Medicilon helps Keye Life's new drug targeting RNA helicase obtain dual approval in China and the United States
On June 11, Keye Life received an implicit approval from the National Medical Products Administration's Center for Drug Evaluation for the clinical trial of its independently developed KY1 small molecule inhibitor IND application. This IND approval means that clinical trials for DHX33-positive recurrent/refractory advanced malignant tumors can be conducted on schedule in China. Previously, KY1 had already received implicit approval for clinical trials from both the US FDA and Taiwan. Shanghai Medicilon Inc. (Medicilon), as a partner of Keye Life, provided efficacy studies and safety evaluation services that comply with both Chinese GLP and U.S. GLP standards for KY1, facilitating its successful dual IND approval in both China and the United States. Having assisted in the approval of 47 dual IND applications in both China and the United States Medicilon's one-stop service continues to empower the global launch of innovative drugs In the wave of g...