证券代码：000963 证券简称：华东医药 公告编号：2025-096 华东医药股份有限公司 关于全资子公司收到药品注册证书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 近日，华东医药股份有限公司（以下简称"公司"）全资子公司 杭州中美华东制药有限公司（以下简称"中美华东"）自主开发的1 类创新药马来酸美凡厄替尼片（商品名：迈瑞东®，公司于2024年6月 收到国家药典委员会核发的《关于迈华替尼片产品通用名称的函》， 本品制剂中文通用名称为马来酸美凡厄替尼片）获得国家药品监督管 理局（NMPA）批准上市，用于具有表皮生长因子受体（EGFR）外显 子21（L858R）置换突变的局部晚期或转移性非小细胞肺癌（NSCLC） 成人患者的一线治疗。现将有关详情公告如下： 一、该药物基本信息内容 产品名称：马来酸美凡厄替尼片 英文名/拉丁名：Mifanertinib Maleate Tablets 商品名：迈瑞东® 剂型：片剂 受理号：CXHS2400040；CXHS2400041 证书编号：2025S03191；2025S03192 第 1 页 共 4 页 药品 ...

Core Viewpoint - The announcement from East China Pharmaceutical indicates that its subsidiary, Zhejiang Daer Biotechnology Co., Ltd., has received FDA approval for the clinical trial application of the DR10624 injection, targeting severe hypertriglyceridemia [1] Group 1: Clinical Trial Approval - The DR10624 injection has been approved by the FDA to conduct clinical trials in the United States for the indication of severe hypertriglyceridemia [1] - The drug has successfully completed Phase II clinical studies for severe hypertriglyceridemia, yielding positive topline results post-blinding [1] Group 2: Clinical Research Results - At the EASL Congress 2025, Daer Biotechnology reported that the Phase Ib/IIa clinical study of DR10624 for obesity combined with hypertriglyceridemia showed a maximum liver fat reduction of 89% and a relative triglyceride reduction exceeding 70% from baseline [1] - A Phase II clinical study for DR10624, targeting metabolic-associated fatty liver disease with high risk of liver fibrosis and alcohol-related fatty liver disease, is set to complete its first subject enrollment by April 2025 [1] Group 3: Additional Approvals - The clinical trial application for DR10624 targeting weight management in type 2 diabetes and overweight or obese populations has also been approved in China [1] - Daer Biotechnology submitted the clinical trial application for DR10624 to the FDA in September 2025 and has recently received approval [1]

Core Viewpoint - Huadong Medicine (000963.SZ) announced that its subsidiary, Zhejiang Daer Biotechnology Co., Ltd. (referred to as "Daer Bio"), has received approval from the U.S. Food and Drug Administration (FDA) for the clinical trial application of the drug DR10624, which targets severe hypertriglyceridemia (SHTG) [1] Group 1 - Daer Bio's DR10624 is a first-in-class long-acting tri-specific agonist targeting fibroblast growth factor 21 receptor (FGF21R), glucagon receptor (GCGR), and glucagon-like peptide-1 receptor (GLP-1R) [1] - The drug is designed with a chimeric peptide segment targeting GLP-1R/GCGR fused with an engineered IgG1 Fc, incorporating a recombinant FGF21 mutant at the C-terminus of Fc [1]

Core Viewpoint - The announcement indicates that East China Pharmaceutical's subsidiary, Zhejiang Daor Biotechnology Co., Ltd., has received FDA approval for clinical trials of the drug DR10624 in the United States [2] Group 1 - East China Pharmaceutical's subsidiary, Daor Biotechnology, has successfully submitted a clinical trial application for the drug DR10624 [2] - The FDA's approval allows Daor Biotechnology to conduct clinical trials in the U.S. market [2]

Core Viewpoint - Huadong Medicine's subsidiary, Zhejiang Daer Biotechnology Co., Ltd., has received FDA approval for clinical trials of its drug DR10624 in the U.S., targeting severe hypertriglyceridemia [1] Company Summary - Huadong Medicine announced that its subsidiary, Zhejiang Daer Biotechnology, has successfully obtained FDA approval for the clinical trial application of DR10624 injection [1] - The approved indication for DR10624 is severe hypertriglyceridemia, a condition characterized by high levels of triglycerides in the blood [1] Industry Summary - The approval from the FDA allows for the commencement of clinical trials in the U.S., which is a significant step for the company in the biopharmaceutical sector [1]

