U.S. Food and Drug Administration (FDA) Has Accepted the New Drug Application (NDA) for Ensartinib

MIAMI–(BUSINESS WIRE)–Xcovery Holdings, Inc., an oncology focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib, an Anaplastic Lymphoma Kinase (ALK) inhibitor for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC). The filing is based on the results of the eXalt3, a randomized global phase III study designed to evaluate the efficacy and safety of ensartinib vs crizotinib in the first-line treatment of ALK-positive NSCLC. The FDA granted the application Standard Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024.

“The FDA’s acceptance of this NDA represents a key milestone for Xcovery in its mission to bring ensartinib as a novel and distinct first-line therapeutic option to ALK-positive NSCLC patients,” said Giovanni Selvaggi, M.D., Chief Medical Officer of Xcovery. “We will continue to work closely with the agency during the review period. This achievement is a testament to our patient-centric vision and has been made possible by the dedication and skills of the entire Xcovery team and stakeholders, with the constant support of the patients, their families and investigators in our clinical trials globally.”

Ensartinib is a next generation ALK inhibitor jointly developed by Xcovery and Betta Pharmaceuticals. In the clinical trials, the drug has demonstrated robust and durable responses in ALK-positive NSCLC patients (both systemically and in the brain), with an extensively studied and well manageable safety profile. The results of the eXalt3 were originally published in JAMA Oncology in September 2021.

About Xcovery

Xcovery is a pharmaceutical 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

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