人福药业进军OAB蓝海!米拉贝隆缓释片ANDA获受理,泌尿仿制药赛道竞争升温
HWHGHWHG(SH:600079) Ge Long Hui·2026-02-11 05:26

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].

人福药业进军OAB蓝海!米拉贝隆缓释片ANDA获受理,泌尿仿制药赛道竞争升温 - Reportify