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Johnson & Johnson's new indication for daratumumab is about to be approved in China

 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 (English trade name: Darzalex) submitted in China (acceptance number: JXSS2000019/JXSS2000020) is already in the “approval” stage.

Multiple myeloma (MM) is an incurable hematological malignancy.

Regardless of the stage of the disease, CD38 is a protein that is highly expressed on multiple myeloma cells in all patients.

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.

The clinical application of Fuhong Henlius daratumomab biosimilar has been approved by the CDE by default on January 12 this year, and it intends to carry out clinical research on the treatment of multiple myeloma (MM).

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