BioPharma Co., Ltd. (hereinafter referred to as “the Company”) received the U.S. Food and Drug Administration's (hereinafter referred to as “FDA”) Investigational New Drug (“IND”) implied license, which granted consent for conducting clinical studies for the treatment of primary Parkinson's disease (hereinafter referred to as the “PD”) in the United States.

2024-07-26

Clinical Trial Registration of VGN-R09b Injection Self-Developed by Vitalgen for Treatment of Primary Parkinson's Disease Successfully Initiated

On July 5, 2024, the Phase 1/2 clinical study of the gene therapy drug VGN-R09b Injection for treatment of primary Parkinson's disease self-developed by Shanghai Vitalgen BioPharma Co., Ltd. (hereinafter referred to as “Vitalgen”) was initiated at Huashan Hospital, Fudan University.

2024-07-05

Vitalgen ASGCT announces the latest Phase I/II clinical data for VGR-R01 in the treatment of BCD

On May 9, 2024, Shanghai Vitalgen BioPharma Co., Ltd. (hereinafter referred to as “Vitalgen”) will globally publish the updated data on the phase I/II clinical trial of gene therapy product VGR-R01 in patients with Bietti crystalline dystrophy (BCD) in oral presentation form for the first time in the 27th Annual Meeting of American Society for Gene & Cell Therapy (ASGCT) to be held in Baltimore, fully demonstrating its excellent efficacy and safety advantages.

2024-05-09