登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：688062 证券简称：迈威生物 公告编号：2025-060 迈威（上海）生物科技股份有限公司 自愿披露关于7MW3711在2025年 欧洲肿瘤内科学会（ESMO）以海报形式 报告数据及最新进展的公告 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： 1、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"）靶向B7-H3的抗体偶联新药 7MW3711将在2025年欧洲肿瘤内科学会（ESMO）大会中以海报形式报告在晚期实体瘤患者中的I/II期 临床研究数据及最新进展：截至2025年9月15日，在4.0mg/kg或以上剂量组的54例可肿评患者中，共有 19例患者达到部分缓解（PR）或完全缓解（CR）。在4.0mg/kg或以上剂量组的7例可肿评食管癌 （EC）患者中，ORR为42.9%，DCR为100.0%。在4.0mg/kg剂量组（每2周给药1次）的可肿评肺癌患者 中，10例小细胞肺癌（SCLC）和13例肺鳞癌（Sq-NSCLC）的客观缓解 ...

Investment Rating - The report maintains a "Buy" rating for the company [5] Core Insights - 9MW3811, an IL-11 monoclonal antibody developed by the company, is leading globally in clinical progress and has received clinical access in China, the US, and Australia, with completed Phase I trials showing good safety [2][17] - The company has licensed global development and commercialization rights for 9MW3811 (excluding Greater China) to Calico Life Sciences, receiving a non-refundable upfront payment of $25 million and potential milestone payments up to $571 million [2][36] - The market potential for treating pathological scars, including hypertrophic scars and keloids, is significant, with the US market projected to grow from $10.3 billion in 2020 to $12.3 billion in 2025, and further to $18.6 billion by 2030 [40][44] Summary by Sections 1. 9MW3811: Targeting Fibrosis and Aging - 9MW3811 effectively blocks the IL-11/IL-11Ra signaling pathway, addressing unmet needs in fibrosis and aging [2][3] - The mechanism of action for 9MW3811 is well-defined, targeting key aging markers and potentially improving metabolic function and chronic inflammation [3][18] - The product is positioned to address the urgent clinical needs in the pathological scar market, with a projected market size of $5.9 billion in China by 2030 [3][40] 2. Multiple Promising Pipeline Products - 9MW1911, a ST2 monoclonal antibody for COPD, is in Phase Ib/IIa trials with all 80 patients enrolled, aiming for efficacy data by the end of 2025 [4][49] - 9MW2821, a Nectin-4 ADC, is leading globally in clinical progress with promising efficacy data across multiple cancer types, including bladder and triple-negative breast cancer [4][55] - The company is developing additional ADCs and TCE platforms, enhancing its pipeline diversity and potential market impact [4][49] 3. Earnings Forecast and Investment Rating - The revenue forecast for 2025-2027 is maintained at approximately $1.11 billion, $1.24 billion, and $2.09 billion respectively, excluding unrecognized business development payments [5] - The report emphasizes the strong potential of the company's pipeline and maintains a "Buy" rating based on these projections [5]

Investment Rating - The report maintains a "Buy" rating for multiple companies in the pharmaceutical and biotech industry, indicating a positive outlook on their growth potential and market performance [6]. Core Insights - The ASCO conference showcased significant advancements in domestic innovative drugs, highlighting the competitive edge of Chinese pharmaceutical companies in the global market [4][12]. - The report emphasizes the clinical value and market potential of several key drugs presented at ASCO, including promising results from various companies [4][12]. Summary by Relevant Sections Domestic Key Research Overview - BaiLi Tianheng's BL-B01D1 demonstrated a 35.3% confirmed overall response rate (cORR) in patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [18]. - DiZhe Pharmaceutical's DZD6008 achieved over 80% overall response rate (ORR) in heavily treated chronic lymphocytic leukemia (CLL) patients, indicating its potential as a new treatment option [4][12]. - FuHong HanLin's PD-L1 ADC showed excellent performance in immune-resistant squamous NSCLC patients, while HLX22 is expected to redefine first-line treatment for advanced gastric cancer [4][12]. - KeLun BoTai's sac-TMT data confirmed long-term survival benefits in third-line EGFR-mutant NSCLC and first-line triple-negative breast cancer (TNBC) [4][12]. - KangNing JieRui's HER2 bispecific ADC demonstrated comparable efficacy and better safety than existing treatments [4][12]. - MaiWei Biotech's 9MW2821 combined with toripalimab is anticipated to be a strong contender in first-line urothelial carcinoma treatment [4][12]. - SanSheng Pharmaceutical updated data on SSGJ-707 for first-line treatment of wild-type NSCLC, with a significant partnership with Pfizer [4][12]. - XinDa Biotech's IBI363 showed potential in activating "cold" tumors, aiming to become a cornerstone drug in immunotherapy [4][12]. - YaSheng Pharmaceutical's Lisaftoclax achieved positive results in patients resistant to venetoclax, filling a treatment gap in myeloid malignancies [4][12]. - ZhengDa TianQing's "DeFu combination" was selected for LBA, potentially offering a new first-line treatment for PD-L1 positive NSCLC [4][12]. - ZeJing Pharmaceutical and ZaiDing Pharmaceutical presented excellent data on ZG006 and ZL-1310 for late-line SCLC treatment, showcasing the global competitiveness of domestic drugs [4][12].

