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News about "National Medical Products Administration "
Junshi Biosciences expands toripalimab’s treatment footprint in China with regulatory approval for a new urothelial carcinoma indication, strengthening immunotherapy options for patients with advanced bladder cancer.
National Medical Products Administration | 25/05/2026 | By News Bureau
Chance Pharma Secures NMPA Acceptance for CXG87 Respiratory Drug NDA
Chance Pharma secures National Medical Products Administration acceptance of NDA for CXG87, marking its first filing and a key step toward commercialisation of a novel respiratory therapy.
National Medical Products Administration | 08/05/2026 | By News Bureau
GSK plc Secures China Approval for Blenrep Combination Therapy in Multiple Myelom
National Medical Products Administration approves Blenrep with bortezomib and dexamethasone for relapsed or refractory patients, backed by strong phase III trial outcomes.
National Medical Products Administration | 21/04/2026 | By News Bureau
Lynk Pharmaceuticals Secures NMPA NDA Acceptance for Zemprocitinib
Lynk Pharmaceuticals announces NMPA acceptance of Zemprocitinib NDA, backed by positive results from a phase-III randomised, double-blind, placebo-controlled clinical trial in China.
National Medical Products Administration | 11/04/2026 | By News Bureau
Altruist Biologics Wins First Commercial Manufacturing License for Hangzhou Facility
Altruist Biologics secures its first GMP commercial manufacturing license for its Hangzhou facility, featuring four 20,000L bioreactors. Achieved in just two months, this milestone highlights strong technical expertise and global-quality standards.
National Medical Products Administration | 09/04/2026 | By News Bureau | 131
National Medical Products Administration approves IND application for HBM7575/SKB575, a long-acting bispecific antibody developed by Harbour BioMed and Kelun-Biotech for treating atopic dermatitis.
National Medical Products Administration | 10/03/2026 | By News Bureau | 115
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.
National Medical Products Administration | 27/02/2026 | By News Bureau | 171
China Grants Priority Review to Leqembi Subcutaneous BLA
The Priority Review and Approval Procedure has been implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under this procedure, the assessment period is expected to be shortened.
National Medical Products Administration | 11/02/2026 | By News Bureau | 129
Delonix Bioworks Secures NMPA IND Clearance for MenB Vaccine Candidate DX-104
China grants IND approval for DX-104 after Australia CTN clearance, paving the way for Phase I trials of Delonix’s engineered Group B meningococcal vaccine.
National Medical Products Administration | 09/02/2026 | By News Bureau | 223
Akeso Secures Fifth NMPA Breakthrough Designation for Ivonescimab
The breakthrough designation supports ivonescimab combined with chemotherapy for first-line treatment of advanced Biliary Tract Cancer (BTC), based on an ongoing phase-III study comparing it with durvalumab-based chemotherapy.
National Medical Products Administration | 07/02/2026 | By News Bureau | 245
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