Core Viewpoint - The demand for tetanus passive immunization agents in China is increasing due to rising injury cases from industrial accidents and traffic incidents, alongside a growing public awareness of health and preventive vaccinations [1][6][7]. Market Overview - The market size of China's tetanus passive immunization agents reached 3.23 billion yuan in 2022, with a year-on-year growth of 17.45% [1][7]. - However, the market is projected to decline to 2.66 billion yuan by 2024 due to a slowdown in real estate development and a decrease in the number of construction workers, who are the primary consumers of these immunization agents [1][7]. Industry Policies - The Chinese government has implemented various policies to support the development of the biological products industry, including tetanus passive immunization agents, creating a favorable environment for industry growth [4]. Industry Chain - The upstream of the tetanus passive immunization agents industry includes plasma, cell culture media, and other biological materials, while the midstream focuses on research and production, and the downstream involves medical institutions and consumers [4][5]. Competitive Landscape - The tetanus passive immunization agents market is divided into four segments, with Jiangxi Biological Products Research Institute holding a significant market share of 65.8% in the tetanus antitoxin sector [7][8]. - The market for tetanus human immunoglobulin is more competitive, with numerous companies including Shenzhen Weiguang Biological Products Co., Ltd. and Hualan Biological Engineering Co., Ltd. [8]. Development Trends - Future advancements in the tetanus passive immunization agents field are expected to include the application of monoclonal antibodies and recombinant DNA technology, leading to more efficient production methods and improved product safety [10][11]. - The increasing coverage of cold chain logistics and the promotion of hierarchical medical policies will enhance the role of grassroots medical institutions in tetanus prevention and treatment, unlocking further market potential [10][11].

Core Insights - The adjustment of the medical insurance drug catalog for 2025 has seen a significant increase in the number of drugs passing the formal review, with a new commercial insurance innovative drug catalog introduced, attracting high industry attention [1][3][5] Summary by Sections Medical Insurance Drug Catalog - The National Healthcare Security Administration (NHSA) received 718 applications for the basic medical insurance catalog, with 534 passing the initial review, including 472 applications from outside the catalog, marking a notable increase from 249 in 2024 [3] - The approved drugs cover various fields such as oncology, chronic diseases, and rare diseases, with a significant number of monoclonal antibody injections passing the review [3][4] Commercial Insurance Innovative Drug Catalog - The newly established commercial insurance innovative drug catalog received 141 applications, with 121 passing the initial review, resulting in a pass rate of approximately 85.82% [5] - This catalog also includes drugs for oncology, chronic diseases, and rare diseases, primarily focusing on Western medicine, with some traditional Chinese medicine included [5][6] Dual Track Submission - Several drugs have simultaneously passed the reviews for both the basic medical insurance catalog and the commercial insurance innovative drug catalog, indicating a strategy to cater to different patient payment capabilities [7][8] - The dual submission approach allows for broader market coverage and addresses the needs of high-value innovative drugs that may not be included in the basic insurance catalog [8] Industry Implications - The increase in the number of drugs passing the reviews reflects the growing investment in innovative drug research and development in China, with a focus on enhancing patient access to essential medications [4][6] - The establishment of the commercial insurance innovative drug catalog signifies the government's commitment to building a multi-tiered medical security system, providing supplementary coverage for high-value drugs not included in the basic insurance [6][8]

