Has Acalabrutinib been launched in China? Can it be reimbursed?

Acalabrutinib was approved for medical use in the United States in 2017, and was approved by the European Union in 2020 November . Acalabrutinib was approved for marketing by the Nikkei China Food and Drug Administration on March 22, 2023. Acalabrutinib is suitable for patients with mantle cell lymphoma (MCL) who have received ≥1 previous treatments, and is also suitable for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Acalabrutinib has not been included in medical insurance, so it is not reimbursable in the country. Common side effects of acalabrutinib include headache, feeling tired, low red blood cells, low platelets, and low white blood cells. It is a second generation tyrosine kinase inhibitor. Acalabrutinib blocks an enzyme called tyrosine kinase that helps B cells survive and grow. By blocking this enzyme, acalabrutinib is expected to slow the accumulation of cancerous B cells in CLL and thereby delay the progression of the cancer.

Acalabrutinib is metabolized mainly byCYP3Aenzyme. ACP-5862 was identified as the major active metabolite in plasma, with a geometric mean exposure (AUC) that was approximately 2-3 times the acalabrutinib exposure. ACP-5862 is approximately 50% less potent than acalabrutinib in inhibiting BTK. Avoid grapefruit products, grapefruit inhibitsCYP3A metabolism, which may increaseserum concentrations of acalabrutinib. Dosage adjustments may be necessary if used together. Use St. John's Wort with caution. If you want to get more high-quality information, you can contact YaDE. YaDE will do its best to learn more about high-quality overseas drugs for you.