浙江天册（深圳）律师事务所 关于 山东未名生物医药股份有限公司 2023 年股票期权激励计划 注销部分股票期权事项的 法律意见书 中国广东省深圳市南山区科发路 222 号康泰创新广场 34 楼 518057 电话：0755-83739000 传真：0755-26906383 致：山东未名生物医药股份有限公司 浙江天册（深圳）律师事务所（以下简称本所）受山东未名生物医药股份有 限公司（以下简称未名医药或公司）委托，担任公司实施 2023 年股票期权激励 计划（以下简称本次激励计划）的专项法律顾问。本所根据《中华人民共和国公 司法》（以下简称《公司法》）、《中华人民共和国证券法》（以下简称《证券 法》）、《上市公司股权激励管理办法》（以下简称《管理办法》）等法律、行 政法规、部门规章及其他规范性文件（以下合称法律法规）及《山东未名生物医 药股份有限公司章程》（以下简称《公司章程》）、《山东未名生物医药股份有 限公司 2023 年股票期权激励计划（草案）》（以下简称《激励计划（草案）》） 的有关规定，就未名医药本次激励计划注销部分股票期权（以下简称本次注销） 相关事项出具本法律意见书。 为出具本法律意见书，本所律师 ...

Financial Performance - The company's operating revenue for Q1 2025 was ¥35,329,856.70, a decrease of 57.84% compared to ¥83,804,783.29 in the same period last year[5] - The net loss attributable to shareholders was ¥36,850,397.17, representing a 33.01% increase from a loss of ¥27,704,081.15 in the previous year[5] - The net cash flow from operating activities was -¥58,614,130.67, a significant decline of 285.59% compared to -¥15,200,975.67 in the same period last year[5] - The basic and diluted earnings per share were both -¥0.0559, a decrease of 33.10% from -¥0.0420 in the previous year[5] - The company reported a 57.84% decrease in operating income primarily due to product recalls[13] - Total operating revenue for the current period is CNY 35,329,856.70, a decrease of 57.8% compared to CNY 83,804,783.29 in the previous period[28] - Net profit for the current period is a loss of CNY 49,818,616.89, compared to a loss of CNY 27,055,340.81 in the previous period, indicating a worsening financial performance[29] - The net profit attributable to the parent company was -36,850,397.17 yuan, compared to -27,704,081.15 yuan in the previous period, indicating a decline[30] - The total comprehensive income amounted to -49,818,616.89 yuan, compared to -27,055,340.81 yuan in the previous period[30] Assets and Liabilities - Total assets at the end of the reporting period were ¥2,167,843,796.67, down 1.28% from ¥2,195,918,588.20 at the end of the previous year[5] - The balance of other receivables increased by 97.55% compared to the beginning of the year, mainly due to prepayments made for the industrial park[8] - The balance of contract liabilities increased by 160.57% compared to the beginning of the year, attributed to pre-received contract payments[10] - Total current assets decreased to CNY 729,876,009.75 from CNY 747,007,338.19, a decline of 2.3%[26] - Total liabilities increased to CNY 190,692,131.12 from CNY 173,612,003.09, an increase of 9.9%[27] - Long-term equity investments slightly decreased to CNY 1,048,822,473.33 from CNY 1,055,730,183.04, a decrease of 0.7%[26] Cash Flow - The company reported a decrease in cash and cash equivalents from RMB 506,403,730.00 at the beginning of the period to RMB 445,010,515.55 at the end of the period[25] - The company’s cash flow management remains a focus, with a significant reduction in cash reserves noted[25] - Cash inflows from operating activities totaled 67,021,948.27 yuan, down from 103,266,237.28 yuan in the previous period[32] - The net cash flow from operating activities was -58,614,130.67 yuan, compared to -15,200,975.67 yuan in the previous period[32] - The cash and cash equivalents at the end of the period were 442,764,542.95 yuan, down from 504,337,388.39 yuan at the beginning of the period[33] - The net cash increase in cash and cash equivalents was -61,572,845.44 yuan, compared to an increase of 63,453,004.06 yuan in the previous period[32] Expenses and Costs - Total operating costs for the current period amount to CNY 79,830,761.69, down 25.0% from CNY 106,361,412.35 in the previous period[29] - Research and development expenses for the current period were CNY 4,880,913.96, down 21.4% from CNY 6,208,293.77 in the previous period[29] - The company reported a financial cost of CNY -803,773.97, indicating a reduction in financial expenses compared to CNY -277,387.95 in the previous period[29] Shareholder Information - The number of ordinary shareholders at the end of the reporting period was 38,037[18] - The company’s top 10 unrestricted shareholders include Shenzhen Yilian Technology Co., Ltd. with 25,204,000 shares, accounting for 3.82%[19] - The company has not disclosed any changes in the participation of major shareholders in margin trading and securities lending activities[19] - The company has not identified any related party relationships or concerted actions among the top 10 shareholders[19] Corporate Actions and Agreements - The company approved a capital increase of RMB 290 million for its wholly-owned subsidiary, Shandong Yandu Biotechnology Co., Ltd., raising its registered capital to RMB 300 million[22] - The company signed a clinical trial technical service agreement for the Phase III clinical trial of recombinant human nerve growth factor eye drops with Tianjin Happy Life Technology Co., Ltd.[21] - The company plans to sign a general contracting agreement for the cleanroom and electromechanical project of the Shandong Weiming Biomedical Industrial Park with Shandong Zhongda Engineering Technology Co., Ltd.[23] - The company’s wholly-owned subsidiary will procure necessary systems and materials for the production workshop of recombinant human nerve growth factor eye drops from Jiangsu Suhao Innovation Technology Group Co., Ltd.[24] Compliance and Reporting - The company did not undergo an audit for the first quarter report[34] - The report was issued by the Board of Directors on April 28, 2025[35]