Core Viewpoint - Zhuhai Tainuo Maibo Pharmaceutical Co., Ltd. (Tainuo Maibo) has submitted its application for listing on the Sci-Tech Innovation Board, marking it as the first company accepted under the newly restarted fifth set of listing standards, attracting significant market attention [1] Company Overview - Tainuo Maibo was established in 2015 and focuses on the research, production, and sales of fully human monoclonal antibody new drugs, utilizing its proprietary HitmAb® technology platform [2][3] - The company aims to develop innovative drugs with independent intellectual property rights to address infectious diseases, autoimmune diseases, malignant tumors, and other medical needs [2] Financial Performance - The company has reported continuous losses, with total losses amounting to 1.567 billion yuan over the reporting periods from 2022 to Q1 2025 [3] - Revenue figures show 4.3398 million yuan in 2022, 15.0559 million yuan in 2024, and 169,300 yuan in Q1 2025, indicating a low sales volume and a production-sales rate of only 0.32% in Q1 2025 [2][3] R&D and Innovation - Tainuo Maibo has invested nearly 1.3 billion yuan in R&D, with a compound annual growth rate of 14.8% from 2022 to 2024 [11] - The company holds 37 domestic and 6 international authorized invention patents, with over 50 additional patents pending [11] Product Pipeline - The main product, Staitouta Monoclonal Antibody Injection, has been approved for sale in China as of February 2025, targeting emergency prevention of tetanus [5][6] - Another key product, TNM001, is in Phase III clinical trials for targeted tumor treatment [5] Market Challenges - The company faces significant competition from established products in the market, with its main competitor's pricing being significantly lower, which may limit market expansion [7][12] - The product has not yet entered the medical insurance system, which poses a challenge for market penetration [7] Financial Health - The company's liabilities have been increasing, with current liabilities reaching 254 million yuan in Q1 2025, representing a significant portion of total liabilities [9] - The asset-liability ratio has been rising, indicating potential pressure on the company's financial flexibility and long-term development [10] Future Prospects - Tainuo Maibo plans to raise 1.5 billion yuan through its IPO, with funds allocated for new drug R&D, expansion of antibody production facilities, and operational capital [13] - The company must navigate short-term cost pressures and long-term policy uncertainties while maintaining its innovation advantage to establish a sustainable commercialization model [13]

Core Viewpoint - Zhuhai Tenomab Pharmaceutical Co., Ltd. (Tenomab) has applied for a change in its listing review status on the Shanghai Stock Exchange's Sci-Tech Innovation Board to "inquired," with plans to raise 1.5 billion RMB [1] Company Overview - Tenomab is an innovative biopharmaceutical company focused on blood product alternatives, equipped with proprietary technology platforms for monoclonal antibody development and production [1] - The company has developed several core technology platforms, including HitmAb® for high-throughput human monoclonal antibody research and a CHO-GS cell platform for efficient antibody expression [1] Key Products - The core product, TNM002 (Stadotamab Injection), is a first-in-class recombinant human monoclonal antibody for tetanus prevention, expected to be approved in China by February 2025 and recognized as a breakthrough therapy by the CDE [2] - Another key product, TNM001, is a potential third global and first domestic long-acting monoclonal antibody for RSV prevention in infants, currently undergoing Phase III clinical trials [2] Fundraising and Investment Plans - The total investment for the new drug development project is approximately 836.5 million RMB, with 830 million RMB planned to be raised from this issuance [3] - The antibody production base expansion project has a total investment of about 381.37 million RMB, with 330 million RMB from the raised funds [3] - The company plans to allocate all raised funds to its main business projects and operational needs [2][3] Financial Performance - In 2022, the company reported revenues of approximately 4.34 million RMB, with projected revenues of 15.06 million RMB in 2024 and 1.69 million RMB in Q1 2025 [3] - The net profit for 2022 was approximately -429 million RMB, with projected losses of -446 million RMB in 2023 and -515 million RMB in 2024 [3] - As of March 31, 2025, total assets are reported at approximately 1.13 billion RMB, with a debt-to-asset ratio of 56.48% [4]

长江商报记者 徐佳 科创板第五套标准重启后，珠海泰诺麦博制药股份有限公司（以下简称"泰诺麦博"）向A股发起冲击。 泰诺麦博是一家创新药企，2025年2月才实现产品商业化。2025年前3个月，公司实现营业收入16.93万 元。 在过往持续高研发投入力度下，2022年至2025年前3个月，泰诺麦博累计亏损15.67亿元。报告期内，公 司研发费用合计12.75亿元。 长江商报记者注意到，尽管直至2025年才有一款产品上市，但泰诺麦博已大额投入销售费用。报告期 内，公司销售费用合计7542.58万元。截至2025年3月末，公司共拥有员工767人，其中研发人员145人、 销售人员350人，销售人员数量为研发人员的2.4倍。 由于自身并不具备盈利能力，泰诺麦博曾多次增资扩股。据不完全统计，申报IPO前四年时间，泰诺麦 博至少获得10.87亿元融资。 本次发行前，泰诺麦博共有49名股东，背后包括高瓴、格力、中金资本等知名资本。本次IPO泰诺麦博 拟募资15亿元。 仅一款产品上市销售费砸7542万 资料显示，泰诺麦博于2015年12月成立。2023年6月，公司完成股份制改制。2025年7月末，上交所正式 受理了泰诺麦博的科创 ...

