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News about "National Medical Products Administration "
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
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
Tenacia and Golden Age Health Partner to Commercialise Ztalmy for CDKL5 Deficiency Disorder in China
Tenacia Biopharmaceuticals has granted Golden Age Health exclusive rights to commercialise Ztalmy, the first approved therapy for CDKL5 deficiency disorder, in Mainland China.
National Medical Products Administration | 03/02/2026 | By News Bureau
China Approves Nucala from GSK for Adult COPD Treatment
China has approved Nucala (mepolizumab) for adult COPD, supported by phase-III MATINEE and METREX trials showing reduced exacerbations in patients with blood eosinophil counts from 150 cells/µL.
National Medical Products Administration | 06/01/2026 | By News Bureau | 169
China Approves Azstarys for ADHD Treatment
ArkBio secures NMPA nod for once-daily ADHD treatment in China.
National Medical Products Administration | 06/01/2026 | By News Bureau | 110
HUTCHMED Gets Priority Review in China for Fanregratinib NDA
HUTCHMED’s NDA for fanregratinib in second-line intrahepatic cholangiocarcinoma has been accepted in China with priority review status, supported by data from a phase II registration trial addressing a high-unmet-need liver cancer indication.
National Medical Products Administration | 02/01/2026 | By News Bureau
Innovent TABOSUN Becomes China's First Approved Domestic Anti CTLA 4 Antibody
Innovent Biologics has received approval from China’s National Medical Products Administration (NMPA) for TABOSUN (Ipilimumab N01 Injection), marking the country’s first domestically developed anti-CTLA-4 monoclonal antibody and a significant milestone in China’s immuno-oncology landscape.
National Medical Products Administration | 26/12/2025 | By News Bureau | 142
WestGene Secures Dual IND Approvals for EB Virus-Related mRNA Therapeutic Cancer Vaccine
WestGene Biopharma has announced that its mRNA therapeutic cancer vaccine, WGc-043, has received dual IND approvals from China's National Medical Products Administration (NMPA) and the US FDA.
National Medical Products Administration | 09/08/2024 | By Aishwarya | 385
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