9月1日，迈威生物科技发布公告称，其8月29日正式向港交所重新递交了H股发行并上市的申请，并于 同日在香港联交所网站刊发了申请资料。这是继今年1月首次申请后的再次尝试。 科创板融资已花光 资料显示，迈威生物成立于2017年，2022年初在上交所科创板上市。公司由唐春山、陈姗娜和刘大涛共 同创立，主营业务为治疗用生物制品的研发、生产与销售，主要产品为抗体和重组蛋白类药物。 作为一家创新型生物医药企业，随着新药研发管线持续推进，多个创新药物处于关键临床试验研究阶 段，整体研发投入仍维持在较高水平。截至今年上半年，迈威生物公司拥有14个处于临床前、临床或上 市阶段的重点品种，包括10个创新药，4个生物类似药，专注于肿瘤和年龄相关疾病，如免疫、眼科、 骨科等领域。其中，已上市品种4个，提交上市许可申请准备阶段的品种1个，处于III 期关键注册临床 阶段品种 2 个。 从上述信息可知，迈威生物需要用钱的地方并不少。虽然有四款产品君迈康、迈利舒、迈卫健及迈粒生 进入商业化阶段，但是上述药品的销售收入也无法弥补公司近年来的亏损状况。 让投资者忧心的地方在于，迈威生物的高投入并没有高产出。虽然君迈康、迈利舒、迈卫健及迈粒生已 ...

Company Overview - Maiwei Biotech (688062.SH) experienced a significant stock price increase, closing at a historical high of 57.60 yuan per share, with a market capitalization of 23.017 billion yuan [1] - The company has submitted a new application for an IPO in Hong Kong and received formal acceptance for its Phase II clinical trial of 9MW3811 injection for pathological scars, with plans to initiate patient enrollment by the end of this year [1][2] Product Development - 9MW3811 is a humanized monoclonal antibody targeting IL-11, which is closely related to aging-related diseases. The drug has shown potential in treating fibrosis-related diseases by inhibiting the abnormal activation of the IL-11/IL-11Rα signaling pathway [2][3] - The drug has received approval for clinical studies in China, the United States, and Australia for advanced malignancies and idiopathic pulmonary fibrosis, with Phase I trials completed in Australia and China [2] Market Potential - The global incidence of pathological scars (HSK) is approximately 25 million, with around 7.4 million cases in China, projected to exceed 10 million by 2030 [3] - The aging intervention market has seen a surge in investment, with total financing in the sector reaching $8.49 billion in 2024, a 122% increase from $3.82 billion in 2023 [1][4] Strategic Partnerships - In June, Maiwei Biotech entered into an exclusive licensing agreement with Calico, a Google-affiliated anti-aging giant, for the development and commercialization of IL-11 targeted therapies outside of China, potentially yielding up to $571 million in milestone payments and royalties [4][7] Competitive Landscape - Maiwei Biotech is the first company in China to develop an IL-11 antibody drug, with 9MW3811 being the first to explore the pathological scar indication in clinical trials [3] - The competitive landscape includes similar drugs like BI 765423 from Boehringer Ingelheim, which has also entered Phase I clinical trials [2]

【导读】贵金属、创新药引爆行情，迈威生物20cm封板 中国基金报记者 晨曦 大家好！9月的第一个交易日，来一起关注上午的市场行情和最新资讯。 9月1日上午，A股市场反复震荡。截至午间收盘，上证指数涨0.12%，深证成指涨0.11%，创业板指涨 0.55%。 | 3862.65 | 12710.24 WA | 2906.03 | www. | | --- | --- | --- | --- | | 上证指数 +0.12% | 深证成指 +0.11% | 创业板指 +0.55% | | 全市场半日成交额为1.85万亿元，较上日略有缩量，全市场超3100只个股上涨。 成交额方面，寒武纪成交额继续登顶，半日成交额达186亿元；新易盛、中际旭创、东方财富等近期热 门股成交额均超过100亿元。 | 序号 代码 | 名称 | | 现价 涨跌 | 涨跌幅 | 成交额 ▼ | | --- | --- | --- | --- | --- | --- | | 1 | 688256 | 赛武纪-U 1447.98 -44.51 | | -2.98% | 186.07亿 | | 2 | 300502 新易盛 | 373.30 17.1 ...

