Core Viewpoint - Recently, Maiwei Biotech announced two significant licensing agreements, potentially exceeding a total value of 4.7 billion RMB, which could enhance the company's operational strength and support its long-term development strategy [2][3][5]. Group 1: Licensing Agreements - Maiwei Biotech signed an exclusive licensing agreement with CALICO, a subsidiary of Alphabet, for the IL-11 targeted therapy, which includes the product 9MW3811. The agreement allows CALICO to develop, produce, and commercialize the product outside of China [3][4]. - The agreement with CALICO includes an upfront payment of 25 million USD (approximately 250 million RMB) and potential milestone payments totaling up to 571 million USD (approximately 4.095 billion RMB), along with royalties based on net sales [3][4]. - The second agreement with Qilu Pharmaceutical involves the product 8MW0511, which is an injectable drug for treating febrile neutropenia in cancer patients. This agreement includes an upfront payment of 3.8 billion RMB and potential sales milestone payments, as well as royalties based on net sales [4][6]. Group 2: Company Background and Financials - Founded in 2017, Maiwei Biotech focuses on the research, production, and sales of innovative drugs and biosimilars, primarily in oncology and other therapeutic areas [3][6]. - As of the end of 2024, the company has three products on the market but has not yet achieved profitability, with accumulated losses [3][6]. - In Q1 2025, the company reported revenue of 44.79 million RMB, a year-on-year decline of 33.7%, and a net loss of 292 million RMB, indicating an increase in losses due to high R&D expenditures [7]. - The company is preparing for an IPO on the Hong Kong Stock Exchange to alleviate financial pressures and enhance its international presence [7].

Core Insights - The company is facing a dangerous expansion paradox with significant fixed asset investments of 1.894 billion yuan and ambitious capacity expansion plans, while experiencing a low capacity utilization rate of only 26.15% and actual drug sales revenue of 145 million yuan [1][2] Group 1: Sales Performance - The company's main products are underperforming, with a drastic decline in sales revenue. The projected sales for three key drugs were expected to reach between 1.435 billion to 1.762 billion yuan by 2025, but actual revenue for 2024 is only 145 million yuan, less than one-tenth of the optimistic forecast [2] - The drug Junmaikang (similar to Adalimumab) saw a 70% drop in shipment volume from approximately 166,900 units in 2023 to 48,800 units in 2024, facing intense competition and high costs [2] - The drug Mailishu (similar to Dexamethasone) also fell short of expectations, with actual sales of only 84,400 units and revenue of 42.09 million yuan in 2023, compared to a forecast of at least 300,000 units and 180 million yuan [2] - The drug Maiweijian (similar to Dexamethasone) was only approved by the end of March 2024, with shipments of just 12,530 units, limited by fewer approved indications and a lengthy market access process [2] Group 2: Capacity Expansion and Financial Strain - Despite poor sales performance, the company has aggressively expanded its production capacity, with fixed assets increasing by 165.49% to 1.653 billion yuan by the end of 2024, and total fixed assets and construction in progress reaching 1.894 billion yuan, accounting for 44.31% of total assets [3] - The actual capacity utilization rate is only 26.15%, with a production and sales rate of 81.08%. The company anticipates annual fixed asset depreciation costs of approximately 130 million yuan, nearly equal to its total drug sales revenue for 2024 [3] Group 3: Debt and Cash Flow Challenges - The company is under significant financial pressure, with short-term borrowings and long-term borrowings due within one year totaling 1.035 billion yuan by the end of 2024, leading to a debt-to-asset ratio of 63.61% and a negative operating cash flow of -956 million yuan [4] - The company is relying on two strategies to address its financial challenges: completing an H-share IPO for capital infusion and hoping for future revenue from unlisted pipelines to cover debts [4] Group 4: Leadership and IPO Uncertainty - The chairman and general manager of the company is under investigation for suspected insider trading, which has caused a significant drop in stock price and raised concerns about the impact on the H-share IPO process [5] - Although the company claims the investigation does not affect daily operations or the IPO plan, the Hong Kong Stock Exchange has strict scrutiny over management stability and integrity, which could delay the IPO process significantly [6] - The company submitted its prospectus for the Hong Kong IPO on January 6, and must complete the hearing or listing within six months, or the prospectus will become invalid, adding pressure to resolve the investigation quickly [6]

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 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 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 ...

