Nature发布CDE团队文章:中国创新药的发展趋势

2022-05-06 写意君 编译 同写意

过去十年间,由于监管改革以及政策变化,中国创新药的临床开发和监管审查过程发生了巨大的变化。这些改革以及新政策出台旨在鼓励创新药的开发,特别是针对罕见、严重或危及生命的疾病,确保相应患者能及时获得药物治

图片

过去十年间,由于监管改革以及政策变化,中国创新药的临床开发和监管审查过程发生了巨大的变化。这些改革以及新政策出台旨在鼓励创新药的开发,特别是针对罕见、严重或危及生命的疾病,确保相应患者能及时获得药物治疗。

近日,为了评估这些改革措施以及政策对中国创新药物发展的影响,北京大学临床药理研究所所长崔一民博士联合国家药品监督管理局药品审评中心副主任王涛以及相关研究人员,对2010-2020年间中国获批的研究性新药(IND)申请数据和新药申请(NDA)数据进行了详细分析。

分析表明,中国创新药审批监管改革显著缩短了IND 和 NDA 审批时间,促进了中国创新药物的发展,近十年来首次IND申请数量急剧增加,获批的NDA数量也在稳步增长。

1 首次IND申请数量急剧增加

统计,2010年至2020年间,国家药品监督管理局(NMPA)一共收到了1636个创新药首次IND申请,首次IND申请数量从2010年的29个增长到了2020年的428个,年均复合增长率高达32%。

值得注意的是,1636个创新药首次IND申请中有1410种(86%)药品来自中国本地的689家制药企业。其中2017年创新药首次IND申请数量增长最为明显,较2016年增长了78%,化药和生物药分别增长 60% 和 159%。

在 1466 份已完成的首次 IND 审查中,有 1404 份(96%)获得批准,62份(4%)被拒绝。拒绝的原因主要包括,申请后缺乏研究信息导致沟通不畅、药物临床获益风险比不合理、违反临床诊断基本原则等。

其中,首次获批IND的创新药数量从2010年的19个快速增长至2020年的393个,年均复合增长率达35%。得益于2015年7月开始的一系列中国监管改革,2016年获批首次IND 的创新药数量显着增加,由2015年的74个增长到了2016年了142个,有效缓解了申请积压,鼓励了医药创新。

 

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 2010-2020中国创新药IND趋势

2 获批创新药NDA数量较少,但整体稳步增长

2010年至2020年NMPA一共收到了101个创新药的NDA申请,其中58个创新药获得批准。近年来,提交和获批的 NDA 数量正在稳步增长。尤其是 2015 年 7 月以来,一共有 42 个(72%)创新药NDA获得批准。

在已完成的 66 个创新药首次 NDA 审查中,58 个(88%)获得批准。拒绝的主要原因是药物或临床研究设计存在重大缺陷、不同开发阶段使用的研究样本不一致以及检查中发现的临床试验数据不真实。

目前已获批的58个创新药中,37个是NMPA批准的新分子实体(NMEs),21个是已经在国外批准或上市的药物,包括传统的疫苗、血液制品、细胞因子等。补充表 1)。同时,58个已获批创新药中,有14 种(24%)是孤儿药,其中 13 种符合美国 FDA 标准的孤儿药资格。

此外,有40 个创新药(69%)获得优先审评,其中 35 个(88%)在 2015 年 7 月之后获得批准。这些数据表明,监管改革措施,尤其是2015 年 8 月推出的优先审查措施鼓励了创新药物的研发。

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2010-2020中国创新药NDA趋势

3 肿瘤治疗是创新药物的主要领域,大部分处于早期开发阶段

通过对首次IND申请获批的创新药进行分析发现,首次 IND 申请获批的创新药物主要治疗领域集中在肿瘤(864个, 62%)感染(166个, 12%)、内分泌疾病(72个, 5%)和心血管疾病(60个, 4%)。其中,2016 年首次 IND 申请获批的肿瘤药物数量显着增加,较2015年增长了133%。

在首次 IND 申请获批的1404个创新药中,至少有 705 个(50%)达到了 I 期,同时分别有 286 个(20%)和 108 个(8%)药物达到了 II 期和 III 期。不过,大多数抗癌药物(57%)尚未超过 I 期。

总体而言中国主要仍旧处于快速跟进和渐进式创新阶段,58个获批NDA的创新药中只有3个是“first in class”,分别是:

