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Johnson & Johnson CD38 monoclonal antibody new indication approved in China, sales of 4.19 billion U.S. dollars in 2020

 Last Update: 2021-05-10
 Source: Internet
 Author: User

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Recently, the official website of the State Food and Drug Administration showed that Xi’an Janssen’s application for new indications for Darzalex injection (Darzalex) in China (acceptance number: JXSS2000019/20) has been approved by the NMPA.

Xi'an Janssen submitted a listing application for this indication to NMPA in April 2020, and was included in the priority review by CDE in October 2020.

Multiple myeloma (MM) is an incurable hematological malignancy.

CD38 is highly expressed in multiple myeloma cells.

Daratumumab is the first fully human monoclonal antibody targeting CD38 approved globally and domestically.

Medicine Rubik's Cube NextPharma

In addition, Xi'an Janssen submitted a listing application for Darzalex Faspro in China on November 6 last year.

In addition, the clinical application of Fuhong Henlius daratumumab biosimilar drug was granted the default approval of CDE on January 12 this year.

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