《中国经营报》记者查询获悉，泰诺麦博方面曾披露称，TNM002于2020年11月在澳大利亚开展I期临 床研究、2021年3月获美国FDA批准IND（新药研究申请）；2021年10月，TNM002完成在澳洲I期临床 研究。该管线在美国的研发进度却至今未公开任何阶段性结果。 TNM002在美国是否已完成 I期和且期临床？ 公司IPO是否正常推进？ 对此，泰诺麦博方面对记者表 示，如需了解公司相关信息，请以上交所披露的公司招股书及问询回复中相关内容为准。 表述引质疑 公司成立10年后，泰诺麦博有了第一个商业化产品。5个月后，公司递交招股书，冲刺科创板上市。 转自：中国经营报 作为科创板第五套上市标准重启后首家获受理的企业，珠海泰诺麦博制药股份有限公司（以下简称"泰 诺麦博"）的IPO进程备受关注。 近期，泰诺麦博披露首轮审核问询函回复，当中就其核心产品斯泰度塔单抗（代码：TNM002）的研发 和商业化进行重点说明。泰诺麦博主要从事全人源单抗新药研发、生产及销售，目前仅有1个产品实现 商业化，即破伤风抗体药物——斯泰度塔单抗注射液。 该公司在招股书称，斯泰度塔单抗于今年2月在国内获批上市，3月完成首次出货。此外，斯泰 ...

中经记者 陈婷 赵毅 深圳报道 作为科创板第五套上市标准重启后首家获受理的企业，珠海泰诺麦博制药股份有限公司（以下简称"泰 诺麦博"）的IPO进程备受关注。 近期，泰诺麦博披露首轮审核问询函回复，当中就其核心产品斯泰度塔单抗（代码：TNM002）的研发 和商业化进行重点说明。泰诺麦博主要从事全人源单抗新药研发、生产及销售，目前仅有1个产品实现 商业化，即破伤风抗体药物——斯泰度塔单抗注射液。 该公司在招股书称，斯泰度塔单抗于今年2月在国内获批上市，3月完成首次出货。此外，斯泰度塔单抗 于2022年8月被美国FDA纳入"快速通道"，未来可在美国直接开展Ⅲ期临床。不过，前述说法在上交所 的问询之下有些出入。 泰诺麦博在问询回复中披露称，斯泰度塔单抗被美国FDA纳入的是快速审评通道（Fast Track），该通 道是美国FDA为了促进新药研发并加速药物审评流程而授予在研药物的一种资格认定。此外，FDA快速 审评通道将允许公司分阶段提交申请资料，即滚动提交，有助于缩短新药上市申请的审批时间。 TNM002"未来可在美国直接开展Ⅲ期临床"并非美国FDA"快速通道"带来的直接影响，而是公司与FDA 沟通斯泰度塔单抗在美国 ...

Core Viewpoint - Zhuhai Tainuo Maibo Pharmaceutical Co., Ltd. has successfully submitted its IPO application to the Sci-Tech Innovation Board, marking it as the first company accepted under the new fifth listing standard for unprofitable enterprises [1][3]. Company Overview - The company was established in 2015 and focuses on the research, production, and sales of fully human monoclonal antibody drugs [4]. - Its core product, Staitouta Monoclonal Antibody Injection, was approved for sale in China in February 2025, making it the first recombinant monoclonal antibody drug for tetanus toxin globally [4]. - Another key product, TNM001, is a potential long-acting monoclonal antibody for RSV prevention in infants, leading in global research [4]. Financial Performance - The company reported minimal revenue from technology transfer in 2022 and 2024, with sales starting in March 2025, generating revenue of 169,300 yuan [5]. - Revenue figures for the years 2022 to Q1 2025 were 4.34 million yuan, 0, 1.51 million yuan, and 16.93 million yuan, respectively, with net losses of 4.29 billion yuan, 4.46 billion yuan, 5.15 billion yuan, and 1.77 billion yuan during the same periods [6]. - Cumulative losses reached 1.567 billion yuan, with unabsorbed losses at 1.024 billion yuan by the end of the reporting period [6]. IPO Details - The IPO aims to raise 1.5 billion yuan, with plans to issue up to 69.08 million shares [3][4]. - The funds will be allocated to new drug research and development, expansion of antibody production facilities, and working capital [4]. Cash Flow and Investment - The company has experienced tight cash flow, with a net cash outflow from operating activities of 1.16 billion yuan during the reporting period, leaving only 420 million yuan in cash as of March 31, 2025 [8]. - Cumulative R&D investment exceeded 1.1 billion yuan over the past three years, with a significant increase in R&D spending relative to revenue [7].