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晚间公告丨8月31日这些公告有看头
Di Yi Cai Jing· 2025-08-31 10:35
Major Events - Huahong Company plans to acquire 97.4988% equity of Huali Micro through a combination of share issuance and cash payment, with stock resuming trading on September 1, 2025, pending shareholder and regulatory approvals [1] - Dongxin Co. intends to invest approximately 211 million yuan in Shanghai Lisan, increasing its stake to 35.87%, as part of a total investment of around 500 million yuan in Lisan Technology [1] - Huaxin Cement is planning to integrate its overseas assets into a subsidiary for potential listing on an overseas stock exchange to enhance financing channels and operational capabilities [2] - *ST Tianmao is voluntarily terminating its A-share listing due to business restructuring uncertainties and will initiate a cash option for shareholders [2] - Meikailong's Vice President Che Guoxing has resigned for personal reasons, with no adverse impact on daily operations [3] - China Rare Earth announced that there are no undisclosed significant matters affecting its stock, despite recent price fluctuations [3] - Maiwei Bio has re-submitted its application for H-share issuance and listing on the Hong Kong Stock Exchange [4][5] Shareholding Changes - Gao Neng Environment's controlling shareholder Li Weiguo plans to reduce his stake by up to 3% to repay debts, with the reduction period set from September 23 to December 22, 2025 [6] - Hu Dian Co.'s senior executive Li Minggui intends to sell up to 0.0083% of the company's shares within three months following the announcement [6] Financing Activities - Maohua Shihua plans to raise no more than 532 million yuan through a private placement at a price of 3.41 yuan per share, with proceeds aimed at enhancing liquidity [7] Major Contracts - Junxin Co.'s subsidiary has signed an investment agreement with the Ministry of Ecology and Natural Resources of Kazakhstan for a solid waste disposal power generation project in Almaty, with a planned processing capacity of at least 2,000 tons per day and an investment of no less than 145 billion tenge (approximately 28 million USD) [8]
迈威生物:9MW3811注射液临床试验申请获受理,重新向香港联交所递交H股发行及上市申请
迈威生物(688062)8月31日晚公告,公司收到国家药品监督管理局(NMPA)签发的《受理通知书》, 9MW3811注射液用于病理性瘢痕适应症的II期临床试验申请已获正式受理。 据介绍,9MW3811是迈威生物自主研发的一款靶向人IL-11的人源化单克隆抗体,属于治疗用生物制品 1类,拥有自主知识产权。9MW3811通过高亲和力结合IL-11,有效抑制IL-11/IL-11Rα信号通路的异常激 活,从而干预纤维化相关疾病的病理进展。其核心优势包括更高的靶点亲和力与信号阻断能力;超过一 个月的长半衰期,更适用于需要长期给药的慢性疾病治疗。 9MW3811目前已在全球获准开展用于晚期恶性肿瘤和特发性肺纤维化的临床研究,并已完成澳洲及中 国I期健康人试验,结果显示其安全性良好、半衰期超过一个月,研发进度处于全球同类靶点领先地 位。迈威生物计划于2025年底启动其用于病理性瘢痕的II期临床试验,成为该适应症领域首批进入临床 阶段的IL-11靶向药物。 针对9MW0321,公司已与巴西、哥伦比亚、新加坡、巴基斯坦、泰国、埃及、秘鲁、沙特阿拉伯等30 个国家签署正式合作协议,除获得巴基斯坦药品监督管理局批准上市外,已向 ...
