Industry Investment Rating - The industry investment rating is "Outperform the Market" and is maintained [2] Core Viewpoints - The report highlights that Maiwei Biotech has achieved two licensing agreements, which will enhance cash flow and may indicate a turning point in its operations [5][14] - The pharmaceutical and biotechnology sector has seen a 1.6% increase this week, underperforming the CSI 300 index by 0.35 percentage points, ranking 23rd among 31 sub-industries [7][20] - The report emphasizes the accelerating trend in licensing out Chinese innovative drugs, with the total licensing amount exceeding 51.9 billion USD in 2024, marking a 27.4% year-on-year increase [18][19] Summary by Sections Weekly Insights - Maiwei Biotech's recent licensing agreements include a 25 million USD upfront payment and potential milestone payments totaling up to 571 million USD with CALICO Life Sciences for IL-11 targeted therapy, and a 3.8 billion CNY upfront payment with Qilu Pharmaceutical for 8MW0511 [5][14][15] - The report notes that the cash flow issues for Maiwei Biotech are expected to be significantly alleviated due to these agreements, with further business development opportunities anticipated [6] Subsector Performance - The pharmaceutical and biotechnology sector increased by 1.6% this week, with all sub-sectors showing growth. The hospital sector had the highest increase at 3.92% [7][24] - The report identifies key investment opportunities in various subsectors, including innovative drugs, medical devices, and medical consumables, with specific companies recommended for investment [8][28][29][30] Recommended and Benefiting Stocks - Recommended stocks include Innovent Biologics, Hengrui Medicine, and medical device companies such as YK Medical and Mindray Medical [8][31] - Benefiting stocks in the innovative drug sector include companies like Zai Lab, BeiGene, and others in both A-shares and H-shares [8][34][35] Market Trends - The report indicates that the innovative drug sector is expected to continue its upward trajectory, driven by strong clinical data and increased business development activities [28] - The medical device sector is projected to benefit from government policies promoting equipment upgrades, with a significant increase in procurement expected in the second quarter of 2025 [29][30]

Core Viewpoint - The company has made significant licensing agreements that enhance cash flow and pave the way for future commercialization of its products, including the injection of Agonist α and IL-11 targeted therapy drugs [1][2]. Group 1: Financial Impact - The total upfront payments from the two transactions amount to over 560 million RMB (3.8 billion + 250 million), which alleviates the company's financial pressure, with an estimated cash balance of approximately 1.23 billion RMB in 2024 [2]. - The agreements include a maximum total transaction amount of 500 million RMB and a tiered royalty percentage based on net sales, which will further support the company's financial health [1]. Group 2: Technological Validation - The two business development targets (8MW0511 and 9MW3811) are self-developed by the company, validating its long-acting fusion protein technology and LALA modification technology's competitive edge [3][4]. - 8MW0511 is the first approved long-acting G-CSF in China, utilizing albumin fusion technology to avoid the toxicity risks associated with PEG modification, demonstrating low immunogenicity and high production efficiency [3]. - 9MW3811 employs LALA modification technology to reduce potential toxicity risks and has shown a long half-life in clinical data, indicating significant market potential in diseases like pulmonary fibrosis [4]. Group 3: Core Assets and Future Potential - The company possesses a proprietary technology platform in the ADC field, with multiple targets and new payloads, showing promising clinical data in combination therapies [5]. - In the TCE field, the company is optimizing target selection and spatial design to reduce cytokine release syndrome (CRS) risks, with preclinical models demonstrating significant tumor suppression effects [5]. - Collaborations with AI companies are being utilized to accelerate target screening and evaluation, enhancing the company's research capabilities [5]. Group 4: Revenue Forecast - The company projects revenues of 851 million, 1.514 billion, and 2.08 billion RMB for 2025-2027, with year-on-year growth rates of 325.97%, 77.91%, and 37.38% respectively [6]. - The expected net profit for the same period is projected to be -591 million, -280 million, and 104 million RMB, with growth rates of 43.4%, 52.65%, and 137.14% respectively [6].

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].

迈威生物(688062)日前对外表示，公司有多项在研品种处于关键注册临床研究阶段。公司核心在研管线 9MW2821已开展3项III期临床，其中宫颈癌为全球首个进入III期的同靶点药物。 迈威生物是一家全产业链布局的创新型生物制药公司，公司一季报显示，公司拥有16个处于临床前、临 床或上市阶段的管线品种，包括12个创新药，4个生物类似药，专注于肿瘤和年龄相关疾病，如免疫、 骨疾病、眼科等领域。其中，已上市品种3个，处于上市许可审评阶段品种1个，提交药品上市许可申请 前（pre-NDA）沟通交流会议申请阶段的品种1个，处于III期关键注册临床阶段品种2个，处于其他不同 临床阶段品种9个。 其中，靶向Nectin-4 ADC（9MW2821）是迈威生物的核心管线。据悉，9MW2821于2025年1月再度被 国家药品监督管理局（NMPA）药品审评中心纳入突破性治疗品种名单，适应症为联合PD-1单抗用于治 疗既往未经系统治疗的、不可手术切除的局部晚期或转移性尿路上皮癌，于2025年2月获得NMPA批准 开展联合注射用JS207用于晚期实体瘤的治疗的临床研究。 目前，9MW2821涉及的适应症方向主要有尿路上皮癌（UC） ...

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