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].

《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 ...

作为一家创新型生物医药企业，迈威生物成立以来一直保持较高的研发投入。2022年-2024年，迈威生 物研发费用分别为7.59亿元和8.36亿元、7.83亿元，而同期公司的营业收入分别为0.28亿元和1.28亿元、 1.998亿元，研发投入远高于公司营业收入。 生物制药行业需要大量的实验验证和临床试验，这一过程耗资巨大，即使销售表现良好也难以立即弥补 前期的巨大开支。自2022年在科创板上市以来，迈威生物一直处于亏损状态。2022年-2024年，迈威生 物净亏损分别为9.55亿元、10.53亿元、10.44亿元。 迈威（上海）生物科技股份有限公司（简称"迈威生物"）近日发布公告称，因涉嫌短线交易，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》。新京报记者注意到，迈威生物正值冲刺港股 上市的关键期，业绩持续亏损的情况下，董事长又遭立案调查，这无疑给公司上市之路增添变数。 董事长去年领薪超270万 公告显示，因涉嫌短线交易，中国证监会根据《中华人民共和国证券法》《中华人民共和国行政处罚 法》等法律法规，决定对迈威生物董事长兼总经理刘大涛立案。 对此，迈威生物表示，本次事项系对刘大涛个人的调查，不会对公 ...

正赴港IPO的迈威生物(688062.SH)，公司董事长被证监会立案。 5月9日，迈威生物公告显示，公司董事长兼总经理刘大涛因涉嫌短线交易，中国证监会决定对其立案。 长江商报记者发现，当前，尽管有三大产品成功上市，但迈威生物的业绩依旧十分难看。 6年来，迈威生物营业收入累计达4.1亿元，净利润亏损约54亿元。其中，2023年和2024年，公司连续两 年亏损超过10亿元。 2025年一季报显示，公司实现营业收入4478.85万元，同比下降33.70%；净利润亏损2.92亿元，同比下 降41.85%。截至2025年一季度末，迈威生物资产负债率达69.86%，为上市后最高水平。 刘大涛持股市值超3亿 5月9日，迈威生物发布公告，公司收到公司董事长兼总经理刘大涛通知，其于近日收到中国证券监督管 理委员会出具的《立案告知书》，因涉嫌短线交易，中国证监会根据相关法律法规，决定对其立案。 迈威生物表示，本次事项系对刘大涛的调查，不会对公司日常经营活动产生重大影响，立案调查期间， 刘大涛将积极配合中国证监会开展调查工作。 个人简历显示，刘大涛于1972年4月出生，药物化学专业博士，高级工程师。 在进入迈威生物前，刘大涛长期从 ...

来源|贝多财经 5月9日晚间，迈威（上海）生物科技股份有限公司（下称"迈威生物"，SH:688062）发布公告，称收到该公司董事长兼总经理刘大涛通知，其于近日收到中 国证监会出具的《立案告知书》。 因涉嫌短线交易，中国证监会根据规定，决定对刘大涛立案。迈威生物在公告表示，本次事项系对刘大涛个人的调查，不会对该公司日常经营活动产生重大 影响，立案调查期间，刘大涛将积极配合中国证监会开展调查工作。 据贝多财经了解，迈威生物是一家科创板上市公司，于2022年1月18日在上海证券交易所科创板上市，IPO发行价为34.8元/股，发行数量为9990万股，募资 总额约34.77亿元，募资净额，募资净额约33亿元。 | 序号 | 项目名称 | 投资总额 | 拟投入募集资 | | --- | --- | --- | --- | | | 年产1,000kg抗体产业化建设项目 | 160,151.70 | 120 | | 2 | 抗体药物研发项目 | 100,000.00 | 100 | | 3 | 补充流动资金 | 78,000.00 | 78 | | | 合计 | 338,151.70 | 298 | 上市首日，迈威生物就跌破 ...