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 根据《中国糖尿病流行病学调查报告》显示，中国有超过 1.18 亿糖尿病患者， 占全球 22%的比例，为全球糖尿病负担最重的国家之一。根据米内网及药智网数 据显示，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。达格列净被我国和 FD ...

证券代码：002603 证券简称：以岭药业 公告编号：2026-003 石家庄以岭药业股份有限公司 剂 型：片剂 申请事项：新药临床试验 申 请 人：石家庄以岭药业股份有限公司 关于中药新药"芪龙定喘片"药物临床试验申请获得 受理的公告 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。 石家庄以岭药业股份有限公司（以下简称"公司"）于 2026 年 1 月 7 日收到 国家药品监督管理局核准签发的《受理通知书》，现将相关情况公告如下： 一、临床试验申请主要内容 药物名称：芪龙定喘片 受 理 号：CXZL2600002 受理日期：2026 年 1 月 7 日 石家庄以岭药业股份有限公司 董事会 通知书意见：根据《中华人民共和国行政许可法》第三十二条的规定，经审 查，决定予以受理。 自受理之日起 60 日内，未收到药审中心否定或质疑意见的，申请人可以按 照提交的方案开展临床试验。 二、芪龙定喘片相关情况 芪龙定喘片拟定的功能主治为：益气活血通络，化痰止咳平喘。用于慢性阻 塞性肺疾病稳定期心肺气虚、痰瘀阻滞证，症见气短喘息，动则加重，咳嗽，咳 痰质黏，伴乏力，懒言，胸 ...

证券代码：002603 证券简称：以岭药业 公告编号：2026-001 石家庄以岭药业股份有限公司 关于全资子公司获得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"）的全资子公司 以岭万洲国际制药有限公司（以下简称"以岭万洲"）向国家药品监督管理局 药品审评中心申报的盐酸伐昔洛韦片的上市许可申请，获得国家药品监督管理 局的批准，取得药品注册证书。 现将相关情况公告如下： 一、药品基本情况 证书编号：2025S03983 药品通用名称：盐酸伐昔洛韦片 批准文号：国药准字 H20256426 剂型：片剂 规格：0.5g（按 C13H20N6O4计） 注册分类：化学药品 4 类 申请事项：药品注册（境内生产） 生产企业：以岭万洲国际制药有限公司 二、药品的其他相关情况 伐昔洛韦作为阿昔洛韦的前体药物，在体内快速转化为阿昔洛韦，竞争性 抑制病毒 DNA 聚合酶，阻断病毒 DNA 合成，达到抗病毒的效果。盐酸伐昔 洛韦片主要适应症为：治疗带状疱疹、治疗单纯疱疹病毒感染、预防（抑制） 单纯疱疹病毒感染 ...

Core Viewpoint - Yiling Pharmaceutical's subsidiary, Yiling Wanzhou International Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing authorization application of Valaciclovir Hydrochloride Tablets, indicating a significant advancement in the company's product portfolio and potential market opportunities [1] Group 1: Product Approval - Yiling Wanzhou has obtained the drug registration certificate for Valaciclovir Hydrochloride Tablets from the National Medical Products Administration [1] - Valaciclovir is a prodrug of Acyclovir, which rapidly converts to Acyclovir in the body, competitively inhibiting viral DNA polymerase to block viral DNA synthesis [1] Group 2: Indications and Market Potential - The primary indications for Valaciclovir Hydrochloride Tablets include the treatment of shingles, treatment of herpes simplex virus infections, and prevention (suppression) of recurrent herpes simplex virus infections [1] - Valaciclovir Hydrochloride Tablets are classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025 Edition) [1]

Core Viewpoint - Yiling Pharmaceutical has received approval from the National Medical Products Administration for the marketing authorization application of Valaciclovir Hydrochloride Tablets through its wholly-owned subsidiary Yiling Wanzhou [1] Group 1: Company Developments - Yiling Pharmaceutical's wholly-owned subsidiary Yiling Wanzhou has obtained the drug registration certificate for Valaciclovir Hydrochloride Tablets [1] - The company's wholly-owned subsidiary Hengshui Wanyang has received the approval notice for the marketing application of the chemical raw material drug Dapagliflozin [1]

