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创新药再传捷报!华东医药0.3%罗氟司特乳膏国内Ⅲ期数据惊艳,破局自免蓝海
Quan Jing Wang· 2025-07-21 09:26
近日,华东医药(000963)股份有限公司(以下简称"华东医药")全资子公司杭州中美华东制药有限公司 宣布,其创新皮肤外用制剂0.3%罗氟司特乳膏(ZORYVE)在中国斑块状银屑病Ⅲ期临床试验中获得积极 顶线数据。ZORYVE乳膏凭借其创新机制和独特剂型优势,有望将进一步提升公司在自身免疫领域和皮 肤外用制剂领域的核心竞争力,同时为中国银屑病患者提供突破性治疗方案。 疗效与安全双优,填补银屑病临床空白 ZORYVE乳膏是全球首个被批准用于治疗斑块型银屑病(包括间擦性银屑病)的局部外用PDE4抑制剂。 其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,目前被美国FDA批准用于治疗特应性皮炎、脂溢性皮炎和斑块状银屑病。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。 据介绍,本研究为一项多中心、随机、双盲、赋形剂对照的Ⅲ期临床研究,以评估每日一次0.3%罗氟 司特乳膏在≥6岁中国斑块状银屑病受试者中的有效性、安全性和PK特征。研究由北京大学人民医院的 张建中/周城教授牵头,在全国31家临床中心开展, ...
420亿杭州医药龙头,董事长连庄
21世纪经济报道· 2025-07-17 13:53
记者丨 韩璐 编辑丨陈晓平 420亿杭州老牌药企,董事长顺利连庄。 7月17日,华东医药发布公告,新一届董事会一致同意, 选举吕梁为董事长 ,且聘任其为总经 理,吕本人也身兼战略委员会召集人。 吕梁掌舵的华东医药,以仿制药起家。 上市24年间,其在多数年份净利增长在20%以上, 整体规模超过400亿 。吕于2019年一出任 董事长,即以子公司中美华东为旗舰,全力转向创新药。 吕梁 50岁的吕梁,将开启第三个董事长任期。 作为职业经理人,他担纲一号位6年,成功带领这家传统药企,赶上创新药热潮,6月以来,已 有多款新药获批在美进行试验。 "公司采用自主研发和外部引进相结合的方式。"官方回复《21CBR》记者,其聚焦肿瘤、内分 泌和自身免疫三大核心领域,进行研发布局。 一众利好之下,华东医药市值大涨,截至17日,市值已达770亿元,年初以来上涨约28%。 腾笼换鸟 据首席科学家刘东舟介绍,截至2025年4月,其创新药管线已超80项,其中自研项目50项。 吕梁已手握多款重磅产品。 2024年底,中美华东与ImmunoGen合作的爱拉赫,获批上市,成为全球唯一批准用于治疗铂 类耐药卵巢癌的、靶向FRα的ADC药物。 几 ...
