On March 22, 2022 Xcovery Holdings, Inc., an oncology focused bio-pharmaceutical company, reported that Xcovery’s affiliate Betta Pharmaceuticals has received the National Medical Products Administration (NMPA)’s approval of ensartinib in China for the first-line treatment of ALK-positive non-small cell lung cancer (NSCLC) (Press release, Xcovery, MAR 22, 2022, View Source [SID1234610616]). Ensartinib has been previously approved for the second-line treatment of ALK-positive NSCLC in China in 2020.

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Ensartinib is a next generation ALK inhibitor jointly developed by Xcovery and Betta Pharmaceuticals. NMPA’s nod in China marked the first ensartinib approval based on the results of the eXalt3 study, an Xcovery sponsored randomized global phase III study, designed to evaluate the efficacy and safety of ensartinib in the first-line treatment of ALK-positive NSCLC. Results of the eXalt3 were published in JAMA Oncology in September 2021.

"I am very pleased to see ensartinib’s first-line approval in China," said Giovanni Selvaggi, Xcovery’s CEO and CMO, "This is the first successful step of our global regulatory strategy to bring ensartinib as a first-line option to ALK-positive NSCLC patients worldwide."