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迈威生物(688062):由仿及创渐入佳境 ADC深度布局引领潮流
Xin Lang Cai Jing· 2025-05-02 10:39
Group 1 - The company has a rich pipeline focusing on oncology and chronic diseases, with 16 products in the market or clinical stages, including 3 biosimilars that are rapidly increasing in sales [1] - The Nectin-4 ADC has potential for best-in-class (BIC) status, with ongoing phase III clinical trials for both monotherapy and combination therapy, aiming to establish a competitive barrier in the treatment of urothelial carcinoma [1] - The internationalization process is accelerating, with the expansion of biosimilar markets along the "Belt and Road" initiative, laying the foundation for future innovative products to enter the global market [1] Group 2 - The company has completed an integrated layout for research, production, and sales, with three products already on the market and core ADC pipelines entering the registration clinical stage, indicating promising future revenue [2] - Revenue forecasts for 2025, 2026, and 2027 are projected to be 613 million, 1.03 billion, and 1.80 billion respectively, with a reasonable equity value of 13.447 billion, corresponding to a stock price of 33.65 [2] - The company is preparing for a mainboard listing on the Hong Kong Stock Exchange to further promote its internationalization efforts [1]
迈威(上海)生物科技股份有限公司2025年第一季度报告
Shang Hai Zheng Quan Bao· 2025-04-29 06:35
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].
迈威生物:2025一季报净利润-2.92亿 同比下降41.75%
Tong Hua Shun Cai Bao· 2025-04-28 10:32
一、主要会计数据和财务指标 | 报告期指标 | 2025年一季报 | 2024年一季报 | 本年比上年增减(%) | 2023年一季报 | | --- | --- | --- | --- | --- | | 基本每股收益(元) | -0.7300 | -0.5100 | -43.14 | -0.6000 | | 每股净资产(元) | 3.2 | 6.02 | -46.84 | 8.27 | | 每股公积金(元) | 14.91 | 14.91 | 0 | 14.63 | | 每股未分配利润(元) | -12.73 | -9.90 | -28.59 | -7.35 | | 每股经营现金流(元) | - | - | - | - | | 营业收入(亿元) | 0.45 | 0.68 | -33.82 | 0.04 | | 净利润(亿元) | -2.92 | -2.06 | -41.75 | -2.41 | | 净资产收益率(%) | -20.50 | -8.24 | -148.79 | -7.07 | 数据四舍五入,查看更多财务数据>> | 名称 | 持有数量(万股) | 占总股本比 | 增减情况 | | --- ...
迈威生物(688062) - 2025 Q1 - 季度财报
2025-04-28 09:50
Financial Performance - The company's revenue for Q1 2025 was ¥44,788,452.49, representing a decrease of 33.70% compared to ¥67,555,138.51 in the same period last year[4] - The net profit attributable to shareholders was -¥291,728,135.28, worsening from -¥205,658,524.39 year-on-year[4] - The basic and diluted earnings per share were both -¥0.73, compared to -¥0.51 in the same period last year[4] - The net loss for Q1 2025 was CNY 292,457,640.37, compared to a net loss of CNY 206,210,666.06 in Q1 2024, indicating a worsening of 41.8%[27] - The company recorded a negative comprehensive income of CNY 292,498,768.44 for Q1 2025, compared to a negative comprehensive income of CNY 206,087,581.46 in Q1 2024[27] - The total comprehensive income attributable to minority shareholders for Q1 2025 was -729,505.09 RMB, compared to -552,141.67 RMB in Q1 2024, indicating a decline[29] Research and Development - Research and development (R&D) expenses totaled ¥208,545,133.67, an increase of 14.49% from ¥182,152,879.71 in the previous year[4] - R&D expenses accounted for 465.62% of revenue, up by 195.98 percentage points from 269.64% in the previous year[5] - The company continues to invest heavily in clinical trials for multiple research projects, contributing to high R&D expenses[8] - The company is focusing on differentiated innovation in R&D, achieving notable results in its pipeline[12] Clinical Trials and Product Development - The company has 16 core products in various stages, including 12 innovative drugs and 4 biosimilars, focusing on oncology and age-related diseases[11] - The innovative drug 9MW2821 has been included in the breakthrough therapy list by the National Medical Products Administration, targeting advanced urinary tract cancer[12] - Clinical trials for 9MW2821 have enrolled over 800 patients, with three key Phase III trials currently ongoing[12] - The company’s 9MW1911 drug for chronic obstructive pulmonary disease (COPD) has completed the enrollment of 80 patients in Phase Ib/IIa trials and is in the follow-up stage[14] - The company is preparing for a larger sample size Phase II clinical trial for 9MW1911, which is the first drug of its kind to enter clinical trials in China[14] - The company has received clinical trial approval for JS207, aimed at treating advanced solid tumors[12] - The clinical safety and efficacy of 9MW2821 