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News about "China NMPA"
Accro Bioscience's AC-101 Enters NMPA Rare Disease Development Pilot Program
Accro Bioscience’s AC-101, a novel selective RIPK2 inhibitor, enters the NMPA CDE Caring Plan-Extension pilot program for rare disease drug development.
China NMPA | 14/09/2026 | By News Bureau | 107
Eisai, Biogen Secure China Approval for Once-Weekly Leqembi Subcutaneous Autoinjector
China approves Leqembi’s once-weekly subcutaneous autoinjector, offering patients with early Alzheimer’s disease a more convenient at-home treatment option.
China NMPA | 04/09/2026 | By News Bureau
Harbour BioMed Secures China IND Approval for HBM7004 in Advanced Solid Tumours
NMPA clearance advances the B7H4xCD3 bispecific antibody toward clinical development, following promising preclinical efficacy and safety results and recent US FDA clearance.
China NMPA | 19/08/2026 | By News Bureau
NMPA Reviews QMS for Vaccine and Drug GMP Compliance
China's NMPA has completed a QMS management review to strengthen vaccine and drug Good Manufacturing Practice (GMP) compliance, supporting WHO WLA standards and PIC/S regulatory requirements.
China NMPA | 13/07/2026 | By News Bureau | 121
China Approves Hengrui Pharma's Water-Free Cyclosporine Eye Drop for Dry Eye Disease
China's drug regulator has approved Hengrui Pharma's Heng Yi, the country's first water-free 0.1 percent cyclosporine ophthalmic solution, expanding treatment options for patients with dry eye disease through Novaliq's EyeSol technology.
China NMPA | 03/07/2026 | By News Bureau | 139
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 | 149
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 | 370
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 | 310
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