Alimentary Tract and Metabolism
Indication——Diabetes mellitus II、NASH
(1) A novel structure of FGF21 mutant protein, which remedies the shortcomings of natural FGF21, e.g., difficult production, short half-life, and thermal instability; a completely new mechanism of metabolic regulation of blood glucose, blood lipids and liver lipids that is different from that of any existing drug; no marketed products with the same target;
(2) Can control multiple functions of metabolic regulation independently from insulin, including regulating glucolipid metabolism, improving insulin resistance, and protecting islet β cells, with a lasting hypoglycemic effect and hardly causing hypoglycemia; superior to existing drugs in terms of efficacy;
(3) Can promote fatty acid oxidation, inhibit lipid synthesis, and lower lipids in blood and the liver, thereby reducing chronic inflammatory reactions due to fat accumulation; significant effect and good efficacy in the treatment of non-alcoholic steatohepatitis (NASH);
(4) Greater potential safety for long-term use, hardly causing hypoglycemia, cardiovascular diseases, intestinal adverse effects or pancreatitis;
(5) Fixed-point PEGylation to prolong the half life and lower immunogenicity; high thermal stability, high bioactivity, and a long half-life.
Next important events and time points
To apply for a pre-IND meeting with the FDA in the fourth quarter of 2020.