冠昊生物控股子公司广州中昊药业有限公司开发的本维莫德(benvitimod),2019年5月在中国通过过优先审评审批程序上市,用于局部治疗成人轻至中度稳定性寻常型银屑病;

中国海洋大学、中国科学院上海药物研究所与上海绿谷制药有限公司研发的甘露特钠胶囊,其活性成分为甘露寡糖二酸(sodium oligomannurarate),2019年11月2日,国家药品监督管理局官网发布消息,甘露特钠获批上市,用于轻度至中度阿尔茨海默病,改善患者认知功能;

珐博进(FibroGen)首创的HIF-PH抑制剂roxadustat(罗沙司他),2018年12月roxadustat率先在中国获得批准,用于透析依赖型慢性肾脏病(DD-CKD)成人患者贫血治疗。2019年8月,该药在中国获批新适应症,用于非透析依赖性慢性肾病(NDD-CKD)成人患者贫血治疗。

相比之下,靶向 EGFR、PDL1 和 HER2 的“me too”药物有 40 多种,其中靶向 EGFR 的获批药物数量最多,其中由4个药物已上市,64个药物进入了临床试验阶段。这些集中的靶点和适应症相同的药物,未来可能会显著降低新药创新效率。

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2010-2020中国获批IND创新药治疗领域、作用靶点以及临床阶段分布

4 IND 和 NDA 批准的速度增加了,但临床试验的速度没有增加

据统计,自2015年7月一系列改革措施出台后至2020年12月,NMPA的IND审批时间比改革前(2010年1月至2015年6月)缩短414天(87天 VS 501天) 。同样地,改革后药品的 NDA 审批时间也比改革前缩短了 441 天(483 天 VS 924 天)

2018 年 7 月,NMPA 将启动药物临床试验的审批程序调整为默示许可制度。就整个临床试验阶段的长度(2,572 天 VS 2,688 天)而言,两个研究阶段的差异并不显着。然而在改革后,首次IND申请获批直至第一个参与者入组的临床试验开始时间反而比改革前长了 59 天(328 天对 269 天)

提高临床试验效率是我国鼓励创新的重要改革方向。然而,受到伦理审查效率、研究者经验和临床试验资源等多重因素的影响,需要对国家临床试验能力进行战略升级来解决。

图片

2015年7月改革前后中国创新药审批时长及临床试验时长对比

总体而言,NMPA自2015年7月以来的一系列监管改革措施促进了中国地方医疗的创新,每年获批的创新药IND申请和NDA申请数量稳步上升,这意味着一系列的改革是有效的。然而,目前,具有相同靶点的多个产品的激烈内卷以及低效的临床试验过程将影响真正有意义的创新药物从 IND 到 NDA 批准的进展。

原始出处:

苏娴, 王海学等 https://www.nature.com/articles/d41573-022-00077-3. 

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    2022-05-17 wjl066452

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    0

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    2022-05-07 ms3000001815106158

    很赞

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1897689, encodeId=b1c4189e689d4, content=<a href='/topic/show?id=892d3e85304' target=_blank style='color:#2F92EE;'>#发展趋势#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37853, encryptionId=892d3e85304, topicName=发展趋势)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c279140, createdName=vividelife, createdTime=Tue May 17 18:59:33 CST 2022, time=2022-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1885760, encodeId=53fa1885e608a, content=<a href='/topic/show?id=3b2112532d8' target=_blank style='color:#2F92EE;'>#Nat#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12532, encryptionId=3b2112532d8, topicName=Nat)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e6f107, createdName=liye789132251, createdTime=Tue Jul 05 05:59:33 CST 2022, time=2022-07-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1220243, encodeId=187f122024332, content=新趋势 , beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3818101931, createdName=wjl066452, createdTime=Tue May 17 10:45:35 CST 2022, time=2022-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1286105, encodeId=f5ce128610520, content=<a href='/topic/show?id=77903209422' target=_blank style='color:#2F92EE;'>#创新#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32094, encryptionId=77903209422, topicName=创新)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512a199, createdName=lilianxiang, createdTime=Sun May 08 07:59:33 CST 2022, time=2022-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1217517, encodeId=522a121e517ab, content=很赞, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bd7a8147527, createdName=ms3000001815106158, createdTime=Sat May 07 07:49:31 CST 2022, time=2022-05-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1217402, encodeId=81dd121e402f4, content=新进展, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8eb45553384, createdName=小松松, createdTime=Fri May 06 18:11:36 CST 2022, time=2022-05-06, status=1, ipAttribution=)]
    2022-05-06 小松松

    新进展

    0

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