The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart Therapeutics’ taletrectinib are set for priority review, while Biotheus Inc.’s PM8002 and Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422)’s SKB264 have been designated as breakthrough therapies (BTDs).
Adrenaline is gaining priority status due to new pediatric specifications aimed at treating acute hypersensitivity reactions and asthma attacks, preventing and managing cardiac arrest and transient atrioventricular block with syncope, and increasing average arterial blood pressure in adult patients with septic shock-related hypotension.
Taletrectinib, an ROS1/NTRK inhibitor initially developed by Daiichi Sankyo (TYO: 4568), was acquired by AnHeart in December 2018 for global development. The drug received BTD status in Greater China in February 2022 and is intended for ROS1-positive patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received ROS1-TKI treatment.
PM8002 features humanized anti-PD-L1 single heavy-chain variable (VHH) domains fused with an anti-VEGF-A IgG1 antibody, designed for first-line treatment of inoperable locally advanced or recurrent metastatic triple-negative breast cancer in combination with chemotherapy. The drug was licensed to BioNTech for global development earlier this year.
SKB264, a TROP2-targeted antibody-drug conjugate (ADC), received BTD status for treating non-resectable locally advanced, recurrent, or metastatic PD-L1 negative and triple-negative breast cancer without prior systematic treatment. This drug was part of a licensing agreement with Merck, Sharp & Dohme (MSD) for territories outside Greater China in May 2022.- Flcube.com
