On July 18, the Plant-Derived Recombinant Human Albumin Injection, developed by Wuhan Oryzogen Biotechnology Co., Ltd. using "rice-sourced hematopoiesis" technology, was officially approved for marketing for the treatment of hypoalbuminemia (≤30g/L) associated with liver cirrhosis. Upon market launch, this product will become the first human serum albumin injection in China developed using recombinant protein technology.
Currently, human serum albumin drugs used in clinical practice are all derived from human plasma through separation and extraction, which carries risks of resource shortages and pathogen transmission. According to publicly available data, the market size for human serum albumin therapeutic drugs in China had already reached RMB 25.8 billion in 2020, with heavy reliance on imports—imported products have long held over 60% of the market share—and a significant supply-demand gap for human serum albumin remains.
HY1001 is Oryzogen's first flagship product. Using rice endosperm cells for expression, this recombinant human serum albumin product, produced through extraction and purification, has successfully solved the problems of purity, scalability, and cost associated with recombinant human serum albumin. More importantly, it has eliminated the risk of viral transmission at the source, ensuring the safety of the blood product.
In September 2024, Oryzogen submitted a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of the NMPA for the "hypoalbuminemia" indication, which was included in the priority review and approval process. According to relevant regulations, the review period for drug market approval applications included in the priority review and approval process is 130 days. As of April 2025, the product had entered the new drug approval process. Earlier reports indicated that it left the marketing application queue on April 7 and subsequently entered the second-stage deficiency response phase on April 25. With a normal three-month cycle, it ultimately completed the review process and successfully received approval for marketing.
This is the first Class 1 innovative drug produced using a rice endosperm cell bioreactor in China and internationally. Its approval for clinical research represents a milestone event for plant bioreactor research and utilization in China, providing a new pathway for protein drug production in the country.
Plant-Derived Recombinant Human Serum Albumin Injection (OsrHSA, HY1001) is a recombinant human serum albumin product expressed using rice endosperm cells and produced through extraction and purification. Its clinical trial progress is as follows:
In April 2017, it received a Drug Clinical Trial Approval from the former China Food and Drug Administration (now NMPA), with registration classification: Class 1 Therapeutic Biological Product. In November 2019, it received a Clinical Trial Notification approving a change to the Phase I clinical trial protocol.
In August 2019, it received FDA approval to enter clinical studies in the United States. In July 2020, Phase I clinical studies were completed in the U.S.
In December 2022, HY1001 completed Phase II clinical trials, achieving the primary clinical study endpoints.
In February 2024, HY1001 completed Phase III clinical trials, demonstrating non-inferior efficacy compared to control human serum albumin with a favorable safety profile.
Since 1981, attempts have been made internationally to replace plasma-derived human serum albumin with recombinant human serum albumin, but due to bottlenecks in safety, scalability, and cost, no product has successfully entered the market. Oryzogen's independently developed, internationally leading plant recombinant protein expression and purification technology platform has these bottlenecks, successfully solving the issues of purity, scalability, and cost associated with recombinant human serum albumin. Phase I clinical study results have demonstrated that OsrHSA has a very favorable safety and tolerability profile. To date, Oryzogen has been granted 41 related to its technology platform and recombinant human serum albumin. This project has also received support from numerous major science and technology projects of the Ministry of Science and Technology, as well as from the National Development and Reform Commission, and the governments of Hubei Province and Wuhan City.