首次突破！药明生物与Amicus达成独家商业化生产战略合作

药明生物与Amicus公司达成独家商业化生产战略合作

WuXi Biologics and Amicus Sign Exclusive Manufacturing Partnership 

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上海和美国新泽西州克兰伯里

2019年2月12日

——药明生物首次与合作伙伴建立独家生物药原液和制剂商业化生产合作

全球领先的开放式生物制药技术平台公司药明生物（WuXi Biologics, 2269.HK）和专注于为罕见代谢疾病患者发现、开发和提供高质量药物的全球生物技术公司Amicus（Nasdaq: FOLD）今日共同宣布，双方针对新一代庞贝氏症疗法ATB200达成独家商业化生产战略合作。

根据合作协议，药明生物将成为ATB200项目商业化阶段的独家原液生产合作伙伴和主要制剂供应合作伙伴，通过“药明生物提供全球双重供应”策略以及覆盖欧盟、中国以及美国地区的全球商业化生产供应链网络赋能Amicus，分别有两个原液和制剂基地为其提供高质量生产服务，有效保障产品稳定供应，同时大幅降低Amicus如采用不同供应商而带来的技术转移风险。

ATB200项目自2012年起从一个“主意（idea）”开始在药明生物平台上开发，在公司全球领先生物制药技术及强劲产能实力的支持下，目前已顺利进入三期临床试验阶段。此次独家商业化生产合作协议初始期限为五年，此后每两年自动续期一次，直至协议取消为止。这再次彰显了药明生物强大的商业化生产能力和一流的全球化高质量体系。公司正在持续以卓有成效的“跟随药物分子发展阶段扩大业务（Follow-the-Molecule）”战略为全球客户提供从概念到商业化生产的一体化服务。

“与药明生物建立长期合作关系标志着我们的深度合作开启新篇章。”Amicus公司总裁兼首席运营官Bradley L. Campbell先生表示，“得益于过去五年双方开展的紧密合作，我们成功把庞贝氏症疗法从研发推进至商业化生产阶段。公司正在推进庞贝氏症项目的关键性试验来支持全球注册申报工作，我们相信与药明生物的战略合作将有效保障全球庞贝氏症患者用药，期待双方紧密合作持续造福全球患者。”

“我们非常兴奋能与Amicus深化战略合作关系，这也是公司首次与客户建立独家商业化生产合作。ATB200是糖基化优化的重组酶，其工艺开发和生产的要求和难度都极高，为该药提供一体化服务进一步证明了药明生物在开发和生产高难度生物药领域处于全球领先地位。”药明生物首席执行官陈智胜博士表示，“此项合作是药明生物实施‘跟随药物分子发展阶段扩大业务’战略的重大里程碑，我们有望首次赋能合作项目从细胞株开发成功快速推进至提交上市申请（BLA）阶段。衷心祝愿Amicus在该项目上取得成功，造福全球庞贝氏症患者。药明生物将持续加快和变革全球生物创新药开发和生产进程，为拯救更多患者生命做出积极贡献。”

关于Amicus

Amicus Therapeutics（纳斯达克股票代码：FOLD）是一家致力于为罕见代谢疾病患者发现、开发和提供高质量创新药的全球性生物技术公司。公司立足于“以患者为中心”，针对罕见代谢疾病打造了强大的先进在研产品线。更多信息请访问www.amicusrx.com，以及Twitter和LinkedIn。

关于药明生物

药明生物（股票代码：2269.HK）作为一家香港上市公司，是全球领先的开放式、一体化生物制药能力和技术赋能平台。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务，帮助任何人、任何公司发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。截至2018年6月30日，在药明生物平台上研发的综合项目达187个，包括98个处于临床前研究阶段，78个在临床早期（I期，II期）阶段，10个在后期临床（III期）以及1个在商业化生产阶段。预计到2021年，公司在中国、爱尔兰、新加坡、美国规划的生物制药生产基地合计产能约22万升，这将有力确保公司通过健全强大的全球供应链网络为客户提供符合全球质量标准的生物药。如需更多信息，请访问：www.wuxibiologics.com.cn。

相关阅读

WuXi Biologics and Amicus Sign Exclusive Manufacturing Partnership 

SHANGHAI and CRANBURY, N.J.

February 12, 2019 

WuXi Biologics ("WuXi Bio") (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, and Amicus Therapeutics ("Amicus") (Nasdaq: FOLD), a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases, announced that the companies have entered into an exclusive commercial manufacturing partnership for Amicus' Pompe biologic ATB200.

Per the strategic agreement, WuXi Biologics will be the exclusive commercial drug substance manufacturing partner and key commercial drug product supplier. WuXi Biologics will enable and support Amicus with its "Global Dual Sourcing within WuXi Biologics" strategy and manufacture both the drug substance and drug product, each at two sites across its global commercial supply network in EU, China and US. This approach effectively ensures a global and robust supply chain while at the same time minimizes the intra-company technology transfer risk associated with traditional approaches of using different suppliers. The contract has an initial five-year term and then automatically renewed every two years until cancelled. This agreement showcases the strong commercial manufacturing expertise and global premier quality system of WuXi Biologics as well as its powerful "Follow-the-Molecule" strategy that enables a global client base from discovery to commercial manufacture. The ATB200 program was initiated at WuXi Biologics in 2012 and now progresses through a pivotal study enabled by the global leading technology platform and unparalleled manufacturing capacity at WuXi Biologics.

"This long-term supply agreement is another significant step forward in our relationship with WuXi Biologics," said Mr. Bradley L. Campbell, President and Chief Operating Officer of Amicus Therapeutics, Inc. "Over the past five years we have successfully collaborated in the scale up of our Pompe biologic from research to commercial scale while maintaining all key quality attributes. We look forward to continuing this important manufacturing partnership as we advance our Pompe program in a pivotal study to support global regulatory approvals, and we are confident in our ability to supply patients around the world."

"We are excited about this exclusive commercial manufacturing partnership with Amicus, our first since the inception of the company. WuXi Biologics has again been recognized as a global leader in enabling the success of our clients. This is particularly the case in overcoming the development and manufacturing challenges associated with difficult biologics, such as this recombinant enzyme with special glycoform to potentially achieve improved potency," said Dr. Chris Chen, Chief Executive Officer of WuXi Biologics. "This important milestone is also the first success of our 'Follow-the-Molecule' strategy progressing from cell line development to potential BLA filing. We wish Amicus every success in this program to benefit Pompe patients globally! We are proud to be associated with continually improving and transforming the development and commercial manufacture of biologics, and helping to improve the lives of many patients."

About Amicus

Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare metabolic diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a robust pipeline of cutting-edge, first- or best-in-class medicines for rare metabolic diseases. For more information please visit the company's website at www.amicusrx.com, and follow on Twitter and LinkedIn.

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is the only open-access biologics technology platform in the world offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and value proposition to our global clients. As of June 30, 2018, there were a total of 187 integrated projects, including 98 projects in pre-clinical development stage, 78 projects in early-phase (phase I and II) clinical development, 10 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 220,000 liters by 2021, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network. For more information on WuXi Biologics, please visit www.wuxibiologics.com.

注：本信息不构成药明生物的信息披露或投资建议