Core Viewpoint - The company Maiwei Biopharma is facing challenges in achieving significant revenue growth from its products, particularly in the competitive landscape of the domestic innovative drug market, despite having several products approved for commercialization [1][3]. Financial Performance - In 2023 and 2024, the company's revenue was 128 million yuan and 200 million yuan, respectively, with drug sales contributing 42.09 million yuan and 145 million yuan [3]. - The company reported significant R&D expenses of 836 million yuan in 2023 and 783 million yuan in 2024, leading to net losses of 1.053 billion yuan and 1.044 billion yuan for the respective years [3]. - The company's debt situation is concerning, with a cash balance of 1.193 billion yuan and total borrowings of 922 million yuan short-term and 1.12 billion yuan long-term, resulting in an increase in the debt-to-asset ratio from 42.24% to 63.61% [9]. Product Portfolio - Maiwei Biopharma has three products in the commercialization stage: Junmaikang, Mailishu, and Maiweijian, with Junmaikang being a biosimilar to Adalimumab [2]. - Mailishu generated sales of 124 million yuan in 2024, marking a 195.5% increase year-on-year, making it the company's leading product [3]. - The company is struggling with market penetration for Junmaikang, which is the sixth Adalimumab biosimilar in the market, facing challenges due to established competitors and market dynamics [5][7]. Market Dynamics - The innovative drug market in China has seen successful entries from other companies, such as Qilu Pharmaceutical and Fuhong Hanlin, which have achieved significant sales with their biosimilars [4]. - The market for TNF inhibitors, including Adalimumab, is not well established in China, with leading competitors only achieving sales of around 1 billion yuan [5]. - Maiwei Biopharma's sales strategy has shifted to focus on core regions and partnerships due to previous losses and low return rates in certain areas [7]. Future Outlook - The company plans to introduce three new products over the next three years to enhance revenue generation and is considering an IPO in Hong Kong to alleviate cash flow issues [9]. - The pipeline includes promising candidates like 9MW2821, which is in phase 3 clinical trials and has potential for significant market impact if approved [10].

Core Viewpoint - The company received an inquiry letter from the Shanghai Stock Exchange regarding its 2024 annual report, prompting a detailed response about its operational performance and product sales [1][2]. Group 1: Operational Performance - In 2024, the company achieved operating revenue of 200 million yuan, a year-on-year increase of 243.53% [2][19]. - The company has three commercialized products: Junmaikang, Mailishu, and Maiweijian, with varying sales performance and challenges [2][3]. - Junmaikang's sales volume significantly decreased by 66.61%, with 48,821 units shipped in 2024 [2][10]. - Mailishu's sales revenue increased by 195.50%, with a total revenue of 12.44 million yuan in 2024 [3][5]. - Maiweijian achieved a total revenue of 14.46 million yuan in 2024, with a gross margin of 78.47% [4][11]. Group 2: Product Analysis - Junmaikang's sales were impacted by its late market entry and intense competition, leading to a strategic shift in sales approach [6][9]. - Mailishu's cost increased by 1,122.70% compared to the previous year, resulting in a decrease in gross margin by 9.96 percentage points [5][6]. - Maiweijian's market entry was slow, with only 75 hospitals approved by the end of 2024, attributed to its limited indications compared to the original drug [12][14]. Group 3: Market Trends and Strategies - The TNF-α drug market in China grew from 3.5 billion yuan in 2019 to 42.9 billion yuan in 2023, with a compound annual growth rate of 17.5% [6][7]. - The company plans to expand Maiweijian's indications to include SREs, which could enhance its market presence [23][24]. - The company is actively pursuing international collaborations and expanding its product pipeline to enhance revenue streams [25][26]. Group 4: Financial Outlook - The company anticipates gradual revenue growth and a reduction in net losses over the next three years, with a low risk of expanding losses [20][19]. - The company is focusing on improving operational efficiency and expanding its commercialized product offerings to achieve profitability [20][21].

Core Viewpoint - The company, Maiwei (Shanghai) Biotechnology Co., Ltd., reported a significant increase in revenue for 2024, driven by its commercialized products and technical services, while facing challenges in market penetration and competition in the biopharmaceutical sector [3][21]. Financial Performance - In 2024, the company achieved a revenue of 200 million RMB, representing a year-on-year growth of 56.28% [3]. - The revenue breakdown includes 145 million RMB from antibody drugs and 55 million RMB from technical services [3]. - The sales volume of the product Junmaikang decreased by 66.61% year-on-year, with a total shipment of 48,821 units [3][10]. Product Analysis - The company has three commercialized products: Junmaikang, Mailishu, and Maiweijian, with detailed sales revenue, costs, and gross margins provided [3][5]. - Junmaikang's sales revenue for 2024 was 124.37 million RMB, with a gross margin of 6.25% [5]. - Mailishu's sales revenue was 145.94 million RMB, with a gross margin of 86.87% [5]. - Maiweijian's sales revenue reached 145.92 million RMB, with a gross margin of 78.47% [5]. Market Dynamics - The TNF-α drug market in China grew from 3.5 billion RMB in 2019 to 10.1 billion RMB in 2023, with a projected growth to 42.9 billion RMB by 2032 [7]. - The competitive landscape for Junmaikang is challenging, with multiple similar products already in the market, leading to a decline in its sales volume [9][10]. Strategic Adjustments - The company is optimizing its regional operating model to improve efficiency and resource utilization, transitioning from self-operated sales to cooperative sales in underperforming areas [10][21]. - The company plans to expand the indications for Maiweijian to enhance its market competitiveness and sales revenue [25][21]. Research and Development - The company has several products in the pipeline, with multiple candidates entering Phase III clinical trials, expected to launch between 2028 and 2031 [20][21]. - The company is actively pursuing international collaborations and market expansions, particularly in emerging markets [26][27]. Technical Services - The technical service revenue composition includes significant contracts with major clients, contributing to the overall revenue [15][19]. - The company has received substantial payments for milestone achievements in its technical service agreements [15].

