证券代码：688062 证券简称：迈威生物 公告编号：2025-026 迈威（上海）生物科技股份有限公司 自愿披露关于迈粒生®获得国家药品监督管理局 批准上市的公告 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： 近日，迈威（上海）生物科技股份有限公司（以下简称"公司"）全资子公 司江苏泰康生物医药有限公司提交的注射用阿格司亭α（商品名：迈粒生®，曾用 名：注射用重组（酵母分泌型）人血清白蛋白-人粒细胞集落刺激因子（I）融合 蛋白，产品代号：8MW0511）上市申请获得国家药品监督管理局批准，适用于 成年非髓性恶性肿瘤患者在接受容易引起发热性中性粒细胞减少症的骨髓抑制 性抗癌药物治疗时，使用本品降低以发热性中性粒细胞减少症为表现的感染发生 率。迈粒生®为公司首个创新药上市品种，亦是首个国内上市的采用白蛋白长效 融合技术开发的 G-CSF 药物。现将相关情况公告如下： 一、药品基本情况 药品名称：注射用阿格司亭α 剂型：注射剂 规格：20mg/瓶 受理号：CXSS2300099（药品注册证书尚在制证中） 适应 ...

Group 1 - The innovative pharmaceutical ETF (560900) has seen a 2.20% increase as of May 29, 2025, with significant trading volume [1] - The CSI Innovative Pharmaceutical Industry Index (931152) rose by 2.32%, with notable gains from constituent stocks such as Zhixiang Jintai (688443) up 8.91%, Sangfor Technologies (688336) up 7.41%, and Maiwei Biotech (688062) up 5.78% [1] - Over the past two weeks, the innovative pharmaceutical ETF (560900) has accumulated a 3.94% increase, ranking it among the top comparable funds [2] Group 2 - CITIC Securities believes that leading innovative pharmaceutical companies have entered a profit phase, with potential for nonlinear profit explosions as commercialization expands [2] - The investment opportunities in the innovative pharmaceutical sector are linked to the clinical progress of molecules under research and the entire commercialization phase, which can last up to ten years [2] - The innovative pharmaceutical ETF closely tracks the CSI Innovative Pharmaceutical Industry Index, which selects no more than 50 representative listed companies involved in innovative drug research and development [2] Group 3 - Morgan Asset Management is integrating its "Global Vision Investment Technology" product line to help investors capitalize on quality technology companies amid a new wave of AI-driven technological advancements [2] - Various actively managed funds focus on emerging industry trends, including the Morgan Emerging Power Fund and the Morgan Smart Connectivity Fund, which targets opportunities in artificial intelligence [3] - The Morgan Hang Seng Technology ETF (513890) and the Morgan CSI Innovative Pharmaceutical Industry ETF (560900) provide passive investment options for technology and innovative pharmaceutical sectors, respectively [3]

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]

论上市公司的ESG的风险点， 上市公司ESG暴露出十大风险问题， 一是生产安全与污染排放，风险表现在制造业、采矿业等高危行业易发生安全事故（如火灾、爆炸）或污染物超标排放（废气、废水、固废）。如，2024年 一季度制造业安全风险事件占比超70%，陕西煤业因生产安全问题被处罚23次。 二是资源利用与绿色转型压力，风险表现在高能耗企业面临碳排放配额收紧、环保技术升级压力。若未能实现减污降碳协同发展，可能触发政策处罚或市场 准入限制。 三是消费者权益侵害，风险表现在虚假宣传、产品质量问题、服务承诺不兑现等。如，劲仔食品因"深海小鱼"宣传争议被质疑误导消费者，引发舆论危机； 拼多多、京东2024年三季度因虚假营销被投诉283起，占社会风险事件的近1/3。 经深入研究和论证， #论企业社会责任# 王连升认为， 上市公司ESG（环境、社会、治理）风险是企业在可持续发展过程中面临的核心挑战，涉及合规性、声誉、运营稳定性等多方面。 八是金融行业连带风险，风险表现在银行信贷管理漏洞、保险业务违规可能引发系统性风险。如，2024年三季度，工商银行、中国银行等6家银行因信贷管 理不到位被罚，涉及风险事件274起。 九是监管趋严与合 ...

Group 1 - The recombinant protein sector experienced a decline of 1.53%, ranking among the top declines in concept sectors as of the market close on May 26 [1][2] - Within the recombinant protein sector, notable declines were observed in companies such as Sanofi (三生国健) and Yipin Pharmaceutical (一品红), while a few companies like ST Wanfang (*ST万方) and Xilong Science (西陇科学) saw increases of 3.19% and 2.76% respectively [1][2] Group 2 - The recombinant protein sector faced a net outflow of 276 million yuan, with 33 stocks experiencing net outflows, and 17 stocks seeing outflows exceeding 10 million yuan [2] - The stock with the highest net outflow was Sanofi (三生国健), which had a net outflow of approximately 46.36 million yuan, followed by companies like Betta Pharmaceuticals (贝达药业) and Xilong Science (西陇科学) with net outflows of 32.77 million yuan and 29.11 million yuan respectively [2][3] Group 3 - The top gainers in the recombinant protein sector included ST Wanfang (*ST万方) and Kaiyin Technology (凯因科技), which saw net inflows of 9.82 million yuan and 11.86 million yuan respectively [3] - Other companies with significant net inflows included Guoyao Modern (国药现代) with 14.46 million yuan and Rejing Biological (热景生物) with 35.44 million yuan [3]

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].