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基石药业HDAC6抑制剂CS3003在中国I期临床试验获批

2019-03-13 不详 美通社

基石药业(苏州)有限公司(以下简称“基石药业”,香港联交所代码:2616.HK)宣布,中国国家药品监督管理局(NMPA)近期批准公司选择性靶向组蛋白去乙化酶6(HDAC6)抑制剂CS3003在中国开展首个人体I期临床试验。这是一项在中国和澳洲同步开展的多中心I期剂量爬坡研究,受试者为晚期实体瘤和复发或难治性多发性骨髓瘤的患者。基石药业董事长兼首席执行官江宁军博士表示:“CS3003是基石药业在中国

基石药业(苏州)有限公司(以下简称“基石药业”,香港联交所代码:2616.HK)宣布,中国国家药品监督管理局(NMPA)近期批准公司选择性靶向组蛋白去乙化酶6(HDAC6)抑制剂CS3003在中国开展首个人体I期临床试验。这是一项在中国和澳洲同步开展的多中心I期剂量爬坡研究,受试者为晚期实体瘤和复发或难治性多发性骨髓瘤的患者。


基石药业董事长兼首席执行官江宁军博士表示:“CS3003是基石药业在中国第九个获得临床批件的候选药物。目前国内外尚无同类产品获批,我们认为CS3003有潜力成为全球同类首款HDAC6选择性抑制剂,并且给患者带来一种新的有效治疗选择。”

“HDAC6选择性抑制剂可作为单药治疗也可与常规标准疗法联用,有在多发性骨髓瘤中展示更好的疗效的潜力。临床前研究数据以及同类产品的临床前和早期临床研究还发现,CS3003较广谱HDAC抑制剂可能具备更好的安全性,以及有在不同的适应症中开发与免疫检查点抑制剂联合治疗的潜力。我们会尽快启动CS3003在中国临床试验。”基石药业首席科学官王辛中博士表示。

关于CS3003

CS3003是一种选择性靶向组蛋白去乙化酶6(HDAC6)的小分子抑制剂。主要位于细胞质的HDAC6与其他HDAC家族成员不同,对DNA组蛋白乙酰化几乎没有影响。HDAC6受到抑制后可以增强细胞质的微管蛋白的乙酰化,并且丧失清除未折叠或错误折叠的蛋白质的能力,从而促进细胞的凋亡。HDAC6的选择性抑制在多发性骨髓瘤中产生更好的疗效并且相对于HDAC广谱抑制剂具有改善的安全性。CS3003在实体瘤中还具有与PD-(L)1抗体药物联用的潜力,以扩展免疫检查点抑制剂的临床活性。

关于基石药业

基石药业是一家生物制药公司,专注于开发及商业化创新肿瘤免疫治疗及分子靶向药物,以满足中国和全球癌症治疗的殷切医疗需求。2019年2月26日,基石药业在香港联合交易所有限公司主板上市,股票代码:2616.HK。

自基石药业于2015年底成立以来,已集结了在临床前研究、临床开发以及商业化方面拥有丰富经验的世界级管理团队。通过内部研究及外部合作组成的双重创新来源,公司已建立由14种肿瘤候选药物组成的强大抗肿瘤药物管线,具有单一及联合疗法的重大潜力及协同效益,其中包括从Agios及Blueprint获得的在大中华地区拥有独家许可的四项资产。公司目前的产品组合中有四款处于或接近关键性试验的后期候选药物。基石药业的业务模式专注于临床开发,同时,公司正迅速发展其商业化及生产能力。基石药业获得著名风险投资和私募股权基金破纪录的股本投资金额,A、B轮融资共筹集了约4.12亿美元。凭借经验丰富的团队、丰富的管线、强大的临床开发驱动的业务模式和充裕资金,基石药业的愿景是通过为全球癌症患者带来创新差异化肿瘤疗法,成为全球知名领先的中国生物制药公司。

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    2020-02-09 lingaifan
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    2019-08-07 xzw113
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    2019-06-22 jklm09

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