The Center for Drug Evaluation (CDE) website has indicated that repotrectinib, a next-generation ROS1/TRK/ALK tyrosine kinase inhibitor (TKI) licensed by China-based biopharmaceutical company Zai Lab Ltd (NASDAQ: ZLAB), is on track to receive breakthrough therapy designation (BTD) status in China for the treatment of NTRK fusion-positive advanced solid tumors that have previously failed TRK TKI treatment.
Zai Lab’s Strategic Licensing Deal with Turning Point Therapeutics
In July 2020, Zai Lab entered into a USD 176 million licensing agreement with Turning Point Therapeutics, the US originator of repotrectinib, securing exclusive development and commercialization rights to the drug in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan.
Repotrectinib’s Prior BTD and Priority Review Statuses
Repotrectinib has already been granted BTD statuses in China for use in ROS1-positive metastatic non-small cell lung cancer (NSCLC) patients who have previously received frontline ROS1 TKI plus chemotherapy, as well as those who have received one frontline ROS1 TKI and have not undergone chemotherapy or immunotherapy. The drug was awarded this status in June 2022. Furthermore, in May of this year, repotrectinib was granted priority review status for the treatment of locally advanced or metastatic ROS1-positive NSCLC in China.-Fineline Info & Tech
