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Kanghong Pharmaceutical: Subsidiary KHN921 Injection Approved by FDA to Conduct Clinical Trials
Kanghong Pharmaceutical announced that its subsidiary Chengdu Hongji Biological Technology Co., Ltd. received an email from the U.S. Food and Drug Administration (FDA) granting approval for KHN921 injection to conduct clinical trials in the United States. KHN921 injection is an AAV gene therapy product independently developed by Hongji Biological, used to treat hypertrophic cardiomyopathy (HCM) related to MYBPC3 gene mutations. The product is based on the company’s proprietary intellectual property rights, utilizing a novel adeno-associated virus designed with cell-specific receptors as the delivery vector, employing an innovative administration method to precisely target cardiac muscle tissue and achieve efficient transduction.