Recently, a company in the Zhongguan Village Life Science ParkCHIGENOVOWith the U.S. Food and Drug Administration (FDA) regarding its self-developedInternational Multicenter Phase 3 Clinical Trial Protocol for ZVS101e Injection Reached Consensus. According to the plan,CHIGENOVO Co., Ltd. to Launch Pivotal Clinical Trials in the U.S., Japan, EU, and Asia-Pacific Region Simultaneously, a milestone event marking a critical step forward for the product towards global commercialization.
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The successful approval of this Phase 3 clinical trial protocol not only validates CHIGENOVO's independent innovation capabilities in the field of gene therapy but also further strengthens CHIGENOVO’s strategic determination to build a global clinical development system. In the future, CHIGENOVO will adhere to a global mindset, strictly comply with ICH-GCP international standards and regulatory requirements of various countries, and steadily advance the clinical trial process, aiming to accelerate the approval and market launch of ZVS101e injection to provide a treatment option for BCD patients worldwide who currently have no available treatment.About Bietti's Crystalline Dystrophy (BCD)
Crystalline Retinal Degeneration (BCD) is a specific type of retinitis pigmentosa., with typical changes being the deposition of yellow-white shiny crystalline substances on the retina. Clinical manifestations include night blindness, progressive vision loss, and narrowing of the visual field. Patients typically become blind around the age of 40, and currently, there is no effective treatment available. There are approximately 60,000 to 140,000 BCD patients in China, making it one of the significant causes of irreversible bilateral blindness among the working-age population.BCD is caused by mutations in the CYP4V2 gene., inherited in an autosomal recessive manner, gene mutations lead to the loss of function of their encoded proteins, making them suitable for gene replacement therapy.
ZVS101e Injection is a gene therapy product co-developed by Yang Liping's research team from the Department of Ophthalmology at Peking University Third Hospital and CHIGENOVO Co., Ltd., which completed intellectual property rights conversion in March 2021.Granted FDA Orphan Drug Designation in the United States in August 2021In December 2022, it received Phase I/II clinical trial approvals in both China and the United States, becoming the world's first BCD gene therapy product to enter the clinical stage.As of now, ZVS101e has completed 3 clinical trials, with a total of 29 subjects enrolled, making it theThe BCD gene therapy product with the largest sample size and longest observation period currentlyThe research results show that ZVS101e has excellent safety and significant efficacy, and some clinical trial results have been published inSignal Transduction and Targeted Therapy(Impact Factor 39.3). The product wasIncluded in China's CDE Breakthrough Therapy Directory in June 2024 due to groundbreaking treatment effectsIn July 2024, it once again received the U.S. FDA's Regenerative Medicine Advanced Therapy (RMAT) designation due to its significant efficacy, becoming the first gene therapy product in China to be awarded this honor by the FDA.
