证券代码：688062 证券简称：迈威生物 公告编号：2024-034 迈威（上海）生物科技股份有限公司 2024 年第二次临时股东大会决议公告 本公司董事会及全体董事保证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。 重要内容提示： 本次会议是否有被否决议案：无 一、 会议召开和出席情况 （一） 股东大会召开的时间：2024 年 6 月 12 日 会议采取现场投票和网络投票相结合的表决方式，表决程序符合《中华人民 共和国公司法》和《迈威（上海）生物科技股份有限公司章程》的规定。会议由 公司董事会召集，董事长刘大涛先生主持会议。 （三） 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及 其持有表决权数量的情况： （五） 公司董事、监事和董事会秘书的出席情况 1、 公司在任董事 9 人，出席 9 人； | 1、出席会议的股东和代理人人数 | 82 | | --- | --- | | 普通股股东人数 | 82 | | 2、出席会议的股东所持有的表决权数量 | 207,067,213 | | 普通股股东所持有表决权数量 | 207,067,2 ...

证券代码：688062 证券简称：迈威生物 迈威（上海）生物科技股份有限公司 投资者关系活动记录表 编号：2024-05-01 特定对象调研 □分析师会议 □媒体采访 □业绩说明会 投资者关系 活动类别 □新闻发布会 路演活动 □现场参观 其他 证券公司策略会 参与单位 中泰证券、东方证券、国海证券、国信证券、东吴基金、兴业基 金、丹羿投资、西部证券、南华基金、朱雀基金、东海证券资管、 玖鹏资产、东海证券自营、摩根、大朴资产、古曲基金、蜂巢基 金、深梧资产、国泰君安资管、中信建投证券、中银基金、中银资 管、乾惕投资、冲积资产、华宝基金、国华兴益保险、国泰基金、 ...

Investment Rating - The investment rating for the company is "Buy," indicating an expected stock performance that will exceed the market by more than 15% over the next 12 months [3][18]. Core Views - The company has successfully showcased its innovative drug 9MW2821 at the 2024 ASCO conference, highlighting its potential in treating various solid tumors [18]. - The company is progressing well with its research pipeline, with several products entering commercialization, including three biosimilars [18]. - Revenue forecasts for the company are optimistic, with projected revenues of 241 million in 2024 and 1,007 million in 2025, reflecting significant growth rates of 88.3% and 318.3% respectively [18][19]. Financial Summary - The company reported a revenue of 128 million in 2023, with a substantial growth rate of 361% compared to the previous year [19]. - The projected EBITDA for 2024 is -956 million, indicating ongoing investment in research and development [19]. - The net profit for 2023 was -1,059 million, with expectations of a slight improvement to -1,094 million in 2024 [19]. Research and Development - The company is advancing its innovative antibody-drug conjugate platform, with multiple candidates in clinical trials [18]. - The safety profile of 9MW2821 shows common treatment-related adverse events such as leukopenia and anemia [18]. Market Position - The company is positioned to capitalize on the growing market for innovative therapies, with a focus on oncology [18]. - The company has received regulatory recognition for several of its products, enhancing its competitive edge in the market [18].

Investment Rating - The investment rating for the company is "Buy" (maintained) with a target price of 32.45 CNY [1]. Core Views - The company has a well-established ADC platform with promising clinical data across multiple indications. The ADC technology platform utilizes site-specific conjugation technology, achieving a DAR value of 4, which enhances drug uniformity and therapeutic window compared to traditional random conjugation methods [1]. - The company reported a significant increase in revenue for 2023, with a total revenue of 1.28 billion CNY, representing a year-on-year growth of 361%. However, the net loss for the same period was 1.053 billion CNY, an increase in loss of 10.3% year-on-year [1][3]. - The company is advancing its clinical trials, with the Nectin-4 ADC 9MW2821 showing promising early data for multiple indications, including urothelial carcinoma and cervical cancer [1]. Financial Data Summary - Revenue (in million CNY): - 2022: 27.73 - 2023: 127.84 - 2024E: 310.64 - 2025E: 893.40 - 2026E: 1,343.68 - Revenue Growth Rate (%): - 2022: 70.88 - 2023: 361.03 - 2024E: 143.00 - 2025E: 187.60 - 2026E: 50.40 [3][4]. - Net Profit (in million CNY): - 2022: -955.23 - 2023: -1,053.43 - 2024E: -915.00 - 2025E: -655.20 - 2026E: -159.93 [3][4]. Clinical Pipeline - The company has multiple ADCs in clinical stages, including 9MW2811 (TROP2 ADC) and 7MW3711 (B7-H3 ADC), with ongoing trials for various cancers [1]. - The Nectin-4 ADC 9MW2821 is currently in advanced clinical trials for urothelial carcinoma, with early data showing an overall response rate (ORR) of 62.2% and a disease control rate (DCR) of 91.9% [1]. Market Expansion - The company is actively expanding into overseas markets, with total contract amounts exceeding 13.71 million USD. Agreements have been signed in 12 countries for the biosimilar drug Dexamethasone and in 13 countries for Adalimumab [1].

