▎药明康德/报道
中国上海，2020年1月3日——药明康德子公司合全药业今日宣布，其位于常州市的寡核苷酸原料药公斤级生产车间正式投入运营。这一重要里程碑标志着合全药业能够为全球客户提供寡核苷酸原料药从临床前到商业化的一站式工艺开发及生产服务，赋能客户推动寡核苷酸的创新疗法早日进入市场，造福全球病患。
▲寡核苷酸公斤级合成操作间
近年来，核酸药物的研究逐渐成为全球创新药领域的热门方向，更有多款核酸药物获FDA批准上市。为了帮助客户加速新药上市，合全药业不断加强寡核苷酸平台建设。此次投入运营的生产车间面积为2800平方米，坐落于合全药业常州原料药研发及生产一体化基地。投产后，常州基地的寡核苷酸原料药单批合成最大规模将会上升到1摩尔（mol），能够更好地满足客户日益增长的需求。目前合全药业的寡核苷酸平台能够支持各种类型的寡核苷酸产品，如脱氧核糖核酸（DNA），核糖核酸（RNA）和吗啉代反义寡核苷酸（PMO）以及多肽共轭的吗啉代反义寡核苷酸（PPMO）等。此外，合全药业依托其业界领先的小分子工艺研发及生产平台，在处理复杂的寡核苷酸与其他分子形式的偶联化学，以及开创固相、液相相结合的新一代寡核苷酸合成技术方面具有独到优势。“借助于合全药业小分子CMC（化学、生产和控制）平台的规模优势、技术能力以及符合全球标准的质量体系，我们为寡核苷酸新药开发者提供了强大的一站式赋能平台。”合全药业首席执行官陈民章博士表示，“此次公斤级生产车间正式投入运营，将帮助全球客户将更多的寡核苷酸药物早日推向商业化，造福全球病患。”目前，合全药业常州基地可为全球客户提供涵盖小分子、寡核苷酸和多肽等多种分子形式的原料药从临床前到商业化的工艺研发及生产服务。该基地近年来还多次通过包括美国食品药品监督管理局（FDA）及中国国家药品监督管理局（NMPA）的检查，拥有符合国际标准的质量体系。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临床前到商业化，高效、灵活、高质量的一站式CMC（化学、生产和控制）解决方案。更多信息，请访问公司网站：www.STApharma.com.cn药明康德（股票代码：603259.SH/2359.HK）为全球生物医药行业提供全方位、一体化的新药研发和生产服务。通过赋能全球制药、生物科技和医疗器械公司，药明康德致力于推动新药研发进程，为患者带来突破性的治疗方案。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和高效的研发服务，助力客户提升研发效率，服务范围涵盖化学药研发和生产、细胞及基因疗法研发生产、医疗器械测试等领域。目前，药明康德的赋能平台正承载着来自全球30多个国家的3700多家合作伙伴的研发创新项目，致力于将更多新药、好药带给全球病患，早日实现“让天下没有难做的药，难治的病”的愿景。更多信息，请访问公司网站：www.wuxiapptec.com
WuXi STA Opens Oligonucleotide Large-Scale Manufacturing Facility
State-of-the-art facility expands WuXi STA's capacity and capability for this novel modality, providing a one-stop shop from preclinical to commercial
Shanghai, January 3, 2020: STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – today announced the opening of its large-scale oligonucleotide active pharmaceutical ingredient (API) manufacturing facility in Changzhou, China. This significant milestone marks WuXi STA's establishment of a comprehensive one-stop platform to support the process R&D and manufacture of oligonucleotide APIs from preclinical to commercial. It enables customers around the world to advance promising new oligonucleotide therapies more rapidly to market for the benefit of patients.
Nucleic acid drugs have gradually become a hot area in the global innovative drug industry and many nucleic acid drugs have been approved by the U.S. FDA in recent years. To help customers accelerate new drugs to market, WuXi STA is continuously strengthening its oligonucleotide platform. The new facility, with over 30,000 square feet, is located at WuXi STA's Changzhou site. With its operation, the Changzhou site can manufacture oligonucleotide APIs up to 1 mol/synthesis run, to better meet the increasing demand of our customers.WuXi STA's comprehensive platform covers the development and manufacturing of a variety of oligonucleotide modalities including DNA, RNA, Morpholino oligonucleotide (PMO) and peptide conjugates (PPMO). In addition, the company's industry-leading small molecule process chemistry organization adds further value in handling complex conjugation chemistry that involves oligonucleotide and other molecular modalities, as well as a combination of solid and solution phase chemistry to support next-generation oligonucleotide manufacturing technology development. "By leveraging our small-molecule CMC (Chemical, Manufacturing, and Control) technology and capability platform as well as global standard quality system, WuXi STA provides a robust one-stop shop for oligonucleotide innovators. The opening of this large scale manufacturing facility will empower more global partners to expedite the development and commercialization of oligonucleotide drugs to benefit patients worldwide," commented Dr. Minzhang Chen, CEO of WuXi STA.WuXi STA's Changzhou site can now provide services involving small molecule, oligonucleotide and peptide process R&D and manufacturing from laboratory to commercial scales. During the past years, it has successfully passed multiple inspections from the U.S. Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA), adhering to the highest regulatory standards.
About WuXi STA
STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec (WuXi STA), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences 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 integrated CMC (Chemical, Manufacturing, and Control) solutions from preclinical to commercial uses. For more information, please visit: http://www.STApharma.com
About WuXi AppTec
WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 3,700 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that "every drug can be made and every disease can be treated." Please visit: http://www.wuxiapptec.com