Investment Rating - The report indicates a positive investment outlook for the pharmaceutical and biotechnology industry, particularly focusing on innovative drugs and their potential in the market [1]. Core Insights - The report highlights the significant achievements of domestic innovative drugs showcased at the upcoming ASCO 2025 conference, emphasizing the growing innovation capabilities of Chinese pharmaceutical companies [6][7]. - A strategic collaboration between 3SBio and Pfizer regarding the PD-1/VEGF dual antibody has been established, which includes a global licensing agreement with potential payments up to $4.8 billion based on development milestones and sales performance [2][6]. - Three domestic Class 1 innovative drugs have been approved for market launch, targeting prevalent diseases such as influenza, cancer, and diabetes, marking a critical step in the innovation and internationalization of domestic original drugs [2][6]. Market Performance Review - During the period from May 17 to May 24, the Shanghai Composite Index closed at 3348.37, down 0.57%, while the pharmaceutical industry index rose by 1.78%, ranking first among 31 primary industry indices [1][12]. - The weekly performance of various sectors within the pharmaceutical industry showed positive growth, with notable increases in chemical preparations (3.49%), biological products (1.74%), and medical services (1.42%) [1][12]. Upcoming Events - The ASCO annual meeting, a major international conference in oncology, is scheduled to take place from May 30 to June 3, 2025, in Chicago, where numerous innovative research results from domestic companies are expected to be presented [6][7]. Key Companies to Watch - The report suggests focusing on companies with strong innovation capabilities, including Heng Rui Medicine, Innovent Biologics, BeiGene, and 3SBio, as they are expected to showcase significant advancements at ASCO 2025 [7][19]. - It also recommends monitoring companies involved in high-end medical devices and those benefiting from market concentration in chain pharmacies and comprehensive medical services [8][19].

Core Viewpoint - Maiwei Biotech has not achieved profitability since its IPO three years ago, facing regulatory scrutiny due to declining product shipment volumes, slow hospital access, and debt repayment pressures [2][3][5]. Financial Performance - As of the end of 2024, Maiwei Biotech's short-term borrowings and long-term borrowings due within one year amount to 1.035 billion yuan [3]. - The company reported a net loss of approximately 1.044 billion yuan for 2024, with cumulative losses exceeding 3 billion yuan from 2022 to 2024 [3][4]. - The cash and cash equivalents balance is approximately 1.228 billion yuan, indicating a tight liquidity situation [3]. Product Performance - The shipment volume for Junmaikang in 2024 was 48,821 units, a decrease of 66.61% year-on-year, while Maiweijian shipped 12,530 units with 75 hospitals approved [5]. - The slow market access for Maiweijian is attributed to its limited approved indications compared to the original drug, which has three approved indications [7]. Strategic Initiatives - The company plans to address short-term debt pressures by optimizing revenue structure and matching debt maturities, aiming to reduce reliance on external financing [3][9]. - Maiwei Biotech is pursuing a Hong Kong IPO to enhance liquidity, with the application submitted in January 2025 [9][10]. Regulatory Issues - The chairman of Maiwei Biotech is under investigation by the China Securities Regulatory Commission for suspected insider trading, which may impact the IPO process [10].

迈威（上海）生物科技股份有限公司 自愿披露关于多项临床研究成果获选 2025 年美国临床肿瘤学会（ASCO）年会报告的公告 证券代码：688062 证券简称：迈威生物 公告编号：2025-025 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"） 将在 2025 年 5 月 30 日-6 月 3 日于芝加哥举行的 2025 年美国临床肿瘤学会 （ASCO）年会中，以口头报告形式公布靶向 Nectin-4 ADC 创新药 9MW2821 （Bulumtatug Fuvedotin，BFv）联合特瑞普利单抗用于局部晚期或转移性尿路上 皮癌的 Ib/II 期临床研究数据，并以壁报形式公布靶向 B7-H3 ADC 创新药 7MW3711 及靶向 Trop-2 ADC 创新药 9MW2921 临床研究数据。 一、大会入选项目 1、9MW2821 将在 2025 年 ASCO 年会中以口头报告形式与参会专家进行交 流针对与特瑞普利单抗联合治疗局部晚期或转移 ...

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 ...

A股生物制品板块短线拉升，三生国健涨超10%，诺诚健华、荣昌生物、迈威生物、凯因科技、智翔金 泰等跟涨。 ...