On January 11th, 2023, GRP received the years’ first IND approval from FDA.
The sponsor’s product, WS015, is indicated for Hyperuricemia (HUA). HUA is a metabolic disorder syndrome caused by a disorder of purine metabolism, and poorly controlled HUA will develop gout. WS015 dry suspension is an innovative polymer drug that does not absorb orally and does not enter the blood system, but specifically binds and absorbs uric acid and purine precursors in the gastrointestinal tract.
GRP will continue to support our Sponsor as their US Local Agent in the coming phases. GRP is committed to their success into the US Market.
If you would like to view the Sponsor’s Communication on this news. It is available on WeChat. See Link below.
About Global Regulatory Partners Group
Global Regulatory Partners, Inc (GRP) is a global provider of tailored clinical development, regulatory affairs, quality and pharmacovigilance services for pharma, biotech, medical devices and cosmetic industries worldwide. Global Regulatory Partners. Inc, has now over 6 affiliates in 6 countries (USA, Brazil, Mexico, Japan, China and Korea) and more than 500 satisfied clients worldwide.