Investment Rating - The report maintains a positive outlook on the innovative drug and medical device industry, highlighting key targets for investment [5][24]. Core Insights - The innovative drug sector is experiencing high growth, with a focus on companies such as Jiangsu Heng Rui Medicine, Hansoh Pharmaceutical Group, and others. The report emphasizes the potential for value re-evaluation in these firms [5][24]. - Recent business development (BD) deals in the innovative drug sector are expected to catalyze market activity, with notable transactions including Jiangsu Heng Rui Medicine's agreement with Kite for a $1.20 billion upfront payment, potentially reaching $15.20 billion in total [5][24]. - The A-share pharmaceutical sector underperformed the broader market in the third week of October 2025, with the Shanghai Composite Index falling by 1.5% and the SW Biopharma index declining by 2.5% [7][18]. Summary by Sections 1. Continuous Focus on Innovative Drugs and Medical Devices - The report emphasizes the high growth potential in innovative drugs, with key investment targets including Jiangsu Heng Rui Medicine, Hansoh Pharmaceutical Group, and others. Related targets include CSPC Innovation Pharmaceutical [5][24]. 2. A-Share Pharmaceutical Sector Performance - In the third week of October 2025, the A-share pharmaceutical sector saw a decline of 2.5%, underperforming the Shanghai Composite Index, which fell by 1.5%. The report notes that the sector's premium relative to all A-shares is currently at a normal level, with a relative premium rate of 74.5% [7][14][21]. 3. Hong Kong and U.S. Pharmaceutical Sector Performance - The report indicates that the Hong Kong and U.S. pharmaceutical sectors also underperformed, with the Hang Seng Healthcare index dropping by 5.8% and the S&P 500 Healthcare index increasing by only 0.7% during the same period [18][24].

Group 1 - Company Zhejiang Daor Bio-Tech Co., Ltd., a subsidiary of Huadong Medicine, has received approval from the U.S. FDA for its clinical trial application for the drug DR10624 injection [1] - The approved clinical trial is aimed at treating Severe Hypertriglyceridemia (SHTG) [1]

Core Viewpoint - The company announced that its subsidiary, Zhejiang Daor Biotechnology Co., Ltd., has received approval from the U.S. FDA to conduct clinical trials for the drug DR10624, which targets severe hypertriglyceridemia (SHTG) [1] Group 1 - The clinical trial application for DR10624 injection has been approved by the U.S. FDA [1] - The approved indication for DR10624 is severe hypertriglyceridemia (SHTG) [1] - The approval allows the company to initiate clinical trials in the United States [1]

华东医药股份有限公司 关于控股子公司获得药物临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 近日，华东医药股份有限公司（以下简称"公司"） 控股子公司 浙江道尔生物科技有限公司（以下简称"道尔生物"）收到美国食品 药品监督管理局（以下简称"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 （ Severe Hypertriglyceridemia，SHTG）。现将有关详情公告如下： 证券代码：000963 证券简称：华东医药 公告编号：2025-094 二、该药物研发及注册情况 DR10624 是道尔生物自主研发的全球首创（First-in-class）的靶 向成纤维细胞生长因子 21 受体（Fibroblast growth factor 21 receptor， FGF21R）、胰高血糖素受体（Glucagon receptor，GCGR）和胰高血 糖素样肽-1 受体（Glucagon-l ...

Core Viewpoint - The company announced that its subsidiary, Zhejiang Daor Biotechnology Co., Ltd., has received FDA approval for the clinical trial application of the drug DR10624, which targets severe hypertriglyceridemia (SHTG) [1] Company Summary - Zhejiang Daor Biotechnology Co., Ltd. is a subsidiary of the company [1] - The approved drug, DR10624, is intended for the treatment of severe hypertriglyceridemia (SHTG) [1] - The FDA approval allows the company to conduct clinical trials in the United States [1] Industry Summary - The approval of DR10624 indicates potential growth opportunities in the biotechnology sector, particularly in treatments for severe hypertriglyceridemia [1]