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.

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What is preclinical testing?

In the process of preclinical testing of a compound or biological agent into a drug, the compound involved must go through the testing phase. First, we need to identify potential targets that can treat the disease. Then, a variety of compounds or preparations are screened out. Any compound that has shown potential as a drug for the treatment of this disease needs to be tested for toxicity before clinical testing to reduce the possibility of injury. preclinical testing What is the basis of preclinical testing? According to US Food and Drug Administration (FDA) regulations, a series of tests are required before a new drug is approved for use. In the first stage, basic research determines a hypothetical target for the treatment of a certain disease, and then screens small molecules or biological compounds to discover any substance with the potential to treat the disease. Then, a preclinical research phase followed, before which, as described above, the potential toxicity of the compou

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Inventory of the three major in vitro pharmacokinetic research methods

The metabolic properties of a compound are an essential factor in whether or not it can be used as a drug in the clinical setting, so pharmacokinetic studies of newly synthesized compounds are required in drug development. In vitro incubation with liver microsomes, recombinant CYP450 enzyme lines, and in vitro incubation with hepatocytes are some of the more common in vitro drug metabolism methods. 1. In vitro incubation method with liver microsomes The metabolic stability and metabolic phenotypes of candidate compounds in different species of liver microsomes are good predictors of the metabolic properties of compounds in vivo. They are practical tools for evaluating candidate compounds in the pre-development phase of drug development. Liver microsomes include rat liver microsomes, human liver microsomes, canine liver microsomes, monkey liver microsomes, and mouse liver microsomes. In in vitro incubation of the liver, microsomes are the "gold standard" for in vitro d

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Novel Parkinson’s Therapies Possible with New Mouse Model

Parkinson's disease (PD) is a neurodegenerative disorder that is marked by the accumulation of the protein, α-synuclein (αS), into clumps known as Lewy bodies, which diminish neural health. Now, researchers from Brigham and Women's Hospital (BWH) report the development of a mouse model to induce PD-like αS aggregation, leading to resting tremor and abnormal movement control. The mouse responds to L-DOPA, similarly to patients with PD. The team's study (“Abrogating Native α-Synuclein Tetramers in Mice Causes a L-DOPA-Responsive Motor Syndrome Closely Resembling Parkinson’s Disease”) on the use of this transgenic mouse model appears in Neuron . “α-Synuclein (αS) regulates vesicle exocytosis but forms insoluble deposits in PD. Developing disease-modifying therapies requires animal models that reproduce cardinal features of PD. We recently described a previously unrecognized physiological form of αS, α-helical tetramers, and showed that familial PD-causing missense mutati

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