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Pharmaceutical Network November 16, the U.S Food and Drug Administration (FDA) announced that innovative pharmaceutical company Baiji Shenzhou independently developed the new anti-cancer drug "Zebutini", as a "breakthrough therapy" status, "priority review" was approved for listing
Zebutini is expected to be sold in the U.S in the coming weeks, becoming the first Chinese mainland to be approved for sale in the U.S to develop a new cancer drug According to the news posted on the official website of Baiji Shenzhou, the approved "Zebutini" (bruKINSA ™, generic name: Zebutini) has been accelerated by the U.S Food and Regulatory Agency for the treatment of adult set of cell lymphoma patients who have received at least one treatment in the past According to Baiji Shenzhou Senior Vice President and head of global pharmaceutical affairs, "Zebutini" as a Bruton's tyrosine kinase (BTK) small molecule inhibitor, designed to maximize target occupancy, while avoiding off-target binding it is understood that "Zebutini" has been in the group of more than 1,600 patients since the launch of a wide range of clinical programs in 2014 fda approval for Zebutini was based on data on the effectiveness of two clinical trials, showing that Zebutinib had a total remission rate of up to 84% in patients involved in both clinical trials
Zebutini is the first product to be approved for market by Baiji Shenzhou's independent research and development, and the first chinese to be approved for listing in the United States the comment that it rewrites the embarrassing history of China's anti-cancer drugs "only into" and will bring good news to cancer patients around the world in the future Zebutini is expected to sell in the U.S in the coming weeks, according to the company The drug has not yet been approved outside the United States (Complete)