华润双鹤：全资子公司DC6001片FDA临床试验申请获批

Group 1 - The company, China Resources Double Crane (华润双鹤), announced that its wholly-owned subsidiary, Beijing Double Crane Run Chuang Technology Co., Ltd., has received an implied approval from the FDA for the clinical trial application of the drug DC6001, marking the drug's advancement to the clinical trial phase [1] - The drug is indicated for Stargardt disease, with an IND number of 178781, and the total R&D investment amounts to 17.36 million yuan (approximately 2.5 million USD) [1] - The IND application was submitted to the FDA on November 26, 2025, and the confirmation letter was received on December 9, 2025, indicating that the implied approval period has expired, and the company will proceed with subsequent clinical trial work as required by the FDA [1] Group 2 - Additionally, the subsidiary applied for orphan drug designation for a rare pediatric disease on September 23, 2025, which was approved on November 24, 2025; however, there is uncertainty regarding policy support, and final market approval cannot be guaranteed [1]