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：2023-12-01 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 西部证券、远希基金、上证资管、长江养老、汇华理财、东吴基 金、泾溪投资、磐泽资产、南土资产、玖鹏资产、国华兴益资管、 非马投资、冲积资产、东证融汇、招商基金、趣时资产、东海证券 自营、辛禧资本、华商基金、新华基金、宏利基金、嘉实基金、东 方红、财通基金、中信建投、惠升基金、彤源投资、长盛基金、国 ...

证券代码：688062 证券简称：迈威生物 公告编号：2023-049 迈威（上海）生物科技股份有限公司 关于变更签字注册会计师的公告 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。 计服务。有逾 15 年审计相关业务的服务经验，具有在制造业、零售行业和医药 行业的上市公司审计的执业经验。 2、诚信记录情况 迈威（上海）生物科技股份有限公司（以下简称"公司"）分别于 2023 年 4 月 6 日、2023 年 4 月 27 日召开了第一届董事会第二十六次会议、2022 年年度股 东大会，审议通过了《关于续聘公司 2023 年度审计机构的议案》，同意续聘安 永华明会计师事务所（特殊普通合伙）（以下简称"安永华明"）为公司 2023 年度审计机构。具体内容详见公司于 2023 年 4 月 7 日在上海证券交易所网站 （www.sse.com.cn）披露的《迈威（上海）生物科技股份有限公司关于续聘公司 2023 年度审计机构的公告》（公告编号：2023-024）。 近日，公司收到安永华明出具的《关于变更迈威（上海）生物科技股份有 ...

证券代码：688062 证券简称：迈威生物 公告编号：2023-048 受理号：CXSS2300099 审批结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查， 决定予以受理。 二、药品其他相关情况 迈威（上海）生物科技股份有限公司 自愿披露关于注射用 8MW0511 新药上市申请 获得受理的公告 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"迈威生物"或"公 司"）全资子公司江苏泰康生物医药有限公司收到国家药品监督管理局核准签发 的《受理通知书》，注射用 8MW0511 的新药上市申请获得受理，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。由于 药品的研发周期长、审批环节多，容易受到一些不确定性因素的影响，本次新药 上市申请能否获得批准存在不确定性，敬请广大投资者谨慎决策，注意防范投资 风险。现将相关情况公告如下： 一、药品基本情况 药品名 ...

证券代码：688062 证券简称：迈威生物 公告编号：2023-047 重要内容提示： 9MW2821 是迈威（上海）生物科技股份有限公司（以下简称"迈威生物" 或"公司"）自主研发的创新药，公司已经向国家药品监督管理局药品审评中心 （以下简称"CDE"）递交了关于"9MW2821 对比研究者选择的化疗治疗既往 接受过含铂化疗和 PD-（L）1 抑制剂治疗的无法手术切除的局部晚期或转移性 尿路上皮癌的随机、开放、对照、多中心Ⅲ期临床研究"的方案并获得同意。公 司即将启动 9MW2821 治疗经铂类化疗和 PD-（L）1 抑制剂治疗的局部晚期或转 移性尿路上皮癌的Ⅲ期临床研究。现将相关情况公告如下： 一、药品基本情况 药品名称：9MW2821 剂型：注射剂 注册分类：治疗用生物制品 1 类 适应症：尿路上皮癌 二、药品的其他相关情况 9MW2821 为迈威生物首款靶向 Nectin-4 的定点偶联 ADC 新药，为公司利 用 ADC 药物开发平台联合自动化高通量杂交瘤抗体分子发现平台两项平台技术 开发的创新品种，是国内同靶点药物中首个开展临床试验的品种。该品种通过具 有自主知识产权的偶联技术连接子及优化的 AD ...

