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.

Medicilon and Binhui Biopharmaceutical Have Reached a Strategic Collaboration to Jointly Draw a New Blueprint for the Development of New Biological Drugs

On March 18, Medicilon and Binhui Biopharmaceutical (Binui Bio) announced a strategic collaboration. The two parties will work together to jointly explore the possibilities in cutting-edge fields such as oncolytic viruses, nucleic acid drugs and protein drugs. Gather and Work Together to Create Advantages Facilitate the Research and Development of Oncolytic Viruses, Nucleic Acids, Proteins and Other Drugs As a one-stop biopharmaceutical comprehensive preclinical R&D service CRO, Medicilon has been developing and accumulating for 20 years, always adhering to the spirit of innovation, and has successfully constructed bi/multi-specific antibodies, ADCs , mRNA vaccines , small nucleic acid drugs , PROTAC , and CGT technical service platform that have helped 421 INDs obtain clinical approval. It is this outstanding achievement that has earned Medicilon wide recognition in the industry and laid a solid foundation f...

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A Nickel-Catalyzed Reductive Alkylation of Aryl Bromides and Chlorides for Sp3-Sp2 Bond Formation

In 2012, a nickel-catalyzed reductive alkylation method of aryl bromides and chlorides was reported. Under the optimized conditions, a variety of aryl and vinyl bromides as well as active aryl chloride can be reductively coupled with alkyl bromides in high yields. The protocols were highly functional-group tolerant and the reactions were not air or moisture sensitive. The reaction showed different chemoselectivity than conventional cross-coupling reactions. Substrates bearing both anelectrophilic and nucleophilic carbon resulted in selective coupling at the electrophilic carbon (R-X) and no reaction occurred at the nucleophilic carbon (R-[M]). The 2010 Nobel Prize in Chemistry was awarded for the Pd-catalyzed cross-coupling, and in the past decade the progress in cross-coupling has not only had a significant impact on academic research but has also influenced the industrial synthetic application. The transition-metal-catalyzed union of nucleophilic organo-boronic acids with elect...

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What is Toxicokinetics?

Toxicokinetics is essentially the study of “how a substance gets into the body and what happens to it in the body”. Four processes are involved in toxicokinetics. The study of the kinetics (movement) of chemicals was originally conducted with pharmaceuticals and thus the term pharmacokinetics became commonly used. In addition, toxicology studies were initially conducted with drugs. However, the science of toxicology has evolved to include environmental and occupational chemicals as well as drugs. Toxicokinetics is thus the appropriate term for the study of the kinetics of all toxic substances. Frequently the terms toxicokinetics , pharmacokinetics , or disposition may be found in the literature to have the same meaning. Disposition is often used in place of toxicokinetics to describe the time-course of movement of chemicals through the body (that is, how does the body dispose of a xenobiotic?). The disposition of a toxicant along with its’ biological reactivi...

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