China’s Center for Drug Evaluation (CDE) has indicated on its website that taletrectinib, an ROS1/NTRK inhibitor co-developed by AnHeart Therapeutics and Innovent Biologics Inc. (HKG: 1801), has been filed for marketing approval. The drug is intended to treat ROS1 fusion positive non-small cell lung cancer (NSCLC) in patients who have previously received a ROS1-targeted tyrosine kinase inhibitor.
Global Expansion and Partnerships for Taletrectinib
Taletrectinib, originally developed by Daiichi Sankyo, was acquired by AnHeart for global development, manufacturing, and commercialization in December 2018. In July 2020, AnHeart entered into a licensing agreement with South Korea-based NewG Lab Pharma, granting exclusive rights for clinical development and commercialization in South Korea. In June 2021, AnHeart and Innovent agreed to collaborate on the development and commercialization of taletrectinib in Greater China, where it received breakthrough therapy designation (BTD) in February 2022.
Companion Diagnostics and Licensing Deals
AnHeart partnered with tumor precision diagnosis specialist Guardant Health in February of this year, with Guardant Health providing companion diagnostics for taletrectinib. Last month, AnHeart signed another licensing deal with Japan-based biopharma Nippon Kayaku Co., Ltd, granting them marketing and distribution rights to the drug in Japan.- Flcube.com
