2025年12月11日，康哲药业(00867)宣布，用于治疗急性缺血性卒中的1类创新药注射用Y-3(拟定中文通 用名：注射用洛贝米柳)的新药上市许可申请(NDA)已获得中国国家药品监督管理局(NMPA)受理。 康哲药业表示，中枢神经系统是其核心优势领域之一，已逐步形成深度产品布局，夯实市场基础。注射 用Y-3如获批上市，将与在售创新药维图可(丛集性癫痫)、原研品牌药黛力新(焦虑、抑郁)以及处于NDA 审评中的改良型新药ZUNVEYL(阿尔茨海默症)在专家网络与市场资源上产生高效协同。凭借康哲药业 卓越的商业化经验与合规高效的运营体系，加速推动创新疗法惠及更多患者，为中国缺血性脑卒中患者 带来疗效优异、作用更全面的新一代脑细胞保护剂。 注射用Y-3是全球首个基于脑卒中病理过程重要靶点PSD95-nNOS和MPO开发的脑细胞保护剂，作用于 缺血性脑卒中缺血级联反应多个关键病理过程，通过多靶点高选择性协同，更有利于发挥脑细胞保护作 用。产品具有优异的治疗缺血性脑卒中和潜在的预防卒中后抑郁焦虑症状的作用。注射用Y-3的中国Ⅲ 期临床研究达到主要疗效终点，患者临床获益明显，整体安全性良好。主要研究结果未来计划在国际学 ...

Core Insights - Stroke has become the leading cause of death and disability among adults in China, with at least one in five deaths attributed to stroke [1] - The "China Neurological Disease Report 2024" highlights the increasing incidence of stroke, particularly among younger populations, and notes significant gender and regional differences in stroke prevalence [1][2] Summary by Sections Stroke Incidence and Mortality - In 2019, there were 3.94 million stroke cases in China, with 2.87 million being ischemic strokes, accounting for approximately 72.8% of cases [1] - The age-standardized incidence rate for ischemic stroke is rising, currently at 145 per 100,000, while the age-standardized mortality rate is 56.5 per 100,000 [1] Trends in Ischemic Stroke - The number of deaths from ischemic stroke in China increased by 171.1% from 1990 to 2019, correlating with the aging population [2] - The age-standardized mortality rate for ischemic stroke has shown a declining trend from 2005 to 2009, attributed to improvements in the healthcare system and public health education [2] Hemorrhagic Stroke Characteristics - The age-standardized incidence rate for hemorrhagic stroke is approximately 56 per 100,000, with a mortality rate of 65.1 per 100,000 [2] - Hemorrhagic stroke is characterized by a younger demographic, with higher incidence rates in males compared to females, and regional disparities showing higher rates in the north versus the south [2] Preventive Measures - Over 85% of hemorrhagic strokes are preventable through the management of risk factors such as high blood pressure, poor diet, air pollution, tobacco use, high body mass index, and high blood sugar [3] - Effective intervention on these risk factors can not only prevent the occurrence of hemorrhagic strokes but also reduce the risk of recurrence [3]

Core Viewpoint - The article emphasizes that summer is not a safe season for cerebrovascular diseases, highlighting the increased risk of strokes due to high temperatures and temperature fluctuations caused by air conditioning [1][2]. Group 1: Cerebrovascular Disease Risks - The incidence of cerebrovascular diseases, particularly ischemic strokes, significantly increases when temperatures exceed 33°C [1]. - The temperature difference between air-conditioned environments and outdoor heat can lead to severe vascular stress, particularly when the indoor-outdoor temperature difference exceeds 7°C [1]. Group 2: Mechanisms of Risk - High temperatures can lead to dehydration, reducing blood volume and increasing blood viscosity, which heightens the risk of strokes [2]. - Alternating between extreme temperatures can cause significant fluctuations in blood pressure, increasing the likelihood of both hemorrhagic and ischemic strokes [2]. Group 3: High-Risk Populations - High-risk groups for strokes include individuals with pre-existing cerebrovascular conditions, elderly individuals with vascular hardening, and younger individuals with unhealthy lifestyles [2]. Group 4: Prevention and Response - Recognizing risk factors is crucial for stroke prevention, including adequate hydration, regular sleep patterns, and avoiding extreme temperature changes [2]. - In the event of a stroke, immediate action is critical, as the first 4.5 to 6 hours are vital for effective treatment to minimize brain damage [2].

Core Viewpoint - The article discusses the symptoms of numbness that may indicate the early signs of a stroke, emphasizing the importance of recognizing these symptoms for timely medical intervention [1][3]. Group 1: Symptoms of Stroke - Numbness in three specific areas—tongue, face, and one-sided limbs—should raise concerns about the risk of stroke [3][5][6]. - Tongue numbness can affect speech and swallowing, indicating potential brain blood supply issues [5]. - Facial numbness may lead to asymmetrical facial expressions, signaling possible nerve damage due to insufficient blood flow [5]. - One-sided limb numbness is a common precursor to stroke, often indicating that one side of the brain is affected [6]. Group 2: Characteristics of Numbness Related to Stroke - Numbness from cerebrovascular diseases typically occurs suddenly without warning, and may happen during rest or physical activity [6][7]. - It is often unilateral, affecting one side of the body, and can progress from transient to persistent numbness as blood supply issues worsen [6]. - Unlike numbness caused by other conditions, such as cervical or lumbar spine issues, stroke-related numbness does not improve with position changes [7]. Group 3: Accompanying Symptoms - Stroke-related numbness is often accompanied by weakness, dizziness, headaches, vision problems, and memory decline [8]. - Other alarming signs include sudden dizziness, vomiting, tinnitus, and instability while standing [8]. Group 4: Risk Factors for Stroke - Stroke risk factors include both uncontrollable factors (age, gender, genetic background) and controllable factors (hypertension, diabetes, high cholesterol, smoking, and poor lifestyle choices) [9]. - Sedentary behavior can increase blood viscosity and lead to plaque formation in blood vessels, heightening stroke risk [10]. - High salt and oil intake can elevate blood pressure and cholesterol levels, contributing to vascular damage [12]. - Emotional fluctuations and severe snoring during sleep can also increase the likelihood of stroke by affecting blood pressure and oxygen levels [14][16]. Group 5: Recommendations for Prevention - It is advised to take breaks from sitting every hour to promote blood circulation [11]. - Daily salt intake should be limited to under 5 grams, and healthier cooking oils should be used [13]. - Stress management techniques, such as deep breathing and meditation, are recommended to mitigate emotional impacts on vascular health [14]. - Individuals experiencing severe snoring should adjust their sleeping positions and seek medical evaluation [17]. - Smoking cessation is crucial, as smokers face a significantly higher risk of stroke compared to non-smokers [18].