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The first domestic CAR-T cell product was recognized as a breakthrough therapeutic product, and the R&D investment exceeded 700 million yuan

 Last Update: 2021-09-05
 Source: Internet
 Author: User

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On August 17, Shanghai Fosun Pharmaceutical (Group) Co.

According to the official website of CDE, the deadline for the publication of "Breakthrough Therapy" application for Akirensai injection is August 16, 2021

Source: CDE official website

On June 22, Fosun Kate announced that the National Medical Products Administration has formally approved its new drug application for the treatment of human CD19 autologous CAR-T cell therapy product Akirensai injection.

Akilunza injection is the target for Fosun Kite to introduce Yescarta (Axi-Cel), the world’s first CAR-T product approved for the treatment of non-Hodgkin’s lymphoma from Kite, for technology transfer and authorized for local production in China.

At present, Akirensai injection has been officially listed, but the official price has not been announced

Image source: official website of the National Medical Insurance Administration

According to the "Working Procedures for the Evaluation of Breakthrough Therapy Drugs (Trial)" issued by the State Food and Drug Administration in July this year, the Center for Drug Evaluation will communicate and exchange priority allocation resources for drugs included in the Breakthrough Therapy Program, strengthen guidance and promote drug research and development , Accelerate listing

Up to now, five CAR-T therapies have been approved for the market worldwide.

5 CAR-T products approved by the U.

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