Zhitong Finance App News, China Biopharmaceutical (01177) announced that the Group's self-developed Class 1 innovative drug “Unecritinib (TQ-B3101)” (trade name: Ambernib), has obtained marketing approval from the China National Drug Administration for the treatment of ROS1-positive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). This is the first domestically produced targeted drug approved for the treatment of ROS1-positive adult patients with locally advanced or metastatic non-small cell lung cancer.

Anectinib is a small molecule inhibitor of tyrosine kinase Ros1/Alk/c-Met independently developed by the group. The findings have been published in internationally renowned academic conferences or journals such as the American Society of Clinical Oncology (ASCO) Annual Meeting, American Society of Hematology (ASH) Annual Meeting, European Lung Cancer Conference (ELCC), Frontiers in Pharmacology, and Signal Transduction and Targeted Therapy. In June 2022, anectinib submitted a marketing application for a new drug in China based on a “Phase II Single Arm, Multicenter Clinical Study Evaluating the Efficacy and Safety of TQ-B3101 Capsule Monotherapy in ROS1-Positive NSCLC Subjects” (TQ-B3101-II-01).