Anrate Recombinant Human Serum Albumin (rHSA) Approved for Marketing

Anrate Recombinant Human Serum Albumin (rHSA) has been approved for marketing, filling the global gap and ushering in a new chapter in biopharmaceuticals!

On April 8, 2024, Recombinant Human Serum Albumin (rHSA) Injection independently developed by Tonghua Anrate Biopharmaceutical Co., Ltd. (hereinafter referred to as Anrate) completed registration in Russia and obtained marketing approval from the Ministry of Health of the Russian Federation under the Eurasian Economic Union (Министерство здравоохранения Российской Федерации). In 2023, Anrate’s rHSA Injection finished Phase III clinical trials in Russia, meeting predefined endpoints and delivering safe, effective and reliable clinical outcomes. For this launch, Anrate secured approval in Russia for products in three concentrations (5%, 10% and 20%) with multiple specifications including soft bags and hard vials. Beyond Russia, Anrate has established cooperation with multiple Belt and Road Initiative countries such as Turkey and Uzbekistan, built extensive partnerships with Austria, Mexico, Algeria, Indonesia and other nations, and plans to file for an FDA Fast‑Track clinical application in the United States.

The world’s first commercially launched recombinant human serum albumin injection signifies that Anrate, a landmark achievement of China’s Major Special Project for Innovative Drug Development under the 12th Five‑Year Plan and the National Key R&D Program of “Green Biomanufacturing” under the 14th Five‑Year Plan, has developed the world’s first and only marketed rHSA injection product. Its significance lies not only in addressing the acute shortage of plasma‑derived human serum albumin (pHSA) and acting as a safe, reliable alternative, but also in filling a global gap in the biopharmaceutical industry. Meanwhile, as the world’s largest rHSA production facility, Phase I workshop of Anrate’s raw material and finished‑formulation manufacturing base with an annual output of 50 tons has successfully passed trial operation and obtained the Drug Production License, and is poised for commissioning. This will greatly advance the global biopharmaceutical industry and safeguard the life safety and biosafety of more patients worldwide.

In the global pharmaceutical sector, plasma‑derived human serum albumin (pHSA) has long been hailed as the “golden life‑saving drug”, playing an irreplaceable role in treating critically ill patients with shock, burns and other severe conditions. However, the supply of pHSA has long been constrained by shortages of blood‑derived products and zoonotic contamination. In addition, the commercialization of recombinant human serum albumin has encountered substantial challenges, namely three core bottlenecks: attaining maximum purity, large‑scale production and minimal production cost. In 2008, Medway, an rHSA injection manufactured via the Pichia pastoris expression system and developed by Japan’s Mitsubishi Tanabe Pharma Corporation, obtained marketing approval. Nevertheless, due to flaws in clinical trial data, suboptimal glycosylation and purification processes that led to high immunogenicity, the product was withdrawn from the market within less than one year.

Confronted with unprecedented challenges, Anrate has persisted in research and development, forging a pioneering path leading global industrial progress.

Front‑end R&D Innovation
Anrate develops and optimizes rHSA based on technological platforms for high‑efficiency expression modification and large‑scale fermentation of recombinant proteins. At the genetic modification level, proprietary R&D improves recombinant protein expression efficiency and reduces glycosylation at the source. During fermentation, accumulated technical expertise optimizes biological elements required for cellular engineering, ensuring product stability and recombinant protein expression efficiency throughout the fermentation process. For purification procedures, Anrate enhances separation and purification efficiency to achieve ultra‑high purity, breaking core bottlenecks in the albumin industry and realizing high‑purity, low‑cost and ultra‑large‑scale production. Compared with Mitsubishi Tanabe Pharma’s product, Anrate has increased product purity by nearly 1,000‑fold, lowered glycosylation levels from 45% to below 3%, and produced rHSA with a molecular structure nearly identical to that of neonatal serum albumin from the human liver. This fundamentally avoids supply shortages of blood‑derived albumin and immunogenicity risks of recombinant human albumin, eliminates viral contamination, and elevates product quality to an unprecedented standard.

Back‑end Industrial Expansion
By proactively constructing its rHSA production base, Anrate has rapidly rolled out its global commercialization strategy. The Phase I workshop of Anrate’s raw material and finished‑formulation manufacturing base with an annual output of 50 tons is currently the world’s largest rHSA production line, marking another key milestone following the approval of its 5‑ton‑annual‑capacity production line in 2018. Furthermore, backed by its unique core technologies featuring high economic value and replicability, Anrate plans to build five 50‑ton‑annual‑output rHSA production lines within 3–5 years and 12 such lines within 10 years. Upon full operation, the total annual production capacity is projected to reach 600 tons (60 million vials) with an output value of RMB 30 billion. This will effectively support the establishment of a global rHSA supply system and stably provide safe alternative serum albumin injection products for global patients.

The successful launch of Anrate’s rHSA Injection ushers in a new era of global biopharmaceutical innovation. Its cutting‑edge technologies and forward‑looking development roadmap are driving industrial disruption in the global albumin sector, bringing infinite possibilities to the future of the global biopharmaceutical industry.

Beyond rHSA injectable formulations, global demand for rHSA in pharmaceutical excipients, medical device coatings, cell therapy, vaccine development and other fields is steadily rising. Anrate has actively deployed rHSA as raw and auxiliary materials for cell and gene therapy (CGT). Anrate’s rHSA has the following characteristics:

1.Higher product safety with zero risk of animal‑derived contamination.

2.Superior quality reliability: ton‑scale production capacity, excellent batch‑to‑batch stability, and unlimited single‑batch supply capacity.

3.Stable supply: all production materials are domestically sourced to ensure a stable supply chain.

Partial Product Display of Recombinant Human Serum Albumin (rHSA):

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