{"errCode":0,"errMsg":"success","timeStamp":"1777280932","data":{"trueId":"6917529027643091107","title":"联拓生物心肌病新药上市申请被纳入优先审评","author":[],"tags":[],"detail":"\u003cp\u003e4月22日，联拓生物宣布，中国国家药品监督管理局已接受旗下新药mavacamten用于治疗有症状的梗阻性肥厚型心肌病（oHCM）成人患者的新药上市申请，并将其纳入了优先审评。\u003c/p\u003e\u003cp\u003e \u003c/p\u003e\u003cp\u003e\u003cimg data-type=\"image_card\" src=\"https://img.hubpd.com/hubpd/spider/full/5b14e512e48b568ed66bec75e94d2c4036fa2db3.jpg\"/\u003e\u003c/p\u003e\u003cp\u003e国家药品审评中心网站截图\u003c/p\u003e\u003cp\u003e \u003c/p\u003e\u003cp\u003e“肥厚型心肌病显著影响患者的生活质量，目前缺乏有效的治疗方案，临床上急需创新药物。”北京协和医院院长、心脏病学教授、EXPLORER-CN研究牵头研究者张抒扬教授表示：“作为首个靶向疾病病理生理机制的药物，mavacamten有望改善中国有症状的梗阻性肥厚型心肌病的治疗现状，并对患者的健康状况及日常生活能力产生积极影响。”\u003c/p\u003e\u003cp\u003e \u003c/p\u003e\u003cp\u003emavacamten是首个且目前唯一获得美国FDA批准的心肌肌球蛋白抑制剂，适用于治疗症状性纽约心脏协会心功能II-III级的有症状的梗阻性肥厚型心肌病成人患者，以改善功能能力和症状。除在美国外，该药也在澳大利亚、加拿大和巴西获得了监管部门的上市批准。联拓生物于2020年8月获得了百时美施贵宝旗下全资子公司MyoKardia的许可授权，2022年2月，mavacamten在中国获得了突破性疗法资格认定，用于治疗有症状的梗阻性肥厚型心肌病患者。\u003c/p\u003e\u003cp\u003e \u003c/p\u003e\u003cp\u003e此次新药上市申请的递交是基于mavacamten的全球关键III期EXPLORER-HCM临床试验的数据结果：在运动能力、功能状态和患者报告结局以及缓解左心室流出道梗阻的能力方面可为患者带来具有临床意义的改善。EXPLORER-HCM试验达到了其预先设定的所有主要和次要研究终点，且具有统计学意义。\u003c/p\u003e\u003cp\u003e \u003c/p\u003e\u003cp\u003e联拓生物首席执行官王轶喆博士表示：“mavacamten作为已得到临床验证的治疗方案，是治疗梗阻性肥厚型心肌病的同类首创药物。如今我们离将这一创新药物惠及患者的目标又进了一步。”\u003c/p\u003e\u003cp\u003e \u003c/p\u003e\u003cp\u003e责编：乔靖芳\u003c/p\u003e\u003cp\u003e主编：张赫\u003c/p\u003e\u003cp\u003e校对：王卓\u003c/p\u003e","createdAt":1682151684,"updatedAt":1682151686,"source":0,"reprintedUrl":"https://m.peopledailyhealth.com/articleDetailShare?articleId=d32d6472d60948829ede97fb1447e9e9","type":0,"vShowStyle":0,"transCodingObjKey":"https://img.hubpd.com/hubpd/644399067969990001cdc2eb","transCodingObjKeyMp4":"https://img.hubpd.com/hubpd/","mpIcon":"https://img.hubpd.com/hubpd/9e30480a-9baf-11ec-a5f1-4abf23cf0462.png","mpName":"人民日报健康客户端","mpIsVerified":true,"mpId":"5476377146882583281","covers":["https://img.hubpd.com/hubpd/spider/full/5b14e512e48b568ed66bec75e94d2c4036fa2db3.jpg"],"coversType":0,"blurImage":"","publishedAt":1682149980,"classificationName":"健康","tap":4333,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"6917529027643091107|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":[],"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0},"hisHots":{"hotData":[{"trueId":"8935141660704993916","title":"北京仍有核酸检测亭正常运转，采样免费","author":null,"tags":null,"source":0,"reprintedUrl":"https://m.peopledailyhealth.com/smallVideo/999669c6c0db40c1a06c7f747f6cdd8b","type":0,"vShowStyle":0,"mpIsVerified":false,"covers":null,"coversType":0,"blurImage":"","publishedAt":1678782085,"tap":0,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"8935141660704993916|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":null,"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0},{"trueId":"1152921504608063740","title":"国家及省级集采续签，含石药集团、科伦制药等","author":null,"tags":null,"source":0,"reprintedUrl":"https://m.peopledailyhealth.com/articleDetailShare?articleId=ef4088089ab040669d4b2d38b4754bae","type":0,"vShowStyle":0,"mpIsVerified":false,"covers":null,"coversType":0,"blurImage":"","publishedAt":1650979860,"tap":0,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"1152921504608063740|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":null,"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0},{"trueId":"7782220156098707667","title":"创新医疗器械获批231款，肿瘤介入领域占比接近1/5","author":null,"tags":null,"source":0,"reprintedUrl":"https://m.peopledailyhealth.com/articleDetailShare?articleId=be5ca9923f85418b8b7c3717929c5e2b","type":0,"vShowStyle":0,"mpIsVerified":false,"covers":["https://img.hubpd.com/hubpd/spider/full/55c3342423de33310130ade84a516331615fab1d.jpg"],"coversType":0,"blurImage":"","publishedAt":1697341080,"tap":0,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"7782220156098707667|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":null,"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0},{"trueId":"288230376153187748","title":"世卫组织宣布猴痘疫情构成“国际关注的突发公共卫生事件”","author":null,"tags":null,"source":0,"reprintedUrl":"https://m.peopledailyhealth.com/articleDetailShare?articleId=c109a2aa88f6452f9e81c3a706728ce1","type":0,"vShowStyle":0,"mpIsVerified":false,"covers":null,"coversType":0,"blurImage":"","publishedAt":1658586180,"tap":0,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"288230376153187748|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":null,"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0}],"mpName":"人民日报健康客户端","mpIcon":"https://img.hubpd.com/hubpd/9e30480a-9baf-11ec-a5f1-4abf23cf0462.png","mpIntro":"人民日报健康客户端","mpId":"5476377146882583281","mpIsVerified":true},"similar":[{"trueId":"4611686018432286900","title":"3·15晚会曝光外泌体，如何识别“万能药”类骗局？","author":null,"tags":null,"source":0,"type":0,"vShowStyle":0,"mpIcon":"https://img.hubpd.com/hubpd/31d196b7-761f-11ed-a9a9-22962b792b88.jpg","mpName":"大河健康报","mpIsVerified":false,"mpId":"1441151880758618862","covers":["https://img.hubpd.com/hubpd/4a26b05f-2370-11f1-9d5a-721e9fc8121a.png","https://img.hubpd.com/hubpd/4a283d79-2370-11f1-9d5a-721e9fc8121a.png","https://img.hubpd.com/hubpd/4a2830fd-237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