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迈威生物(688062) - 迈威生物第二届董事会第二十六次会议决议公告
2025-12-08 09:45
证券代码:688062 证券简称:迈威生物 公告编号:2025-075 迈威(上海)生物科技股份有限公司 第二届董事会第二十六次会议决议公告 表决结果:9 票同意,0 票反对,0 票弃权。 本议案尚需提交至 2025 年第三次临时股东大会审议。 (二)审议通过《关于修订部分公司治理制度的议案》 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、董事会会议召开情况 迈威(上海)生物科技股份有限公司(以下简称"公司")第二届董事会 第二十六次会议通知于 2025 年 12 月 3 日以书面方式送达全体董事,于 2025 年 12 月 8 日以现场结合通讯方式召开。会议由董事长刘大涛先生主持,会议应到 董事 9 人,实到董事 9 人。会议的召集、召开程序和方式符合《公司法》等法 律法规以及《迈威(上海)生物科技股份有限公司章程》(以下简称"公司章 程")的有关规定,会议决议合法、有效。 二、董事会会议审议情况 (一)审议通过《关于取消监事会、修订〈公司章程〉及相关议事规则的 议案》 为贯彻落实新修订的《中华人民共和国公司法》及 ...
迈威生物:12月8日召开董事会会议
Mei Ri Jing Ji Xin Wen· 2025-12-08 09:38
每经头条(nbdtoutiao)——处方药变"瘾品":国内首次报告普瑞巴林滥用致成瘾病例,网络平台暴 露"无病历可购药"漏洞,列管与否尚需科学考量 (记者 王晓波) 截至发稿,迈威生物市值为171亿元。 每经AI快讯,迈威生物(SH 688062,收盘价:42.75元)12月8日晚间发布公告称,公司第二届第二十 六次董事会会议于2025年12月8日以现场结合通讯方式召开。会议审议了《关于修订部分公司治理制度 的议案》等文件。 2024年1至12月份,迈威生物的营业收入构成为:医药制造行业占比99.92%,其他业务占比0.08%。 ...
迈威生物(688062) - 迈威生物关于以集中竞价交易方式回购股份进展的公告
2025-12-01 09:46
证券代码:688062 证券简称:迈威生物 公告编号:2025-071 二、 回购股份的进展情况 重要内容提示: | 回购方案首次披露日 | 2025/6/27 | | --- | --- | | 回购方案实施期限 | 年 月 日~2026 年 月 日 2025 6 26 6 25 | | 预计回购金额 | 2,500万元~5,000万元 | | 回购用途 | □减少注册资本 √用于员工持股计划或股权激励 | | | □用于转换公司可转债 | | | □为维护公司价值及股东权益 | | 累计已回购股数 | 43.75万股 | | 累计已回购股数占总股本比例 | 0.11% | | 累计已回购金额 | 2,069.50万元 | | 实际回购价格区间 | 40.61元/股~58.02元/股 | 一、 回购股份的基本情况 迈威(上海)生物科技股份有限公司(以下简称"公司")于 2025 年 6 月 26 日召开第二届董事会第十九次会议,审议通过了《关于以集中竞价交易方式回购 股份方案的议案》,同意公司使用自有资金和/或股票回购专项贷款通过上海证券交 易所交易系统以集中竞价交易方式回购公司已发行的部分人民币普通股(A ...
