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The drug regulatory landscape in China: Progress and Reform Deborah Seah
April 20, 2023
Since 2015 when drug approval policies and process have begun its reform, China has seen improvements in both the speed and predictability of drug approvals over the past few years.
Monthly Pharma News Review of PharmaSources (February) - Chinese Drug review and approval Caicai/PharmaSources
March 14, 2023
The anti-PD-L1 monoclonal antibody Adebrelimab from Hengrui Pharmaceuticals was approved for marketing, and the Class 3 chemotherapy Limaprost tablets from Sino Biopharm were approved for marketing.
Monthly News Review of PharmaSources (February) - R&D Caicai/PharmaSources
March 13, 2023
In R&D, Chipscreen chidamide Ⅲ test reaches preset indicators, the company plans to submit an application for the marketing of a new indication.
Weekly Pharmaceutical News Review | PharmaSources.com (Feb. 28th to March.4th) PharmaSources.com
March 16, 2022
The most talked-about news of this week is the successful overseas marketing of Nanjing LEGN.US's CAR-T, which not only demonstrates the strength of China's innovative biologics but also eases the anxiety of Chinese innovative drug companies.
CDE Issues Document to Promote the Launch Progress of COVID-19 Vaccines, Global Overiew of 7 Vaccine Clinical Trials PharmaSources/Xiaoyaowan
August 21, 2020
CDE Issues Document to Promote the Launch Progress of COVID-19 Vaccines, Global Overiew of 7 Clinical Trials.
The Second CAR-T Therapy in China Applied for Marketing PharmaSources/Dopine
July 01, 2020
On June 30, according to the official website of CDE, the marketing application of a CAR-T therapy, JWCAR029 by JW Therapeutics was accepted by CDE.
Novartis' Global Innovative siRNA Long-Acting Lipid-lowering Therapy Submitted Clinical Application in China PharmaSources/Xiaoyaowan
July 01, 2020
On June 28, the CDE official website showed that Novartis' siRNA long-acting lipid-lowering drug Inclisiran submitted a clinical application in China and has been accepted and accepted.
Yangtze River Receiving Another 2 Clinical Trial Implied Permissions CPhI.CN
April 27, 2020
Yangtze River Receiving Another 2 Clinical Trial Implied Permissions in the Battle for the First Generic of the Blockbuster MM Drug Pomalidomide.
LianBio Announces Mavacamten Granted Breakthrough Therapy Designation in China PharmaSources.com
February 16, 2022
LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines...
The 7th Enterprise Applying for CAR-T in China: What are the Advantages of Unicar? Dopine
February 26, 2018
2017 was an important node in the development of CAR T-cell immunotherapy, where the two cell immunotherapies of Novartis and Gilead were successively approved by FDA.

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