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Screenshot source: CDE official website MIL62 is based on the independent innovation of Tianguang biological glyco-based transformation antibody technology platform research and development products, the target of action is CD20.
It can specifically bind to CD20 proteins on B cells and kill lymphocytes from B cells or B cells in the immune system through a variety of mechanisms, including antibody-dependent cell-mediated cytotoxicity (ADCC), cytoxicity (CDC), direct apoptosis, antibody-mediated phagocytosis (ADCP).
, as a type II CD20 antibody, MIL62 has different anti-tumor mechanisms compared with type I CD20 antibody, according to Tianguangshi Bioreclosed Data.
based on type II antibodies and tumor cells have a stronger binding stability, on this basis, if the antibody Fc and Fc-Rs affinity can be further modified, the ADC effect of antibodies can be increased hundreds of times.
because of the unique binding table of type II antibodies to CD20, it causes the recombination of the cytoskeleton protein actin Actin, which leads to homogenous adhesion between cells and causes strong cell death induction effects.
anti-CD20 antibody action mechanism (Screenshot Source: References) This MIL62 injection has been tacitly approved by clinical trials and is intended to be developed for lupus nephritis.
it is learned that the study for the evaluation of MIL62 combined with McCorvey ester capsules and other standard treatment of lupus nephritis dose increase 1b study, evaluation of safety, pharmacogenetics, preliminary clinical efficacy, immunogenicity.
followed by randomized, double-blind, placebo-controlled clinical phase 2 studies with a 76-week total renal remission rate (CRR).
It's worth noting that the CD20 antibody Ottoju monoantigen, previously developed by Roche, has completed Phase 2 clinical trials, and the results show that type II CD20 antibodies benefit patients with lupus erythematosus nephritis, for which it has also been recognized by the FDA as a breakthrough therapy.
lupus nephritis is one of the most common secondary immunonephroidal globitis diseases in China, with 539,600 cases of lupus nephritis in China in 2019, according to statistics.
in China, nearly half of patients with systemic lupus erythematosus have lupus nephritis.
that the approval of the MIL62 injection of Tianguang Bio means that the new drug is about to be clinically explored in the field of lupus nephritis.
addition, MIL62 injections have previously been approved for a number of clinical trials in China.
The clinical study of the drug's combined treatment of relapsed/difficult-to-treat folytic lymphoma and marginal lymphoma is currently in clinical phase 2, and the clinical study of the new selective BTK inhibitor ICP-022 tablets for the treatment of recurrence/difficult-to-treat CD20-B cell lymphoma is currently in clinical phase 1.
: The Drug Review Center (CDE.Retrieved Dec 1,2020, from. 2) Beijing Tianguangshi Biotechnology Co., Ltd. prospectus. Retrieved Sep 28, 2020, from Source: Medical Mission Hills