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Results For "China-National-Medical-Products-Administration"

13 News Found

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


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


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


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


InnoCare announces priority review of Orelabrutinib for the treatment of R/R MZL by NMPA
News | September 06, 2022

InnoCare announces priority review of Orelabrutinib for the treatment of R/R MZL by NMPA

Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.


Ascletis announces IND approval of Oral RdRp Inhibitor ASC10 for COVID-19 by China NMPA
Drug Approval | August 22, 2022

Ascletis announces IND approval of Oral RdRp Inhibitor ASC10 for COVID-19 by China NMPA

Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA


China NMPA approves Tislelizumab for metastatic nasopharyngeal cancer
Drug Approval | June 12, 2022

China NMPA approves Tislelizumab for metastatic nasopharyngeal cancer

Tislelizumab is now approved in nine indications in China


InxMed raises US $ 15 million in Series B+ financing
Startup | May 09, 2022

InxMed raises US $ 15 million in Series B+ financing

The plan is to advance innovative therapies to drug-resistant cancers


Ascletis increases ritonavir production capacity to 530 million tablets a year
Biotech | March 14, 2022

Ascletis increases ritonavir production capacity to 530 million tablets a year

Ritonavir oral tablet is a pharmacokinetic booster of multiple oral antiviral drugs targeting viral proteases and a component of the approved oral antiviral drug Paxlovid (Nirmatrelvir 300 mg tablet + ritonavir 100 mg tablet co-administration package)


China approves BeiGene’s tislelizumab
Drug Approval | March 12, 2022

China approves BeiGene’s tislelizumab

Tislelizumab is now approved for seven indications in China