Core Insights - The global first recombinant human albumin injection (rice) named "Aofumin" has been launched by Wuhan Heyuan Biotechnology Co., Ltd, marking a significant milestone in the biopharmaceutical field in China [1][3] - The product addresses the safety supply issues of "life-saving drugs" in clinical settings and aims to ensure the safety of drug supply in the country [3] Company Overview - Wuhan Heyuan Biotechnology has developed an innovative plant-based recombinant protein expression and purification technology platform, overcoming previous challenges related to safety, scalability, and cost in producing recombinant human serum albumin [2] - The company has secured over 80 patents related to its technology platform and recombinant human serum albumin, supported by various national and local government projects [2] Product Details - The recombinant human albumin injection (rice) is derived from rice endosperm cells and has been clinically proven to be as effective as plasma-derived albumin, with excellent safety and tolerability [2] - The product has a domestic market demand of approximately 1,000 tons per year, with 69% of the current supply being imported, highlighting a significant supply gap in the market [1] Regulatory Milestones - The product received acceptance from the National Medical Products Administration (NMPA) in September 2024 and was included in the priority review process, leading to its approval for market launch on July 18, 2025 [2] Future Plans - The company plans to establish an industrialization base to ensure the production of domestically developed alternatives and is initiating international multi-center Phase III clinical trials under FDA regulations to expand its indications [3]

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]