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Since 2010, at the end of each year, The Antibody Society has published a report summarizing advances in the development of new drugs in the field of antibodies.
this year is the agency's 12th report.
16 antibody drugs, including antibody-coupled drugs, are under regulatory review in the U.S. or the European Union and have the opportunity to receive the world's first regulatory approval in 2021, according to the report.
However, the two drugs in the report were approved by the FDA in late December 2020: Margenza (margetuximab-cmkb): a HER2 targeted therapy developed by Retain pharmaceutical partner MarcroGenics, approved by the FDA for metastasis 2 positive breast cancer patients who have received ≥2 anti-herbal treatments, at least one of which is used to treat metastasis in adults.
The drug is a new Fc domain optimized immune-enhanced monoantigenist developed using TheMacroGenics proprietary Fc optimization technology platform, which has HER2 binding and anti-proliferation effects similar to curto-bead monoantigen, while its engineered Fc domain enhances the participation of the immune system.
it is worth noting that Margenza is the first HER2 targeted therapy to significantly improve progress-free lifetime (PFS) compared to crater bead monoantigen in head-to-head Phase 3 clinical trials.
- Ebanga (ansuvimab-zykl, mAb114): The drug, a single anti-drug developed by Ridgeback Biotherapeutics, has been approved by the FDA for use in adults and children, including newborns born to mothers who test positive for the Ebola virus RT-PCR in Zaire, to treat infections caused by the Zaire Ebolavirus virus.
Ebanga is the second Ebola treatment approved by the FDA after the regenerative meta-three-antibody cocktail therapy Inmazeb, which blocks the binding of the Ebola virus to a cell receptor and prevents the virus from entering the cell.
following is a combing of the remaining 14 antibody drugs in the report, supplemented by updates based on information on the company's website.
the top 10 antibody drugs (tanezumab, narsoplimab, evinacumab, aducanumab, tralokinumab, teplizumab, inolimomab, bimekizumab, anifrolumab, sutimlimab) is used for non-cancer adaptation, and the last 4 antibody drugs (oportuzumab monatox, dostarlimab, balstilimab, loncastuximab tesirine) are used for cancer adaptation.