零突破：中国创新药Zanubrutinib迈入FDA大门！

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Time of issue:2019-11-26 16:13
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零突破：中国创新药Zanubrutinib迈入FDA大门！

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Categories:最新消息
Author:
Origin:
Time of issue:2019-11-26 16:13
Views:

Information

2019年11月14日（美国时间），美国食品药品监督管理局（FDA）正式批准了Zanubrutinib（英文商品名：BRUKINSA™），用于治疗既往接受过至少一项疗法的成年套细胞淋巴瘤（MCL）患者。

南京华讯知识产权顾问有限公司

Zanubrutinib是百济神州公司自主研发的一款口服BTK小分子抑制剂，它的特点在于最大化对BTK靶点的特异性结合，从而最大程度减小脱靶效应而带来的毒副作用。多项基础研究表明布鲁顿酪氨酸蛋白激酶（Bruton’s tyrosine kinase，BTK）对恶性B细胞的生存及发展中起着重要作用，如果能够抑制BTK的活性，就可以杀死很多B细胞淋巴癌细胞进而让患者获益。在治疗多种B细胞癌症的临床试验中，Zanubrutinib都显示出良好的疗效和安全性，具备成为“best-in-class”药物的潜力。它还是首个获得FDA四大特殊通道资格认定的中国自主研发抗癌新药，实力可见一斑。

南京华讯知识产权顾问有限公司

专利方面，百济神州于2014年递交了Zanubrutinib的化合物专利申请并于2017年获得授权。该专利为CN104884458B，拥有多个国家和地区的多项授权或在审中同族专利，具体如下：

申请号	标题	申请日
AU2014256633	Fused heterocyclic compounds as protein kinase inhibitors	2014-04-22
BR112015025260	COMPOSTOS HETEROCÍCLICOS FUNDIDOS COMO INIBIDORES DA PROTEÍNA QUINASE	2014-04-22
CA2902686	Fused heterocyclic compounds as protein kinase inhibitors	2014-04-22
CN201480003692.3	作为蛋白质激酶抑制剂的稠合杂环化合物	2014-04-22
CY20171100310T	ΣΥΓΧΩΝΕΥΜΕΝΕΣ ΕΤΕΡΟΚΥΚΛΙΚΕΣ ΕΝΩΣΕΙΣ ΩΣ ΑΝΑΣΤΟΛΕΙΣ ΠΡΩΤΕΪΝΙΚΗΣ ΚΙΝΑΣΗΣ	2017-03-10
DK2014787642T	KONDENSEREDE HETEROCYKLISKE FORBINDELSER SOM PROTEINKINASEHÆMMERE	2014-04-22
EA201591908	Fused heterocyclic compounds as protein kinase inhibitors	2014-04-22
EP2014787642	Fused heterocyclic compounds as protein kinase inhibitors	2014-04-22
ES2014787642T	Compuestos heterocíclicos fusionados como inhibidores de proteína cinasa	2014-04-22
HK16110324	作為蛋白激酶抑制劑的稠合雜環化合物	2016-08-31
HRP20170217T	FUZINIRANI HETEROCIKLIČKI SPOJEVI KAO INHIBITORI PROTEIN KINAZE	2017-02-09
HUE14787642	Kondenzált heterociklusos vegyületek protein-kináz inhibitorként	2014-04-22
JP2016509281	タンパク質キナーゼ阻害剤としての縮合複素環化合物	2014-04-22
KR1020157030395	발명의명칭단백질키나제억제제로서의융합된헤테로시클릭화합물	2014-04-22
LT14787642T	KONDENSUOTI HETEROCIKLINIAI JUNGINIAI KAIP BALTYMŲ KINAZĖS INHIBITORIAI	2014-04-22
MX2015013481	Fused heterocyclic compounds as protein kinase inhibitors.	2014-04-22
NZ711540	Fused heterocyclic compounds as protein kinase inhibitors	2014-04-22
PL2014787642T	POŁĄCZONE ZWIĄZKI HETEROCYKLICZNE JAKO INHIBITORY KINAZY BIAŁKOWEJ	2014-04-22
PT2014787642T	COMPOSTOS HETEROCÍCLICOS FUNDIDOS COMO INIBIDORES DA PROTEÍNA QUINASE	2014-04-22
RS20170260	Fused heterocyclic compounds as protein kinase inhibitors	2014-04-22
SG11201506764W	Fused heterocyclic compounds as protein kinase inhibitors	2014-04-22
SI201430148	Fused heterocyclic compounds as protein kinase inhibitors	2014-04-22
US15/969864	SUBSTITUTED PYRAZOLO[1,5-a]PYRIMIDINES AS BRUTON'S TYROSINE KINASE MODULATORS	2018-05-03
US14/951494	Substituted imidazo[1,2-b]pyrazoles as bruton'S tyrosine kinase modulators	2015-11-25
US14/723417	Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators	2015-05-27
US15/359871	Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators	2016-11-23
PCT/CN2014/075943	Fused heterocyclic compounds as protein kinase inhibitors	2014-04-22
ZA201508504	Fused heterocyclic compounds as protein kinase inhibitors	2015-11-18

