Maiwei Biologics Submits Marketing Applications for 2 Biosimilar Drugs of Disulumab

ArticleMedicine Guanlan

On December 22, Maiwei Bio-Bio announced that the National Medical Products Administration (NMPA) of China has accepted the marketing application of two biosimilar drug varieties of Disulumab injection developed by its wholly-owned subsidiary Taikang Bio, namely 9MW0321 and 9MW0311

9MW0321 is a recombinant fully human anti-RANKL monoclonal antibody injection that can inhibit the activation of OPG/RANKL/RANK signaling pathway by binding to RANKL, thereby inhibiting tumor growth and reducing bone destruction, and is used to prevent solid tumors.

Bone is one of the common metastatic sites of malignant tumors, and the clinical needs are vast

According to the press release, during the clinical development stage, Maiwei Biologics carried out a comparative study on the pharmacokinetics of 9MW0321 and the original drug desulumab injection in healthy subjects with the original drug desulimab injection as a control.

The other 9MW0311 is also a recombinant fully human anti-RANKL monoclonal antibody injection, which is a biosimilar of the research drug Prololi, which is a researcher of disulfan antigen, and is used to treat osteoporosis in postmenopausal women

According to the press release, Disumab has been proven to significantly increase bone density and improve the osteoporosis of patients in clinical applications

Reference materials:

[1] The marketing application of 9MW0321, a biosimilar drug of Mabwell Biodisulumab injection, was accepted.