CBX - China Biotech XYZ

Hansoh conducted a new clinical study to evaluate the efficacy of anti-B7H4 ADC in combination with anti-PD-L1 or anti-VEGF mAbs for treating solid tumors. This marks the 3rd clinical trial for HS-20089 in China. HS-20089 is a novel B7-H4 targeted ADC with a TOPOi payload (DAR=6) , developed by Hansoh and licensed to GSK with an $85 million upfront payment. Factors controlling B7-H4 and B7-H4 receptor expression The clinical study This study contains four combination therapy cohorts, each consisting of a dose exploration part and a dose expansion part. The combination includes Adebrelimab, an anti-PD-L1 monoclonal antibody, either with or without platinum, or Bevacizumab with or without platinum. Adebrelimab was an anti-PD-L1 monoclonal antibody discovered and launched by Hengrui in China as their second anti-PD-(L)1 therapy. The clinical trial identified as NCT06336707 is expected to enroll a total of 1,048 participants, while the trial registered in China (CTR20241023) showed an e...

 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 4...