荃信生物裘霁宛:“高效研发+生态合作”破局行业定律
Core Insights - The article discusses the innovative approach of Quanxin Biopharmaceuticals in the biopharmaceutical industry, breaking the "double ten rule" by developing five promising clinical-stage products with an investment of less than 1.3 billion yuan [2][3] - The company focuses on autoimmune diseases and has established a collaborative ecosystem to enhance its research, clinical, and commercialization processes, aiming for international market entry by 2025 with a projected overseas licensing deal worth $555 million [3][5] Group 1: Company Strategy - Quanxin Biopharmaceuticals has successfully created five clinical-stage innovative products with over 1 billion yuan in R&D investment, including one drug already on the market and two in phase III clinical trials [4][5] - The company emphasizes efficient use of funds and time, focusing on a clear development direction in antibody drug research for autoimmune and allergic diseases [4][6] - The company has formed deep collaborations with major pharmaceutical companies, leveraging their sales networks and resources to accelerate clinical trials and commercialization [5][6] Group 2: Market Expansion - In 2025, Quanxin Biopharmaceuticals plans to make significant strides in international markets, having signed a licensing agreement with Caldera Therapeutics for its long-acting dual antibody QX030N, which could yield up to $545 million in additional payments [7][8] - The company aims to target autoimmune disease markets with real clinical demand and high success rates, particularly in the respiratory and digestive fields, anticipating rapid growth in antibody drug applications [8]
华东医药:白马药企转型创新,开启发展新阶段-20250610
Soochow Securities· 2025-06-10 00:23
证券研究报告·公司深度研究·化学制药 华东医药(000963) 白马药企转型创新,开启发展新阶段 2025 年 06 月 09 日 买入(维持) | [Table_EPS] 盈利预测与估值 | 2023A | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | --- | | 营业总收入(百万元) | 40,624 | 41,906 | 45,915 | 49,414 | 52,228 | | 同比(%) | 7.71 | 3.16 | 9.57 | 7.62 | 5.69 | | 归母净利润(百万元) | 2,839 | 3,512 | 4,032 | 4,555 | 5,154 | | 同比(%) | 13.59 | 23.72 | 14.81 | 12.96 | 13.17 | | EPS-最新摊薄(元/股) | 1.62 | 2.00 | 2.30 | 2.60 | 2.94 | | P/E(现价&最新摊薄) | 27.06 | 21.88 | 19.05 | 16.87 | 14.91 | [Table_Tag] [Tabl ...
华东医药(000963) - 2025年5月15日投资者关系活动记录表(投资者接待日活动)
2025-05-16 11:24
Group 1: Financial Performance - In 2024, the company achieved a revenue growth of 21.24% and a net profit growth of 52.59% compared to 2021, reaching historical highs [2] - The company completed its seventh three-year plan successfully and is now entering the eighth three-year plan with higher goals [14] Group 2: Innovation and R&D - The company has over 80 innovative drug pipelines, with nearly 50 self-developed projects, focusing on oncology, endocrinology, and immunology [3] - In 2024, the company received 4 NDA/BLA approvals and 14 clinical approvals in China and the U.S. [3] - The R&D team consists of over 330 members, with more than 60% holding advanced degrees [3] Group 3: Key Product Developments - The company launched several innovative products, including the first ADC drug for platinum-resistant ovarian cancer and the first biosimilar of ustekinumab in China [2] - The GLP-1 receptor agonist HDM1002 has over 800 participants in clinical trials, showing good safety and efficacy [5][6] - The ADC project HDM2005 for treating advanced malignancies has completed initial dosing stages without dose-limiting toxicity [9] Group 4: AI and Technology Integration - The company established an AI drug design platform, enhancing drug development efficiency through deep integration of AI and traditional methods [10] Group 5: Aesthetic Medicine Sector - The aesthetic medicine division has developed a comprehensive product matrix, covering various treatment methods and achieving significant growth since its inception [12][13] - The company aims to become a leading provider of comprehensive aesthetic solutions globally, with a focus on innovative product launches [12] Group 6: Market Strategy and Future Outlook - The company plans to balance R&D investments with revenue growth, focusing on enhancing project quality and efficiency [15][16] - The domestic aesthetic medicine market is expected to grow, supported by new product launches and increasing consumer demand [19] - The company is optimistic about its industrial microbiology segment, aiming for accelerated development in the next three years [20]
