▎WuXi AppTec Content Team Report

Today (August 16), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,Pfizer's New Indication Application for Axitinib Tablets Accepted for Review, specific indications have not been disclosed.. Public data show that axitinib is aTyrosine kinase inhibitors capable of inhibiting VEGFR1-3 activity (TKI), which has been previously approved in China for the treatment of renal cell carcinoma。

Screenshot source:CDE Official Website

Axitinib is an orally administered, potent, and highly selective tyrosine kinase inhibitor targeting vascular endothelial growth factor receptors 1, 2, and 3. By inhibiting the signaling system of vascular endothelial growth factor receptors, it comprehensively halts tumor progression. The product was initially approved by the U.S. FDA for marketing in 2012 and received approval in China in 2015, with its first indication being the treatment of...Adult patients with advanced renal cell carcinoma (RCC) who have previously failed treatment with a tyrosine kinase inhibitor or cytokine therapy.

According to the official website of the Chinese Clinical Trial Registry and Information Disclosure Platform, in addition to targeting renal cell carcinoma, Pfizer has also completed an international multi-center (including China) Phase 3 clinical study to evaluate Axitinib for treatment.Patients with advanced hepatocellular carcinoma who have failed one previous anti-angiogenic therapyEfficacy and safety.

Screenshot Source: Official Website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform

Besides, in recent years, due toDrugs Targeting the VEGF Signaling PathwayAndImmune Checkpoint InhibitorsThe combination pattern of co-administration has been validated in the treatment of various cancer types, and researchers are also evaluating it in multiple clinical studies of combination therapies.The efficacy of Axitinib in different cancer types.For example: in combination with Merck's PD-1 inhibitor Pembrolizumab, in combination with Junshi Biosciences' Toripalimab, in combination with Alphamab Oncology’s PD-L1/CTLA-4 bispecific antibody KN046, etc. These research results have been announced multiple times at international academic conferences.

The acceptance of Axitinib's new indication application in China marks another significant progress for this product.

[1] Official of the Center for Drug Evaluation, National Medical Products Administration of ChinaWebsite. Retrieved Aug 16, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2]Superhero Inlyda震撼来袭！. Retrieved May 13, 2025, from https://mp.weixin.qq.com/s/agwnOvans1P_SPDHvWEsfg