Core Viewpoint - Yiling Pharmaceutical's subsidiary, Yiling Wanzhou International Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing authorization application of Valaciclovir Hydrochloride Tablets, obtaining the drug registration certificate [1] Group 1 - Yiling Pharmaceutical's full ownership of Yiling Wanzhou International Pharmaceutical Co., Ltd. is confirmed [1] - The approved drug, Valaciclovir Hydrochloride Tablets, is a significant addition to the company's product portfolio [1] - The approval from the National Medical Products Administration marks a key milestone for the company in expanding its market presence [1]

Core Viewpoint - Yiling Pharmaceutical's wholly-owned subsidiary, Yiling Wanzhou International Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing authorization application of Valaciclovir Hydrochloride Tablets, obtaining the drug registration certificate [1] Group 1 - The approval signifies a significant milestone for Yiling Pharmaceutical in expanding its product portfolio [1] - Valaciclovir Hydrochloride Tablets are expected to enhance the company's competitive position in the antiviral drug market [1] - The drug registration certificate allows the company to commence marketing and distribution of the product in China [1]

Core Viewpoint - Yiling Pharmaceutical's wholly-owned subsidiary, Hengshui Wanyang, has received approval for the market launch of Dapagliflozin, a selective SGLT-2 inhibitor for treating type 2 diabetes [1] Company Summary - Dapagliflozin is designed to block glucose reabsorption in the kidneys, promoting glucose excretion and lowering blood sugar levels [1] - The approval of Dapagliflozin is expected to enhance Yiling Pharmaceutical's product portfolio in the diabetes treatment market [1] Industry Summary - The Chinese diabetes medication market is projected to reach 52.7 billion yuan in 2024, with Dapagliflozin expected to capture a market share of 12.83% [1] - The market capacity for Dapagliflozin in China is anticipated to grow to 7.38 billion yuan in 2025, representing a year-on-year increase of 35% [1] - Sales volume for Dapagliflozin is expected to reach 1.78 billion tablets in 2025, reflecting a growth of 38% year-on-year [1] - The demand for Dapagliflozin raw materials in China is projected to be 17.48 tons in 2024, showing a year-on-year increase of 38.51% [1]

Core Viewpoint - Yiling Pharmaceutical has received approval from the National Medical Products Administration for a new drug clinical trial of "Qilong Dingchuan Tablets," aimed at treating chronic obstructive pulmonary disease (COPD) [1] Group 1 - The drug "Qilong Dingchuan Tablets" is intended to benefit patients by invigorating qi, promoting blood circulation, resolving phlegm, and alleviating cough and asthma [1] - The proposed indications for the drug include treatment during the stable phase of COPD, specifically for patients with qi deficiency and phlegm-stasis syndrome [1] - Symptoms targeted by the drug include shortness of breath, cough with sticky phlegm, fatigue, and other related signs [1]

Core Viewpoint - Yiling Pharmaceutical's Ziziphus jujuba seed planting base has passed the GAP extension inspection by the Hebei Provincial Drug Administration, marking it as the first of its kind in the country to achieve this certification [1] Group 1: GAP Extension Inspection Results - The GAP extension inspection is a comprehensive compliance check of the entire production process of medicinal materials, ensuring safe and effective medication, promoting industry standardization, enhancing market recognition and brand value, and facilitating sustainable resource utilization [3] - Yiling Pharmaceutical's Ziziphus jujuba seed base has established and implemented a complete, standardized, and traceable quality management system throughout the processes of sourcing, planting, harvesting, processing, storage, and transportation [3] Group 2: Company and Product Information - Ziziphus jujuba is commonly used in clinical settings for treating insomnia, neurasthenia, and irritability caused by menopause, with Yiling Pharmaceutical producing various medications that utilize this ingredient [4] - Yiling Pharmaceutical has developed a standardized planting base of 4,760 acres and a wild nurturing base of 3,200.49 acres located in Nansai Township, Neiqiu County, Xingtai City, which is recognized as a geographical indication product [4][5] Group 3: Development and Economic Impact - The establishment of the base not only promotes the rapid and healthy development of the local medicinal material planting industry but also enhances the income of local farmers, transforming Ziziphus jujuba into a profitable industry [6] - Yiling Pharmaceutical adheres to a development model of "company + base + farmers," creating a new model for rural revitalization that drives industry, technology, employment, product value enhancement, and wealth creation for local communities [6]