Medicilon Assists Hebei Changshan Biochemical Pharmaceutical Co obtain approval for clinical research on Class 1 new drug CSCJC3456 tablets

On January 8, 2024, Hebei Changshan Biochemical Pharmaceutical Co., Ltd. (Changshan Pharmaceutical) issued an announcement, saying that its holding subsidiary Changshan Kaijiejian Biopharmaceutical Research and Development (Hebei) Co., Ltd. has recently received the approval of the National Medical Products Administration (NMPA) to issue a "Drug Clinical Trial Approval Notice" for the new Class 1 chemical drug CSCJC3456 tablets.

Shanghai Medicilon Inc. (Medicilon), as a partner of Changshan Pharmaceutical, has efficiently completed most of the preclinical research work of CSCJC3456, including drug efficacy, pharmacokinetics and safety evaluation promoting the project to quickly complete the preclinical research and development process.

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Medicilon’s One-Stop Shop to Assist Drug Preclinical Research and Development

As a one-stop preclinical R&D service platform, Medicilon actively expands its development layout in popular areas of innovative drugs and continues to pay close attention to the trend of oncology drug R&D. Medicilon has established more than 370 tumor drug efficacy evaluation models, including humanized tumor transplant models, xenograft tumor transplant models, transgenic mouse tumor models, etc. In addition, Medicilon has comprehensive preclinical research service capabilities and can provide systematic in vivo pharmacodynamics, pharmacokinetics, and safety evaluation research services that comply with both Chinese GLP and U.S. GLP standards. Medicilon has also obtained AAALAC certification and complies with NMPA, FDA GLP standards. Medicilon has participated in the research and development of new drugs and generic drug projects, and 420 of them have passed the approval of NMPA, FDA, and TGA and entered clinical trials.

About Changshan Pharmaceutical

Changshan Pharmaceutical was established in 2000. It is one of the few leading companies in China that has a complete industrial chain of heparin products and is able to engage in the research, development, production and sales of crude heparin, heparin raw materials and heparin preparations. In 2011, Hebei Changshan Biochemical Pharmaceutical Co., Ltd. was listed on the ChiNext of Shenzhen Stock Exchange (stock code: 300255).

Changshan Pharmaceutical is committed to the research, development, production and sales of innovative drugs in the fields of cardiovascular and cerebrovascular diseases, diabetes, tumors and other major diseases. It has 2 national-level R&D platforms, 3 provincial-level R&D platforms, and 2 projects have been selected as major national science and technology projects for “Major New Drug Creation”. At present, the Phase III clinical study of the Class 1 new drug ebenatide developed by the holding subsidiary has been successfully completed, and a new drug marketing application will be submitted soon. The new drug clinical trial application (IND) in China for the Class 1 new drug CSCJC3456 tablets has been approved by the National Medical Products Administration (NMPA).

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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Enzyme Activity Assay Service

Enzymatic assay Lance Assay Alphascreen Assay Z’-LYTE Assay Adapta Assay Kinase-Glo Assay ADP-Glo Assay Ligand Binding Assay ELISA Assay HTRF Assay Enzyme activity assays are laboratory methods for measuring enzymatic activity. They are vital for the study of enzyme kinetics and enzyme inhibition. Enzyme units : Amounts of enzymes can either be expressed as molar amounts, as with any other chemical, or measured in terms of activity, in enzyme units. Medicilon provides various enzyme activity assays for kinases , phosphatases, proteinases, deacetylase, peptidase, esterase, and other enzymes. Our line of well-characterized immunoassays and biochemical kits ensures accurate and reproducible results. Enzyme is a large category of bio-molecules that catalyze various biological processes including metabolic processes, cellular signaling and regulation, cell division and apoptosis. Enzymatic reactions convert substrate molecules into chemically modified molecules products with high sp

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