Ensartinib secures first approval for 1st line treatment in ALK+ NSCLC

23 March 2022

Florida, USA-based oncology focused bio-pharmaceutical firm Xcovery says its China-based affiliate Betta Pharma (SHE: 300558), which is its majority shareholder, has received approval from the National Medical Products Administration (NMPA) for ensartinib in China for the first-line treatment of ALK-positive non-small cell lung cancer (NSCLC).

Ensartinib has been previously approved for the second-line treatment of ALK-positive NSCLC in China in 2020. Betta Pharma’s shares edged up 2.4% to 55.74 renminbi on the news.

Ensartinib is a next generation ALK inhibitor jointly developed by Xcovery and Betta Pharma. The 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.

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