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.
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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