合全药业与英派药业签署战略合作协议

昨日，子公司合全药业与专注于靶向抗癌新发的英派药业签署战略合作协议。根据协议，合全药业将成为英派药业在CDMO（合作研究开发生产）领域的首选合作伙伴，并在MAH制度下为其整个新药管线项目提供从原料药到制剂的管理，加速英派药业新药在美国和中国上市的进程。英派药业总裁、首席执行官包骏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。

合全药业首席执行官陈民章博士（图左）与英派药业首席执行官包骏博士（图右）合影

双方团队合影

英派药业致力于研发具有自主知识产权的靶向抗癌新药，公司产品管线丰富，包括PARP抑制剂（IMP4297）、Wee1抑制剂（IMP7068）、其他DDR靶点抑制剂及Hedgehog通路抑制剂（IMP5471）。合全药业与英派药业的合作开始IMP4297项目，从原料药（API）的研发生产，到制剂的开发，再到临床试验申请及后续临床批次生产，多年来合全为英派实现了该产品的一站式CMC服务。不仅如此，合全还利用自身的平台优势和深厚的技术储备为IMP4297项目提供了完善的处方前制剂开发及晶型研究和处方工艺研究，确定了优质稳定的晶型和处方工艺，为后续制剂的临床生产，新药注册和商业化打下了扎实的基础。目前，该项目（属于化药1.1类新药）在中国已开展三期临床试验，早期临床数据显示了同类更优的安全性及更宽的治疗窗口。

不久前，全国人民代表大会公布了新修订的《药品管理法》。新版的《药品管理法》专设了“药品上市许可持有人”（MAH）新章节，对持有人的条件、权利、义务、责任等做出了全面系统的规定。双方在这个大背景下签署战略合作，不仅进一步激发了创新药企的活力，还有利于整合资源配置，推动产业升级。此外，MAH制度更进一步强化了药品监管力度，并有助于提升药品的安全性和质量。

英派药业总裁、首席执行官包骏博士表示：“我们与合全药业多年来已经形成了良好的合作，英派在研的项目管线基本都在合全完成。专业的人做专业的事，我们相信合全药业全球领先的一体化CMC（化学，生产和控制）平台以及高效、灵活的解决方案，能帮助我们更快地将产品从临床试验推向商业化。”

合全药业首席执行官陈民章博士表示：“我们很欣喜地看到合作伙伴英派药业在管线进程上取得的突破。合全期待利用自身十多年来打造的规模优势和创新能力，以及符合全球标准的质量体系助力合作伙伴加快新药上市的进程，造福全球病患。“

关于英派药业

英派药业于2009年6月成立，致力于研发具有自主知识产权的用于治疗癌症等重大疾病的最佳同类药 (best-in-class)，并将其商业化。英派药业旗下注册有上海瑛派药业和澳大利亚英派药业两个子公司。英派药业以 DNA 损伤应答 (DNA Damage Response, DDR) 为重点靶标搭建研发平台，构建独特的产品管线。临床前实验数据和临床试验数据显示，英派药业的 IMP4297与 Olaparib 及其它已经上市的 PARP 抑制剂相比，在临床上可能表现出更好的药效和更低的毒性，有望开发成为一个 PARP 抑制剂最佳同类药。更多信息，请访问公司网站：www.impacttherapeutics.com

关于合全药业

合全药业是在中美两地均有运营的子公司，服务于生命科学行业，拥有卓越的化学创新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

WuXi STA Forms Strategic Partnership with Impact Therapeutics

Yesterday, STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – and Impact Therapeutics, a biotech focused on innovative drug discovery and development in anti-cancer therapeutics, announce the signing of a strategic partnership agreement. Under the terms of this agreement, WuXi STA will become the preferred Contract Development and Manufacturing Organization (CDMO) partner of Impact Therapeutics, providing services covering the entire product development process of Impact’s pipeline new drug candidates for both drug substance and drug product. The new partnership will accelerate Impact Therapeutics’ new pipeline drug development towards commercialization both in China and in the US.

Impact Therapeutics holds independent intellectual property rights for a diverse anti cancer therapeutics drug pipeline that includes PARP Inhibitors (IMP4297), Wee1 Inhibitors (IMP7068), DDR target Inhibitors and Hedgehog Pathway Inhibitors (IMP5471). Currently, IMP4297 is about to begin Phase III clinical trials in China, with early clinical data targeting better safety and a wider treatment window.

On August 26, 2019, the government of China passed amendments to the Drug Administration Law, which will take effect on December 1, 2019. The revised Drug Administration Law adds a new chapter to better establish the Drug Marketing Authorization Holder (MAH) System including new evaluation and approval systems. The collaboration between innovative pharmaceutical companies and their CDMO partners in this context is vital to optimize the resource allocation and accelerate the new drug development process. Furthermore, the MAH system will strengthen drug regulation and improve drug quality and safety.

“We have formed an excellent partnership with WuXi STA over the last few years, and almost all of our pipeline molecules are developed in partnership using their comprehensive service platform. We chose WuXi STA to be our preferred CDMO partner because of their dedication as well as their world-leading integrated CMC (Chemistry, Manufacturing and Control) platform. This means they are able to expedite our products from clinical trial to commercial launch much faster.” said Dr. Jun Bao, President & CEO of Impact Therapeutics.

Dr. Minzhang Chen, CEO of WuXi STA, commented: “We are delighted to see the breakthroughs being made by Impact Therapeutics’ diverse pipeline. We are looking forward to further leveraging the scale and innovation capabilities at WuXi STA, along with our global standard quality systems to help our partners accelerate the process of launching new drugs to benefit global patients.”

About Impact Therapeutics

Impact Therapeutics is a privately held clinical-stage biopharmaceutical company incorporated in Nanjing, China, dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. The lead program PARP inhibitor IMP4297 is ready for Phase 3 study in China. Impact has assembled most comprehensive global DNA damage response (DDR) pipeline of novel drug candidates generated by in-house discovery platform, and now is expanding to other novel synthetic lethality targets to broaden pipeline coverage. Impact has raised $46 million USD up to date invested by recognized venture capital firms including Lilly Asia Ventures. Currently series D fundraising is ongoing. For more information, please visit: www.impacttherapeutics.com

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