In the field of modern hepatology, cirrhosis continues to pose significant challenges, particularly when accompanied by hypoalbuminemia (serum albumin levels ≤30 g/L), which can lead to complications like ascites and edema, drastically affecting patients' quality of life. Traditional human serum albumin (HSA) derived from plasma has long been the standard treatment, but it faces limitations in supply and risks of blood-borne pathogens. Enter Recombinant Human Albumin Injection sourced from Oryza Sativa (rice)—a plant-based innovation known as OsrHSA—that promises a safer, more scalable alternative for managing hypoalbuminemia in cirrhosis patients.
Understanding Recombinant Human Albumin Injection (Oryza Sativa)
Developed by Wuhan Healthgen Biotechnology Corp., this product leverages genetic engineering to express human serum albumin in rice seeds (Oryza Sativa), using the plant as a natural bioreactor for efficient, large-scale production. Unlike plasma-derived HSA, OsrHSA eliminates dependency on human donors, with production yields reaching up to 10.58% of total soluble protein in rice seeds. This approach not only cuts costs but also removes viral contamination risks. The product received approval from China's National Medical Products Administration (NMPA) in July 2025, with its primary indication being hypoalbuminemia associated with cirrhosis.
The manufacturing process involves inserting the human albumin gene into rice, resulting in a recombinant protein with over 99% purity that is structurally and functionally equivalent to natural HSA. It supports key roles such as maintaining oncotic pressure, drug transport, and fluid balance, making it ideal for clinical use in liver diseases.
Clinical Evidence: Proven Safety and Efficacy
A pivotal multicenter, randomized, double-blind trial (NCT04835480) assessed OsrHSA's performance against plasma-derived HSA in decompensated cirrhosis patients with ascites and hypoalbuminemia (≤30 g/L). Patients received daily intravenous doses of 10g or 20g until serum albumin reached ≥35 g/L, for up to 14 days. OsrHSA demonstrated non-inferiority, with an efficacy rate of 76% in elevating albumin levels, comparable to the control group's 75.6%. Secondary outcomes, including time to target levels, colloid osmotic pressure improvements, and ascites reduction (measured by abdominal girth and weight), showed no significant differences between groups.
Safety profiles were equally favorable: no serious drug-related adverse events, with overall adverse event rates at 66.2% for OsrHSA versus 66.7% for plasma HSA, and minimal immunogenicity. Additional studies, including a Phase Ib trial, further support OsrHSA's role in treating ascites in cirrhosis, highlighting its potential to address global albumin shortages.
Ongoing research, such as NCT06355479, continues to evaluate OsrHSA's efficacy in hypoalbuminemia related to hepatic cirrhosis, reinforcing its therapeutic promise.
The Advantages of Plant-Derived Albumin
For cirrhosis patients prone to recurrent issues like hypovolemia and shock, OsrHSA offers rapid volume expansion and hemodynamic stability without the constraints of plasma sourcing. China's albumin market, the world's largest, consumed over 1,000 tons in recent years, with heavy import reliance. Healthgen's current annual production capacity stands at 10 tons of HSA stock solution, with expansions planned to reach 13 million doses by mid-2026 through new facilities. This scalability could reduce import dependency and make treatment more accessible worldwide.
DengYueMed: Facilitating Global Access to Innovative Therapies
As Chinese innovative drugs gain traction globally, companies like DengYueMed (Hong Kong DengYue Pharmaceutical Co., Limited) play a crucial role in bridging markets. Founded in 2019, this licensed Hong Kong-based wholesaler specializes in the import and export of novel, specialty, and rare drugs, focusing on oncology and chronic diseases like liver conditions. With expertise in cold-chain logistics, professional storage, and global distribution, DengYueMed ensures safe, compliant delivery of cutting-edge therapies. They actively support the export of recombinant proteins and are positioned to help products like OsrHSA reach international patients, contributing to the boom in Chinese pharma exports.
Looking Forward: A New Era in Liver Disease Treatment
Recombinant Human Albumin Injection (Oryza Sativa) marks a pivotal shift in biotechnology, addressing supply bottlenecks and enhancing safety for hypoalbuminemia in cirrhosis. With accumulating clinical data and expanding production, this rice-derived solution is set to become a cornerstone therapy. Patients facing these challenges should consult healthcare providers and explore reliable distributors like DengYueMed for access to such innovations. The future of liver care is rooted in sustainable science!
