Core Viewpoint - The article discusses the key deployments in the 2023 Central Document No. 1, focusing on agricultural modernization through technological innovation and the development of new productive forces in agriculture [5][6][7]. Group 1: Key Deployments in Agricultural Technology Innovation - The document emphasizes strengthening integrated innovation by enhancing the overall effectiveness of the agricultural technology innovation system, promoting enterprise-led innovation, and focusing on key areas such as seeds and agricultural machinery [5]. - It highlights the expansion of application scenarios through modern information technology and biotechnology, showcasing the significant role of agricultural drones and artificial intelligence in transforming agricultural practices [6]. - The document stresses the importance of promoting the transformation of agricultural technology achievements to address practical issues faced by farmers, ensuring that innovations reach rural areas effectively [7]. Group 2: Agricultural Bio-Manufacturing Paths Worth Noting - The article identifies high-value utilization of agricultural by-products, such as straw, as a key focus, indicating a shift from mere utilization to profitable applications [8]. - It discusses the potential of synthetic biology to enhance agricultural productivity by producing essential proteins and bio-fertilizers, thereby reducing reliance on chemical fertilizers [10]. - The development of new agricultural applications, including biodegradable materials and bio-pesticides, is highlighted as a means to promote green transformation in agriculture [11]. Group 3: Market Overview of Agricultural Bio-Manufacturing - As of February 9, 2025, there are 161 companies in the A-share market related to the "synthetic biology" concept, with a total market value of approximately 1.69 trillion yuan, averaging 10.5 billion yuan per company [15]. - The agricultural bio-manufacturing sector includes around 20 companies focusing on areas such as animal vaccines and feed additives, indicating a gradual industrial application of synthetic biology in agriculture [17]. - Key companies in this sector are noted for their focus on replacing feed, plant breeding, bio-pesticides, and precision farming, showcasing the diverse applications of synthetic biology in agriculture [17].

Core Viewpoint - The company has received approval for clinical trials of its drug candidate DR10624, which targets hypertriglyceridemia (HTG) [1] Group 1 - The company's subsidiary, Zhejiang Daor Biotechnology Co., Ltd., has been granted the Clinical Trial Approval Notice by the National Medical Products Administration [1] - The approved clinical trial will allow the company to proceed with testing the efficacy and safety of DR10624 injection [1] - The indication for the drug candidate is specifically for high triglyceride levels in the blood [1]

Core Viewpoint - The company has received approval for a clinical trial of its drug candidate DR10624, which targets hypertriglyceridemia (HTG) [1] Group 1 - The company’s subsidiary, Zhejiang Daor Biotechnology Co., Ltd., has been granted a clinical trial approval notice by the National Medical Products Administration [1] - The approved clinical trial will allow the company to proceed with testing the efficacy and safety of DR10624 injection [1] - The indication for the clinical trial is specifically for high triglyceride levels in the blood [1]

证券代码：000963 证券简称：华东医药 公告编号：2026-004 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 适应症：高甘油三酯血症（Hypertriglyceridemia，HTG） 申请事项：临床试验 申请人：浙江道尔生物科技有限公司 结论：根据《中华人民共和国药品管理法》及有关规定，经审查， 2025 年 11 月 26 日受理的 DR10624 注射液临床试验申请符合药品注 册的有关要求，同意本品开展高甘油三酯血症的临床试验。 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 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"）收到国家药 品监督管理局（以下简称"NMPA"）核准签发的《药物临床试验批 准通知书》（通知书编号：2026LP00301），由道尔生物申报的 DR10624 注射液临床试验申请已获得批准，可以开展临床试验，适应症为高甘 油三酯血症（Hy ...

每经AI快讯，据华东医药（000963）官微2月4日消息，日前，华东医药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(NMPA)签发的《受理通知书》，罗氟司特乳膏(ZORYVE)0.05%上市 许可申请获得受理，申报适应症为：适用于2岁至5岁轻度至中度特应性皮炎患者的局部外用治疗。 ...

本报讯 （记者张敏）2月3日晚间，华东医药股份有限公司（以下简称"华东医药"）发布公告称，其全 资子公司杭州中美华东制药有限公司（以下简称"中美华东"）的创新皮肤外用制剂罗氟司特乳膏 （ZORYVE®）0.05%上市许可申请获国家药品监督管理局（NMPA）受理，适用于2岁至5岁轻度至中 度特应性皮炎患者的局部外用治疗。这标志着该系列产品研发进程取得重要里程碑，同时将进一步巩固 并提升公司在自免皮肤治疗领域的核心竞争力。 公告显示，ZORYVE®的活性成分为罗氟司特（Roflumilast），是一种高活性和高选择性的非类固醇类 磷酸二酯酶-4（PDE4）抑制剂，PDE4是一种细胞内酶，可增加促炎介质的生成并减少抗炎介质的生 成，抑制PDE4可减轻炎症反应。 我国特应性皮炎（AD）患病人群基数庞大，临床需求亟待填补。据国金证券研究，我国AD患者总数约 6700万人，市场存在显著未满足需求。另据我国流行病学数据，1岁至7岁儿童群体患病率达12.94%， 凸显了针对低龄患者群体安全有效治疗方案的巨大缺口。 罗氟司特乳膏此次申报的核心价值在于精准切入了一个存在明确未满足需求的细分市场。目前，国内针 对2至5岁特应性皮炎 ...

