Heyuan Biotech's IPO passed the listing committee meeting to further explore the field of recombinant human albumin drugs

The Zhitong Finance App learned that on July 1, Wuhan Heyuan Biotechnology Co., Ltd. (Heyuan Biotech for short) passed the Shanghai Stock Exchange Science and Technology Innovation Board Listing Committee meeting. The sponsor of the IPO is Cathay Pacific Haitong Securities, which plans to raise 2.4 billion yuan.

According to the prospectus, Heyuan Biology is an innovative biomedical enterprise with the world's leading plant bioreactor technology platform. The company has established an internationally leading rice endosperm cell bioreactor expression system with independent intellectual property rights, including the upstream rice endosperm cell bioreactor efficient recombinant protein expression platform (OryzPUR) and the downstream technology recombinant protein purification technology platform (OryzPUR).

At present, the company's rice endosperm cell recombinant protein expression technology has successfully achieved a high level of expression of target proteins. It can solve the problems of low expression levels, complicated purification processes, and large-scale production difficulties in other expression systems. Compared with prokaryotic cells or other eukaryotic cell expression technologies, it is safer, cheaper, and more environmentally friendly.

In terms of protein expression, the company expects the target protein expression to be as high as 20-30g per kilogram of brown rice. Furthermore, the company has continuously optimized recombinant human albumin purification technology, and has now been able to increase the purity of recombinant human albumin to over 99.9999%.

In the main economic battleground, recombinant human albumin is widely used, and the domestic market space is large. In 2020, the domestic human serum albumin treatment drug market reached 25.8 billion yuan. Domestic human serum albumin drug production capacity has been limited for a long time, supply is tight, and import dependence is severe. Imported products have long occupied more than 60% of the market, and have large clinical needs and national strategic needs.

The company's core product HY1001 has completed phase III clinical research in China. Research results show that it has reached the main and secondary clinical research endpoints, showing good safety. In September 2024, HY1001's drug marketing license application (NDA) was accepted. The drug marketing review is progressing smoothly. Most of the review procedures have been completed. It is expected that it will be approved for marketing in the near future. The approved indication is expected to be “liver cirrhosis hypoalbuminemia.”

In terms of production, the company's headquarters and R&D production base project are located in Optics Valley Biotech City (Wuhan National Biological Industry Base). The company has built a commercial-scale intelligent cGMP production line with an annual output of 10 tons of osrHSA stock solution and formulation in 2023, and has obtained a pharmaceutical production license. At the same time, in September 2024, the company started construction of a 120-ton OSRHSA solution cGMP intelligent production line with an annual output of 120 tons and its supporting engineering facilities (the “recombinant human albumin industrialization base construction project”). The project covers a total area of about 70,000 square meters.

On the financial side, in 2022, 2023 and 2024, Heyuan Biotech achieved operating income of approximately RMB 13.3997 million, RMB 24.2641 million, and RMB 252.161,000; during the same period, the company achieved net profit of about -144 million yuan, -187 million yuan, and -151 million yuan, respectively.