Summary of Huadong Medicine Conference Call Company Overview - **Company**: Huadong Medicine - **Industry**: Pharmaceutical Key Points and Arguments Business Strategy and Performance - Huadong Medicine focuses on maximizing efficiency rather than scale, which is reflected in its continuous growth in performance, particularly in the generic drug sales and innovation drug advancement [2][4] - The company's stock price is closely linked to its performance, recovering from a decline due to centralized procurement pressures since 2022, with a positive outlook for 2025 due to favorable policies and temporary procurement pauses in certain departments [2][7] Innovation and Product Pipeline - Significant progress has been made in the innovation drug sector, with a comprehensive pipeline established, particularly in oncology, autoimmune diseases, and metabolic disorders [3][11] - The company has a complete lineup in the endocrine metabolic field, including commercialized liraglutide and upcoming biosimilars of semaglutide, focusing on small molecule GLP-1 and dual-target/triple-target drugs in the weight loss market [2][19][25] Response to Market Challenges - Despite facing centralized procurement pressures, Huadong Medicine maintains a positive long-term growth outlook, especially with new products being launched and a strong sales capability in generics [5][10] - The company has effectively mitigated procurement pressures through a robust patent strategy, limiting competition in the short term [9] Financial Performance - The industrial segment has shown a return to double-digit growth since Q2 2022, indicating strong overall capabilities and resilience in traditional business areas [12] - The stock price has shown a recovery trend, with expectations for continued growth driven by performance recovery and favorable market conditions [7][40] Future Development Directions - The company’s future strategy focuses on four key areas: special raw materials (SRA), animal health, wellness, and medical aesthetics, with optimistic prospects in the medical aesthetics sector despite recent challenges [33][36] - The innovation drug sector is expected to see significant sales growth, with several products projected to reach over 1 billion in sales by 2025 [37] Collaborations and Acquisitions - Recent collaborations include projects in monoclonal antibodies and ADCs, enhancing the product line and market competitiveness [17][20] - The company has successfully introduced several products that complement existing treatments, indicating a strategic approach to expanding its portfolio [15] Market Position and Competitive Advantages - Huadong Medicine has established a strong competitive position in the autoimmune disease market through a diverse product range and differentiated capabilities in topical formulations [31] - The company’s diabetes treatment portfolio includes key drugs with annual sales exceeding 5 billion, showcasing its strong market presence [24] R&D and Management Changes - The R&D system has been restructured to enhance product development efficiency, led by experienced professionals from major pharmaceutical companies [13] - The company is actively pursuing innovative technologies such as ADCs and PROTACs, with several products entering clinical stages [22][38] Overall Market Outlook - The overall outlook for Huadong Medicine remains positive, with expectations for continued growth across various business segments, including pharmaceuticals and wellness products [8][34] - The company is well-positioned to leverage its strengths in innovation and market adaptability to drive future performance [40]

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" [4] Core Insights - The innovative drug sector has seen a significant increase in institutional interest, with the total heavy positions in Biotech innovative drugs reaching 80.371 billion yuan, a quarter-on-quarter growth of 39% [7][18] - The proportion of heavy positions in Biotech innovative drugs relative to the overall market has increased to 2.39%, up by 0.49 percentage points, indicating sustained enthusiasm from institutions towards the innovative drug sector [19][25] - The heavy positions in Biotech innovative drugs account for 24.93% of the total heavy positions in the pharmaceutical industry, reflecting a rise of 5.49 percentage points [19][25] Summary by Sections Weekly Review of New Drug Market - From July 28 to August 1, 2025, the top five companies in the new drug sector by stock price increase were: Zhongsheng Pharmaceutical (29.53%), WuXi AppTec (17.72%), CSPC Pharmaceutical Group (14.60%), Maiwei Biotech (12.08%), and Haizhi Pharmaceutical (11.76%) [14][15] - The top five companies by stock price decrease were: Kintor Pharmaceutical (-19.09%), Hualing Pharmaceutical (-16.19%), Junsheng Pharmaceutical (-13.24%), Kintor Pharma (-12.70%), and Yunding New Drug (-11.29%) [14][15] Key Analysis of New Drug Industry - The report analyzed the latest heavy positions of all funds in the innovative drug sector as of June 30, 2025, focusing on A-share and Hong Kong Biotech companies [18] - The heavy positions in Biotech innovative drugs accounted for 7.05% of the total market capitalization, an increase of 0.93 percentage points [23][28] New Drug Approval and Acceptance - This week, 13 new drug or new indication applications were approved, including drugs such as Risperidone orally disintegrating film and Nivolumab injection [33][34] - Additionally, 6 new drug or new indication applications were accepted, including drugs like Eptinezumab injection and Edaravone tablets [35][36] Clinical Application Approval and Acceptance - A total of 50 new drug clinical applications were approved this week, while 44 new drug clinical applications were accepted [37]

