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东诚药业下属公司获得药物临床试验批准通知书
Zhi Tong Cai Jing· 2025-08-22 04:32
Core Viewpoint - Dongcheng Pharmaceutical (002675.SZ) announced that its subsidiary LNC PHARMA PTE.LTD. received FDA approval for the clinical trial of 225Ac-LNC1011 injection, which will soon commence Phase I clinical trials [1] Summary by Relevant Sections - **FDA Approval**: The FDA has completed the safety review of the 225Ac-LNC1011 injection application and has issued a Study May Proceed Letter (SMP), allowing the proposed prostate cancer clinical study to move forward [1] - **Next Steps**: Following the issuance of the SMP, the 225Ac-LNC1011 injection must undergo clinical trials and receive FDA review and approval before it can be marketed and sold in the United States [1]
立方制药:收到药品临床试验批准通知书
news flash· 2025-04-24 09:31
Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of Beipaidu Acid Tablets, a drug aimed at lowering LDL-C by inhibiting cholesterol synthesis in the liver [1] Group 1: Product Information - Beipaidu Acid Tablets are classified as a Class 3 chemical drug in the registration application [1] - The original drug was approved for market release in the United States in 2020 and has not yet been launched domestically [1] Group 2: Company Position - The company is the third domestic enterprise to receive approval for clinical trials of this drug [1] - The approval of the clinical trial application is not expected to have a significant impact on the company's short-term performance [1]