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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.
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To Accelerate Linking up with the International Standards, China Making Efforts to Join PIC/S, Another World-class Organization
PharmaSources/Dishui Sinan
January 30, 2019
The “Work Plan for 2019” of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) was fresh out on Jan. 1, 2019, and the news “China will Join PIC/S, Another World-class Organization...
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Amgen receives NMPA approval for Repatha in China
biospectrumasia
January 29, 2019
Repatha is an innovative biologic medicine proven to effectively lower LDL-C
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Bio-Thera Solutions Files IND for Phase 1 Clinical Trial with BAT8003
americanpharmaceuticalreview
December 29, 2018
Bio-Thera Solutions announced the company has filed an Investigational New Drug Application (IND) with the China National Medical Products Administration (NMPA) for the company's anti-Trop2 Antibody-Drug Conjugate (ADC)....
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Chi-Med announces commercial launch of Elunate
biospectrumasia
November 28, 2018
Elunate is for the treatment of patients with metastatic colorectal cancer (CRC) that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan.
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China's NMPA approves Gilead's Vemlidy for HBV
biospectrumasia
November 20, 2018
HBV is highly prevalent in China with an estimated 20 million people meeting current guidelines for therapy accounting
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China's NMPA approves Gilead's Vemlidy for HBV
biospectrum
November 20, 2018
HBV is highly prevalent in China with an estimated 20 million people meeting current guidelines for therapy – accounting for almost one-third of all patients currently requiring therapy worldwide.
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NMPA Accepts Biosimilar New Drug Application for IBI303, a Biosimilar Candidate to Humira (adalimumab)
firstwordpharma
November 14, 2018
Innovent Biologics, Inc. (Innovent) (HKEX: 1801), a world-class China-based biopharmaceutical company that develops
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I-Mab and Genexine Announce China IND Approval for Innovative Immunotherapy
pharmafocusasia
November 05, 2018
I-MAB Biopharma Co., Ltd., a Shanghai-based biotech company exclusively focused on innovative biologics in immuno-oncology and autoimmune diseases...
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China approves first "Made in China" cancer drug
biospectrumasia
September 07, 2018
The colorectal cancer drug developed by Chi-Med are to be marketed in China under the brand name Elunate