Group 1: Clinical Data and Drug Efficacy - The latest clinical data for Nectin-4 ADC (9MW2821) shows an overall response rate (ORR) of 43.5% and a disease control rate (DCR) of 81.7% among 115 evaluable solid tumor patients [5] - In the 1.25 mg/kg dose group for urothelial carcinoma, the ORR reached 62.2% and the DCR was 91.9% [5] - For cervical cancer, the ORR was reported at 50% and the DCR at 100% in a preliminary study involving 6 evaluable patients [7] Group 2: Market Potential and Growth - The osteoporosis patient population in China exceeds 300 million, with a prevalence rate of 19.2% among individuals over 50 years old [11] - The market for denosumab (迈利舒®) in osteoporosis is projected to reach RMB 7.82 billion by 2030, driven by increased accessibility and favorable clinical outcomes [11] - The company anticipates achieving breakeven or profitability through multiple product lines, including upcoming launches from 2023 to 2026 [14] Group 3: Pipeline and Development - The company has 14 pipeline projects, with 10 being innovative drugs, and is focusing on international collaborations for products like anti-Nectin-4 ADC and anti-B7-H3 ADC [14] - The company is actively pursuing clinical trials for 9MW3811, a monoclonal antibody targeting IL-11, which is currently in Phase I trials in China, Australia, and the US [13] - The ADC platform includes three innovative products in clinical stages: Nectin-4 ADC (9MW2821), Trop-2 ADC (9MW2921), and B7-H3 ADC (7MW3711) [9]

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：2023-10-01 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 东吴证券、广发基金、保银投资、第一北京、永盈基金、金鹰基 金、亘曦资产、银华基金、东方基金、国联基金、重阳投资、趣时 资产、财通基金、磐耀资产、鑫元基金、浙商自营、华泰自营、禧 参与单位 ...

Financial Performance - The company's operating revenue for the current period is CNY 9,550,011.97, representing a year-on-year increase of 1.92%[3] - The net profit attributable to shareholders of the listed company is CNY -259,761,460.08, with a year-to-date loss of CNY -673,286,515.50[3] - The net profit attributable to shareholders after deducting non-recurring gains and losses is CNY -262,156,441.27 for the current period, with a year-to-date loss of CNY -677,691,454.78[3] - Basic and diluted earnings per share for the current period are both CNY -0.65, with a year-to-date figure of CNY -1.68[3] - The total revenue for the year-to-date period increased by 387.22%, primarily due to a licensing agreement with DISC MEDICINE, INC. and sales of the drug Mai Li Shu®[14] - The company reported a net loss of CNY -668,496,734.05 attributable to shareholders, slightly improved from CNY -686,548,898.54 in the previous year[26] - The total comprehensive income for the period was CNY -671,829,240.37, slightly better than CNY -686,570,753.60 in the previous year[26] - The net profit for the first three quarters of 2023 was a loss of ¥676,619,021.82, compared to a loss of ¥692,443,802.24 in the same period last year, showing an improvement of about 2.4%[46] - The company reported a total profit of ¥-676,041,100.24, which is an improvement from ¥-692,443,802.24 in the previous year, indicating a positive change of approximately 2.4%[46] Cash Flow and Liquidity - The cash flow from operating activities is CNY -562,458,858.54 year-to-date[3] - The net cash flow from operating activities was negative at CNY -562,458,858.54, worsening from CNY -507,698,762.84 year-over-year[27] - Cash received from sales and services increased to CNY 90,276,727.22, a substantial rise from CNY 997,350.00 in the same period last year[27] - The cash and cash equivalents at the end of the period decreased to CNY 1,809,447,557.54 from CNY 2,715,179,589.74, reflecting a decline of approximately 33.4%[28] - The company recorded a total cash outflow from investing activities of CNY 732,547,641.13, compared to CNY 1,055,422,462.69 in the previous year[27] - The financing activities generated a net cash inflow of CNY 328,498,573.88, a significant decrease from CNY 3,589,758,174.71 in the previous year[28] - The company received CNY 280,000,000.00 from the recovery of investments, down from CNY 590,000,000.00 year-over-year[27] - Cash and cash equivalents decreased to approximately ¥1.76 billion from ¥2.49 billion year-over-year[40] Assets and Liabilities - The total assets of the company as of September 30, 2023, amount to CNY 4,450,532,150.65, compared to CNY 4,619,475,225.93 at the end of the previous period[19] - The company's inventory as of September 30, 2023, is CNY 152,847,845.26, an increase from CNY 79,049,785.33[19] - The total liabilities increased to CNY 1,536,379,427.68, up from CNY 1,108,864,451.65, representing a growth of approximately 38.5% year-over-year[20] - The company's total equity showed a significant negative balance in retained earnings, amounting to CNY -3,371,203,295.52, compared to CNY -2,697,916,780.02 in the previous year[20] - Total assets as of September 30, 2023, were ¥4.45 billion, a decrease of 3.66% from ¥4.62 billion at the end of the previous year[32] - Equity attributable to shareholders of the listed company decreased by 16.87% to ¥2.92 billion from ¥3.52 billion[32] - The total liabilities and equity amounted to ¥4.45 billion, down from ¥4.62 billion year-over-year[44] Research and Development - Research and development expenses decreased by 30.03% in the current period, with the ratio of R&D expenses to operating revenue decreasing by 734.81 percentage points[15] - Total R&D investment amounted to approximately ¥153.68 million, a decrease of 30.03% year-over-year from ¥494.11 million[32] - R&D investment as a percentage of operating revenue was 1,609.23%, down 734.81 percentage points from the previous year's 496.54%[32] - Research and development expenses were ¥494,110,768.85, slightly decreased from ¥535,195,015.88 in 2022, reflecting a reduction of approximately 7.7%[45] Other Income and Expenses - The company reported non-operating income of approximately ¥2.39 million for the current period, with a total of ¥4.40 million from the beginning of the year to the reporting period[33] - The company received government subsidies totaling approximately ¥1.32 million during the current period, contributing to its non-operating income[33] - The company recorded an investment income of ¥1,366,910.34, up from ¥300,336.67 in the previous year, representing a growth of approximately 354.5%[46] - The financial expenses showed a net income of ¥-26,622,479.36, compared to ¥-23,401,724.74 in the previous year, indicating an increase in financial costs[45] - The company experienced a credit impairment loss of ¥965,231.48, contrasting with a gain of ¥-1,015,242.53 in the previous year, reflecting a significant change in credit quality[46] - The company’s sales expenses surged to ¥161,278,252.49, compared to ¥67,224,930.24 in the previous year, marking an increase of approximately 139.9%[45] - Other comprehensive income after tax was ¥4,789,781.45, compared to ¥5,873,048.64 in the previous year, showing a decrease of about 18.5%[46]