每经记者｜许立波 每经编辑｜魏官红 点评：最高人民法院驳回原告钟大放再审申请，意味着诺思格持续近两年的股权纠纷接近尘埃落定，尽 管公司称该诉讼案未对公司利润产生影响，但一定程度上对公司的外部声誉与投资者的信心造成了扰 动。 NO.3 华东医药：子公司依达拉奉片上市许可申请获受理 7月30日，华东医药公告称，公司全资子公司中美华东收到国家药品监督管理局签发的《受理通知 书》，由中美华东申报的依达拉奉片（研发代码：TTYP01）用于治疗急性缺血性脑卒中的上市许可申 请获得受理。依达拉奉是神经系统药物中的重磅品种，相对于院内给药14天的依达拉奉注射液，依达拉 奉口服片剂可以降低医药资源占用，适合患者自主长期给药。 点评：依达拉奉片如顺利获批上市，将进一步丰富华东医药心脑血管产品管线，在市场推广上有望与公 司现有产品形成有效协同。此外，尽管依达拉奉片为2.2类改良药，但剂型创新带来适应场景拓展，或 对原有注射剂市场形成部分替代，具备一定市场空间。 NO.4 南新制药：近期正筹划购买某一国内药品技术等资产组事项 丨 2025年7月31日 星期四 丨 NO.1 A股合成生物龙头华恒生物拟赴港上市 7月30日，华恒生物公告 ...

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, has received a drug registration acceptance notice from the National Medical Products Administration (NMPA) for edaravone tablets, aimed at treating acute ischemic stroke [1][3]. Drug Information - Drug Name: Edaravone Tablets - Application: Domestic production drug registration and marketing license - Registration Category: Chemical drug category 2.2 - Specification: 30mg - Indication: To improve neurological symptoms and functional impairments caused by acute ischemic stroke (AIS) and enhance daily living capabilities [1]. R&D and Registration Status - Edaravone is a novel free radical scavenger that has been shown to inhibit lipid peroxidation and endothelial cell damage, improving brain edema and tissue damage [3]. - The injectable form of edaravone has been approved in Japan and China for AIS treatment, but it requires intravenous administration, limiting patient compliance [3]. - The oral formulation, TTYP01, developed by Shanghai Aozong Biotechnology, is a modified new drug that allows for self-administration and room temperature storage, enhancing convenience and compliance [3][4]. - The clinical trial for TTYP01 was completed in June 2024, showing efficacy and safety comparable to the injectable form while improving patient adherence [3]. Impact on the Company - The approval of edaravone tablets is expected to enrich the company's cardiovascular product pipeline and create synergies with existing products [6]. - The drug is anticipated to meet the urgent clinical needs of stroke patients, potentially becoming a significant product in the treatment field [5][6]. - The company has invested approximately 100.81 million yuan in the development of edaravone tablets [5]. Future Considerations - Following the acceptance notice, the drug will undergo review by the NMPA's drug evaluation center, with the approval timeline and market competition remaining uncertain [6].

