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 global innovative drug development, dual IND applications in China and the United States have become an essential and indispensable strategy for pharmaceutical companies' internationalization. Medicilon, as one of the first CRO companies in China to provide a complete set of new drug clinical research applications that comply with both Chinese GLP and U.S. GLP standards, now has a 29,000-square-meter laboratory accredited as a GLP laboratory by the NMPA. This laboratory meets the GLP standards of the U.S. FDA, Australia's TGA, and the EU's EMEA, and has passed ABSL-2 registration. The animal testing facilities are AAALAC accredited and can simultaneously house various experimental animals, including non-human primates, dogs, mice, rats, rabbits, guinea pigs, and miniature pigs. In addition, Medicilon has introduced the Provantis data acquisition system, EMPOWER chromatography workstation management system, Chromeleon chromatography data system, and LIMS laboratory sample management system to ensure research compliance and the authenticity of data, and to facilitate the conversion of research data to SEND format to meet the requirements for U.S. FDA submissions.

As of the end of April 2024, Medicilon has been involved in the research and development of a cumulative total of 480 IND-approved clinical projects for new drugs and generics. Among these, 66 IND applications have received approval from the U.S. FDA, and 47 IND applications have achieved dual IND approvals in both China and the United States. Through its professional R&D capabilities, stringent quality control, and efficient regulatory submission services, Medicilon continues to empower more and more innovative drugs to go global, competing in the global market!

About Keye Life

Keye Life focuses on the research and clinical application of precise cancer treatment technology as its main business, aiming to become a pioneering innovative leader in this field. Cancer is a complex disease. The overall survival rates of some cancers have improved several times, but there are still cancers referred to as incurable. The fundamental approach to treating such challenging cancers lies in exploring new mechanisms and targets of cancer initiation and progression. Shenzhen Keye Life Technology Co., Ltd. is rooted in long-term basic research, continuously innovating, and developing novel targets and innovative drugs with independent intellectual property rights.

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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