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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
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