这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 政策动向 国家药监局：2025年我国药品抽检合格率99%以上 据央视新闻报道，2025年我国药品抽检1.97万批次，抽检合格率保持在99%以上。全国药监部门全方位 筑牢药品安全底线，全国药品安全形势保持总体稳定。 药械审批 宣泰医药：获得注射用硫酸艾沙康唑药品注册证书 宣泰医药(688247)1月6日公告，近日，公司收到国家药品监督管理局核准签发的《药品注册证书》，批 准公司注射用硫酸艾沙康唑上市。注射用硫酸艾沙康唑适用于治疗成人患者下列感染：侵袭性曲霉病， 侵袭性毛霉病。 资本市场 翔宇医疗：截至2025年末脑机接口相关产品尚未实现规模化销售 1月6日，翔宇医疗(688626.SH)发布异动公告，近期资本市场对人脑工程、脑机接口等概念关注度较 高，相关板块股价涨幅较大。公司目前主要聚焦非侵入式脑机接口技术，覆盖作业疗法、运动疗法、认 知言语、吞咽等康复全场景布局，与当前国际上的侵入式脑机接口技术路线存在差异。公司在脑机接口 方面的投入，目前在技术、产品、渠道市场等方面形成一定的布局，但招投标和销售等具有滞后性，截 ...

二、药品的其他相关情况 注射用硫酸艾沙康唑适用于治疗成人患者下列感染：侵袭性曲霉病，侵袭性毛霉病。 注射用硫酸艾沙康唑原研产品为辉瑞公司开发，于2022年6月在国内获批上市，同年谈判纳入医保乙类 品种目录，随后迎来医院市场快速放量。根据摩熵医药销售数据，该产品2024年年度及2025年上半年度 销售额分别为人民币2.04亿元、1.72亿元。 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性依法承担法律责任。 近日，上海宣泰医药科技股份有限公司（以下简称"公司"）收到国家药品监督管理局（以下简称"国家 药监局"）核准签发的《药品注册证书》，批准公司注射用硫酸艾沙康唑上市。现将相关情况公告如 下： 2026年1月7日 一、药品基本情况 1、药品名称：注射用硫酸艾沙康唑 2、注册分类：化学药品4类 3、申请事项：药品注册 4、药品批准文号：国药准字H20256410 5、剂型：注射剂 6、规格：0.2g（按C??H??F?N?OS计） 7、上市许可持有人：上海宣泰医药科技股份有限公司 本次注射用硫酸艾沙康唑获得国家药监局批准上市，有利于进一步丰富公 ...

北京商报讯(记者丁宁)1月6日晚间，宣泰医药(688247)发布公告称，近日，公司收到国家药监局核准签 发的《药品注册证书》，批准公司注射用硫酸艾沙康唑上市。 宣泰医药表示，本次注射用硫酸艾沙康唑获得国家药监局批准上市，有利于进一步丰富公司的产品线， 提升公司竞争力，对公司未来的经营业绩产生积极的影响。 ...

人民财讯1月6日电，宣泰医药(688247)1月6日公告，近日，公司收到国家药品监督管理局核准签发的 《药品注册证书》，批准公司注射用硫酸艾沙康唑上市。注射用硫酸艾沙康唑适用于治疗成人患者下列 感染：侵袭性曲霉病，侵袭性毛霉病。 ...

宣泰医药(688247.SH)发布公告，近日，公司收到国家药品监督管理局(简称"国家药监局")核准签发的 《药品注册证书》，批准公司注射用硫酸艾沙康唑上市。注射用硫酸艾沙康唑适用于治疗成人患者下列 感染：侵袭性曲霉病，侵袭性毛霉病。 ...

宣泰医药公告称，公司收到国家药监局核准签发的《药品注册证书》，批准注射用硫酸艾沙康唑上市， 药品批准文号为国药准字H20256410，规格为0.2g。该药品适用于治疗成人侵袭性曲霉病、侵袭性毛霉 病。原研产品2024年、2025年上半年销售额分别为2.04亿元、1.72亿元。获批上市利于丰富公司产品 线、提升竞争力，但销售情况有不确定性。 ...

宣泰医药(688247.SH)发布公告，近日，公司收到国家药品监督管理局(简称"国家药监局")核准签发的 《药品注册证书》，批准公司注射用硫酸艾沙康唑上市。注射用硫酸艾沙康唑适用于治疗成人患者下列 感染：侵袭性曲霉病，侵袭性毛霉病。 ...

