STA Pharmaceutical (WuXi STA), the subsidiary of WuXi AppTec, has become the prefered CDMO partner of Impact Therapeutics, the Shanghai-based biotech company focused on anti-cancer drug discovery and development.
Under the terms of this agreement, WuXi STA will provide services covering the entire product development process of Impact’s pipeline new drug candidates for both drug substance and drug product.
The partnership aims to accelerate Impact Therapeutics' anti-cancer drug pipeline towards commercialisation in China and in the US.
“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 can expedite our products from clinical trial to commercial launch much faster,” said Dr Jun Bao, President & CEO of Impact Therapeutics.
Anti-cancer therapeutics
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.
Regulatory approvals
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 the new evaluation and approval systems.
The collaboration between innovative pharmaceutical companies and their CDMO partners in this context is vital to optimise the resource allocation and accelerate the new drug development process.
Furthermore, the MAH system will strengthen drug regulation and improve drug quality and safety. 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.”
