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]

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].

科创板第五套上市标准受理"关闸"逾两年后，于近日再次纳新。近期，珠海泰诺麦博制药股份有限公司（以下简称"泰诺麦博"）科创板 IPO获得受理，系科创板第五套上市标准重启后首个以该标准申报科创板IPO的项目。泰诺麦博是一家致力于血液制品替代疗法的创新生物 制药企业，公司核心产品斯泰度塔单抗注射液（即"重组抗破伤风毒素全人源单克隆抗体TNM002"，商品名：新替妥）已于2月获批上市。 不过，斯泰度塔单抗注射液于3月实现的销售收入仅16.93万元。泰诺麦博也提示了斯泰度塔单抗注射液面临的市场竞争风险。由于目前仅 有一款产品实现商业化且上市时间较短，报告期内，泰诺麦博持续亏损，于2022—2024年累计亏损约13.9亿元。 重启后首单受理落地 上交所官网显示，7月31日，泰诺麦博科创板IPO获得受理，成为重启科创板第五套上市标准后首家以该标准申报上市并获得受理的企业。 招股书显示，泰诺麦博成立于2015年，是一家面向全球市场、致力于血液制品替代疗法的创新生物制药企业。致力于全人源单抗新药的开 发、制造、商业化及全球特异性血液制品的潜在替代，以满足广泛的临床需求，造福病患。 在成立十周年之际，泰诺麦博迎来了第一个上市的产 ...

Group 1: Company Overview - Zhuhai Tainomai Bo Pharmaceutical Co., Ltd. (Tainomai Bo) has submitted its IPO application, marking a significant step for the fifth listing standard on the Sci-Tech Innovation Board [1] - The company was established in 2015 and its core product, Staitouta Monoclonal Antibody Injection (New Taituo), is the world's first recombinant anti-tetanus toxin monoclonal antibody drug [2] - Staitouta is recognized as a breakthrough therapy and has been included in the priority review process by the Chinese drug regulatory authority [2] Group 2: Product Details - Staitouta is expected to reduce reliance on human blood products for passive immunity against tetanus, with approval for sale in China anticipated by February 2025 [3] - The drug addresses a significant public health threat, as tetanus has a mortality rate close to 100% without medical intervention and remains high even with modern medical care [3] - Traditional passive immunization methods require complex procedures, while Staitouta offers a simplified administration process [4] Group 3: Financial Performance - Despite the product's potential, Tainomai Bo's revenue remains limited, with reported revenues of 4.34 million RMB in 2022, 0 in 2023, and 1.51 million RMB in 2024, with only 16,930 RMB in Q1 2025 [5] - The company has incurred significant losses, with net profits of approximately -4.29 billion RMB in 2022 and -1.77 billion RMB in Q1 2025, leading to a cumulative loss of 1.02 billion RMB by March 2025 [5] Group 4: Market Position and Competition - Tainomai Bo's pricing strategy for Staitouta is a concern, as it lacks a competitive edge compared to tetanus human immunoglobulin, which is covered by medical insurance and has significantly lower prices [6][8] - The company is developing multiple antibody candidates to mitigate reliance on a single product, including TNM001, which is in Phase III clinical trials [9] Group 5: Industry Trends - The introduction of the fifth listing standard on the Sci-Tech Innovation Board is expected to attract more companies, including those outside the biopharmaceutical sector [10] - The market for RSV treatments is projected to reach $12.8 billion globally by 2030, indicating a competitive landscape for Tainomai Bo's products [9] - Other non-pharmaceutical companies are also preparing to apply for the fifth listing standard, indicating a growing interest in diverse sectors [11][12]

Core Viewpoint - Zhuhai Tainuo Maibo Pharmaceutical Co., Ltd. has received approval for its IPO application on the Sci-Tech Innovation Board, marking it as the first company to apply under the newly reintroduced fifth listing standard for unprofitable enterprises since June 18, 2023 [1][2] Company Overview - Tainuo Maibo was established in 2015 and is an innovative biopharmaceutical company focused on developing novel drugs [1] - The company's core product, Staitouta Monoclonal Antibody Injection (New Timo®), is expected to be approved for sale in China by February 2025, representing a significant innovation in the field of tetanus prevention [1] - Another key product, TNM001, is a long-acting monoclonal antibody for the prevention of RSV in healthy and high-risk infants, currently undergoing Phase III clinical trials [1] Financial Performance - The company's main business revenues for 2022-2024 and Q1 2025 were 330,000 yuan, 0 yuan, 15 million yuan, and 169,300 yuan respectively [2] - Net losses during the same period were 429 million yuan, 446 million yuan, 515 million yuan, and 177 million yuan [2] - R&D expenses for the same years were 323 million yuan, 393 million yuan, 425 million yuan, and 134 million yuan [2] - The company has not yet generated revenue from its main products, relying instead on patent technology transfer income [2] IPO Fundraising Plans - Tainuo Maibo aims to raise 1.5 billion yuan through its IPO, with allocations of 830 million yuan for new drug R&D, 330 million yuan for expanding antibody production facilities, and 340 million yuan for working capital [1] Industry Context - As of August 1, 2023, a total of 38 companies have applied for listing under the fifth standard, with 20 successfully listed and 12 withdrawing their applications [3] - Other companies that have passed the review under this standard include He Yuan Bio and Bei Xin Life, both from the biopharmaceutical sector [3] - Three additional companies are currently in the queue for IPO under the fifth standard, with varying stages of review [3]

