证券代码：002581 证券简称：ST未名 公告编号：2025-079 山东未名生物医药股份有限公司 关于获得一类创新药重组人神经生长因子 SMR001 滴眼液 III 期临床试验伦理批件的自愿性信息披露公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，不存在虚假 记载、误导性陈述或重大遗漏。 山东未名生物医药股份有限公司（以下简称"公司"）全资子公司山东衍渡 生物科技有限公司自主研发的一类创新药重组人神经生长因子 SMR001 滴眼液 （以下简称"SMR001 滴眼液"）治疗中至重度干眼症 III 期关键注册临床试验 近日获得了组长单位首都医科大学附属北京同仁医院伦理委员会的审查批件，批 准项目正式开展。现将相关情况公告如下： 剂型：滴眼液 注册分类：治疗用生物制品 1 类 适应症：中至重度干眼症 临床研究阶段：III 期临床研究 组长单位：首都医科大学附属北京同仁医院 审查意见：同意临床试验 二、药品临床试验进展情况 SMR001 滴眼液是公司重点开发的眼科一类创新生物药，采用中国仓鼠卵巢 细胞（CHO）表达系统，是国内首款以重组人神经生长因子为有效成分的滴眼制 剂。该产品通过修复受损的角膜 ...

Core Viewpoint - ST Unimed (002581.SZ) announced that its wholly-owned subsidiary, Shandong Yandu Biotechnology Co., Ltd., has received ethical approval from the Beijing Tongren Hospital for the Phase III pivotal registration clinical trial of its innovative drug, SMR001 eye drops, aimed at treating moderate to severe dry eye syndrome [1] Company Summary - SMR001 eye drops are a key development for the company, representing the first recombinant human nerve growth factor-based eye drop formulation in China [1] - The product utilizes a Chinese hamster ovary (CHO) cell expression system, indicating a sophisticated biopharmaceutical development process [1] - SMR001 is designed to repair damaged corneal nerves and promote epithelial regeneration, positioning it as a novel treatment option for moderate to severe dry eye syndrome [1]

Core Viewpoint - ST Unimed (002581.SZ) announced that its wholly-owned subsidiary, Shandong Yandu Biotechnology Co., Ltd., has received ethical approval from the Ethics Committee of Beijing Tongren Hospital, affiliated with Capital Medical University, to conduct a Phase III clinical trial for its innovative drug, recombinant human nerve growth factor SMR001 eye drops, aimed at treating moderate to severe dry eye syndrome [1] Summary by Categories Company Developments - The ethical approval for the Phase III clinical trial signifies that the project has met the necessary ethical compliance requirements to proceed [1] - The initiation of this clinical trial is not expected to have a significant impact on the company's operating performance in the short term [1]

Core Viewpoint - The announcement highlights that ST Unimed's wholly-owned subsidiary, Shandong Yandu Biotechnology Co., Ltd., has received ethical approval for its innovative drug SMR001 eye drops, aimed at treating moderate to severe dry eye disease, allowing the commencement of Phase III clinical trials [1] Group 1 - The innovative drug SMR001 is a recombinant human nerve growth factor [1] - The ethical approval was granted by the Ethics Committee of Beijing Tongren Hospital, affiliated with Capital Medical University [1] - The Phase III key registration clinical trial is now officially set to begin [1]

Core Viewpoint - The announcement highlights that Weiming Pharmaceutical's wholly-owned subsidiary, Shandong Yandu Biological, has received ethical approval for its innovative drug SMR001 eye drops, aimed at treating moderate to severe dry eye syndrome, marking a significant step in its clinical development [1] Company Summary - Weiming Pharmaceutical's SMR001 eye drops have completed key Phase II clinical studies, demonstrating effectiveness for moderate to severe dry eye syndrome [1] - The product has now progressed to the critical Phase III registration clinical trial after receiving approval from the ethics committee of Beijing Tongren Hospital, affiliated with Capital Medical University [1] Industry Summary - The global prevalence of dry eye syndrome ranges from approximately 5% to 50%, with China reporting a prevalence of about 21% to 30%, indicating a substantial market opportunity [1] - The market for dry eye treatments is expected to grow, although the high risk and long development cycles associated with drug research may limit short-term impacts on financial performance [1]

Market Overview - The biopharmaceutical sector experienced a slight decline of 0.0% on November 3, with Olin Bio leading the drop [1] - The Shanghai Composite Index closed at 3976.52, up 0.55%, while the Shenzhen Component Index closed at 13404.06, up 0.19% [1] Top Performers - Sangfor Biopharma (688336) saw a significant increase of 7.88%, closing at 78.71 with a trading volume of 220,700 shares and a turnover of 1.754 billion yuan [1] - ST Weiming (002581) rose by 4.99%, closing at 8.20 with a trading volume of 82,400 shares [1] - Other notable gainers included C-Muyuan (688765) with a 3.61% increase, closing at 128.01, and Nossland (920047) with a 3.47% increase, closing at 27.41 [1] Underperformers - Olin Bio (688319) led the declines with a drop of 6.26%, closing at 23.52 and a trading volume of 126,900 shares [2] - Aopumai (688293) fell by 4.95%, closing at 58.82, while Hualan Vaccine (301207) decreased by 3.87%, closing at 21.10 [2] - Other significant losers included Changchun High-tech (000661) and Baiyin Suisi (301080), both experiencing declines of 3.60% [2] Capital Flow - The biopharmaceutical sector saw a net outflow of 155 million yuan from institutional investors, while retail investors contributed a net inflow of 227 million yuan [2] - The overall retail investor net outflow was 71.79 million yuan [2] Individual Stock Capital Flow - Rongchang Bio (688331) had a net inflow of 77.01 million yuan from institutional investors, representing 8.95% of its total [3] - Junshi Biosciences (688180) also saw a significant net inflow of 66.44 million yuan, accounting for 14.16% [3] - Olin Bio (688319) experienced a net outflow of 38.14 million yuan from retail investors, which was 14.13% of its total [3]

