Chinagene's Gene-Editing Therapy ZVS203e Injection Receives FDA IND Clearance for Retinitis Pigmentosa

Dec 22, 2023 11:12 CST Updated 11:12

CHIGENOVO

Clinical Genetic Diagnosis, Prevention, and Gene Therapy Drug Development for Hereditary Eye Diseases

Eastern Time (ET)December 20, 2023，CHIGENOVO Co., Ltd.'s first ophthalmic gene-editing Class 1 innovative drug, ZVS203e Injection, which has independent intellectual property rights, has been approved for clinical trials by the U.S. Food and Drug Administration (FDA).（IND）Tacit Consent。This event marks a brand-new breakthrough for CHIGENOVO in the field of gene editing technology for new drug development, and is another significant milestone in the company's deep overseas expansion of its R&D pipeline following the ZVS101e injection.

AboutRHORetinitis Pigmentosa Caused by Mutations（ RHO-RP ）

RP is a group of progressive monogenic blinding eye diseases characterized by the progressive and selective loss of retinal photoreceptor cells and retinal pigment epithelial cells. The incidence rate worldwide is approximately 1/3500, and it is one of the leading causes of irreversible bilateral blindness in the working-age population.RHOGene mutations are most common in autosomal dominant RP. The initial clinical manifestation of RP is night blindness, with most patients developing symptoms during childhood or adolescence. As the condition progresses, the visual field gradually narrows and central vision declines progressively, leading to legal blindness between the ages of 20 and 65. Currently, there are no approved drugs available globally.

About ZVS203e Injection

ZVS203e Injection utilizes the third-generation artificial nuclease CRISPR/Cas9 to target mutationsRHOTargeted gene editing to treat diseases at their root cause by addressing pathogenic genes, achieving a one-time administration with lifelong curative effects. This drug received FDA Orphan Drug Designation in July 2022 and completed the world's first investigator-initiated clinical study (IIT) conducted at Peking University Third Hospital in September 2023.RHOInjection administration in RP patients with gene mutations showed good safety and efficacy in the first patient.

E.N.D

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