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Today,According to the CDE official website, "ZVS203e Injection" developed by CHIGENOVO Co., Ltd. has obtained clinical trial implied permission for the treatment of patients carrying the RHO-R135W (RHO c.403C>T) mutation.Retinitis Pigmentosa(Retinitis Pigmentosa, RP) patients.
It is reported that ZVS203e injection is a gene-editing therapeutic drug.Utilizing the third-generation artificial nuclease CRISPR/Cas9 to perform site-directed editing on the mutation hotspot of the RHO gene, achieving a one-time administration with lifelong curative effects.The drug received FDA Orphan Drug Designation in 2022, and the related research findings were published in the prestigious international biology journal eLife in June 2023.On December 20, 2023, ZVS203e Injection developed by CHIGENOVO received the Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA).CHIGENOVO Co., Ltd.Specializing in genetic eye disease gene diagnosis and gene therapy drug development, CHIGENOVO is committed to providing precise diagnosis and treatment "one-stop" services for patients with hereditary eye diseases. Based on the diagnostic platform, CHIGENOVO has established a genetic eye disease database and large cohorts, summarizing the mutation spectrum of Chinese patients to provide therapeutic targets for drug development; on this basis, it develops drugs with independent intellectual property rights, including gene replacement therapy and gene editing therapy.
A complete drug development system has been established, including target screening, basic research, animal experiment validation, stem cell validation, AAV virus research and production, clinical trial operations, and drug registration applications.