have been validated, with significant potential in treating various cancers[12] - The company’s innovative drug 9MW3011 for treating Polycythemia Vera (PV) has completed the first patient enrollment in an open-label Ib phase clinical study, with plans for a phase II study in the US in the first half of 2025[15] - 9MW3011 is the first targeted TMPRSS6 monoclonal antibody for PV treatment globally, with 78% of patients unable to control hematocrit levels and a significant thrombotic event rate of 34-41%[15] - The company’s product 1MW5011 for osteoarthritis is in phase II clinical trials, with advantages over existing intra-articular therapies, including oral administration and better long-term treatment compliance[17] - The company’s antibody-drug conjugate 7MW3711 has received clinical trial approval for a multi-center study in advanced solid tumors, expected to start in April 2025[17] - The company’s biosimilar drug 9MW0813 has submitted a pre-NDA communication request to the National Medical Products Administration, with a formal NDA submission planned for 2025[17] Financial Position - The total assets at the end of the reporting period were ¥4,191,356,415.53, a decrease of 1.97% from ¥4,275,508,853.05 at the end of the previous year[5] - The equity attributable to shareholders decreased by 18.59% to ¥1,277,151,626.39 from ¥1,568,877,364.27 at the end of the previous year[5] - Total liabilities increased to CNY 2,928,033,610.17, up from CNY 2,719,730,804.72, representing a growth of 7.7%[24] - The company's equity attributable to shareholders decreased to CNY 1,277,151,626.39 from CNY 1,568,877,364.27, a decline of 18.6%[24] - The cash and cash equivalents decreased to CNY 80,860,527.91 from CNY 86,293,283.11, a drop of 6.0%[23] - The company reported cash and cash equivalents of approximately CNY 1.12 billion, a slight decrease from CNY 1.19 billion at the end of 2024[22] Cash Flow - The net cash flow from operating activities was -¥216,616,741.17, an improvement from -¥330,596,938.03 in the same period last year[4] - Cash inflows from operating activities in Q1 2025 totaled 59,382,060.81 RMB, down 34.4% from 90,544,176.33 RMB in Q1 2024[30] - Cash outflows from operating activities in Q1 2025 were 275,998,801.98 RMB, a decrease of 34.5% compared to 421,141,114.36 RMB in Q1 2024[30] - Cash inflows from investing activities in Q1 2025 were 32,155,778.45 RMB, down 70.2% from 107,716,644.21 RMB in Q1 2024[31] - The net cash flow from investing activities for Q1 2025 was -54,977,359.47 RMB, an improvement from -175,788,921.01 RMB in Q1 2024[31] - Cash inflows from financing activities in Q1 2025 amounted to 751,840,000.00 RMB, a decrease of 44.6% from 1,360,160,000.00 RMB in Q1 2024[31] - The net cash flow from financing activities for Q1 2025 was 181,132,528.98 RMB, down 68.9% from 584,440,756.11 RMB in Q1 2024[31] - The ending cash and cash equivalents balance for Q1 2025 was 1,136,965,756.42 RMB, compared to 1,721,702,106.25 RMB at the end of Q1 2024, indicating a decrease of 33.9%[31] Market Presence and Strategy - The company has shipped a total of 418,088 units of its product Mai Li Shu® and has established access in 1,986 hospitals across 30 provinces[19] - The company’s product Mai Wei Jian® was approved for market on March 29, 2024, with 14,320 units shipped by the end of the reporting period[19] - The company has received a drug production license from the Shanghai Municipal Drug Administration, enhancing its capabilities as a marketing authorization holder[20] - The company is actively integrating AI technology into its biopharmaceutical development, partnering with leading AI firms to improve research efficiency[19] - The company is actively expanding its market presence in oncology and respiratory diseases, with a strong emphasis on innovative therapies[12]
迈威生物(688062) - 迈威生物关于对全资子公司泰康生物增资的公告
2025-04-28 09:47
证券代码:688062 证券简称:迈威生物 公告编号:2025-021 迈威(上海)生物科技股份有限公司 关于对全资子公司泰康生物增资的公告 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: 增资标的名称:迈威(上海)生物科技股份有限公司(以下简称"公司" 或"迈威生物")的全资子公司江苏泰康生物医药有限公司(以下简称"泰康 生物")。 资金来源及增资金额:公司拟使用自有资金向泰康生物增资 40,000 万 元。 统一社会信用代码:91321291678341722J 法定代表人:刘大涛 注册资本:48,000 万元人民币 本次增资已经公司第二届董事会第十八次会议审议通过,无需提交股东 大会审议。 本次增资不构成关联交易,亦不构成《上市公司重大资产重组管理办法》 规定的重大资产重组情形,不会改变公司合并报表范围。 一、本次增资概述 泰康生物系公司的全资子公司,按照公司集团化战略部署,公司拟使用自 有资金向泰康生物增资 40,000 万元,增资完成后,泰康生物注册资本由 48,000 万元增至 88,000 万 ...
迈威生物:2025年第一季度净亏损2.92亿元
news flash· 2025-04-28 08:56
迈威生物公告,2025年第一季度营收为4478.85万元,同比下降33.70%;净亏损2.92亿元,去年同期净 亏损2.06亿元。 ...
