Ensartinib Secured Its First Approval for 1st Line Treatment in ALK+ NSCLC

PALM BEACH GARDENS, Fla.–(BUSINESS WIRE)–Xcovery Holdings, Inc., an oncology focused bio-pharmaceutical company, today announced 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). Ensartinib has been previously approved for the second-line treatment of ALK-positive NSCLC in China in 2020.

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.”

About Xcovery

Xcovery is a biopharmaceutical company working to improve the lives of patients with cancer by discovering and developing small molecules that precisely target cancer growth mechanisms. Xcovery is developing a pipeline of drugs targeting a wide range of advanced solid tumors with a focus on lung cancer. For more information, visit www.xcovery.com.

Forward‐Looking Statements

This press release contains forward‐looking statements that are based on company management’s current beliefs and expectations and are subject to currently unknown information, risks and circumstances and actual results may vary from what is being currently projected.

Contacts

Kevin Sang

Chief Operating Officer

(561) 835-9356

[email protected]