ABL Bio Expands Strategic Collaboration with WuXi Biologics and Licenses WuXiBody™ Platform for Novel Immune Check Point Bispecifics for $220 Million
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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）与专注于肿瘤免疫和神经退行性疾病抗体新药开发的韩国生物技术公司ABL Bio Corporation（ABL Bio, 298380.KS）今日宣布，双方针对多个全新双特异性抗体和一款肿瘤免疫项目开发达成新合作协议，进一步深化战略伙伴关系。
根据合作协议条款，ABL Bio公司获得授权使用药明生物具有自主知识产权的生物制药技术平台，包括WuXiBody™平台和CD3抗体发现平台，推进多个双特异性抗体发现、开发和商业化进程，并开发靶向全新免疫检查点受体的双特异性抗体。药明生物将获得总额高达2.2亿美元的授权首付款、产品批准注册和商业化里程碑付款，以及产品上市后按全球销售额计算的销售提成。
2018年11月，药明生物与ABL Bio公司针对多个创新双特异性抗体开发与临床生产达成独家战略合作，此次新合作进一步拓展了双方合作的宽度和深度。
“我们很兴奋与药明生物深化战略合作，”ABL Bio公司创始人兼首席执行官Sang Hoon Lee博士表示，“此次合作将使公司产品管线实现协同效应，基于不同双特异性抗体平台开发新一代疗法，跻身全球肿瘤免疫和神经退行性疾病领域领先地位。”
“我们很高兴与ABL Bio公司扩大合作范围，这再次彰显药明生物作为开发和生产双特异性抗体等高难度创新生物药的全球行业领导者，其国际水准的技术实力已获广泛认可。这也是去年8月WuXiBody™平台亮相以来，公司在全球范围内达成的第七笔合作。”药明生物首席执行官陈智胜博士表示，“WuXiBody™迅速获得业界青睐，也进一步证明了该平台突破同类技术平台局限性，显著降低双特异性抗体生产成本等优势。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，我们将持续投资开发全球领先的创新技术，不断加快和变革全球生物药开发和生产进程。”
关于WuXiBody™
WuXiBody™是药明生物具有自主知识产权的双特异性抗体技术平台，有望成为业界最好的双特异性抗体平台之一。该平台突破了绝大多数双特异性抗体平台技术瓶颈，有效克服了双特异性抗体开发过程中表达量低、多聚体高、纯化收率低等挑战，具有为每个项目节约6到18个月研发时间以及显著降低双特异性抗体生产成本等优势。目前已开发的双特异性抗体表达量最高达16g/L。同时，WuXiBody™平台还兼具独特的灵活性，可以构建各种不同的价数（如二价、三价或四价双特异性抗体）和结构，以满足不同项目的生物学特性需求。
关于ABL Bio
ABL Bio（股票代码：298380.KS）是一家专注肿瘤免疫和神经退行性疾病抗体疗法开发的韩国生物技术公司。ABL Bio于2016年成立，三年内成功募资近1.7亿美元，并在2018年12月登陆韩国证券交易所（KOSDAQ）。公司在研产品ABL001，即靶向VEGF和DLL4的肿瘤治疗双特异性抗体，目前正处于一期临床试验阶段。ABL Bio正在积极开发多个围绕4-1BB靶点的双特异性抗体和多个基于双特异性抗体的全球首创（First-in-Class）和同类最佳（Best-in-Class）免疫疗法。在神经退行性疾病领域，ABL Bio正利用其双特异抗体专长，开发旨在最大化提高血脑屏障穿透性和疗效的新一代产品。现阶段，公司研发进展最快的产品ABL301，是靶向α-突触核蛋白的双特异性抗体，可以通过受体介导的转胞吞作用穿透血脑屏障，用于治疗帕金森。如需更多信息，请访问：www.ablbio.com。
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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药明生物与ABL Bio针对多个双抗达成独家开发与生产战略合作
ABL Bio Expands Strategic Collaboration with WuXi Biologics and Licenses WuXiBody™ Platform for Novel Immune Check Point Bispecifics for $220 Million
SHANGHAI and SEOUL, South Korea
February 26, 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 ABL Bio Corporation ("ABL Bio") (298380.KS), a South Korean biotechnology company developing antibody therapeutics for immuno-oncology and neurodegenerative diseases, today announced the expansion of their strategic partnership for novel bispecific antibodies and immune-oncology program.
