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迈威生物(688062) - 迈威生物投资者关系活动记录表(2024年05月01)
2024-05-31 09:17
证券代码:688062 证券简称:迈威生物 迈威(上海)生物科技股份有限公司 投资者关系活动记录表 编号:2024-05-01 特定对象调研 □分析师会议 □媒体采访 □业绩说明会 投资者关系 活动类别 □新闻发布会 路演活动 □现场参观 其他 证券公司策略会 参与单位 中泰证券、东方证券、国海证券、国信证券、东吴基金、兴业基 金、丹羿投资、西部证券、南华基金、朱雀基金、东海证券资管、 玖鹏资产、东海证券自营、摩根、大朴资产、古曲基金、蜂巢基 金、深梧资产、国泰君安资管、中信建投证券、中银基金、中银资 管、乾惕投资、冲积资产、华宝基金、国华兴益保险、国泰基金、 ...
迈威生物:9MW2821亮相ASCO,创新研发顺利
GF SECURITIES· 2024-05-30 04:01
Investment Rating - The investment rating for the company is "Buy," indicating an expected stock performance that will exceed the market by more than 15% over the next 12 months [3][18]. Core Views - The company has successfully showcased its innovative drug 9MW2821 at the 2024 ASCO conference, highlighting its potential in treating various solid tumors [18]. - The company is progressing well with its research pipeline, with several products entering commercialization, including three biosimilars [18]. - Revenue forecasts for the company are optimistic, with projected revenues of 241 million in 2024 and 1,007 million in 2025, reflecting significant growth rates of 88.3% and 318.3% respectively [18][19]. Financial Summary - The company reported a revenue of 128 million in 2023, with a substantial growth rate of 361% compared to the previous year [19]. - The projected EBITDA for 2024 is -956 million, indicating ongoing investment in research and development [19]. - The net profit for 2023 was -1,059 million, with expectations of a slight improvement to -1,094 million in 2024 [19]. Research and Development - The company is advancing its innovative antibody-drug conjugate platform, with multiple candidates in clinical trials [18]. - The safety profile of 9MW2821 shows common treatment-related adverse events such as leukopenia and anemia [18]. Market Position - The company is positioned to capitalize on the growing market for innovative therapies, with a focus on oncology [18]. - The company has received regulatory recognition for several of its products, enhancing its competitive edge in the market [18].
迈威生物:优质ADC平台型公司,多适应症临床数据良好
Tianfeng Securities· 2024-05-26 06:30
| --- | --- | --- | --- | |-----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|------------------------------------------------------| | | 迈威生物( 688062 ) | | 证券研究报告 2024 年 05 月 26 日 | | | | 投资评级 | | | 优质 | ADC 平台型公司,多适应症临床数据良好 | 行业 医药生物 | / 化学制药 | | | | 6 个月评级 | 买入(维持评级) | | 事 ...
迈威生物:迈威生物关于全资子公司开立募集资金专项账户并签订募集资金专户存储四方监管协议的公告
2024-05-20 09:44
证券代码:688062 证券简称:迈威生物 公告编号:2024-028 迈威(上海)生物科技股份有限公司 关于全资子公司开立募集资金专项账户 并签订募集资金专户存储四方监管协议的公告 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。 一、募集资金基本情况 根据中国证券监督管理委员会出具的《关于同意迈威(上海)生物科技股份 有限公司首次公开发行股票注册的批复》(证监许可[2021]3859 号),公司首次 向社会公开发行人民币普通股 99,900,000 股,每股发行价格为人民币 34.80 元, 募集资金总额为人民币 3,476,520,000.00 元 ,募集资金净额为人民币 3,303,432,172.40 元,其中超募资金金额为人民币 323,432,172.40 元。上述募集资 金已于 2022 年 1 月 10 日全部到位,安永华明会计师事务所(特殊普通合伙)对 公司本次公开发行新股的资金到位情况进行了审验。 为规范公司募集资金管理和使用,保护投资者权益,公司设立了相关募集资 金专项账户。募集资金到账后,已全部存放 ...
