Tmb-355, a new AIDS drug from Zhongyu, a Taiwan based enterprise, was recognized by FDA as a breakthrough therapy

Breakthrough therapy design (BTD) was established by the U.S Food and Drug Administration (FDA) in July 2012 to accelerate the development and review of new drugs to treat serious or life-threatening diseases BTD is another new drug review channel after fast track, accelerated approval and priority review Drugs certified as "breakthrough therapy" can receive more close guidance from senior FDA officials during research and development, so as to provide patients with new treatment options in the shortest time According to the latest announcement of Zhongyu new drug, its new drug tmb-355 intravenous injection has obtained the breakthrough treatment qualification approved by the US Food and Drug Administration (FDA), and its application in multiple drug resistance patients has obtained the breakthrough treatment qualification Subsequently, the FDA will designate a special person to assist in communicating with the company and guiding the development of development plans for the listing of the drug Before that, the intravenous injection of tmb-355 (ibalizumab), a new AIDS drug, has been approved by the US FDA for rapid review and orphan drugs The production of ibalizumab, a monoclonal antibody drug for AIDS treatment of Zhongyu new drug, is contracted by Wuxi biopharmaceutical R & D and production base of Wuxi Pharmaceutical Co., Ltd About Zhongyu new drug Zhongyu new drug (English: taimed biological, abbreviated to TMB, formerly known as Yuchang Biotechnology) is a biotechnology company in Taiwan, established by Taiwan's state-owned national development fund with an investment of 20 million US dollars in 2007 Ibalizumab was originally developed by tanox In 2006, Genentech acquired tanox, and then Genentech sold the patent of ibalizumab to Zhongyu new drug Ibalizumab is a non immune monoclonal antibody that binds to CD4, the main receptor of HIV, and inhibits the entry process of the virus Founded in 1997 by Chen liangbo, Yang Yumin and Tsai ing Wen, with he Dayi, academician of the Central Research Institute, as the company's consultant, Tsai ing Wen was the company's first chairman About tmb-355 tmb-355 (ibalizumab), a humanized single antibody designed for the treatment of HIV infection (acquired immune deficiency syndrome), is authorized by Genentech company of the United States Zhongyu new drug has completed the clinical test of tmb-355 phase II Part II in 2011, with a total of 113 AIDS patients Zhongyu new drug also participated in the AIDS prevention and control plan fully subsidized by Bill & Melinda Gates Foundation The first three-year plan led by Dr he Dayi and Aaron Diamond AIDS research center used tmb-355 to explore the possibility of preventing human AIDS infection.