Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Ensacove
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 18, 2024
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Undisclosed
Product Type : Other Small Molecule
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 HCl
Therapeutic Area : Undisclosed
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions
Details : Undisclosed
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
December 27, 2022
Lead Product(s) : Ensartinib HCl
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : BPI-361175
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 26, 2022
Lead Product(s) : BPI-361175
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
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 : Undisclosed
Product Type : Other Small Molecule
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
Lead Product(s) : Vorolanib
Therapeutic Area : Oncology
Study Phase : Phase II
Recipient : Washington University School of Medicine
Deal Size : Inapplicable
Deal Type : Inapplicable
Vorolanib + Atezolizumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 04, 2020
Lead Product(s) : Vorolanib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Recipient : Washington University School of Medicine
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Study Phase : Undisclosed
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Expanded Access to Ensartinib for Participants With ALK+ NSCLC
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 31, 2019
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Highest Development Status : Undisclosed
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Vorolanib
Therapeutic Area : Oncology
Study Phase : Phase I
Recipient : Washington University School of Medicine
Deal Size : Inapplicable
Deal Type : Inapplicable
Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 27, 2018
Lead Product(s) : Vorolanib
Therapeutic Area : Oncology
Highest Development Status : Phase I
Recipient : Washington University School of Medicine
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Study Phase : Phase II
Recipient : Memorial Sloan Kettering Cancer Center
Deal Size : Inapplicable
Deal Type : Inapplicable
Treating Patients With Melanoma and ALK Alterations With Ensartinib
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 05, 2018
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Recipient : Memorial Sloan Kettering Cancer Center
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 10, 2016
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable