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Application for Marketing of Category I Innovative Drug “TQ-B3139”

Recently, Sino Biopharm announces that application for marketing of the Category I antitumor innovative drug “TQ-B3139” developed by the Group has been submitted to and accepted by the National Medical Products Administration of the People’s Republic of China. The indication for this application is the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are positive for anaplastic lymphoma kinase (ALK) and the specifications are 100mg, 125mg and 150mg.


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TQ-B3139 is a Category I innovative drug jointly developed by the Group and Centaurus BioPharma Co., Ltd., and both parties jointly own the intellectual property rights. TQ-B3139 is a tyrosine kinase receptor inhibitor with significant inhibitory effect on both ALK and MET receptor tyrosine kinase (“c-Met”). This product can inhibit not only the phosphorylation of ALK and its downstream AKT and ERK1/2 in NCI-H3122 cells (expressing EML4-ALK fusion gene), but also the phosphorylation of c-Met and its downstream ERK1/2 in SNU-5 cells (c-Met high expression). TQ-B3139 could induce NCI-H3122 cell cycle arrest in G1 phase and induce NCI-H3122 cell apoptosis. Phase III clinical data show that TQ-B3139 can significantly prolong the progression-free survival of newly-treated ALKpositive NSCLC patients, and can well control the occurrence and development of brain metastases in patients, with specific data to be announced at an upcoming academic meeting.


TQ-B3139 is an anti-tumor molecular targeted drug with a new chemical structure, which has the advantages of safety and effectiveness, and has not yet been marketed in China or abroad. The application for marketing of TQ-B3139 is expected to change the treatment pattern of domestic ALK positive NSCLC patients, fulfil unmet clinical needs, and benefit patients.