Drug name: Taletrectinib
CAS:1505515-69-4
Code name: IBI-344, AB-106, DS-6051b
Indication: Non-small cell lung cancer, solid solid tumors
Original Research Company: Cinda Bio
On March 5, 2024, Cinda Biopharmaceutical Group and Baoyuan Pharmaceuticals announced that the second New Drug Marketing Application (NDA) for the next-generation ROS1 tyrosine kinase inhibitor (TKI), tareltinib adipate capsules (“tareltinib”), has been accepted by the Center for Drug Evaluation (CDE) of the National Drug Administration (NDA) of the People's Republic of China (NDA) for use in the treatment of patients without ROS1 TKI for the locally advanced or first-line treatment for adult patients with metastatic ROS1-positive non-small cell lung cancer (NSCLC).
On November 23, 2023, Cinda BioPharma Group and Programmed Pharmaceuticals announced that the New Drug Application (NDA) for the next-generation ROS1 tyrosine kinase inhibitor (TKI), telatinib (tareltinib), has been accepted by the Center for Drug Evaluation (CDE) of the National Drug Administration (NDA) of the People's Republic of China (NDA) for use in patients who have failed treatment with an ROS1-TKI for the treatment of locally advanced, ROS1-positive or metastatic non-small cell lung cancer in adult patients.
The NDA was accepted based on positive results from a Phase II clinical study, TRUST-I (NCT04395677). The trial is a multicenter, open-label, single-arm trial conducted in China to evaluate the safety, tolerability and efficacy of telatinib in Chinese patients with ROS1-positive non-small cell cancer.
On March 1, 2022, Cinda Biopharmaceutical Group and Baoyuan Pharmaceuticals announced that Taletrectinib has been added to the list of breakthrough therapeutics by the Center for Drug Evaluation (CDE) of the National Drug Administration (NMPA) of China for the proposed indication of patients who have not been previously treated with a ROS1 tyrosine kinase inhibitor (TKI) and those who have received a ROS1 TKI in the past. ROS1 fusion-positive non-small cell lung cancer patients previously untreated with a ROS1 TKI. The current inclusion of tareltinib in the Breakthrough Therapy Drug class is based on the results of its Phase 2 TRUST trial as a potent next-generation ROS1 inhibitor for the treatment of patients with ROS1 fusion-positive non-small cell lung cancer.
