药明生物授权天境生物使用全球创新平台WuXiBody™开发三个双特异性抗体并扩大战略合作
I-Mab Biopharma Expands Strategic Collaboration with WuXi Biologics and Licenses WuXiBody™ Platform for Three Bispecific Antibody Programs
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上海，2018年9月26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）与聚焦于肿瘤免疫和自身免疫疾病治疗领域的生物创新药研发公司天境生物今日共同宣布，双方进一步扩大战略合作关系，药明生物授权天境生物使用全球创新的WuXiBody™双特异性抗体平台开发三个双特异性抗体新药，并成为这些项目的独家工艺开发和生产合作伙伴，为天境生物提供强有力支持。
根据合作协议条款，天境生物获得授权使用药明生物已申请专利的WuXiBody™技术平台，借力该平台推进天境生物自主研发的抗体类产品管线中三个双特异性抗体的研发及商业化进程。药明生物将获得平台授权首付款、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。
2017年4月，药明生物与天境生物宣布针对多个具有全球首创（First-in-Class）和同类最佳（Best-in-Class）潜力的创新生物药开发达成战略合作，基于双方在天境生物多个候选药物的临床前药学研究、工艺转移、优化以及大规模生产等方面合作的快速进展，双方决定将合作范围扩大至生物药发现领域。
天境生物创始人和首席执行官臧敬五博士表示：“此次关于双特异性抗体与药明生物扩大战略合作再次丰富了天境生物日益壮大的独家研发管线，为公司布局新一代生物药提供有力支持。这些源于尖端技术研发的产品，具有为相应治疗领域的现有疗法带来跨越性提升的潜力。药明生物具有世界领先的技术实力和成本效益优势，和这样优秀的全球知名技术平台合作能够为天境生物开发创新性生物药赋能，进一步推动我们成为覆盖全产业链的生物医药企业。”
“药明生物已经成功为天境生物的多个临床项目提供生产服务，我们很高兴能拓展战略合作范围，这也是公司本月在全球推出双特异性抗体开发平台WuXiBody™后达成的首个合作项目。”药明生物首席执行官陈智胜博士表示，“药明生物具有自主知识产权的双特异性抗体开发平台WuXiBody™不仅突破了同类技术平台的局限性，同时还具有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16g/L，并且达到一步Protein A纯化后纯度和收率均超过95%。我们将持续致力于投资开发全球领先的创新技术，实现变革生物药开发和生产进程的愿景。”
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，并且达到一步Protein A纯化后纯度和收率均超过95%。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。
关于天境生物
天境生物由三境生物和天视珍于2017年合并成立，并迅速组建起一支经验丰富，具有国际顶水平的研发团队。同年，天境生物完成B轮1.5亿美元融资。2018年6月29日，再次成功完成2.2亿美元的C轮融资，并成为目前中国创新药领域C轮最大的融资之一，由弘毅资本领投并获得多家知名机构跟投。天境生物致力于为全球患者提供Best-in-Class及First-in-Class创新生物药，聚焦于肿瘤免疫和自身免疫疾病治疗领域的研究。目前，天境生物已经启动一个临床二期研发项目，同时计划在中国和美国进行其他多个包括二期和三期在内的多中心临床试验。如需更多信息，请访问：http://www.i-mabbiopharma.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，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。
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药明生物2018年中期业绩骄人：营收创历史，增长61.2%至10.54亿元
I-Mab Biopharma Expands Strategic Collaboration with WuXi Biologics and Licenses WuXiBody™ Platform for Three Bispecific Antibody Programs
SHANGHAI, September 26, 2018
WuXi Biologics (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing and I-Mab Biopharma (“I-Mab”), a biotech company focusing exclusively on innovative biologics in immuno-oncology and auto-immune diseases, jointly announce today that I-Mab has expanded strategic collaboration with WuXi Biologics and licensed proprietary WuXiBody™ Platform to develop three bispecific antibodies . WuXi Biologics will also be the exclusive partner to develop and manufacture these bispecifics.
Under the terms of the agreement, I-Mab has rights to use the proprietary WuXiBody™ Platform to research, develop and commercialize three bispecific antibodies generated from I-MAB’s proprietary pipeline. WuXi Biologics will receive an upfront payment as well as development, regulatory and commercial milestone payments, and will be entitled to royalties based on global sales of these bispecific antibodies.
In April 2017, I-Mab and WuXi Biologics announced a strategic development and manufacturing partnership for multiple biologics of First-in-Class or Best-in-Class potential from I-Mab’s pipeline. The announcement today further expands that collaboration into biologics discovery.
“The expanded partnership with WuXi Biologics for bispecific antibodies is an important addition to our growing proprietary portfolio of next-wave biologics, which results from cutting-edge discovery technologies with the potential to transform standards of care in the respective therapeutic areas,” said Dr. Jingwu Zang, the founder and Chief Executive Officer of I-Mab. “Collaborating with a globally renowned biologics technology platform company like WuXi Biologics helps us develop and manufacture these innovative biologics with world-class technical expertise and cost-effectiveness, propelling us one step closer to being an end-to-end fully integrated biopharmaceutical company.”
“WuXi Biologics has enabled several clinical manufacturing programs for I-Mab. We are excited to expand our strategic partnership and announce the first WuXiBody™ partnership since we globally launched the exciting platform this month,” said Dr. Chris Chen, Chief Executive Officer of WuXi Biologics. “Our proprietary WuXiBody™ bispecific platform addresses technical limitations of bispecific platforms and tremendously reduces cost of making these biologics. We have achieved 16g/L in cell culture titer, 95+% purity after one-step Protein A purification and 95+% yield for Protein A step. WuXi Biologics will continue to invest to develop next-generation globally leading technologies to transform biologics discovery, development and manufacturing.”
About WuXiBody™ Platform
WuXiBody™, a proprietary bispecific antibody platform of WuXi Biologics, is potentially the Best-in-Class bispecific platform in the field. It can effectively eliminate CMC challenges of bispecific antibodies, expedite bispecific development by 6-18 months and significantly reduce manufacturing cost, a current limitation of most bispecific platforms. WuXiBody™ bispecifics have achieved 16g/L in cell culture titer, 95+% purity after one-step Protein A purification and 95+% yield for Protein A step. WuXiBody™ Platform enables almost any mAb sequence pairs to be assembled into bispecific constructs. They are characterized to have low immunogencity, 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 I-Mab
Facilitated by a merger between Third Venture Biotech and Tasgen Bio, followed by a Series B financing of US$150 million in 2017, I-Mab has rapidly built a highly experienced team with world-class R&D capabilities. On June 29, 2018, I-Mab announced that it had successfully raised US$220 million in Series C financing with a group of reputable investors led by Hony Capital, representing one of the largest amounts ever raised in Series C by an innovative biotech company in China. I-Mab focuses on discovery and development of First-in-Class and Best-in-Class biologics in the areas of immuno-oncology and auto-immune diseases. The company has already initiated a Phase 2 clinical trial and is prepared to submit multiple IND applications for additional clinical trials in China and the US, including a number of Phase 2 and Phase 3 studies. For more information on I-Mab, please visit http://www.i-mabbiopharma.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