证券代码：688062 证券简称：迈威生物 公告编号：2024-028 迈威（上海）生物科技股份有限公司 关于全资子公司开立募集资金专项账户 并签订募集资金专户存储四方监管协议的公告 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。 一、募集资金基本情况 根据中国证券监督管理委员会出具的《关于同意迈威（上海）生物科技股份 有限公司首次公开发行股票注册的批复》（证监许可[2021]3859 号），公司首次 向社会公开发行人民币普通股 99,900,000 股，每股发行价格为人民币 34.80 元， 募集资金总额为人民币 3,476,520,000.00 元 ，募集资金净额为人民币 3,303,432,172.40 元，其中超募资金金额为人民币 323,432,172.40 元。上述募集资 金已于 2022 年 1 月 10 日全部到位，安永华明会计师事务所（特殊普通合伙）对 公司本次公开发行新股的资金到位情况进行了审验。 为规范公司募集资金管理和使用，保护投资者权益，公司设立了相关募集资 金专项账户。募集资金到账后，已全部存放 ...

证券代码：688062 证券简称：迈威生物 公告编号：2024-027 迈威（上海）生物科技股份有限公司 自愿披露关于 9MW2821 用于三阴性乳腺癌适应症 （TNBC）临床研究进展的公告 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。 重要内容提示： 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"） 采用自主知识产权研发的创新药 9MW2821 目前针对尿路上皮癌、宫颈癌、食管 癌、乳腺癌等多个适应症正在开展多项临床研究。近日，9MW2821 联合免疫检 查点抑制剂治疗三阴性乳腺癌适应症（TNBC）的临床试验申请已获得国家药品 监督管理局受理。根据目前单药治疗的临床数据显示，在接受 1.25mg/kg 剂量治 疗并可肿瘤评估的 20 例局部晚期或转移性三阴性乳腺癌受试者中，客观缓解率 （ORR）和疾病控制率（DCR）分别为 50%和 80%。为广大投资者进一步了解 上述研究临床试验数据的情况，现将相关临床试验结果数据公告如下： 一、药品基本情况 9MW2821 为迈威生物靶向 Nectin-4 的定点 ...

Investment Rating - The report gives an "Accumulate" rating for the company, indicating a positive outlook for its stock performance [3][20]. Core Views - The company achieved significant revenue growth in 2023, with operating income reaching 128 million yuan, a year-on-year increase of 361%. However, it reported a net loss attributable to shareholders of 1.053 billion yuan, compared to a loss of 955 million yuan in the same period last year [14][24]. - The company is entering a commercial phase with successful sales of its products, including adalimumab and dexamethasone biosimilars, and has a robust pipeline with the Nectin-4 ADC showing promising clinical data [6][20][25]. - The company is expected to continue its growth trajectory, with projected EPS for 2024-2026 being -2.59, -1.86, and -0.23 yuan respectively, reflecting a gradual improvement [20]. Financial Performance Summary - In 2023, the company reported an operating income of 128 million yuan, a 361% increase year-on-year, but a net loss of 1.053 billion yuan [14][24]. - For Q1 2024, the company reported an operating income of 68 million yuan, a staggering 1572% increase year-on-year, with a net loss of 206 million yuan [23][24]. - The company’s revenue growth is attributed to the sales of its biosimilars and licensing agreements, contributing positively to its financial performance [24]. Clinical Development and Pipeline - The Nectin-4 ADC, 9MW2821, has shown differentiated efficacy in clinical trials for treating advanced esophageal squamous cell carcinoma (ESCC) and cervical cancer, with FDA granting it "Fast Track Designation" [4][30]. - Clinical data for 9MW2821 indicates an overall response rate (ORR) of 62.2% for treating relapsed/refractory UC, outperforming the competitor Padcev [15][18]. - The company has a comprehensive pipeline with multiple products in various stages of development, indicating a strong focus on research and development [6][20].

