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].

医药行业 证券研究报告 |深度报告 2025/12/01 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 | 证券分析师: | 程晓东 | | --- | --- | | 分析师登记编号: | S1190511050002 | | 证券分析师: | 李忠华 | | 分析师登记编号: | S1190524090001 | P2 报告摘要 核心结论：禾元生物是国内植物源重组蛋白药物领军者，以独创水稻胚乳细胞生物反应器技术打破血浆依赖，核心产品 HY1001（重组人白蛋白）国内先发上市、美国推进III期，成本远低于血浆来源，120吨产能+全球化布局支撑2030年营 收超30亿，技术壁垒与商业化确定性突出，具备高投资价值。 一、公司与核心技术：植物源蛋白产业化闭环，指标全球领先。公司拥有二大核心技术平台：1、重组蛋白高效表达平 台：历经三代迭代，重组蛋白表达量达20-30g/kg，核心依赖胚乳特异性启动子改造等专利技术；2、蛋白纯化平台：纯 度达99.9999%，内毒素符合中美药典，纯化成本较微生物体系降30%+。 二、产品管线：HY1001领跑，多梯队支撑增长。（1）核心产品 HY1001：2025年7月 ...