{"errCode":0,"errMsg":"success","timeStamp":"1778319725","data":{"trueId":"5476377146884814572","title":"这些1类创新药已进入审批审评，大部分为肿瘤新药","author":[],"tags":[],"detail":"\u003cp\u003e进入2023年下半年，据人民日报健康客户端不完全统计，还有23款2022年12月31日前申报上市的国产1类新药，在审批审评的路上，或有望迎来收获期，其中包括PD-L1单抗、GFR抑制剂、CAR-T疗法等多种类型药物。\u003c/p\u003e\u003cp\u003e \u003c/p\u003e\u003cp\u003e就适应症而言，仍以涵盖非小细胞肺癌、多发性骨髓瘤、鼻咽癌等肿瘤适应症为主，包括倍而达的甲磺酸瑞泽替尼胶囊、银珠医药的羧胺三唑软胶囊、奥赛康的ASK120067片、科伦药业的泰特利单抗注射液、李氏大药厂的首克注利单抗注射液胶襄等多款产品。\u003c/p\u003e\u003cp\u003e \u003c/p\u003e\u003cp\u003e“在2015年药品审批制度改革以前，新药上市申请大约需要28个月的时间。2017年10月两办发文《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》发布后，新药上市申请的优先品种审评审批时间平均12-14个月，相比以往缩短了近一半，这对患者的健康和我国医药产业的良性发展而言都有重要的意义。”清华大学医学院研究员陈晓媛研究员接受人民健康采访时表示。\u003c/p\u003e\u003cp\u003e \u003c/p\u003e\u003cp\u003e\u003cimg data-type=\"image_card\" src=\"https://img.hubpd.com/hubpd/spider/full/e4a8fc2b3743a0439a7ee94590c37e0c08b38f1e.jpg\"/\u003e\u003c/p\u003e\u003cp\u003e \u003c/p\u003e\u003cp\u003e从审批审评速度来看，其中，石药集团的纳乐舒单抗注射液、鞍石生物的伯瑞替尼肠溶胶囊、科济药业的泽沃基奥仑赛、合源生物的赫基仑赛注射液、爱科百发的齐瑞索韦肠溶胶囊、传奇生物的西达基奥仑赛等6款创新药已被纳入优先审评，审评速度有望加快。\u003c/p\u003e\u003cp\u003e \u003c/p\u003e\u003cp\u003e从受理时间来看，百奥泰的巴替非班注射液、倍而达药业的甲磺酸瑞泽替尼胶囊、银珠医药的羧胺三唑软胶囊等9个1类新药是2022年之前申报上市，其余14个的上市申请是2022年获得受理。\u003c/p\u003e\u003cp\u003e \u003c/p\u003e\u003cp\u003e从创新性来看，在这些上市申请的品种中，科济药业的泽沃基奥仑赛、传奇生物的西达基奥仑赛都是靶向BCMA的CAR-T疗法。京新药业的治疗失眠的新型小分子药物安达西尼胶囊于去年4月申报上市，该药有望成为催眠镇静药物蓝海市场十五年来首款新药。\u003c/p\u003e\u003cp\u003e \u003c/p\u003e\u003cp\u003e \u003c/p\u003e\u003cp\u003e“从制药大国到制药强国跨越、从以仿制药为主向创新药引领跨越、从高速增长向高质量发展跨越、从工业时代监管向信息时代监管跨越的伟大进程中，创新、转型与超越是我们这个时代药品监管最鲜明的特征。强化基础研究及成果转化、关注国际生物医药研究前沿热点、营造政产学研全链条原始创新研发环境、完善我国药物创新体系定位和布局、引导差异化创新，是加强我国新药研发原始创新、推动我国创新引领医药行业高质量发展的重要保障。”上海医药集团新药注册与临床研发部注册副总监王海燕在接受人民日报健康客户端采访时表示。\u003c/p\u003e\u003cp\u003e \u003c/p\u003e\u003cp\u003e责编：齐钰\u003c/p\u003e\u003cp\u003e校对：毛圆圆\u003c/p\u003e","createdAt":1688976417,"updatedAt":1688976420,"source":0,"reprintedUrl":"https://m.peopledailyhealth.com/articleDetailShare?articleId=b2b7ec64187d4595988c3cf56e4f33df","type":0,"vShowStyle":0,"transCodingObjKey":"https://img.hubpd.com/hubpd/64abbc238a569e00011eed8b","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/e4a8fc2b3743a0439a7ee94590c37e0c08b38f1e.jpg"],"coversType":0,"blurImage":"","publishedAt":1688977680,"classificationName":"农林牧副渔","tap":105,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"5476377146884814572|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":[],"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0},"hisHots":{"hotData":[{"trueId":"8070450532250300152","title":"东阳光药丙肝1类新药英强布韦上市申请获受理","author":null,"tags":null,"source":0,"reprintedUrl":"https://m.peopledailyhealth.com/articleDetailShare?articleId=1d857cea3a2d4d54ba7be1dc86923304","type":0,"vShowStyle":0,"mpIsVerified":false,"covers":["https://img.hubpd.com/hubpd/spider/full/e6e1d3c2fba871e4ea2db2d6f536413e5aa2681e.jpg"],"coversType":0,"blurImage":"","publishedAt":1692068460,"tap":0,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"8070450532250300152|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":null,"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0},{"trueId":"1441151880760026901","title":"中疾控：猴痘已在全球70多个国家和地区传播","author":null,"tags":null,"source":0,"reprintedUrl":"https://m.peopledailyhealth.com/articleDetailShare?articleId=40246b09046048f1aa84fc7e6e565a0c","type":0,"vShowStyle":0,"mpIsVerified":false,"covers":["https://img.hubpd.com/hubpd/spider/full/5b7da3a2b61c5446cb7d116d4397949fceea3fbe.jpg"],"coversType":0,"blurImage":"","publishedAt":1660120500,"tap":0,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"1441151880760026901|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