Core Viewpoint - Unimed Pharmaceutical's subsidiary, Tianjin Unimed, has been suspended from production and sales due to regulatory measures, significantly impacting the company's operations and revenue potential [2][3]. Group 1: Company Operations - Tianjin Unimed, primarily engaged in the production and sales of interferon drugs, generated revenue of 217 million yuan in 2024, accounting for 60.09% of Unimed Pharmaceutical's total revenue [2]. - The company's interferon business achieved revenue of 303 million yuan in 2023, representing 70.47% of total revenue, an increase from approximately 229 million yuan in 2022, which was 64.27% of total revenue [3]. - The main products contributing to Unimed's revenue are nerve growth factor and interferon products, which together account for over 90% of total revenue, with both categories having a gross margin close to 80% [2]. Group 2: Regulatory Issues - The suspension of Tianjin Unimed's production and sales is due to the interferon α2b spray being found non-compliant with biological activity standards, leading to procurement suspensions in multiple regions [2]. - The company must complete rectification and inspection to resume production, and products must meet national standards before being sold again [3]. - If the suspension lasts longer than three months, it may trigger additional risk warnings for the company [2].

Core Viewpoint - Unimed Pharmaceutical has reported a significant loss, with its major subsidiary, Tianjin Unimed Biopharmaceutical Co., Ltd., contributing 60% of its revenue, now facing production suspension due to regulatory issues [1][2]. Group 1: Company Performance - Unimed Pharmaceutical's stock price dropped to 7.42 yuan, a decrease of 9.95%, resulting in a market capitalization of 4.895 billion yuan following the announcement of the subsidiary's production halt [3]. - Tianjin Unimed's revenue for 2024 was 217 million yuan, with a net profit loss of 14 million yuan, highlighting its critical role in Unimed's overall financial performance [2][5]. - The company's interferon α2b spray, a key product, has been suspended from procurement by multiple regions due to quality issues, further impacting revenue [4][5]. Group 2: Regulatory and Operational Challenges - The Tianjin Municipal Drug Administration has mandated a production and sales suspension for Tianjin Unimed, requiring the completion of rectification and inspection before resuming operations [1][3]. - Unimed Pharmaceutical has initiated a self-inspection process following a quality control failure reported by the Shanghai Drug Administration, which found that a batch of the interferon α2b spray did not meet biological activity standards [4][5]. - If Tianjin Unimed cannot resume production within three months, Unimed Pharmaceutical may face additional risk warnings under the Shenzhen Stock Exchange regulations [2]. Group 3: Financial Implications - The interferon business accounted for 79.52%, 70.56%, and 60.09% of Unimed's revenue from 2022 to 2024, indicating its diminishing but still significant contribution to the company's financial health [5]. - Despite the high gross margin of 79.92% for the interferon products in 2024, Unimed has struggled with profitability, reporting a historical loss of 332 million yuan in 2023 [5].

