On November 15, Kanghong Pharmaceutical announced that the KH631 eye injection declared by its subsidiary, Hongji Biology, obtained the drug clinical trial approval Notice of China Drug Administration and agreed to carry out clinical trials.
So far, reporters learned through the National Drug Administration official website, this is our country the first approved to enter the clinic, for the treatment of neovascular (wet) age-related macular degeneration (nAMD) gene therapy product.
Age-related macular degeneration (age-related macular degeneration) is one of the three leading causes of blindness, and the prevalence of early AMD in Chinese people over the age of 50 is between 1.7% and 9.5%, and the prevalence of late AMD is between 0.2% and 1%. The prevalence of AMD increases with age. Aging of the population will lead to a significant increase in the prevalence of AMD.
Currently, anti-VEGF drugs are commonly used in clinical treatment of nAMD, but this treatment method requires frequent and lasting intraocular injection, which not only increases the cost and risk of treatment, but also causes great psychological burden for patients.
Described as the third revolution in the medical field, gene therapy refers to the introduction of foreign genes into target cells to correct or compensate for defective and abnormal genes for therapeutic purposes.
KH631 eye injection is a new generation ophthalmic gene therapy product and a Class 1 biological new drug developed by Kanghong Pharmaceutical Co., LTD., with independent intellectual property rights. It is featured in tissue-specific, immunogenicity, controllability of expression and infection efficiency, and has shown sustained efficacy in preclinical disease models. It is expected to achieve the potential efficacy of "one treatment, a lifetime cure", and has a huge future prospect.