迈威生物: 迈威生物自愿披露关于9MW3811注射液临床试验申请获得国家药品监督管理局受理的公告
Zheng Quan Zhi Xing· 2025-08-31 10:13
Core Viewpoint - Maiwei (Shanghai) Biotechnology Co., Ltd. has received acceptance from the National Medical Products Administration (NMPA) for the clinical trial application of 9MW3811 injection for the treatment of pathological scars, marking a significant step in the drug's development process [1][2]. Drug Information - Drug Name: 9MW3811 Injection - Application: Clinical trial registration for domestic production - Acceptance Number: CXSL2500751 - Applicant: Maiwei (Shanghai) Biotechnology Co., Ltd. - Approval Conclusion: The application has been accepted according to the Administrative Licensing Law of the People's Republic of China [1]. Mechanism and Efficacy - IL-11 is a cytokine that plays a crucial role in chronic inflammation and fibrosis-related diseases, significantly involved in the fibrotic processes of various organs [1]. - 9MW3811 effectively inhibits the abnormal activation of the IL-11/IL-11Rα signaling pathway, which is critical in the progression of fibrosis-related diseases [1]. - Preclinical studies have shown that 9MW3811 exhibits significant efficacy in models of pulmonary fibrosis and has potential applications in other fibrosis-related diseases [2]. Market Potential - The global patient population for pathological scars is approximately 25 million, with around 7.4 million in China, and the incidence is on the rise, expected to exceed 10 million in China by 2030 [2]. - Targeted therapy against IL-11 presents significant clinical value and market prospects [2]. Development Progress - The company has completed Phase I trials in Australia and China, demonstrating good safety and a half-life exceeding one month, positioning it as a leader in the global development of similar targeted therapies [2]. - The company plans to initiate Phase II clinical trials for pathological scars by the end of 2025, aiming to be among the first IL-11 targeted drugs in this indication [2]. Licensing Agreement - The company has entered into an exclusive licensing agreement with CALICO LIFE SCIENCES LLC, granting CALICO global rights outside Greater China, with an upfront payment of $25 million and potential milestone payments up to $571 million [3]. - CALICO, a subsidiary of Alphabet, focuses on anti-aging therapies, indicating a broad application potential for 9MW3811 in various fibrotic diseases and aging-related conditions [3][4].
迈威生物: 迈威生物关于重新向香港联交所递交H股发行并上市的申请并刊发申请资料的公告
Zheng Quan Zhi Xing· 2025-08-31 10:13
迈威(上海)生物科技股份有限公司(以下简称"公司")已于 2025 年 8 月 29 日向香港联合交易所有限公司(以下简称"香港联交所")重新递交了发 行 H 股股票并在香港联交所主板挂牌上市(以下简称"本次发行")的申请, 并于同日在香港联交所网站刊登了本次发行的申请资料。该申请材料为公司按 照香港证券及期货事务监察委员会(以下简称"香港证监会")及香港联交所 的要求编制和刊发,为草拟版本,其所载资料可能会适时作出更新及修订,投 资者不应根据其中的资料作出任何投资决定。 本次发行如果最终实施,发行对象将仅限于符合相关条件的境外投资者及 依据中国相关法律法规有权进行境外证券投资的境内合格投资者,公司将不会 在境内证券交易所的网站和符合监管机构规定条件的媒体上刊登该申请资料, 但为使境内投资者及时了解该等申请资料披露的本次发行以及公司的其他相关 信息,现提供该申请资料在香港联交所网站的查询链接供查阅: 证券代码:688062 证券简称:迈威生物 公告编号:2025-046 迈威(上海)生物科技股份有限公司 关于重新向香港联交所递交 H 股发行并上市的申请 并刊发申请资料的公告 本公司董事会及全体董事保证本公告内 ...
迈威生物: 迈威生物自愿披露关于地舒单抗注射液获得巴基斯坦上市许可的公告
Zheng Quan Zhi Xing· 2025-08-31 10:13
Core Viewpoint - Maiwei Biotech has received registration approval for two biosimilar drugs, 9MW0311 and 9MW0321, from the Drug Regulatory Authority of Pakistan, marking a significant milestone in the company's global commercialization strategy [1][4]. Drug Information - 9MW0311 (Rexeva) is approved for osteoporosis treatment in postmenopausal women at high risk of fractures, with a specification of 60mg and registration number 127267 [1]. - 9MW0321 (Denosu) is approved for treating giant cell tumor of bone (GCTB) in adults and adolescents, with a specification of 120mg and registration number 127268 [2]. Market Potential - Pakistan, with a population of 240 million, represents a significant emerging market for pharmaceuticals, driven by increasing medical demand [1]. - The global market for denosumab drugs for osteoporosis treatment is projected to reach $1.317 billion in 2024 [2]. International Expansion - The company has signed formal cooperation agreements with 30 countries, including Brazil, Colombia, and Indonesia, to expand the market for 9MW0311 and 9MW0321 [3]. - Registration applications for these drugs have been submitted to five additional countries, including Jordan and Egypt, with more applications in preparation [3]. Competitive Advantage - The approval of these biosimilars enhances the company's core competitiveness and supports its ongoing efforts to penetrate emerging markets [4].
迈威生物重新向香港联交所递交H股发行并上市的申请
Bei Jing Shang Bao· 2025-08-31 10:09
北京商报讯(记者丁宁)8月31日晚间,迈威生物(688062)发布公告称,公司已于8月29日向香港联交所重 新递交了发行H股股票并在香港联交所主板挂牌上市的申请,并于同日在香港联交所网站刊登了本次发 行的申请资料。该申请材料为公司按照香港证券及期货事务监察委员会及香港联交所的要求编制和刊 发,为草拟版本,其所载资料可能会适时作出更新及修订,投资者不应根据其中的资料作出任何投资决 定。 ...
