华润双鹤：全资子公司DC6001片获FDA药物临床试验默示许可

Core Viewpoint - China Resources Double Crane announced that its wholly-owned subsidiary, Double Crane Run Chuang, has received effective approval for the clinical trial application of the new drug DC6001 from the FDA, entering the clinical trial phase for Stargardt disease [1] Group 1 - The drug DC6001 has previously received clinical trial approval from the National Medical Products Administration [1] - The IND application for the drug was submitted on November 26, 2025, and the confirmation letter was received on December 9, 2025 [1] - The drug has been designated as a rare pediatric disease drug by the FDA [1] Group 2 - The total R&D investment for the drug has reached 17.36 million yuan [1] - The drug is still in the early clinical stage, and there is uncertainty regarding its market launch [1]