uBriGene Biosciences, a China-based advanced therapy medicinal product (ATMP) CDMO, has entered a strategic partnership with Beijing Innovec Biotherapeutics Inc., a gene therapy company, to jointly advance clinical translation and industrialization of AAV gene therapies for hereditary eye diseases. The collaboration builds on successful IND approvals for Innovec’s IVB103 (China and US) and IVB102 (FDA) projects, with uBriGene providing comprehensive GMP-grade AAV manufacturing and regulatory support for additional pipeline candidates.
Bottleneck in clinical-grade AAV supply; partnership addresses vector manufacturing constraint delaying gene therapy development
Development Roadmap
Phase
Activity
Timeline
Current
Agreement execution; tech transfer for new AAV candidate
Q1 2026
Manufacturing
GMP batch production for IND-enabling studies
2026
Regulatory
Dual NMPA/FDA IND submissions
2026-2027
Clinical
Phase I/II initiation for hereditary eye disease indications
2027
Expansion
Pipeline project manufacturing scale-up
Ongoing
Forward‑Looking Statements This brief contains forward‑looking statements regarding AAV gene therapy clinical translation timelines, GMP manufacturing scale-up success, and regulatory approval pathways for hereditary eye disease treatments. Actual results may differ due to AAV vector immunogenicity challenges, ocular gene therapy durability limitations, and competitive dynamics with established players (Novartis, Roche, Biogen).-Fineline Info & Tech
By Fineline Cube 