Core Viewpoint - Unimed Pharmaceutical is facing its most severe survival test since its establishment due to significant production management deficiencies identified by the Tianjin Drug Administration, leading to a suspension of production and sales [1][3][5]. Financial Performance - Unimed's subsidiary, Tianjin Unimed, generated revenue of 217 million yuan in 2024, accounting for 60.09% of the company's total revenue, with interferon products contributing over 70% to this figure in the past three years [7][8]. - The company's total revenue for 2024 was approximately 360 million yuan, a decrease of 16.14% compared to 2023, with the interferon segment experiencing a 28.59% decline in revenue [8][10]. - The net loss for the company has been increasing, reaching 137 million yuan in 2024, with a significant quarterly loss of 167 million yuan in Q4 due to the suspension of core products [10][12]. Regulatory and Compliance Issues - This incident marks the second major quality issue for Tianjin Unimed in 2024, following a previous failure of the "human interferon α2b spray" to meet biological activity standards, resulting in procurement suspensions from several provinces [9][12]. - The company has faced continuous non-standard audit opinions for eight consecutive years, raising concerns about the fairness of drug pricing and ownership disputes of subsidiaries [9][12]. Market Reaction - Following the news of the production suspension, Unimed's stock price plummeted to 7.42 yuan per share, hitting the daily limit down, with a total market capitalization of approximately 4.895 billion yuan [3][10]. - The stock has been trading below 10 yuan since the second half of 2024, reflecting a nearly 90% decline from its peak in 2015 [10][12]. Future Outlook - The suspension of production has cut off the company's main cash flow and led to the urgent recall of inventory valued at 23.16 million yuan. If production does not resume within three months, the company may face ST (special treatment) status and potential delisting risks [12]. - The company is attempting to establish a special rectification team, but historical issues and a lack of market confidence complicate recovery efforts [12].

Core Viewpoint - Unimed Pharmaceutical faces significant operational challenges due to regulatory issues with its subsidiary Tianjin Weiming Biopharmaceutical Co., which has been ordered to suspend production and sales due to non-compliance with drug production quality management standards [1][2]. Group 1: Regulatory Issues - Tianjin Weiming was found to have production practices that do not meet the 2010 revised Drug Production Quality Management Standards, leading to a suspension of production and sales [1]. - The company must complete rectification and inspection before resuming production, which could take up to three months [1]. - If production is not restored within three months, Unimed may face additional risk warnings and could be subject to special treatment (ST) [1]. Group 2: Financial Impact - Following the announcement, Unimed's stock price dropped by 9.95%, closing at 7.42 yuan per share, with a market capitalization of 4.895 billion yuan [1]. - In 2024, Tianjin Weiming generated revenue of 217 million yuan, accounting for 60.09% of Unimed's total revenue, but reported a net loss of 14.0037 million yuan [1][2]. - The recall of a specific batch of interferon α2b spray due to non-compliance resulted in a revenue reduction of 23.1672 million yuan for Unimed [2]. Group 3: Historical Performance - Unimed has experienced fluctuating performance, with five out of the last seven years resulting in losses, particularly since 2018 [3]. - The company has faced multiple operational setbacks, including the suspension of its subsidiary Weiming Tianyuan due to environmental regulations and significant revenue declines in its core products [3][4]. - The ongoing control disputes over Beijing Kexing have further complicated Unimed's operational stability and financial performance [4]. Group 4: Current Business Structure - Unimed's operations are heavily reliant on three key subsidiaries: Tianjin Weiming, Xiamen Weiming, and Beijing Kexing [5]. - The revenue from the previously significant product, nerve growth factor, has decreased to 139 million yuan, representing only 38.59% of total revenue in 2024 [5]. - With Tianjin Weiming's current regulatory issues, Unimed faces potential operational crises as it relies on this subsidiary for a substantial portion of its income [5].

