据禾元生物方面介绍，该重组人白蛋白注射液（水稻）是利用水稻胚乳细胞表达，经提取、纯化的重组 人血清白蛋白产品。2024年9月，该产品获得国家药监局NDA受理，被纳入优先审评审批程序。2025年 7月18日，获得国家药监局批准上市，是全球首个获批上市的植物源重组人白蛋白注射液。 禾元生物董事长杨代常在论坛致辞中表示，奥福民获批上市并已完成首批患者临床应用，是我国生物医 药领域的一项重大突破，更是解决临床"救命药"供应安全问题的里程碑事件。禾元生物将加产业化基地 建设，早日投产实现自主研发的国产替代，保障国家药品供应安全。同时启动在FDA法规下的国际多中 心三期临床试验，拓展适应症研究，让全世界患者用上安全、可及的"中国造"重组人白蛋白。 据禾元生物官网介绍，人血清白蛋白广泛用于肝硬化腹水、脑水肿，失血性休克、严重烫伤烧伤、术后 扩充血容量和癌症的放化疗等治疗，还在药物辅料、干细胞、细胞治疗、培养基添加剂、细胞冻存保护 剂与疫苗赋形剂等具有广泛用途，在我国市场需求约为1000吨/年，据2024年中检院批签发数据，进口 占比达到69%。传统人血白蛋白依赖血浆提取，潜藏血源安全风险，同时在人口老龄化加剧、献血率走 低 ...

Core Viewpoint - Wuhan Heyuan Biotechnology Co., Ltd. plans to raise 3.502 billion yuan through its IPO on the Sci-Tech Innovation Board, with significant investments allocated for the industrialization of plant-derived recombinant human serum albumin, new drug development, and working capital [1][2][3] Fundraising Plan - The company aims to raise 3.502 billion yuan, with 1.909 billion yuan designated for the construction of a plant-derived recombinant human serum albumin industrialization base, 794 million yuan for new drug research and development, and 800 million yuan for working capital [1][2] - The fundraising projects are aligned with the company's current R&D pipeline and future commercialization needs, enhancing its core competitiveness and sustainable development [1][3] Product Development - Heyuan Biotechnology's core product, HY1001, has completed Phase III clinical trials in China, achieving primary and secondary endpoints with good safety profiles [1][4] - The company has submitted a New Drug Application (NDA) for HY1001 for the treatment of hypoalbuminemia, which was accepted in September 2024, and is currently progressing smoothly through the review process [2][5] Clinical Trials and Pipeline - The company has multiple products in various stages of clinical trials, including HY1002, HY1003, HY1004, and HY1005, with ongoing studies demonstrating good safety and efficacy [2][3] - The plant-derived recombinant human serum albumin has shown non-inferiority to plasma-derived products in clinical data, although the human use history is relatively short [6] Market Position and Challenges - The establishment of the industrialization base is expected to meet market demand and enhance the company's profitability and market influence [2][3] - Despite the promising clinical data, there are concerns regarding market acceptance among doctors and patients, which could impact commercialization [6]