Group 1: Clinical Progress and Data - The drug 9MW2821 is the first in its class to report preliminary clinical data for cervical cancer, with a Nectin-4 expression detection rate of 89.67% in the population and 67.82% in the overall cervical cancer population [7][8] - As of September 25, 2023, 40 patients have been enrolled in the study, with an overall response rate (ORR) of 40.54% and a disease control rate (DCR) of 89.19% among those treated with 1.25 mg/kg [8][9] - The only approved ADC drug for cervical cancer globally is TIVDAK® (Tisotumab Vedotin), which is used for recurrent or metastatic cervical cancer [9] Group 2: Market and Clinical Needs - Cervical cancer is the fourth most common cancer among women globally, with 600,000 new cases and 340,000 deaths reported in 2020 [9][10] - In China, there were 150,700 new cases and 55,700 deaths in 2022, ranking 8th and 9th respectively in new cases and deaths [10] - There is a significant unmet clinical need for effective treatments in cervical cancer, as indicated by the high incidence and mortality rates [10][11] Group 3: Future Development Plans - The company plans to actively communicate with regulatory agencies to expedite the clinical development of 9MW2821 for cervical cancer, focusing on both single-agent and combination therapies [11][12] - For esophageal cancer, 9MW2821 has received Fast Track Designation from the FDA, with ongoing Phase II trials showing an ORR of 30% and a DCR of 73.3% [11][12] - The company aims to expand its clinical strategy across multiple indications, including bladder cancer, with plans for further trials and regulatory submissions [12][13] Group 4: Commercialization Strategy - The company emphasizes building a robust commercialization team, particularly in oncology and autoimmune diseases, to enhance market penetration and sales growth [23][24] - As of the end of 2023, the company had 572 sales personnel, focusing on self-sales and partnerships with local distributors [23][24] - The company anticipates reaching a breakeven point in cash flow starting in 2024, driven by the launch of multiple products and international collaborations [24][25] Group 5: International Expansion - The company has signed formal agreements for market entry in several countries, including Pakistan, Morocco, and the Philippines, and is actively pursuing regulatory approvals for its products [20][21] - The total population along the "Belt and Road" initiative is approximately 4.4 billion, with significant economic potential, making it a key focus for the company's international strategy [21][22] - The company is committed to controlling management costs and improving operational governance to support its international expansion efforts [25]

