AstraZeneca has applied for a new indication listing for its BTK inhibitor, Acalabrutinib, in China.

Public information shows that Acalabrutinib (generic name: Acalabrutinib Capsules) is Platform tradinga Bruton's tyrosine kinase (BTK) inhibitor, previously approved in China for two indications. Based on pipeline information from AstraZeneca's official website, it is speculated that the new indication for Acalabrutinib application may be for the first-line treatment of chronic lymphocytic leukemia (CLL).

Acalabrutinib is a next-generation highly selective BTK inhibitor that inhibits its activity through covalent binding with BTK. In B cells, BTK signal activation is a critical pathway for B cell proliferation, transport, chemotaxis, and adhesion. Acalabrutinib was first approved in China in March 2023 for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy; in September of the same year, Acalabrutinib was approved for a second indication, as monotherapy for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy.

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