证券研究报告 | 行业周报 gszqdatemark a 2025 10 26 年 月 日 医药生物 十年维度看，CDMO 的投资节奏是怎样演变的？【周专题&周观 点】【总第 419 期】 一、当周（10.20-10.24）回顾与周专题： 当周（10.20-10.24）申万医药指数环比+0.58%，跑输创业板指数，跑输沪深 300 指数。本周周报，我们探讨了十年维度看，CDMO 的投资节奏演变。 二、近期复盘： 1、当周表现：本周市场整体向上，上证突破十年新高，科技引领反弹。医药整体 震荡。医药看结构，创新药涨幅有限，个别主题和个股逻辑驱动为主，部分业绩 票、流感主题、机器人相关标的表现较好。 2、原因分析：本周市场向上，科技反攻，医药热度又下来了点。创新药在上周 5 个 BD 和周末 ESMO 数据还有信达百亿以上美金 BD 后，仍然没有很好表现，我们 认为不是产业逻辑的问题，还是在消化前期累计的交易问题，不改变中长期产业 逻辑，继续看好。这周以个别主题和个股逻辑驱动为主，业绩期业绩驱动的业绩 票，全市场映射的机器人逻辑，以及日本流感爆发带动国内带来的流感主题表现。 其他个股逻辑为主。我们认为创新药板块筹码 ...

在A股上市医药企业纷纷冲击香港资本市场的浪潮中，又一家药企宣布加入这一行列。海特生物（300683）最新公告显示，公司拟发行H股并在香港联交所 上市。拟赴港上市背后，海特生物深陷业绩亏损"泥潭"，今年前三季度净利亏损1.58亿元，同比进一步增亏。此外，截至三季度末，海特生物货币资金明 显"缩水"，较年初降近六成。 海特生物在二级市场上的表现也让投资者忧心。10月23日，海特生物股价大幅收跌7.15%，已跌破发行价。对于海特生物而言，公司在推进港股上市进程的 同时，也需要着力改善经营状况，恢复市场信心。 筹划赴港上市 净利连续三年亏损 实际上，海特生物业绩颓势早已显现，公司归属净利润已连续三年出现亏损。 10月23日，海特生物发布公告称，根据公司总体发展战略及运营需要，公司拟在境外发行股份（H股）并在香港联交所上市。 海特生物表示，此次赴港上市系为深化公司全球化战略布局，加快海外业务发展，提升公司国际化品牌形象，同时打造多元化资本运作平台，增强公司的境 外融资能力，助力公司高质量发展。 资料显示，海特生物主营业务为大分子生物药、小分子化学药、原料药与医药中间体的生产销售，同时也为国内外的制药企业提供制剂和原料药 ...

其中，多位知名基金经理管理的基金"现身"本次定增名单中。比如，中欧基金经理葛兰管理的基金认购 金额超6亿元，工银瑞信基金经理赵蓓管理的基金认购金额超2亿元，富国基金经理朱少醒管理的基金认 购金额接近1亿元。 多位基金经理参与 近日，多家公募基金参与同一家创新药公司的新股增发，引发广泛关注。 根据百利天恒发布的公告，本次获配新股的特定对象包括中欧、易方达、工银瑞信、富国、景顺长城、 广发、汇添富基金等多家专业投资机构。 9月20日至23日，广发、中欧、富国、工银瑞信、易方达基金等多家公募发布了旗下部分基金投资百利 天恒非公开发行股票的公告。 据了解，百利天恒是一家位于四川的生物医药上市公司，具备包括小分子化学药、大分子生物药及 ADC(抗体偶联药物)的全系列药品研究开发能力。 9月19日，百利天恒发布了2025年度向特定对象发行A股股票发行情况报告书。根据报告书，本次向特 定对象发行股票数量不超过14149312股，定价基准日为9月5日，发行价格为317元/股，发行价格与发行 底价的比率为119.16%。本次最终认购对象共有18家专业投资机构，合计获配11873817股，获配总额为 37.64亿元。 获配机构中 ...

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].

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]