迈威生物:迈威生物自愿披露关于9MW2821用于三阴性乳腺癌适应症(TNBC)临床研究进展的公告
2024-05-12 07:34
证券代码:688062 证券简称:迈威生物 公告编号:2024-027 迈威(上海)生物科技股份有限公司 自愿披露关于 9MW2821 用于三阴性乳腺癌适应症 (TNBC)临床研究进展的公告 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: 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") 采用自主知识产权研发的创新药 9MW2821 目前针对尿路上皮癌、宫颈癌、食管 癌、乳腺癌等多个适应症正在开展多项临床研究。近日,9MW2821 联合免疫检 查点抑制剂治疗三阴性乳腺癌适应症(TNBC)的临床试验申请已获得国家药品 监督管理局受理。根据目前单药治疗的临床数据显示,在接受 1.25mg/kg 剂量治 疗并可肿瘤评估的 20 例局部晚期或转移性三阴性乳腺癌受试者中,客观缓解率 (ORR)和疾病控制率(DCR)分别为 50%和 80%。为广大投资者进一步了解 上述研究临床试验数据的情况,现将相关临床试验结果数据公告如下: 一、药品基本情况 9MW2821 为迈威生物靶向 Nectin-4 的定点 ...
进入商业化时代,ADC管线潜力十足
INDUSTRIAL SECURITIES· 2024-05-06 07:32
#summary# ⚫ 事件:公司公布 2023 年年报,实现营业收入 1.28 亿元(同比+361%), 实现归母净利润-10.53 亿元(22 年同期为-9.55 亿元),实现扣非归母净利 润-10.60 亿元(22 年同期为-9.67 亿元)。公司公布 2024 年一季报,实现 营业收入 0.68 亿元(同比+1572%),实现归母净利润-2.06 亿元(23 年同 期为-2.41 亿元),实现扣非归母净利润-2.18 亿元(23 年同期为-2.42 亿 元)。 公司点评报告(带市场行情) #相关报告 relatedReport# 《医药生物行业 2024 年度策略报 告:创新+国际化,攻守兼备,静待 花开》2023-12-05 #分析师: emailAuthor# 孙媛媛 sunyuanyuan@xyzq.com.cn S0190515090001 ⚫ 盈利预测与估值:公司坚持差异化创新和全产业链布局策略,阿达木和地 舒单抗成功实现商业化,管线形成了丰富梯队布局,nectin-4 ADC 有望凭 借差异化的疗效和适应症实现国际化,我们看好公司长期发展,预计公司 2024-2026 年 EPS 分别为- ...
迈威生物(688062) - 迈威生物投资者关系活动记录表(2024年04月01)
2024-04-30 08:14
证券代码:688062 证券简称:迈威生物 迈威(上海)生物科技股份有限公司 投资者关系活动记录表 编号:2024-04-01 特定对象调研 □分析师会议 □媒体采访 业绩说明会 投资者关系 活动类别 □新闻发布会 路演活动 □现场参观 其他 证券公司策略会 参与单位 国联证券、东方证券、德邦证券、海通证券、诺安基金、健顺投 资、东盈投资、嘉实基金、正圆投资、瑞华投资、汇丰晋信、毅木 资产、安信证券、东方基金、红塔红土、中金资管、尚诚资管、东 海资管、龙远投资、开思基金、仙人掌、前海云溪基金、淡水泉、 中邮基金、Point72、蜂巢基金、天风国际、鹤禧投资、中金基 ...
