Investment Rating - The report provides a positive outlook on the MASH non-invasive diagnosis technology, suggesting it could accelerate new drug development in the pharmaceutical and biotechnology sector [2]. Core Insights - The pharmaceutical and biotechnology sector experienced a decline of 0.65% from August 25 to August 29, underperforming compared to the Wind All A index (1.9%) and the CSI 300 index (2.71%). Only the medical research outsourcing (4.9%) and other biological products (0.14%) sectors saw gains, while in vitro diagnostics (-4.12%), raw materials (-3.34%), and vaccines (-0.59%) faced significant declines [2][7]. - The FDA has accepted the proposal for using VCTE-LSM as a reasonable alternative endpoint for clinical trials in adults with MASH and moderate to advanced fibrosis. This non-invasive method is expected to enhance patient compliance and could lead to a surge in drug development in the MASH area within the next two to three years [2][13]. - The report emphasizes the potential for domestic companies in China to leverage their cost advantages and forward-looking strategies in the field of non-invasive companion diagnostics, particularly in the MASH drug development competition [2]. Market Weekly Review - The pharmaceutical and biotechnology sector's performance was notably weaker than the broader market indices, with specific sub-sectors like medical research outsourcing and other biological products showing resilience [7][8]. - Individual stocks such as Tianchen Medical (30.1%), Ailis (25.6%), and Maiwei Biotech-U (22.4%) performed well, while stocks like Lifang Pharmaceutical (-13.9%), Yuekang Pharmaceutical (-11.9%), and Kanghua Biotech (-11.1%) faced significant losses [10][12]. Industry News and Key Company Announcements - On August 28, Kangfang Biotech announced that its drug AK112 received approval for treating advanced non-squamous non-small cell lung cancer, with promising clinical trial results expected to be presented at an international conference [12]. - The report highlights various companies' financial performances, with notable revenue changes and profit margins, indicating a mixed outlook across the sector [16][17].

重要消息 随着公募基金2025年半年报披露完毕，中央汇金持仓的ETF明细全部出炉。 Wind统计显示，截至6月末，中央汇金投资有限责任公司及其子公司中央汇金资产管理有限责任公司等"国家队"合计持有股票ETF市值1.28万亿元，较去 年底增加近23%。 中央汇金资产大举加仓股票ETF，6月末持有的股票ETF数量是去年底的1.58倍，多只宽基ETF获得10亿份级别以上的增持。 重要的消息有哪些 1．8月30日，商务部新闻发言人就美国撤销三星等三家在华半导体企业"经验证最终用户"授权答记者问。商务部新闻发言人表示，美方此举系出于一己之 私，将出口管制工具化，将对全球半导体产业链供应链稳定产生重要不利影响，中方对此表示反对。 2．随着公募基金2025年半年报披露完毕，中央汇金持仓的ETF明细全部出炉。Wind统计显示，截至6月末，中央汇金投资有限责任公司及其子公司中央汇 金资产管理有限责任公司等"国家队"合计持有股票ETF市值1.28万亿元，较去年底增加近23%。 3．中上协消息，2025年上半年，全市场上市公司实现营业收入35.01万亿元，同比增长0.16%。第二季度营收18.11万亿元，同比增长0.43%，环比增 ...

随着公募基金2025年半年报披露完毕，中央汇金持仓的ETF明细全部出炉。 Wind统计显示，截至6月末，中央汇金投资有限责任公司及其子公司中央汇金资产管理有限责任公司等"国家队"合计持有股票ETF市值1.28万亿元，较 去年底增加近23%。 重要消息 中央汇金资产大举加仓股票ETF，6月末持有的股票ETF数量是去年底的1.58倍，多只宽基ETF获得10亿份级别以上的增持。 重要的消息有哪些 1 ． 8月30日，商务部新闻发言人就美国撤销三星等三家在华半导体企业"经验证最终用户"授权答记者问。商务部新闻发言人表示，美方此举系出于一己之 私，将出口管制工具化，将对全球半导体产业链供应链稳定产生重要不利影响，中方对此表示反对。 2 ． 随着公募基金2025年半年报披露完毕，中央汇金持仓的ETF明细全部出炉。Wind统计显示，截至6月末，中央汇金投资有限责任公司及其子公司中央汇 金资产管理有限责任公司等"国家队"合计持有股票ETF市值1.28万亿元，较去年底增加近23%。 3．中上协消息，2025年上半年，全市场上市公司实现营业收入35.01万亿元，同比增长0.16%。第二季度营收18.11万亿元，同比增长0.43% ...

这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！政策动 向 广州"穗新保"新增60种创新药械和6家医院 8月28日，广州市医保局举办"穗新保"新增试点医院签约活动，6家试点商保公司与6家新增试点医疗机 构签署合作协议。广州快速推进"穗新保"扩容提质，全新升级"穗新保"保障范围，新增"60+6"的产品目 录及试点医院。 21点评："穗新保"作为全国首个同步涵盖"港澳药械通"及本地创新药械的商业保险，重点保障省、市创 新药械目录和"港澳药械通"内尚未纳入医保支付范围的产品费用，此前已纳入44种。 山东加强省级仿制药质量和疗效一致性评价补助资金管理 近日，山东省药监局、山东省财政厅联合印发《山东省省级仿制药质量和疗效一致性评价补助资金管理 办法和实施细则》，持续支持和激励山东省药品上市许可持有人开展仿制药一致性评价工作。《细则》 自2025年9月1日起施行，有效期至2027年8月31日。 8月29日，国家药监局官网显示，恒瑞医药（600276）申报的1类新药泽美妥司他片(商品名：艾瑞璟)获 批上市，为国内获批的首个国产EZH2抑制剂，适用于既往接受过至少1线系统性治疗的复 ...

