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]
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