":null,"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0},{"trueId":"4899916394581485044","title":"打破国外垄断，首个国产二尖瓣介入器械获批上市","author":null,"tags":null,"source":0,"reprintedUrl":"https://m.peopledailyhealth.com/articleDetailShare?articleId=9acabced52884fefb2a2472a0cd6b4af","type":0,"vShowStyle":0,"mpIsVerified":false,"covers":["https://img.hubpd.com/hubpd/spider/full/2ecdd047a3d32d071bf840e0ee1e2fa1c2048ef2.jpg"],"coversType":0,"blurImage":"","publishedAt":1694215320,"tap":0,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"4899916394581485044|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":null,"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0},{"trueId":"7205759403793885130","title":"陈晓红委员：加快构建智慧化养老照护服务新体系","author":null,"tags":null,"source":0,"reprintedUrl":"https://m.peopledailyhealth.com/articleDetailShare?articleId=b5a8e4cf636c4e2b8e7cc4f953121e3a","type":0,"vShowStyle":0,"mpIsVerified":false,"covers":["https://img.hubpd.com/hubpd/spider/full/9e183e2805d0d9bb74154d4533a23af255d28980.jpg"],"coversType":0,"blurImage":"","publishedAt":1646373360,"tap":0,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"7205759403793885130|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":"7493989779949665552","title":"贝泽昔替尼片等3款创新药获批上市","author":null,"tags":null,"source":0,"reprintedUrl":"https://www.cnpharm.com/c/2026-05-06/1096627.shtml","type":0,"vShowStyle":0,"mpIcon":"https://img.hubpd.com/hubpd/ad28ec10-c530-11ec-be45-ce7461699b21.png","mpName":"中国医药报","mpIsVerified":false,"mpId":"60209","covers":null,"coversType":0,"blurImage":"","publishedAt":1778035920,"tap":0,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"7493989779949665552|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":null,"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0},{"trueId":"7782220156101115247","title":"中华人民共和国国民经济和社会发展第十五个五年规划纲要","author":null,"tags":null,"source":0,"reprintedUrl":"http://paper.people.com.cn/rmrb/pc/content/202603/14/content_30145216.html","type":0,"vShowStyle":0,"mpIcon":"https://img.hubpd.com/hubpd/4b733bd8-b9a5-11ed-8d88-763443d37210.png","mpName":"人民日报","mpIsVerified":false,"mpId":"576460752303423721","covers":null,"coversType":0,"blurImage":"","publishedAt":1773417600,"tap":0,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"7782220156101115247|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":null,"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0},{"trueId":"3458764513825583623","title":"临床急需境外药品审评优化的法治实践","author":null,"tags":null,"source":0,"reprintedUrl":"http://bk.cnpharm.com/zgyyb/2026/03/24/324087.html","type":0,"vShowStyle":0,"mpIcon":"https://img.hubpd.com/hubpd/ad28ec10-c530-11ec-be45-ce7461699b21.png","mpName":"中国医药报","mpIsVerified":false,"mpId":"60209","covers":null,"coversType":0,"blurImage":"","publishedAt":1774281600,"tap":0,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"3458764513825583623|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":null,"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0},{"trueId":"864691128460207273","title":"【“十五五”发展局长谈】织密安全防护网 激活创新动力源","author":null,"tags":null,"source":0,"reprintedUrl":"http://bk.cnpharm.com/zgyyb/2026/03/28/324166.html","type":0,"vShowStyle":0,"mpIcon":"https://img.hubpd.com/hubpd/ad28ec10-c530-11ec-be45-ce7461699b21.png","mpName":"中国医药报","mpIsVerified":false,"mpId":"60209","covers":null,"coversType":0,"blurImage":"","publishedAt":1774627200,"tap":0,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"864691128460207273|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":null,"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0}]}