EMA完成药明生物cGMP原液及制剂生产基地Trogarzo上市批准前检查
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上海
2019年2月19日
——药明生物将成为中国首家EMA GMP认证的生物制药公司
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）今日宣布，欧洲药品管理局（EMA）已在药明生物cGMP原液和无菌制剂生产基地顺利完成中裕新药艾滋病治疗抗体Trogarzo™上市批准前检查（PAI），并且无重大缺陷项。药明生物将在近期针对EMA检查结果提交回复意见，预计今年5月获得EMA GMP证书。
这是中国生物制药企业首次完成EMA药品上市批准前GMP检查，也是公司继去年3月成为中国首家美国FDA GMP认证的生物制药企业后取得的又一重大里程碑，进一步确立了药明生物在全球生物制药领域的领先地位和品牌。顺利通过EMA检查后，药明生物将拥有中国首个EMA GMP认证的生物药原液生产基地、中国首个EMA GMP认证的生物药无菌制剂生产基地以及中国首个EMA GMP认证的细胞库生产基地。公司无锡生产基地同时通过美国及欧盟GMP双重认证，将有力地为全球客户提供商业化生产服务。
“我们对于此次检查结果感到异常兴奋，这再次彰显药明生物已建立符合全球标准的一流质量体系。感谢全球客户对公司的信任以及全体员工孜孜不倦追求卓越质量所付出的努力。”药明生物CEO陈智胜博士表示，“以FDA与EMA检查结果为支撑，药明生物将继续以国际最高质量标准拓展全球化生产布局，为所有客户提供优质服务。此次检查将助力公司更好贯彻‘跟随药物分子发展阶段扩大业务（Follow-the-Molecule）’战略，继续加快和变革生物药发现、开发和生产进程，生产更多高质量生物药，造福全球患者。”
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。
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EMA Completed Pre-Approval Inspection of cGMP DS and DP Facilities for Trogarzo™ at WuXi Biologics
SHANGHAI
February 19, 2019
——WuXi Biologics completed EMA GMP Inspection, the first biologics company in China
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, today announced that the European Medicines Agency (EMA) has completed the Pre-Approval Inspection (PAI) of the company's cGMP Drug Substance (DS) and Drug Product (DP) manufacturing facilities for the production of TaiMed Biologics' Trogarzo™ with no critical findings. WuXi Biologics will submit responses to the EMA inspection report in March 2019 and expects to obtain GMP certification for its facilities in May 2019.
This is the first such inspection of its kind in China, marking yet another critical milestone for WuXi Biologics, further endorsing the quality operations and the reputation of the company as a global leading biomanufacturing player. Upon completion of this inspection, WuXi Biologics will be honored to have the first cGMP biologics DS facility, the first cGMP biologics DP facility and the first cGMP cell banking facility in China to be approved by the EMA for commercial manufacturing. The DS and DP facilities also made headlines in March 2018 for being the first in China to pass the U.S. FDA inspection enabling the facilities to supply biologics globally.
"We are excited about this inspection result, which manifests our world-class quality system that meets global quality standards. We are thankful to our global clients who trust WuXi Biologics and to our staffs who tirelessly strive for excellence in quality," commented Dr. Chris Chen, CEO of WuXi Biologics. "WuXi Biologics is committed to the continued expansion of our global manufacturing footprint, of the highest quality, as underlined by the recent FDA and EMA inspections. This result further allows us to expedite 'Follow-the-Molecule' strategy for our clients, and continue to accelerate and transform how biologics are discovered, developed and manufactured. More high quality biologics will surely benefit patients globally."
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.
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