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Johnson & Johnson's blockbuster CD38 monoclonal antibody daratumomab subcutaneous injection approved in China

 Last Update: 2021-10-21
 Source: Internet
 Author: User

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Article source: Medical Rubik's Cube Info

Author: Shi Bei

On October 11, the official website of the State Food and Drug Administration showed that Johnson & Johnson's CD38 monoclonal antibody daratumomab injection (subcutaneous injection) has been approved for marketing by NMPA for the treatment of patients with primary light chain amyloidosis

Daretuzumab subcutaneous injection is a fixed-dose compound composed of Daretuzumab and recombinant human hyaluronidase PH20 (rHuPH20), and the trade name is DARZALEX FASPRO

Clinical data shows that compared with intravenous injections, subcutaneous injections have a similar overall response rate and pharmacokinetic characteristics, and only need about 3-5 minutes, while intravenous injections require several hours

An open-label, randomized, active controlled trial code-named ANDROMEDA (NCT03201965) evaluated VCd (bortezomib, cyclophosphamide, dexamethasone) with or without DARZALEX FASPRO in newly diagnosed patients with light chain amyloidosis Curative effect

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

Medicine Rubik's Cube NextPharma

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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