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（003020）公告，公司收到国家药品监督管理局下发的贝派度酸片《药物临床试验批准通知 书》。贝派度酸片是一种三磷酸腺苷-柠檬酸裂解酶抑制剂，通过抑制肝脏中胆固醇的合成来降低LDL- C。该产品原研药于2020年在美国获批上市，尚未在国内上市。本次注册申请分类为化学药品3类。国 家药品监督管理局药品审评中心数据显示，公司为国内第3家获批临床企业。贝派度酸片药品临床试验 申请获得批准，对公司短期业绩不会产生重大影响。 ...