智通财经APP讯，华东医药(000963.SZ)公告，公司全资子公司杭州中美华东制药有限公司(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》，罗氟司特乳膏(ZORYVE®)0.05%上市许 可申请获得受理，申报适应症为：适用于2岁至5岁轻度至中度特应性皮炎患者的局部外用治疗。 ...

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., has received acceptance for the marketing authorization application of Roflumilast cream (ZORYVE®) 0.05%, aimed at treating mild to moderate atopic dermatitis in children aged 2 to 5, marking a significant milestone in the product's development and enhancing the company's competitive edge in the autoimmune skin treatment sector [1][2]. Product Advantages - ZORYVE® contains Roflumilast, a highly selective non-steroidal phosphodiesterase-4 (PDE4) inhibitor that reduces inflammation by inhibiting the enzyme that increases pro-inflammatory mediators [2]. - The product was developed in collaboration with Arcutis Biotherapeutics, granting Huadong exclusive rights for development, registration, production, and commercialization in Greater China and Southeast Asia [2]. - Atopic dermatitis is a prevalent chronic inflammatory skin condition affecting both children and adults, with significant impacts on quality of life [2]. Market Demand - There are approximately 67 million atopic dermatitis patients in China, indicating a substantial unmet clinical need, particularly for children aged 1 to 7, with a prevalence rate of 12.94% [3]. - The introduction of Roflumilast cream addresses a clear gap in treatment options for children aged 2 to 5, who currently rely on traditional topical corticosteroids and calcineurin inhibitors [3]. - The cream's once-daily dosing regimen enhances treatment adherence, making it a more suitable option for young patients [3]. Strategic Development - Huadong Medicine is systematically introducing a range of Roflumilast products, including higher concentrations for older patients and other skin conditions, to establish a comprehensive presence in the autoimmune skin disease market [4]. - The company is focusing on a dual strategy of "introducing partnerships" and "independent innovation" to build a competitive product pipeline in autoimmune diseases, covering various conditions such as psoriasis and rheumatoid arthritis [5]. - Ongoing collaborations and clinical trials for other products further demonstrate the company's commitment to expanding its portfolio in the autoimmune sector [6]. Strategic Partnerships - In early 2026, Huadong Medicine deepened its strategic partnership with Denmark's MC2 Therapeutics to commercialize the Biomee® series in Greater China, enhancing its position in the topical skin treatment market [7]. - The acceptance of the Roflumilast cream application signifies the company's innovative capabilities and marks a phase of growth in the autoimmune skin disease field [7]. - With multiple differentiated product pipelines, Huadong Medicine aims to strengthen its influence in the multi-billion-dollar autoimmune market in China [7].

每经AI快讯，2月3日，华东医药（000963）(000963.SZ)公告称，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》，罗氟司特乳膏(ZORYVE)0.05%上市许可申请获得受理，申报适应症 为适用于2岁至5岁轻度至中度特应性皮炎患者的局部外用治疗。该药物是中美华东与美国Arcutis Biotherapeutics,Inc.合作引进的创新皮肤外用制剂产品，中美华东拥有在大中华区及东南亚的独家权 益。罗氟司特乳膏0.05%相比传统治疗手段有安全性优势，且可用于所有部位，每日一次给药，提高治 疗依从性。该产品研发进程中的重要里程碑，将提升公司在自免皮肤治疗领域的核心竞争力。但药品审 评审批时间、审批结果及未来市场竞争形势存在不确定性。 ...

Group 1 - The core viewpoint of the news highlights the positive performance of the medical innovation sector, with the CSI Medical and Medical Device Innovation Index showing mixed results among its constituent stocks, led by Aimeike with a 2.18% increase [1] - The Medical Innovation ETF has seen continuous net inflows over the past 12 days, with a peak single-day net inflow of 41.83 million yuan, totaling 234 million yuan, averaging 19.54 million yuan per day [1] - Policy support for the pharmaceutical industry is ongoing, with Shanghai accelerating the implementation of major industrial projects in fields such as integrated circuits, biomedicine, and artificial intelligence [1] Group 2 - The CSI Medical and Medical Device Innovation Index consists of 30 listed companies with good profitability, growth potential, and research innovation capabilities, reflecting the overall performance of profitable and growth-oriented pharmaceutical and medical device companies [2] - As of January 30, 2026, the top ten weighted stocks in the index include WuXi AppTec, Mindray Medical, and Heng Rui Medicine, accounting for 63.9% of the total index weight [2] - The success rate of Phase I clinical trials for dozens of AI-derived pipelines entering trials in 2025 is projected to be as high as 80%-90%, significantly exceeding traditional levels of 40%-65% [1]