Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Approves Ensartinib for ALK-Positive Locally Advanced or Metastatic NSCLC
Details : Ensacove (ensartinib) is an ALK inhibitor, small molecule drug candidate, which is indicated for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).
Product Name : Undisclosed
Product Type : Small molecule
Upfront Cash : Not Applicable
December 18, 2024
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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).
Product Name : X-396
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
March 13, 2024
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Betta Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : X-396
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
March 22, 2022
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Betta Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable