Financial Performance - The company has not yet achieved profitability and has accumulated losses due to the short market presence of its three products and high R&D investments, totaling CNY 782.87 million in the reporting period, a decrease of 6.33% year-on-year [3]. - The company raised a net amount of CNY 3,303.43 million during its IPO on the Shanghai Stock Exchange in January 2022, relying on external financing for operational capital [4]. - The company does not plan to distribute cash dividends or increase capital through stock transfers for the 2024 fiscal year [11]. - The company reported a significant increase in revenue, achieving a total of $XX million, representing a YY% growth compared to the previous quarter [20]. - The company's operating revenue for 2024 reached ¥199,781,622.22, representing a year-on-year increase of 56.28% compared to ¥127,835,534.42 in 2023 [28]. - The net loss attributable to shareholders for 2024 was ¥1,043,919,217.28, a slight improvement from a loss of ¥1,053,432,676.66 in 2023 [28]. - The cash flow from operating activities showed a net outflow of ¥956,443,630.18, which increased from ¥782,728,279.34 in the previous year [28]. - The sales revenue from pharmaceutical products was ¥144,592,000, a significant increase of 243.53% from ¥42,089,600 in the previous year [31]. - The basic earnings per share for 2024 was -¥2.61, compared to -¥2.64 in 2023 [29]. - The company's total assets decreased by 4.03% to ¥4,275,508,853.05 in 2024 from ¥4,455,048,440.71 in 2023 [28]. - Research and development expenses accounted for 391.86% of operating revenue, a decrease of 261.93 percentage points from the previous year [29]. - The company received government subsidies amounting to ¥26,381,537.32 in 2024, which was higher than the ¥11,313,759.15 received in 2023 [35]. Research and Development - The company plans to continue significant R&D investments, with expenses of CNY 758.61 million, CNY 835.78 million, and CNY 782.87 million for the years 2022, 2023, and 2024 respectively [5]. - The company has 16 products in various stages, including 12 innovative drugs and 4 biosimilars, focusing on oncology and age-related diseases [3]. - The company has 13 products in its core pipeline, requiring continued substantial R&D investments for their development [6]. - The company emphasizes the importance of clinical value in drug development, aligning with recent regulatory guidelines to ensure that the benefits of new drugs outweigh the risks [9]. - The company is actively involved in the research and development of new drugs, including a new oral compound (1MW5011) derived from glucosamine [17]. - The company is committed to adhering to current Good Manufacturing Practices (cGMP) to ensure high-quality production standards [17]. - The company is exploring corrective and preventive actions (CAPA) to enhance its operational efficiency and product quality [17]. - The company has established four core ADC technologies, which enhance the safety and efficacy of its ADC products [81]. - The company employs a modular R&D model, utilizing wholly-owned subsidiaries for high-innovation projects to enhance management flexibility and R&D efficiency [192]. Product Development and Approvals - The company has three products commercialized and one under review for market approval, which is expected to improve financial conditions and facilitate a path to profitability [4]. - As of the report date, the company has 3 products approved for market, 1 under review for market approval, and 1 in the pre-NDA communication stage, with a focus on oncology and age-related diseases [41]. - The company received FDA approval for the clinical trial of 7MW3711 for advanced malignant solid tumors in February 2024, and 9MW3011 was granted orphan drug designation [41]. - In March 2024, 9MW0321 received approval from the National Medical Products Administration for treatment of bone giant cell tumors, marking it as the first approved biosimilar in China [41]. - 9MW2821 has received multiple designations from the FDA, including orphan drug status and fast track designation for various cancer treatments throughout 2024 [42][43]. - The company plans to further enhance its sales and marketing capabilities with 4 commercialized products expected by 2025 [40]. - The company is actively expanding its clinical research, with multiple ongoing Phase III trials