近期，创新药IPO如火如荼！ 格隆汇获悉，珠海泰诺麦博制药股份有限公司（简称"泰诺麦博"）于7月31日向上交所递交了招股书，拟采用第五套标 准寻求科创板上市，由华泰联合证券担任保荐人。 这也是科创板第五套标准重启以来，首家受理的公司。 值得注意的是，就在昨天，来自广州的创新药企业必贝特在过会2年多之后，终于成功拿到了IPO注册路条。 而此前的7月，禾元生物和北芯生命先后过会，均是采用的科创板第五套标准。 这一系列事件，被业内解读为"又一个属于创新药行业的IPO窗口期正式开始"。 01 创始人是美国国籍，高瓴、康哲药业参投 泰诺麦博成立于2015年12月，由HUA XIN LIAO和郑伟宏联合创办，公司2023年6月完成股改，总部位于珠海市金湾 区。 目前，公司无控股股东，HUA XIN LIAO和郑伟宏为共同实际控制人，二人合计控制泰诺麦博33.1%的股权。 1953年出生的HUA XIN LIAO是美国国籍，在公司任董事长。他毕业于美国北卡罗莱纳大学教堂山分校生物化学专 业，博士学位。他曾任美国杜克大学助理教授、副教授、教授；回国后曾任暨南大学特聘教授、教授。 郑伟宏出生于1973年10月，中国国籍，毕业于 ...

Core Viewpoint - The recent surge in IPOs for innovative drug companies indicates the opening of a new window for the innovative drug industry, with several companies, including Zhuhai Tainomai Bo Pharmaceutical Co., Ltd., seeking to go public on the STAR Market [1][21]. Company Overview - Zhuhai Tainomai Bo Pharmaceutical Co., Ltd. was founded in December 2015 by HUA XIN LIAO and Zheng Weihong, with its headquarters located in Jinwan District, Zhuhai City [3][4]. - The company currently has no controlling shareholder, with HUA XIN LIAO and Zheng Weihong jointly controlling 33.1% of the shares [4]. Investment and Valuation - Tainomai Bo has undergone multiple rounds of financing, with major institutional investors including Hillhouse Capital and Kangzhe Pharmaceutical. The post-investment valuation was approximately 5.273 billion yuan in March 2025 [5]. - The company aims to meet the listing standards of the STAR Market, with an expected market value of no less than 4 billion yuan and at least one core product approved for Phase II clinical trials [5]. Product Pipeline - The company focuses on blood product alternatives, with its core product, Staitouta Monoclonal Antibody Injection, already on the market. It is the world's first recombinant anti-tetanus toxin monoclonal antibody drug [6][9]. - Tainomai Bo is developing eight antibody drugs and candidates, including TNM001, which is in Phase III clinical trials for respiratory syncytial virus (RSV) prevention [7][15]. Financial Performance - The company has reported significant losses over the past three years, totaling over 1.567 billion yuan, with plans to raise 1.5 billion yuan through the IPO to fund new drug development and expand its antibody production base [17][19]. - Revenue from the core product Staitouta Monoclonal Antibody Injection began in March 2025, following its approval in February 2025, with initial sales of 169,300 yuan [18]. Market Competition - The Staitouta Monoclonal Antibody Injection faces competition from traditional blood products and other monoclonal antibody products currently in development, which may impact its market penetration [11][12][21]. - The company must effectively promote its innovative product to gain recognition among healthcare professionals and patients to overcome the challenges posed by established competitors [11][21].

