In the medical world, human serum albumin is hailed as a "golden life-saving drug." It is the most widely used blood product, yet it remains trapped in traditional constraints—relying entirely on human plasma extraction. This not only leads to a perennial shortage of clinical supplies but also leaves the risk of viral transmission ever-present.

Recently, Heyuan Bio, which just listed on the Science and Technology Innovation Board, is bringing with it "rice hematopoietic" technology, which is expected to break the limitations of traditional methods for preparing human serum albumin.

The birth of Heyuan Biotechnology stems from a technological breakthrough by Professor Yang Daichang's team at Wuhan University. In 2006, Yang Daichang founded Heyuan Biotechnology with his technological achievements. In July of this year, Heyuan Biotechnology's core product HY1001 (Aofumin Recombinant Human Albumin Injection) was approved for marketing, becoming the first plant-derived recombinant human albumin drug in China.

The capital market reacted swiftly and enthusiastically. On its first day of trading on the Science and Technology Innovation Board, Heyuan Bio's stock price surged by over 200%, and continued to climb the following day. As of the closing bell on October 29, its market capitalization had quietly surpassed that of several traditional blood product giants.

It is worth noting that Heyuan Bio is also the first pharmaceutical company to be listed after the Science and Technology Innovation Board restarted the fifth set of listing standards.

"Golden medicine" grows in rice paddies

"Rice as a lifeblood"—On October 28, Heyuan Biotechnology listed on the Science and Technology Innovation Board with this core technology. As Heyuan Biotechnology is not yet profitable, it also became one of the first newly registered companies in the Science and Technology Innovation Growth Layer since the "1+6" reform of the Science and Technology Innovation Board.

On the opening day, Heyuan Bio's stock price surged by over 200%, and by the close, its total market capitalization exceeded 32.5 billion yuan. On the 29th, the company suspended trading mid-day due to abnormal stock price fluctuations. After resuming trading, it closed at 113.22 yuan per share, up 24.28%, bringing its market capitalization to 40.5 billion yuan, surpassing many leading domestic blood product companies, such as Tiantan Biological Products .Hehualan Biological。

Heyuan Biotechnology's core technology is "rice-based hematopoiesis," namely, the world's first plant-derived recombinant human albumin. According to its prospectus, this technology has overcome the technical challenges of recombinant human serum albumin by introducing the human serum albumin gene into rice cells through biotechnology, inducing them to grow into complete rice seedlings. The rice raw materials are then extracted and purified in a pharmaceutical workshop to obtain recombinant human serum albumin with a purity of 99.9999% or higher. In short, Heyuan Biotechnology has turned rice paddies into "pharmaceutical workshops," making "rice-based hematopoiesis" a reality, thus overcoming the limitation of traditional human serum albumin production, which mainly relies on plasma extraction.

In clinical applications, human serum albumin is known as the "golden life-saving drug" and has a wide range of uses, including hypoalbuminemia caused by liver disease, kidney disease, burns, and scalds, hemorrhagic shock, blood volume replacement, and adjuvant therapy for radiotherapy and chemotherapy of malignant tumors. However, the traditional method of relying on plasma extraction is not only limited by insufficient plasma collection, but also carries the potential risk of virus transmission.

Furthermore, China's clinical use of human serum albumin relies primarily on two supply channels: domestic extraction from human plasma and imports. In recent years, the domestic supply of human serum albumin has faced a significant shortage. According to data released by the National Institutes for Food and Drug Control (NIFDC), as of 2024, the total domestic demand for human serum albumin continued to grow, and the proportion of imports also increased, reaching 69%.

Therefore, recombinant human albumin products not only help avoid the risks of plasma extraction, but also help improve the self-sufficiency of human serum albumin.

In July 2025, the National Medical Products Administration (NMPA) announced the approval of Heyuan Biotechnology's recombinant human albumin injection (rice) (trade name: Aofumin) for marketing. In August 2025, Heyuan Biotechnology announced the completion of its first prescription, marking its first clinical application in patients with cirrhosis and hypoalbuminemia.

There is competition among multiple technological paths.

The industry has explored various approaches to recombinant human albumin technology. Over the past few decades, researchers have been investigating the production of recombinant human serum albumin using various expression systems, including strains such as Escherichia coli, Saccharomyces cerevisiae, Kluyveromyces lactis, and Pichia pastoris.

Subsequently, researchers discovered that plant seeds, especially cereal crop seeds, are promising candidates for producing recombinant proteins.These vectors are used because they enable high accumulation of recombinant proteins , exhibiting characteristics such as high protein yield, good stability, long-term storage, and good control over production scale. For example, in a 2003 paper, human lysozyme was successfully expressed in rice seeds, and in 2008, lactoferrin for oral administration was successfully expressed in rice seeds.

However, the existence of multiple technological approaches means that Heyuan Bio also faces competitors.

Public information shows that, in addition to Heyuan Biotechnology, there are four other companies in China that are developing recombinant human albumin drugs, and the raw materials for these companies are mostly yeast.

The most advanced among them is Tonghua Anruit, whose product was approved for marketing in Russia and Kyrgyzstan in 2024, becoming the world's first approved recombinant human albumin product. Its Phase III clinical trial in China has also been completed. In addition, Shenzhen Progene has also completed its Phase III clinical trial in China. Shandong Jiantong Biotechnology is currently conducting its Phase I clinical trial in China, and North China Pharmaceutical...Preclinical studies are underway.

To date, HeYuan Bio's recombinant human albumin has only been approved for one indication: the treatment of hypoalbuminemia (≤30g/L) in liver cirrhosis. HeYuan Bio stated that hypoalbuminemia in liver cirrhosis is one of the largest indications for human albumin, accounting for approximately 30% of the overall market size.

However, due to the declining incidence of hepatitis, the market space for this indication is gradually shrinking. Heyuan Biotechnology predicts that there will be 567,000 patients with cirrhosis and hypoalbuminemia in my country in 2022, which will decrease to 455,000 by 2030.

For HeYuan Bio, expanding indications is essential to improving commercial returns. However, the prospectus shows that its recombinant human albumin is currently still in clinical trials for hypoalbuminemia in liver cirrhosis, and no progress has been made on other indications.

The company seems more eager to enter the US market. In August of this year, it stated that it had completed a Category C communication meeting with the FDA (US Food and Drug Administration) on the "global multicenter clinical trial design" and reached a consensus on the international multicenter Phase III clinical trial protocol. The company also stated that its plan for 2025 is to complete the US Phase III clinical trial and submit a marketing application in 2026. Over the next three years, it will actively promote the launch of its core products and the expansion of indications.

Besides recombinant human albumin, among HeYuan Bio's other major products, the most advanced is recombinant human lactoferrin lysozyme oral solution, used to treat acute diarrhea caused by rotavirus infection and acute viral diarrhea in children, currently undergoing phase III clinical trials. In addition, there is recombinant human α-1 antitrypsin, used to treat α-1 antitrypsin deficiency (AATD), which has completed phase I clinical trials.

Source: https://finance.eastmoney.com/a/202510293549013296.html