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 approval and commercialization of Wuhan Heyuan Bio's "rice blood production" raises urgent questions about the regulatory requirements for using genetically modified rice in pharmaceutical production [2][3][5]. Group 1: Product Overview - "Rice blood production" refers to the recombinant human albumin injection made from genetically modified rice, which is the world's first innovative drug of its kind, approved for market on July 18 [3][6]. - The recombinant human serum albumin is widely used in clinical settings for treating various conditions, and China has a significant reliance on imported albumin, with imports accounting for 69% as of mid-2024 [6][8]. Group 2: Regulatory Challenges - Heyuan Bio needs to obtain an agricultural genetically modified organism safety certificate to cultivate genetically modified rice on a large scale, which is currently in the application process [5][13]. - The safety certificate for genetically modified rice is difficult to obtain, with only two varieties having received approval, compared to 25 for corn and 10 for soybeans [16]. Group 3: Financial Aspects - Heyuan Bio has reported losses of approximately 480 million yuan over the past three years and plans to raise 2.4 billion yuan through an IPO, with 1.657 billion yuan allocated for the construction of a production base for the recombinant human albumin [5][14]. - The company has established a commercial-scale production line capable of producing 10 tons of recombinant human albumin annually and plans to expand to a 120-ton capacity by 2026 [14]. Group 4: Production and Supply Chain - To meet the projected annual demand of 120 tons of albumin, Heyuan Bio would require approximately 6,667 to 10,909 acres of land for rice cultivation, based on the yield of 20-30 grams of albumin per kilogram of brown rice [14]. - The company has received approval for production trials on a total of 14,900 acres in western China, classified as level II safety, indicating low risk to human health and the environment [15]. Group 5: Industry Implications - The lack of clear regulatory guidelines for "pharmaceutical industrial genetically modified rice" complicates the approval process, as current regulations primarily address agricultural genetically modified organisms [17][19]. - The regulatory body is preparing to draft management guidelines for this type of plant-based bioreactor, indicating a potential shift in oversight as the industry evolves [19].