Asia Sheng Medicine: Global Phase III clinical study of first-line treatment for Ph+ ALL approved by the US FDA and European EMA.
Yasheng Pharmaceuticals announced that the company's original class 1 new drug, alectinib, combined with chemotherapy for the treatment of newly diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia, has been approved to conduct a global Phase III clinical study by the U.S. Food and Drug Administration and the European Medicines Agency. As the second global Phase III study of alectinib approved by regulatory agencies in Europe and America, the POLARIS-1 study will enroll participants in multiple countries and centers simultaneously, accelerating the market approval process for alectinib, especially in the European and American markets.
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