August 19, 2025
PPTA and its members support scientific and technological developments that have the potential to benefit patients, and acknowledge the recent approval of recombinant albumin in China. However, as with any new therapy, robust data from large numbers of patients in real-world settings will be critical to fully understanding and establishing its safety and efficacy profile.
Recently, regulatory authorities in China approved rice- (Oryza sativa) based recombinant human serum albumin for the treatment of liver cirrhosis with hypoalbuminemia (≤ 30g/L) in China, which accounts for less than ten percent of total global albumin use. The clinical use of recombinant human serum albumin in other patient populations will require additional evidence to support its safety and efficacy.
In the last several decades, human plasma-derived serum albumin produced by PPTA members has been used to treat tens of millions of critically ill patients globally and its safety and efficacy profile is well established. PPTA members will continue to manufacture human serum albumin for the treatment of patients with shock, trauma, burns, decompensated liver cirrhosis and other disease states that meets global regulators standards and highest industry standards.
For more on human plasma-derived medicines, visit pptaglobal.org.
Contact: media@pptaglobal.org