AstraZeneca Submits NDA for Acalabrutinib Maleate Tablets in China

On August 17, the CDE website showed that the marketing application for AstraZeneca's Acalabrutinib Maleate Tablets (Acalabrutinib Maleate Tablets) was accepted.

Acalabrutinib is a second-generation selective BTK inhibitor independently developed by AstraZeneca. It inhibits the activity of BTK through covalent binding. In B cells, BTK signaling activates pathways required for B-cell proliferation, trafficking, chemotaxis, and adhesion.

In October 2017, acalabrutinib capsules were approved for the first time in the United States for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, under the trade name Calquence. In November 2019, the indication for acalabrutinib capsules was expanded to include chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). In August 2022, AstraZeneca launched acalabrutinib tablets in the United States for all approved indications, including MCL, CLL, and SLL.

In March 2022, Acalabrutinib capsules were approved in China for MCL, with the trade name Kang Keqi. In December of the same year, the second indication for acalabrutinib was submitted for marketing in China, intended for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

Currently, six BTK inhibitors have been launched globally. Apart from acalabrutinib, the other five are ibrutinib (AbbVie/Johnson & Johnson), zanubrutinib (BeiGene), orelabrutinib (InnoCare/Biogen), tirabrutinib (Ono Pharmaceutical/Gilead), and pirtobrutinib (Eli Lilly, BTK C481S inhibitor).

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