登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：002603 证券简称：以岭药业 公告编号：2026-002 石家庄以岭药业股份有限公司 关于全资孙公司收到化学原料药上市申请批准通知书的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误导性陈述或重大遗 漏。 近日，石家庄以岭药业股份有限公司（以下简称"公司"）全资孙公司万洋衡水制药有限公司（以下简 称"衡水万洋"）收到国家药品监督管理局下发的《化学原料药上市申请批准通知书》，由衡水万洋提交 的"达格列净"化学原料药上市申请已获批准。现就相关事项公告如下： 一、批准通知书基本内容 化学原料药名称：达格列净 申请事项：境内生产化学原料药上市申请 登记号：Y20240000873 生产企业名称：万洋衡水制药有限公司 主要结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关要求， 批准注册。质量标准、生产工艺及标签照所附执行。 二、药品的基本情况 达格列净（Dapagliflozin）是一种高选择性、可逆性的钠-葡萄糖协同转运蛋白2（SGLT-2）抑制剂，它 可以阻断肾脏近曲小管对葡萄糖的重吸收， ...

格隆汇1月7日丨以岭药业(002603.SZ)公布，全资孙公司万洋衡水制药有限公司（简称"衡水万洋"）收到 国家药品监督管理局下发的《化学原料药上市申请批准通知书》，由衡水万洋提交的"达格列净"化学原 料药上市申请已获批准。达格列净（Dapagliflozin）是一种高选择性、可逆性的钠-葡萄糖协同转运蛋白 2（SGLT-2）抑制剂，它可以阻断肾脏近曲小管对葡萄糖的重吸收，促进尿糖排泄以降低血糖，治疗2 型糖尿病。 ...

人民财讯1月7日电，以岭药业（002603）1月7日公告，近日，公司的全资子公司以岭万洲向国家药监局 药品审评中心申报的盐酸伐昔洛韦片的上市许可申请，获得国家药监局的批准，取得药品注册证书。公 司全资孙公司衡水万洋收到国家药品监督管理局下发的《化学原料药上市申请批准通知书》，由衡水万 洋提交的"达格列净"化学原料药上市申请已获批准。 ...

以岭药业公告，全资孙公司衡水万洋提交的"达格列净"化学原料药上市申请已获批准。达格列净 （Dapagliflozin）是一种高选择性、可逆性的钠-葡萄糖协同转运蛋白2（SGLT-2）抑制剂，它可以阻断 肾脏近曲小管对葡萄糖的重吸收，促进尿糖排泄以降低血糖，治疗2型糖尿病。2024年中国糖尿病用药 市场规模达527亿元，其中达格列净市场份额占12.83%。2025年中国达格列净市场容量预计达73.8亿 元，同比增长35%；销售量17.8亿片，同比增长38%；2024年中国达格列净原料药用度17.48吨，同比增 长38.51%，销售呈现持续增长的趋势。 ...

Core Viewpoint - The approval of the raw materials for Palbociclib and Dapagliflozin indicates compliance with national drug registration requirements, enhancing the company's product line and competitiveness, and promoting sustainable and healthy development [2]. Group 1: Product Approvals - The company received the approval notice for the raw materials of Palbociclib and Dapagliflozin from the National Medical Products Administration [1]. - Palbociclib is a CDK4/6 inhibitor used for treating hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer [1]. - Dapagliflozin is an SGLT-2 inhibitor used for improving blood sugar control and reducing cardiovascular risks in adults with heart failure [1]. Group 2: Strategic Implications - The approval of these raw materials will enrich the company's product line, enhancing its competitiveness in the pharmaceutical market [2]. - The introduction of these drugs is expected to contribute to the company's continuous, stable, and healthy development [2].

Core Viewpoint - The company has received approval from the National Medical Products Administration for the marketing of two active pharmaceutical ingredients: Palbociclib and Dapagliflozin [1] Group 1: Product Approvals - Palbociclib is a CDK4/6 inhibitor indicated for the treatment of hormone receptor-positive (HR+), HER2-negative locally advanced or metastatic breast cancer [1] - Dapagliflozin is a novel oral hypoglycemic agent classified as an SGLT-2 inhibitor, which can be used as monotherapy or in combination therapy to improve blood glucose control based on diet and exercise [1]

本次获批的临床适应症为："本品配合饮食运动，用于单独使用盐酸二甲双胍血糖控制不佳的成人2型糖 尿病患者。"三药联合复方制剂药物作用机制互补，覆盖糖尿病的多重病理生理机制，可有效控制血 糖，且安全性和耐受性良好;同时可减少服药数量、简化降糖方案、提高患者治疗依从性，具有较高的 临床开发价值。该产品将为2型糖尿病患者提供新的治疗选择，并进一步丰富集团在代谢疾病领域的产 品线。 智通财经APP讯，石药集团(01093)发布公告，集团开发的普卢格列汀达格列净二甲双胍缓释片(该产品) 已获中华人民共和国国家药品监督管理局批准，可在中国开展临床试验。 该产品为全球首款获批临床的由普卢格列汀、达格列净和盐酸二甲双胍组成的三药联合复方制剂。普卢 格列汀是一种二肽基肽酶-4(DPP-4)抑制剂，通过抑制DPP-4，使内源性活性胰高血糖素样肽-1(GLP-1) 水平升高，从而增强β细胞和α细胞对葡萄糖的敏感性，增加葡萄糖刺激的胰岛素分泌，并增强葡萄糖 对胰高血糖素分泌的抑制作用，进而改善高血糖。达格列净是一种钠—葡萄糖协同转运蛋白 2(「SGLT2」)抑制剂，通过抑制SGLT2，减少滤过葡萄糖的重吸收，从而促进尿糖排泄。二甲双胍 ...

