Zhuhai Tanomab Biopharma Co., Ltd. (referred to as Tanomab) has updated its IPO application status on the Shanghai Stock Exchange's Sci-Tech Innovation Board to "registration submitted." Huatai United Securities is the sponsor, with plans to raise 1.5 billion yuan. Founded in 2015, the company is an innovative biopharmaceutical enterprise targeting the global market and dedicated to developing alternative therapies for blood products. Guided by the principle of "creating clinical value," Tanomab adheres to a differentiated innovation and competition strategy. It focuses on the development, manufacturing, and commercialization of fully human monoclonal antibody new drugs, as well as the potential replacement of global specific blood products, aiming to meet broad clinical needs and benefit patients.

The company's core product, Statudetab Injection (also known as "Recombinant Anti-Tetanus Toxin Fully Human Monoclonal Antibody TNM002," brand name: Xintituo®), was approved for marketing in China in February 2025. It is a global first-in-class recombinant anti-tetanus toxin monoclonal antibody drug. Recognized as a breakthrough therapy by China's CDE and included in the priority review process (it is also the first domestic innovative biologic in the anti-infective field to be designated as a breakthrough therapy), it has also been granted Fast Track designation by the U.S. FDA. This represents a globally leading innovative advancement in the field of tetanus prevention.

Another core product, "Recombinant Anti-Respiratory Syncytial Virus Fully Human Monoclonal Antibody TNM001," has submitted a New Drug Application (NDA) for both non-high-risk and high-risk infant populations, which has been accepted and included in the priority review process.

Through years of accumulation, the company has established several core technology platforms with proprietary intellectual property rights, including the "High-throughput Fully Human Monoclonal Antibody R&D Integrated Technology Platform HitmAb®," the "High-efficiency Antibody Expression CHO-GS Cell Platform," the "Process Development Platform," and the "Bioanalysis Platform." It has continuously cultivated and enhanced core capabilities in innovative drug R&D and industrialization, covering key areas such as drug discovery, engineering cell line construction, process and quality development, pharmacological research, toxicological research, pharmacokinetic studies, clinical development, and large-scale production compliant with international GMP standards.

Candidate antibody drugs incubated through the HitmAb® platform possess mature antibody structures screened through real human immune tolerance environments. As fully human antibodies, they offer advantages such as high specificity, strong affinity, and excellent safety. This effectively reduces adverse consequences related to antibody drug immunogenicity, lowers clinical safety risks, and increases the probability of successful drug development.

Based on these core technology platforms, as of the signing date of the prospectus, the company has developed multiple antibody molecules as candidate drugs, covering disease areas including infectious diseases and pain-related disorders. Among them, the global first-in-class Statudetab Injection has been approved for marketing. TNM001 (anti-RSV monoclonal antibody) has submitted an NDA for non-high-risk and high-risk infant populations, which has been accepted and included in priority review. Two candidate drugs, TNM009 (anti-NGF monoclonal antibody) and TNM005 (anti-VZV monoclonal antibody), have completed Phase I clinical trials. One candidate drug, TNM006 (anti-HCMV monoclonal antibody), has received IND approval, and three candidate drugs are in the preclinical stage. Among these products, Statudetab Injection and TNM005 are either global first-in-class or have the potential to be global first-in-class.

Financially, for the years 2024 and 2025, the company achieved operating revenues of approximately 150.559 million yuan and 512.249 million yuan, respectively. During the same periods, the company reported net losses of approximately 515 million yuan and 601 million yuan, respectively.