STA Pharmaceutical partner Innocare has received approval by the National Medical Products Administration of China (NMPA) for Orelabrutinib. Under the marketing authorisation holder (MAH) policy, WuXi STA provided support including drug substance, amorphous solid dispersion, tablet and packaging for this product. With four of its sites inspected at the same time, WuXi STA successfully passed the pre-approval inspection (PAI) for Orelabrutinib from NMPA.
From September 15 to October 3 in 2020, the 18-day PAI involved four WuXi STA’s sites in China spanning drug substance manufacturing, amorphous solid dispersions manufacturing using spray dried dispersion, tablet manufacturing, and drug substance process R&D, drug product R&D and clinical materials manufacturing. All of them successfully passed the inspection without major observations and key observations. WuXi STA says its integrated quality system ensured streamlined process and efficient collaboration among different functional teams in different locations.
InnoCare co-founder, chairman, and CEO Dr Jasmine Cui said: “We are excited that Orelabrutinib was approved by NMPA. As our important partner of this innovative drug, WuXi STA has provided CMC support from clinical trials to commercialization, and successfully passed PAI for Orelabrutinib. We look forward to working with WuXi STA to address more unmet medical needs.”
Dr Minzhang Chen, CEO of WuXi STA, commented: “We sincerely congratulate our partner InnoCare on the approval of Orelabrutinib. The successful PAI is the result of close team collaboration between WuXi STA and our partner InnoCare. We will continue to leverage our industry-leading technical capabilities, along with our end-to-end CMC platform to empower our partners to accelerate their pathway to market for the benefit of global patients.”
