Chinese approval for Ascletis' HCV drug is first homegrown success
Chinese approval for Ascletis' HCV drug is first homegrown success
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DOI：
10.1038/nbt0818-675a
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发表时间：
2018-08
影响因子：
46.9
通讯作者：
Shannon E. Ellis
中科院分区：
文献类型：
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作者：
Shannon E. Ellis
今年6月，Ascletis成为第一家获得批准的中国生物技术公司，其国产新药Ganovo（danoprevir）用于治疗丙型肝炎病毒（HCV）感染。中国重组后的药品监管机构中国国家药品监督管理局（CNDA;原中国食品药品监督管理局）批准了这种抗病毒药物，这种新药现在正与吉利德科学公司的重磅药物索非布韦（sofosbuvir）直接竞争。杭州的Ascletis是中国科学家建立的第一批生物技术之一。吴金子辞去葛兰素史克（GlaxoSmithKline）全球艾滋病药物研发副总裁一职，成立了Ascletis，该公司随后成为首家在2011年由一位当地房地产投资者和其他来自中国和美国的投资者牵头的A轮融资中筹集到1亿美元资金的当地生物技术公司。从那时起，它就引领了当今蓬勃发展的生物技术产业，旨在为中国的医疗保健行业提供新药。Ascletis的领先地位也使其成为第一家在香港证券交易所上市的前收入生物技术公司。36，482，2018）。无论他们能够获得什么样的估值，都将为随后的生物技术行业设定标准。但当阿斯克勒提斯出发时，很难看到他们如何能够成功。当时中国的监管障碍意味着新药需要数年时间才能获得批准。患者可获得的少数创新药物是进口的，通常是在其他地方获得上市许可数年之后。在全球范围内，当时甚至没有直接作用的抗病毒剂（DAA）获得批准。第一种直接作用于HCV的抗病毒药物Sovaldi（sofosbuvir）来自吉利德科学公司，于2013年获得FDA批准。尽管如此，Ascletis还是从总部位于巴塞尔的罗氏公司获得了Ganovo的许可，并指望在主场优势下击败跨国公司。Ascletis已经展示了强大的开发能力，在33个月内，Ganovo完成了三个阶段的临床研究，并通过了工厂的良好生产检查规范（GMP）检查。目前，中国估计有1000万至4000万丙型肝炎病毒感染者的标准治疗是干扰素治疗，与根除该疾病的直接作用剂相比，干扰素治疗效果较差，副作用更多。Ganovo抑制HCV NS 3/4A蛋白酶，这对HCV复制至关重要。在中国大陆进行的一项3期试验中，Ganovo与聚乙二醇化干扰素和利巴韦林联合治疗12周，治愈了97%的基因型1非阿尔茨海默病患者。更多的全球
In June, Ascletis became the first Chinese biotech to get an approval for a new locally produced drug, Ganovo (danoprevir), to treat hepatitis C virus (HCV) infections. China’s revamped drug regulator, the China National Drug Administration (CNDA; formerly the China Food and Drug Administration) greenlit the anti-viral agent, a new drug that is now in direct competition with Gilead Sciences’ blockbuster drug Sovaldi (sofosbuvir). Ascletis of Hangzhou was one of the first biotechs established by a Chinese returnee scientist. Jinzi Wu left his job as vice president of global HIV drug discovery at GlaxoSmithKline to set up Ascletis, which went on to become the first local biotech to raise $100 million in venture A financing in a 2011 round led by a local real-estate investor and others from China and the US. Since then, it has led the way for today’s burgeoning biotech industry aimed at supplying China’s healthcare sector with new medicines. Ascletis’ pole position has also resulted in it becoming the first pre-revenue biotech to list on the Hong Kong Stock Exchange (Nat. Biotechnol. 36, 482, 2018). Whatever valuation they are able to obtain will set the bar for the biotechs that follow. But when Ascletis set out, it was hard to see how they could succeed. Regulatory hurdles inChina at the time meant that new drugs took years to gain approval. The few innovative drugs available to patients were imported, usually several years after having received market authorization elsewhere. Globally, there was not even a direct-acting antiviral agent (DAA) approved at that time. The first direct-acting antiviral for HCV, Sovaldi (sofosbuvir) from Gilead Sciences, gained FDA approval in 2013. Nonetheless, Ascletis licensed Ganovo from Basel-based Roche counting on a home court advantage against their multinational counterparts. Ascletis has demonstrated strong development capability, taking Ganovo through three phases of clinical studies and passing good manufacturing inspections practice (GMP) inspection for their factory, all in 33 months. Currently, the standard of care for China’s estimated 10 to 40 million people living with HCV is interferon treatment, which is less effective and has more side effects than the direct-acting agents that eradicate the disease. Ganovo inhibits HCV NS3/4A protease, which is critical to HCV replication. In a phase 3 trial conducted in mainland China, Ganovo, combined with PEGylated interferon and ribavirin, cured 97% of genotype 1, non-cirrhotic patients treated for 12 weeks. Additional global