Core Viewpoint - Maiwei Biotech (Shanghai) Co., Ltd. is under investigation by the China Securities Regulatory Commission (CSRC) for suspected short-term trading by its chairman and general manager, Liu Datao, which is stated to not significantly impact the company's daily operations [1][3]. Company Overview - Maiwei Biotech was listed on the Shanghai Stock Exchange's Sci-Tech Innovation Board on January 18, 2022, with an IPO price of 34.8 yuan per share, raising approximately 3.477 billion yuan [3]. - The company focuses on the development of drugs for tumors and age-related diseases, with a product pipeline that includes over 10 drug assets [5]. Financial Performance - The company's revenue for 2023 was approximately 1.28 billion yuan, with a net loss of about 1.059 billion yuan. For the first ten months of 2024, revenue increased to around 1.60 billion yuan, but the net loss remained significant at approximately 864 million yuan [8][9]. - In 2024, the revenue reached about 2.00 billion yuan, reflecting a growth of approximately 56.28% compared to 2023, but the net loss was still around 1.044 billion yuan [8][9]. - In the first quarter of 2025, the company reported revenue of approximately 44.79 million yuan, a decline of 33.70% year-on-year, with a net loss of about 292 million yuan [10]. Investment and Funding - The company plans to raise funds through a listing on the Hong Kong Stock Exchange to support clinical trials and the development of its core products [5]. - The total investment for various projects amounts to approximately 338.15 million yuan, with significant allocations for antibody industrialization and drug research and development [4]. Management and Compensation - Liu Datao received a total compensation of approximately 31.78 million yuan in 2023, which included direct salary and substantial stock-based payments [11][12]. - For the first ten months of 2024, Liu's compensation was about 27.05 million yuan, indicating a high level of executive pay despite the company's ongoing losses [11].

Core Viewpoint - The company, Maiwei Biotech, is actively advancing its innovative drug pipeline and has announced a capital increase for its wholly-owned subsidiary, Jiangsu Taikang Biopharmaceutical Co., Ltd, to enhance its operational capabilities and financial strength [15][18][20]. Financial Data - The company reported that its first-quarter financial statements are not audited [3]. - The company has a total of 16 core products in various stages of development, including 12 innovative drugs and 4 biosimilars, focusing on oncology and age-related diseases [5]. Drug Development Progress - The innovative drug 9MW2821 has been included in the list of breakthrough therapies by the National Medical Products Administration (NMPA) and is undergoing clinical trials for multiple cancer types, with over 800 patients enrolled [5][6]. - The drug 9MW1911, targeting chronic obstructive pulmonary disease (COPD), has completed its Phase Ib/IIa clinical trial with 80 patients and is preparing for a larger Phase II trial [6]. - The drug 9MW3011, aimed at treating polycythemia vera (PV), has initiated its first patient enrollment in a Phase Ib clinical study and is set to begin a Phase II study in the U.S. [7]. - The company is also developing 1MW5011 for osteoarthritis, which is currently in Phase II clinical trials [8]. Market Potential - The global market for COPD is projected to reach $60 billion by 2032, with significant growth expected in China [6]. - The company’s innovative drugs are positioned to address unmet medical needs in various therapeutic areas, including oncology and respiratory diseases, indicating a strong market potential [5][6][7]. Capital Increase - The company plans to increase the capital of Jiangsu Taikang Biopharmaceutical by 400 million yuan, raising its registered capital from 480 million yuan to 880 million yuan [16][18]. - This capital increase has been approved by the company's board and does not require shareholder approval, ensuring a streamlined process for enhancing the subsidiary's financial strength [17][20]. Academic and Strategic Collaborations - The company is actively participating in academic conferences and has published research on its drug candidates, showcasing its commitment to innovation and collaboration in the biopharmaceutical field [10]. - Strategic partnerships with AI technology firms are being pursued to enhance drug development efficiency and address unmet clinical needs [10].