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CStone Approved to Start China Bridging Trial of Leukemia Drug

publication date: Jul 22, 2019

CStone Pharma of Suzhou was approved by China's NMPA to start a Phase I bridging study of ivosidenib (Tibsorovo®) to treat relapsed or refractory acute myeloid leukemia (R/R AML) with an IDH1 mutation. One year ago, CStone acquired China rights to ivosidenib from Boston's Agios in a $424 million agreement. Agoix was approved to market the drug in the US last year. The stand-alone China trial is designed to evaluate the efficacy, safety and pharmacokinetics of ivosidenib in China patients with IDH1 mutant R/R AML. More details....

Stock Symbol: (HK: 2616) (NSDQ: AGIO)

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