AstraZeneca's BTK Inhibitor Acalabrutinib Maleate Tablets Approved in China

Nov 05, 2024 15:13 CST Updated 15:13

AstraZeneca

Biopharmaceutical Manufacturer

▎Edited by the WuXi AppTec content team

Today (November 5), the latest announcement on the official website of the National Medical Products Administration (NMPA) of China revealed that the marketing application for acalabrutinib maleate tablets (Malate Acalabrutinib Tablets) submitted by AstraZeneca has been approved.Public information shows,Acalabrutinib is a Bruton's tyrosine kinase (BTK) inhibitor., the capsule form of this product has previously been approved in China, and this time the tablet form has been approved for marketing in China for the first time.

Screenshot source:CDE Official Website

Acalabrutinib is a new generation of highly selective BTK inhibitor that inhibits its activity by covalently binding to BTK. In B cells, BTK signaling leads to the activation of pathways required for B cell proliferation, trafficking, chemotaxis, and adhesion.

IncludingIncluding China, multiple countries and regions around the world,Acalabrutinib capsules have been approved for marketing.Used for treatmentAdult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy; andMonotherapy is indicated for adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have received at least one prior therapy.。

In August 2022, AstraZeneca announced acalabrutinibTablet FormulationApproved in the U.S. for all current indications of the capsule formulation, including CLL, SLL, and relapsed or refractory MCL in adult patients. This approval is based on the results of the ELEVATE-PLUS trial.The study results showed that, compared with acalabrutinib capsules, the tablets demonstrated consistent efficacy, safety, and dosing. Moreover, the tablets can be taken with gastric acid-reducing agents, including proton pump inhibitors (PPIs), antacids, and H2 receptor antagonists (H2RAs).。

According to a previous press release by AstraZeneca, patients suffering from blood cancers such as chronic lymphocytic leukemia and mantle cell lymphoma are typically older and may face multiple conditions requiring intervention, including gastroesophageal reflux disease (GERD) and peptic ulcer disease.Acalabrutinib tablets can be co-administered with proton pump inhibitors, allowing more patients to benefit from this treatment.。

This time, this productAcalabrutinibTablet FormThe approval in China will also bring new treatment options to more Chinese patients.

ReferenceData:

[1] Information on the Delivery of Drug Approval Documents on November 5, 2024. Retrieved Nov 05，2024. From https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20241105145400132.html

[2] CALQUENCE® (acalabrutinib) tablet formulation approved in the US across current indications. Retrieved Aug 5 ,2022 , from https://www.astrazeneca-us.com/media/press-releases/2022/calquence-acalabrutinib-tablet-formulation-approved-in-the-us-across-current-indications-08052022.html#

This article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media, but unauthorized reproduction by media or institutions in any form to other platforms is strictly prohibited.For forwarding authorization and other cooperation needs, please contact wuxi_media@wuxiapptec.com.

Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it imply that WuXi AppTec supports or opposes these views. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.