Zhongyin Biotech's AAV Gene Therapy ZVS101e for Bietti’s Crystalline Dystrophy Granted Breakthrough Therapy Designation by CDE

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2024Year6Month29Day,CDEThe official website shows that CHIGENOVO Co., Ltd.ZVS101eThe injection has been included in the list of breakthrough therapies for the treatment of crystalline retinal degeneration (BCD）。

This milestone event isZVS101eA major breakthrough from scientific theory to clinical application in humans, with clinical results demonstrating safety and efficacy.ZVS101eThe Excellent Clinical Value and Huge Potential for Future Market Launch of the Injection.

On the other hand, CHIGENOVO's R&D platform has further strengthened its ability to translate early-stage disease treatment target research into final therapeutic product applications, and it will contribute more to the treatment of genetic diseases in the future.

AboutZVS101e

ZVS101eIs ContainedCYP4V2Gene RecombinationAAVVector.ZVS101eAfter subretinal administration of the injection, it can efficiently infect retinal cells and achieve specific expression within the cells.CYP4V2Protein, compensating for the loss of protein function caused by gene mutations, therebyBCDThe retinal function of patients plays an effective therapeutic role. This alternative treatment drug will be suitable for all carriers.CYP4V2Gene MutationsBCDPatient.

In2021The first investigator-initiated clinical trial was conducted in [Year], targeting internationally.BCDThe First Gene Therapy Clinical Trial for the Disease (NCT04722107), and obtained in the United States in the same yearFDAOrphan Drug Designation.2022YearZVS101eInjection Solution Obtained in China and the USINDApproval,2023Year2Monthly CompletionI/IIThe first subject enrolled in the Phase clinical trial is targeted worldwide.BCDThe first registrational clinical trial has been initiated. Currently, the drug has completedI/IIPhase clinical trial, about to enterIIIPhase of clinical trial.

About CHIGENOVO

CHIGENOVO Co., Ltd. is a leader in ophthalmic gene therapy, specializing in genetic eye disease diagnosis and the development of gene therapy drugs as a national high-tech enterprise. It is committed to providing "one-stop" services for precise diagnosis and treatment for patients with hereditary eye diseases. CHIGENOVO has established a genetic eye disease database and large cohorts based on its diagnostic platform, 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, striving to achieve a "from zero to one" breakthrough. It has currently established target screening, basic research, animal experiment validation, stem cell validation,AAVA complete drug development system including virus research and production, clinical trial operations, and drug registration submissions.

Source: CHIGENOVO