12月15日晚间，迈威生物(688062)公告称，为满足公司经营发展的资金需求，实现公司可持续发展，提 升公司国际化水平，公司拟在境外发行股份（H股）并在香港联交所主板上市，公司将在股东大会决议 有效期内选择适当的时机和发行窗口完成本次发行H股并上市。 截至目前，迈威生物正积极与相关中介机构就本次发行H股并上市的相关工作进行商讨，除董事会审议 通过的相关议案外，其他关于本次发行H股并上市的具体细节尚未确定，本次发行H股并上市是否能通 过审议和审核/备案程序并最终实施具有重大不确定性。 当晚披露的另一份公告显示，为把握国家新时代西部大开发战略机遇，深化东西部科技成果转移转化合 作，在重要战略支点上拓展国内和国际两个市场，迈威生物拟与重庆高新区管委会、大健康基金签订项 目投资合作协议，在重庆高新区直管园范围内，共同投资建设迈威生物骨健康创新药项目。 该项目在依托西部（重庆）科学城生物药CDMO先进制造基地的基础上，使用约3500平方米厂房/楼 宇，以骨健康领域为核心，将相关管线创新药的研发、药品批文（含药品生产许可B证）、商业化生 产、商业化权益及销售等落地至重庆高新区。 公告显示，该项目计划总投资20亿元，其中 ...

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：2024-11-01 | --- | --- | --- | |------------|-------|-----------------------------------------------------------------| | | | 特定对象调研 □分析师会议 | | 投资者关系 | □ | 媒体采访 业绩说明会 | | 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、线上交流会 | | 参与单位 | | 东方证券、天治基金、冲积资产、华安基金、富国基金、创金合信基 | | | | 金、晨响集团、天弘基金、泾溪投资、红筹投资、中泰资管、鹏扬基 | | | | 金、中康资产、上海乾瞻投资、东吴证券、兴全基金、中泰证券、浙商 | | | | 证券、国联安基金、湘财基金、西部证券、开源证券、中金证券、金信 | | | | 基金、国金资管、光大证券资管、东证融汇资管、惠升基金、中信证 | | | | 券、前海开源、闻天投资、中信资管 、兴海荣投资、 ...

证券研究报告 非金融公司|公司点评|迈威生物（688062） 收入稳步放量，创新品种持续推进 请务必阅读报告末页的重要声明 glzqdatemark1 2024年11月04日 证券研究报告 |报告要点 公司发布 2024 年三季报，营收 1.41 亿元，同比增长 41.79%，单季度来看，2024Q3 营收 2557 万元，同比增长 167.73%。已上市品种 3 个，单季度来看，迈利舒实现销售收入 2356.24 万 元，迈卫健单季度实现销售收入 148.76 万元。9MW2821 在 Q3 获准启动 2 项Ⅲ期临床研究。 |分析师及联系人 SAC：S0590521070002 郑薇 聂丽逻 请务必阅读报告末页的重要声明 1 / 6 非金融公司|公司点评 glzqdatemark2 2024年11月04日 迈威生物(688062) 收入稳步放量，创新品种持续推进 | --- | --- | |----------------------------|-------------------| | | | | 行 业： | 医药生物/化学制药 | | 投资评级： | 买入（维持） | | 当前价格： | 22. ...

