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合全药业与TESARO公司签署全球商业化供应协议

2017-07-25 佚名 MedSci原创

上海2017年7月24日电 /美通社/ -- 药明康德集团企业合全药业,一家全球领先的小分子工艺研发和生产平台,今日宣布与专注于肿瘤学的TESARO生物医药公司签署了一份关于ZEJULA™ (niraparib)的原料和中间体的供应协议。

根据双方签署的5年协议,合全药业将会为TESARO最新产品ZEJULA提供原料和中间体的商业化供应。ZEJULA是一种口服活性强的多聚(ADP-核糖)聚合酶(PARP)抑制剂。该药于2017年3月27日被美国食品和药物管理局(FDA)批准用于对铂类化疗完全或部分反应的复发性上皮性卵巢癌、输卵管或原发性腹膜癌的成年患者的维持治疗。该产品现已在美国患者中投入使用。此次协议是合全药业与TESARO公司多年以来在新药研发和生产领域形成的合作伙伴关系的成功延伸。此前合全药业成功协助TESARO加快新药申请的提交,并促成该产品得到美国FDA的最终批准。

ZEJULA是目前市场上唯一一款无论患者BRCA突变或生物标志物状态如何,都能在临床上显著延长复发性卵巢癌患者的无进展生存期的PARP抑制剂。它的疗效已经在3期临床试验中得到了证明。

“我们与TESARO公司已经合作多年,ZEJULA是一款对患者至关重要的新药,我们很荣幸能够成为ZEJULA的全球供应商,”合全药业首席执行官陈民章博士表示。“依托我们先进的研发和生产平台,合全药业一直致力于推动合作伙伴的创新药研发和商业化,造福全球病患。我们与TESARO的合作非常成功,期待未来与TESARO团队更紧密合作,加快其新药研发和商业化进程。”

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    2017-07-27 yeaweam
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