合全药业与爱科百发宣布建立工艺研发和生产的战略合作
WuXi STA and Ark Biosciences Sign CMC Development and Manufacturing Agreement
药明康德子公司合全药业与专注于创新药，特别是抗病毒和呼吸系统疾病药物研发的生物制药公司爱科百发签署战略合作协议，在工艺研发和生产方面为爱科百发提供“端到端”的一站式服务，在药品上市许可持有人制度（MAH）下助力爱科百发加速新药研发。爱科百发创始人、首席执行官邬征博士及合全药业首席执行官陈民章博士等共同出席了签约仪式。
双方签约仪式现场合影
作为一家专注于创新药物研发的生物制药公司，爱科百发在拥有自主研发项目的基础上，还积极引进外部研发项目，其首款抗呼吸道合胞病毒（RSV）新药ziresovir已在全球完成三项1期临床试验，国际多中心2期临床进展顺利；去年8月再次引进一款潜在新药并拥有其全球权益，用于治疗特发性肺纤维化。此次与合全药业建立战略合作关系，爱科百发正是看中了合全药业业界领先的从临床前到商业化， 从API到制剂的一体化CMC（化学，生产和控制）平台，以及符合全球标准的质量体系。同时，随着药品上市许可持有人制度（MAH）在国内日趋完善，爱科百发希望依托合全药业这个成熟的平台来更快速地优化制药工艺、降低生产成本、控制风险、提高经营效率，并加快新药上市的步伐。
“我们非常高兴能与合全药业这样一家在业内享有盛名的新药CDMO（合作研究开发生产）企业签署战略合作协议。” 爱科百发创始人、首席执行官邬征博士表示，“合全药业成熟的赋能平台和业界领先的规模及创新能力定会助力我们事半功倍。有了合全的协助，我们能够将主要精力放在产品研发和管线扩展上，并加速从临床向商业化迈进。”
合全药业首席执行官陈民章博士表示：“我们很高兴能与爱科百发成为战略合作伙伴。赋能客户，并助力其加速推动新药从临床到商业化是合全药业的使命。我们将与爱科百发携手共进，早日将更多抗病毒和呼吸系统疾病的新药推向市场，造福广大病患。”
关于爱科百发
爱科百发是一家面对全球市场，专注于创新药，特别是抗病毒和呼吸系统疾病新药研发的生物制药公司。公司办公室位于上海张江高科技园区，在苏州工业园区设有研发中心。爱科百发拥有自主研发和外部引进的药物研发项目，正在开展中国和全球临床试验。
如需获取更多信息，请访问：
www.arkbiosciences.com
或 www.arkbiosciences.com.cn
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
WuXi STA and Ark Biosciences Sign CMC Development and Manufacturing Agreement
STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – and Ark Biosciences, a global biotech company focusing on innovative drug discovery and development, especially in the area of viral infection and respiratory disease, today announced a strategic partnership for CMC development and manufacturing.
Under the terms of the collaboration, Ark Biosciences will utilize the Marketing Authorization Holder (MAH) scheme to accelerate drug development and WuXi STA will provide an integrated solution in process R&D and manufacturing.
Ark Biosciences’ pipeline includes active discovery programs of its own, those of its partners, as well as in-licensed drug assets for clinical development. Ark’s leading program, a novel respiratory syncytial virus (RSV) F-protein inhibitor Ziresovir (AK0529), has completed three phase I clinical trials and is currently in global multi-center phase II clinical trial. The company also entered into a license agreement with Roche in August 2018 for the global rights of a potential new standard-of-care treatment for idiopathic pulmonary fibrosis.
WuXi STA was selected as the strategic partner thanks to its industry leading “end-to-end” CMC platform for new drug development from preclinical to commercial – for both API and finished dosage forms – as well as its expertise and track record for meeting global quality standards. The company is at the forefront of implementing China’s MAH pilot program and is helping many domestic innovative drug development partners. By using WuXi STA, partners are able to optimize manufacturing processes, significantly reduce commercial production costs, mitigate business risk, and improve operational efficiency.
“We’re delighted to partner with such a well-respected, world-class CDMO such as WuXi STA,” said Dr. Jim Wu, CEO of Ark Biosciences. “WuXi STA’s enabling end-to-end CMC platform, scale, and innovation capabilities will help us to move our drug candidates from the clinical-stage to commercialization more efficiently.”
Dr. Minzhang Chen, CEO of WuXi STA, commented: “Our mission is to empower and accelerate customers to develop innovative drugs from clinical to commercial – faster and more efficiently. We are delighted to become the strategic partner of Ark Biosciences and look forward to helping them advance their drug candidates towards the clinic, bringing innovative medicines for the benefit of patients around the world.”
About ARK BIOSCIENCES
ARK BIOSCIENCES is a global biotechnology company focusing on innovative drug discovery and development, especially in the fields of infection and respiratory disease, for world-wide markets. It has its corporate office in the Zhangjiang Hi-tech Park of Shanghai, and its R&D Center in Suzhou Biobay, the heart of pharmaceutical innovation in China. ARK BIOSCIENCES has its own active discovery programs, active development partnerships, and licensed drug assets under development.
For more information, please visit:
www.arkbiosciences.com
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