Revenue and Sales Performance - Revenue for the current reporting period increased by 167.73% year-over-year, driven by a 163.22% increase in drug sales revenue to 25.05 million yuan[2][8] - Cumulative revenue from the beginning of the year to the end of the reporting period increased by 41.79%, with drug sales revenue growing 287.12% to 90.715 million yuan[2][8] - Revenue for the first three quarters of 2024 reached 141,095,928.06 RMB, a 41.8% increase compared to 99,511,384.04 RMB in the same period of 2023[21] - Cash received from sales and services in the first three quarters of 2024 was 180,722,393.45 RMB, doubling from 90,276,727.22 RMB in 2023[24] - Cash received from selling goods and providing services was 299.14 million yuan, an increase of 72.97 million yuan compared to the previous period[25] Profit and Loss - Net profit attributable to shareholders for the current reporting period was -249.11 million yuan, with a cumulative net loss of -694.09 million yuan from the beginning of the year[2] - Net loss for the first three quarters of 2024 was 696,015,164.94 RMB, a 2.9% increase from 676,619,021.82 RMB in 2023[22] - Total comprehensive loss for the first three quarters of 2024 was 697,030,853.80 RMB, a 3.8% increase from 671,829,240.37 RMB in 2023[23] - Basic and diluted earnings per share for the first three quarters of 2024 were both -1.74 RMB, compared to -1.68 RMB in 2023[23] R&D Expenses - R&D expenses for the current reporting period amounted to 158.88 million yuan, accounting for 621.42% of revenue, a decrease of 987.81 percentage points year-over-year[3][8] - Cumulative R&D expenses from the beginning of the year to the end of the reporting period were 481.01 million yuan, representing 340.91% of revenue, a decrease of 155.63 percentage points year-over-year[3][8] - R&D expenses for the first three quarters of 2024 were 481,008,266.28 RMB, a slight decrease of 2.6% compared to 494,110,768.85 RMB in 2023[21] Assets and Liabilities - Total assets at the end of the reporting period were 4.50 billion yuan, a slight increase of 0.95% compared to the end of the previous year[3] - Shareholders' equity attributable to the parent company decreased by 25.79% to 1.92 billion yuan compared to the end of the previous year[3] - The company's total liabilities as of September 30, 2024, were 2,592,617,747.89 yuan, with a significant increase in short-term borrowings to 907,717,127.46 yuan[18][19] - The company's total equity as of September 30, 2024, was 1,904,971,009.25 yuan, with a decrease in undistributed profits to -4,445,439,800.10 yuan[19][20] Non-Recurring Gains - Government subsidies contributed 5.19 million yuan to non-recurring gains for the current reporting period, with a cumulative amount of 20.14 million yuan from the beginning of the year[5][6] - Financial asset investment gains and fair value changes contributed 650,412.80 yuan to non-recurring gains for the current reporting period, with a cumulative amount of 2.50 million yuan from the beginning of the year[5][6] Product Pipeline and Clinical Trials - The company has 15 core products in clinical or market stages, including 11 innovative drugs and 4 biosimilars, covering major disease areas such as oncology, immunology, bone diseases, ophthalmology, and hematology[12] - The company's recombinant anti-Nectin-4 antibody-drug conjugate (9MW2821) received FDA Fast Track designation for treating locally advanced or metastatic Nectin-4 positive triple-negative breast cancer[13] - 9MW2821 has been approved by the NMPA to initiate Phase II clinical trials for treating triple-negative breast cancer either as a monotherapy or in combination with PD-1 inhibitors[13] - As of the report date, 9MW2821 has received 3 FDA Fast Track designations and 1 Orphan Drug designation for treating esophageal cancer, cervical cancer, and triple-negative breast cancer[13] - 9MW2821 was included in the CDE's Breakthrough Therapy list for treating locally advanced or metastatic urothelial carcinoma in August 2024[13] - The company initiated 2 Phase III pivotal registration clinical studies for 9MW2821 during the reporting period, targeting cervical cancer and first-line treatment of urothelial carcinoma in combination with PD-1 monoclonal antibody[13] - The company's recombinant human vascular endothelial growth factor receptor-antibody fusion protein (9MW0813) completed Phase III clinical trial head-to-head comparison with the original drug Eylea® in August 2024, with data locked ahead of schedule. The research data is expected to be obtained by the end of 2024, and the market application is planned to be submitted in 2025, potentially becoming one of the top three Eylea® biosimilars in China[14] Marketed Products and Sales - As of the reporting period, the company has three marketed products: Mailishu®, Maijian®, and Junmaikang®. Mailishu® achieved sales revenue of 235.624 million yuan in Q3 2024, with access to 1,336 hospitals and coverage in 2,632 pharmacies[15] - Maijian® achieved sales revenue of 14.876 million yuan in Q3 2024, with access to 42 hospitals and coverage in 653 pharmacies[15] - Junmaikang® has been approved for marketing since March 2022, with access to 270 hospitals and coverage in 1,370 pharmacies[15] - The company signed commercialization agreements for Mailishu® and Maijian® with pharmaceutical companies in Brazil and Jordan in August and September 2024, respectively. For Junmaikang®, agreements were signed with companies in Jordan and Peru in September 2024, covering dozens of overseas markets with a cumulative milestone amount of 14.285 million USD[16] Shareholder Information - The company's largest shareholder, Langrun (Shenzhen) Equity Investment Fund, holds 140,560,000 shares, representing 35.18% of the total shares[9] - The second-largest shareholder, Ningbo Meishan Bonded Port Area Zhongjun Jianlong Investment Partnership, holds 20,000,000 shares, accounting for 5.01% of the total shares[9] - The third-largest shareholder, Liu Datao, holds 15,100,000 shares, representing 3.78% of the total shares[9] - The company's top 10 shareholders include several institutional investors such as China Merchants Bank, China Construction Bank, and China Minsheng Bank, holding shares through various funds[10] Cash Flow - Net cash flow from operating activities was -668.22 million yuan, a decrease of 105.76 million yuan compared to the previous period[25] - Net cash flow from investing activities was -203.17 million yuan, an improvement of 248.53 million yuan compared to the previous period[25] - Net cash flow from financing activities was 827.13 million yuan, an increase of 498.64 million yuan compared to the previous period[26] - Cash paid for goods and services was 21.92 million yuan, a decrease of 35.85 million yuan compared to the previous period[25] - Cash paid to employees was 365.18 million yuan, an increase of 54.74 million yuan compared to the previous period[25] - Cash received from investments was 322.06 million yuan, an increase of 41.22 million yuan compared to the previous period[25] - Cash paid for investments was 290.91 million yuan, an increase of 20.18 million yuan compared to the previous period[25] - Cash received from borrowings was 2.24 billion yuan, an increase of 1.81 billion yuan compared to the previous period[26] - Net increase in cash and cash equivalents was -45.19 million yuan, an improvement of 635.00 million yuan compared to the previous period[26] Operating Costs and Expenses - Operating costs for the first three quarters of 2024 were 844,467,620.30 RMB, up 8.9% from 775,388,223.53 RMB in 2023[21] - Sales expenses for the first three quarters of 2024 were 168,466,717.93 RMB, a 4.5% increase from 161,278,252.49 RMB in 2023[21] - Management expenses for the first three quarters of 2024 were 158,902,611.01 RMB, up 10.2% from 144,203,638.77 RMB in 2023[21] - Financial expenses for the first three quarters of 2024 were 22,740,778.95 RMB, compared to a financial income of 26,622,479.36 RMB in 2023[21] Monetary Funds and Financial Position - As of September 30, 2024, the company's monetary funds amounted to 1,564,341,685.47 yuan, with total assets of 4,497,588,757.14 yuan[17][18][19][20]

