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（ ...

证券代码：688062 证券简称：迈威生物 公告编号：2024-024 迈威（上海）生物科技股份有限公司 关于公司副总经理、核心技术人员离职及新增核心 技术人员的公告 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"） 董事会近日收到公司高级管理人员、核心技术人员张锦超先生的书面辞职报告。 张锦超先生因个人原因申请辞去所任职务，辞任后将不再担任公司及所有子公司 任何职务，将不再被认定为核心技术人员。 张锦超先生与公司签署了相关协议对其应承担的保密义务和竞业限制义 务作出了约定，其在任职期间参与研究并申请的专利均为职务成果，相应的知识 产权归属于公司，与公司不存在涉及职务成果、知识产权纠纷或潜在纠纷的情形， 其离职不影响公司知识产权权属的完整性。 张锦超先生离职后，其负责的工作将由公司研发总裁 HAI WU（武海） 先生负责，现已完成所负责项目的工作交接。张锦超先生的离职不会对公司整体 研发创新能力、持续经营能力和核心竞争力产生实质性影响。 根据 ...

证券研究报告 | 2024年04月19日 我们维持对于公司营收的预测，预计2024-26 年营收4.17/8.87/14.31 亿元， 同比增长 226%/113%/61%；由于公司持续的研发投入，我们小幅下调 2024-25 年的利润预测，预计 2024-26 年净利润-7.49/-5.16/-1.26 亿元（24-25 年 前值-6.48/-4.35 亿元）。公司的 Nectin-4 ADC 研发进度领先，早期临床数 据优秀，且有差异化的适应症布局，维持"增持"评级。 风险提示：创新药研发失败或进度低于预期；创新药销售不及预期。 相关研究报告 | --- | --- | |----------------------------------------|-----------------------------| | | | | | | | 基础数据 | | | 投资评级 | 增持(维持) | | 合理估值 | | | 收盘价 总市值/流通市值 | 31.28 元 12499/6386 百万元 | | 52 周最高价/最低价 近 3 个月日均成交额 | 37.00/19.44 元 89.29 百万元 | ...

Investment Rating - The report maintains a "Buy" rating for the company [6]. Core Views - The drug 9MW2821 is progressing well, being the first to disclose clinical efficacy data for the same target in cervical cancer and esophageal cancer. It has completed the first patient enrollment in a domestic Phase III trial for locally advanced or metastatic urothelial carcinoma and has received FDA fast track designation for esophageal squamous cell carcinoma [1][2]. - The company has a rich pipeline of innovative products, with several in early clinical stages, including 9MW2921 (TROP2) and 7MW3711 (B7-H3) in Phase I/II, and 8MW0511, a next-generation long-acting G-CSF, which has received acceptance for new drug application [2][3]. - The company is entering a harvest period for its biosimilars, with three products already launched and significant sales achieved in 2023 [2][3]. Summary by Sections 1. 9MW2821 Development Progress - 9MW2821 has shown promising results in treating cervical cancer, with an overall response rate (ORR) of 40.54% and a disease control rate (DCR) of 89.19% in a clinical trial [22]. - The drug has also received FDA fast track designation for treating esophageal squamous cell carcinoma, addressing a significant unmet need in patients who have failed prior treatments [34][36]. 2. Rich Pipeline of Innovative Products - The company is developing multiple innovative drugs, including 9MW2921 and 7MW3711, which are in early clinical stages. The new ADC platform IDDC™ is expected to enhance the efficacy and safety of these products [2][45]. - The company has also entered into exclusive licensing agreements for its TMPRSS6 monoclonal antibody, with a potential transaction value of up to $412.5 million [2]. 3. Profit Forecast and Investment Recommendations - Revenue projections for 2024-2026 are estimated at 241 million, 1.007 billion, and 2.29 billion yuan, primarily driven by biosimilars and innovative drug sales [3][4]. - The DCF valuation method suggests a reasonable value of 39.20 yuan per share, indicating significant upside potential from the current price of 31.00 yuan [3][6].

| --- | --- | |-------------------------------------------------------|------------------------------| | 迈威生物（ 买入（维持） | 688062.SH) ： ADC | | 所属行业：医药生物 / 化学制药 当前价格 ( 元 ) ： 31.2 | 多个数据发布，国内类似药商业 | | 证券分析师 | 化顺利推进 | | | | 业绩：公司 2024 年 4 月 9 日发布年报，2023 年度营业收入 1.28 亿元，技术服务 收入 8559.53 万元，药品销售收入 4209 万元，研发投入为 8.36 亿元，归母净亏 损为 10.53 亿元，主要原因是君迈康与迈利舒上市时间较短，且公司一直保持较 高的研发投入。公司拥有 10 个创新药，4 个生物类似药在临床，已上市品种 3 个， NDA 阶段 1 个，III 期阶段品种 3 个。公司具备抗体、ADC 及重组蛋白药物的研 发和产业化能力。截至 23 年底公司在职员工 1491 人，其中技术研发人员 398 名。 9MW2821（Nectin-4 ADC ...

Investment Rating - The report maintains a "Buy-A" rating for the company, indicating a positive outlook for investment returns over the next six months [3][9][22]. Core Insights - The company is steadily advancing its commercialization efforts, with strong sales expectations for biosimilars and a rich pipeline of products that provide long-term growth potential. The company has a robust research and development capability, particularly in the ADC (Antibody-Drug Conjugate) field, which differentiates its market position [3][17]. - Revenue projections for 2024-2026 are adjusted to 368 million, 1.33 billion, and 2.44 billion yuan, reflecting growth rates of 188%, 261%, and 83% respectively [3][19]. Financial Data Summary - The company reported a revenue of 128 million yuan in 2023, a significant increase of 361% year-on-year, primarily driven by technology service income and sales from its product, Mylis [15][19]. - The company incurred a loss of 1.05 billion yuan in 2023, with a notable increase in sales, management, and R&D expenses due to commercialization efforts and clinical advancements [15][19]. - The projected operating income for 2024 is 368 million yuan, with a gross margin expected to decrease from 98.9% in 2023 to 90.0% in 2024 [19]. Pipeline and Product Development - The company has three biosimilar products approved for market, with ongoing efforts to expand into emerging markets. The product Mylis has already seen significant distribution and sales [15][17]. - The ADC pipeline is progressing well, with the Nectin-4 ADC showing promising results in clinical trials for multiple indications, including UC (Urothelial Carcinoma) and CC (Cervical Cancer) [15][17]. Market Position and Strategy - The company has established a comprehensive production system, with significant capacity for antibody and recombinant protein production, supporting its transition from R&D to commercial production [17]. - The company is actively pursuing market entry in various regions, including recent submissions for product approvals in Pakistan and Indonesia [15][17].