Core Viewpoint - ST Unimed (002581.SZ) reported a significant increase in revenue for Q3, achieving 141 million yuan, which is double the total revenue of the first two quarters of the year, leading to a total revenue of 212 million yuan for the first three quarters [1] Group 1: Financial Performance - The company faced challenges in the first half of the year due to the suspension of production and sales at its subsidiary Tianjin Unimed, resulting in poor revenue and profit performance [1] - The financial performance improved in Q3, aided by the accelerated investment and consolidation of Sichuan Gukang Pharmaceutical Co., which is expected to contribute significantly to the company's overall financial results [1] - Gukang Pharmaceutical is projected to achieve revenues of 73.93 million yuan and a net profit of 4.15 million yuan in 2024, with net profit accelerating to 9.85 million yuan in the first four months of 2025, surpassing the total for 2024 [1] Group 2: Business Development - The company is focusing on sustainable development and has a robust pipeline of core products, including the nerve growth factor injection product [2] - The fully-owned subsidiary Shandong Yandu Biotechnology is developing a range of biopharmaceuticals, including a second-generation nerve growth factor eye drop, which is entering Phase III clinical trials [2] - The Chinese ophthalmic drug market is expected to grow at a compound annual growth rate of 19.1% from 2024 to 2030, indicating a significant market opportunity for the company's products [2] Group 3: Strategic Initiatives - The company is actively promoting rectification measures for Tianjin Unimed and is progressing with the construction of the Shandong Unimed Biopharmaceutical Industrial Park, which is set to commence in 2024 [3] - These initiatives are expected to enhance the company's operational performance and governance, potentially leading to continued revenue and profit recovery in the future [3]

Core Points - ST Unimed (002581.SZ) released its Q3 2025 financial report on October 29, 2025 [1] - As of October 28, 2025, six institutional investors disclosed holdings in ST Unimed A-shares, totaling 139 million shares, which represents 21.07% of the total share capital [1] - The institutional investors include Xiamen Hengxing Group Co., Ltd., Shenzhen Jialian Private Securities Investment Fund Management Co., Ltd. - Jialian No. 1 Securities Investment Fund, Shenzhen Yilian Technology Co., Ltd., Shenzhen Juyunlai Investment Partnership (Limited Partnership), Beijing Peking University Unimed Bioengineering Group Co., Ltd., and Shenwan Hongyuan Securities Co., Ltd. [1] - The total institutional holding percentage decreased by 1.31 percentage points compared to the previous quarter [1] - In terms of public funds, 13 public funds were not disclosed in this period compared to the previous quarter, including Southern CSI 1000 ETF, Huaxia CSI 1000 ETF, GF CSI 1000 ETF, Fortune CSI 1000 Index Enhanced A, and China Merchants CSI 1000 Index Enhanced A [1]

Core Viewpoint - ST Unimed (未名医药) reported a significant decline in profitability despite a revenue increase in Q3 2025, primarily due to the suspension of its core subsidiary, Tianjin Unimed, affecting its operations and stock status [1][3]. Financial Performance - In Q3 2025, ST Unimed achieved a revenue of 141 million yuan, marking a 35.94% year-on-year increase, but the cumulative revenue for the first three quarters fell by 32.62% to 212 million yuan [2][3]. - The net profit attributable to shareholders for the first three quarters was a loss of 68.81 million yuan, a drastic decline of 570.46% compared to a profit of 14.63 million yuan in the same period last year [2][3]. - The basic and diluted earnings per share were both -0.1043 yuan, reflecting a year-on-year decrease of 569.82% [2]. Operational Challenges - The operational difficulties stem from the suspension of Tianjin Unimed's production and sales since April 2025 due to regulatory compliance issues, which has severely impacted the company's revenue [3][5]. - Tianjin Unimed accounted for 60.09% of the company's total revenue in 2024, highlighting its critical role in ST Unimed's financial health [3]. Strategic Actions - ST Unimed has resolved historical equity issues with its wholly-owned subsidiary, Xiamen Unimed, by regaining 34% of its shares from Hangzhou Qiangxin Biotechnology Co., Ltd. through a settlement agreement [4]. - The company is actively seeking new growth opportunities, including a 45 million yuan investment in Sichuan Gukang Pharmaceutical Co., Ltd., acquiring a 51% stake and providing financial support of up to 55 million yuan [5].

每经AI快讯，ST未名（SZ 002581，收盘价：7.43元）10月28日晚间发布公告称，公司第六届第八次董 事会会议于2025年10月28日以通讯方式召开。会议审议了《2025年第三季度报告》等文件。 2025年1至6月份，ST未名的营业收入构成为：制药业务分部占比100.0%。 截至发稿，ST未名市值为49亿元。 每经头条（nbdtoutiao）——A股突破4000点！十年沉寂终迎爆发，科技主线重塑市场，"慢牛"新格局开 启！ （记者 王晓波） ...