中国的Ascletis没有干扰素HCV候选药报告积极临时PhII

StephenW

China's Ascletis reports positive interim PhII on interferon-free HCV candidate
by EJ Lane | Jun 22, 2016 6:40am


Positive data from a Phase II EVEREST combination study of danoprevir (ASC08A) and ravidasvir (ASC16) keeps Hangzhou-based biotech Ascletis Pharmaceuticals in hot contention to get the first modern hepatitis C (HCV) therapy approved in China.

The company said in a press release that interim data presented at the Asian Pacific Association for the Study of the Liver Single Topic Conference in HCV showed the Taiwan leg of the trial produced a 100% virologic response rate following 12 weeks of treatment.

According to Ascletis, the interim data presented of the virologic response of 38 Chinese HCV genotype 1 noncirrhotic patients is expected to show the primary endpoint was met when it releases the full results in September.

The focus in China for chronic hepatitis C is genotype 1b as nearly two-thirds of the 30 million estimated cases fall in that category.

The race to get China FDA approval for an interferon-free HCV therapy sees Gilead Sciences ($GILD) awaiting review completion even as the company negotiates with the government on a possible price. Johnson & Johnson ($JNJ) and Bristol-Myers Squibb ($BMY) are also on the pathway to bring direct-acting antivirals to approval in China.

But as a domestic firm, Ascletis has a leg up on the candidate--which was in-licensed from Roche ($RHHBY) in 2013--in a regulatory pathway it won in April that awards local manufacture and expedites China FDA approvals for domestic firms.

"I'm very glad that we received the priority review from CFDA and positive Phase II data for our IFN-free regimen," Jinzi Wu, founder, president and CEO of Ascletis said in a statement. "Ascletis is taking both triple and IFN-free regimens to market and providing quality and affordable treatment for Chinese HCV patients."

China's standard of care for HCV is a 48-week regimen of peginterferon with ribavirin, which sees many patients head abroad for front-line therapies.

Among funding sources, Ascletis raised $20 million from Goldman Sachs ($GS) in December of last year, building on $35 million in an earlier funding round led by C-Bridge Capital, with Tasly Pharma and Singapore-based Pavilion Capital offering support.

Ascletis also has candidates for the treatment of liver cancer licensed from Alnylam Pharmaceuticals ($ALNY) and Johnson & Johnson unit Janssen, ASC09, aimed at HIV.

- here's the release

StephenW

中国的Ascletis自由干扰素HCV候选人报告的积极临时PhII
由EJ巷| 2016年6月22日早上6:40

中国的Ascletis没有干扰素HCV候选药报告的积极临时PhII
从danoprevir（ASC08A）和ravidasvir（ASC16）的第二阶段EVEREST联合研究正数据可使总部位于杭州的生物技术制药Ascletis在炎热的竞争获得批准的中国第一个现代化的丙型肝炎（HCV）疗法。

该公司在一份新闻稿中说，在亚太协会肝癌单一主题会议，在HCV的研究提出的临时数据显示，在审判台站产生以下治疗12周100％的病毒学应答率。

据Ascletis，提出了中国38 HCV基因型1肝硬化的患者病毒学应答的临时数据预计将显示主要终点时，它释放在九月的全部结果被满足。

慢性丙型肝炎在中国的重点是基因1b型为3000万估计病例近三分之二落入这一类。

比赛获得中国FDA批准的无干扰素治疗丙肝看到Gilead Sciences公司（GILD $），即使该公司与政府协商就可能的价格等待审核完成。强生公司（JNJ $）和施贵宝（BMY $）也都在通路带来直接作用抗病毒药物在中国的批准。

但作为一个国内公司，Ascletis对候选人一条腿 - 这是许可在2013年从罗氏（RHHBY $） - 在调控途径它4月荣获​​大奖的当地制造和加快中国FDA批准为国内公司。

“我很高兴，我们收到了CFDA优先审查和第二阶段的积极数据，我们免费IFN-方案，”妗子吴Ascletis的创始人，总裁兼首席执行官在一份声明中说。 “Ascletis正在采取两种三联和免费IFN-方案推向市场，并为中国的HCV患者的品质和实惠的治疗。”

中国的护理标准HCV是聚乙二醇干扰素与利巴韦林，看到很多病人前往国外一线治疗的48周方案。

在资金来源，Ascletis在去年12月提出的从高盛（$ GS）2000万$，在较早的资金由C-桥资本圆头LED基础上亿$ 35与天士力制药和新加坡馆资本提供支持。

Ascletis也有肝癌从Alnylam制药（$ ALNY）和强生公司单位扬森，ASC09，针对HIV许可的治疗候选人。

- 这里的释放