Core Viewpoint - The biopharmaceutical sector experienced a decline of 0.37% on November 7, with He Yuan Bio leading the drop. The Shanghai Composite Index closed at 3997.56, down 0.25%, while the Shenzhen Component Index closed at 13404.06, down 0.36% [1]. Group 1: Stock Performance - Wan Ze Co. (000534) saw a significant increase in stock price, closing at 22.51 with an 8.80% rise and a trading volume of 754,200 shares, amounting to 1.681 billion yuan [1]. - Tibet Pharmaceutical (600211) closed at 46.05, up 2.74%, with a trading volume of 80,600 shares, totaling 371 million yuan [1]. - Anke Bio (300009) increased by 2.25%, closing at 10.93 with a trading volume of 442,300 shares, amounting to 482 million yuan [1]. - The overall biopharmaceutical sector saw a net outflow of 678 million yuan from institutional investors, while retail investors had a net inflow of 304 million yuan [2][3]. Group 2: Capital Flow - The main capital inflow was observed in Tibet Pharmaceutical, with a net inflow of 26.13 million yuan from institutional investors, while retail investors had a net outflow of 36.64 million yuan [3]. - Anke Bio also experienced a net inflow of 23.91 million yuan from institutional investors, with retail investors seeing a net outflow of 13.09 million yuan [3]. - The overall trend indicates a mixed sentiment in the biopharmaceutical sector, with institutional investors pulling back while retail investors showed some interest [2][3].

Core Viewpoint - The domestic first eye drop formulation containing recombinant human nerve growth factor, SMR001, is advancing towards market launch, with recent approval for its Phase III clinical trial aimed at treating moderate to severe dry eye disease [1][2]. Group 1: Product Development - ST Unimed's subsidiary, Shandong Yandu Biotechnology Co., has developed SMR001 eye drops, which are the first in China to use recombinant human nerve growth factor as an active ingredient [1][2]. - The product aims to repair damaged corneal nerves and promote epithelial regeneration, potentially offering a new treatment option for moderate to severe dry eye disease [1][2]. Group 2: Market Potential - The prevalence of dry eye disease globally ranges from 5% to 50%, with China reporting a rate of approximately 21% to 30%, indicating a significant public health issue [1]. - The incidence of dry eye among the 18-35 age group in China has reached 63%, a 400% increase over the past decade, driving growth in the pharmaceutical market [2]. - The Chinese ophthalmic drug market is projected to reach 44 billion yuan by 2025 and 108.4 billion yuan by 2030, with the dry eye drug segment expected to grow to 4.79 billion yuan in 2024, reflecting a compound annual growth rate of 16.17% from 2020 to 2024 [2]. Group 3: Clinical Trial Progress - SMR001 eye drops received a clinical trial notification on May 25, 2020, completed Phase I trials by February 26, 2022, and has shown effectiveness in treating moderate to severe dry eye disease in Phase II trials [3]. - The recent approval for the Phase III clinical trial marks a significant step in validating the efficacy and safety of SMR001 for patients with moderate to severe dry eye disease [3].

Core Viewpoint - ST Unimed (002581.SZ) announced that its wholly-owned subsidiary, Shandong Yandu Biotechnology Co., Ltd., has received ethical approval for the Phase III clinical trial of its innovative drug, recombinant human nerve growth factor SMR001 eye drops, for the treatment of moderate to severe dry eye syndrome [1] Summary by Categories Clinical Development - The ethical approval from the Ethics Committee of Beijing Tongren Hospital, affiliated with Capital Medical University, allows the project to officially commence [1] - The approval signifies that the project has a compliant ethical foundation for conducting clinical trials [1] Financial Impact - The short-term impact on the company's operating performance is not expected to be significant due to the nature of the clinical trial approval [1]

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]