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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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).

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Medicilon's fluorescent probes and labeling platforms can provide fluorescent probe design and synthesis services for scientific institutions, drug R&D companies, and other customers. Design and synthesis steps Fluorescent probes are tools used to detect, measure and analyze biomolecules, cells and tissues. They achieve these purposes by emitting and receiving fluorescent signals. Medicilon can complete the design and synthesis of fluorescent probes for biomolecules. Selection of target molecules and determination of target. Selection of fluorescent dyes. Design of molecular structure. Synthesize probe molecules. Testing the properties of probe molecules. Custom synthesis Medicilon's fluorescent probes and labeling platforms can provide fluorescent probe design and synthesis services for scientific institutions, drug R&D companies, and other customers. After years of development, Medicilon's fluorescent probes and labeling platforms have accumulated rich experience...

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Medicilon has synthesized over 10,000 individual compounds from gram to kilogram quantities, and many compounds are synthesized with more than ten synthetic steps. The overall synthesis success rate is over 95%. High quality products from mg to kg scale Reagents, intermediates, building blocks, and scaffolds Preparation of API or reference standards Development of synthetic routes for impurities and metabolites On-site analytical support Product delivered with COA Medicilon offers integrated drug discovery services -- Chemistry, Biology & Preclinical Services

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