FDA Approves the clinical trial of Baiji Shenzhou anticancer drug bgb-3111 in the United States

June 24, 2015 / BIOON / - Baiji Shenzhou has obtained the application of FDA new drug research (ind), and will conduct bgb-3111 clinical research Bgb-3111 is a specific inhibitor of bruston's tyrosine kinase (Btk) for the treatment of B-cell malignant tumors It has been reported that the drug is highly selective and effective in oral administration, and can play a role in receptor signaling, which plays a key role in B-cell cancer John oyler, CEO of beigene and CEO of Baiji, said: "we are very pleased to obtain FDA approval to conduct bgb-3111 clinical research in the United States Btk is a very effective B cell tumor targeting inhibitor Preclinical studies have shown that bgb-3111 may be more effective and safer than commercially available drugs We are looking forward to conducting clinical trials in the United States in the coming months " The Beijing based company has completed dose escalation experiments in Australia and received $97 million in financing from all parties in May Baiji Shenzhou is mainly engaged in tumor targeting and tumor immunity research Three small molecule drugs have entered the first phase of experiments, they are: bgb-3111, bgb-283 (the second generation BRAF oncogene, EGFR inhibitor of epidermal growth factor receptor), bgb-290 (PARP inhibitor); at the same time, PD-L1 drug is also under research, aiming at med14736 (AstraZeneca) and mpd3280a (genes under Roche's banner) Tech) is also working on clinical trials At the beginning of this month, the patient took bgb-a317 (humanized PD-1 monoclonal antibody) developed by Baiji Shenzhou for the first time to treat advanced cancer Source: China's beigene gets U.S FDA ind nod on o topology candidate bgb-3111