for 9MW2821 targeting various cancers [44]. - The company has received FDA designations for 3 "Fast Track Designations" and 1 "Orphan Drug Designation" for its core pipeline product 9MW2821, indicating strong clinical data performance [73]. Market Expansion and Strategic Partnerships - The company is focused on expanding its market presence through strategic partnerships and collaborations, particularly in the development of antibody-drug conjugates (ADC) [17]. - The company aims to enhance its international brand influence by focusing on emerging markets such as South America and countries along the "Belt and Road" initiative, which have significant pharmaceutical market potential [66]. - The company has signed formal cooperation agreements with 16 countries for the product 9MW0113 and submitted registration applications in 5 countries, with more applications in preparation [69]. - The company has established a strategic partnership with a Saudi Arabian pharmaceutical company for product registration and commercialization in multiple countries in the Middle East and North Africa [68]. - The company is actively negotiating with multiple international pharmaceutical giants to maximize the value of its R&D pipeline through various collaboration models [71]. - The company has established an international business department and a business development department to promote overseas markets and global business cooperation [94]. Production and Quality Management - The company has completed the trial production of ADC drugs at its Taizhou production base, with 4 batches of raw ADC and 7 batches of formulations produced, all meeting quality standards [78]. - The Taizhou production base has completed the construction of antibody and recombinant protein drug production facilities, with a capacity of 8,000L for antibody drugs and 4,000L for recombinant protein drugs [196]. - The company has established a comprehensive quality management system based on Chinese GMP, US FDA cGMP, and EU EMA GMP standards, covering the entire product lifecycle [197]. - The company has achieved compliance with EU QP audit standards at the Jinshan production base, expected to be certified by January 2025 [199]. - The company has implemented a unified management system for procurement, enhancing visibility and traceability in the supply chain [193]. Clinical Trials and Patient Outcomes - 9MW2821 demonstrated an objective response rate (ORR) of 40.54% in recurrent or metastatic cervical cancer, with a disease control rate (DCR) approaching 90% [49]. - 9MW2821 is the first ADC to disclose clinical efficacy data in cervical and esophageal cancer among similar pipelines in the domestic market [48]. - The company has initiated a Phase III clinical study for 9MW2821 in combination with Toripalimab for first-line treatment of locally advanced or metastatic urothelial carcinoma, with a mid-term analysis planned for 2027 and NDA submission expected in 2027 [135]. - 9MW2821 has shown promising results in treating advanced esophageal squamous cell carcinoma, with an ORR of 23.1% and DCR of 69.2% in a Phase II trial [141]. - The company has completed patient enrollment for the Phase II/III clinical study of 9MW0211, which is currently in the follow-up stage [149]. - The company plans to complete the follow-up for 9MW0211 by the end of 2025 [149]. Innovative Drug Development - 1MW5011 is a potential first-in-class small molecule drug for osteoarthritis, showing promising preclinical efficacy and safety results [159]. - 9MW1911 is the first domestically developed macromolecule drug targeting the non-Th2 pathway, with two Phase I clinical trials completed in China, involving 76 healthy subjects, showing good safety and tolerability [154]. - 9MW3011 is currently in multiple Phase Ib clinical studies for treating patients with polycythemia vera, with the first patient enrolled in March 2024 and expected completion in mid-2026 [183]. - 9MW2921, a novel antibody-drug conjugate targeting Trop-2, has received approval for clinical trials in July 2023, focusing on advanced solid tumors, with ongoing I/II phase studies led by Fudan University [187]. - 7MW3711, a novel antibody-drug conjugate targeting B7-H3, is expected to enter the global market with a projected size of $300 million in 2027, growing to $5.5 billion by 2032, reflecting a compound annual growth rate of 74.2% [168].

前十大流通股东累计持有： 6212.33万股，累计占流通股比： 30.43%，较上期变化： 93.85万股。 | 名称 | 持有数量(万股) | 占总股本比 | 增减情况 | | --- | --- | --- | --- | | | | 例(%) | (万股) | | 海南拾玉私募基金管理有限公司-苏州永玉股权投资合伙 | | | | | 企业(有限合伙) | 1310.84 | 6.42 | 不变 | | 深圳市前海中睿鼎盛资产管理有限公司-中睿鼎盛君华1号 | | | | | 私募证券投资基金 | 1024.86 | 5.02 | 不变 | | 汇添富医疗服务灵活配置混合A | 725.61 | 3.55 | 118.63 | | 汇添富达欣混合A | 511.19 | 2.50 | -51.96 | | 工银前沿医疗股票A | 500.00 | 2.45 | -70.01 | | 汇丰晋信智造先锋股票A | 484.12 | 2.37 | 新进 | | 中银创新医疗（002173）混合A | 454.62 | 2.23 | 102.28 | | 鹏华医药科技股票A | 427.86 | 2.10 | ...

Core Insights - The Shanghai Stock Exchange Sci-Tech Innovation Board 100 Index (000698) has shown a positive performance with a 0.61% increase as of March 28, 2025, with notable gains from stocks like Maiwei Bio (688062) up 13.94% and Shenzhou Cell (688520) up 6.51% [1][2] - The upcoming annual performance briefing for the Sci-Tech Innovation Board from April 28 to May 9, 2024, will feature seven "sub-industry dialogue days" focusing on sectors such as AI, robotics, and new energy, aimed at helping investors compare industry dynamics and company advantages [2] - The Sci-Tech 100 Index ETF (588030) has closely tracked the performance of the Sci-Tech Innovation Board 100 Index, with a significant growth in scale of 9.22 billion over the past year [2][3] Performance Metrics - As of March 27, 2025, the Sci-Tech 100 Index ETF has achieved a maximum monthly return of 27.67% since its inception, with the longest consecutive monthly gain being three months and a total increase of 37.87% during that period [2] - The ETF has outperformed its benchmark with an annualized excess return of 0.64% over the past year, while the maximum drawdown this year has been 7.83% [3] - The management fee for the Sci-Tech 100 Index ETF is 0.15%, and the custody fee is 0.05%, making it one of the lowest in its category [3] Top Holdings - As of February 28, 2025, the top ten weighted stocks in the Sci-Tech 100 Index include Sitaiwei (688213), Baiji Shenzhou (688235), and Hengxuan Technology (688608), collectively accounting for 24.45% of the index [3]

本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 证券代码：688062 证券简称：迈威生物 公告编号：2025-008 迈威（上海）生物科技股份有限公司 自愿披露关于与君实生物就阿达木单抗注射液 合作开发协议签订补充协议的公告 重要内容提示： 2025 年 3 月 26 日，迈威（上海）生物科技股份有限公司（以下简称"公司" 或"迈威生物"）、公司全资子公司江苏泰康生物医药有限公司（以下简称"泰 康生物"）、上海君实生物医药科技股份有限公司（以下简称"君实生物"）、 君实生物全资子公司苏州众合生物医药科技有限公司（以下简称"苏州众合"） 签订《关于<重组人源抗 TNF-α 单克隆抗体注射液合作开发协议>之补充协议》 （以下简称"本补充协议"），对君实生物为药品上市许可持有人（Marketing Authorization Holder，以下简称"MAH"）期间的权益分享条款进行重新约定， 现将相关情况公告如下： 1、针对重组人源抗 TNF-α 单克隆抗体注射液（现称"阿达木单抗注射液"， 商品名：君迈康®）的中国大陆区域内 ...

