VGN-R09b, first domestically developed gene therapy drug for the treatment of primary Parkinson’s disease and aromatic L-amino acid decarboxylase deficiency approved for clinical trials in China

On April 19, 2024, Shanghai Vitalgen BioPharma Co., Ltd., alongside its wholly-owned subsidiary, Shanghai TaiChang Biotechnology Co., Ltd. (hereinafter referred to as the “Company”), received the Green Light from the National Medical Products Administration (NMPA) to embark on clinical trials for their groundbreaking gene therapy drug VGN-R09b. The drug, developed and manufactured entirely in-house, targets the treatment of primary Parkinson’s disease (PD) and aromatic L-amino acid decarboxylase deficiency (AADCD).

2024-04-19

Vitalgen’s Breakthrough “New Productivity” Brings Rays of Hope to Global BCD Patients

Shanghai Vitalgen BioPharma Co., Ltd. (Vitalgen) has unveiled a groundbreaking treatment that promises to transform the lives of individuals suffering from Bietti Crystalline Dystrophy (BCD). Developed in-house, their revolutionary VGR-R01 injection has successfully completed Phase I/II clinical trials by September, 2023, marking a significant milestone as the world’s first IND-approved and clinically tested therapy for this intended indication. Leading the charge in this crucial research are Professor Wei Wenbin from Beijing Tongren Hospital, CMU, and Professor Sun Xiaodong from Shanghai General Hospital. Recently, the remarkable progress achieved by Vitalgen’s VGR-R01 injection, from animal models to intended indications and molecular breakthroughs, has garnered widespread attention. Its outstanding clinical efficacy has earned it a dedicated feature on Beijing TV’s renowned show, “Good Morning Beijing”.

2024-04-19

Xu Feng, Secretary of Shanghai Municipal Party Committee for Science and Technology, Leads Research Visit to Vitalgen

On April 18, 2024, a high-profile delegation led by Xu Feng, Secretary of Shanghai Municipal Party Committee for Science and Technology, descended upon Shanghai Vitalgen BioPharma Co., Ltd. (hereinafter referred to as “Vitalgen” or the “Company”). Accompanying Xu Feng were Meng Xing, the Director of the Office of Secretary of Shanghai Municipal Party Committee for Science and Technology, and Dong Liangyan, Deputy Director of the Biotechnology and Pharmaceutical Department of Science and Technology Commission of Shanghai Municipality.

2024-04-18

Nine Innovative R&D Achievements of Vitalgen Soon to be Unveiled at ASGCT Annual Meeting

On March 27, 2024, Shanghai Vitalgen Biomedical Co., Ltd. (hereinafter referred to as "Vitalgen") announced that it will participate in the 27th Annual Meeting of American Society of Gene & Cell Therapy (ASGCT) to be held in Baltimore from May 7 to May 11, 2024. During the meeting, Vitalgen will present nine of its latest R&D achievements covering gene therapies, gene editing technology platforms and product pipelines in the form of oral and poster presentations. As one of the key oral presentations, the Phase 1/2 clinical trial data of VGR-R01, a gene therapy independently developed by Vitalgen for the treatment of Bietti crystalline dystrophy (BCD), will be announced for the first time globally.

2024-03-27

The IND Application of China’s First Independently Developed Gene Therapy Drug VGN-R09b for the Treatment of AROMATIC L-Amino Acid Decarboxylase Deficiency and Primary Parkinson's Disease Has Been Accepted

January 24, 2024 - VGN-R09b, independently developed and manufactured by Shanghai Vitalgen BioPharma Co., Ltd. and its wholly-owned subsidiary Shanghai Taichang Biotechnology Co. Ltd. (hereinafter referred to as the “Company”), has obtained the acceptance notice issued by the NMPA, with the indications to primary Parkinson's disease (PD) and aromatic L-amino acid decarboxylase deficiency (AADCD), and it is the first gene therapy variety to submit the IND application and be accepted in China.

2024-01-24

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).

2023-07-13

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 from May 16 to 20, 2023. Founded in 1996, ASGCT has over 5,000 members worldwide. It is the largest non-profit organization specializing in CGT research and also the most authoritative and credible organization in the CGT field. ASGCT gathers thousands of academics, FDA officials, industry representatives, and investors from around the world each year.With the coexistence of opportunities and challenges in CGT R&D in China in recent years, Vitalgen has been focusing on independent innovation and encouraging its R&D, transformation and clinical teams to work together to continuously transform research into scientific and technological achievements to serve patients by addressing the urgent clinical needs. 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.

2023-05-04

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).

2023-04-27

An early clinical study on VGN-R08b injection, a gene therapy product independently developed by Vitalgen, for the treatment of type II Gaucher disease (GD2) was initiated successfully

The first clinical study on the gene therapy product named VGN-R08b injection independently developed by Shanghai Vitalgen Biomedical Co., Ltd. (hereinafter referred to as "Vitalgen"), titled an exploratory clinical study to evaluate the tolerability and safety of VGN-R08b by intracerebroventricular injection in patients with type II Gaucher disease, was successfully initiated in Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine on March 1, 2023.

2023-03-01

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