STA Pharmaceutical Co., Ltd., (WuXi STA), a subsidiary of WuXi AppTec, and Impact Therapeutics, a biotech company focused on developing anti-cancer therapeutics, have signed a strategic partnership agreement under which WuXi STA will become the preferred contract development and manufacturing partner of Impact Therapeutics. WuXi STA will provide services covering the entire product development process of Impact’s pipeline of new drug candidates for both drug substance and drug product. The new partnership aims to accelerate Impact Therapeutics’ new pipeline of drug candidates towards commercialization in China and the U.S.
 
Impact Therapeutics’ anti-cancer therapeutics pipeline includes PARP Inhibitors (IMP4297), Wee1 Inhibitors (IMP7068), DDR target Inhibitors and Hedgehog Pathway Inhibitors (IMP5471). Currently, IMP4297 is in Phase III 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.
 
“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 and chief executive officer of Impact Therapeutics.
 
Dr. Minzhang Chen, chief executive officer of WuXi STA, said, “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.”