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
2025-08-31 09:45
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: | 回购方案首次披露日 | 2025/6/27 | | --- | --- | | 回购方案实施期限 | 年 月 年 月 日 2025 6 26 日~2026 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 | 0万股 | | 累计已回购股数占总股本比例 | 0% | | 累计已回购金额 | 0万元 | | 实际回购价格区间 | 0元/股~0元/股 | 一、 回购股份的基本情况 证券代码:688062 证券简称:迈威生物 公告编号:2025-047 迈威(上海)生物科技股份有限公司 关于以集中竞价交易方式回购股份进展的公告 二、 回购股份的进展情况 根据《上市公司股份回购规则》《上海证券交易所上市公司自律监管指引第 7 号——回购股份》等相关规定,公司在回购股份期间,应当在每个月的 ...
迈威生物(688062) - 迈威生物自愿披露关于9MW3811注射液临床试验申请获得国家药品监督管理局受理的公告
2025-08-31 09:45
证券代码:688062 证券简称:迈威生物 公告编号:2025-048 迈威(上海)生物科技股份有限公司 自愿披露关于 9MW3811 注射液临床试验申请 获得国家药品监督管理局受理的公告 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。 申请人:迈威(上海)生物科技股份有限公司 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、药品的其他相关情况 白介素-11(IL-11)是一种在慢性炎症和纤维化相关疾病中发挥关键作用的 细胞因子,广泛参与肺、皮肤、肾脏和肝脏等多个器官的纤维化进程,并与衰老 相关疾病的发生密切相关(Nature,2024)。病理性瘢痕主要包括增生性瘢痕、 瘢痕疙瘩、挛缩瘢痕等,在其形成过程中,IL-11 的作用尤为突出。2022 年发表 在 Journal of Investigative Dermatology 上的研究论文"CD39 Fibroblasts Enhance 1 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 ...
迈威生物(688062) - 迈威生物自愿披露关于地舒单抗注射液获得巴基斯坦上市许可的公告
2025-08-31 09:45
(1)9MW0311 药品名称:Rexeva 规格:60mg 上市许可号:127267 (2)9MW0321 药品名称:Denosu 规格:120mg 上市许可号:127268 二、药品的其他相关情况 证券代码:688062 证券简称:迈威生物 公告编号:2025-049 迈威(上海)生物科技股份有限公司 自愿披露关于地舒单抗注射液 获得巴基斯坦上市许可的公告 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") 近日收到合作客户 The Searle Company Limited 的通知,公司两款地舒单抗注射 液 9MW0311 和 9MW0321(国内商品名:迈利舒®和迈卫健®)已获得巴基斯坦 药品监管局(Drug Regulatory Authority of Pakistan,DRAP)的注册批准。巴基 斯坦是重要的"一带一路"国家,人口达 2.4 亿,医药需求日益增长,具备广阔 的市场潜力,是公司重点布局的新兴市场之一。这是巴基斯坦药 ...
迈威生物(688062) - 迈威生物关于重新向香港联交所递交H股发行并上市的申请并刊发申请资料的公告
2025-08-31 09:45
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。 迈威(上海)生物科技股份有限公司(以下简称"公司")已于 2025 年 8 月 29 日向香港联合交易所有限公司(以下简称"香港联交所")重新递交了发 行 H 股股票并在香港联交所主板挂牌上市(以下简称"本次发行")的申请, 并于同日在香港联交所网站刊登了本次发行的申请资料。该申请材料为公司按 照香港证券及期货事务监察委员会(以下简称"香港证监会")及香港联交所 的要求编制和刊发,为草拟版本,其所载资料可能会适时作出更新及修订,投 资者不应根据其中的资料作出任何投资决定。 本次发行如果最终实施,发行对象将仅限于符合相关条件的境外投资者及 依据中国相关法律法规有权进行境外证券投资的境内合格投资者,公司将不会 在境内证券交易所的网站和符合监管机构规定条件的媒体上刊登该申请资料, 但为使境内投资者及时了解该等申请资料披露的本次发行以及公司的其他相关 信息,现提供该申请资料在香港联交所网站的查询链接供查阅: 中文: 证券代码:688062 证券简称:迈威生物 公告编号:2025-04 ...