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Results For "National-Medical-Products-Administration"

40 News Found

Zydus’ new drug application of Desidustat tablets accepted by China Medical System Holdings
Drug Approval | April 23, 2024

Zydus’ new drug application of Desidustat tablets accepted by China Medical System Holdings

Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients


NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer
Drug Approval | March 30, 2024

NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer

If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy


Briefs: IOL Chemicals and Pharmaceuticals and Auro Peptides
News | February 20, 2024

Briefs: IOL Chemicals and Pharmaceuticals and Auro Peptides

IOL Chemicals and Pharmaceuticals’ product approved by CDE of NMPA, China


Jiangsu Alphamab, 3D Medicines and Glenmark sign license agreement for Envafolimab
News | January 29, 2024

Jiangsu Alphamab, 3D Medicines and Glenmark sign license agreement for Envafolimab

Glenmark will be responsible for further developing, registering, and commercializing Envafolimab in India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America


Nucala approved in China for use in severe asthma with an eosinophilic phenotype
News | January 16, 2024

Nucala approved in China for use in severe asthma with an eosinophilic phenotype

Approval based on a separate phase III trial among Chinese patients reinforcing mepolizumab’s efficacy and safety data


Imfinzi plus chemotherapy approved in China as for metastatic biliary tract cancer
Drug Approval | November 16, 2023

Imfinzi plus chemotherapy approved in China as for metastatic biliary tract cancer

Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient


Jiangsu Hengrui Pharmaceuticals gets NMPA approval of oteseconazole Ccapsules
Drug Approval | August 22, 2023

Jiangsu Hengrui Pharmaceuticals gets NMPA approval of oteseconazole Ccapsules

Oteseconazole Capsules were found to be safe and more effective than fluconazole


Kintor Pharma completes first patient enrollment in long-term safety phase III trial of KX-826
News | July 21, 2023

Kintor Pharma completes first patient enrollment in long-term safety phase III trial of KX-826

The Long-term Safety Trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023


Innovent announces 2nd BTD by NMPA for Olverembatinib for treatment of patients with SDH-deficient GIST
Biotech | June 03, 2023

Innovent announces 2nd BTD by NMPA for Olverembatinib for treatment of patients with SDH-deficient GIST

Olverembatinib is the first and only third-generation BCR-ABL inhibitor approved in China for the treatment of adult patients with tyrosine kinase inhibitors


ENHERTU approved in China for patients with HER2 positive metastatic breast cancer treated withantiHER2-based regimens
News | February 28, 2023

ENHERTU approved in China for patients with HER2 positive metastatic breast cancer treated withantiHER2-based regimens

First approval for Daiichi Sankyo and AstraZeneca’s ENHERTU in China