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Biopharmaceutical company Apollomic announced today that APL-106 (uproleselan) has been approved by china's National Drug Administration (NMPA) Drug Review Center (CDE) to conduct a Phase III briditation study of APL-106 (uproleselan) in combination with chemotherapy to treat recurrence/difficult acute myeloid leukemia (AML).
acute myeloid leukemia (AML) is a type of cancer caused by excessive growth of bone marrow blood cells, characterized by a large number of abnormal cells growing rapidly in the bone marrow and blood, which interferes with hematosis.
may include tiredness, difficulty breathing, susceptible bruising and bleeding, increased risk of infection, etc.
AML is one of the most common leukaemias in adults," said Dr. Yu Guoliang, global chief executive of Apollomics, a company.
we are pleased that CDE recognizes the need to improve outcomes for this patient population.
we want to start clinical trials in China because we are committed to providing new and effective treatment options for AML patients."
, APL-106 (uproleselan) is fast-track certified by the U.S. Food and Drug Administration (FDA) and a breakthrough therapy certification for the treatment of adult patients with relapsed/difficult-to-treat AML.
APL-106 has also been awarded the FDA and the European Union's "orphan drug title."
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