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Recent popular reports from Yimaike ★ Invitation to the event2021 Oncolytic Virus Drug Development Forum is about to open in Shanghai ★ The financing has reached hundreds of millions in half a year, and the oncolytic virus has entered the fast laneYimai New Observation Click on the picture and register now May 27, 2021 /Medicine news eMedClub News/--Recently, TG Therapeutics announced that the US FDA has accepted the BLA application of the CD20 monoclonal antibody Ublituximab combined with oral PI3K-δ and CK1-ε inhibitor UKONIQ for the treatment of chronic lymphocytic leukemia ( CLL) and small lymphocytic lymphoma (SLL) patients.
Ublituximab is a third-generation CD20 antibody, which has been modified to remove fucose to greatly increase the ADCC activity, and it targets the specific epitope of CD20 on mature B lymphocytes.
UKONIQ (umbralisib) is a once-daily PI3K-delta inhibitor that can uniquely inhibit CK1-epsilon and can overcome some of the tolerance problems associated with the first-generation PI3K-delta inhibitor.
The combination of ublituximab and umbralisib is called "U2".
The BLA submission is based on the results of the global phase III study UNITY-CLL, which aims to evaluate the effectiveness and safety of ublituximab and umbralisib in the treatment of patients with relapsed or refractory CLL.
Previously, the combination therapy of ublituximab and umbralisib has obtained fast track certification from the US FDA and certification of orphan drug for the treatment of CLL.
Michael S.
Weiss, CEO of TG Therapeutics, said: "We are delighted, FDA accepted ublituximab the BLA, which is an important milestone enables us to offer new treatment options for the further CLL and SLL patients.
We look forward to take Cooperating with the FDA in the next review.
"CD20CD20 is a human B lymphocyte-restricted differentiation antigen, encoded by the MS4A1 gene (located at 11q12).
This antigen is a hydrophobic four-pass transmembrane protein with a molecular weight of approximately 35kD, alias There are B lymphocyte surface antigen B1, Bp35, leukocyte surface antigen Leu-16, transmembrane 4-domain subfamily A member 1, etc.
The protein function may be involved in regulating B cell activation and proliferation, and may act as a calcium ion channel.
▲ Expression of CD markers at different developmental stages of B lymphocytes (picture source: Science Direct) CD20 antigen is mainly present on pre-B and mature B lymphocytes, and is expressed on most B-cell non-Hodgkin lymphoma cells, but not expressed For stem cells, original B cells, normal plasma cells or other normal tissues.
Immature plasma cells and stimulated plasma cells may express CD20.
▲The expression of CD19 and CD20 and related tumor conditions during the development of B lymphocytes (picture source: Clin Cancer Res) Monoclonal antibodies targeting CD20 can be divided into three generations.
The first generation uses human-mouse chimeric monoclonal antibodies-Li Tuximab is the representative; the second generation is represented by the humanized monoclonal antibody-ofatumumab; the third generation is represented by the atuzumab whose Fc segment of the monoclonal antibody is modified.
The Fc segment of the third-generation anti-CD20 monoclonal antibody has undergone glycosylation modification, which can improve the specificity of the antibody and the affinity of binding to the antigen.
The third-generation anti-CD20 monoclonal antibody Atuzumab was successfully developed by Roche and was approved by the FDA for marketing in 2013.
At the same time, based on the specificity of CD20, in addition to CD20 monoclonal antibodies, more and more targeted therapies choose CD20, such as double antibodies, ADC, CAR-T and so on.
According to Clinicaltrail data, there are 867 clinical registration trials related to CD20 worldwide.
▲ Clinicaltrail queries CD20 interventional research data (picture source: Clinicaltrail) Reference materials: 1.
https://ir.
tgtherapeutics.
com/news-releases/news-release-details/tg-therapeutics-announces-fda-acceptance-biologics- license2.
