Tetranome Biotech Passes STAR Market Listing Committee Review with Core Product Stetudotamab Injection Approved in China

Stock News
04/03

On April 3, Zhuhai Tetranome Biopharmaceutical Co., Ltd. (Tetranome Biotech) passed the listing committee review of the Shanghai Stock Exchange's STAR Market. Huatai United Securities is the sponsor for the offering, which aims to raise 1.5 billion yuan. According to the prospectus, Tetranome Biotech is an innovative biopharmaceutical company targeting the global market and dedicated to replacement therapies for blood products. The company focuses on the development, manufacturing, and commercialization of fully human monoclonal antibody drugs, aiming to provide potential substitutes for specific blood products globally to meet broad clinical needs and benefit patients.

The company's core product, Stetudotamab Injection (also known as "recombinant fully human anti-tetanus toxin monoclonal antibody TNM002," brand name: Xintituo®), was approved for marketing in China in February 2025. It is a first-in-class recombinant anti-tetanus toxin monoclonal antibody drug globally. It has been designated as a breakthrough therapy by China's Center for Drug Evaluation (CDE) and included in the priority review process, marking the first domestically developed innovative biologic in the anti-infective field to receive breakthrough therapy designation. Additionally, the U.S. FDA has granted it Fast Track designation. The product holds globally leading innovative significance in the field of tetanus prevention.

Another core product, "recombinant fully human anti-respiratory syncytial virus 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.

Financially, Tetranome Biotech reported revenues of approximately 15.06 million yuan and 51.22 million yuan for the years 2024 and 2025, respectively. During the same periods, the company recorded net losses of approximately 515 million yuan and 601 million yuan.

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