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On November 16, Compu Biopharmaceutical Technology (Shanghai) Co., Ltd. ("Compu Biopharmaceuticals") announced that it had launched a multi-center, randomized, double-blind, placebo-controlled clinical trial of KPG-818 for the treatment of systemic lupus erythematosus (SLE) in the United States.
program recruited 64 subjects to assess the safety, tolerance, pharmacodynamics and initial efficacy of KPG-818 and to determine the recommended dose for clinical IIb/III.
application for this clinical study was recently approved by the FDA.
addition, Compu Biopharmaceuticals has recently received FDA approval for a phase IIa clinical trial of KPG-818 for the treatment of new coronavirus pneumonia in the United States.
KPG-818 is the latest generation of oral small molecule immunomodulation drugs designed and developed by Compu Biopharmaceuticals with globally independent intellectual property rights, belonging to the CRBN E3 Ubiquitin connective enzyme complex (Cullin-RING E3 ubiquitin ligase complex, CRL4-CRBN) regulator.
preclinical study data show that KPG-818 has a very high affinity for target CRBN, which can effectively regulate the expression levels of cytokines such as TNF-α, IL-6, IL-2, IL-10, and efficiently degrade zinc finger transcription factors Aiolos (IKZF3) and Ikaros (IKZF1), which are closely related to B lymphocyte development and proliferation.
KPG-818 demonstrated good GLP toxicological tolerance and pharmacodynamic characteristics in preclinical trials.
phase I clinical study of KPG-818 in healthy subjects has successfully concluded in the United States, demonstrating good dose tolerance (2-30 mg) and pharmacodynamic characteristics.
is currently conducting Phase I clinical trials in the United States to treat a variety of blood tumors (test number: NCT04283097).
systemic lupus (SLE) is a complex chronic autoimmune disease caused by the body's immune system attacking its own tissues.
, according to Frost and Sullivan, the number of people living with SLE globally will be about 7.7 million in 2019 and will grow to 8.6 million by 2030.
in China, with about 1 million SLE patients in 2019.
more than half a century ago, only one targeted treatment (Baileys monoantial) has been approved by the FDA for treatment of SLE.
, current clinical treatments are not only ineffective but are often accompanied by more serious adverse reactions.