Company Overview - Wuhan Heyuan Biotechnology Co., Ltd. (Heyuan Bio) is an innovative biopharmaceutical company that has developed a leading plant-based bioreactor technology platform for protein expression [1] - The company has established a proprietary rice endosperm cell bioreactor expression system, which includes upstream and downstream technologies for efficient recombinant protein expression and purification [1] Market Opportunity - The domestic market for recombinant human serum albumin (rHSA) is significant, with a market size of 25.8 billion RMB in 2020 [2] - The supply of human serum albumin drugs in China is constrained, with over 60% of the market relying on imports, indicating a strong clinical and strategic demand [2] Product Development - The core product, HY1001, has completed Phase III clinical trials, demonstrating good safety and efficacy [2] - The New Drug Application (NDA) for HY1001 is expected to be accepted by September 2024, targeting the treatment of "hypoalbuminemia due to liver cirrhosis" [2] Production Capacity - The company has established a commercial-scale production line capable of producing 10 tons of OsrHSA per year and has obtained a drug manufacturing license [2] - A new production line with a capacity of 120 tons of OsrHSA is under construction, covering an area of approximately 70,000 square meters [2] Financial Performance - Heyuan Bio reported revenues of approximately 13.4 million RMB, 24.3 million RMB, and 25.2 million RMB for the years 2022, 2023, and 2024, respectively [3] - The company incurred net losses of approximately 144 million RMB, 187 million RMB, and 151 million RMB for the same periods [3] Key Financial Metrics - Total assets as of December 31, 2024, are projected to be approximately 1.061 billion RMB, with total liabilities leading to an asset-liability ratio of 43.37% [5] - The net profit attributable to the parent company is expected to be -151.4 million RMB for 2024, with a basic and diluted earnings per share of -0.56 RMB [5]

Core Viewpoint - Wuhan Heyuan Biotechnology Co., Ltd. plans to raise 3.502 billion yuan through its IPO on the Sci-Tech Innovation Board, with significant investments allocated for the industrialization of plant-derived recombinant human serum albumin, new drug development, and working capital [1][2][3] Fundraising Plan - The company aims to raise 3.502 billion yuan, with 1.909 billion yuan designated for the construction of a plant-derived recombinant human serum albumin industrialization base, 794 million yuan for new drug research and development, and 800 million yuan for working capital [1][2] - The fundraising projects are aligned with the company's current R&D pipeline and future commercialization needs, enhancing its core competitiveness and sustainable development [1][3] Product Development - Heyuan Biotechnology's core product, HY1001, has completed Phase III clinical trials in China, achieving primary and secondary endpoints with good safety profiles [1][4] - The company has submitted a New Drug Application (NDA) for HY1001 for the treatment of hypoalbuminemia, which was accepted in September 2024, and is currently progressing smoothly through the review process [2][5] Clinical Trials and Pipeline - The company has multiple products in various stages of clinical trials, including HY1002, HY1003, HY1004, and HY1005, with ongoing studies demonstrating good safety and efficacy [2][3] - The plant-derived recombinant human serum albumin has shown non-inferiority to plasma-derived products in clinical data, although the human use history is relatively short [6] Market Position and Challenges - The establishment of the industrialization base is expected to meet market demand and enhance the company's profitability and market influence [2][3] - Despite the promising clinical data, there are concerns regarding market acceptance among doctors and patients, which could impact commercialization [6]