Summary of CXO Industry Conference Call Industry Overview - The CXO industry is expected to recover in 2024 after rapid growth from 2020 to 2023, with leading companies seeing a resurgence in overseas orders, indicating a turning point in operations [1] - The Hong Kong stock market's activity and the reform of the Sci-Tech Innovation Board are providing new growth momentum for the CXO industry [1] Key Insights - **Overseas Biopharmaceutical Investment**: After two years of decline, overseas biopharmaceutical investment is stabilizing and expected to rebound in 2024, although growth slowed in the first half of the year [1][4] - **R&D Investment Growth**: Global pharmaceutical companies are increasing R&D investments, with the proportion of R&D spending to revenue reaching a ten-year high of 25.2%, totaling over $190 billion in 2024, a 73% increase from five years ago [4] - **Domestic Investment Trends**: Domestic biopharmaceutical investment has been declining, with a projected 21% decrease in 2024. However, a recovery is anticipated in the second half of the year due to increased activity in the Hong Kong market and reforms in the Sci-Tech Innovation Board [5] - **Emerging Trends**: The trend of innovative drugs going overseas is becoming clearer, with upfront payments becoming a significant funding source for innovative drug companies [2][6] Geopolitical Impact - Geopolitical factors are highlighting the importance of China's CXO industry in the global supply chain, with cost control needs driving overseas orders to China [1][8] - Chinese companies are actively expanding overseas production capacity to mitigate geopolitical risks [8] Market Dynamics - The penetration rate of global pharmaceutical R&D outsourcing is expected to reach 50% in 2024 and may exceed 60% in the future, driven by cost reduction and efficiency improvements [1][9] - The small molecule chemical drugs continue to dominate the market, with significant demand for drug research outsourcing [9] Company Performance - **CRO Industry**: The CRO industry is expected to stabilize by 2025, benefiting from a recovery in demand. WuXi AppTec reported a 37% year-on-year increase in orders, indicating a trend towards consolidation among leading companies [13] - **CDMO Sector**: The multi-peptide CDMO sector is experiencing high demand, with WuXi AppTec's multi-peptide business revenue growing by 112% year-on-year [16] - **ADC and CGMO Performance**: ADC's CGMO maintained high growth in the first half of 2025, with revenue exceeding expectations and a year-on-year increase of over 60% [11] Financial Metrics - Some companies are reporting positive growth in revenue and profits, with certain firms achieving year-on-year revenue growth of 14%, 118%, and 28.1% [10] - WuXi Biologics reported a 16% year-on-year revenue increase in the first half of 2025, exceeding previous guidance [12] Conclusion - The CXO industry is at a pivotal moment, with signs of recovery in overseas demand and domestic investment. The geopolitical landscape and ongoing reforms are likely to shape the future trajectory of the industry, presenting both opportunities and challenges for companies involved in this sector [1][2][8]

Core Viewpoint - The chairman of Maiwei Biotech, Liu Datao, has been penalized for short-term trading of the company's stock, violating securities laws, and must return related profits to the company [2][6]. Company Overview - Liu Datao has served as the general manager and director of Maiwei Biotech since June 1, 2020, and became chairman on June 1, 2023, earning a total salary of 7.4 million yuan over the past three years [5]. - Under Liu's leadership, Maiwei Biotech has made significant progress in product research and development, focusing on innovative drugs and biosimilars, with a portfolio that includes antibodies, ADC drugs, and recombinant proteins [6]. Financial Performance - Since its establishment in 2017, Maiwei Biotech has consistently reported losses, with a cumulative net loss exceeding 6 billion yuan as of the first quarter of 2025, primarily due to substantial R&D investments totaling over 4.425 billion yuan [8]. - The company has faced cash flow challenges, with 1.119 billion yuan in cash on hand against 1.073 billion yuan in short-term loans and 210 million yuan in current non-current liabilities, alongside 962 million yuan in long-term debt [8]. Product Pipeline and Market Strategy - As of the first quarter of this year, Maiwei Biotech has 16 core products in various stages of development, including 12 innovative drugs and 4 biosimilars, with 3 products already on the market [6]. - The company is rapidly advancing its international strategy, having secured formal agreements for its products in multiple countries, including submissions for market approval in Pakistan and Indonesia [6].

Core Viewpoint - The article discusses the growth and significance of International Multi-Center Clinical Trials (MRCT) in the pharmaceutical industry, highlighting the shift towards biological drugs and the increasing participation of domestic companies in MRCTs [1][9][21]. Group 1: Overview of MRCT - MRCT refers to clinical trials conducted simultaneously at multiple centers across different regions to evaluate the efficacy, safety, and applicability of new drugs or treatments [2][3]. - MRCT has gained global recognition in the pharmaceutical and medical device industries, becoming a primary source of clinical trial data for product registration in multiple countries [9][21]. Group 2: Current Status of MRCT in China - The number of MRCTs in China peaked in 2021, saw a decline, and is projected to reach a new high of 336 in 2024, representing a 15% year-on-year increase [9][11]. - The transition from small molecule chemical drugs to large molecule biological drugs is evident, with biological trials surpassing chemical trials for the first time in 2023 [11][21]. - In 2024, 55.4% of MRCTs will be biological trials (186 trials), while chemical trials will account for 150 trials [11][13]. Group 3: MRCT Phases and Trends - The majority of MRCTs in China are Phase III trials, maintaining over 55% of the total, followed by Phase II (21.1%) and Phase I (17.0%) trials [13][21]. - The increase in Phase I trials is attributed to improved review and approval efficiency, allowing for faster market entry of drugs based on early clinical data [13][21]. Group 4: Company Landscape in MRCT - Foreign companies like AstraZeneca, Sanofi, and Merck dominate MRCTs in China, holding the top positions in trial numbers [17][19]. - Domestic companies such as BeiGene, Zai Lab, and Ascentage Pharma are increasingly active in MRCTs, with their participation rising significantly from less than 3% in 2015 to 30.1% in 2024 [15][17]. Group 5: Future Trends in MRCT - The trend towards MRCTs is expected to continue, driven by supportive policies and an improving market environment, enhancing the market position of domestic companies [21][23]. - Biotech companies are increasingly engaging in MRCTs as a first step towards internationalizing their products for overseas registration [21][23].

