药明生物加速赋能多个抗新型冠状病毒中和抗体研发
药明生物加速赋能多个抗新型
冠状病毒中和抗体研发
WuXi Biologics Enables Development of Multiple Neutralizing Antibodies for Novel Coronavirus
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中国，上海
2020年1月29日
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，公司通过卓越的一体化生物制药能力和技术赋能平台，紧急推动多个通过国际合作引进的2019新型冠状病毒（2019-nCoV）中和抗体开发，积极应对新型冠状病毒感染肺炎疫情。初步研究表明这些来自全球生物技术公司的抗体可有效中和新型冠状病毒。
药明生物已组建超过百名研发人员的专项团队，全力投入多个新型冠状病毒中和抗体的开发和生产。该项目预计将于两个月内完成首批抗体样品生产，供应临床前毒理试验和初步人体临床试验，后续将迅速放大到2000至12000升生产规模，在公司已投入运营的四个生产基地同步生产。放大后抗体药一批生产量预计最多可供80000人使用。
“面对当前严峻的疫情挑战，药明生物迅速响应，利用公司在传染病治疗生物药领域开发和生产的丰富经验，积极推动抗新型冠状病毒中和抗体开发，传统历时12至18个月的全部开发工作有望在4至5个月内高质量完成，确保提供及时有效的疫情干预措施。”药明生物首席执行官陈智胜博士表示，“药明生物携手多家国际和国内生物技术公司、医院和医学院等各方力量共抗疫情，充分践行‘赋能全球合作伙伴，造福广大病患’的使命，期待我们早日打赢这场疫情防控阻击战。”
此前，全球首个黄热病单抗和寨卡病毒单抗在药明生物一体化生物制药技术平台赋能下，分别于7个月和9个月内完成新药临床试验申请（IND）的所有临床前CMC研究工作。
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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2019年6月30日，在药明生物平台上研发的综合项目达224个，包括106个处于临床前研究阶段，102个在临床早期（I期，II期）阶段，15个在后期临床（III期）以及1个在商业化生产阶段。预计到2022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将超过28万升，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。
WuXi Biologics Enables Development of Multiple Neutralizing Antibodies for Novel Coronavirus
SHANGHAI, China
January 29, 2020
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, has stepped up its efforts in enabling the development of multiple neutralizing antibodies for Novel Coronavirus (2019-nCoV) with its integrated technology platforms. These antibodies from global biotech companies are potent in neutralizing 2019-nCoV in preliminary studies.
WuXi Biologics has established a 100+ R&D team dedicated to the development and manufacturing of multiple neutralizing antibodies for 2019-nCoV. The first batch of antibody is expected to be produced in 2 months, ready for preclinical toxicology studies and initial human clinical studies. Large scale manufacturing will be initiated following the studies at the company's four GMP facilities with single batch bioreactor capacity ranging from 2,000 to 12,000 liters. A single batch at this scale combined is expected to treat up to 80,000 patients.
"Confronted by this severe outbreak, WuXi Biologics has taken prompt actions to accelerate the development of multiple neutralizing antibodies for 2019-nCoV, based on our extensive biologics development and manufacturing experience in the fields of infectious diseases. Compared with the traditional timeline of 12 to 18 months, all studies from DNA to IND could hopefully be completed in 4-5 months while maintaining high quality. This way we can provide effective and timely interventions for the disease caused by 2019-nCoV," said Dr. Chris Chen, CEO of WuXi Biologics. "Continuing in our mission of 'enabling global partners and benefiting patients worldwide', WuXi Biologics will actively work together with global and domestic biotechnology companies, hospitals, medical institutions and other parties to win the battle against this infectious disease."
Enabled by the proprietary technology platforms at WuXi Biologics, all preclinical CMC for the world's first yellow fever antibody and world's first Zika virus antibody were completed in a record timeline of 7 and 9 months, respectively.
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform 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 strong value proposition to our global clients. As of June 30, 2019, there were a total of 224 integrated projects, including 106 projects in pre-clinical development stage, 102 projects in early-phase (phase I and II) clinical development, 15 projects in late-phase (phase III) development and one project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, Singapore, and the U.S. exceeding 280,000 liters by 2022, 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