证券代码：688062 证券简称：迈威生物 公告编号：2025-024 问题一 关于经营业绩 1 主要客户、服务内容、合同对价、交付进展、收入确认进度及依据、销售回款 情况等。（4）结合营业收入分季度波动情况，说明第四季度营业收入环比增长 超 100%的原因及合理性。（5）结合公司主要在研产品的研发进度、预计上市 时间、预计销售规模等，说明公司是否存在亏损扩大风险，以及公司拟采取的 提高经营质效措施。 关于经营业绩。年报显示，2024 年公司实现营业收入 2.00 亿元，同比增长 56.28%，具体为抗体药物收入 1.45 亿元，技术服务收入 0.55 亿元。药物销售 方面，公司已有君迈康、迈利舒、迈卫健等 3 款产品获批上市，其中君迈康全 年发货 48,821 支，同比下降 66.61%，迈卫健全年发货 12,530 支，累计准入医 院 75 家。请你公司：（1）分产品列示公司三款商业化产品的销售收入、成本、 毛利率，并分析变动情况及原因。（2）结合市场需求、竞争格局、竞品销售情 况、价格成本波动等因素，分别说明君迈康发货量大幅下降、迈卫健医院准入 进度较慢的原因，分析是否符合行业趋势，并补充说明公司拟采取 ...

国泰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 2024 年报告的信息披露监管问询函的专项核查意见 上海证券交易所： 根据贵所《关于迈威（上海）生物科技股份有限公司2024年报告的信息披 露监管问询函》（上证科创公函【2025】0064号）（以下简称"《问询函》"） 的要求，国泰海通证券股份有限公司（以下简称"国泰海通"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"公司"）首次公开发行 股票并在科创板上市的保荐机构及持续督导机构，对问询函相关问题进行了审 慎核查，并出具核查意见如下： 本核查意见中若出现总计数尾数与所列数值总和尾数不符的情况，均为四 舍五入所致。本核查意见中所列示的包括但不限于收入、利润及产能规划等数 据的相关测算和预计均不构成业绩承诺或盈利预测。如无特别说明，本核查意 见中使用的简称或名词释义与《迈威（上海）生物科技股份有限公司2024年年 度报告》（以下简称"2024年报"）一致。 问题一 关于经营业绩 关于经营业绩。年报显示，2024 年公司实现营业收入 2.00 亿元，同比增长 56.28%，具体为抗体药物收入 1.45 亿元，技术服务收入 0.55 ...

就上海证券交易所科创板公司管理部 《关于对迈威(上海)生物科技股份有限公司2024年报告的信息披露监管问询函》 中部分涉及财务报表项目问询意见的专项说明 年报显示，2024年公司实现营业收入2.00亿元，同比增长56.28%，具体为抗体药物收入1.45亿元， 技术服务收入0.55亿元。药物销售方面，公司已有君迈康、迈利舒、迈卫健等3款产品获批上市，其中 君迈康全年发货48,821支，同比下降66.61%，迈卫健全年发货12,530支，累计准入医院75家。请你公 司：（1）分产品列示公司三款商业化产品的销售收入、成本、毛利率，并分析变动情况及原因。（2） 结合市场需求、竞争格局、竞品销售情况、价格成本波动等因素，分别说明君迈康发货量大幅下降、 迈卫健医院准入进度较慢的原因，分析是否符合行业趋势，并补充说明公司拟采取的改进措施。（3） 说明公司技术服务收入的具体构成，包括但不限于技术服务收入对应的主要客户、服务内容、合同对 价、交付进展、收入确认进度及依据、销售回款情况等。（4）结合营业收入分季度波动情况，说明第 四季度营业收入环比增长超 100%的原因及合理性。（5）结合公司主要在研产品的研发进度、预计上 市时 ...