Core Viewpoint - Unimed Pharmaceutical's subsidiary Tianjin Unimed has been suspended from production and sales due to non-compliance with drug production quality management standards, significantly impacting the company's operations and raising concerns about its internal controls and compliance management [1][2]. Group 1: Company Impact - Tianjin Unimed, a key subsidiary, accounted for 60.09% of Unimed Pharmaceutical's revenue in 2024, generating 217 million yuan [1]. - The suspension of production is expected to exacerbate Unimed Pharmaceutical's operational difficulties, with a projected revenue decline of 16.14% to 360 million yuan and a net loss of 137 million yuan in 2024, representing a 58.70% increase in losses [2]. - The company's stock price fell to the daily limit on April 25, reflecting investor concerns about the ongoing situation [2]. Group 2: Regulatory and Compliance Issues - The suspension was triggered by violations of the 2010 revised Drug Production Quality Management Standards, indicating serious quality management issues within the company [1]. - The company has established a special rectification team to address the root causes and develop a corrective action plan, although the timeline for resuming production remains uncertain [2]. - The incident serves as a warning for the entire industry regarding the importance of adhering to drug production quality standards to ensure patient safety [1].

Policy Developments - Seven departments, including the Ministry of Industry and Information Technology, issued the "Implementation Plan for the Digital Transformation of the Pharmaceutical Industry (2025-2030)", emphasizing the integration of artificial intelligence across the pharmaceutical supply chain [1] Drug and Device Approvals - Kangtai Biological announced that its subsidiary Minhai Biological's application for the marketing authorization of an adsorbed tetanus vaccine has been accepted by the National Medical Products Administration [2] - Hendi Pharmaceutical received approval for the marketing application of arginine ibuprofen, a non-steroidal anti-inflammatory drug with superior solubility and faster absorption compared to regular ibuprofen [3] - Tianyao Pharmaceutical's subsidiary obtained a drug registration certificate for injectable hydrocortisone sodium succinate, used for critical conditions such as allergic shock and severe adrenal insufficiency [4] Financial Reports - Wantai Biological reported a net loss of 52.78 million yuan in Q1 2025, with revenue of 401 million yuan, a year-on-year decline of 46.76%, primarily due to market adjustments and government procurement impacts [5] - Heng Rui Pharmaceutical's Q1 2025 report showed a revenue of 7.206 billion yuan, a year-on-year increase of 20.14%, and a net profit of 1.874 billion yuan, up 36.9%, largely due to a licensing payment from IDEAYA [6] - Kingstone Pharma reported a revenue of 291 million yuan in Q1 2025, down 19.65%, with a net profit of 62.85 million yuan, a decrease of 30.02% [8] - Baijun Medical achieved a revenue of 100 million yuan in Q1 2025, a 31.3% increase, with a net profit of 32.50 million yuan, up 290.69%, driven by stable sales of existing products and successful new product launches [9] Capital Market Activities - Tonghe Pharmaceutical plans to invest 11 million yuan to increase its stake in Hangzhou Boya Biomedical Co., Ltd., raising its ownership from 16.34% to 24.93% [10] - Chengyuan Biotechnology announced the completion of several million yuan in equity financing, aimed at upgrading its gene synthesis technology platform [11] Industry Developments - Zhang Wenhong's team announced significant progress in developing a broad-spectrum antiviral drug for monkeypox, which is set to enter clinical approval stages [12] - Qianxin Biotechnology signed a licensing agreement with Caldera Therapeutics for its long-acting dual antibody QX030N, granting global exclusive rights for development and commercialization [13] Public Sentiment Alerts - Weiming Pharmaceutical announced that its important subsidiary, Tianjin Weiming, was suspended from production and sales, which could trigger further risk warnings if production does not resume within three months [14]