迈威生物(688062) - 2024 Q1 - 季度财报
2024-04-29 10:21
Financial Performance - The company reported a total revenue of 12,198,186.66 RMB for the quarter, with a non-operating loss of 6.98 RMB[4]. - Total operating revenue for Q1 2024 was ¥67,555,138.51, a significant increase of 1,572.42% compared to ¥4,039,353.81 in Q1 2023[36]. - The net loss attributable to the parent company for the first quarter was ¥-205,535,439.79, compared to a loss of ¥-241,682,020.95 in the same period last year, showing an improvement of approximately 14.9%[30]. - Basic and diluted earnings per share for the first quarter were both ¥-0.51, consistent with the previous year's loss of ¥-0.60[30]. - The company reported a net loss attributable to shareholders of ¥205,658,524.39 for Q1 2024[44]. - In Q1 2024, the company reported a net loss of approximately $206.21 million, compared to a net loss of $241.70 million in Q1 2023, representing an improvement of about 14.7%[60]. Assets and Liabilities - Total assets increased to ¥4,641,815,291.15 as of March 31, 2024, up from ¥4,455,048,440.71 at December 31, 2023, representing a growth of approximately 4.2%[23]. - Current liabilities rose to ¥1,051,476,382.89, compared to ¥816,386,767.78 at the end of 2023, indicating an increase of about 28.8%[25]. - Long-term borrowings increased significantly to ¥1,022,315,828.62 from ¥887,715,828.62, reflecting a rise of approximately 15.1%[25]. - The company's total liabilities reached ¥2,246,111,836.00, up from ¥1,881,800,377.46, marking an increase of around 19.4%[25]. - The total equity attributable to shareholders decreased to ¥2,406,709,424.56 from ¥2,583,701,890.99, a decline of about 6.9%[26]. - The company's equity attributable to shareholders decreased by 6.85% from approximately $2.58 billion at the end of 2023 to approximately $2.41 billion at the end of Q1 2024[66]. Cash Flow - Cash received from sales of goods and services was ¥67,054,698.79, slightly down from ¥69,851,466.03 in the first quarter of 2023, a decrease of about 4.0%[30]. - Net cash flow from operating activities for Q1 2024 was -¥330,596,938.03, worsening from -¥152,672,130.25 in Q1 2023[41]. - Cash inflow from investment activities in Q1 2024 was ¥107,716,644.21, compared to ¥60,303,273.40 in Q1 2023[41]. - Cash outflow from investment activities totaled ¥283,505,565.22 in Q1 2024, down from ¥315,063,627.10 in Q1 2023[41]. - Cash inflow from financing activities was ¥1,360,160,000.00 in Q1 2024, significantly higher than ¥237,826,431.33 in Q1 2023[41]. - Net cash flow from financing activities for Q1 2024 was ¥584,440,756.11, compared to ¥170,283,340.69 in Q1 2023[41]. - The ending balance of cash and cash equivalents as of Q1 2024 was ¥1,721,702,106.25, down from ¥2,251,409,951.93 in Q1 2023[41]. Product Development and Market Presence - As of the end of the reporting period, the company had 14 products in clinical or上市 stages, including 10 innovative drugs and 4 biosimilars[17]. - The company has launched three products: Junmaikang®, Mailishu®, and Maiweijian®[11]. - The objective response rate (ORR) for the 9MW2821 drug in the cervical cancer cohort was 40.54%, with a disease control rate (DCR) close to 90%[20]. - The company is focusing on oncology and age-related diseases, with ongoing clinical trials for various treatments[17]. - The company is in the process of expanding its market presence and product lines in the rheumatology and chronic disease sectors[11]. - The company has three products currently on the market, with one in the licensing review stage and three in critical III phase clinical trials[17]. - The company has received FDA approval for its new generation antibody-drug conjugate (ADC) 7MW3711 