Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Accepts New Drug Application for Ensartinib
Details : X-396 (ensartinib), an Anaplastic Lymphoma Kinase (ALK) inhibitor, its NDA filling has been accepted by USFDA, for adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).
Brand Name : X-396
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 13, 2024
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Study Phase : Approved
Sponsor : Betta Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : X-396
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 22, 2022
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Sponsor : Betta Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
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