Summary of the Conference Call for Maiwei Biotech Company Overview - Maiwei Biotech is an innovative biopharmaceutical company focused on oncology and age-related diseases, with a comprehensive industry chain layout [3][4]. Key Developments in Innovative Drugs - Significant progress has been made in both innovative drugs and biosimilars. The company has developed several best-in-class products using its ADC platform, including next-generation ADC technologies [3]. - The third-generation long-acting white blood cell enhancer 8MW0,511 is expected to be approved for market launch in 2025, with a peak sales potential of 798 million yuan [3][7]. - The Nectin-4 ADC (2,821) is the fastest progressing ADC in China, currently in Phase III clinical trials for indications such as urothelial carcinoma, cervical cancer, and triple-negative breast cancer, with a mid-term analysis expected in 2026-2027 [3][5]. - The only marketed Trop-2 ADC, Trodelvy, is projected to exceed $1.5 billion in sales in 2024, showing over 50% year-on-year growth [3][5]. Unique Advantages of ADC Platform - Maiwei Biotech's ADC platform has unique advantages in target selection, linker design, and payload selection, aimed at improving efficacy and safety [4]. - The company focuses on high-expression target antigens and employs DAR-controlled conjugation technology to enhance ADC stability and reduce off-target effects [4]. Clinical Stage ADC Products - The company has three ADC products in clinical stages: Nectin-4 ADC (2,821), Trop-2 ADC, and B7-H3 ADC, with Nectin-4 ADC being the most advanced [5]. - The sales peak for Nectin-4 ADC in urothelial carcinoma is estimated to reach 2.298 billion yuan [5]. Emerging Innovative Projects - In addition to the highlighted products, Maiwei Biotech is developing other promising projects, including white blood cell enhancer 8MW0,511 and other innovative drugs that show strong potential [6]. Progress in White Blood Cell Enhancers - The long-acting white blood cell enhancer 8MW0,511 has been accepted for market approval and is expected to fill a market gap upon its launch [7]. Other Innovative Therapies - The company is advancing several important pipelines, including SST2 inhibitors in COPD, which are in Phase III clinical trials, and a new oral drug for osteoarthritis, RP901, which is a first-in-class product [8]. Breakthroughs in Pulmonary Fibrosis Treatment - Maiwei Biotech has developed a product, Batilizumab, for the treatment of idiopathic pulmonary fibrosis, which is expected to become a commercial development and licensing choice, accelerating its clinical development and commercialization [9]. Expectations in Biosimilars - The biosimilar business is gradually ramping up, with expected peak sales of 990 million yuan for Macon, 1.06 billion yuan for Meilisu, and 568 million yuan for Maiweijian [10]. Revenue Projections and Overall Assessment - Revenue projections for 2025 and 2026 are estimated at 850 million yuan and 1.514 billion yuan, respectively. The company is expected to focus on commercializing its differentiated targets globally and advancing its clinical pipeline [11].

Investment Rating - The report initiates coverage with a "Buy" rating for the company [9]. Core Insights - The company is positioned as an innovative biopharmaceutical enterprise with a comprehensive industry chain layout, focusing on ADCs, antibodies, and recombinant protein drugs, primarily targeting oncology and age-related diseases [5][17]. - The ADC technology platform is advanced, with the Nectin-4 ADC expected to become a best-in-class (BIC) product, showing promising clinical results compared to existing therapies [6][9]. - The company has a robust pipeline of innovative drugs and biosimilars, with significant revenue growth projected from 2024 to 2026 [8][10]. Summary by Sections Company Overview - The company was established in 2017 and went public on the Shanghai Stock Exchange in 2022, focusing on the research, production, and sales of biopharmaceuticals [17]. - It has 16 products at various stages, including 12 innovative products and 4 biosimilars, with 3 products already on the market [17]. ADC Technology Platform - The company has developed a next-generation ADC targeted conjugation technology platform (IDDCTM), which includes proprietary technologies that enhance drug stability and efficacy [6][28]. - The Nectin-4 ADC (9MW2821) is the fastest progressing ADC in China for treating urothelial carcinoma, currently in Phase III clinical trials [6][9]. Innovative Product Pipeline - The company is advancing multiple differentiated targets, including 9MW1911 (for COPD) and 9MW3011 (for blood disorders), with significant global development progress [7][30]. - The biosimilars have begun commercializing, contributing to cash flow for innovative drug development [7][30]. Financial Projections - Revenue forecasts for 2024, 2025, and 2026 are projected at 2.09 billion, 8.51 billion, and 15.14 billion RMB, respectively, with significant year-on-year growth rates [8][10]. - The company expects to achieve a net profit margin improvement, with net losses decreasing from 1.09 billion RMB in 2024 to 258 million RMB in 2026 [10].

Financial Performance - Total revenue for 2024 reached RMB 19,878.57 million, a 55.50% increase compared to RMB 12,783.55 million in the previous year[3] - The company's net profit attributable to shareholders was RMB -106,691.89 million, with a basic earnings per share of RMB -2.67[3] - The company reported a weighted average return on equity of -51.67%, a decrease of 17.13 percentage points from -34.54% in the previous year[3] Assets and Equity - Total assets decreased by 4.45% to RMB 425,701.55 million from RMB 445,504.84 million[4] - Shareholders' equity attributable to the parent company decreased by 40.17% to RMB 154,593.85 million, with net asset value per share dropping by 40.19% to RMB 3.87[4] Revenue Drivers - The increase in revenue was primarily driven by significant sales growth of the drug Mai Li Shu® and the approval of Mai Wei Jian® in March 2024[5] Research and Development - The company maintained a high level of R&D investment as multiple innovative drugs are in critical trial stages[6] Operating Costs - Operating costs and sales expenses increased due to further market expansion and commercialization efforts[5] Financial Data Caution - The financial data presented is preliminary and unaudited, with final figures to be disclosed in the annual report[7] - Investors are advised to be cautious due to potential investment risks associated with the preliminary financial data[7]

