China-based Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its recombinant human growth hormone Fc fusion protein injection AK2017. The drug will be assessed for treating children with growth deficiencies due to endogenous growth hormone deficiency.
Mechanism of Action and Preclinical Data
AK2017’s N-terminal growth hormone amino acid sequence is identical to the amino acid sequence of human endogenous growth hormone. It can bind with the human growth hormone receptor and activate the JAK/STAT signaling pathway, thereby upregulating the transcription and expression of genes such as insulin-like growth factor, promoting protein synthesis and growth of bones, viscera, and the body. The Fc region at the C-terminal can prolong the half-life of the drug, which is significant for reducing the frequency of administration and improving patient compliance. Pre-clinical study data have shown that AK2017 injection is safe and effective, with a pharmacodynamic effect of increasing body growth and a significant long-term effect compared to routine daily administered human growth hormone. Currently, there is no long-term growth hormone-like Fc fusion protein on the market domestically or internationally.
Future Prospects and Market Potential
The approval for the clinical study of AK2017 marks a significant step forward in addressing the unmet medical needs of children with growth hormone deficiencies. Anhui Anke Biotechnology’s commitment to advancing AK2017 underscores its dedication to developing innovative therapies that improve patient outcomes and quality of life.-Fineline Info & Tech