Core Viewpoint - Maiwei Biotech is facing dual pressures of performance and financial challenges, with a significant decline in revenue and an increase in net losses in the first half of 2025 [1][2]. Financial Performance - In the first half of 2025, Maiwei Biotech reported revenue of 101 million yuan, a year-on-year decrease of 12.43% [2]. - The net loss attributable to shareholders reached 551 million yuan, worsening from a loss of 445 million yuan in the same period last year [2]. - Cumulatively, the net loss since the company's listing has exceeded 3.5 billion yuan [2]. Business Operations - Maiwei Biotech specializes in the research, production, and sales of innovative drugs and biosimilars, with key products including antibodies, ADC drugs, and recombinant proteins [2]. - The company experienced a revenue increase in previous years, with 2022 revenue at 27.73 million yuan and 2024 revenue reaching 200 million yuan, but faced its first revenue decline since listing in 2025 [2]. R&D Investment and Financial Health - The company has significantly higher R&D expenditures compared to its revenue, with investments of 759 million yuan, 836 million yuan, and 783 million yuan from 2022 to 2024, and 392 million yuan in the first half of 2025 [3]. - The asset-liability ratio has risen sharply from 24% at the time of listing to 77.54% by mid-2025, indicating increasing financial strain [3]. Financing Strategies - To alleviate financial pressure, Maiwei Biotech is exploring multiple financing channels, including plans to establish an "A+H" structure and apply for a listing on the Hong Kong Stock Exchange [4]. - The company is also seeking to issue up to 500 million yuan in targeted debt financing tools to manage its liabilities and support project development [4]. - As of mid-2025, the company had a guarantee balance for subsidiaries amounting to 1.919 billion yuan, which is 234.58% of its net assets [4].

迈威生物正面临业绩与财务的双重压力。8月29日，迈威生物披露2025年半年报显示，上半年实现营收 1.01亿元，同比下降12.43%；归母净利润亏损5.51亿元，较去年同期亏损进一步扩大；扣非归母净利润 亏损亦有所增加。从过往表现看，迈威生物上市至今尚未实现盈利，归母净利润已累计亏损超35亿元。 与此同时，迈威生物财务状况持续收紧，资产负债率攀升至77.54%，短期借款压力显著。为缓解财务 压力，迈威生物正通过赴港上市、申请债务融资工具及大额授信等方式进行"输血"，但持续亏损与高负 债下的经营压力仍未减轻。 上市以来亏损超35亿元 上半年，迈威生物营收出现下滑趋势、净利润亏损持续扩大，经营基本面进一步承压。 财报数据显示，迈威生物2025年上半年实现营业收入1.01亿元，同比下降12.43%；从盈利端表现来看， 归属于上市公司股东的净利润亏损5.51亿元，较去年同期的4.45亿元亏损进一步扩大；扣除非经常性损 益后，净亏损达5.74亿元，而去年同期亏损为4.61亿元。 迈威生物在半年报中对本次业绩表现作出解释，营收下降系去年同期迈威（美国）就9MW3011项目与 美国DISCMEDICINE,INC.达成的独 ...

Core Viewpoint - Maiwei Biotech is facing dual pressures of performance and financial strain, with significant losses and rising debt levels impacting its operations [1][2][3] Financial Performance - In the first half of 2025, Maiwei Biotech reported revenue of 101 million yuan, a year-on-year decline of 12.43% [2] - The net loss attributable to shareholders reached 551 million yuan, worsening from a loss of 445 million yuan in the same period last year [2][3] - Cumulative net losses since the company's listing have exceeded 3.5 billion yuan [3] Revenue and Profitability - The decline in revenue is attributed to the absence of high income from a licensing agreement with DISCMEDICINE, INC. in the previous year and a significant reduction in technical service income [3] - Research and development expenses have surged due to investments in clinical trials for multiple pipeline products, contributing to the increased net loss [3] Financial Condition - The company's asset-liability ratio has risen sharply to 77.54%, with short-term borrowings posing significant pressure [5] - Research and development expenditures have consistently outpaced revenue, with R&D costs accounting for 387.57% of revenue in the first half of 2025, an increase of 108.74 percentage points year-on-year [5] Funding Strategies - To alleviate financial pressure, Maiwei Biotech is pursuing multiple financing avenues, including a planned secondary listing in Hong Kong and the issuance of debt financing tools [7][8] - The company has applied for a debt financing tool of up to 500 million yuan and seeks a total credit/funding limit of up to 6.2 billion yuan from financial institutions [7][8] Corporate Governance Issues - The chairman and CEO of Maiwei Biotech is under investigation for alleged insider trading, adding uncertainty to the company's ongoing efforts to list in Hong Kong [7]

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(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 ...

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].