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News|Articles|January 11, 2021
WuXi STA Supports Approval from NMPA for Orelabrutinib from InnoCare
Author(s)Pharmaceutical Technology Editors
WuXi STA served as the marketing authorization holder (MAH) and offered end-to-end support, including drug substance, amorphous solid dispersion, tablet, and packaging for the product.
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STA Pharmaceutical (WuXi STA), a WuXi AppTec Company, announced on Jan. 6, 2020 that its partner, InnoCare, a biopharmaceutical company based in China, has received approval by the National Medical Products Administration of China (NMPA) for orelabrutinib, a Bruton Tyrosine Kinase inhibitor for the treatment of cancer and autoimmune diseases.
According to a WuXi company press release, WuXi STA served as the marketing authorization holder (MAH) and offered end-to-end support, including drug substance, amorphous solid dispersion, tablet, and packaging for the product. Additionally, WuXi STA’s facilities were inspected throughout September and October of 2020 and successfully passed the pre-approval inspection (PAI) by NMPA for orelabrutinib.
“We are excited that [o]relabrutinib was approved by NMPA,” said Dr. Jasmine Cui, InnoCare co-founder, chairman, and CEO, in the press release. “As our important partner of this innovative drug, WuXi STA has provided CMC [chemistry, manufacturing, and controls] 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.”
“We sincerely congratulate our partner InnoCare on the approval of [o]relabrutinib,” added Dr. Minzhang Chen, CEO of WuXi STA, in the press release. “The successful PAI is the result of close team collaboration between WuXi STA and our partner InnoCare.”
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