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On November 30, 2023, the Investigational New Drug (IND) application for "JWK001 Injection," a Class I innovative gene therapy independently developed by Chengdu Jinweike Biotechnology Co., Ltd. for neovascular age-related macular degeneration (nAMD), was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).
Image Source: CDE Official WebsiteJWK001 Injection delivers AAV carrying a newly self-designed anti-VEGF protein expression cassette to ocular cells through subretinal administration, enabling sustained and efficient expression of the anti-VEGF protein. JWK001 Injection features an innovative multi-target gene expression cassette designed to increase coverage for patients insensitive to single-target therapies, enhancing drug efficacy.JWK001 Injection is undergoing an IIT clinical trial at the Ophthalmology Department of West China Hospital, Sichuan University, led by Professor Lu Fang's team.The first subject in the low-dose group completed the administration at the Ophthalmology Department of West China Hospital, Sichuan University, on June 7, 2023. After three months of clinical observation, a significant reduction in subretinal fluid and other histological signs of improvement were observed. The subject's Best Corrected Visual Acuity (BCVA) improved from 51 letters read before treatment to 58 letters (as measured by the EDTRS corrected visual acuity chart). No local or systemic side effects occurred, indicating good safety. Moreover, after the administration of JWK001 injection, the subject did not require adjuvant therapy.
Yang Yang, Co-founder and CEO of Jinweike Biotechnology, stated: "The continuous tracking results of the first subject in the low-dose group of JWK001 injection show that JWK001 injection has good safety and tolerability, a low effective dose, and patients only need a single administration without adjuvant therapy, bringing great convenience to patients. The IIT clinical results will lay a solid foundation for us to advance to Phase I clinical trials. After the IND is approved, we will accelerate the clinical progress to benefit more patients."Patients benefit."
Source of the article: Jinweike Biotechnology
