Baiji Shenzhou is developing a new Btk inhibitor and publishes the Chinese common name "zebutini"

April 23, 2019 / Meitong news agency / -- Baiji Shenzhou Co., Ltd announced today that the Chinese generic name of the company's independently researched and developed Btk inhibitor was officially confirmed as "zebutini", which was formulated by the national pharmacopoeia commission according to the "naming principles of Chinese generic names of drugs", marking the distance between this new Btk inhibitor and Chinese patients One step closer Dr Wu Xiaobin, general manager and President of Baiji China, said: "the official name of zebutini marks a step closer to doctors and patients Zebotinib is currently undergoing extensive clinical trials around the world, and has submitted the application for listing of new drugs in China and has been included in the priority review We believe that this new anti-cancer drug independently developed by Chinese scientists will bring new treatment means to clinicians as soon as possible, so as to benefit more Chinese and even global patients, so that they can get new treatment opportunities and further improve the quality of life " Zanubruninib (bgb-3111) was born in the research and development center of Beijing Changping Life Science Park of Baiji Shenzhou It was independently developed by the Chinese scientists team of Baiji Shenzhou The drug design of this new Btk inhibitor aims to maximize the specific binding rate of BTK target and minimize the Miss effect With the efficacy and safety demonstrated in a series of clinical trials, including research data obtained in a variety of B-cell malignant tumors such as mantle cell lymphoma, zebutini was awarded "breakthrough therapy" by the US Food and Drug Administration (FDA) in January 2019 Design), which is used to treat adult mantle cell lymphoma (MCL) patients who have received at least one treatment before, has become the first Chinese native anti-cancer drug recognized by FDA, and also marks another important step in the process of Chinese innovative drugs going global In August and October 2018, Baiji Shenzhou submitted to China National Drug Administration (nmpa) a new drug listing application for the treatment of relapsed or refractory mantle cell lymphoma (MCL) and relapsed refractory chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) Both applications have been included in the priority review channel by the drug review center (CDE) After being approved, zebutini will carry out commercial production in the small molecule drug production base of Baiji Shenzhou, located in the industrial park of santian Island, Suzhou At present, zebotinib is carrying out extensive clinical research on multiple adaptive diseases such as mantle cell lymphoma (MCL), Fahrenheit megaglobulinemia (WM), relapsed refractory chronic lymphoblastic leukemia (CLL) / small lymphoblastic lymphoma (SLL), follicular lymphoma (FL) and marginal zone lymphoma (MZL) More than 1300 patients worldwide have been treated with zebutinib As for zanubrutinib, which is a small molecule inhibitor of BTK under research, it is currently undergoing a wide range of key clinical trials around the world, as a single drug and combined with other therapies to treat multiple lymphoma Baiji Shenzhou has carried out a wide range of clinical studies on zebotinib, including a global phase 1 clinical study, a global phase 3 clinical study that has been completed for patients with megaglobulin Fahrenheit disease (WM) compared with ibotinib, a global phase 3 clinical study for patients with previously untreated chronic lymphoblastic leukemia (CLL) / small lymphocyte lymphoma (SLL); A global critical phase 2 clinical study on the treatment of recurrent / refractory (R / R) follicular lymphoma with combination of gazyva ® (obitoluzumab); a global phase 3 clinical study on the comparison of ibotinib with R / RCLL / small Lymphoid Lymphoma (SLL); a global phase 2 clinical study on R / R marginal zone lymphoma (MZL); and a global phase 1 clinical study In China, Baiji Shenzhou has completed two key phase 2 clinical trials of zebutinib, which are used to treat MCL patients and CLL / SLL patients respectively, and also completed the recruitment of key phase 2 clinical trials of zebutinib for WM patients The U.S Food and Drug Administration (FDA) has granted zebotinib the fast track design qualification for treating WM patients and the break through therapy design for treating adult MCL patients who have previously received at least one treatment China National Drug Administration (nmpa) drug review center (CDE) is reviewing zanubrutinib's new drug marketing application (NDA) for R / rmcl and R / RCLL / SLL, both of which are included in the priority review About Baiji Shenzhou, a global, commercial stage, R & D-based biotechnology company, focusing on the research and development of molecular targeting and immunotherapy for tumor At present, Baiji Shenzhou has more than 2200 employees in mainland China, the United States, Australia and Switzerland, and its research product line includes new oral small molecule and monoclonal antibody anti-cancer drugs At present, Baiji Shenzhou is also building a drug combination program for anti-cancer treatment, aiming to bring lasting and far-reaching impact on the life of cancer patients Under the authorization of Xinji company, Baiji Shenzhou began to sell abaxane ® paclitaxel for injection (nano albumin particle binding type), rifomer ® (lenalidomide) and vedasha ® (azacytidine for injection) in China in September 2017 [1] [i] Abraxane ®, Rimage ®, and vidasha ® are registered trademarks of new base Source: Baiji Shenzhou