AstraZeneca's BTK inhibitor acalabrutinib's new indication has been submitted for market approval in China
On August 28, the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration revealed that the market application for acalabrutinib Maleate tablets submitted by AstraZeneca has been accepted. Public information shows that acalabrutinib (generic name: acalabrutinib capsules) is a Bruton's tyrosine kinase (BTK) inhibitor, which has previously been approved for two indications in China. According to AstraZeneca's official pipeline information, it is speculated that the new indication for acalabrutinib's market application this time may be first-line treatment for chronic lymphocytic leukemia (CLL). Information indicates that acalabrutinib is a new generation of highly selective original BTK inhibitor that inhibits its activity by covalently binding to BTK. In B cells, BTK signaling activates pathways required for B cell proliferation, transport, chemotaxis, and adhesion. In China, acalabrutinib was first approved for marketing in March 2023 for the treatment of adult mantle cell lymphoma (MCL) patients who have received at least one prior therapy; it was approved for a second indication in September 2023, as a monotherapy for adult chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) patients who have received at least one prior therapy
According to the latest disclosure on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration on August 28, AstraZeneca (AZN.US) has had its application for the marketing approval of acalabrutinib Maleate tablets accepted. Public information indicates that acalabrutinib (generic name: acalabrutinib capsules) is a Bruton's tyrosine kinase (BTK) inhibitor that has previously been approved for two indications in China. Based on information from AstraZeneca's official pipeline, it is speculated that the new indication for which acalabrutinib is applying for marketing approval this time may be first-line treatment for chronic lymphocytic leukemia (CLL).
Information indicates that acalabrutinib is a new generation of highly selective original BTK inhibitor that inhibits its activity by covalently binding to BTK. In B cells, BTK signaling activates pathways required for B cell proliferation, transport, chemotaxis, and adhesion. In China, acalabrutinib was first approved for marketing in March 2023 for the treatment of adult mantle cell lymphoma (MCL) patients who have received at least one prior therapy; it was approved for a second indication in September 2023, as a monotherapy for adult chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) patients who have received at least one prior therapy
