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Results For "National-Medical-Products-Administration"

75 News Found

HUTCHMED’s Fanregratinib gains priority review in China for aggressive liver cancer
News | January 01, 2026

HUTCHMED’s Fanregratinib gains priority review in China for aggressive liver cancer

ICC is a highly aggressive liver cancer arising from the intrahepatic biliary epithelium


CARsgen submits INDs for next-gen CAR-T therapy targeting hard-to-treat blood cancers
Clinical Trials | December 31, 2025

CARsgen submits INDs for next-gen CAR-T therapy targeting hard-to-treat blood cancers

The applications aim to launch Phase Ib/II trials for relapsed/refractory multiple myeloma and primary plasma cell leukemia, respectively


ENHERTU gains first-ever nod in China for metastatic breast cancer
Drug Approval | December 29, 2025

ENHERTU gains first-ever nod in China for metastatic breast cancer

The approval follows results from the DESTINY-Breast06 phase 3 trial, which showed ENHERTU significantly extended progression-free survival compared to chemotherapy


Sanofi secures two breakthrough nods in China for rare blood disorders
News | December 16, 2025

Sanofi secures two breakthrough nods in China for rare blood disorders

Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia


Innovent Biologics’ experimental weight-loss drug achieves breakthrough in Phase 3 trial
Clinical Trials | November 21, 2025

Innovent Biologics’ experimental weight-loss drug achieves breakthrough in Phase 3 trial

Innovent plans to soon submit a new drug application (NDA) to China’s National Medical Products Administration


Glenmark secures China approval for Ryaltris
Drug Approval | November 10, 2025

Glenmark secures China approval for Ryaltris

The approval granted with zero supplementation requests is an important milestone in Glenmark’s respiratory pipeline


Leqembi wins NMPA nod for once-monthly IV dosing in early Alzheimer’s patients
News | September 30, 2025

Leqembi wins NMPA nod for once-monthly IV dosing in early Alzheimer’s patients

LEQEMBI was initially approved in China in January 2024 for the treatment of Alzheimer’s disease in patients with mild cognitive impairment