What Are the Latest Advancements in Treating Hypoalbuminemia in Cirrhosis Patients?
Summary
Recombinant Human Albumin Injection (Oryza Sativa), or OsrHSA, is a plant-based therapy for hypoalbuminemia (≤30 g/L) in cirrhosis patients, developed by Wuhan Healthgen Biotechnology. Produced from rice grains, it provides a safe alternative to plasma-derived albumin, free from pathogen risks and supply issues. Approved by China's NMPA on July 18, 2025, phase III trials showed non-inferior efficacy in increasing albumin levels and managing ascites. The NCT06355479 study confirmed its safety in decompensated cirrhosis. Hong Kong wholesalers like DengYuePharma specialize in exporting such rare drugs globally, boosting access. This advances sustainable biotech in liver care.- Author Name: todivec312
Hypoalbuminemia, characterized by serum albumin levels ≤30 g/L, is a common complication in patients with cirrhosis, often leading to ascites, edema, and increased infection risk due to impaired liver function. Traditionally, treatment has relied on human serum albumin (HSA) derived from plasma donations, which, while effective, carries risks such as viral transmission, supply shortages, and high costs. Recent innovations in biotechnology have shifted toward recombinant HSA (rHSA) produced from non-animal sources, offering safer, more scalable alternatives.
One promising development is the use of plant-based expression systems for rHSA. For instance, recombinant human albumin derived from Oryza sativa (rice) has shown comparable efficacy to plasma-derived HSA in clinical settings, with the added benefits of reduced immunogenicity and no risk of human pathogen contamination. A multicenter, randomized, double-blind, parallel-group, active-controlled phase III trial demonstrated that OsrHSA (rice-derived rHSA) effectively increased serum albumin levels in cirrhosis patients with hypoalbuminemia, maintaining safety profiles similar to traditional HSA. This approach leverages rice endosperm as a bioreactor, allowing for high-yield production that's environmentally sustainable and cost-effective.
In July 2025, China's National Medical Products Administration (NMPA) approved the Recombinant Human Albumin Injection (Oryza Sativa), marking it as a first-in-class therapy in this category. Developed using advanced bioengineering, this injection is indicated specifically for hypoalbuminemia in cirrhosis, providing a 20% solution that can be administered intravenously. Ongoing studies, including a clinical trial evaluating its efficacy and safety (NCT06355479), further support its role in managing decompensated cirrhosis by improving oncotic pressure and reducing complications like spontaneous bacterial peritonitis.
Beyond efficacy, the global accessibility of such innovations is crucial. As Chinese biopharma continues to expand internationally, companies like DengYueMed are playing a key role in distributing these advanced therapies to markets worldwide, ensuring that patients in regions with limited access to plasma-derived products can benefit from recombinant options. This not only addresses supply chain vulnerabilities but also aligns with broader efforts to make high-quality, affordable biologics available globally.
While these advancements are exciting, treatment should always be guided by a healthcare professional, considering individual patient factors like disease severity and comorbidities. If you're a clinician or patient exploring options, consulting recent guidelines from bodies like the American Association for the Study of Liver Diseases (AASLD) can provide additional context. What are your thoughts on plant-based biologics—game-changer or still emerging?
