华润双鹤(600062.SH)子公司DC6001片获得FDA药物临床试验默示许可

Core Viewpoint - China Resources Double Crane (600062.SH) announced that its wholly-owned subsidiary, Beijing Double Crane Run Chuang Technology Co., Ltd. (referred to as "Double Crane Run Chuang"), has received effective approval from the FDA for the new drug clinical trial application (IND) for DC6001 tablets, marking the drug's entry into the clinical trial phase [1] Group 1 - The drug DC6001 is currently in the early stages of clinical development, pending confirmation of safety, efficacy, and quality control through clinical trials [1] - The drug is subject to objective failure rates and other associated risks during the clinical trial process [1] - According to U.S. drug registration laws and regulations, a series of clinical studies must be conducted in the U.S. and approved by the FDA before the drug can be marketed [1]