美丽健康 | 工信部 【SynBioCon】 获 悉，7月1日，据上交所官网显示， 武汉禾元生物科技股份有限公司 （以下简称：禾元生 物）已通过上市审核委员会审议，并正式递交IPO注册申请，有望成为今年 首个成功上市的重组蛋白企业 。 这家武汉的生物制造企业，拿下了第五套重启后的首家上会资格。 公开资料显示，重组蛋白表达体系包括微生物（细菌、酵母）、动物和植物表达体系等，禾元生物专注 植物源重 组蛋白表达技术 研究与产品开发，基于水稻胚乳细胞生物反应器的表达体系开发 重组人血清白蛋白 （ 1公斤稻 米产出约10克血清白蛋白 ） 。 寻找一种安全、高效、可持续的人血清白蛋白生产方法，一直是全球科学家共同面临的重大课题。 对于连年亏损，禾元生物表示，"由于研发流程复杂，审评标准严格，创新药的研发呈现出投入大、周期长、风险 高的特点，对创新药企业的研发能力和资金实力具有较高的要求。由于药品获批上市前收入来源有限，持续高强 度的研发投入导致众多创新药企业处于亏损状态。" 据悉，禾元生物药品均处于研发阶段，尚无获批上市的药品，营收主要来源于 药用辅料、科研试剂 的销售，规模 相对较小。 | 项目号 | 申报地区 | 产 ...

Core Viewpoint - Wuhan Heyuan Biotechnology Co., Ltd. has successfully passed the IPO review despite three consecutive years of losses, marking a significant milestone as the first company to benefit from the reactivation of the fifth set of listing standards for unprofitable enterprises on the Sci-Tech Innovation Board [2][3]. Group 1: Company Overview - Heyuan Biotechnology was established in 2006 and focuses on innovative drug research and development, primarily generating revenue from non-core products such as research reagents, with projected revenue of 25.21 million yuan in 2024 [2]. - The company has reported losses of 144 million yuan, 187 million yuan, and 151 million yuan from 2022 to 2024, totaling over 480 million yuan in cumulative losses [2]. Group 2: Product and Technology - The core product, HY1001 (plant-derived recombinant human serum albumin injection), is a first-class new drug that has completed phase III clinical trials and is expected to be the first domestically approved recombinant human serum albumin drug, addressing the current 60% import dependency in China [3]. - The "rice blood-making" technology, which utilizes rice embryo cell expression systems, has been recognized with a national technology invention award and is seen as a unique technological pathway that combines synthetic biology and medicine [3]. Group 3: Market and Regulatory Context - The fifth set of standards for the Sci-Tech Innovation Board appears tailored for companies like Heyuan Biotechnology, requiring a minimum market value of 4 billion yuan and at least one core product approved for phase II clinical trials [3]. - The successful IPO of Heyuan Biotechnology serves as a potential model for other unprofitable enterprises in cutting-edge fields such as artificial intelligence and biomedicine [2]. Group 4: Risks and Challenges - The company faces several risks, including the need to successfully launch its core product and demonstrate its efficacy to capture the anticipated market share [4]. - Ongoing patent disputes with Ventria Bioscience may hinder international sales and could result in significant compensation costs if the company loses the case [9]. - If profitability is not achieved in the future, the quality of information disclosure and communication with investors may pose substantial challenges [9].

继未盈利企业适用科创板第五套标准上市等政策被监管重申后，终于迎来首单"破冰"案例。 今年初便有投行人士告诉信风，部分第五套标准的科创板IPO项目与交易所沟通后，可以通过压缩IPO 募资额以进一步推进审核进程。 除了禾元生物，目前在审的第五套科创板IPO项目还包括深圳北芯生命科技股份有限公司（下称"北芯 生命"）、上海恒润达生生物科技股份有限公司（下称"恒润达生"）、哈尔滨思哲睿智能医疗设备股份 有限公司（下称"思哲睿"）、广州必贝特医药股份有限公司（下称"必贝特"）4家公司。 其中，北芯生命、恒润达生处于问询阶段；思哲睿、必贝特则处于提交注册阶段。 早在禾元生物之前，北芯生命就已经主动将IPO募资额从12.74亿元下调至9.52亿元，缩水超3亿元。 7月1日，上交所上市委将对武汉禾元生物科技股份有限公司（下称"禾元生物"）的科创板上市申请做出 审议。 禾元生物正是以第五套标准申报科创板上市，从2022年12月末受理迄今已历时近2年半，实属不易。 信风注意到，此次禾元生物主动下调了IPO募资额。 上会稿显示，禾元生物的IPO募资额为24亿元，较今年3月末披露的招股书中列示的35亿元募资额下滑 了超3成，缩水超1 ...