Market Overview - On September 1, the A-share market experienced fluctuations, with the Shanghai Composite Index rising by 0.12%, the Shenzhen Component Index by 0.11%, and the ChiNext Index by 0.55% [1] - The total trading volume for the market reached 1.85 trillion yuan, slightly lower than the previous day, with over 3,100 stocks rising [1] Key Stocks and Sectors - The top trading stock was Cambrian (688256) with a trading volume of 18.6 billion yuan, followed by Xinyi (300502), Zhongji (300308), and Dongfang Caifu (300059), each exceeding 10 billion yuan in trading volume [1][2] - The precious metals, innovative pharmaceuticals, film and television, tourism, and storage chip sectors saw significant gains, while insurance, military equipment, securities, and airport shipping sectors experienced pullbacks [2] Precious Metals Sector - The precious metals sector surged, with stocks like Haixing (603115), Jintong (601958), and Shengda Resources (000603) hitting the daily limit, while Hunan Gold (002155) and Luoyang Molybdenum (603993) also saw gains [4] - The rise in precious metals is attributed to the recent increase in the U.S. core PCE index, which aligns with expectations for a Federal Reserve rate cut, enhancing the appeal of precious metals as safe-haven assets amid geopolitical risks and trade tensions [4][6] Innovative Pharmaceuticals Sector - The innovative pharmaceutical sector showed strong performance, with Maiwei Bio (688062) hitting the daily limit and other stocks like Baihua Pharmaceutical (600721) and First Pharmaceutical (600833) also experiencing significant gains [7][8] - Maiwei Bio announced the approval of its two biosimilar products in Pakistan, marking a significant milestone as the first biosimilar approved in the country, and has also entered a licensing agreement with Calico Life Sciences for global rights outside Greater China [9] - The recent adjustments in the national medical insurance catalog are expected to increase the attractiveness of innovative drugs, with a focus on new drugs and unique products [9]

【导读】贵金属、创新药引爆行情，迈威生物 20cm 封板 中国基金报记者 晨曦 大家好！ 9 月的第一个交易日，来一起关注上午的市场行情和最新资讯。 9 月 1 日上午， A 股市场反复震荡。截至午间收盘，上证指数涨 0.12% ，深证成指涨 0.11% ，创业板指涨 0.55% 。 | www.bounce 3862.65 | . | was were works 2906.03 | | --- | --- | --- | | 上证指数 +0.12% | 深证成指 +0.11% | 创业板指 +0.55% | 全市场半日成交额为 1.85 万亿元，较上日略有缩量，全市场超 3100 只个股上涨。 成交额方面，寒武纪成交额继续登顶，半日成交额达 186 亿元；新易盛、中际旭创、东方财 富等近期热门股成交额均超过 100 亿元。 | 序号 代码 | 名称 | 现价 涨跌 | 涨跌幅 | 成交额 ▼ | | --- | --- | --- | --- | --- | | = | 688256 寒武纪-U 1447.98 -44.51 | | -2.98% | 186.07亿 | | വ | 300502 新易盛 ...

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].

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：1)更高的靶点亲和力与信号阻断能力；2)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。 格隆汇8月31日丨迈威生物(688062.SH)公布，近日，迈威生物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。 临床前研究表明，9MW3811 在肺纤维化等多种模型中展现出显著疗效，并在瘢痕增生、子宫内膜异常 出血等纤维化相关疾病中显示出潜在应用价值。尤其在人源瘢痕疙瘩动物模型中，9MW3811 可有效缓 解皮肤纤维化进程并缩小既成瘢痕体积。 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。公司计划于 ...

智通财经APP讯，迈威生物(688062.SH)发布公告，近日，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。 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：1)更高的靶点亲和力与信号阻断能力;2)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：1)更高的靶点亲和力与信号阻断能力;2)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。 迈威生物(688062.SH)发布公告，近日，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。 ...

迈威生物8月31日公告，公司近日收到国家药品监督管理局签发的《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。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。 ...