获得1亿美元融资以及FDA快速通道指定后,荣昌生物再次获得FDA批准——启动抗HER2的ADC药物治疗尿路上皮癌的II期临床试验

2020-05-02 MedSci原创 MedSci原创

荣昌生物制药有限公司(RemeGen)宣布,美国食品药品监督管理局(FDA)已批准其新型人源化抗HER2抗体药物偶联物(ADC)RC48(disitamab,vedotin)的研究性新药申请。

荣昌生物制药有限公司(RemeGen)宣布,美国食品药品监督管理局(FDA)已批准其新型人源化抗HER2抗体药物偶联物(ADC)RC48(disitamab vedotin)的研究性新药(IND)申请,以启动其在美国的II期临床试验,用于治疗HER2阳性转移性或不可切除的尿路上皮癌(UC)。

RemeGen此前在2019年美国临床肿瘤学会(ASCO)年会上介绍了RC48在中国的II期临床试验主要数据。数据显示,RC48在HER2阳性UC癌症患者中具有显着的抗肿瘤活性,使其成为疾病状态下针对HER2阳性UC患者的第一种潜在靶向生物疗法。该领域近20年没有新疗法。

RemeGen的博士、创始人和首席执行官房建民表示:"据估计,2020年美国新诊断的尿路上皮癌病例达81400例。获得FDA的批准,我们距离为这种毁灭性疾病提供一种新颖的治疗选择又迈进了一步。"

UC是最常见的膀胱癌类型,是全球第九大最常见的癌症和美国第四大最常见的癌症。

RC48在美国第一个试验的IND审批是紧随RemeGen最近完成的1亿美元融资之后,由礼来亚洲风险投资公司和蓝湖资本牵头。

原始出处:

https://www.firstwordpharma.com/node/1719856?tsid=4

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    2020-11-28 bugit
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  5. 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  6. 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  7. 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    2020-05-04 zhao4618
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    2020-05-02 CHANGE

    又是钱!医学需要投资呀,赞!

    0

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研发出IPI-549的Infinity药品公司正在与百时美施贵宝合作开展II期试验MARIO-275,这是一项全球多中心随机对照试验,评估IPI-549联合纳武单抗用于晚期尿路上皮癌的有效性和安全性,

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2020年4月9日,百济神州自主研发的PD-1单抗替雷利珠单抗(百泽安?)正式获得国家药品监督管理局(NMPA)批准,用于既往接受过治疗的局部晚期或转移性尿路上皮癌患者。至此,替雷利珠单抗成为首个在国

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