华东医药(000963) - 2025年5月13日投资者关系活动记录表
2025-05-13 10:50
Financial Performance - In 2024, the company achieved a revenue of CNY 41.906 billion, with a foreign sales revenue of CNY 1.095 billion, accounting for 2.61% of total revenue [20] - The pharmaceutical industrial revenue reached CNY 13.811 billion, representing 32.96% of total revenue [13] - The medical beauty business generated CNY 2.326 billion in revenue, with the subsidiary Xinkeli Meixue contributing CNY 1.139 billion [10] Business Development - The company completed its seventh three-year plan, achieving record high revenue and net profit attributable to shareholders [1] - The industrial microbiology business reported a revenue of CNY 711 million, a year-on-year increase of 43.12% [5] - The company is focusing on four strategic directions: xRNA, specialty APIs & intermediates, health & biological materials, and animal health [2] Product Pipeline and Innovation - The company is preparing for the commercial launch of the innovative ADC drug, Ailaha (Somatuzumab), targeting platinum-resistant ovarian cancer [3] - The oral GLP-1 receptor agonist HDM1002 has completed Phase III clinical trials for weight management, with over 800 participants enrolled in earlier phases [4] - The company has 15 new patent authorizations in 2024, including core patents for GLP-1R/GIPR dual-target agonists [6] Market Strategy - The company maintains a global operational layout for its medical beauty business, focusing on high-end markets [2] - The company plans to enhance its market coverage and registration processes to stabilize the performance of its core subsidiary, Sinclair [2] - The company aims to improve the accessibility of its innovative high-priced drugs through diverse payment channels and market penetration strategies [21] Challenges and Responses - The medical beauty sector faces challenges due to macroeconomic slowdowns and declining consumer demand, but is expected to stabilize with new product approvals [30] - The company is actively managing production costs and enhancing operational efficiency to mitigate the impact of drug price negotiations and procurement policies on profit margins [19] - The company is committed to maintaining a cash dividend policy while balancing strategic development and shareholder returns [12]
华东医药(000963) - 2025年4月25日投资者关系活动记录表
2025-04-27 09:08
证券代码:000963 证券简称:华东医药 华东医药股份有限公司投资者关系活动记录表 12.29%,环比2024年第四季度增长24.37%,整体经营符合第一季度计 划目标。国内医美全资子公司欣可丽美学积极拓展国内市场,报告期 内实现营业收入2.54亿元,同比下降1.36%,环比2024年第四季度增长 10.64% 。公司持续深化国内高端医美产品布局,高端玻尿酸 MaiLi®Extreme(商品名:魅俪®朔盈®)将于2025年5月正式实现商业化 销售;多功能面部皮肤管理平台Préime DermaFacial也将于2025年内正 式实现商业化销售。此外,重组A型肉毒毒素YY001、能量源设备V30 及Ellansé®伊妍仕®M型等核心医美产品国内上市申请均已获受理,有 望于2026年获批。依托国内差异化医美产品矩阵的持续丰富,叠加消 费升级带来的市场需求扩容,公司国内医美业务成长潜能将加速释放。 编号:2025-002 | | □特定对象调研 □分析师会议 | | --- | --- | | 投资者关系 | □业绩说明会 □媒体采访 | | 活动类别 | □新闻发布会 □路演活动 | | | □现场参观 ☑其他 ...
华东医药股份有限公司2025年第一季度报告
登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码:000963 证券简称:华东医药 公告编号:2025-036 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。 重要内容提示: 1.董事会、监事会及董事、监事、高级管理人员保证季度报告的真实、准确、完整,不存在虚假记载、 误导性陈述或重大遗漏,并承担个别和连带的法律责任。 2.公司负责人、主管会计工作负责人及会计机构负责人(会计主管人员)声明:保证季度报告中财务信息 的真实、准确、完整。 3.第一季度报告是否经审计 □是 √否 一、主要财务数据 (一) 主要会计数据和财务指标 公司是否需追溯调整或重述以前年度会计数据 □是 √否 ■ 其他符合非经常性损益定义的损益项目的具体情况 □适用 √不适用 ■ 截止披露前一交易日的公司总股本: ■ 用最新股本计算的全面摊薄每股收益: ■ (二) 非经常性损益项目和金额 √适用 □不适用 单位:元 公司不存在其他符合非经常性损益定义的损益项目的具体情况。 将《公开发行证券的公司信息披露解释性公告第1号一一非经常性损益》中列举的非经常性损益项目界 定为经常性损益项目的 ...
