合全药业与BioLingus签署独家技术合作及市场推广协议，共同深耕 “舌下给药技术”
WuXi STA and BioLingus sign exclusive technology and marketing collaboration for sublingual delivery
中国上海和美国圣地亚哥，2019年2月19日-药明康德子公司合全药业宣布与总部位于瑞士的新锐生物技术公司BioLingus针对 “舌下给药技术” 签署战略合作协议，成为BioLingus这一技术在CDMO（合作研究开发生产）领域的独家工艺开发、生产以及技术推广合作伙伴。BioLingus的核心技术能够提高不同形式的药物在生物体内的稳定性，使得通过口腔粘膜吸收的舌下给药技术能够从小分子延伸到多肽和蛋白质药物上。目前这项技术已经获得了全球多个主要国家的专利认可。
此次战略合作，BioLingus将利用合全药业在制剂领域的规模优势进一步开拓舌下给药技术的产品管线和使用范围。合全药业作为药明康德控股子公司，拥有一支规模超过千人的工艺研发团队，能够为客户提供新药中间体、原料药及制剂从临床前期工艺开发直至商业化生产的一体化服务。值得一提的是，合全药业的制剂业务近年来得到了飞速发展，随着年产数亿的片剂和胶囊生产线在江苏无锡和上海外高桥制剂新基地相继正式投产，合全打通了固体制剂能力从临床前到商业化的全产业链，并迎来多个临床三期及商业化阶段制剂项目。这次引进的新型舌下给药解决方案将进一步深化合全在口服固体制剂领域的布局，为客户提供更多灵活、多样、先进的解决方案。
“我们与合全药业签署这一技术在CDMO（合作研究开发生产）领域的独家合作协议，正是看中了合全药业领先的一体化CMC（化学，生产和控制）平台，覆盖从临床前到商业化，从API到制剂的全产业链。此外，合全药业的赋能平台还将帮助我们在全球范围内更快速、更广泛地开展业务。” BioLingus首席执行官Yves Decadt博士表示。
“我们很高兴与BioLingus开展合作，通过合全药业的一体化CMC （化学，生产和控制）平台，将BioLingus在舌下给药方面的先进技术和成功经验，应用于全球更多的新药开发进程，赋能更多合作伙伴，为广大病患提供更经济、便捷，有效的给药方式。”合全药业首席执行官陈民章博士表示。
关于BioLingus
BioLingus是一家屡获殊荣的瑞士生物科技公司，主要从事多肽和大分子药物通过口腔粘膜吸收的舌下给药技术，目前该技术还适用于多种药物分子形式，如小分子以及疫苗等。BioLingus不仅拥有数个基于舌下给药技术的多肽和蛋白质产品管线，还致力于通过转让的方式为合作伙伴提供更多技术支持。
关于合全药业
合全药业是在中美两地均有运营的药明康德子公司，服务于生命科学行业，拥有卓越的化学创新药研发和生产的能力和技术平台。作为全球新药合作研究开发生产领域（CDMO）的领军企业，合全药业致力于为全球合作伙伴提供从原料药（API）到制剂，高效、灵活、高质量的一站式解决方案。更多信息，请访问公司网站：www.STApharma.com.cn
关于药明康德
药明康德（股票代码：603259/2359.HK）是国际领先的开放式能力与技术平台公司，为全球制药及医疗器械等领域提供从药物发现、开发到市场化的全方位一体化的实验室研发和生产服务。本着以研究为首任，以客户为中心的宗旨，药明康德通过高性价比、高效率的服务平台帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。药明康德平台涵括小分子药物研发及生产、细胞疗法与基因疗法研发生产、医疗器械测试等，正承载着来自全球30多个国家的3000多家创新合作伙伴的数千个研发创新项目，致力于将最新和最好的医药和健康产品带给全球病患，实现“让天下没有难做的药，难治的病”的梦想。更多信息，请访问公司网站：www.wuxiapptec.com
WuXi STA and BioLingus sign exclusive technology and marketing collaboration for sublingual delivery
SHANGHAI and SAN DIEGO, February 18, 2019: STA Pharmaceutical Co., Ltd., (WuXi STA), a subsidiary of WuXi AppTec – and BioLingus, a Swiss biotech company, announce they have formed an exclusive technology and marketing collaboration for sublingual delivery.
Under the terms of the collaboration, WuXi STA will have exclusive access to BioLingus technology for sublingual and buccal delivery in the contract development and manufacturing organization (CDMO) sector. BioLingus has developed a novel platform – with patents secured in major countries around the world – to stabilize and deliver sublingually (orally under the tongue) drug targets including small molecules, peptides and proteins, that are currently administered to patients via injection.
The collaboration will help further integrate the advantages of WuXi STA drug product services and expedite the development of BioLingus’ pipeline and usage of sublingual delivery technology.
In 2017, WuXi STA merged with WuXi AppTec’s Pharmaceutical Development Services unit, realizing a seamless integration of the entire chemistry, manufacturing and controls (CMC) supply chain. Over the past year, two new commercial drug product facilities – in Shanghai and Wuxi city, Jiangsu province – have come into operation, enabling WuXi STA to support solid dosage drug development from preclinical to commercial, with several phase III and commercial drug product projects underway. The newly introduced sublingual delivery technology will further deepen the scale of solid dosage drug capabilities in WuXi STA, providing customers with more flexible, diverse and advanced solutions.
“We entered into this exclusive collaboration with WuXi STA for this technology in the CDMO sector for a number of reasons. Principally, WuXi STA is one of the world leaders in this field, with an integrated CMC platform from pre-clinical development to commercialization. Furthermore, this partnership will help us develop our own client base on a global scale faster and more broadly than we could do on our own.” said Yves Decadt, CEO of BioLingus.
Dr. Minzhang Chen, CEO of WuXi STA, added: “We are very pleased to partner with BioLingus and to offer their award-winning sublingual delivery technology to global new drug developers via WuXi STA’s integrated CMC platform. This collaboration will therefore offer more economical, convenient and effective delivery solutions for patients globally.”
About BioLingus
Biolingus is an award-winning Swiss biotech company specializing in sublingual delivery, in particular of peptides and macromolecules. The unique technology is also applicable to a wide range of other molecules, going from small molecules to vaccines. In addition to developing its own pipeline of sublingual peptides and proteins, the company is open to partnership programs on proprietary molecules owned by partners.
About WuXi STA
STA Pharmaceutical Co., Ltd. (WuXi STA), a subsidiary of WuXi AppTec, is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA offers our worldwide partners efficient, flexible and high-quality solutions for Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
For more information, please visit: http://www.STApharma.com
About WuXi AppTec
WuXi AppTec is a leading global pharmaceutical and medical device open-access capability and technology platform company with global operations. As an innovation-driven and customer-focused company, WuXi AppTec provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions. With its industry-leading capabilities such as small molecule R&D and manufacturing, cell therapy and gene therapy R&D and manufacturing, and medical device testing, WuXi platform is enabling nearly 3,000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi's dream that "every drug can be made and every disease can be treated." Please visit: http://www.wuxiapptec.com