Financial Performance - The company reported a total revenue of 12,198,186.66 RMB for the quarter, with a non-operating loss of 6.98 RMB[4]. - Total operating revenue for Q1 2024 was ¥67,555,138.51, a significant increase of 1,572.42% compared to ¥4,039,353.81 in Q1 2023[36]. - The net loss attributable to the parent company for the first quarter was ¥-205,535,439.79, compared to a loss of ¥-241,682,020.95 in the same period last year, showing an improvement of approximately 14.9%[30]. - Basic and diluted earnings per share for the first quarter were both ¥-0.51, consistent with the previous year's loss of ¥-0.60[30]. - The company reported a net loss attributable to shareholders of ¥205,658,524.39 for Q1 2024[44]. - In Q1 2024, the company reported a net loss of approximately $206.21 million, compared to a net loss of $241.70 million in Q1 2023, representing an improvement of about 14.7%[60]. Assets and Liabilities - Total assets increased to ¥4,641,815,291.15 as of March 31, 2024, up from ¥4,455,048,440.71 at December 31, 2023, representing a growth of approximately 4.2%[23]. - Current liabilities rose to ¥1,051,476,382.89, compared to ¥816,386,767.78 at the end of 2023, indicating an increase of about 28.8%[25]. - Long-term borrowings increased significantly to ¥1,022,315,828.62 from ¥887,715,828.62, reflecting a rise of approximately 15.1%[25]. - The company's total liabilities reached ¥2,246,111,836.00, up from ¥1,881,800,377.46, marking an increase of around 19.4%[25]. - The total equity attributable to shareholders decreased to ¥2,406,709,424.56 from ¥2,583,701,890.99, a decline of about 6.9%[26]. - The company's equity attributable to shareholders decreased by 6.85% from approximately $2.58 billion at the end of 2023 to approximately $2.41 billion at the end of Q1 2024[66]. Cash Flow - Cash received from sales of goods and services was ¥67,054,698.79, slightly down from ¥69,851,466.03 in the first quarter of 2023, a decrease of about 4.0%[30]. - Net cash flow from operating activities for Q1 2024 was -¥330,596,938.03, worsening from -¥152,672,130.25 in Q1 2023[41]. - Cash inflow from investment activities in Q1 2024 was ¥107,716,644.21, compared to ¥60,303,273.40 in Q1 2023[41]. - Cash outflow from investment activities totaled ¥283,505,565.22 in Q1 2024, down from ¥315,063,627.10 in Q1 2023[41]. - Cash inflow from financing activities was ¥1,360,160,000.00 in Q1 2024, significantly higher than ¥237,826,431.33 in Q1 2023[41]. - Net cash flow from financing activities for Q1 2024 was ¥584,440,756.11, compared to ¥170,283,340.69 in Q1 2023[41]. - The ending balance of cash and cash equivalents as of Q1 2024 was ¥1,721,702,106.25, down from ¥2,251,409,951.93 in Q1 2023[41]. Product Development and Market Presence - As of the end of the reporting period, the company had 14 products in clinical or上市 stages, including 10 innovative drugs and 4 biosimilars[17]. - The company has launched three products: Junmaikang®, Mailishu®, and Maiweijian®[11]. - The objective response rate (ORR) for the 9MW2821 drug in the cervical cancer cohort was 40.54%, with a disease control rate (DCR) close to 90%[20]. - The company is focusing on oncology and age-related diseases, with ongoing clinical trials for various treatments[17]. - The company is in the process of expanding its market presence and product lines in the rheumatology and chronic disease sectors[11]. - The company has three products currently on the market, with one in the licensing review stage and three in critical III phase clinical trials[17]. - The company has received FDA approval for its new generation antibody-drug conjugate (ADC) 7MW3711 for clinical trials targeting advanced malignant solid tumors[60]. - A supply and commercialization agreement was established with an Indian pharmaceutical company for the product 9MW0813, granting exclusive rights for import, registration, and sales in India and ten other countries[60]. - The company submitted listing application documents for products 9MW0113 and 9MW0311 in Pakistan, and for 9MW0113 in Indonesia and Egypt, with additional applications in preparation for other countries[60]. - The company’s ADC technology platform IDDC™ was showcased at the World ADC London conference, highlighting multiple ADC products under development[60]. Shareholder Information - The company has a total of 14,938 common shareholders, with the largest shareholder holding 35.18% of the shares[8]. - The top ten shareholders include Haitong Innovation Securities Co., Ltd. with 4,387,633 shares, representing 1.10% of total shares[52]. - The actual controllers of the company are Mr. Tang Chunshan and Ms. Chen Shanna, with several shareholders being controlled by Mr. Tang[46]. - The company has not disclosed any related party relationships among other shareholders[46]. Research and Development - The company has developed new generation ADC drugs based on systematic core patented technologies, enhancing structural uniformity and stability[20]. - Research and development expenses for Q1 2024 were ¥182,152,879.71, slightly increasing from ¥176,998,516.51 in Q1 2023[36]. - R&D investment totaled approximately $182.15 million, accounting for 269.64% of operating revenue, a decrease of 4,112.21 basis points compared to the previous year[66]. Other Financial Information - Government subsidies recognized in the current period amounted to ¥11,319,889.02, primarily from government subsidy income[49]. - The fair value changes and gains from financial asset investments contributed ¥890,100.42 to the current period's profit[49]. - The company has not reported any non-recurring gains or losses from the disposal of non-current assets[49]. - There were no significant changes in the number of shares borrowed and not returned under the margin trading and securities lending program[52]. - The first quarter financial statements are not audited[53]. - The company has not recognized any impairment losses on receivables in the current period[49]. - There are no significant one-time expenses related to discontinued operations reported for the current period[49].

海通证券股份有限公司 关于迈威（上海）生物科技股份有限公司 副总经理、核心技术人员离职及新增核心技术人员的核查意见 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 发行股票并在科创板上市持续督导保荐机构，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，对公司副总经理、核心技术人员离职及新 增核心技术人员事项进行了核查，具体情况如下： 一、副总经理、核心技术人员离职的具体情况 公司副总经理、核心技术人员张锦超先生因个人原因申请辞去所任职务，其 负责的工作由公司研发总裁 HAI WU（武海）先生负责，于近日完成工作交接， 并办理完毕离职手续。离职后，张锦超先生不在公司及所有子公司担任任何职务， 将不再被认定为核心技术人员。 截至本核查意见签署日，张锦超先生直接持有公司股份 4,000,000 股，通过 公司员工持股平台宁波梅山保税港区中骏建隆投资合伙企业（ ...