百利天恒收到里程碑付款;迈威生物披露阻塞性肺病新药临床进展|医药早参
Mei Ri Jing Ji Xin Wen· 2025-11-30 23:17
Group 1 - SystImmune, a subsidiary of BaiLi TianHeng, received a milestone payment of $250 million from Bristol-Myers Squibb, with potential future payments totaling up to $2.5 billion and additional payments of up to $7.1 billion based on specific development, registration, and sales milestones [1] - The milestone payment is expected to significantly enhance cash flow and support research and development efforts, serving as a benchmark case for domestic innovative drugs going global [1] Group 2 - Sanofi Biologics announced that two executives plan to reduce their holdings by up to 18,800 shares each, representing 0.012% of the company's total share capital, due to personal financial needs [2] - The combined share reduction is minimal and is not expected to have a significant direct impact on the market, reflecting a common phenomenon in the A-share market [2] Group 3 - Maiwei Biotech's innovative drug 9MW1911 has completed Phase IIa clinical trials in patients with moderate to severe chronic obstructive pulmonary disease (COPD), showing good safety and tolerability across all dosage groups [3] - The annual incidence of acute exacerbations of COPD decreased by over 30% compared to the placebo group at the recommended dose for Phase IIb studies, with a significant reduction in the proportion of patients experiencing severe exacerbations [3] - These results lay a solid foundation for the Phase IIb study, potentially providing new treatment options for the large COPD patient population and showcasing the R&D capabilities and market potential of domestic innovative drugs in respiratory diseases [3] Group 4 - Novartis announced that the FDA has approved Onasemnogene abeparvovec (Itvisma) for treating spinal muscular atrophy (SMA) in patients aged two and older with confirmed SMN1 gene mutations, making it the first and only gene therapy for this broad population [4] - The unique aspect of this drug is its one-time fixed-dose administration, which does not require adjustments based on age or weight, potentially changing the disease progression fundamentally and alleviating the burden of long-term medication [4] Group 5 - Novo Nordisk has submitted a supplemental new drug application to the FDA for a 7.2 mg dose of semaglutide injection, aimed at controlling long-term weight in obese adults in conjunction with a low-calorie diet and increased physical activity [5] - This move is expected to strengthen Novo Nordisk's leading position in the GLP-1 market and provide better treatment options for obese adults [5]
迈威(上海)生物科技股份有限公司自愿披露关于9MW1911临床研究进展的公告
Shang Hai Zheng Quan Bao· 2025-11-30 19:14
Core Viewpoint - The announcement details the progress of the clinical research for the innovative drug 9MW1911 developed by Maiwei Biotech, highlighting its safety, tolerability, and efficacy in patients with moderate to severe chronic obstructive pulmonary disease (COPD) [2][4]. Group 1: Drug Overview - 9MW1911 is an innovative monoclonal antibody developed using a high-efficiency B lymphocyte screening platform, targeting the ST2 receptor to block the IL33/ST2 signaling pathway [2]. - The drug has completed a Phase IIa clinical study involving 80 patients with moderate COPD, with a Phase IIb trial expected to start in July 2025 after enrolling at least 120 participants [2][3]. Group 2: Clinical Trial Results - The Phase IIa study (9MW1911-C03) was a randomized, double-blind, placebo-controlled trial assessing safety, tolerability, pharmacokinetics, and preliminary efficacy [3]. - Results indicated that all dosage groups of 9MW1911 showed good safety and tolerability compared to the placebo group, with an adverse event rate of 70% versus 85% for the placebo [4]. - The annualized rate of acute exacerbations in moderate COPD patients decreased by over 30% at the recommended Phase IIb dose compared to the placebo, and the rate of severe exacerbations decreased by over 40% [2][4].
突发!500亿锂电隔膜龙头拟收购资产|盘后公告集锦
Xin Lang Cai Jing· 2025-11-30 11:48
