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Results For "National-Medical-Products-Administration"

54 News Found

Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC
Drug Approval | October 16, 2024

Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC

Enhertu demonstrated clinically meaningful efficacy in previously treated patients


Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer
Drug Approval | August 13, 2024

Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer

Third approval in China for AstraZeneca and Daiichi Sankyo’s Enhertu in less than two years


IOL Chemicals and Pharmaceuticals posts Q1 FY25 PAT at Rs. 29.7 Cr
News | August 10, 2024

IOL Chemicals and Pharmaceuticals posts Q1 FY25 PAT at Rs. 29.7 Cr

The company reported total income at Rs. 509.8 crore in Q1 FY25 as compared to Rs. 570.3 crore in Q1 FY24


Olverembatinib approved for commercialization in Macau China
Drug Approval | July 09, 2024

Olverembatinib approved for commercialization in Macau China

Olverembatinib, a novel drug developed by Ascentage Pharma with support from the National Major New Drug Development program


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