禾元生物招股书称“稻米造血”无需转基因安全证 农业部：需要

Core Viewpoint - The article discusses the regulatory challenges faced by He Yuan Bio in the commercialization of its recombinant human serum albumin derived from genetically modified rice, highlighting the need for an agricultural biosafety certificate from the Ministry of Agriculture and Rural Affairs of China [2][6][11]. Group 1: Company Overview - He Yuan Bio has developed a recombinant human serum albumin injection, which is the first of its kind globally to be derived from genetically modified rice, receiving approval from the National Medical Products Administration on July 18 [5][3]. - The company aims to produce 120 tons of albumin annually, requiring approximately 6,667 to 10,909 acres of land for planting genetically modified rice [1][8]. - He Yuan Bio has established a commercial production line with an annual capacity of 10 tons of recombinant human serum albumin and plans to expand this capacity by 2026 [5][8]. Group 2: Regulatory Challenges - The production of genetically modified rice for pharmaceutical use requires a biosafety certificate, which He Yuan Bio is currently in the process of applying for [2][6][9]. - The company claims that its genetically modified rice is classified as "industrial medicinal genetically modified rice," which it believes does not require the same regulatory approvals as agricultural genetically modified organisms [11][12]. - The Ministry of Agriculture and Rural Affairs has clarified that He Yuan Bio must obtain the necessary biosafety certificate to proceed with the industrial cultivation of genetically modified rice [6][13]. Group 3: Market Context - The domestic market for human serum albumin is heavily reliant on imports, with 69% of albumin being imported as of mid-2024 [5]. - The theoretical annual demand for albumin in China is estimated to be between 1,500 and 1,800 tons, indicating a significant market opportunity for He Yuan Bio if it can successfully scale production [8]. - He Yuan Bio's approach of using rice as a "plant bioreactor" for albumin production is innovative, potentially reducing costs and eliminating the risk of virus transmission associated with blood-derived products [5][8].