华东医药（000963）(000963.SZ)公告，公司控股子公司浙江道尔生物科技有限公司(简称"道尔生物")收 到美国食品药品监督管理局(简称"美国FDA")通知，由道尔生物申报的DR10624注射液药品临床试验申 请已获得美国FDA批准，可在美国开展临床试验，适应症为重度高甘油三酯血症(SHTG)。 ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of Xinlikang capsules, aimed at treating cancer-related fatigue [1] Group 1 - The approval allows the company to conduct clinical trials for Xinlikang capsules [1] - The indication for the clinical trial is specifically for the treatment of cancer-related fatigue [1]

Core Viewpoint - The clinical trial results for APL-1702, a treatment for high-grade squamous intraepithelial lesions (HSIL), have been published in the prestigious journal Med, indicating significant efficacy compared to placebo [1] Group 1: Clinical Trial Results - APL-1702 demonstrated an 89.4% increase in response rate compared to the placebo group, with rates of 41.1% for APL-1702 versus 21.7% for placebo (p=0.0001) [1] - The overall response rate at the 12-month mark reached 44.4%, indicating stable long-term efficacy [1] Group 2: Regulatory Status - APL-1702 is currently under review by the National Medical Products Administration (NMPA) in China, with uncertainty regarding its approval and market launch timeline [1] - The publication of the clinical trial data is not expected to have a significant impact on the company's recent performance [1]

Core Viewpoint - The company has received FDA approval for its clinical trial application for the injectable drug HDM2017, which will be used for Phase I clinical trials in the United States targeting advanced malignant solid tumors [1] Company Summary - The full subsidiary of the company, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., is responsible for the application that received FDA approval [1] - The approved clinical trial will focus on advanced malignant solid tumors, indicating a strategic move into the oncology market [1]

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]

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]