The authoritative international hepatology journal Gut published a commentary highlighting the significant clinical implications of Recombinant Human Albumin Injection (Oryza Sativa)in albumin therapy
The official journal of the British Society of Gastroenterology, Gut (Impact Factor 25.8), recently published an in-depth commentary by Professor Rajiv Jalan of University College London and Professor Paolo Caraceni of the University of Bologna. The article provides an in-depth analysis on the Phase II clinical study of recombinant human albumin injection produced from the rice endosperm developed by a group of Chinese investigators and industry. Titled "New Frontier in Albumin Replacement Therapy", the commentary suggests that this innovative therapy may reshape the paradigm of albumin treatment for cirrhosis patients (Original source link: DOI: 10.1136/gutjnl-2025-336092).
The commentary article indicates that albumin is a multifunctional protein and its physiological functions influenced by multiple factors. Although traditional human serum albumin injections can increase serum albumin concentrations, it contains many stabilizers after the purification process with the wide variability in donated blood，which can have structural damages, especially the cystein-34 residue and the N-terminal alterations, and also the functionality of the albumin is significantly inadequacy. As a result, the function of human albumin in commercial preparations is significantly different from that in the plasma of healthy individuals. It may be these quality issues contributing to the heterogeneous results observed with long-term albumin treatment in decompensated cirrhosis.
The article highlights that, due to the advantages of the rice endosperm expression system, the structure and function of recombinant human albumin injection (Oryza Sativa) is very similar to native human albumin. Moreover, mostly recombinant human albumin remains in the reduced form, which may lead to superior functional capacity. If recombinant human albumin injection (Oryza Sativa) were used to repeat previously failed clinical trials, the results might be positive. The rice expression system inherently avoids the risks associated with derived blood, which is easily scalable, low-cost, and more accessible.
The article further affirms the favorable efficacy and safety profile demonstrated in the Phase II clinical trial of recombinant human albumin injection(Oryza Sativa) and hopes to drive its widespread indications. It concludes that this is a highly exciting time, where the paradigm of albumin treatment strategies may be transformed by the clinical advancement of recombinant human albumin injection (Oryza Sativa), which retains albumin bioactivity while obviating the quality drawbacks of plasma-derived albumin.
【About Recombinant Human Albumin Injection (Oryza Sativa)】
Human serum albumin is one of the most critical therapeutic drugs derived from humanblood. It is primarily used for treating hypoproteinemia, cirrhotic ascites, and burn shock in clinical, while also having broad applications in intensive care, surgical support and as a stabilizer in biopharmaceuticals production, such as vaccine.
The production of human albumin relies on human plasma source, which carries inherent blood safety risks formerly. China is one of the world's largest consumers of human albumin, with an annual demand of approximately 1,000 tons. Over 60% of this demand was imported. With an aging population and a shrinking donor pool, the domestic supply-demand gap for albumin continues to widen.
Based on the independently developed rice endosperm platform (OryzHiExp), Healthgen has achieved a breakthrough by successfully developing the world’s first recombinant human albumin injection derived from a plant expression system. Clinical studies have demonstrated that this product is non-inferior to plasma-derived albumin in efficacy and safety.
In September 2024, the product’s New Drug Application (NDA) was accepted by the National Medical Products Administration (NMPA) in the priority review and approval process. On July 18, 2025, Recombinant Human Albumin Injection(Oryza Sativa) received marketing approval from the NMPA, making it the world’s first plant-derived recombinant human albumin injection to be authorized for market use.
【About Gut】
Launched in 1960, Gut is the official authoritative journal of the British Society of Gastroenterology. It focuses on clinical research related to the digestive tract, liver, biliary system, and pancreatic diseases. The journal’s ISSN is 0017-5749, its EISSN is 1468-3288, and the latest impact factor is 25.8.
