China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving clinical trial approval from the US FDA for its Category 1 innovative gene therapy eye injection KH631. The targeted indication is neovascular (wet) age-related macular degeneration (nAMD), a leading cause of vision loss in older adults.
KH631 Profile
KH631 delivers genetic material through an adeno-associated virus (AAV) vector, offering unique characteristics in terms of tissue specificity, immunogenicity, and expression controllability. Preclinical studies have demonstrated continuous efficacy in disease models, highlighting its potential as a novel treatment for nAMD. The drug has already obtained clinical trial approval in China earlier this month, positioning Kanghong to advance its development globally.
Future Plans
With the FDA’s approval, Kanghong plans to initiate clinical trials in the US, further evaluating the safety and efficacy of KH631. This move underscores Kanghong’s commitment to bringing innovative gene therapies to patients with unmet medical needs, particularly in the area of ophthalmology.-Fineline Info & Tech
