华润双鹤药业股份有限公司关于全资子公司北京双鹤润创科技有限公司DC6001片获得FDA药物临床试验默示许可的公告

Core Viewpoint - The company announced that its wholly-owned subsidiary, Beijing Shuanghe Run Chuang Technology Co., Ltd., has received implied permission from the FDA for clinical trials of the drug DC6001, marking a significant step in its development process [1][2]. Group 1: Drug Information - Drug Name: DC6001 - Dosage Form: Tablet - IND Number: 178781 - Applicant: Beijing Shuanghe Run Chuang Technology Co., Ltd. - Indication: Stargardt disease [6]. Group 2: Regulatory Milestones - The IND application for DC6001 was submitted to the FDA on November 26, 2025, and the confirmation letter was received on December 9, 2025. The implied permission period has now expired, allowing the company to proceed with clinical trials [2]. - The drug received Rare Pediatric Disease Designation (RPDD) from the FDA on November 24, 2025, which may provide certain policy support in the future, although this is subject to regulatory changes [2]. Group 3: Financial Investment - As of the announcement date, the total R&D investment for the drug DC6001 amounts to approximately RMB 17.36 million (unaudited) [3].