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：2024-09-01 | --- | --- | --- | |------------|-------|-------------------------------------------------------------------| | | | 特定对象调研 □分析师会议 | | 投资者关系 | □ | 媒体采访 业绩说明会 | | 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、线上交流会 | | 参与单位 | | 东吴证券、广发证券、东方证券、国盛证券、国投证券、中信证券、野 | | | | 村东方、兴业证券、德邦证券、东北证券、 Point72 、碧云资本、博远基 | | | | 金、呈瑞投资、冲积资产、大朴资产、德邦基金、东方阿尔法、东海基 | | | | 金、东海资管、东海自营、东吴基金、东吴人寿、东吴资管、富荣基 | | | | 金、格林基金、观富资产、观合资产、国海富兰克林、国海证券、国华 | | | | 兴益、国君资管、国泰基金、国 ...

证券研究报告 医药生物 证券分析师 刘闯 S1350524030002 liuchuang@huayuanstock.com 市场表现： -16% -3% 9% 21% 33% 46% 23-0923-1023-1123-1224-0124-0224-0324-0424-0524-0724-0824-09 迈威生物 沪深300 首次覆盖报告 2024 年 9 月 21 日 迈威生物-U (688062.SH) 买入（首次覆盖） ——ADC 核心管线进展积极，商业化稳步推进 投资要点： ➢ 公司 2024 半年报成果显著：迈威生物 2024 年中报业绩显示，上半年公司实现营业收入 1.16 亿元，同比增长 28.42%。其中药品销售收入为 6566.5 万元，较上年同期 1391.65 万元增长 371.85%。同时 9MW3011 项目与美国 DISC MEDICINE, INC.独家许可协议于本期确认技术 授权收入较多。公司 2024 年上半年研发投入为 3.22 亿元，同比降低 5.38%；销售费用 1.13 亿元，同比增长 29.82%，公司商业化不断推进，呈现良好态势。 ➢ 核心管线 Nectin-4 ...

