Kanghong subsidiary gets NMPA nod for ocular drug clinical trials

Chengdu Kanghong Pharmaceutical Group announced that its subsidiary, Chengdu Hongji Biotechnology Co., Ltd., has received a notice of approval for drug clinical trials from the National Medical Products Administration. The approval is for KH658 Ocular Injection, a self-developed gene therapy classified as a Class 1 therapeutic biological product. This innovative drug is approved for clinical trials targeting Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR).

KH658 Ocular Injection also received approval from the U.S. Food and Drug Administration (FDA) on April 26, 2024, to conduct clinical trials in the United States for neovascular (wet) age-related macular degeneration (nAMD). The company emphasizes the inherent uncertainties in drug development, clinical trials, and regulatory approvals, advising investors to exercise caution due to investment risks.