迈威（上海）生物科技股份有限公司 证券代码：688062 证券简称：迈威生物 公告编号：2023-045 迈威（上海）生物科技股份有限公司 关于召开 2023 年半年度暨第三季度 业绩说明会的公告 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、准确性和完整性承担法律责任。 重要内容提示： 会议召开时间：2023 年 10 月 26 日（星期四）上午 10:00-11:00 会 议 召 开 地 点 ： 上 海 证 券 交 易 所 上 证 路 演 中 心 （ 网 址 ： https://roadshow.sseinfo.com/） 会议召开方式：上证路演中心网络互动 投资者可于 2023 年 10 月 19 日（星期四）至 10 月 25 日（星期三）16:00 前登录上证路演中心网站首页点击"提问预征集"栏目或通过公司邮箱 ir@mabwell.com 进行提问。公司将在说明会上对投资者普遍关注的问题进行回 答。 迈威（上海）生物科技股份有限公司（以下简称"公司"）已于 2023 年 8 月 29 日发布公司 2023 年半年度报告，考虑到公司将于 202 ...

重要内容提示： 证券代码：688062 证券简称：迈威生物 公告编号：2023-044 迈威（上海）生物科技股份有限公司 自愿披露关于 2 个品种在 2023 年欧洲肿瘤内科学会 （ESMO）报告数据及其最新进展的公告 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。 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 Nectin-4 的抗体偶联新药 9MW2821 在 ESMO 报告的核心数据：I/II 期临床 研究中，在接受 1.25mg/kg 或以上剂量 9MW2821 治疗并可肿瘤评估的 39 例实 体瘤受试者中，客观缓解率（ORR）和疾病控制率（DCR）分别为 38.5%和 84.6%。 在 1.25mg/kg 剂量组的 18 例尿路上皮癌可肿评受试者中，ORR 和 DCR 分别为 55.6%和 94.4%，这些受试者既往接受过铂类化疗和免疫检查点抑制剂治疗。 截至目前，在 I/II 期临床研究中，在接受 1.25mg/kg 或以上剂量 9MW2821 治疗并可肿瘤评估的 115 例实体 ...

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：2023-09-02 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 中信建投、国海证券、东方证券、华福证券、兴业基金、天治基 金、安信基金、南方基金、天风证券、星石投资、东北证券、汇升 投资、汐泰投资、兴证资管、南土资产、中欧基金、开源证券、鹤 ...