Core Viewpoint - The recent acceptance of the market application for Mirabegron extended-release tablets by Wuhan Renfu Pharmaceutical has sparked renewed interest in the urology generic drug sector, indicating a competitive landscape with multiple companies vying for market share [1][15]. Group 1: Market Potential - Mirabegron is projected to exceed $1.1 billion in global sales by 2024, establishing itself as a leading treatment for overactive bladder (OAB) [2]. - The drug, developed by Astellas Pharma, is the first selective β3-adrenergic agonist for OAB treatment, addressing a market that has lacked new mechanisms for nearly 30 years [5][6]. Group 2: Competitive Landscape - As of now, 16 domestic pharmaceutical companies have received approval for Mirabegron, indicating a crowded market with significant competition [12]. - Astellas maintains a dominant position in the domestic market, holding a 39.53% market share in hospitals as of the first three quarters of 2025, making it difficult for competitors to disrupt its lead [9]. Group 3: Company Strategies - Wuhan Renfu's application for Mirabegron is part of a broader strategy to enhance its portfolio in the urology specialty and expand its non-anesthesia product line [19]. - The company has over 100 approved products, with 25 being the first in the domestic market, showcasing its commitment to building a strong presence in the generic drug sector [16]. Group 4: Industry Trends - The increasing interest in Mirabegron reflects a shift towards high-potential products that combine new mechanisms, strong demand, and insurance coverage, which are becoming attractive targets for pharmaceutical companies [20]. - The ongoing competition in the generic drug market, particularly for Mirabegron, suggests a potential for value reassessment as companies seek to capitalize on cash flow opportunities in a transforming industry [20].

登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：002773 证券简称：康弘药业 公告编号：2025-063 成都康弘药业集团股份有限公司 一．药品基本信息 药品名称：米拉贝隆缓释片 剂型：片剂 规格：50mg 适应症：成年膀胱过度活动症（OAB）患者尿急、尿频和/或急迫性尿失禁的对症治疗。 注册分类：化学药品4类 批准文号：国药准字H20255960 审批结论：根据《中华人民共和国药品管理法》及有关规定，经 关于公司收到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。 成都康弘药业集团股份有限公司（以下简称"公司"）于近日收到国家药品监督管理局签发的米拉贝隆缓 释片的《药品注册证书》（证书编号：2025S03430），批准注册。现将相关情况公告如下： 审查，本品符合药品注册的有关要求，批准注册，发给药品注册证书。 二．产品简介 米拉贝隆为选择性β3肾上腺素受体激动剂，通过作用于膀胱组织，使膀胱平滑肌松弛。 三．对公司的影响 本次米拉贝隆缓释片获批上市，丰富了公司的产品管线。 由于医药产品的生产销售情况可能受到国家政策、市场环境变 ...

（文章来源：证券日报） 证券日报网讯 11月24日晚间，康弘药业发布公告称，公司于近日收到国家药品监督管理局签发的米拉 贝隆缓释片的《药品注册证书》（证书编号：2025S03430），批准注册。 ...

Core Viewpoint - Kanghong Pharmaceutical has received the drug registration certificate for Mirabegron extended-release tablets from the National Medical Products Administration, indicating a significant regulatory approval for the company’s product [1] Company Summary - Kanghong Pharmaceutical (002773.SZ) has announced the approval of Mirabegron, a selective β3 adrenergic receptor agonist, which acts on bladder tissue to relax bladder smooth muscle [1]

Core Viewpoint - Kanghong Pharmaceutical has received the drug registration certificate for Mirabegron extended-release tablets from the National Medical Products Administration, marking a significant milestone for the company in the treatment of overactive bladder (OAB) [1] Company Summary - The approved drug, Mirabegron, is a selective β3 adrenergic receptor agonist that relaxes the bladder smooth muscle [1] - The indication for this approval is for the symptomatic treatment of adult patients with overactive bladder, specifically addressing symptoms such as urgency, frequency, and/or urge incontinence [1]

智通财经APP讯，康弘药业(002773.SZ)公告，公司近日收到国家药品监督管理局签发的米拉贝隆缓释片 的《药品注册证书》，批准注册。米拉贝隆为选择性β3肾上腺素受体激动剂，通过作用于膀胱组织， 使膀胱平滑肌松弛。 ...

格隆汇11月24日丨康弘药业(002773.SZ)公布，近日收到国家药品监督管理局签发的米拉贝隆缓释片的 《药品注册证书》（证书编号：2025S03430），批准注册。米拉贝隆为选择性β3肾上腺素受体激动 剂，通过作用于膀胱组织，使膀胱平滑肌松弛。 ...

格隆汇11月24日丨康弘药业(002773.SZ)公布，近日收到国家药品监督管理局签发的米拉贝隆缓释片的 《药品注册证书》（证书编号：2025S03430），批准注册。米拉贝隆为选择性β3肾上腺素受体激动 剂，通过作用于膀胱组织，使膀胱平滑肌松弛。 ...

南财智讯11月24日电，康弘药业公告，公司收到国家药品监督管理局签发的米拉贝隆缓释片《药品注册 证书》。该产品用于治疗成年膀胱过度活动症（OAB）患者尿急、尿频和/或急迫性尿失禁的对症治 疗。 ...

Core Insights - The company reported a revenue of 41.188 billion yuan for the first half of 2025, representing a year-on-year growth of 3.54% [1] - The net profit attributable to shareholders was approximately 282 million yuan, with a year-on-year increase of 18.56% [1] - The basic earnings per share reached 0.16 yuan, reflecting a growth of 14.29% year-on-year [1] Business Overview - The company is a national wholesale enterprise for narcotic drugs and Class I psychotropic drugs, and it operates in the pharmaceutical and medical device sectors [1] - The main business segments include pharmaceutical commercial operations, covering drug sales, medical devices, traditional Chinese medicine, health products, and supply chain services [1] - The company has expanded its market presence, achieving coverage in all 31 provinces and 164 prefecture-level cities in China [1] Pharmaceutical Wholesale Business - The pharmaceutical wholesale segment generated revenue of 39.052 billion yuan, accounting for over 95% of total revenue, serving more than 8,000 medical institutions [2] - The company is enhancing its "pharmaceutical + internet" strategy, with the online platform "Zhongyao Cloud Business" achieving a transaction volume of approximately 1 billion yuan, a year-on-year increase of 72% [2] Retail Business - The retail segment achieved revenue of 1.947 billion yuan, with brands like "Heping Pharmacy" covering over 850 stores across 22 provinces [2] - The company has opened 616 stores offering outpatient coordination services, improving patient access to medication and health management [2] Product and Service Diversification - The company operates over 280,000 product specifications, with pharmaceutical revenue reaching 33.668 billion yuan and traditional Chinese medicine revenue at 7.210 billion yuan [2] - The company has established standardized planting bases for traditional Chinese medicine and enhanced production capabilities through modern workshops and AI technology [2] Medical Device and Specialty Drugs - The medical device segment generated revenue of 6.884 billion yuan, with 41 SPD projects implemented to improve hospital supply chain management [3] - Revenue from narcotic drugs and Class I psychotropic drugs was 1.736 billion yuan, ensuring stable supply and efficient distribution [3] Innovation and Development - The company is focusing on high-end generic drugs, specialty traditional Chinese medicine, and innovative drug development [3] - Four products, including Mirabegron sustained-release tablets, were approved during the reporting period, with three already in commercial production [3]