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Results For "National-Medical-Products-Administration"

56 News Found

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


Chindex Medical acquires 10 ViewRay MRIdian Systems for advanced cancer treatment
News | January 06, 2023

Chindex Medical acquires 10 ViewRay MRIdian Systems for advanced cancer treatment

Purchase agreement with ViewRay will make state-of-the art precision radiation therapy available in China


InnoCare get approval of Tafasitamab with Lenalidomide for the treatment of refractory diffuse large B-Cell lymphoma in Hong Kong
Drug Approval | December 31, 2022

InnoCare get approval of Tafasitamab with Lenalidomide for the treatment of refractory diffuse large B-Cell lymphoma in Hong Kong

Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration and European Medicines Agency


WuXi STA launches parenteral formulation manufacturing line at Wuxi
News | December 01, 2022

WuXi STA launches parenteral formulation manufacturing line at Wuxi

This is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units


Lynparza approved in China as first-line maintenance treatment with Bevacizumab for HRD- positive advanced ovarian cancer
Drug Approval | September 23, 2022

Lynparza approved in China as first-line maintenance treatment with Bevacizumab for HRD- positive advanced ovarian cancer

One in two women with advanced ovarian cancer has an HRD-positive tumor