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药明生物与美国Inhibrx公司达成独家生产战略合作 | Bilingual News

药明生物与美国Inhibrx公司达成独家生产战略合作 | Bilingual News 药明生物
2018-09-11
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导读:此次“强强联手”是全球生物医药行业最大规模的合作之一。



药明生物与美国Inhibrx公司达成独家生产战略合作


WuXi Biologics and Inhibrx Enter an Exclusive Partnership for GMP Manufacturing


(*Please scroll down for English news.)


中国上海

2018年9月11日

全球领先的开放式生物技术平台公司药明生物(WuXi Biologics, 2269.HK)与创新蛋白药物为核心建立丰富研发管线的美国生物制药公司Inhibrx今日宣布,双方针对Inhibrx的多个创新蛋白药物GMP生产达成独家战略合作


根据合作协议的条件和条款,药明生物将成为Inhibrx公司未来三年开展国际临床试验所有生物新药的GMP生产独家合作伙伴,为Inhibrx整个研发管线的上市进程提供强有力支持。此次“强强联手”彰显了Inhibrx丰富的研发管线以及药明生物国际一流的技术能力和强劲的产能实力。

 

“我们与药明生物在两年前已建立紧密的合作关系。双方合作卓有成效、进展顺利,公司一个在研项目即将于今年10月开展I期临床试验,预计明年还将有四个项目进入新药临床试验申请(IND)阶段,展现了药明生物出色的项目执行和推进能力。”Inhibrx公司首席执行官Mark Lappe先生表示,“此次合作为Inhibrx多样化产品的开发和商业化提供了有力支持,助力公司实现短期规划和长远战略目标。我们期待借助药明生物的一体化生物制药能力和技术赋能平台为全球重大疾病患者带来更多有效的创新疗法。”

 

“我们很高兴能与Inhibrx公司建立独家战略合作关系,为其丰富的研发管线提供国际质量服务。我们双方的独家战略合作是全球生物医药行业最大规模的合作之一,再次充分证明了药明生物作为全球生物药开发和生产领域领导者,其全球顶尖技术实力已经获得广泛认可。”药明生物首席执行官陈智胜博士表示,“药明生物打造了全球最大规模的生物药研发团队之一,在1900名经验丰富科学家的共同努力下,我们每年可以赋能客户将60个项目推至新药临床试验申请(IND)以及3个项目推向生物制品上市申请(BLA)。凭借全球合作伙伴认可的强大生物制药技术能力及全球首屈一指的产能规模,药明生物正在变革全球生物药开发和生产进程。”


 

关于Inhibrx公司

Inhibrx是一家处于临床开发阶段的生物技术公司,致力于为患者提供更多创新蛋白药物。Inhibrx基于传统单克隆抗体(mAb)和融合蛋白的持续改进建立了创新单域抗体(sdAb)平台,该平台开发出的同类最佳药(Best-in-Class)打破了传统疗法的局限性,有效解决了复杂生物学难题。Inhibrx已经与Celgene和Alpha-1基金会建立合作关系,并且获得美国国立卫生研究院(NIH)、美国国立变态反应与传染病研究所(NIAID)和“助力战胜耐药细菌计划”(CARB-X)等多个知名机构资助。如需更多信息,请访问:www.inhibrx.com


 

关于药明生物

药明生物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,我们在中国、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 and Inhibrx Enter an Exclusive Partnership for GMP Manufacturing



SHANGHAI

September 11, 2018

WuXi Biologics (2269.HK, WuXi Bio), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, and Inhibrx, Inc. (Inhibrx), a biopharmaceutical company developing a diverse pipeline of novel protein-based therapeutics, today announced that the companies have entered into an exclusive partnership for the GMP manufacturing of certain of Inhibrx's protein-based therapeutics. The agreement showcases the expansive biologics pipeline of Inhibrx and the world leading technical expertise and capabilities of WuXi Biologics.


Under the terms of the agreement, Inhibrx will subject to certain limitations, exclusively use WuXi Biologics for GMP manufacturing of its human biologic therapeutics for all projects to be initiated within next 3 years which Inhibrx plans to first initiate clinical trials outside of China.  


"We have a very strong working relationship with WuXi Biologics. Over the last two years, WuXi Biologics has executed well on our programs and delivered excellent results, enabling GMP manufacturing of one biologic initiating a Phase 1 clinical study in October and four additional biologics for which IND submission is expected over the next year," said Mark Lappe, Chief Executive Officer of Inhibrx. "This partnership supports our immediate and long-term objectives in developing and commercializing our diverse pipeline. We look forward to working with WuXi Biologics to bring optimized therapeutics to underserved patient populations."


"We are excited about this exclusive partnership, one of the largest in the industry. WuXi Biologics has been well recognized as a global leader in the development and manufacturing of biologics and we are very excited about Inhibrx's large and diverse pipeline," said Dr. Chris Chen, Chief Executive Officer of WuXi Biologics. "This agreement exemplifies our unparalleled capacity in global biologics development and manufacturing. We are able to initiate 60 IND-enabling programs and 3 BLA-enabling programs per year, with support from one of the largest biologics development teams in the industry, composed of approximately 1,900 scientists. With globally recognized technical capabilities and unparalleled capacities, we are transforming how biologics are developed in the global setting."


 

About Inhibrx Inc.

Inhibrx is a clinical-stage biotechnology company developing a diverse pipeline of novel protein-based therapeutics for underserved patient populations. Inhibrx’s novel single domain antibody (sdAb) platforms substantially improve upon conventional monoclonal antibody (mAb) and fusion protein approaches, enabling best in class therapeutics that address complex target biology beyond the capacity of conventional approaches. Inhibrx has collaborations with Celgene and the Alpha-1 Foundation, and has received awards from several granting agencies, including NIH, NIAID and CARB-X. For more information, please visit www.inhibrx.com. 


 

About WuXi Biologics

WuXi Biologics, 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

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