不稳定、退市风险高等特点，投资者面临较大的市场风险。投资者应充分了解科 创板的投资风险及本公司所披露的风险因素，审慎作出投资决定。 武汉禾元生物科技股份有限公司 Wuhan Healthgen Biotechnology Corp. （武汉东湖新技术开发区神墩五路 268 号） 首次公开发行股票并在科创板上市 招股说明书 保荐人（主承销商） 中国（上海）自由贸易试验区商城路 618 号 联席主承销商 北京市朝阳区安立路 66 号 4 号楼 武汉禾元生物科技股份有限公司 招股说明书 致投资者的声明 一、公司上市的目的 公司是一家创新驱动的生物医药企业，面向世界科技前沿，坚持原始创新， 建立了全球领先的水稻重组蛋白质表达体系，公司 OryzHiExp 第三代技术平台已 实现 20-30g/kg 糙米人白蛋白表达量水平，突破了重组人白蛋白药物的底层关键 核心技术，具有高产量、工艺简单、低成本、易实现规模化生产等优势，公司 在技术上实现了"从 0 到 1"的突破。截至本招股说明书签署日，公司已构建 了两大技术平台，拥有 8 个在研药品管线，其中 HY1001 已顺利获批上市，尚 有 5 个产品处于临床研究阶段，另有多 ...

Company Overview - The company is an innovative biopharmaceutical enterprise with a globally leading plant bioreactor technology platform, specifically a rice endosperm cell bioreactor expression system [1][3] - The company has developed multiple products including drugs, pharmaceutical excipients, and research reagents based on its rice endosperm cell bioreactor expression system [1] Product Pipeline - As of now, the company has a total of 8 drug candidates in its pipeline, with the fastest progressing product, recombinant human albumin injection (OsrHSA, HY1001), expected to receive approval by July 2025 for the indication of "hypoalbuminemia due to liver cirrhosis" [2] - Five products are currently in clinical trials, while several others are in preclinical research stages [2] Core Technology - The company has established an internationally leading rice endosperm cell bioreactor expression system, which includes upstream and downstream technologies for efficient recombinant protein expression and purification [3] Production Capacity - The company has built a commercial-scale production line capable of producing 10 tons of OsrHSA raw liquid annually and 1 million dosage forms, with a cGMP intelligent production line [4] - A new production line with a capacity of 120 tons of OsrHSA raw liquid is under construction, expected to be completed by September 2024 [4] Intellectual Property - The company holds a total of 21 domestic invention patents and 62 foreign invention patents [4] Research and Development - The company has strong research capabilities, having independently or led 3 national major science and technology projects and 2 provincial key projects [5] - The company has published 20 SCI papers and books related to its core technologies and products [5] Awards and Recognition - The company's core technology has received national awards, including the Second Prize of National Science and Technology Invention and an Excellent Patent Award from the National Intellectual Property Administration [6] Financial Performance - The company's revenue for the years 2022, 2023, 2024, and the first half of 2025 was 13.40 million, 24.26 million, 25.22 million, and 12.71 million respectively [7] - Research and development expenses for the same periods were 110.50 million, 159.10 million, 116.79 million, and 55.94 million, indicating significant investment in R&D [8] Development Strategy - The company aims to provide green, safe, accessible, and sufficient biopharmaceutical products globally, focusing on unmet clinical needs and leveraging its technological advantages [9] Competitive Advantages - The company’s main competitive advantages include its ideal recombinant protein drug preparation platform, a large potential market for recombinant human albumin, and the safety and environmental benefits of its products [10] Industry Characteristics - The biopharmaceutical industry is characterized by interdisciplinary applications, continuous technological iteration, long R&D cycles, high investment, and regulatory barriers [15] Market Demand - The clinical demand for human serum albumin drugs in China is significant, with a market size projected to grow from 25.8 billion in 2020 to 57 billion by 2030 [16] Future Innovations - The company plans to focus on original innovations in rice endosperm cell expression technology, accelerate the development of long-acting drugs based on recombinant human albumin, and advance multiple therapeutic recombinant biological products [14]

Core Viewpoint - Wuhan Heyuan Biotechnology Co., Ltd. (referred to as "Heyuan Biotechnology") has been under scrutiny since its IPO application on the Sci-Tech Innovation Board, which has faced delays for over two years. The company has recently updated its financial data, indicating continued losses and no commercialization achieved during the reporting period [1][4][8]. Financial Performance - Heyuan Biotechnology reported a total net loss exceeding 500 million yuan from 2021 to the first half of 2024, with specific annual losses of approximately 134 million yuan, 144 million yuan, 187 million yuan, and 78.59 million yuan respectively [8]. - The company's revenue for the same period was approximately 25.52 million yuan, 13.40 million yuan, 24.26 million yuan, and 9.53 million yuan [8]. IPO Details - The company aims to raise 3.502 billion yuan through its IPO, which is one of the highest amounts among existing companies on the Sci-Tech Innovation Board [1][10]. - The IPO process has included two rounds of inquiries, and the company has yet to receive a chance for a board meeting [4][8]. Product Development - Heyuan Biotechnology is known for its innovative "rice blood production" technology, extracting human serum albumin from rice. Its core product, HY1001, has completed Phase III clinical trials and is expected to receive approval in China by 2025 and in the U.S. by 2026 [4][5][6]. - The company estimates that sales revenue for HY1001 will reach 444 million yuan in 2026 and 1.567 billion yuan by 2030, with significant market potential [6]. Market Position and Competition - As of November 30, 2024, there are no recombinant human serum albumin products available in the domestic market, giving Heyuan Biotechnology a competitive edge [5]. - The company emphasizes the safety and environmental benefits of its recombinant human serum albumin, which is not dependent on plasma sources [5][6]. Production Capacity and Risks - The company plans to invest approximately 1.909 billion yuan in the construction of a production base for recombinant human serum albumin, aiming for an annual capacity of 120 tons [10][11]. - There are concerns regarding whether the new production capacity can be effectively utilized, as well as the feasibility of the investment projects [10][11][12].