US$6.5 billion acquisition of the company to obtain Johnson & Johnson's new FcRn antibody drug approved for clinical use in China

Text|Pharmaceutical Mission Hills

The Center for Drug Evaluation (CDE) of the National Medical Products Administration of China revealed that the new class 1 drug nipocalimab injection declared by Johnson & Johnson's Janssen company has obtained a clinical trial implied license, and plans to develop a treatment for systemic type.
Myasthenia gravis (gMG)
.
Public information shows that nipocalimab (M281) is a clinically-proven potential "best-in-class" anti-FcRn antibody, obtained from Johnson & Johnson's acquisition of Momenta for approximately US$6.

Screenshot source: CDE official website

Nipocalimab is an IgG1 antibody that binds to FcRn developed by Momenta.
It binds to FcRn to prevent FcRn from binding to disease-causing autoantibodies
.
The role of FcRn is to help the recycling and reuse of antibodies, thereby increasing the level of autoantibodies in the blood

According to data from a phase 2 study previously published by Momenta, nipocalimab treats systemic myasthenia gravis.
All four nipocalimab treatment groups showed improvement in the scores of the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale
.
In the single ascending dose (SAD) and multiple ascending dose (MAD) phase 1 clinical studies carried out in healthy volunteers, nipocalimab also demonstrated safety and tolerability and verified its mechanism

In the 98-day MAD study, the candidate drug showed no serious adverse events, was well tolerated, and reduced circulating IgG levels by up to 89%, with an average reduction of 84%
.
Momenta once stated in a press release that nipocalimab is designed to be an effectorless, high-affinity, pH-insensitive monoclonal antibody to improve patient life

The clinical data of this product supports its potential as a "best-in-class" anti-FcRn therapeutic drug to meet the unmet medical needs in immune-mediated diseases
.
Autoimmune diseases driven by autoantibodies include myasthenia gravis, hemolytic diseases of the fetus and newborns, as well as other serious skin diseases, rheumatism, nervous system diseases, blood system diseases and kidney diseases

Reference materials:

[1] Center for Drug Evaluation (CDE) of China National Medical Products Administration.