【转|太平洋农业-禾元生物深度】水稻胚乳里的生物密码：禾元生物重组蛋白技术的产业化革命

Company Overview - He Yuan Bio, established in 2006, specializes in the research and development of plant-derived recombinant protein expression technology and products, aiming to create world-class biopharmaceuticals based on plant bioreactor technology [5]. - The company has developed two core technology platforms: a high-efficiency recombinant protein expression platform and a protein purification platform, achieving a recombinant protein expression yield of 20-30g/kg and a purification purity of 99.9999% [14][19]. Product Pipeline - The core product, HY1001 (recombinant human albumin), is expected to receive domestic approval by July 2025 and has completed FDA Type C communication for its Phase III clinical trial design in the U.S. [2][27][28]. - Other products in the pipeline include HY1002 (lactoferrin lysozyme oral solution), HY1003 (α-1 antitrypsin), and additional candidates targeting various medical conditions, with a total of 19 recombinant proteins under development [2][25]. Market and Competition - The domestic human recombinant albumin market is projected to grow from 39.5 billion RMB in 2024 to 57 billion RMB by 2030, with a CAGR of 6% [3][41]. - Currently, 62.9% of the domestic market is supplied by imports, with He Yuan Bio positioned as a leading domestic player in the recombinant HSA market, indicating strong potential for import substitution [3][42]. - The global demand for HSA is expected to reach 800 tons by 2030, with emerging markets heavily reliant on imports [3][41]. Cost and Production Advantages - The production cost of HY1001 is projected to be significantly lower than that of plasma-derived human albumin, with estimates suggesting a cost reduction of over 50% once the 120-ton production line is fully operational [54][56]. - The company has established a commercial-scale production line capable of producing 10 tons of HSA per year and is expanding to a 120-ton capacity by 2024 [22]. Clinical and Regulatory Progress - HY1001 has shown non-inferiority to plasma-derived human albumin in clinical trials, demonstrating comparable efficacy and safety profiles [52][49]. - The product has been recognized by FDA experts as a "historical innovation," supporting its global clinical trial design [28]. Future Outlook - The market for recombinant human albumin is expected to expand significantly, with projected sales revenue for HY1001 reaching approximately 15.67 billion RMB by 2030, driven by increasing treatment rates for liver cirrhosis and low albumin levels [58]. - The company anticipates a growing demand for its products, particularly in light of the limitations of plasma-derived products and the increasing focus on safety and supply stability [45][47].