In the realm of modern medicine, cirrhosis remains a prevalent chronic liver disease, often accompanied by hypoalbuminemia (serum albumin levels ≤30 g/L), leading to complications such as ascites and edema that severely impact patients' quality of life. Traditional treatments rely on albumin derived from human plasma, but supply is limited, and there's a potential risk of blood-borne diseases. In recent years, an innovative solution—Recombinant Human Albumin Injection (from Oryza Sativa)—is transforming this landscape. This plant-based recombinant human serum albumin (OsrHSA), expressed in rice, offers a safe and effective option for cirrhosis patients.

What is Recombinant Human Albumin Injection (Oryza Sativa)?

This product, developed by Wuhan Healthgen Biotechnology Corp. in China, utilizes genetic engineering to insert the human serum albumin gene into rice (Oryza Sativa), turning the plant into a bioreactor for large-scale production. Unlike plasma-derived albumin, this recombinant version bypasses the limitations of human plasma donation—every 25 kg of rice can yield the equivalent of 5 liters of human plasma albumin. This boosts production efficiency, reduces costs, and eliminates viral contamination risks. Currently, the product has received marketing approval from China's National Medical Products Administration (NMPA), with its primary indication being hypoalbuminemia in cirrhosis (≤30 g/L).

During production, rice seeds are engineered to express high-purity human serum albumin, achieving over 99% purity. Structurally and functionally, this plant-derived albumin closely mirrors human albumin, effectively maintaining colloid osmotic pressure, transporting drugs, and regulating fluid balance.

Clinical Evidence: Balancing Safety and Efficacy

A multicenter, randomized, double-blind, non-inferiority Phase II clinical trial (HY1001, NCT04835480) evaluated 220 patients with decompensated cirrhosis and ascites. Patients with serum albumin ≤30 g/L were randomized to receive OsrHSA or plasma-derived human serum albumin (pHSA) via intravenous infusion of 10g or 20g daily until albumin levels reached ≥35 g/L (up to 14 days).

The results showed OsrHSA achieved an effective rate of 76% in elevating serum albumin levels, comparable to pHSA's 75.6%, confirming non-inferiority. Secondary endpoints, including time to target albumin levels, changes in colloid osmotic pressure, and improvements in ascites (e.g., reductions in abdominal girth and body weight), showed no significant differences between groups. Importantly, OsrHSA demonstrated excellent safety: no drug-related serious adverse events, with adverse event rates similar to pHSA (66.2% vs. 66.7%), and low immunogenicity (no significant increases in anti-drug or anti-host cell protein antibodies). This study provides robust evidence for OsrHSA as a viable alternative to plasma albumin, particularly in regions facing supply shortages.

Another study further affirms that rice-derived recombinant albumin serves as a safe and effective option in decompensated cirrhosis patients, potentially alleviating global albumin shortages.

Why Choose Plant-Derived Albumin?

Cirrhosis patients often face recurrent hospitalizations and complication risks, with hypoalbuminemia being a key issue. Traditional albumin depends on plasma donations, constrained by donor availability and safety screening, whereas recombinant technology ushers in an era of sustainable production. As the world's largest albumin consumer, China produced and imported over 1,000 tons in 2024, with imports accounting for more than 69%. OsrHSA's production capacity stands at 10 tons annually, with plans to expand to 130 tons by 2026, significantly reducing import dependency.

Moreover, this product excels in clinical use: rapid volume expansion, hemodynamic stabilization, and effective relief of cerebral edema, cirrhotic ascites, and more. For chronic disease patients, opting for a virus-free alternative is especially crucial.

DengYueMed: Driving Innovative Drugs Globally

In the global pharmaceutical market, Chinese innovative drugs are experiencing a surge. As a leading Hong Kong-based pharmaceutical import/export wholesaler, DengYueMed (Hong Kong DengYue Medicine) specializes in novel, specialty, and rare drugs, particularly in oncology and chronic diseases. DengYueMed offers professional drug storage, temperature-controlled transportation, and global express services, ensuring safe and efficient delivery to patients. They have successfully exported various recombinant protein drugs, such as the fusion human serum albumin recombinant granulocyte colony-stimulating factor (Mailisheng), and are actively involved in promoting Chinese innovative drugs worldwide. For cutting-edge products like OsrHSA, DengYueMed is partnering with collaborators to facilitate international registration and distribution, helping more cirrhosis patients access this breakthrough therapy.

Conclusion: Looking Ahead

Recombinant Human Albumin Injection (Oryza Sativa source) represents a major advancement in biotechnology for liver disease treatment. It not only addresses the bottlenecks of traditional albumin supply but also provides a safer choice for hypoalbuminemia in cirrhosis patients. As clinical data accumulates and production scales up, this "rice albumin" is poised to become a standard part of therapy. If you or a loved one is facing similar health challenges, consult a healthcare professional and stay informed through reliable channels like DengYueMed for the latest drug updates. The path to health begins with innovation!