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、准确性和完整性承担法律责任。 近日，华润双鹤药业股份有限公司(以下简称"公司")控股子公司双鹤天安药业(贵州)股份有限公司(以下 简称"双鹤天安")收到了国家药品监督管理局(以下简称"国家药监局")颁发的盐酸吡格列酮分散片(以下 简称"该药品")《药品补充申请批准通知书》。现将相关情况公告如下： 一、通知书主要内容 ■ 二、药品相关情况 盐酸吡格列酮分散片用于2型糖尿病的治疗。 双鹤天安自2017年启动该药品的一致性评价工作，于2024年12月16日向国家药监局提交一致性评价申 请，于2024年12月20日获得受理通知书，并于2025年11月21日获得国家药监局批准通过一致性评价。 截至本公告日，公司针对该药品开展一致性评价累计研发投入为人民币882.27万元(未经审计)。 三、同类药品的市场状况 盐酸吡格列酮片由日本武田制药(Takeda)研制开发，于1999年7月在美国获批上市，商品名 为"ACTOS"，于2004年在中国获批上市，现已撤市。根据全球71国家药品销售数据库显示，2024年盐 酸吡格列酮片剂 ...

Core Viewpoint - The recent decision by the National Medical Products Administration to cancel the registration certificates of 80 drugs, including commonly used medications, has led to significant price increases for certain products, such as the compound drug Taining suppository, which is now priced over 900 yuan for a box of six [1][2]. Group 1: Drug Cancellations - The cancellation includes various commonly used drugs, such as loratadine tablets, finasteride tablets, and vitamin B2 tablets, all of which were voluntarily requested by the companies, indicating a strategic business decision rather than a response to safety concerns [2][3]. - The majority of the cancelled drugs are not exclusive products, meaning that other companies holding similar product registrations can continue their production and sales, mitigating potential supply shortages [2][3]. Group 2: Foreign Pharmaceutical Companies - Over 40 of the cancelled drugs are produced by foreign companies, reflecting a strategic adjustment in response to the implementation of national centralized procurement policies that have significantly reduced drug prices [2][3]. - Notable products among the cancellations include loratadine tablets from Fecar Huari, salbutamol inhalation solution from GlaxoSmithKline, and the compound drug Taining suppository from Xi'an Janssen, all of which were once market leaders [2][3]. Group 3: Market Dynamics - The cancellation of these drugs is indicative of a broader trend where foreign pharmaceutical companies are shifting their focus to more competitive innovative drugs due to declining profit margins on original drugs amid increasing competition from generic products [3][4]. - The market for inhalation medications, such as salbutamol, is becoming increasingly competitive as domestic companies improve their product quality and pricing, leading to a loss of market share for original products [4][5]. - The ongoing price control measures for chronic disease medications, including diabetes drugs, are further squeezing the profit margins of original drugs, prompting companies to rationally decide to cancel their product registrations when market returns do not cover operational costs [5].