淋巴瘤是一组起源于淋巴造血系统的恶性肿瘤的统称，是全球范围内发病率增速最快的恶性肿瘤之一。在目前已知的淋巴瘤70多个亚型中，套细胞淋巴瘤（MCL）起源于“套区”的B细胞，侵袭性较强，预后很差，中位生存期仅为3至4年。据统计，全球套细胞淋巴瘤新发病例超过3.5万例，中国约超过6000例。多数套细胞淋巴瘤患者在确诊时已处于疾病晚期，面临着治疗手段有限、预后不良的困境。

基于Zanubrutinib在两项套细胞淋巴瘤临床试验中的有效性数据，美国FDA作出了此项批准。在Zanubrutinib用于治疗复发/难治性MCL患者的多中心II期临床试验BGB-3111-206（clinicaltrials.gov登记号：NCT03206970）中，总缓解率（完全缓解和部分缓解综合；ORR）为84%，包括59%的完全缓解（CR）以及24%的部分缓解，此项试验的中位持续缓解时间（DOR）为19.5个月，中位随访时间为18.4个月。在全球I/II期临床试验BGB-3111-AU-003（clinicaltrials.gov登记号：NCT02343120）中，ORR为84%，包括22%的完全缓解以及62%的部分缓解，此项试验的中位DOR为18.5个月，中位随访时间为18.8个月。

就中国市场而言，2018年8月和10月，百济神州分别向国家药品监督管理局（NMPA）提交了Zanubrutinib治疗复发/难治套细胞淋巴瘤（MCL）和慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）的上市申请。这两项申请都被药品审评中心（CDE）纳入了优先审评通道，相信很快也会获批。届时它将造福更多国内外套细胞淋巴瘤患者，带来治疗的新希望。另外，Zanubrutinib还在多项临床试验中，作为单药或组合疗法，治疗多种类型的B细胞血液癌症。我们期待它在未来还能有更多斩获，为更多患者造福。

据路透社报道，百济神州15号对外公布了抗癌药Zanubrutinib在美国的定价，具体价格为，一个为期30天的疗程需花费12935美元，约合人民币90642元。一家美国投资银行预计，Zanubrutinib未来的销售额有望达到8.36亿美元，约合人民币58.58亿元，针对套细胞淋巴瘤的药物销售额将达到9000万美元，约合人民币6.31亿元。路透社指出，借助新药Zanubrutinib，中国药企百济神州将与强生、艾伯维、阿斯利康等多家国际制药企业的相关产品展开竞争。

从曾经的仿制药大国，到如今首款本土原研抗癌药Zanubrutinib迈入FDA大门获批上市，是中国医药行业从“中国制造”到“中国智造”的华丽转身。这是中国创新药在走向全球的进程中迈出的重大一步，实现中国原研新药出海“零突破”。在中国创新药企走向世界的进程中，百济神州留给历史的会是浓墨重彩的一笔。未来世界医药市场格局中，中国的创新药企将会拥有更大的话语权。

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