从概念至今17月!药明生物祝贺Tychan完成全球首创寨卡病毒单抗临床安全研究

从概念至今仅17月!药明生物祝贺Tychan完成全球首创寨卡病毒单抗临床安全研究

WuXi Biologics Congratulates Tychan on Completing Human Safety Studies for the First-in-Class Zika Virus Antibody in Record Speed

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中国上海，2018年10月29日

-Tychan公布了全球首创治疗性寨卡病毒单抗Tyzivumab在健康志愿者中的安全性和药代动力学数据

-Tyzivumab从药物发现到完成人体安全性研究仅历时17个月，创业界纪录

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）的合作伙伴Tychan近日宣布在新加坡成功完成全球首创治疗性寨卡病毒单抗Tyzivumab的I期临床安全性试验，药明生物对此表示祝贺。

Tychan是一家位于新加坡的临床阶段生物技术公司，专注于应用颠覆性技术为新发传染病患者带来拯救生命的创新疗法。借力药明生物的赋能平台，Tyzivumab从药物发现到完成人体安全性研究仅历时17个月，创下业界纪录，这将促使Tychan持续专注于开发针对新发传染病的潜在创新性疗法。

研究显示，Tyzivumab在最高剂量的人体试验中安全性及耐受性均表现良好，为其进一步在寨卡病毒感染者中开展Ib期临床试验奠定了基础，目前该研究正在招募受试者。

“作为全球首创治疗性寨卡病毒单抗，Tyzivumab的安全性得到证明是Tychan发展历程中的一个重大里程碑。这让我们更加坚定信念，继续夯实针对新发传染病开发创新疗法的快速响应能力，有效干预新发传染病的爆发，避免造成严重的生命和财产损失。”Tychan公司董事会主席Teo Ming Kian先生表示。

“我们很荣幸赋能合作伙伴Tychan为开发Tyzivumab提供有力支持，并创纪录地在9个月内完成了从细胞株构建到新药临床试验申请（IND）的所有工作，这展现了公司全球领先的技术能力和研发速度。药明生物持续致力于加快开发和生产更多患者亟需的生物药，从而高效应对各类新发传染病。”药眀生物首席执行官陈智胜博士表示。

相关阅读

关于Tyzivumab

Tyzivumab是全球首个进入临床试验阶段的寨卡病毒抗体新药，能直接作用于病毒表面的包膜（E）蛋白上的特异性“四元表位”，限制病毒融入宿主细胞从而抑制病毒复制。

关于临床试验

此次在新加坡进行的首次人体临床试验在大约24名健康志愿者中进行。在Ia期临床试验中，志愿者被随机分为六组，每组接受单剂量的抗寨卡病毒单克隆抗体治疗。研究的主要终点是安全性和耐受性，次要终点包括药代动力学特征和免疫原性。Ib期临床试验将在大约28名确诊的寨卡病毒感染者中进行，这些患者将被依次纳入四组分别接受单剂量的抗寨卡病毒单克隆抗体治疗。这两项试验均由新加坡中央医院传染病学系高级顾问、ViREMiCS联席主任Jenny Low副教授领导的SingHealth调查组进行。新加坡临床研究中心（SCRI）作为Academic Research Organisation的合作伙伴，提供临床试验稽查、数据管理和分析支持。

关于Tychan

Tychan是一家新加坡临床阶段生物技术公司，专注于应用颠覆性技术为新发传染病患者带来拯救生命的疗法。在与监管机构的积极协调下，公司正在加速新型病原体从临床前研究推进至临床试验。公司由麻省理工学院和SMART的教授Ram Sasisekharan博士、杜克-新加坡国立大学教授Ooi Eng Eong博士共同创立，他们分别是生物制药研发和急性病毒感染生物学领域的权威专家，淡马锡控股公司则是Tychan的创始投资人。

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。

WuXi Biologics Congratulates Tychan on Completing Human Safety Studies for the First-in-Class Zika Virus Antibody in Record Speed

SHANGHAI, October 29, 2018

-Tychan reports safety and pharmacokinetic data in healthy volunteers for the first-in-class anti-Zika therapeutic antibody, Tyzivumab

-Completion of Tyzivumab from discovery to human safety studies was in a record time of 17 months

WuXi Biologics (2269.HK), a leading global open-access biologics technology platform company that offers end-to-end solutions for biologics discovery, development and manufacturing, today congratulates its partner Tychan on successful completion of Phase-1 safety trials in Singapore for Tyzivumab, first-in-class monoclonal antibody (mAb) therapeutic for Zika, Tyzivumab, in Singapore.

Tychan, a Singapore clinical-stage biotechnology company, is focused on bringing life-saving treatments for emerging infections to those in need through disruptive technologies. In partnership with WuXi Biologics, the completion of Tyzivumab from discovery to human safety studies was in a record time of 17 months, which enables Tychan focusing on making potential therapeutics for emerging infectious agents.

Research shows Tyzivumab to be safe and well tolerated up to the highest dose tested. This paves the way for this antibody to be tested in Zika patients in a Phase 1b study for which Tychan has received regulatory approval from the Health Sciences Authority of Singapore. Recruitment of patients is ongoing for this study.

“Demonstration of the safety of Tyzivumab is an important milestone that puts Tychan firmly on a path towards a true rapid response capability for emerging infectious diseases that is so critically needed to overcome the threats of increasing epidemics that have often caused great misery to human lives and severe economic impact,” said Teo Ming Kian, Chairman of the Board, Tychan.

“WuXi Biologics is the proud partner to enable IND filing of this exciting program in 9 months, which showcases our world-class capabilities and speed. We are committed to expediting development and manufacturing of much needed biologics for emerging infectious agents,” said Dr. Chris Chen, Chief Executive Officer of WuXi Biologics.

About Tyzivumab

Tyzivumab is the first-in-class monoclonal antibody designed and engineered to treat Zika infected patients to enter the clinic. Tyzivumab is directed against a specific quaternary epitope of the envelope (E) protein on the surface of the virus, limiting viral fusion to host cells and preventing viral replication.

About the Trial

The first in human Phase 1a clinical trial was conducted in Singapore in approximately 24 healthy volunteers. Volunteers in the Phase 1a trial were randomised into one of six groups each receiving a single dose of the anti-Zika monoclonal antibody. The primary endpoints of the study were safety and tolerability, and secondary endpoints include pharmacokinetics and immunogenicity. The Phase 1b trial will be conducted in approximately 28 patients with confirmed Zika infection who will be sequentially included in 4 groups each receiving a single dose of the anti-Zika monoclonal antibody. Both trials are administered by SingHealth Investigational Medicine Unit, led by Associate Professor Jenny Low, Senior Consultant, Department of Infectious Diseases, Singapore General Hospital and Co-Director, Viral Research and Experimental Medicine Centre@SingHealth Duke-NUS (ViREMiCS). The Singapore Clinical Research Institute as the Academic Research Organisation partner provides oversight, data management and analytical support.

About Tychan

Tychan, a Singapore clinical-stage biotechnology company, is focused on bringing life-saving treatments for emerging infections to those in need through disruptive technologies. In a coordinated effort with regulatory authorities, we are accelerating the translation from non-clinical studies to clinical trials for emerging pathogens. Founded by Professor Ram Sasisekharan of Massachusetts Institute of Technology (MIT) /Singapore MIT Alliance for Research and Technology (SMART) and Professor Ooi Eng Eong of Duke- National University of Singapore (Duke-NUS), their expertise spans the fields of biologics development and biology of acute viral infections. Temasek is the founding investor of Tychan Pte. Ltd. For more information on Tychan Pte Ltd, please visit: www.tychan.com.

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