Breakthrough! Zhongyin Tech's ZVS101e Injection Enters Pivotal Phase III Clinical Trial, Accelerating Treatment for Inherited Retinal Disease
CHIGENOVO
Clinical Genetic Diagnosis, Prevention, and Gene Therapy Drug Development for Hereditary Eye Diseases
November 19, 2024, enterprises within Zhongguancun Life Science ParkCHIGENOVO Co., Ltd. has reached an agreement with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) on the Phase III clinical trial protocol for ZVS101e injection.As the most critical milestone event in the process of new drug development to market approval, this marks the official entry of ZVS101e Injection into the pivotal Phase III clinical trial stage. CHIGENOVO will strictly adhere to regulatory requirements and clinical trial protocols, completing tasks such as initiating various trial centers, recruiting subjects, and conducting visits, laying a solid scientific foundation for the early market launch of ZVS101e to benefit patients with hereditary eye diseases.
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About BCD
BCD is a special type of retinitis pigmentosa, with typical changes characterized by yellowish-white crystalline deposits in the retina. Clinically, it manifests as progressive vision loss and visual field constriction. Patients usually become blind around the age of 40, and currently, there is no effective treatment available. There are approximately 60,000 to 100,000 BCD patients in China, making it one of the significant causes of irreversible bilateral blindness in the working-age population and a key focus of blindness prevention efforts. BCD is caused by mutations in the CYP4V2 gene, inherited in an autosomal recessive pattern. The gene mutation leads to the loss of function of the encoded protein, making it suitable for gene replacement therapy.
About ZVS101e
ZVS101e is a recombinant AAV vector containing the human CYP4V2 gene. After subretinal administration of ZVS101e injection, it can efficiently infect retinal cells and specifically express the CYP4V2 protein in the cells, compensating for the loss of protein function caused by gene mutations, thereby effectively treating retinal function in BCD patients. This gene replacement therapy will be applicable to all BCD patients carrying CYP4V2 gene mutations.
About CHIGENOVO
CHIGENOVO Co., Ltd. is a leader in ophthalmic gene therapy, specializing in genetic eye disease diagnosis and gene therapy drug development as a national high-tech enterprise. It is committed to providing precise diagnosis and treatment "one-stop" solutions 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. Currently, it has established a complete drug development system, including target screening, basic research, animal experiment validation, stem cell validation, AAV virus research and production, clinical trial operations, and drug registration applications.
