On November 14, according to foreign media reports, the U.S. Food and Drug Administration (FDA) announced that brukinsa, a Btk inhibitor independently developed by Baiji Shenzhou, was approved for marketing as a treatment for adult mantle cell lymphoma (MCL) patients who had received at least one treatment in the past.
According to the report,This is the first new anticancer drug in China, which has been independently developed by Chinese enterprises and approved in FDA, which has brought the original new drug to sea in China.。 In China, zebutini has also submitted an application for new drug listing.
Mantle cell lymphoma usually responds well to the initial treatment, but eventually rebounds or stops responding to drugs, and cancer cells continue to grow.Clinical trials have shown that zebotinib therapy reduces tumor size in 84% of patients。
Previously,Zebutini was awarded by FDA one after another.。
It is reported that Baiji Shenzhou is also carrying out two global clinical phase III head-to-head studies of ibotinib against megaglobulinemia of Fahrenheit and chronic lymphocytic leukemia with zebotinib. New anti-cancer drugs made in China will compete with foreign products.
At home, zebotinib has also submitted a new drug listing application, and is expected to be sold in the United States in the next few weeks.