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Overview of the Approval Trends of Pharmaceutical Products in the First Half of 2019
PharmaSources/Suyi
July 11, 2019
Clinically Imperative Overseas New Drugs Approved Accounting for a Larger Number
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NMPA grants priority review to BeiGene's sNDA for tislelizumab
biospectrumasia
July 08, 2019
The sNDA for tislelizumab as a potential treatment for patients with previously treated locally-advanced or metastatic UC was accepted by the NMPA in May 2019.
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Different Clinical Layouts of Chinese-produced Products for Marching into the Anti-PD-1 Monoclonal Antibody Market
PharmaSources/Xiaoyaowan
July 04, 2019
The marketing of camrelizumab means the beginning of the next stage of competition for layouts centering on multiple new indications.
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NMPA accepts NDA for biosimilar product candidate of Rituximab
biospectrumasia
June 28, 2019
IBI301 is a recombinant human-mouse chimeric anti-cell surface protein (anti-CD20) monoclonal antibody for injection co-developed by Lilly and Innovent for the treatment of non-Hodgkin's lymphoma (NHL) and other diseases.
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Henlius biosimilar HLX02 gets NDA acceptance from NMPA
biospectrumasia
May 09, 2019
HLX02 is a biosimilar developed by Henlius with independent intellectual property for the treatment of HER2 positive metastatic breastcancer (BC) and metastatic gastric cancer (GC)
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China National Medical Products Administration Approves Sinovant's Clinical Trial Application for Derazantinib
prnewswire
April 29, 2019
Sinovant Sciences today announced that its Clinical Trial Application (CTA) for derazantinib has been accepted by the Center for Drug Evaluation at the China National Medical Products Administration (NMPA)
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China’s NMPA approves Novartis’ Cosentyx and Merck’s Keytruda
pharmaceutical-technology
April 23, 2019
Novartis has announced that the Chinese National Medical Product Administration (NMPA) has approved its plaque psoriasis drug Cosentyx (secukinumab).
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Global Innovative Drugs Speeding up to Enter China with the Help from Policies
PharmaSources/1℃
April 17, 2019
The National Medical Products Administration (NMPA) and National Health Commission of China organized relevant experts on Mar. 28, 2019 to...
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NMPA approves Novartis's Cosentyx for psoriasis patients
biospectrumasia
April 03, 2019
Cosentyx is the first biologic approved in China that specifically inhibits interleukin-17A (IL-17A), a cornerstone cytokine involved in the inflammation of psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS)
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China National Medical Products Association Approves SPINRAZA
americanpharmaceuticalreview
March 01, 2019
Biogen announced that SPINRAZA has been approved by the China National Medical Products Association for the treatment of 5q spinal muscular atrophy,expanding the company’s presence in China.