for clinical trials targeting advanced malignant solid tumors[60]. - A supply and commercialization agreement was established with an Indian pharmaceutical company for the product 9MW0813, granting exclusive rights for import, registration, and sales in India and ten other countries[60]. - The company submitted listing application documents for products 9MW0113 and 9MW0311 in Pakistan, and for 9MW0113 in Indonesia and Egypt, with additional applications in preparation for other countries[60]. - The company’s ADC technology platform IDDC™ was showcased at the World ADC London conference, highlighting multiple ADC products under development[60]. Shareholder Information - The company has a total of 14,938 common shareholders, with the largest shareholder holding 35.18% of the shares[8]. - The top ten shareholders include Haitong Innovation Securities Co., Ltd. with 4,387,633 shares, representing 1.10% of total shares[52]. - The actual controllers of the company are Mr. Tang Chunshan and Ms. Chen Shanna, with several shareholders being controlled by Mr. Tang[46]. - The company has not disclosed any related party relationships among other shareholders[46]. Research and Development - The company has developed new generation ADC drugs based on systematic core patented technologies, enhancing structural uniformity and stability[20]. - Research and development expenses for Q1 2024 were ¥182,152,879.71, slightly increasing from ¥176,998,516.51 in Q1 2023[36]. - R&D investment totaled approximately $182.15 million, accounting for 269.64% of operating revenue, a decrease of 4,112.21 basis points compared to the previous year[66]. Other Financial Information - Government subsidies recognized in the current period amounted to ¥11,319,889.02, primarily from government subsidy income[49]. - The fair value changes and gains from financial asset investments contributed ¥890,100.42 to the current period's profit[49]. - The company has not reported any non-recurring gains or losses from the disposal of non-current assets[49]. - There were no significant changes in the number of shares borrowed and not returned under the margin trading and securities lending program[52]. - The first quarter financial statements are not audited[53]. - The company has not recognized any impairment losses on receivables in the current period[49]. - There are no significant one-time expenses related to discontinued operations reported for the current period[49].
迈威生物: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副总经理、核心技术人员离职及新增核心技术人员的核查意见
2024-04-19 11:16
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 副总经理、核心技术人员离职及新增核心技术人员的核查意见 海通证券股份有限公司(以下简称"海通证券"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"迈威生物"或"公司")首次公开 发行股票并在科创板上市持续督导保荐机构,根据《证券发行上市保荐业务管理 办法》《上海证券交易所科创板股票上市规则》《上海证券交易所上市公司自律 监管指引第 11 号——持续督导》《上海证券交易所科创板上市公司自律监管指 引第 1 号——规范运作》等有关规定,对公司副总经理、核心技术人员离职及新 增核心技术人员事项进行了核查,具体情况如下: 一、副总经理、核心技术人员离职的具体情况 公司副总经理、核心技术人员张锦超先生因个人原因申请辞去所任职务,其 负责的工作由公司研发总裁 HAI WU(武海)先生负责,于近日完成工作交接, 并办理完毕离职手续。离职后,张锦超先生不在公司及所有子公司担任任何职务, 将不再被认定为核心技术人员。 截至本核查意见签署日,张锦超先生直接持有公司股份 4,000,000 股,通过 公司员工持股平台宁波梅山保税港区中骏建隆投资合伙企业( ...
迈威生物:迈威生物关于公司副总经理、核心技术人员离职及新增核心技术人员的公告
2024-04-19 11:14
证券代码:688062 证券简称:迈威生物 公告编号:2024-024 迈威(上海)生物科技股份有限公司 关于公司副总经理、核心技术人员离职及新增核心 技术人员的公告 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: 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") 董事会近日收到公司高级管理人员、核心技术人员张锦超先生的书面辞职报告。 张锦超先生因个人原因申请辞去所任职务,辞任后将不再担任公司及所有子公司 任何职务,将不再被认定为核心技术人员。 张锦超先生与公司签署了相关协议对其应承担的保密义务和竞业限制义 务作出了约定,其在任职期间参与研究并申请的专利均为职务成果,相应的知识 产权归属于公司,与公司不存在涉及职务成果、知识产权纠纷或潜在纠纷的情形, 其离职不影响公司知识产权权属的完整性。 张锦超先生离职后,其负责的工作将由公司研发总裁 HAI WU(武海) 先生负责,现已完成所负责项目的工作交接。张锦超先生的离职不会对公司整体 研发创新能力、持续经营能力和核心竞争力产生实质性影响。 根据 ...