风险提示： 1、CDMO订单进度不达预期；2、大客户依赖风险；3、原料药产品价格下行。 免责声明 根据《证券期货投资者适当性管理办法》及配套指引，本资料仅面向华创证券客户中的金融机构专业投资者，请勿对本资料进行任何形式的 转发。若您不是华创证券客户中的金融机构专业投资者，请勿订阅、接收或使用本资料中的信息。 本资料难以设置访问权限，若给您造成不便，敬请谅解。感谢您的理解与配合。 摘要 九洲药业从特色原料药/中间体起家，依靠多年技术积累和客户资源优势，公司以小分子为底座、 TIDES为增量的CDMO平台正进入"验证产能释放+订单后端化"的收获期，有望驱动新一轮成长。 CDMO业务：成长主引擎，项目漏斗结构健康，订单能见度高 。 公司CDMO业务以成熟的小分子药 物技术平台为根基，覆盖创新药从临床前CMC到商业化生产的全生命周期服务，深度嵌入诺华、罗 氏、艾力斯等国内外龙头药企供应链，核心项目如诺欣妥、瑞博西利持续贡献收入，合作产品伏美替 尼的快速放量有望为CDMO业务带来持续增量。公司原料药CDMO项目管线丰富（截至2025H1，已上 市38个、III期90个、I/II期1086个），驱动收入稳健增长；同时，公 ...

Summary of Conference Call on Commercial Health Insurance and Innovative Drugs Industry Overview - The conference focused on the commercial health insurance (CHI) sector in China, particularly its integration with the national medical insurance system and the implications for innovative drug companies [1][2]. Key Points and Arguments Integration of Commercial Health Insurance and National Medical Insurance - The National Healthcare Security Administration (NHSA) has led the establishment of a commercial insurance directory, addressing fragmentation in the commercial insurance industry and enhancing the importance of pharmaceutical companies and their products [1][3]. - The commercial health insurance directory aims to provide a platform for innovative drugs, similar to centralized procurement but with a greater emphasis on clinical and economic evaluations rather than just fund calculations [2][4]. Innovative Drug Coverage and Payment Models - Commercial health insurance is adapting to high treatment costs, such as CAR-T therapy, by implementing partial reimbursement and pay-for-performance models to alleviate patient financial burdens [1][5]. - The NHSA's increasing payment for innovative drugs is projected to reach approximately CNY 200 billion by 2024, yet the share of commercial insurance remains low, around CNY 12.5 billion [7][10]. Market Dynamics and Challenges - The high-end medical insurance market in China is currently underdeveloped, with a total market size of less than CNY 10 billion, primarily due to economic factors and the limited purchasing power of potential customers [8][9]. - The commercial health insurance sector is expected to see significant growth, with projections indicating that by 2030, health insurance investments could reach CNY 25 trillion, with CNY 500 billion allocated for innovative drugs, increasing the reimbursement share from 1/16 to 1/4 [10][11]. Future Trends and Opportunities - The future growth of commercial health insurance is anticipated to focus on mid-tier medical insurance, particularly for patients with pre-existing conditions, which can fill gaps in the current healthcare system [13][19]. - The integration of commercial insurance with national healthcare is expected to facilitate a one-stop settlement model, enhancing patient access to innovative treatments and improving overall healthcare service quality [11][27]. Characteristics of Newly Added Drugs - The drugs included in the commercial insurance directory this year are characterized by small market sizes, high costs, and uncertain efficacy, which allows for real-world studies to support future inclusion in the national insurance system [20][21]. Operational Changes in Insurance Companies - Future operational changes in commercial insurance companies may include direct settlement models, where patients do not need to pay upfront, and a focus on different customer segments through business separation [25][27]. Additional Important Insights - The average reimbursement rate for million medical insurance is around 40%, indicating a significant portion of funds is allocated to operational costs rather than patient payouts [18]. - The commercial health insurance market in China has substantial growth potential, with current insurance density and depth significantly lower than OECD averages, suggesting room for expansion [16][17]. This summary encapsulates the critical insights from the conference call, highlighting the evolving landscape of commercial health insurance in China and its implications for innovative drug companies.

Core Viewpoint - Junsheng Tai Pharmaceutical-B (02511) experienced a significant increase of over 6%, currently trading at 3.03 HKD with a transaction volume of 1.1919 million HKD, following positive results from its clinical trial for HTD1801 in Type 2 Diabetes Mellitus (T2DM) patients [1] Group 1 - The clinical trial (HARMONY) for HTD1801 against Dapagliflozin achieved its primary endpoint and showed improvements in several key cardiovascular metabolic indicators compared to Dapagliflozin [1] - HARMONY is the third Phase III trial to report positive results for HTD1801, following the SYMPHONY-1 and SYMPHONY-2 trials, reinforcing its potential as a foundational treatment for cardiorenal metabolic diseases (CKM) [1] - The company plans to initiate a New Drug Application (NDA) for the HTD1801 project within this year [1]