新“救星”，石药集团新型降脂药首仿来袭

北京药研汇02-14

高血脂症是导致动脉粥样硬化、冠心病等心血管疾病的罪魁祸首，同时也是糖尿病、肾衰竭等严重疾病的潜在风险。高血脂症是导致心血管疾病和糖尿病等严重健康问题的主要原因，尤其在老年人中普遍，占全球死亡率的三分之一。2026年2月13日，据中国国家药品申报中心（CDE）官网显示，石药集团欧意药业有限公司按化药注册分类3类申报的贝派度酸片临床试验申请获默示许可。本次拟定适应症为：作为饮食的辅助治疗，与其他降低...

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imitation","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"01093":1.5},"content_text":"高血脂症是导致动脉粥样硬化、冠心病等心血管疾病的罪魁祸首，同时也是糖尿病、肾衰竭等严重疾病的潜在风险。高血脂症是导致心血管疾病和糖尿病等严重健康问题的主要原因，尤其在老年人中普遍，占全球死亡率的三分之一。2026年2月13日，据中国国家药品申报中心（CDE）官网显示，石药集团欧意药业有限公司按化药注册分类3类申报的贝派度酸片临床试验申请获默示许可。本次拟定适应症为：作为饮食的辅助治疗，与其他降低低密度脂蛋白胆固醇（LDL-C）的疗法联合使用，或在无法联用时单独使用，以降低成人原发性高脂血症（包括杂合子家族性高胆固醇血症（HeFH））患者的 LDL-C 水平。贝派度酸作为一种创新型的非他汀类降脂药物，以其独特的作用机制脱颖而出。它不仅能有效抑制肝脏内胆固醇的合成，还能通过上调肝细胞表面的低密度脂蛋白胆固醇（LDL-C）受体，促进“坏胆固醇”LDL-C的肝脏吸收。与传统的他汀类药物相比，贝派度酸在减少肌肉酸痛、肌无力、肌肉僵硬或痉挛等副作用方面表现出显著优势，其作用机制与他汀类药物相互补充，为联合用药提供了巨大的潜力。贝派度酸是一种三磷酸腺苷-柠檬酸裂解酶抑制剂，其核心作用在于降低低密度脂蛋白胆固醇（LDL-C）水平。对于那些无法接受他汀类治疗的成年患者而言，贝派度酸提供了一个新的治疗选择，有助于降低心肌梗死和冠状动脉血运重建的风险。贝派度酸原研为美国生物制药公司Esperion，2020年2月21日，在美国FDA首次批准上市，商品名：Nexletol。作为近20年来FDA首次批准的口服非他汀类降胆固醇药物，为患者提供了与现有药物互补的一种新疗法。可用于对他汀类不耐受或单独使用他汀类无法有效控制血脂的患者。2021年贝派度酸片全球销售额为1.2亿美元，增长率为442.9%。据预计贝派度酸片可能会占领多达四分之一的胆固醇药物市场，并有望达到20亿至30亿美元的峰值销售额。国内仿制情况，贝派度酸片原研药及仿制药均未尚未在国内上市。截至目前为止，国内已有甘李药业山东有限公司、江西施美药业、合肥立方制药、石药集团欧意药业4家药企申报的贝派度酸片临床申请均获受理，首仿之争已拉开帷幕。高血脂，作为心血管疾病及相关死亡的“头号元凶”，其危害不容小觑。世界心脏联盟（WHF）数据显示，全球约39%的成年人胆固醇水平超标，每年因此丧生的人数以百万计。现有的降脂“主力军”——他汀类药物，却面临诸多挑战。由于服药依从性等问题，许多患者难以达到理想的低密度脂蛋白胆固醇（LDL-C）水平。而且，他汀类药物潜在的副作用，如肝功能损害等，让约10%的患者出现不耐受情况。在此背景下，贝派度酸凭借独特的作用机制和出色的安全性脱颖而出，为那些不耐受他汀或急需有效降脂的患者带来了新的希望。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 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