华东医药2025年一季报稳定发力,扣非归母净利润达历史最好水平,创新成果加速兑现
Quan Jing Wang· 2025-04-24 13:09
Core Insights - The company reported a stable growth trend in Q1 2025, with revenue of 10.736 billion yuan, a year-on-year increase of 3.12%, and a net profit of 915 million yuan, up 6.06% [1] - The pharmaceutical industrial sector continues to be a key growth driver, with core subsidiary China East Pharmaceutical achieving revenue of 3.621 billion yuan, a 6.52% increase, and a net profit of 843 million yuan, up 12.20% [2] - The company is focusing on innovation, with over 80 projects in its pipeline, and has significantly increased R&D investment by 49.60% to 880 million yuan in Q1 2025 [4] Business Segments - The innovative drug sales in the pharmaceutical industrial sector are gaining momentum, particularly with the expansion of reimbursement indications for the Bai Ling series products [2] - The CAR-T product, Zewokaiolun, has shown strong sales performance, with over 200 certified medical institutions and 154 effective orders placed by the partner company [3] - The company’s self-developed GLP-1 receptor agonist, HDM1002, has entered the final stages of clinical trials, indicating a robust pipeline in the endocrine field [5][6] Medical Aesthetics - The medical aesthetics segment is showing resilience, with the subsidiary Sinclair achieving approximately 238 million yuan in revenue, a 24.37% increase from the previous quarter [9] - The company has a portfolio of 40 high-end medical aesthetic products, with 26 already launched globally, indicating a strong market presence [9] - New products in the medical aesthetics field, including injectable products, are expected to drive further growth in 2025 [10] Future Outlook - The company aims to leverage its innovative capabilities and product differentiation to expand its market share in the medical aesthetics sector, which is projected to grow steadily [12] - The pharmaceutical industrial sector is expected to maintain a strong growth trajectory, supported by ongoing market expansion and product pipeline development [12] - The overall performance in Q1 2025 reflects the company's commitment to innovation and growth, positioning it for future success in the pharmaceutical and medical aesthetics industries [12]
华东医药(000963) - 2025年4月18日投资者关系活动记录表
2025-04-18 14:58
Financial Performance - In 2024, the company achieved a revenue of CNY 41.906 billion, a year-on-year increase of 3.16% [4] - The net profit attributable to shareholders was CNY 3.512 billion, up 23.72% year-on-year [4] - The net profit after deducting non-recurring gains and losses was CNY 3.352 billion, reflecting a growth of 22.48% [4] - Compared to 2021, revenue and net profit grew by 21.24% and 52.59%, respectively [4] Business Segments Performance Pharmaceutical Industry - The pharmaceutical segment generated a revenue of CNY 13.811 billion, with a year-on-year growth of 13.05% [5] - The net profit for this segment was CNY 2.876 billion, increasing by 29.04% [5] - R&D investment in the pharmaceutical industry reached CNY 2.678 billion, a 16.77% increase [5] Aesthetic Medicine - The domestic aesthetic medicine subsidiary reported a revenue of CNY 1.139 billion, growing by 8.32% [6] - The UK subsidiary, Sinclair, generated approximately CNY 0.967 billion, a decline of 25.81% due to global economic challenges [6] Industrial Microbiology - The industrial microbiology segment achieved a revenue of CNY 0.711 billion, a significant increase of 43.12% [25] - Growth rates for specific areas included 38% for specialty raw materials and intermediates, 20% for xRNA, and 142% for health and biological materials [25] R&D and Product Development - The company has over 80 innovative drug candidates in its pipeline [5] - The oral small molecule GLP-1 receptor agonist HDM1002 has shown promising results in clinical trials, with over 800 participants [17] - The ADC pipeline includes more than 12 projects, with ongoing clinical trials for several candidates [14] Market Strategy and Future Outlook - The company plans to actively participate in medical insurance negotiations for new products [6] - There is a focus on expanding market presence in both domestic and international markets, particularly in the aesthetic medicine sector [26] - The company anticipates a gradual recovery in overseas aesthetic medicine markets [26] Investor Relations and Communication - The annual performance meeting was attended by 381 institutional and individual investors [2] - The chairman emphasized the commitment to high-quality development and strategic goals for the upcoming three-year plan [27]