规格：30mg 证券代码：000963 证券简称：华东医药 公告编号：2025-077 华东医药股份有限公司 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。 资子公司杭州中美华东制药有限公司（以下简称"中美华东"）收到国 家药品监督管理局（NMPA）签发的《受理通知书》（受理号： CXHS2500088 ） ， 由 中 美 华 东 申 报 的 依 达 拉 奉 片 （ 研 发 代 码 ： TTYP01）用于治疗急性缺血性脑卒中的上市许可申请获得受理。现 将有关详情公告如下： 一、该药物基本信息内容 药物名称：依达拉奉片 申请事项：境内生产药品注册上市许可 注册分类：化学药品2.2类 申报适应症：改善急性缺血性脑卒中（Acute Ischemic Stroke, AIS） 所致的神经症状和功能障碍，提高日常生活能力。 申请人：杭州中美华东制药有限公司 拉奉口服生物利用度，有助于惠及更多患者。因此，TTYP01片上市 后，将进一步满足脑卒中患者迫切的临床需求，有望成为该治疗领域 的潜力品种。 依达拉奉片如顺利获批上市，将进一步丰富公司心脑血管产品管 线，在市场推广上 ...

（编辑 姚尧） 证券日报网讯 7月30日晚间，华东医药发布公告称，2025年7月30日，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"）收到国家药品监督管理局（NMPA）签发的《受理通知书》，由中 美华东申报的依达拉奉片（研发代码：TTYP01）用于治疗急性缺血性脑卒中的上市许可申请获得受 理。 ...

北京商报讯（记者 王寅浩 实习记者 宋雨盈）7月30日，华东医药发布公告称，公司全资子公司杭州中 美华东制药有限公司收到国家药品监督管理局签发的《受理通知书》，由中美华东申报的依达拉奉片用 于治疗急性缺血性脑卒中的上市许可申请获得受理。 公告显示，依达拉奉是一种新型自由基清除剂，已证明其可以抑制脂质过氧化和血管内皮细胞损伤，并 改善脑水肿、组织损伤、延迟神经元死亡。依达拉奉通过与缺血后脑损伤密切相关的氧自由基反应而发 挥其对脑缺血损伤的保护作用。 ...

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, has received a notice of acceptance from the National Medical Products Administration (NMPA) for the marketing authorization application of Edaravone tablets for the treatment of acute ischemic stroke [1] Company Summary - The application for Edaravone tablets, with the development code TTYP01, has been officially accepted by the NMPA [1] - Edaravone is a novel free radical scavenger that has been shown to inhibit lipid peroxidation and endothelial cell damage, improve brain edema, tissue injury, and delay neuronal death [1] - The mechanism of Edaravone involves reacting with oxygen free radicals closely related to ischemic brain injury, providing protective effects against brain ischemic damage [1]

人民财讯7月30日电，华东医药（000963）7月30日晚间公告，公司全资子公司中美华东收到国家药品监 督管理局签发的《受理通知书》，由中美华东申报的依达拉奉片(研发代码：TTYP01)用于治疗急性缺 血性脑卒中的上市许可申请获得受理。依达拉奉是神经系统药物中的重磅品种，相对于院内给药14天的 依达拉奉注射液，依达拉奉口服片剂可以降低医药资源占用，适合患者自主长期给药。 ...

华东医药（000963）公告，全资子公司中美华东申报的依达拉奉片用于治疗急性缺血性脑卒中的上市许 可申请已获国家药品监督管理局受理。依达拉奉片是一种新型自由基清除剂，旨在改善脑卒中患者的神 经症状和功能障碍。与现有的依达拉奉注射液相比，该口服片剂更便于患者自行给药。中美华东已与澳 宗生物签署独家许可协议，获得该药在中国大陆及港澳台地区的开发、注册、生产及商业化权益。截至 目前，公司在该项目上已投入约1.01亿元，包括项目引进首付款1亿元。 ...