Group 1 - Yinlun Co., Ltd. plans to establish a joint venture company, Suzhou Yizhi Lingqiao Drive Technology Co., Ltd., with an investment of 10 million yuan, holding a 20% stake, to enhance the development of embodied intelligent robot components [1] - Zhimin Da's controlling shareholder plans to transfer 5.03 million shares, representing 3.00% of the total share capital, through an inquiry transfer method [1][2] - ST Ningke's subsidiary plans to invest 100 million yuan in a technical transformation project for the production of bio-fermentation products, aiming to enhance market competitiveness [3][4] Group 2 - Fujian Jinsen's chairman resigned due to work reasons, and the resignation will take effect after the election of a new chairman [5][6] - Kanghong Pharmaceutical's subsidiary received approval for clinical trials of Songling Xue Mai Kang capsules, aimed at treating functional ventricular premature beats [7][8] - Ruizhi Pharmaceutical plans to sell a 32.59% stake in its associate company, Guangdong Shenghetang Health Food Co., Ltd., for 60 million yuan [9] Group 3 - Meili Cloud's shareholder, China Metallurgical Paper Group, is undergoing bankruptcy reorganization, with its shares frozen and partially pledged [10] - Mongolian Grass Ecological plans to raise up to 1.495 billion yuan through a private placement for various ecological projects and working capital [11] - Aikelan's major shareholder plans to reduce their stake by up to 3% due to personal funding needs [12] Group 4 - Chaojie Co., Ltd. has three shareholders planning to reduce their stakes by a total of up to 3.73% for personal funding needs [13] - Haitai Biological's director plans to reduce their stake by up to 0.14% for personal funding needs [14] - New Guodu's executives plan to reduce their stakes by a total of up to 50.19 million shares for personal funding needs [15] Group 5 - Zhiguang Electric's vice chairman plans to reduce their stake by up to 304.06 million shares for personal funding needs [16] - *ST Jinbi's controlling shareholder plans to transfer 47.0853 million shares, making Yuan Yi Cheng Wu the new controlling shareholder [17][18] - Kaizhong Precision received a project designation from a leading global new energy battery manufacturer, with expected sales of approximately 700 million yuan [19][20] Group 6 - Defang Nano's director plans to reduce their stake by up to 133,200 shares for personal funding needs [21] - ST Hongtai's stock will have its risk warning removed, changing its name and increasing the price fluctuation limit [22] - Guoanda's directors plan to reduce their stakes by a total of up to 101,700 shares for personal funding needs [23] Group 7 - Lanshi Heavy Industry plans to acquire 100% of Qingdao Equipment for 99.9821 million yuan to enhance its delivery capabilities [24] - Qingdao Bank's major shareholder plans to increase its stake to no more than 19.99%, pending regulatory approval [25]

Core Viewpoint - The company, Maiwei Biotech, is under investigation by the China Securities Regulatory Commission (CSRC) for suspected short-term trading involving its chairman and general manager, Liu Datao, but this investigation is stated to not significantly impact the company's daily operations [1] Group 1: Company Overview - Maiwei Biotech is an innovative biopharmaceutical company with a full industry chain layout, focusing on products such as antibodies, ADC drugs, recombinant proteins, and small molecule chemical drugs [3] - The company has not yet achieved profitability and has accumulated losses exceeding 3 billion yuan over the past three years [5] Group 2: Financial Performance - From 2022 to 2024, the company's net profits were reported as -955 million yuan, -1.053 billion yuan, and -1.044 billion yuan respectively, indicating consistent losses [5] - In 2024, the company achieved approximately 200 million yuan in revenue, representing a year-on-year growth of 56.28%, while still reporting a net loss of 1.044 billion yuan [5] Group 3: Funding and Market Position - Maiwei Biotech was listed on the Shanghai Stock Exchange's Sci-Tech Innovation Board in January 2022, raising a net amount of 3.303 billion yuan [7] - The company is currently advancing its IPO process in Hong Kong, having submitted an application to the Hong Kong Stock Exchange for H-share listing on January 6, 2025 [7] - As of May 9, the company's stock price closed at 19.99 yuan per share, with a total market capitalization of 7.988 billion yuan [7]