Group 1: Aier Eye Hospital - In 2024, Aier Eye Hospital achieved an outpatient volume of 16.94 million, a year-on-year increase of 12.14% [1] - The company reported a total revenue of 20.98 billion yuan, reflecting a growth of 3.02% compared to the previous year [2] - The net profit attributable to shareholders was 3.56 billion yuan, up by 5.87% year-on-year [2] - The company introduced several advanced medical technologies and products, including the INTENSITY™ intraocular lens and new dry eye treatment technology [1][3] Group 2: Tonghuashun - Tonghuashun reported a revenue of 4.19 billion yuan in 2024, marking a 17.47% increase from the previous year [5] - The net profit attributable to shareholders reached 1.82 billion yuan, a significant growth of 30% year-on-year [4][5] - The increase in revenue and profit was primarily driven by a recovery in the securities market and rising demand for financial information services [4] Group 3: Yiwei Lithium Energy - Yiwei Lithium Energy achieved a revenue of 1.28 billion yuan in Q1 2025, with a net profit of 110.11 million yuan, reflecting a 16.60% increase in net profit [7] - The company reported a significant increase in the shipment of energy storage batteries, with a year-on-year growth of 80.54% [8] - The company is expanding into emerging markets such as eVTOL and drones, with ongoing projects and production facilities being established [9] Group 4: Huadong Medicine - Huadong Medicine reported a revenue of 10.74 billion yuan in Q1 2025, a 3.12% increase year-on-year [10] - The net profit attributable to shareholders was 914.71 million yuan, up by 6.06% compared to the same period last year [11] - The company achieved its highest historical level of net profit excluding non-recurring gains and losses, reaching 897.34 million yuan [10] Group 5: Muyuan Foods - Muyuan Foods reported a revenue of 36.06 billion yuan in Q1 2025, a year-on-year increase of 37.26% [17] - The company turned a profit with a net profit of 44.91 billion yuan, compared to a loss of 23.79 billion yuan in the same period last year [18] - The significant growth was attributed to increased pig prices and sales [17] Group 6: China Aluminum - China Aluminum reported a revenue of 55.78 billion yuan in Q1 2025, with a net profit of 3.54 billion yuan, reflecting a year-on-year increase of 58.78% [21] - The company successfully managed market price fluctuations, resulting in increased product sales and profits [21] Group 7: Hengrui Medicine - Hengrui Medicine achieved a revenue of 72.06 billion yuan in Q1 2025, a 20.14% increase year-on-year [22] - The net profit attributable to shareholders was 18.74 billion yuan, up by 36.9% compared to the previous year [22] - The increase in profit was significantly influenced by a licensing payment received during the reporting period [22] Group 8: Bull Group - Bull Group reported a revenue of 16.83 billion yuan in 2024, reflecting a 7.24% increase year-on-year [13] - The net profit attributable to shareholders was 4.27 billion yuan, a growth of 10.39% compared to the previous year [13] - The company experienced growth in its electrical connection and smart lighting businesses, as well as rapid development in its new energy sector [14]

Core Viewpoint - Unimed Pharmaceutical's subsidiary, Tianjin Unimed Biopharmaceutical Co., has been suspended from production and sales due to non-compliance with GMP standards, which may significantly impact the company's operations and could lead to further risk warnings if production does not resume within three months [1][6]. Financial Performance - In 2024, Tianjin Unimed generated revenue of 217 million yuan and a net profit of -14.0037 million yuan, accounting for 60.09% of Unimed's total revenue and 9.8% of its consolidated net profit [4]. - Unimed's 2024 annual report indicated a total revenue of 360 million yuan, a year-on-year decrease of 16.14%, and a net loss of 137 million yuan, with losses widening by 58.70% compared to the previous year [8]. Regulatory Actions - The suspension was initiated following a GMP compliance inspection by the Tianjin Municipal Drug Administration, which found that Tianjin Unimed's production practices did not meet the required standards [5][6]. - In response, Unimed has established a special rectification team to identify issues and develop a corrective action plan while cooperating with regulatory authorities to address deficiencies [7]. Market Reaction - Following the announcement, Unimed's stock price fell by 2.49%, closing at 8.24 yuan per share, with a total market capitalization of 5.436 billion yuan [9].