Clinical Trial Data of Recombinant Human Albumin Injection (Oryza Sativa) was published in the journal “Gut”

Source：Posted by Themecurve| Time：2025

Clinical Trial Data of Recombinant Human Albumin Injection (Oryza Sativa) was published in the journal “Gut”

Source：Posted by Themecurve| Time：2025

Key Findings of the clinical trials:

• Significant increases in serum albumin levels were observed in patients received OsrHSA.
• The proportion of patients whose serum albumin levels reached ≥35 g/L at any time up to 14 days indicated that overall, OsrHSA was non-inferior to plasma-derived HSA.
• There were no statistical differences in the change in colloid osmotic pressure and serum albumin from baseline to end of treatment, median time to target albumin levels, and the proportion of patients with an improved body weight or abdominal circumference between OsrHSA and plasma-derived HSA groups.
• No drug-related serious adverse events were observed;
• There was no clinically significant antialbumin antibody or anti-host cell protein (HCP) antibody development in the patients treated with OsrHSA compared with those treated with plasma-derived HAS, which confirms low immunogenic risk of OsrHSA.

“OsrHSA Recombinant Human AlbuminInjection provides a more accessible alternative for cirrhosis patients, especially in plasma-derived HSAresourcelimited regions,” said the leading investigator of the study.