Under the terms of the agreements, ABL Bio has rights to use WuXi Biologics' proprietary discovery platforms, including WuXiBody™ and CD3 platform, to research, develop and commercialize multiple bispecific antibodies, as well as rights to develop new bispecific antibodies targeting novel immune check point receptor. WuXi Biologics will receive an upfront payment as well as development, regulatory and commercial milestone payments of about $220 million, and will be entitled to royalties based on global sales of these programs.
In November 2018, ABL Bio and WuXi Biologics announced an exclusive development and clinical manufacturing partnership for multiple bispecific antibodies. This announcement today further strengthens the breadth and depth of the companies' collaboration.
"We are quite excited about this collaboration with WuXi Biologics," said Dr. Sang Hoon Lee, CEO of ABL Bio. "I believe that the partnership with WuXi Biologics will bring a synergy for developing our bispecific antibody pipelines. It will help us to develop novel immune-oncology therapies on different bispecific platforms and lead us to step up to be a global top-tier biotechnology company for immuno-oncology and neurodegenerative disease treatment."
"We are glad to expand the partnership with ABL Bio, which manifests that WuXi Biologics has been well recognized as a global leader in the development and manufacturing of next-generation biologics such as bispecific antibodies. This is the 7th partnership we signed since we globally launched this exciting platform last August," said Dr. Chris Chen, CEO of WuXi Biologics. "Quick adoption of our WuXiBody™ bispecific platform further validates that this proprietary platform addresses most technical limitations of current bispecific platforms and can potentially tremendously reduce the cost of making these biologics. WuXi Biologics will continue to invest in developing globally leading next-generation technologies to accelerate and transform biologics discovery, development and manufacturing. With globally recognized technical capabilities and unparalleled capacities, we are transforming how biologics are developed in the global setting."
About WuXiBody™
WuXiBody™, a proprietary bispecific antibody platform of WuXi Biologics, is potentially the Best-in-Class bispecific platform in the field. It can effectively break through the CMC barriers of bispecific antibodies development, expedite the process by 6-18 months and significantly reduce manufacturing cost, a severe limitation of other current bispecific platforms. WuXiBody™ bispecifics have achieved 16g/L in cell culture titer. WuXiBody™ Platform enables almost any mAb sequence pairs to be assembled into bispecific constructs. They are characterized as low immunogenicity, long in vivo half-life like mAbs and excellent stability. WuXiBody™ Platform also owns its unique structural flexibility, which makes it convenient to build various formats with different valency (2, 3 or 4 binding sites) to meet the requirements of different bispecific targets.
About ABL Bio
ABL Bio (298380:KS) is a South Korean biotechnology company developing antibody therapeutics for immuno-oncology and neurodegenerative diseases. Founded in 2016, ABL Bio successfully raised close to $170 million USD in 3 years and listed in Korean stock exchange (KOSDAQ) in December, 2018. ABL001, a bispecific antibody (BsAb) targeting VEGF and DLL4 is currently in Phase 1 clinical trial for oncology. ABL Bio is also actively developing multiple 4-1BB based T cell engaging bispecific antibodies and several innovative First-in-Class and Best-in-Class bispecific antibody-based immunotherapies. In the neurodegenerative disorder space, ABL Bio is harnessing its BsAb expertise to develop next-generation BsAbs designed to maximize blood–brain barrier (BBB) penetrance and therapeutic efficacy. The most advanced molecule is ABL301, an α-synuclein-targeting BsAb that penetrates the BBB via a receptor-mediated transcytosis (RMT) and is in development for Parkinson's disease (PD). For more information, check out www.ablbio.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
