Beijing Innovec Pharmaceutical Technology Co., Ltd., a leading gene therapy company based in China, has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its IVB103 treatment for neovascular (wet) age-related macular degeneration (nAMD). This follows a clinical trial approval for the same indication in the US, which was granted in July this year.
IVB103 is an in-house developed gene therapy for nAMD that is administered intravitreally and has demonstrated best-in-class potential in pre-clinical studies. Innovec Pharma has partnered with uBriGene Biosciences, a domestic firm providing comprehensive CDMO services for the IVB103 project. These services include strain library construction, plasmid and AAV process development, GMP production, testing, methodology validation, stability research, and application documentation writing.- Flcube.com