Category: ODD/BTA/FTA Status Region: Asia · China Company: Anheart Therapeutics

Innovent Biologics and AnHeart Therapeutics Receive NMPA Breakthrough Designation for Taletrectinib in ROS1-Positive Non-Small Cell Lung Cancer

Innovent Biologics and AnHeart Therapeutics Receive NMPA Breakthrough Designation for Taletrectinib in ROS1-Positive Non-Small Cell Lung Cancer
Innovent Biologics, Inc a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, together with AnHeart Therapeutics ("AnHeart"), a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapies, today jointly announced that the Center for Drug Evaluation (CDE) of China's Nation Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to taletrectinib (Innovent R&D code: IBI-344, Anheart R&D code: AB-106) for both first-line tyrosine kinase inhibitor (TKI)-na

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