ZUNVEYL(葡萄糖酸苯加兰他敏肠溶片)
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康哲药业(00867.HK)抗急性缺血性卒中1类新药注射用Y-3中国上市许可申请已获受理
Ge Long Hui· 2025-12-11 11:30
根据国家卫健委发布的《脑血管病防治指南(2024年版)》,我国每年新发卒中约394万例,占全球新发 病例三分之一,其中缺血性卒中占比约72%,年新发病例超280万;现患病的卒中患者已超2800万人。 2021年中国死因监测数据显示,卒中死亡占全国总死亡人数的23%。过去三十年,我国卒中相关残疾的 疾病负担持续加重,叠加人口老龄化加快等因素,未来卒中防控压力将进一步增大,给患者家庭和社会 带来巨大挑战。此外,卒中后抑郁和焦虑是卒中常见并发症,发病率分别达到约30%和25%,会影响患 者神经功能恢复,甚至增加死亡风险,严重影响患者预后。注射用Y-3对广大卒中患者长期神经功能改 善和总体预后具有重大潜在价值,市场前景广阔。 于2023年8月24日,集团通过公司全资附属公司与一家以临床需求为导向、创新与研发驱动的新药企业 南京宁丹新药技术股份有限公司就产品签署合作协议("协议")。根据协议,本集团获得产品在中国大 陆、香港特别行政区、澳门特别行政区的独家推广权。协议期限为永久。 中枢神经系统(CNS)是集团核心优势领域之一,已逐步形成深度布局。注射用Y-3的加入,将进一步丰 富及优化集团CNS领域的差异化创新管线,并 ...
康哲药业(00867.HK)中期溢利同比增长3.1%至9.3亿元
Ge Long Hui· 2025-08-18 13:28
Core Viewpoint - 康哲药业 reported a 10.8% year-on-year increase in revenue to RMB 4.002 billion for the six months ending June 30, 2025, with a net profit growth of 3.1% to RMB 930 million, and basic earnings per share rising by 4.2% to RMB 0.3892 [1] Financial Performance - Revenue increased by 10.8% to RMB 4.002 billion [1] - Net profit grew by 3.1% to RMB 930 million [1] - Basic earnings per share rose by 4.2% to RMB 0.3892, compared to RMB 0.3734 in the 2024 interim period [1] - Interim dividend declared at RMB 0.1555 per share, up 3.2% [1] Product Development - The product portfolio has been enriched with the addition of innovative products ZUNVEYL and MG-K10 [1] - ZUNVEYL's New Drug Application (NDA) was accepted by the National Medical Products Administration (NMPA) in July 2025 [1] - The injection product LIZHENRAN was approved for market entry in China in July 2025 [1] - Five existing innovative drugs are progressing steadily in commercialization, with scale effects becoming apparent [1] Strategic Initiatives - The company is focusing on specialty areas and actively deploying new retail and new media strategies to enhance its consumer healthcare product offerings [1] - The skin health business "德镁医药" is set to be independently listed on the Hong Kong Stock Exchange to unlock its independent value and high growth potential [1]