全球首家披露"乳腺癌+宫颈癌+食管癌"治疗数据，这家公司核心产品有望实现对肿瘤细胞的精准打击， 现有3款产品商业化进展顺利、后续管线产品取得积极进展，同时公司已覆盖海外市场数十个国家的正 式合作协议或框架协议的签署，有望通过授权加速拓展海外市场。 迈威生物-U（688062）精要： ①ADC药物是近年创业药研发最火热的领域之一，该药物可实现对肿瘤细胞的精准打击，尤其在实体瘤 治疗领域拥有较大优势，Frost&Sullivan预计2030年国内市场有望达662亿元； ②国信证券张佳博看好公司核心产品9MW2821是研发进度最快的国产Nectin-4 ADC，在尿路上皮癌、 宫颈癌中已经进入到3期注册性临床，在食管癌、乳腺癌等适应症中同样开展了多项临床； ③公司目前已有3款生物类似药获批上市，TROP2 ADC和B7-H3 ADC等后续管线产品取得积极进展，同 时公司已完成覆盖海外市场数十个国家的正式合作协议或框架协议的签署，有望通过授权出海的方式拓 展海外市场； ④张佳博预计公司2024-26年营收分别为4.17/8.87/14.31亿元，同比增长226%/113%/61%，归母净利 润分别为-7.49/-5. ...

证券研究报告 | 2024年09月13日 迈威生物-U（688062.SH） 优于大市 Nectin-4 ADC 展现泛瘤种潜力，快速推进注册临床 Nectin-4 ADC 在多个适应症中快速推进临床。迈威生物的核心产品 9MW2821 是研发进度最快的国产 Nectin-4 ADC，在尿路上皮癌（UC）、宫颈癌（CC） 中已经进入到 3 期注册性临床。此外，9MW2821 在食管癌（EC）、乳腺癌（BC） 等适应症中同样开展了多项临床。除了在 UC 适应症外，9MW2821 也披露了在 CC、EC 和 TNBC 的临床数据，希望凭借差异化的适应症与 PADCEV 展开竞争。 公司将在海外开展 9MW2821 的临床，结合在国内全面的临床数据支持，有望 通过授权出海的方式拓展海外的市场。 后续管线产品取得积极进展。公司的 ST2 单抗 9MW1911 目前正在进行 COPD 的 2 期临床，进度在国内公司中领先。7MW3711（B7-H3 ADC）、9MW2921（TROP2 ADC）正在进行 1/2 期临床。8MW0511（长效升白针）的上市申请已获受理。 公司已经具备较好的商业化能力，后续产品的获批上市及 ...

证券研究报告 | 2024年09月13日 迈威生物-U（688062.SH） 优于大市 Nectin-4 ADC 展现泛瘤种潜力，快速推进注册临床 Nectin-4 ADC 在多个适应症中快速推进临床。迈威生物的核心产品 9MW2821 是研发进度最快的国产 Nectin-4 ADC，在尿路上皮癌（UC）、宫颈癌（CC） 中已经进入到 3 期注册性临床。此外，9MW2821 在食管癌（EC）、乳腺癌（BC） 等适应症中同样开展了多项临床。除了在 UC 适应症外，9MW2821 也披露了在 CC、EC 和 TNBC 的临床数据，希望凭借差异化的适应症与 PADCEV 展开竞争。 公司将在海外开展 9MW2821 的临床，结合在国内全面的临床数据支持，有望 通过授权出海的方式拓展海外的市场。 后续管线产品取得积极进展。公司的 ST2 单抗 9MW1911 目前正在进行 COPD 的 2 期临床，进度在国内公司中领先。7MW3711（B7-H3 ADC）、9MW2921（TROP2 ADC）正在进行 1/2 期临床。8MW0511（长效升白针）的上市申请已获受理。 公司已经具备较好的商业化能力，后续产品的获批上市及 ...

迈利舒放量显著，Nectin-4 ADC 进展迅速 ——迈威生物 2024 年中报点评 核心观点 ⚫ 迈利舒迅速放量，药品销售收入大幅增长。公司发布 24 年中报，实现营业收入 1.16 亿元（同比+28.42%），归母净利润-4.45 亿元（同比-7.61%），扣非归母净 利润-4.61 亿元（同比-10.88%）。其中药品销售收入 6,566.50 万元（同比 +371.85%），主要系迈利舒新增发货 116,994 支，新增准入医院 487 家，上半年销 售已超 23 年全年。 ⚫ Nectin-4 ADC 临床进展迅速，多适应症全面铺开。公司 Nectin-4 ADC 今年以来披 露了多个适应症的积极数据，24 年上半年已在多瘤种中迅速推进多项临床试验： 1）尿路上皮癌：启动联用 PD-1 抑制剂一线治疗的 III 期临床试验；2）宫颈癌：启 动单药二/三线治疗的 III 期临床试验（全球首个在该适应症进入 III 期的同靶点药 物），联用 PD-1 抑制剂一线治疗的 IND 获受理；3）三阴性乳腺癌：启动联用 PD1 抑制剂一线治疗或单药二线治疗的 II 期临床试验；4）食管癌：联用 PD-1 抑制 ...