Core Viewpoint - Wuhan Heyuan Biotechnology Co., Ltd. is advancing its plant-based recombinant human serum albumin industrialization base project, which is expected to significantly impact domestic supply and health security by reducing reliance on imported products [3][5]. Group 1: Project Development - The construction of the first phase of the industrialization base is underway, with 490 workers on-site as of June 3 [1]. - The main structure of the project was completed in late April, and internal construction is currently ongoing, with equipment installation and debugging scheduled for July [3]. - The project is expected to be operational by the second quarter of 2026, with a total building area of approximately 70,000 square meters [3]. Group 2: Production Capacity and Strategic Importance - Once completed, the facility is projected to produce 12 million doses of recombinant human serum albumin injection annually, which could replace about 25% of the domestic import volume [3][5]. - The project is deemed strategically significant for public health and national defense, as it aims to ensure a stable supply of essential medical products [3][5]. Group 3: Innovation and Technology - Heyuan Biotechnology has developed the world's first plant-based recombinant human serum albumin using rice, marking a significant innovation in the field [5][6]. - The company has established a unique plant expression system and four core technology platforms, which are crucial for the development of new drugs [6].

天风证券（601162）股份有限公司杨松,曹文清近期对贝达药业（300558）进行研究并发布了研究报告《2025年 第一季度收入快速增长，展望今年即将迎来多项进展》，给予贝达药业增持评级。 贝达药业 事件 公司发布2024年年度报告及2025年一季报：2024年收入28.92亿元，同比增长17.74%，归母净利润4.03亿元，同 比增长15.67%，扣非归母净利润4.10亿元，同比增长55.92%；2025年第一季度营业收入9.18亿元，同比增长 24.71%；归母净利润1.00亿元，同比增长1.99%；扣非净利润1.64亿元，同比增长83.59%。非经常性损益主要系 投资公司股价变动所致。 提升管理效率，精简研发费用，同时加大销售推广力度 2024年销售费用为10.94亿元，销售费用率为37.8%，同比上升3pct；研发费用为5.02亿元，研发费用率为 17.4%，同比下降8.7pct；管理费用为2.69亿元，管理费用率9.3%，同比下降1.4pct。2024年公司加大销售投入， 年度投入10.9亿元，相较2023年同比增长28.10%。2025Q1销售费用为2.80亿元，销售费用率为30.53%，同比基 ...

近日，位于光谷生物城的禾元生物"稻米造血"产业化基地项目一期主体结构封顶，全面 转入设备安装与调试阶段，冲刺2026年建成投产。达产后，可年产1200万支重组白蛋白注射 液。 禾元生物董事长杨代常表示，项目建成后可实现公司研发的创新药——奥福民商业规模 化生产，对满足我国国民健康需求、摆脱长期进口依赖、确保供应链安全具有重要战略意 义。 创新药是生物医药产业的前沿领域、创新赛道，业界常用"九死一生"形容创新药从研发 到上市应用的坎坷历程。 在创新药领域，来自中国光谷的好消息不断。光谷生物城产业发展处相关负责人表 示："2024年下半年至今，正大天晴润欣、深圳福沃药业和上海甫康药业等一批创新药企业 正加速向光谷聚集。"光谷生物城招商部最新统计数据显示，今年一季度，一批创新药项目 落户光谷，签约金额近45亿元。 长三角、大湾区等沿海发达地区的"新朋友"落子光谷，带来优质创新资源；诞生于武汉 的创新药企业逐渐崭露头角，一系列前沿的、充满科幻感的创新成果正在武汉加速孕育。 "光谷拥有深厚的生物产业发展基础，我们将和光谷创新生态的优秀公司合作，加强创 新药研发。"在光谷生物城一季度招商引资大会上，上海甫康药业董事长沈孝 ...