Congratulations to Gluetacs Therapeutics’ new drug clinical research application for GT919, the first molecular glue degradation agent pipeline, approved by the FDA
Recently, Gluetacs Therapeutics (Gluetacs)’s first class 1 new drug, GT919 Capsules, a molecular glue degradation agent pipeline, was approved by the US Food and Drug Administration (FDA) to enter clinical trials. It is for the treatment of malignant hematological tumors.
The pipeline was previously approved by the National Medical Products Administration (NMPA) for clinical trials on December 20, 2022, and is currently undergoing Phase I clinical trials in China. This is the first product pipeline of Gluetacs that has been approved for clinical trials in both China and the United States, and it is another milestone in the globalization process of Gluetacs. For the research and development of GT919, Shanghai Medicilon Inc, (Medicilon) relied on its solid R&D strength to efficiently complete the drug discovery to clinical application for GT919, including drug discovery, pharmaceutical research, and preclinical research based on Medicilon’s one-stop preclinical research services platform. This has been highly recognized by Gluetacs.
Medicilon’s One-Stop Preclinical R&D Service Platform
Empowering new drug research and development with faster and more economical
The approval of new drugs is inseparable from the full collaboration of both parties. With the mutual trust and support of Medicilon and Gluetacs, Medicilon provided one-stop preclinical R&D services for GT919, helping to obtain clinical approval, which demonstrated the R&D innovation strength of innovative pharmaceutical companies. It also once again reflects the capabilities and advantages of Medicilon’s one-stop biopharmaceutical preclinical R&D service platform.
Relying on the technological advantages and R&D platform advantages accumulated over the past 19 years, Medicilon has continuously expanded the upstream and downstream areas of the industrial chain around the needs of new drug R&D, and successfully created a comprehensive and integrated preclinical CRO service model. Not only can the research and development links be seamlessly connected in series, but also can be integrated into a parallel research and development model. Therefore, Medicilon presents the service advantages of strict planning, efficient coordination, and orderly advancement, which can empower new drug research and development in faster, better, and less costly ways.
