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News about "China NMPA"
Antengene Corporation receives CDE endorsement to begin pivotal phase 3 CLINCH-3 study of ATG-022
Antengene has received approval from China’s Center for Drug Evaluation to initiate the pivotal Phase 3 CLINCH-3 study of ATG-022, advancing the development of its innovative antibody-drug conjugate for CLDN18.2-positive gastric cancers.
China NMPA | 30/05/2026 | By News Bureau
XellSmart Secures Fourth FDA and NMPA Clearance for iPSC-Derived Cell Therapy Targeting MSA-P
XellSmart receives US FDA and China NMPA clearance for Phase I/II trials of its iPSC-derived neuron progenitor therapy for MSA-P, expanding its CNS pipeline spanning PD, ALS and spinal cord injury.
China NMPA | 03/03/2026 | By News Bureau | 203
GSK's Linerixibat Granted Priority Review in China for Cholestatic Pruritus in PBC
China’s drug regulator has accepted GSK’s linerixibat for priority review to treat cholestatic pruritus in primary biliary cholangitis, supported by Phase III data showing significant and sustained itch relief.
China NMPA | 27/02/2026 | By News Bureau | 173
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