CBX - China Biotech XYZ

 Hengrui is seeking IND approval for HRS9531, an orally administered GLP-1/GIP dual receptor agonist, in China. The subcutaneous formulation is being evaluated in phase 2 trials for patients with type 2 diabetes and for patients who are overweight. Metabolic actions of GLP-1 and GIP on key target tissues. In 2021, Hengrui filed a patent (WO/2023/098777) for the subcutaneous injection and oral tablet of GLP-1/GIP dual receptor agonist. The oral version contains 2.5-30 mg API of 18#. 18# in the patent Results of clinical study of subcutaneous  HRS9531 In June 2023, Hengrui reported the PK and PD results of the phase 1 study of subcutaneous HRS9531:  Sixty and 30 subjects were recruited into SAD and MAD respectively. The most common adverse events were abdominal distension and nausea in SAD, and urine ketone body present and nausea in MAD. Drug exposure were proportional to dose from 0.9-8.1 mg. The median Tmax and mean t1/2 were 48-72 h and 156-182 h in SAD, and 48-72 h and 169-192 h aft