科创板第五套上市标准

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泰诺麦博三年多亏损超15亿负债率高企,创新药企乘东风还是成冬风?
Sou Hu Cai Jing· 2025-08-13 04:42
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]
科创板第五套标准新进展!时隔两年,拿到批文!
券商中国· 2025-08-09 04:53
Core Viewpoint - The approval of Guangzhou Bibet Pharmaceutical Co., Ltd.'s IPO marks a significant development for companies choosing the fifth listing standard of the Sci-Tech Innovation Board, indicating a gradual resumption of the IPO process for unprofitable tech firms [1][2]. Group 1: Company Overview - Bibet is a biopharmaceutical company focused on innovative drug development, particularly in oncology, autoimmune diseases, and metabolic diseases, aiming to create first-in-class drugs and address unmet clinical needs [4]. - The company has been granted approval under the fifth listing standard, which requires a market value of at least RMB 4 billion and at least one core product approved for phase II clinical trials [6]. Group 2: IPO Process and Timeline - Bibet received approval from the Sci-Tech Innovation Board's listing committee on January 11, 2023, and submitted its IPO registration application to the CSRC on June 1, 2023, after a two-year wait for the IPO approval [2][3]. - Since the resumption of the fifth listing standard in June 2025, there are currently six unprofitable companies in the IPO queue, with two having received approval, including Bibet [10][11]. Group 3: Financials and Fundraising - Bibet plans to raise approximately RMB 2 billion through its IPO, with allocations of RMB 500 million for working capital, RMB 950 million for new drug development, and RMB 550 million for the construction of a research and development center and formulation industrialization base [7]. - The company reported zero revenue for 2022 and 2023, with net losses of RMB 188.34 million, RMB 172.76 million, and an expected loss of RMB 56 million for 2024, totaling a cumulative loss of RMB 417.09 million [8].
证监会同意!重启后又一家
Shang Hai Zheng Quan Bao· 2025-08-08 14:22
Core Viewpoint - Guangzhou Bibetter Pharmaceutical Co., Ltd. has received approval from the China Securities Regulatory Commission for its IPO application on the Sci-Tech Innovation Board after a 14-month hiatus [1][8]. Company Overview - Bibetter focuses on major diseases such as tumors, autoimmune diseases, and metabolic diseases, developing First-in-Class drugs and innovative drugs to meet unmet clinical needs [2]. - The company plans to issue up to 90 million shares and aims to raise 2.005 billion yuan, with 949 million yuan allocated for new drug R&D, 555 million yuan for the construction of a R&D center and formulation industrialization base, and 500 million yuan for working capital [2]. Financial Performance - Bibetter reported no operating revenue for 2022, 2023, and 2024, with net losses of 188 million yuan, 173 million yuan, and 55.998 million yuan respectively [2]. - Total assets decreased from 587.2168 million yuan in 2022 to 332.4771 million yuan in 2024, while equity attributable to shareholders dropped from 468.3349 million yuan to 290.2201 million yuan over the same period [3]. - The company has a high R&D expense ratio, with R&D expenses of 167 million yuan, 158 million yuan, and 120 million yuan for the years 2022 to 2024, significantly above the average of comparable companies [3][5]. Market Position and Future Prospects - As of the date of the prospectus, Bibetter has one Class 1 innovative drug, BEBT-908, approved for market, with other products in various clinical trial phases [4][6]. - The company is expected to maintain high R&D expenditures and will likely continue to operate at a loss in the foreseeable future, with no dividends anticipated post-IPO [6]. - The market potential for its core products targeting high-incidence cancers is significant, with an expected post-IPO market valuation of no less than 4 billion yuan [8]. Shareholding Structure - Before the issuance, the company has no controlling shareholder, with the actual controller, Qian Changgeng, holding 43.96% of the shares [9].
