Roche与Ascletis在中国合作研发和生产丙肝治疗药物danoprevir

罗氏与歌礼携手为中国患者量身定制创新丙肝药物

瑞士巴塞尔，中国上海-2013年4月15日

罗氏与歌礼生物科技（杭州）有限公司（以下简称“歌礼”）今日联合宣布在中国合作研发和生产罗氏丙肝新药

Danoprevir。

目前中国约有1000万慢性丙肝患者，其中大多数患者的病毒基因为1b型。该基因型的患者被证实对Danoprevier 有很高的应答率。因此，罗氏与歌礼决定联合开发这款新药，将帮助缓解丙肝这一严重的公共卫生问题，并为广大 的中国丙肝患者提供全新的有效治疗方案。

根据合作协议，歌礼将出资并负责创新药物Danoprevir在中国大陆和港澳台地区的开发、注册以及生产工作。罗 氏将根据阶段性成果向歌礼支付药物开发及商业化里程金。双方将在临床开发和商业化运作方面展开合作。合作协 议中还涉及了销售提成费。

谈及该合作，罗氏制药亚太区总裁陆可先生表示：“罗氏战略的出发点就是为患者带来创新性、差异化的药品。罗 氏之所以决定研发Danoprevir这款创新药物，是因为其在治疗丙肝1b型病毒基因患者方面具有光明的前景，而选 择与歌礼携手则是罗氏将此战略付诸行动的又一体现。”

歌礼生物科技（杭州）有限公司总裁兼首席执行官吴劲梓博士表示：“目前中国市场上还没有直接作用于病毒的丙 肝治疗药物（DAAs)。罗氏是丙肝创新药物研发的全球领导者，歌礼非常荣幸能够与罗氏合作，为中国患者量身定 制这一丙肝创新药物，并最终将其推向市场。截至目前，Danoprevir的临床试验数据非常鼓舞人心，我们期待着 这一创新药物尽早让更多的丙肝患者切实受益。”

* 了解更多有关中国丙型肝炎现状和治疗趋势的信息 >>

关于Danoprevir

Danoprevir是罗氏一款蛋白酶抑制剂，对于1型和4型基因型丙肝患者具有显著的疗果。蛋白酶抑制剂已成为未来 丙肝高效治疗药物的核心成分。

关于歌礼生物科技（杭州）有限公司

歌礼生物科技（杭州）有限公司是一家新兴的生物技术公司，致力于癌症和传染性疾病重要新疗法的发现、开发和 商业化。歌礼专注于为发展中的中国制药市场进行创新药物的临床开发和生产。歌礼由富有创业精神的管理层和资 深的科研团队组成，具有为美国和欧洲的大型跨国制药和新兴生物技术公司成功发现并开发药物的经验。如需获得 更多信息，请访问www.ascletis.com（中国以外地区）和www.ascletis.com.cn（中国地区）。

关于罗氏

罗氏总部位于瑞士巴塞尔，在制药和诊断领域是世界领先的以研发为基础，以创新为驱动的健康医疗公司。作为全 球最大的生物技术公司，罗氏在抗肿瘤、抗病毒、炎症、代谢和中枢神经系统领域拥有切实有效的差异化药品；同 时罗氏也是体外诊断和基于组织的肿瘤诊断的市场领导者，以及糖尿病管理领域的先驱者。罗氏倡导的“个体化医 疗”方案旨在提供创新的药品和诊断工具，从而切实改善人类的健康水准、生活质量以及患者的生存期。

2012年，罗氏全球的员工数量已超过82, 000名，研发项目投资超过80亿瑞士法郎，销售额达455亿瑞士法郎。美国的基因泰克公司（Genentech）是罗氏 全资拥有的集团成员之一，此外罗氏也是中外制药株式会社（Chugai）的控股方。

如需更多罗氏集团信息请登陆罗氏全球网站：www.roche.com.

如需获得更多信息，请联系：

歌礼生物科技（杭州）有限公司

总裁兼首席执行官，吴劲梓博士

jinzi.wu@ascletis.com

罗氏合作部

罗氏合作传播部，Emilie Vincent 女士

emilie.vincent@roche.com

罗氏中国

罗氏制药传播部，时莹莹 女士

elle.shi@roche.com

Roche and Ascletis enter collaboration

to advance treatment options for Chinese patients with Hepatitis C

Basel, Switzerland and Shanghai, China – 15 April 2013 

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Ascletis announced today that they have entered into a collaboration to develop and commercialize Roche’s investigational drug danoprevir in China for the treatment of Hepatitis-C Virus (HCV).

It is estimated that over 10 million patients in China are chronically infected with HCV. The majority of these are genotype 1b, which has proven highly responsive to danoprevir. Roche and Ascletis are joining forces to develop a therapy with the potential to address a serious public health problem and to provide an effective new treatment option for Chinese patients with HCV.  

Under the terms of the agreement, Ascletis will fund and be responsible for the development, regulatory affairs and manufacturing of danoprevir in greater China, including Taiwan, Hong Kong and Macau and receive payments upon reaching certain development and commercial milestones from Roche. Ascletis and Roche will collaborate for the clinical development and the commercialization. The contract also involves royalties.  

Commenting on the agreement, Luke Miels, Head of Roche Pharmaceuticals Asia Pacific, said: “Our strategy is based on bringing innovative, differentiated medicines to patients. The decision to develop danoprevir based on its promising profile in HCV Genotype 1b patients, and to do this via a collaboration with our partner Ascletis represents another example of this strategy in action. ”

Jinzi J. Wu, PhD, President and CEO at Ascletis added: “No marketed direct antiviral agents (DAAs) are currently available for hepatitis C in China. Roche is a global leader in the development of innovative Hepatitis C therapies, and we are pleased to be collaborating with Roche to develop and eventually commercialize this much needed medicine for Chinese patients. Furthermore, we are very encouraged by the clinical data that have emerged to date and looking forward to bringing this novel DAA to patients in need. ”

About danoprevir

Danoprevir is an investigational protease inhibitor from Roche that is active against HCV genotypes 1 and 4. Protease inhibitors have become a core component of highly effective future HCV treatments.

About Ascletis

Ascletis is an emerging biotechnology company, dedicated to discovering, developing and commercializing important new treatments for cancer and infectious diseases. Ascletis is focused on clinical development of innovative medicines and commercialization for the growing Chinese pharmaceutical marketplace. Ascletis has assembled an entrepreneurial management and senior scientific team with a track record of successful pharmaceutical discovery and development at major global pharmaceutical and emerging biotechnology companies in the United States and Europe. For more information, please visit www.ascletis.com outside China orwww.ascletis.com.cn inside China.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

For further information:

Ascletis

Jinzi J. Wu, PhD, President and CEO

jinzi.wu@ascletis.com

Joan Kureczka (Media)

Kureczka-Martin Associates

Joan@kureczka-martin.com

Roche Partnering

Emilie Vincent, Head of Roche Partnering Communications

emilie.vincent@roche.com

Roche China Communications

Elle Shi,  Product Communications Manager

elle.shi@roche.com