DNA Therapeutics

1.1 DNA Therapeutics for Human Use

The primary development focus of naked plasmid therapeutics is angiogenic factors gene therapy. As of now, there are a total of two approved naked plasmid drugs for human use globally: Neovasculgen, launched in Russia in 2011, and Collategene, introduced to the Japanese market in 2019. Several other naked plasmid drugs are currently in the Phase II-III clinical stages. Encoding genes include HGF, VEGF-A, SDF-1 (CXCL12), and among others.

1.2 DNA Therapeutics for Animal Use

Different from human medicines, DNA vaccines have been more successful for animal use, including veterinary and pet.

Approved naked plasmid DNA in human and animal

Yaohai Bio-Pharma Offers One-Stop CDMO Solution for Plasmid DNA

• Microbial Strain Engineering and Screening
• Microbial Cell Banking (PCB/MCB/WCB)
• Upstream Process Development
• Downstream Process Development
• Formulation Development
• GMP Manufacturing
• Fill and Finish
• Analytical and Testing
• Regulatory Affairs

Reference:

[1] Pagliari S, Dema B, Sanchez-Martinez A, Montalvo Zurbia-Flores G, Rollier CS. DNA Vaccines: History, Molecular Mechanisms and Future Perspectives. J Mol Biol. 2023 Dec 1;435(23):168297. doi: 10.1016/j.jmb.2023.168297.