科创板第五套纳新 泰诺麦博闯关
Bei Jing Shang Bao· 2025-08-04 16:00
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”首单受理“破冰” 非药企案例有望落地
2 1 Shi Ji Jing Ji Bao Dao· 2025-08-04 11:32
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]
时报观察丨借“智”资深专业机构 精准识别科创企业
Zheng Quan Shi Bao Wang· 2025-08-01 23:37
Group 1 - The core point of the article is that Zhuhai Tenomab Pharmaceutical Co., Ltd. has become the first company to apply the professional institutional investor system in the Sci-Tech Innovation Board IPO process, which aims to enhance the identification of technology-driven enterprises and their investment value [1][2] - The introduction of the professional institutional investor system is intended to leverage the insights of leading venture capital and industry funds to improve the efficiency of capital market resource allocation [1] - Tenomab's disclosure of a professional institutional investor that acquired 3.94% of its shares prior to the IPO indicates a positive signal for the company, which is currently in a loss-making phase [1] Group 2 - The professional institutional investor system is a well-established practice in foreign markets, such as the Hong Kong Stock Exchange's rules regarding "professional investors" [2] - Unlike foreign markets, the reform in the Sci-Tech Innovation Board is a pilot program limited to companies under the fifth listing standard, ensuring flexibility and exploration without imposing unnecessary barriers to listing [2] - Regulatory authorities have detailed the criteria for recognizing professional institutional investors based on investment experience and holding duration, which helps prevent sudden share acquisitions and ensures the system's rigor and standardization [2]
借“智”资深专业机构 精准识别科创企业
Zheng Quan Shi Bao· 2025-08-01 17:45
Group 1 - The core viewpoint of the news is that Zhuhai Tenomab Pharmaceutical Co., Ltd. has become the first company to apply for an IPO under the new system for qualified institutional investors on the Sci-Tech Innovation Board, which aims to enhance the identification of technology-driven enterprises and their commercial prospects [1][2] - The introduction of the qualified institutional investor system is intended to leverage the insights of leading venture capital and industry funds to improve the efficiency of resource allocation in the capital market [1][2] - Tenomab disclosed that a qualified institutional investor acquired 3.94% of its shares within 24 months prior to the IPO application, which is seen as a positive indicator for the company, especially as it is still in a loss-making phase [1] Group 2 - The qualified institutional investor system is a well-established practice in foreign markets, such as the Hong Kong Stock Exchange, which includes specific regulations for "qualified investors" [2] - Unlike foreign markets, the reform on the Sci-Tech Innovation Board is a pilot program limited to companies under the fifth set of listing standards, ensuring flexibility and exploration without imposing unnecessary barriers to listing [2] - Regulatory authorities have detailed criteria for identifying qualified institutional investors based on investment experience, holding period, and other factors, which helps prevent sudden stock acquisitions and ensures the system's rigor and standardization [2]
科创板第五套上市标准重启后首家,泰诺麦博IPO获受理,拟募资15亿元
Cai Jing Wang· 2025-08-01 13:02
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]
科创板第五套上市标准重启后,首家受理企业来了!
中国基金报· 2025-08-01 06:28
Core Viewpoint - The IPO application of Zhuhai Tainomai Bo Pharmaceutical Co., Ltd. has been accepted, marking it as the first company to utilize the fifth set of standards for the Sci-Tech Innovation Board since its restart on June 18, 2025 [2][5]. Group 1: IPO Details - Tainomai Bo's IPO application was accepted on July 31, 2025, with Huatai Securities as the sponsor [2][3]. - The company plans to raise 1.5 billion RMB for new drug research and development, expansion of antibody production facilities, and to supplement working capital [12][13]. Group 2: Company Background - Tainomai Bo is an innovative biopharmaceutical company focused on global markets, specializing in blood product alternatives [8]. - The company has developed the "First-in-Class" Staitouta monoclonal antibody injection, recognized as a breakthrough treatment drug in the anti-infection field [9]. Group 3: Financial Performance - The company reported minimal revenue, with the Staitouta monoclonal antibody injection expected to generate sales starting in March 2025 [9]. - Tainomai Bo has incurred continuous net losses, with cumulative losses reaching 1.024 billion RMB by the end of the reporting period [11].
时报观察 审核提速 科创板第五套标准迎“尖子生”
Zheng Quan Shi Bao· 2025-07-22 19:07
Core Viewpoint - The approval of He Yuan Bio's registration application marks the first IPO under the newly restarted fifth listing standard of the Sci-Tech Innovation Board, indicating a shift towards a more inclusive and efficient regulatory approval mechanism [1][2]. Group 1: Regulatory Changes - The China Securities Regulatory Commission (CSRC) has approved He Yuan Bio's registration, which is the first company to fully navigate the IPO review process under the fifth listing standard [1]. - The time taken from approval to registration was just over ten working days, reflecting an evolution towards a more efficient approval process [1]. Group 2: Industry Impact - Other companies in the IPO queue, such as BeiXin Life, SiZheRui, HengRunDa, and BiBeiTe, are also applying for listing under the fifth standard, all belonging to the pharmaceutical sector and characterized by core technologies despite being unprofitable [1]. - The fifth listing standard has activated the financing needs of unprofitable companies with "sci-tech" attributes, leading to a surge in applications and adjustments in fundraising amounts [1][2]. Group 3: Future Outlook - The fifth listing standard has been a crucial pathway for unprofitable hard-tech enterprises to access capital markets, with 20 pharmaceutical companies already successfully listed [2]. - The expansion of this standard to include fields like artificial intelligence, commercial aerospace, and low-altitude economy is expected to provide more convenient financing channels for hard-tech companies [2]. - The regulatory changes aim to balance inclusivity and risk prevention, allowing truly impactful companies to list without being hindered by profitability status, thus fostering innovation and industrial upgrades [2].