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The First Bladder Cancer Targeted Therapy Filed the Import Drug Clinical Trial Applications to Start the Road of Marketing in China
PharmaSources/Xiaoyaowan
December 04, 2019
According to the CDE website, the Erdafitinib Tablets developed by Janssen under J & J has recently been filed the import drug clinical trial applications in China ...
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Forging Ahead-About Chinese Pharmaceutical Enterprises’ Passing of WHO PQ
PharmaSources/zhulikou431
December 03, 2019
As a significant part of the world pharmaceutical industry, the Chinese pharmaceutical industry has undoubtedly been deeply involved in each link of the cooperation and ...
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The injection consistency evaluation may be comprehensively implemented as the NMPA takes frequent actions (1)
PharmaSources/zhulikou431
November 14, 2019
Technicians of pharmaceutical enterprises have significantly more to learn in the second half of 2019 with the promulgation of the Drug Administration Law (2019 Revision).
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The injection consistency evaluation may be comprehensively implemented as the NMPA takes frequent actions (2)
PharmaSources/zhulikou431
November 14, 2019
Point 1: Applicants must comprehensively understand the products applied for
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The injection consistency evaluation may be comprehensively implemented as the NMPA takes frequent actions (3)
PharmaSources/zhulikou431
November 14, 2019
Point 7: The quality research must follow the ideas of ICH Q8 Guideline
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History of the “Sky-high Priced” Imported Drug to China: Nusinersen Injection
PharmaSources/zhulikou431
November 14, 2019
Nusinersen Injection, the world’s first SMA (Spinal Muscular Atrophy) precision targeted therapy, was completed the intrathecal injection to the first SMA patients in China on Oct. 10, 2019, marking a new milestone of SMA treatment.
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Another Anti-PD-L(1) Monoclonal Antibody Filed the IND Application in China to Join the 40+ Applicants! Sales of Keytruda to Rank Second in the World in 2019
PharmaSources/1°C
November 14, 2019
MSD released the Q3 financial report on Oct. 29, 2019. Its figures, especially the figures of its oncology business, were no longer shining, with keywords including Keytruda, Gardasil 9, and China.
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Shanghai Green Valley’s Class 1 New Drug for Alzheimer’s Disease Conditionally Approved for Marketing and Already Having the Registration Approval!
PharmaSources/Caicai
November 14, 2019
The National Medical Products Administration of China (NMPA) released on its website yesterday (Nov. 2, 2019) some big news that shocks the industry.
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Breaking News! China’s Humira Biosimilar Produced by Bio-Thera to be Marketed Soon
PharmaSources/Caicai
November 05, 2019
The marketing application of Bio-Thera’s adalimumab (acceptance No.: CXSS1800018) has recently been under the “under approval” status, which is expected to be approved for marketing soon for treating ankylosing spondylitis (AS).
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The approval of Salubris’ Teriparatide is making waves again in the osteoporosis drug market in China
PharmaSources/Dopine
October 29, 2019
The second teriparatide biosimilar will arrive in China and is expected to churn the market.