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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
Core Viewpoint - Kangzheng Pharmaceutical announced that its new drug Y-3 for injection has received acceptance for its New Drug Application (NDA) from the National Medical Products Administration (NMPA) in China, aimed at treating acute ischemic stroke and potentially preventing post-stroke depression and anxiety [1] Group 1: Product Development and Clinical Trials - Y-3 is the first brain cell protector developed based on key targets in the pathological process of stroke, specifically targeting PSD95-nNOS and MPO, which may enhance its protective effects on brain cells [1][2] - The Phase III clinical trial involved nearly 1,000 acute ischemic stroke patients and demonstrated significant clinical benefits and good overall safety, with results expected to be published in international academic journals [1][2] Group 2: Market Context and Demand - Approximately 3.94 million new stroke cases occur annually in China, with ischemic strokes accounting for about 72%, indicating a significant market need for effective treatments [3] - The burden of stroke-related disabilities has increased over the past 30 years, compounded by an aging population, which poses challenges for patients and society [3] Group 3: Strategic Partnerships and Market Position - The company has signed a permanent exclusive promotion agreement for Y-3 with Nanjing Ningdan New Drug Technology Co., Ltd., enhancing its market presence in mainland China, Hong Kong, and Macau [3] - Y-3's addition to the company's CNS portfolio will strengthen its innovative pipeline and synergize with existing products, potentially leading to improved treatment options for ischemic stroke patients [4]
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]