本报讯(记者王镜茹)近日，广东泰恩康（301263）医药股份有限公司(以下简称"泰恩康")宣布重大突 破，其全资子公司山东华铂凯盛生物科技有限公司(以下简称"山东华铂凯盛")收到国家药品监督管理局 签发的非那雄胺他达拉非胶囊《药品注册证书》(药品批准文号：国药准字H20256305)，商品名为爱廷 列，成为国内首家获批该药品的企业，为男性良性前列腺增生(BPH)治疗领域带来全新解决方案。 非那雄胺他达拉非复合制剂作为一种创新组合药物，在治疗良性前列腺增生(BPH)方面展现出独特的多 靶点治疗优势。该复合制剂包含5mg非那雄胺和5mg他达拉非两种活性成分，分别针对BPH的不同病理 机制发挥作用。 相较于传统单药治疗方案，非那雄胺他达拉非胶囊的临床优势尤为突出，全方位提升患者治疗效果与用 药体验。 随着全球人口老龄化加剧，良性前列腺增生已成为影响中老年男性健康的重要公共卫生问题。此前，该 药品由美国VERU公司开发(商品名：ENTADFI)，于2021年12月获美国FDA批准上市，山东华铂凯盛作 为国内首家获得该药品注册证书的企业，成功实现了该复方制剂的国产化落地，填补了国内良性前列腺 增生复方治疗药物的市场空白 ...

Core Viewpoint - Baiyunshan has received approval for the registration of Tadalafil tablets, positioning it as a successor to its existing product, Jin Ge (Sildenafil) [1][3]. Group 1: Product Overview - Tadalafil is a PDE5 inhibitor similar to Sildenafil, primarily used for treating erectile dysfunction (ED) [1][3]. - Tadalafil has advantages over Sildenafil, including lower dosage, longer half-life, and less impact from high-fat meals and alcohol [3]. Group 2: Market Dynamics - The domestic market for Tadalafil has not performed as well as Sildenafil, facing intense competition and a dual market structure of hospital and retail sales [3][4]. - In 2024, Tadalafil's sales in public hospitals were only RMB 186 million, indicating a limited market size [7]. - The introduction of centralized procurement policies has compressed the market ceiling for Tadalafil in hospitals [4]. Group 3: Competitive Landscape - In 2024, Tadalafil's total sales in hospitals were RMB 142 million, with the original drug, Cialis, holding a 30.14% market share, while generic competitors have gained significant volume [7][11]. - The retail market for Tadalafil is much larger, with total sales of approximately RMB 2.906 billion in 2024, split between offline and online pharmacies [14]. - The online retail market is highly fragmented, with various brands competing for market share [20]. Group 4: Challenges and Future Outlook - Baiyunshan faces challenges in establishing Tadalafil as a blockbuster product due to the competitive landscape and lack of first-mover advantage [23]. - The company is also exploring other male health medications, such as Dapoxetine, but the overall market for these products is limited [24]. - Jin Ge's sales and revenue have declined in 2024, indicating potential saturation in its market [24][25].