The China Center for Drug Evaluation (CDE) website has indicated that Roche’s (SWX: ROG) Lunsumio (mosunetuzumab) and AnHeart Therapeutics’ taletrectinib are on track to receive priority review status. Mosunetuzumab, a bispecific antibody targeting CD20 and CD3, has already been approved for the treatment of adult recurrent refractory follicular lymphoma (FL) in the EU and US in June and December 2022, respectively. The priority status in China is due to the drug’s conditional approval eligibility for third-line recurrent or refractory FL.
Taletrectinib, a small-molecule inhibitor targeting ROS1 and NTRK, originated by Daiichi Sankyo and 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. The drug’s marketing approval filing in China last week has earned it priority status as a product with breakthrough designation and is also eligible for conditional approval.- Flcube.com
