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    [{"orgOrder":0,"company":"Xcovery","sponsor":"Betta Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ensartinib Secured Its First Approval for 1st Line Treatment in ALK+ NSCLC","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Xcovery","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. Food and Drug Administration (FDA) Has Accepted the New Drug Application (NDA) for Ensartinib","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"}]

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

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              X-396 (ensartinib), an Anaplastic Lymphoma Kinase (ALK) inhibitor, its NDA filling has been accepted by USFDA, for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).

              Lead Product(s): Ensartinib

              Therapeutic Area: Oncology Product Name: X-396

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 13, 2024

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

              Details:

              NMPA’s nod in China marked first ensartinib approval based on results of 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.

              Lead Product(s): Ensartinib

              Therapeutic Area: Oncology Product Name: X-396

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Betta Pharmaceuticals

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 22, 2022

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