Regulatory Changes - The National Health Commission has issued a notice prohibiting medical institutions from using misleading names for outpatient services that imply efficacy, emphasizing the need for clear and accurate naming practices [1] Drug Procurement - The National Medical Insurance Administration announced that 480 pharmaceutical companies are competing in the 11th batch of national drug procurement, with 55 drugs proposed for inclusion, averaging 15 companies per drug, and some drugs having over 40 participating companies [2] Legal Actions Against Fraud - The Supreme People's Court reported a significant increase in the prosecution of medical insurance fraud cases, with 1,156 cases involving 2,299 individuals concluded in 2024, marking a 131.2% year-on-year increase and recovering over 402 million yuan in lost funds [3] Drug Approvals - Innovent Biologics announced that its oral GLP-1R agonist IBI3032 has received FDA approval for clinical trials, with plans to initiate Phase I trials in mid-2025 targeting overweight or obese individuals [4] - Dyne Therapeutics received breakthrough therapy designation from the FDA for its investigational therapy DYNE-251 for Duchenne muscular dystrophy, with data expected by the end of 2025 [5] - Xinhua Pharmaceutical's subsidiary, Xinda Pharmaceutical, has received a drug registration certificate for Finasteride tablets, which are included in the national medical insurance drug list [6][7] Mergers and Acquisitions - Shanghai TuoJing announced the acquisition of 82% of Wuhan Kanglu Biological for 328 million yuan, focusing on advancements in molecular diagnostics [8] Financial Performance - Jiuzhou Pharmaceutical reported a 3.86% increase in revenue to 2.871 billion yuan and a 10.7% increase in net profit to 526 million yuan for the first half of 2025 [10] Strategic Investments - Yabao Pharmaceutical plans to acquire a traditional Chinese medicine project for 22 million yuan, enhancing its R&D pipeline and competitive edge [11] Shareholder Actions - Chenshin Pharmaceutical announced that a major shareholder plans to reduce their stake by up to 3% through market transactions, which is not expected to significantly impact the company's governance or operations [12]

Core Viewpoint - The recent acceptance of Zhuhai Tainuo Maibo Pharmaceutical Co., Ltd.'s IPO application marks the first project under the reactivated fifth listing standard of the Sci-Tech Innovation Board after a two-year hiatus, indicating ongoing support for innovative pharmaceutical companies in the capital market [1][3][4]. Company Overview - Tainuo Maibo, established in 2015, focuses on innovative biopharmaceuticals aimed at blood product alternatives, with its core product, TNM002 (Staidota Monoclonal Antibody Injection), being the first-in-class recombinant anti-tetanus toxin monoclonal antibody drug approved in China [3][4]. - The company has faced continuous losses, with a cumulative loss of approximately 1.39 billion yuan from 2022 to 2024, primarily due to its focus on long-term, high-investment R&D projects [1][9]. Financial Aspects - Tainuo Maibo plans to raise 1.5 billion yuan through its IPO, allocating 830 million yuan for new drug R&D, 330 million yuan for antibody production base expansion, and 340 million yuan for working capital [4]. - The company reported a mere 169,300 yuan in sales revenue for its core product in March, highlighting challenges in market penetration and competition [6][9]. Market Competition - The core product faces competition from established therapies such as tetanus immunoglobulin and tetanus antitoxin, which have been in clinical use for years, resulting in a more mature market with higher clinical awareness [6][7]. - The company acknowledges the risk of slow market penetration due to the need for extensive promotion and acceptance of its innovative therapy among healthcare professionals and patients [6][9]. Regulatory Environment - The reactivation of the fifth listing standard reflects a more rational view of the high-risk, high-investment nature of the biopharmaceutical industry, with the capital market showing continued interest in antibody drugs and innovative therapies [4][5]. - Regulatory scrutiny will focus on the company's core technology barriers, clinical value, and the efficiency of fund utilization, particularly in relation to its ongoing losses and R&D investments [10].

Group 1 - In July, the number of companies applying for listing on the Hong Kong Stock Exchange decreased significantly, with only 21 companies submitting applications, marking the lowest monthly figure since April 2025 [1][2] - Meanwhile, 17 A-share listed companies announced plans for an IPO in Hong Kong, setting a new monthly high for the year, indicating a continued acceleration of A-share companies seeking to list in Hong Kong [2] - The A-share IPO market saw 9 companies go public in July, with all but one passing the review, and the new stocks listed experienced significant gains, with the highest increase reaching 479.12% [4][5] Group 2 - The China Securities Regulatory Commission (CSRC) issued only 3 approvals for companies seeking to list abroad in July, a sharp decline from 20 in June [2] - The number of companies terminating their IPO applications in July was 6, a decrease from 10 in June, indicating a potential stabilization in the IPO process [6] - The A-share market had only one company accepted for IPO review in July, which is the first under the fifth set of listing standards for the Sci-Tech Innovation Board [7]