The China Securities Regulatory Commission (CSRC) has issued its approval for the initial public offering registration of Zhuhai Tainuo Maibo Pharmaceutical Co., Ltd.

The company intends to list on the Shanghai Stock Exchange's STAR Market, with Huatai United Securities acting as its sponsor. It aims to raise 1.5 billion yuan through the offering.

According to its prospectus, the company was established in 2015 and is an innovative biopharmaceutical firm focused on developing blood product replacement therapies for the global market.

Its core product, the Staidutai Monoclonal Antibody Injection (also known as recombinant anti-tetanus toxin fully human monoclonal antibody TNM002, trade name: Xintituo®), was approved for marketing in China in February 2025.

This product is a first-in-class recombinant monoclonal antibody against tetanus toxin. It has been designated as a breakthrough therapy by China's Center for Drug Evaluation (CDE) and included in a priority review process—marking it as the first domestically developed innovative biologic in the anti-infective field to receive such a designation.

It has also been granted Fast Track designation by the U.S. Food and Drug Administration (FDA), holding globally leading and transformative significance in the field of tetanus prevention.

The company's other core product, "recombinant anti-respiratory syncytial virus fully human monoclonal antibody TNM001," has had its New Drug Application (NDA) submitted and accepted for review, targeting both non-high-risk and high-risk infant populations, and it has also been included in a priority review program.

Through years of development, the company has established several proprietary core technology platforms, including the "HitmAb® High-throughput Fully Human Monoclonal Antibody R&D Integrated Technology Platform," the "High-efficiency Antibody Expression CHO-GS Cell Platform," a process development platform, and a bioanalysis platform.

It has continuously built comprehensive core capabilities for innovative drug development and commercialization, covering key areas such as drug discovery, engineering cell line construction, process and quality development, pharmacological research, toxicology studies, pharmacokinetic research, clinical development, and large-scale production compliant with international GMP standards.