Taletinib was granted Breakthrough Therapy Designation BTD by the CDE in for the treatment of adult patients with advanced or metastatic ROSpositive NSCLC who have been previously treated with ROS TKIs, as well as patients with ROSpositive NSCLC who have not been treated with ROS TKIs. In addition, taloratatinib has also been granted orphan drug designation ODD and breakthrough therapy designation BTD by the US FDA for the treatment of ROSpositive nonsmall cell lung cancer. Based on the results of the TRUSTI and TRUSTII studies, Nuvation Bio submitted an NDA for taretinib to the U. FDA for the treatment of patients with ROSpositive advanced NSCLC full approval regardless of the number of treatment lines. The FDA accepted this NDA in December and granted priority review.
In June , Innovent Biologics and Baoyuan Pharmaceutical, now a subsidiary saudi arabia phone number list of Nuvation Bio NYSE: NUVB, signed an exclusive license agreement to jointly develop and commercialize talentinib in Greater China including mainland China, Hong Kong, Macau and Taiwan.
"Start with Integrity, Succeed with Action" Developing highquality biopharmaceuticals that ordinary people can afford is Innovent's mission and goal. Founded in , Innovent Biologics is committed to the research, development, production and commercialization of innovative drugs in major disease areas such as oncology, autoimmunity, metabolism, ophthalmology, etc., so that our work can benefit more lives. The company has products approved for marketing, including sintilimab injection Daboshu® , bevacizumab injection Dayoutong® , adalimumab injection Sulixin® , rituximab injection Dabohua®, pemigatinib tablets Dabotan® , orebactinib tablets Nailike® , ramucirumab injection Ciranze®, sepretib capsules Ruitu®, ikiorencel injection Fucosu® , tolcizumab injection Symbile® , floxacin tablets Dabot® , pitubutinib tablets Jepali® and talentinib adipate capsules Dabolu® . At present, there are varieties under review by NMPA, new drug molecules have entered Phase III or key clinical studies, and another new drug varieties have entered clinical research.