Ascletis获得$ 20M高盛在比赛中中国HCV批准

StephenW

1. Ascletis gets $20M from Goldman in race to China HCV approval
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Hangzhou-based biotech Ascletis Pharmaceuticals has raised $20 million in funding from Goldman Sachs ($GS), gearing up as it looks to win pole position in the China hepatitis C treatment market and possibly tap the capital markets.

In September, the company raised $35 million in a funding round led by C-Bridge Capital, with Tasly Pharma and Singapore-based Pavilion Capital also in the round to fund pipeline expansion, global regulatory filings and GMP-certified manufacturing.

The latest funds from Goldman, according to a press release, would also help the company build R&D efforts for a company founded in 2011 with $100 million in startup capital and now with four in-licensed candidates, covering oncology and infectious diseases.
Ascletis CEO Jinzi Wu

"2015 is an important year in the history of Ascletis, as we continue to deliver results in the HCV field, and move forward with the construction of our manufacturing facility," Jinzi Wu, founder, president and CEO, said in a statement.

"In the future, we will continue to develop our existing products and explore new opportunities with domestic and global partners through a flexible, open and innovative business model, with the aim of effectively delivering new products to China and the rest of the world."

In September, Ascletis won approval to begin a Phase II trial of danoprevir (ASC08) in Taiwan in combination with danoprevir, ASC16 (PPI-668), for an interferon-free HCV treatment. That followed a June clinical trial application in Taiwan following the completion of a successful interferon-containing Phase II trial with ASC08. Danoprevir was licensed for China rights from Roche ($RHHBY) (which halted work in 2013) and ASC16 licensed from Presidio Pharmaceuticals.

The Phase II trial started in September, while a clinical trial application rests with China FDA, marking it as the first Chinese company to seek a clinical trial in-country for an interferon-free HCV treatment.

Pricing for the HCV treatment, if approved, in China is in sharp focus as Gilead ($GILD) is still working with Chinese regulators on approval for HCV treatment Sovaldi and is in talks separately with China on possible pricing, the company recently told FiercePharmaAsia.

Ascletis hopes to start a Phase III trial of ASC08 in 2016 in China with marketing as early as 2017, with ASC16 slated by 2018.

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

China has recently eased multiregional clinical trial hurdles as part of an effort to clear nearly 20,000 medicine approval requests pending and allowing more innovative therapies to reach the market, according to a briefing by the country's State Council.

That may benefit Ascletis with trials in both Taiwan and mainland China for HCV and which has candidates for the treatment of liver cancer licensed from Alnylam Pharmaceuticals ($ALNY) as well as licensed from Johnson & Johnson ($JNJ) unit Janssen, ASC09, aimed at HIV.

- here's the release

StephenW

1. Ascletis获得$ 20M高盛在比赛中中国HCV批准
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杭州的生物技术Ascletis制药已募集$ 2000万美元的资金从高盛（$ GS），摩拳擦掌，因为它看起来赢得杆位在中国丙型肝炎治疗市场，并有可能挖掘资本市场。

在9月，公司的资金由C-桥资本全面带动培养了$ 3500万与天士力制药和新加坡的阁资本也全面资助管道扩展，全球监管机构备案，并GMP认证的生产。

高盛最新的基金，根据一份新闻稿中，也将有助于为成立于2011年$ 1亿美元的启动资金，现在有四个在授权的候选人，涵盖肿瘤学和传染病一家公司共建研发力度。
Ascletis CEO金子武

“2015年是Ascletis历史上重要的一年，随着我们不断取得成果，在HCV领域，向前迈进，我们的生产设施的建设，”金子吴，创始人，总裁兼首席执行官，在一份声明中说。

“在未来，我们将继续发展我们现有的产品，并通过一个灵活，开放，创新的商业模式探索与国内和全球合作伙伴的新机遇，以有效地提供新产品，以中国和世界其他地区的目标。”

九月，Ascletis获得了批准，开始的danoprevir（ASC08）在台湾II期临床试验，结合danoprevir，ASC16（PPI-668），对于干扰素无丙肝治疗。随后在台湾六月份的临床试验申请完成一个成功的含干扰素II期临床试验用ASC08之后。 Danoprevir被授权中国从罗氏（$ RHHBY）（它在2013年停止工作）的权利和ASC16距离Presidio制药许可。

第二阶段试验的9月份开始，而临床试验应用在于与中国的FDA，这标志着它作为第一家中国公司，寻求临床试验在国内的干扰素无丙肝治疗。

定价为HCV治疗，如获批准，在中国形成了鲜明的重点，因为吉利德（$ GILD）还在洽谈中分别就可能的价格正与中国监管机构的批准丙肝治疗Sovaldi，并与中国，该公司最近告诉FiercePharmaAsia。

Ascletis希望开始一个III期临床试验ASC08 2016年在中国市场，早在2017年，有ASC16到2018年预计。

慢性丙型肝炎在中国的重点是基因1b型，专家说，有近三分之二的该类别3000万估计病例。

中国最近放宽多区域临床试验的障碍作为努力清除等待，并允许更多的创新疗法，以达到市场的近2万名医药审批申请的一部分，据介绍该国的国务院。

这可能有利于Ascletis与丙型肝炎病毒在台湾和中国大陆的审判，并且具有候选肝癌的治疗从Alnylam制药（$ ALNY）许可，以及来自强生公司（$ JNJ）单位扬森，ASC09授权的，旨在感染艾滋病毒。