海通证券股份有限公司 1 二、本次继续使用部分暂时闲置募集资金进行现金管理的基本情况 （一）投资目的 为提高募集资金使用效率，在不影响募投项目开展、募集资金使用计划和保 证募集资金安全的前提下，公司及全资子公司将合理利用部分暂时闲置募集资金 进行现金管理，提高募集资金使用效益、增加股东回报。 关于迈威（上海）生物科技股份有限公司 继续使用部分暂时闲置募集资金进行现金管理的核查意见 海通证券股份有限公司（以下简称"海通证券"或"保荐机构"）作为迈威 （上海）生物科技股份有限公司（以下简称"迈威生物"或"公司"）首次公开 发行股票并上市的持续督导保荐机构，根据《证券发行上市保荐业务管理办法》 《上市公司监管指引第2号——上市公司募集资金管理和使用的监管要求》《上海 证券交易所科创板股票上市规则》《上海证券交易所上市公司自律监管指引第11 号——持续督导》《上海证券交易所科创板上市公司自律监管指引第1号——规范 运作》等有关规定，对公司继续使用部分暂时闲置募集资金进行现金管理的事项 进行了核查，具体情况如下： 一、募集资金基本情况 根据中国证券监督管理委员会于 2021 年 12 月 7 日出具的《关于同意迈威 （ ...

本公司监事会及全体监事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 一、监事会会议召开情况 证券代码：688062 证券简称：迈威生物 公告编号：2025-006 迈威（上海）生物科技股份有限公司 第二届监事会第十五次会议决议公告 表决结果：3 票同意，0 票反对，0 票弃权。 具体内容详见与本公告同日刊登于上海证券交易所网站（www.sse.com.cn） 的《迈威（上海）生物科技股份有限公司关于继续使用部分暂时闲置募集资金 进行现金管理的公告》。 特此公告。 迈威（上海）生物科技股份有限公司 迈威（上海）生物科技股份有限公司（以下简称"公司"）第二届监事会 第十五次会议通知于 2025 年 1 月 17 日以书面方式送达全体监事，于 2025 年 1 月 22 日以现场结合通讯方式召开。会议由监事会主席楚键先生主持，会议应到 监事 3 人，实到监事 3 人。会议的召集、召开程序和方式符合《公司法》等法 律法规以及《迈威（上海）生物科技股份有限公司章程》（以下简称"公司章 程"）的有关规定，会议决议合法、有效。 二、监事会会议审议情况 （一 ...

Financial Performance - The company expects a net loss attributable to shareholders of the parent company for 2024 to be between -970 million and -1,160 million CNY, continuing the trend of losses compared to the previous year [2]. - The expected net profit attributable to shareholders of the parent company, excluding non-recurring gains and losses, is projected to be between -1,000 million and -1,190 million CNY [2]. - The total profit for the previous year was -1,055.29 million CNY, with a net profit attributable to shareholders of the parent company at -1,053.43 million CNY [5]. - The company anticipates continued negative net profit attributable to shareholders of the parent company for the 2024 fiscal year [6]. Sales and Market Expansion - The company reported a significant increase in sales revenue due to market expansion, particularly from the drug Mai Li Shu®, which saw a substantial rise in sales compared to the previous year [6]. - The drug Mai Wei Jian® was approved for market launch in March 2024, contributing to increased sales revenue [6]. Operating Costs and R&D - Operating costs and sales expenses have increased in line with the expansion of commercialization efforts [6]. - The company maintains a high level of research and development investment, with multiple innovative drugs in critical trial stages [6]. Forecast Accuracy and Data Status - There are no significant uncertainties affecting the accuracy of this earnings forecast [7]. - The data provided is preliminary and subject to change, with final audited financial data to be disclosed in the 2024 annual report [8].