7月31日，珠海泰诺麦博制药股份有限公司(简称：泰诺麦博)上交所科创板IPO已受理。华泰证券为其保 荐机构，拟募资15亿元。 | | | | 早见: 门儿 | | --- | --- | --- | --- | | 序号 | 项目名称 | 项目投资总额 | 拟投入募集资金金额 | | | 新药研发项目 | 83,650.00 | 83,000.00 | | 2 | 抗体生产基地扩建项目 | 38.137.30 | 33,000.00 | | 3 | 补充营运资金项目 | 34,000.00 | 34,000.00 | | | 合计 | 155,787.30 | 150,000.00 | 财务方面，于2022年度、2023年度、2024年度及2025年1-3月，公司实现营业收入为433.98万元、0、 1505.59万元、16.93万元人民币;同期，净利润分别约为-4.29亿元、-4.46亿元、-5.15亿元、-1.77亿元人 民币。 据招股书，泰诺麦博成立于2015年，是一家面向全球市场、致力于血液制品替代疗法的创新生物制药企 业。公司以"创造临床价值"为导向，秉持差异化创新和竞争战略，致力于全人源单抗新药的 ...

7月31日，上交所官网显示，珠海泰诺麦博制药股份有限公司（下称："泰诺麦博"）科创板IPO获受理，保荐机构为华泰联合证券有限责任公司。泰诺麦博 也成为科创板第五套上市标准重启后首家获得受理的企业。 其招股书显示，此次IPO，泰诺麦博拟募资15亿元。该公司计划本次募集资金用于新药研发项目、抗体生产基地扩建项目和补充营运资金项目。 选择科创板第五套上市标准 泰诺麦博成立于2015年，是一家主要从事全人源单抗新药研发、生产及销售的创新型生物制药公司。 该公司依托自主开发的 "高通量全人源单克隆抗体研发综合技术平台HitmAb®"，在全人源单抗领域探索更高安全性与有效性的抗体药物，已成功开发全 球同类首创的斯泰度塔单抗注射液。 创新生物药从早期研发到商业化生产是一个漫长的过程，需经历包括早期药物发现、CMC/药学研究、非临床研究、I 至III期临床试验等研发阶段。通常 而言，创新生物药从早期药物发现到完成临床试验往往需要10年至15年，且需要数千万美元到上亿美元的巨额研发投入。 2022年至2025年1-3月各期期末，泰诺麦博不存在研发支出资本化的情况，研发投入分别为 3.23亿元、3.93亿元、4.25亿元及1.3 ...

Core Viewpoint - Zhuhai Tainuo Maibo Pharmaceutical Co., Ltd. has received acceptance for its IPO on the Sci-Tech Innovation Board, marking the first company to be accepted under the resumed fifth listing standard since June 18, 2023, which supports unprofitable enterprises in various advanced technology sectors [2][4]. Group 1: Company Overview - The company was established in December 2015 and transformed into a joint-stock company in June 2023, with a registered capital of approximately 391.46 million yuan and a total of 767 employees as of March 2025 [7]. - The company focuses on innovative biopharmaceuticals aimed at global markets, particularly in blood product alternatives, with a commitment to creating clinical value through differentiated innovation [8]. Group 2: Main Business - The core product, Staitouta Monoclonal Antibody Injection (brand name: Xintimuo®), was approved for sale in China in February 2025 and is the world's first tetanus monoclonal antibody drug, recognized as a breakthrough therapy by the China CDE and included in the FDA's Fast Track program [8]. - Another key product, TNM001, is a potential long-acting monoclonal antibody for RSV prevention in infants, currently undergoing Phase III clinical trials [8]. Group 3: Shareholding Structure - The company has no controlling shareholder, with actual control held by Huaxin Liao and Zheng Weihong, who collectively control 33.10% of the company's shares [9]. Group 4: Financial Performance - The company reported revenues of 4.34 million yuan in 2022, 0 yuan in 2023, and projected revenues of 15.06 million yuan in 2024, with net losses of 394.34 million yuan, 467.69 million yuan, and 530.40 million yuan for the respective years [10]. - As of March 31, 2025, the company's asset-liability ratio was 56.48%, with a significant increase in R&D investment as a percentage of revenue, reaching 79331.93% in the first quarter of 2025 [11][12]. Group 5: IPO Fundraising and Investment Projects - The company plans to raise 1.5 billion yuan through its IPO, with 340 million yuan allocated for working capital and the remainder for two key projects: new drug development and the expansion of antibody production facilities [14].