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

Core Viewpoint - China Resources Double Crane (华润双鹤) announced that its wholly-owned subsidiary, Beijing Double Crane Run Chuang Technology Co., Ltd. (双鹤润创), has received effective status for its new drug clinical trial application (IND) for the drug DC6001 from the FDA, marking the drug's advancement into the clinical trial phase [1] Group 1 - The IND application for DC6001 was submitted to the FDA on November 26, 2025, and the FDA confirmed receipt of the application on December 9, 2025 [1] - According to FDA regulations, the company can commence human clinical trials as the 30-day implied approval period has elapsed without receiving a Clinical Hold notice from the FDA [1] - The company will proceed with subsequent clinical trial work in an orderly manner in accordance with FDA requirements [1]