证券代码：000963 证券简称：华东医药 公告编号：2025-095 华东医药股份有限公司 关于2022年限制性股票激励计划预留授予限制性股票第二 个解除限售期解除限售股份上市流通的提示性公告 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。 特别提示： 1、公司 2022 年限制性股票激励计划预留授予限制性股票第二个 解除限售条件成就，本次符合解除限售条件的激励对象共计 16 人， 可解除限售的限制性股票数量为 17.50 万股，占目前公司总股本的 0.01%。 2、本次解除限售的限制性股票上市流通日为 2025 年 10 月 29 日。 华东医药股份有限公司（以下简称"华东医药"、"公司"）于 2025 年 10 月 13 日召开第十一届董事会第三次会议，审议通过了《关于 2022 年限制性股票激励计划预留授予限制性股票第二个解除限售期 解除限售条件成就的议案》。根据《上市公司股权激励管理办法》公 司《2022 年限制性股票激励计划》（以下简称"《激励计划》"）的相 关规定及公司 2022 年第一次临时股东大会的授权，公司为符合条件 的激励对象办理了解除限 ...

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for its innovative drug, Maleate Mevanertinib Tablets (brand name: Mairuidong), for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 21 (L858R) substitution mutations [1][2] Group 1 - Maleate Mevanertinib Tablets are a new, potent, highly selective, orally active irreversible EGFR/HER2 small molecule inhibitor, representing a novel national class 1 innovative drug with independent intellectual property rights [2] - The drug irreversibly inhibits tyrosine kinase autophosphorylation by covalently binding to the kinase regions of EGFR (ErbB1) and HER2 (ErbB2), leading to downregulation of ErbB signaling and suppression of tumor growth [2] Group 2 - Huadong Medicine aims to actively promote the commercialization of Mairuidong post-approval, providing better clinical benefits to patients and striving to make it accessible to a wider patient population [1] - Mairuidong is the second innovative drug launched by Huadong Medicine within a week, following the approval of Remabizine Injection, which is part of a combination product for renal function assessment [1]

Core Viewpoint - Huadong Medicine's innovative drug, Mevanertinib (brand name: Mairuidong), has received approval from the National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the EGFR exon 21 (L858R) substitution mutation, marking a significant advancement in lung cancer treatment options [1][4]. Company Developments - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., has successfully developed and launched Mevanertinib, which is a first-class innovative drug with independent intellectual property rights [1][5]. - The company has achieved a milestone by obtaining approval for two innovative drugs within a week, showcasing its commitment to advancing its product pipeline [1][4]. - The company is actively preparing for the commercialization of Mevanertinib to provide better clinical benefits to patients [1][4][8]. Industry Context - Lung cancer remains the most prevalent and deadly malignancy globally, with NSCLC accounting for approximately 85% of primary lung cancer cases [2]. - In China, the incidence of lung cancer is particularly high, with over 1.06 million new cases reported in 2024, and the EGFR mutation is present in about 50% of lung adenocarcinoma patients [2]. - The targeted drug market for NSCLC in China is projected to reach 182.87 billion yuan by 2030, with a compound annual growth rate (CAGR) of 13.2% [2]. Clinical Insights - Mevanertinib is a novel, potent, and highly selective irreversible EGFR/HER2 small molecule inhibitor, demonstrating superior safety and tolerability compared to existing third-generation EGFR-TKIs in patients with the L858R mutation [3][4]. - The approval of Mevanertinib is based on a Phase III clinical trial that met predefined efficacy standards, indicating its potential to fulfill unmet clinical needs in the treatment of NSCLC [3][4]. Future Outlook - The approval of Mevanertinib is expected to provide significant market growth opportunities, as it addresses the clinical demand for effective treatments in patients with the EGFR L858R mutation [4][6]. - Huadong Medicine is focused on developing a diverse pipeline of innovative drugs, particularly in oncology, with over 80 projects currently in development [5][6][8].

Core Viewpoint - Huadong Medicine's subsidiary has received approval for a new innovative drug, marking a significant advancement in treatment options for specific lung cancer patients [1] Company Summary - Huadong Medicine's wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., has developed a Class 1 innovative drug, Mevanertinib tablets (brand name: Mairuidong) [1] - The drug has been approved by the National Medical Products Administration for use in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have the EGFR exon 21 (L858R) substitution mutation [1]

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].