Company Focus - Enjie Co., Ltd. plans to acquire 100% equity of Zhongke Hualian, leading to a stock suspension [2] - Canadian Solar Inc. and its controlling shareholder plan to establish a joint venture to adjust their U.S. market operations [3] - Jiarong Technology intends to acquire 100% of Hangzhou Lanan, with stock resuming trading [3] Equity Changes - ST Tianrui's controlling shareholder is planning a change in control, resulting in stock suspension [4] Shareholding Changes & Buybacks - Shanghai Chuangtou intends to reduce its stake in Zhongwei Company by no more than 1% [5] Operations & Performance - China Shenhua's subsidiary successfully completed a 168-hour trial run of its power generation unit, transitioning to commercial operation [6] - Baillie Tianheng received a milestone payment of $250 million from Bristol-Myers Squibb for the iza-bren project [7] - Jiangxi Copper is in the informal offer stage to acquire shares of SolGold Plc [8] - Aorede plans to sign a 635 million yuan computing power procurement agreement [9] - Maiwei Bio's clinical research for 9MW1911 shows significant reductions in acute exacerbation rates for COPD patients [10] - Huayang Co. has launched a high-performance carbon fiber project with an annual production capacity of 200 tons [10] Financing & Capital Increase - Ganfeng Lithium plans to issue $100 million in exchangeable notes to the China-Africa Development Fund [11] Stock Price Fluctuations - Tongyu Communications confirmed normal operations amid stock price fluctuations [12] - Rongji Software reported normal operations despite stock price declines [13] Other - Xianglou New Materials' application for a specific stock issuance has been accepted by the Shenzhen Stock Exchange [15] - JinkoSolar received a prepayment of 220 million yuan for a fire incident at its battery workshop [15] - Dameng Data's general manager has had his detention lifted [15] - Dongpeng Beverage has received approval from the CSRC for its overseas listing [16]
迈威生物创新药9MW1911公布IIa期临床研究结果
Bei Jing Shang Bao· 2025-11-30 09:05
Core Viewpoint - Maiwei Biotech (688062) announced the completion of Phase IIa clinical study for its innovative drug 9MW1911 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) [1] Group 1: Clinical Study Results - The study involved 80 patients with moderate to severe COPD, with a control group of 20 patients receiving a placebo [1] - All dosage groups of 9MW1911 demonstrated good safety and tolerability compared to the placebo [1] - The annualized exacerbation rate of moderate COPD decreased by over 30% at the recommended Phase IIb dose (N=30) compared to the placebo group [1] - The annualized exacerbation rate for severe COPD decreased by over 40% compared to the placebo group [1] - The proportion of patients experiencing severe exacerbations was significantly lower in the treatment group (13.3% vs 35%) compared to the placebo group [1]
迈威生物:创新药9MW1911已完成在COPD患者中的IIa 期临床研究
Mei Ri Jing Ji Xin Wen· 2025-11-30 08:14
Core Viewpoint - Maiwei Biotech (688062.SH) announced the successful completion of Phase IIa clinical trials for its innovative drug 9MW1911 in patients with moderate to severe chronic obstructive pulmonary disease (COPD), demonstrating good safety and tolerability across all dosage groups [1] Group 1: Clinical Research Results - In the recommended dosage for Phase IIb studies, the annual incidence of acute exacerbations in moderate to severe COPD patients was reduced by over 30% compared to the placebo group [1] - The annual incidence of severe acute exacerbations decreased by over 40%, with a significant reduction in the proportion of patients experiencing severe acute exacerbations [1] - The company is actively advancing the Phase IIb clinical research for 9MW1911 in the COPD indication [1]
迈威生物抗ST2单抗创新药9MW1911公布IIa期临床研究结果
Zheng Quan Shi Bao Wang· 2025-11-30 08:02
人民财讯11月30日电,11月30日,迈威生物宣布自主研发的抗ST2单抗创新药(研发代号:9MW1911)已 完成在中重度慢性阻塞性肺疾病(COPD)患者中的IIa期临床研究。研究结果显示,与安慰剂相比, 9MW1911所有剂量组均表现出良好的安全性与耐受性;总体的不良事件发生率与安慰剂组相似 (70%vs85%);在IIb期研究推荐剂量(RP2D)下,中重度COPD急性加重年化发生率较安慰剂组降低超 30%,重度急性加重年化发生率较安慰剂组降低超40%。9MW1911是迈威生物基于高效B淋巴细胞筛选 平台自主研发的抗ST2单抗创新药,属于治疗用生物制品1类,可高亲和力结合ST2受体,从而阻断 IL33/ST2信号通路。 ...
迈威生物(688062.SH):正在积极推进9MW1911在COPD适应症开展的IIb期临床研究
Ge Long Hui A P P· 2025-11-30 07:47
Core Viewpoint - Maiwei Biotech (688062.SH) has completed the Phase IIa clinical study of its innovative drug 9MW1911 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD), showing promising safety and efficacy results compared to placebo [1] Group 1: Clinical Study Results - The Phase IIa study involved 80 patients, with 20 in the placebo group [1] - All dosage groups of 9MW1911 demonstrated good safety and tolerability compared to the placebo [1] - The annualized rate of acute exacerbations of COPD decreased with increasing doses of 9MW1911 [1] Group 2: Efficacy Metrics - In the recommended Phase IIb dose (RP2D) study involving 30 patients, the annualized rate of acute exacerbations in moderate COPD patients was reduced by over 30% compared to the placebo group [1] - The annualized rate of severe acute exacerbations decreased by over 40% compared to the placebo group [1] - The proportion of patients experiencing severe acute exacerbations was significantly lower in the treatment group (13.3%) compared to the placebo group (35%) [1] Group 3: Future Developments - The company is actively advancing the Phase IIb clinical study of 9MW1911 for COPD indications [1]