Armstrong Biopharmaceutical Information "TG Therapeutics third-generation CD20 antibody submitted for FDA listing application" Yimaike has always been committed to original news reports such as cutting-edge technology, industry trends, and industry insights of innovative biopharmaceuticals.
The high-end matrix of all media users has reached 160,000+, of which Industrial users accounted for more than 50%, scientific research and clinical users accounted for about 30%, and investment institutions accounted for more than 5%.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
Ublituximab is a third-generation CD20 antibody, which has been modified to remove fucose to greatly increase the ADCC activity, and it targets the specific epitope of CD20 on mature B lymphocytes.
UKONIQ (umbralisib) is a once-daily PI3K-delta inhibitor that can uniquely inhibit CK1-epsilon and can overcome some of the tolerance problems associated with the first-generation PI3K-delta inhibitor.
The combination of ublituximab and umbralisib is called "U2".
The BLA submission is based on the results of the global phase III study UNITY-CLL, which aims to evaluate the effectiveness and safety of ublituximab and umbralisib in the treatment of patients with relapsed or refractory CLL.
Previously, the combination therapy of ublituximab and umbralisib has obtained fast track certification from the US FDA and certification of orphan drug for the treatment of CLL.
Michael S.
Weiss, CEO of TG Therapeutics, said: "We are delighted, FDA accepted ublituximab the BLA, which is an important milestone enables us to offer new treatment options for the further CLL and SLL patients.
We look forward to take Cooperating with the FDA in the next review.
"CD20CD20 is a human B lymphocyte-restricted differentiation antigen, encoded by the MS4A1 gene (located at 11q12).
This antigen is a hydrophobic four-pass transmembrane protein with a molecular weight of approximately 35kD, alias There are B lymphocyte surface antigen B1, Bp35, leukocyte surface antigen Leu-16, transmembrane 4-domain subfamily A member 1, etc.
The protein function may be involved in regulating B cell activation and proliferation, and may act as a calcium ion channel.
▲ Expression of CD markers at different developmental stages of B lymphocytes (picture source: Science Direct) CD20 antigen is mainly present on pre-B and mature B lymphocytes, and is expressed on most B-cell non-Hodgkin lymphoma cells, but not expressed For stem cells, original B cells, normal plasma cells or other normal tissues.
Immature plasma cells and stimulated plasma cells may express CD20.
▲The expression of CD19 and CD20 and related tumor conditions during the development of B lymphocytes (picture source: Clin Cancer Res) Monoclonal antibodies targeting CD20 can be divided into three generations.
The first generation uses human-mouse chimeric monoclonal antibodies-Li Tuximab is the representative; the second generation is represented by the humanized monoclonal antibody-ofatumumab; the third generation is represented by the atuzumab whose Fc segment of the monoclonal antibody is modified.
The Fc segment of the third-generation anti-CD20 monoclonal antibody has undergone glycosylation modification, which can improve the specificity of the antibody and the affinity of binding to the antigen.
The third-generation anti-CD20 monoclonal antibody Atuzumab was successfully developed by Roche and was approved by the FDA for marketing in 2013.
At the same time, based on the specificity of CD20, in addition to CD20 monoclonal antibodies, more and more targeted therapies choose CD20, such as double antibodies, ADC, CAR-T and so on.
According to Clinicaltrail data, there are 867 clinical registration trials related to CD20 worldwide.
▲ Clinicaltrail queries CD20 interventional research data (picture source: Clinicaltrail) Reference materials: 1.
https://ir.
tgtherapeutics.
com/news-releases/news-release-details/tg-therapeutics-announces-fda-acceptance-biologics- license2.
Armstrong Biopharmaceutical Information "TG Therapeutics third-generation CD20 antibody submitted for FDA listing application" Yimaike has always been committed to original news reports such as cutting-edge technology, industry trends, and industry insights of innovative biopharmaceuticals.
The high-end matrix of all media users has reached 160,000+, of which Industrial users accounted for more than 50%, scientific research and clinical users accounted for about 30%, and investment institutions accounted for more than 5%.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
