11/18/19: 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 in 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 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 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