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Tianjing Bio-Bio announced today that the combination of lemzoparlimab (also known as TJC4) and azacitidine (AZA) for the treatment of newly diagnosed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in a combined clinical trial (NCT04202003) has been China completed its first patient administration
.
Lemzoparlimab is a highly differentiated CD47 monoclonal antibody independently developed by Tianjing Bio.
It retains strong anti-tumor activity while minimizing the binding to normal red blood cells, avoiding the production of similar CD47 antibodies in clinical trials Common side effects such as severe anemia
.
AZA is a nucleoside analogue, which can inhibit methyltransferase and achieve anti-tumor effects through DNA hypomethylation and direct cytotoxicity of abnormal hematopoietic cells in bone marrow
The clinical study is a phase 2 clinical study, which will be based on the previously conducted lemzoparlimab monotherapy dose-climbing trial in China to evaluate newly diagnosed AML patients who are not suitable for intensive chemotherapy and mid- to high-risk MDS patients who have not received treatment Among them, the safety, tolerability and efficacy of lemzoparlimab combined with AZA
.
Recruitment of patients for related trials is expected to be completed in the fourth quarter of 2021, and it is expected that key clinical registration studies will be launched in 2022
Dr.
Shen Huaqiong, CEO of Tianjing Bio, said: “Lemzoparlimab has demonstrated gratifying differentiated advantages and therapeutic potential in the phase 1 clinical trials conducted in China and the United States
.
We will continue this development momentum and rapidly develop lemzoparlimab-related Combination drug research
Tianjing Bio is accelerating the clinical development of lemzoparlimab in China and the United States, making it the first CD47 antibody drug approved for the treatment of hematological malignancies in China
.
Currently, Tianjing Biosciences has carried out clinical trials of lemzoparlimab, Rituxan® (rituximab) and Keytruda® (pembrolizumab) in the United States for the treatment of non-Hodgkin's lymphoma (NHL) and advanced solid tumors.