伴随AI驱动新一轮科技浪潮的兴起，摩根资产管理整合旗下"全球视野投科技"产品线，从主动管理到被 动投资产品，助力投资者从全球视野布局优质科技企业，把握时代浪潮下的投资机遇。 主动管理方面，摩根新兴动力基金（A类：377240 C类：014642）从长期视角争取把握新兴产业趋势； 摩根智慧互联基金（A类：001313 C类：016919）聚焦人工智能相关领域机会；摩根动力精选基金（A 类：006250 C类：013137）关注新能源车产业链、人形机器人等领域；摩根慧选成长基金（A类： 008314 C类：008315），布局A+H优质成长企业；摩根太平洋科技基金（PRC人民币对冲（累计） 968061，PRC人民币（累计）968962，PRC美元份额（累计）968063）精选太平洋地区优质科技企业。 长江证券认为，当前我国生物制造、量子科技、具身智能、6G等未来产业的产业化仍处于较为初期的 阶段，产业链各个环节有巨大的发展潜力，在政策大力推动下，我国未来产业有望加速发展，加速全产 业链中各个环节的发展。 创新药企ETF紧密跟踪中证创新药产业指数，中证创新药产业指数从主营业务涉及创新药研发的上市公 司证券中，选取 ...

交银国际指出，中国内地集采政策优化给予医院和企业更多灵活性及自主权，药品挂网规则统一则有利 于加速行业出清，利好优质龙头处方药企业。考虑到 2025H2医保丙类目录等利好政策有望正式落地、 板块回调后估值仍处历史低位，我们建议短期情绪波动企稳后可关注盈利高增长或盈亏平衡时间点明 确、估值有较大修复弹性的创新药标的。 5月16日，A股三大指数集体走低，科创医药板块逆市回升。相关ETF方面，截至发稿，科创医药ETF （588860）翻红，现涨0.16%。成分股方面，迈威生物-U涨超5%，首药控股-U、科前生物、英诺特、 康希诺、百奥泰等多股跟涨。 （本文机构观点来自持牌证券机构，不构成任何投资建议，亦不代表平台观点，请投资人独立判断和决 策。） 科创医药ETF（588860）紧密跟踪的上证科创板生物医药指数，是从科创板市场中选取50只市值较大的 生物医药、生物医学工程、生物农业、生物质能、其他生物业领域上市公司证券作为指数样本，以反映 科创板市场代表性生物医药产业上市公司证券的整体表现。 中信建投指出，在全球化格局重塑背景下，中国医药行业需"立足于内，开拓于外"，推动技术自主可 控、加速国际化布局，捕捉全球医药产 ...

《投资者网》蔡俊 迈威生物（688062.SH，下称"公司"）在关键时刻，迎来一场风波。 5月，公司披露董事长兼总经理刘大涛收到证监会出具的《立案告知书》，其因涉嫌短线交易被立案调查，该事项针对个人不会对公司日常经营活动产生重 大影响。 目前，公司正处于港股IPO的过程中。现金流的捉襟见肘和负债率的高企，已让公司到了一个关键时刻。追溯上市以来的路程，公司自上而下变化正将趋势 推至一个十字路口。 极度渴求资金 2017年，刘大涛与唐春山联合创立迈威生物。早前，刘大涛履历过上海莱士、上海医药等企业，担任过研发总监的职位。不同于专业背景出身，主修材料专 业的唐春山一直在商海摸爬滚打，先在海南创业，再收购江西省的多家药企打造青峰医药集团。 彼时，创新药正值黄金期，大量资本涌入风口，公司及创始人趁势快速崛起。刘大涛与唐春山以收购方式向公司注入多家企业，通过不断整合资源将业务覆 盖到产业链的研发、生产、销售等环节。 风口期的创新药，研发赛道是估值的黄金标准。公司主营单抗、双抗、ADC等热门领域，IPO前最后一轮投后估值60亿元，股东包括东方富海、正心谷、海 通资本等机构。2022年，公司沿用第五套标准，即未盈利、无上市产 ...

华夏时报（www.chinatimes.net.cn）记者 于娜 见习记者 赵文娟 北京报道 近日，一则公告让迈威生物-U陷入舆论漩涡。据公告，公司董事长兼总经理刘大涛收到中国证监会出具的《立案 告知书》，因其涉嫌短线交易，证监会决定对其立案。事实上，这家创新药企正深陷"多事之秋"，一边是董事长 突遭立案调查的公司治理危机，一边是持续恶化的财务状况，不仅让正在推进的港股IPO计划蒙上阴影，更让市 场对其本已脆弱的资金链产生更深忧虑。在投资者交流平台，"经营稳定性""IPO进展""资金压力"等关键词频频出 现，折射出这家创新药企面临的多重困境。 "此次事件可能会导致审查过程更加严格甚至可能暂停其上市进程。特别是，如果证监会最终认定刘大涛的行为违 反了相关法律法规，那么公司不仅会面临法律风险，还可能导致投资者信心下降，进一步加剧融资难度。"经济学 家、新金融专家余丰慧在接受《华夏时报》记者采访时表示。 迈威生物-U表示，本次事项系对刘大涛先生个人的调查，不会对公司日常经营活动产生重大影响，立案调查期 间，刘大涛先生将积极配合中国证监会开展调查工作。但此消息一出，迈威生物-U股价应声下跌，市场用真金白 银投出了担忧 ...