CDE – Talk Bio

Bayer Receives Breakthrough Therapy Designation in US and China for Sevabertinib in First-Line HER2-Mutant NSCLC

3 weeks ago talkbio0Tagged Bayer, Breakthrough Therapy Designation, CDE, China, First line treatment, HER2-mutant, Non-Small Cell Lung Carcinoma, sevabertinib, United States Food and Drug Administration

Bayer; sevabertinib; Breakthrough Therapy Designation; HER2-mutant NSCLC; FDA; China CDE; first-line treatment

China’s fast, low-cost gene and cell therapy testing boom draws Western interest

1 month ago talkbio0Tagged Advanced Therapy Medicinal Products, ATMP regulation China, CDE, Cell Therapy, China, clinical trial review, Clinical Trials, gene therapy, N-methyl-N-2-(methylsulfinyl)ethylpropionic acid amide, reforms, Shortened, therapies testing, Western biotech

China clinical trials; gene therapy; cell therapy; advanced therapy medicinal products; ATMP regulation China 2025; shortened clinical trial review; cheap clinical trials; Western biotech in China; NMPA CDE reforms; novel therapies testing

Insilico Medicine and TaiGen sign exclusive licensing deal for AI-designed PHD inhibitor ISM4808 to treat anemia in chronic kidney disease

2 months ago talkbio0Tagged AI-driven, Anemia, CDE, China, Chronic Kidney Diseases, Clearance, clinical-stage biotech, Drug Discovery, Generative AI, Indonesian language, Insilico Medicine, ISM4808, License Agreement, Oral cavity, Ph.D., Pharma, PHD inhibitor, TaiGen Biotechnology

Insilico Medicine; TaiGen Biotechnology; license agreement; ISM4808; PHD inhibitor; anemia of Chronic Kidney Disease; CKD anemia; AI-driven drug discovery; Pharma.AI; Greater China rights; oral PHD inhibitor; IND clearance; China CDE; generative AI; clinical-stage biotech