凯莱英涨停,创新药企ETF(560900)拉升涨近2%,机构:创新药企正处于关键转型期
Xin Lang Cai Jing· 2025-04-24 02:32
Group 1 - The innovative pharmaceutical ETF (560900) has risen by 1.80%, with the underlying index, the China Innovative Drug Industry Index (931152), increasing by 1.60% [1] - Key stocks such as Kailaiying (002821) rose by 10.01%, Maiwei Biotech (688062) by 7.23%, and Rongchang Biotech (688331) by 6.57% [1] - Galaxy Securities indicates that innovative pharmaceutical companies are in a critical transformation period, with Changchun High-tech's R&D investment reaching 2.69 billion yuan in 2024, a year-on-year increase of 11.20%, accounting for nearly 20% of revenue [1] Group 2 - Morgan Asset Management is integrating its "Global Vision Investment Technology" product line to assist investors in capturing investment opportunities in quality tech companies globally [2] - The actively managed Morgan Emerging Power Fund aims to grasp emerging industry trends from a long-term perspective, while the Morgan Smart Connectivity Fund focuses on opportunities in the AI sector [2] - The Morgan Pacific Technology Fund selects quality tech companies in the Pacific region [2] Group 3 - The passive investment options include the Morgan Hang Seng Technology ETF (513890) for exposure to Hong Kong tech assets and the Morgan China Innovative Drug Industry ETF (560900) for Chinese innovative pharmaceutical companies [3] - The Morgan NASDAQ 100 Index Fund provides one-click access to global tech leaders [3]
迈威生物(688062) - 迈威生物2024年年度股东大会决议公告
2025-04-21 10:15
本次会议是否有被否决议案:无 一、 会议召开和出席情况 (一) 股东大会召开的时间:2025 年 4 月 21 日 (二) 股东大会召开的地点:上海市浦东新区李冰路 576 号创想园 3 号楼 103 会议室 证券代码:688062 证券简称:迈威生物 公告编号:2025-020 迈威(上海)生物科技股份有限公司 2024年年度股东大会决议公告 本公司董事会及全体董事保证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: (三) 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及 其持有表决权数量的情况: | 1、出席会议的股东和代理人人数 | 138 | | --- | --- | | 普通股股东人数 | 138 | | 2、出席会议的股东所持有的表决权数量 | 199,591,712 | | 普通股股东所持有表决权数量 | 199,591,712 | | 3、出席会议的股东所持有表决权数量占公司表决权数量的比 | 49.9478 | | 例(%) | | | 普通股股东所持有表决权数量占公司表决权数量的比例(%) | 49 ...
迈威生物(688062) - 北京植德(上海)律师事务所关于迈威(上海)生物科技股份有限公司2024年年度股东大会的法律意见书
2025-04-21 10:04
北京植德(上海)律师事务所 关于迈威(上海)生物科技股份有限公司 2024 年年度股东大会的 法律意见书 植德沪(会)字[2025]0005 号 关于迈威(上海)生物科技股份有限公司 2024 年年度股东大会的 法律意见书 植德沪(会)字[2025]0005 致:迈威(上海)生物科技股份有限公司(贵公司) 北京植德(上海)律师事务所(以下简称"本所")接受贵公司的委托,指 派律师出席并见证贵公司 2024 年年度股东大会(以下简称"本次会议")。 本所律师参加本次会议进行见证,并根据《中华人民共和国公司法》(以下 简称"《公司法》")、《中华人民共和国证券法》(以下简称"《证券法》")、 《上市公司股东会规则》(以下简称"《股东会规则》")、《律师事务所从事 证券法律业务管理办法》(以下简称"《证券法律业务管理办法》")、《律师 事务所证券法律业务执业规则(试行)》(以下简称"《证券法律业务执业规则》") 等相关法律、行政法规、规章、规范性文件及《迈威(上海)生物科技股份有限 公司章程》(以下简称"《公司章程》")的规定,就本次会议的召集与召开程 序、召集人资格、出席会议人员资格、会议表决程序及表决结果等事宜 ...
迈威生物(688062) - 迈威生物2024年年度股东大会会议资料
2025-04-15 09:00
迈威(上海)生物科技股份有限公司 2024 年年度股东大会会议资料 2025 年 4 月 | 2024 年年度股东大会会议须知 2 | | --- | | 2024 年年度股东大会会议议程 4 | | 2024 年年度股东大会会议议案 6 | | 议案一、关于公司《2024 年年度报告》及摘要的议案 6 | | 议案二、关于公司《2025 年度财务预算报告》的议案 7 | | 附件一:2025 年度财务预算报告 8 | | 议案三、关于公司《2024 年度财务决算报告》的议案 9 | | 附件二:2024 年度财务决算报告 10 | | 议案四、关于公司 2024 年度利润分配方案的议案 13 | | 议案五、关于续聘公司 2025 年度审计机构的议案 14 | | 附件三:拟聘会计师事务所的基本情况 15 | | 议案六、关于公司《2024 年度董事会工作报告》的议案 17 | | 附件四:2024 年度董事会工作报告 18 | | 议案七、关于公司《2024 年度监事会工作报告》的议案 25 | | 附件五:2024 年度监事会工作报告 26 | | 议案八、关于公司 2025 年度董事、监事薪酬方案的议 ...