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 : Phase II
Sponsor : Betta Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 17, 2025
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Sponsor : Betta Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Undisclosed
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 09, 2024
Lead Product(s) : Ensartinib
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
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
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
April 22, 2022
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 : 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) : Ensartinib
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Fudan University
Deal Size : Inapplicable
Deal Type : Inapplicable
X-396 (Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 04, 2020
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Sponsor : Fudan University
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) : Ensartinib
Therapeutic Area : Oncology
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
The Absorption, Metabolism and Excretion of [14C]Ensartinib in Human
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 15, 2019
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Betta Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
X-396(Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 27, 2018
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Sponsor : Betta Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable