On April 8, 2022 The board of directors (the "Board") of Sino Biopharmaceutical Limited (the "Company", together with its subsidiaries, the "Group") reported that "TQ-B3525", an innovative drug self-developed by the Group, has been included by the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration of China in the list of breakthrough therapy drugs (Press release, Sino Biopharmaceutical, APR 8, 2022, View Source(e)_0407_1829(2).pdf [SID1234633501]). The indication is relapsed/ refractory follicular lymphoma that has failed at least two prior lines of therapy.
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TQ-B3525 is a novel and selective oral PI3K (phosphatidylinositol 3-kinase) α/δ inhibitor. Studies have shown that PI3K is closely associated with tumours. TQ-B3525 is a dual inhibitor of PI3K catalytic subunits α/δ. It can not only overcome the drug resistance problem caused by the increase of PI3Kα subunit activity when inhibiting PI3Kδ subunit alone, but also significantly reduce the toxicity compared with PI3K pan-inhibitors. Currently, the Group has initiated a number of clinical studies on TQ-B3525 in China, mainly targeting haematological tumours, and some of them have entered Phase II clinical trials.
The CDE has established the Procedure for Breakthrough Therapy Drugs to encourage research and development of new drugs to meet clinical needs and to expedite the review and approval of new drug varieties. Follow-up communication and review and approval of the innovative drugs that have been included as breakthrough therapy drugs can be carried out in accordance with the accelerated procedures.