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On March 12, Yifan Pharmaceutical issued an announcement stating that the subsidiary received approval from NMPA regarding the approval of recombinant human growth hormone-Fc fusion protein for injection in accordance with the Drug Clinical Trial Approval Notice, and agreed to carry out children’s growth hormone deficiency and Clinical trials of adult growth hormone deficiency related diseases.
It is reported, F-899 is the company owned subsidiary with its unique molecular structure DiKineTM platform-based design to develop a long-acting recombinant human growth hormone (Growth Hormone, GH) new molecule, the company has a Chinese all interests within the therapeutic class 1 Biopharmaceuticals also commissioned Shanghai Yiyi to conduct follow-up research and development.
A new long-acting recombinant human growth hormone (GH) molecule designed and developed based on its unique DiKineTM molecular structure platform .
It is a class 1 therapeutic biological drug that the company has all the rights and interests in China and entrusted Shanghai Yiyi to carry out follow-up research and development.
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F-899 is a fusion protein of recombinant human GH homodimer and mutated human IgG2-Fc (Immunoglobulin G2-Fragment crystallizable).
GH monomers wherein the amino acid sequence listed with the same human pituitary growth hormone secretion, binds to human growth hormone receptor can induce an intracellular tyrosine kinase JAK2 (Janus Kinase 2, Janus kinase 2), a plurality of downstream cellular activation signal path into the upregulation of IGF series transcription and expression of the gene, promoting the growth and maintenance of body tissues and organs function.
F-899 by the CHO (Chinese Hamster Ovary, Chinese hamster ovary cells) fine expression cells, cultured in serum-free production.
Compared with the short-acting drugs recombinant human growth hormone, in vivo half-life was significantly extended length.