这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 政策动向 国家医保局详解"双目录" 12月9日，国家医保局对2025年医保药品目录进行了解读，并阐释了医保支持真创新的多维路径。 据国家医保局披露，经相应程序，本次基本医保目录新增114种药品，包括三种准入途径：105种谈判新 增（独家产品），7种竞价新增（非独家产品），2种国家集采中选药品直接调入。29种临床已被替代或 长期未生产供应的药品被调出，其中9种尚有相同治疗主成分的其他剂型在目录内，不减少目录编号。 在新增药品中，111种为5年内新上市品种，占比近98%，50种为1类新药，无论是比例还是数量都创历 年新高。从治疗领域看，新增药品涵盖了肿瘤、抗感染、慢性病、罕见病、精神疾病等重点领域。 今年国家医保局同步发布了首个商保创新药目录，包含18家企业的19款创新药，其中1类新药有9种，约 占50%。 21点评：多款创新药的快速落地有效解决了临床痛点。另外，首版商保创新药目录的同步推出，与基本 医保形成了有效互补，既保障了普通患者的基础用药需求，也为需要高价创新药的患者提供了更多支付 支持。 药械审批 福安药业：子 ...

Group 1 - Jicheng Electronics won a total of 15 bids from the State Grid Corporation, with a total bid amount of approximately 215 million yuan, accounting for 8.27% of the company's projected revenue for 2024 [2] - Jianmin Group's chemical generic drug, Ambrutoro Oral Solution, has been approved for market launch by the National Medical Products Administration, aimed at treating cough and wheezing caused by chronic bronchitis and emphysema [3] - Taiji Industry's subsidiary plans to transfer accounts receivable not exceeding 85 million USD to optimize cash flow, with an expected service fee of approximately 285,000 USD [4] Group 2 - Nanjing Pharmaceutical's subsidiary plans to invest 398 million yuan in a modern pharmaceutical logistics expansion project, with a construction period of approximately 35 months [5] - Ruili Kemi received a development notification from a well-known domestic flying car company to supply core components [6] - Ding Tong Technology announced that several executives plan to reduce their holdings by a total of no more than 45,300 shares, representing about 0.032% of the total share capital [7][8] Group 3 - Ninghu Expressway's subsidiary plans to invest no more than 9.033 billion yuan in the construction of the Nanyang Yangtze River Bridge South Connection Project [10] - Wuliangye announced a mid-term profit distribution plan for 2025, proposing a cash dividend of 25.78 yuan per 10 shares, totaling approximately 10 billion yuan [12] - Beixin Road and Bridge's subsidiary won a bid for a project worth 180 million yuan [14] Group 4 - Minhe Livestock reported a 7.75% month-on-month increase in sales revenue from commodity chick sales in November [15] - Xuelong Group plans to invest 100 million yuan to establish a wholly-owned subsidiary for vertical integration in the aluminum and magnesium technology sector [16] - Shengnong Development reported a 15.77% year-on-year increase in sales revenue in November, with significant growth in both poultry and processed meat products [17] Group 5 - Xingyu Co., Ltd. plans to repurchase shares worth 200 million to 300 million yuan for employee stock ownership plans [18] - Quan Chai Power intends to use 50 million yuan of idle funds to purchase structured deposit products [19] - Shibei High-tech appointed Zhao Junhong as the new deputy general manager [20] Group 6 - Fuan Pharmaceutical's subsidiary received a drug registration certificate for injectable isavuconazole, expanding its anti-infection product line [21] - Xiaoming Co. reported a 49.73% year-on-year decline in chicken product sales revenue in November [22] - Baiao Chemical adjusted its share repurchase price ceiling to no more than 48.95 yuan per share [23] Group 7 - Hefei China reported a 26.02% year-on-year decline in consolidated revenue for the first 11 months [24] - Laimei Pharmaceutical's subsidiary received medical device registration certificates for two endoscope products [25][26] - Xiantan Co. reported an 11.63% year-on-year increase in chicken product sales revenue in November [27] Group 8 - Qilin Security received government subsidies totaling 5.4014 million yuan [28] - Blue Sky Gas's controlling shareholder's 30.9134 million shares were judicially frozen, accounting for 4.33% of the total share capital [29] - Tieke Railway signed a contract for high-speed railway fasteners worth 654 million yuan, accounting for 41.08% of the company's projected revenue for 2024 [30] Group 9 - David Medical's electric surgical table received a medical device registration certificate [31] - Zhendong Pharmaceutical's affiliate's core product new drug application was accepted by the CDE [32] - Shanghai Pharmaceutical's apple acid sitagliptin tablet application for market approval was granted by the National Medical Products Administration [33] Group 10 - Nanjiao Food reported a 1.14% year-on-year increase in consolidated revenue for November [34]

福安药业（300194）(300194.SZ)公告，公司全资子公司福安药业集团湖北人民制药有限公司(简称"人民 制药")于近日收到国家药品监督管理局签发的药品注册证书，药品名称：注射用硫酸艾沙康唑。注射用 硫酸艾沙康唑适用于治疗成人患者下列感染：侵袭性曲霉病;侵袭性毛霉病。 ...