On July 31st, Zhuhai Tainomab Pharmaceutical Co., Ltd. (Tainomab) received acceptance for its IPO application on the Shanghai Stock Exchange's Science and Technology Innovation Board (STAR Market). Huatai Securities serves as the underwriter, with the company seeking to raise 1.5 billion yuan.
According to the prospectus, Tainomab was established in 2015 as an innovative biopharmaceutical company targeting global markets and dedicated to blood product alternative therapies. The company is guided by "creating clinical value" and adheres to differentiated innovation and competitive strategies, focusing on the development, manufacturing, commercialization of fully human monoclonal antibody drugs and potential alternatives to global specific blood products to meet extensive clinical needs and benefit patients.
The company's core product, Statedutamab Injection (recombinant anti-tetanus toxin fully human monoclonal antibody TNM002, brand name: Xintituo®, referred to as "Statedutamab Injection" or "TNM002"), was approved for marketing in China in February 2025. This represents the world's first-in-class recombinant anti-tetanus toxin monoclonal antibody drug, recognized by China's CDE as a breakthrough therapy drug and included in the priority review process (also the first domestic innovative biological drug in the anti-infection field to be recognized as breakthrough therapy). It has also been granted Fast Track designation by the US FDA, marking revolutionary global leadership significance in the field of tetanus prevention.
The company's other core product, "recombinant anti-respiratory syncytial virus fully human monoclonal antibody TNM001" (TNM001), is potentially the world's third and China's first prophylactic long-acting anti-RSV monoclonal antibody drug applicable to healthy and high-risk infants. As of the prospectus signing date, TNM001 is undergoing Phase III clinical trials.
All investigational drugs in the company's R&D pipeline adopt fully human monoclonal antibody designs. Currently, both blockbuster drugs have demonstrated good safety and efficacy in clinical trials, with outstanding differentiated competitive advantages in their respective segments.
Additionally, as of the prospectus signing date, the company has developed multiple antibody molecules as candidate drugs, covering infectious diseases and pain-related disease areas. Among them, the globally first-in-class Statedutamab Injection has been approved for marketing, TNM001 (anti-RSV monoclonal antibody) is undergoing Phase III clinical trials, two candidate drugs TNM009 (anti-nerve growth factor NGF monoclonal antibody) and TNM005 (anti-varicella-zoster virus VZV monoclonal antibody) have completed Phase I trials, one candidate drug TNM006 (anti-human cytomegalovirus HCMV monoclonal antibody) has received IND approval, and three candidate drugs are in preclinical stages.
Among these products, Statedutamab Injection and TNM005 are first-in-class globally or have first-in-class potential globally, while TNM001 and TNM006 have potential to be China's first domestically developed products in their categories.
The actual proceeds from this new share issuance, after deducting issuance and other expenses, will be entirely used for projects related to the company's main business and working capital needed for main business development.
Financially, for 2022, 2023, 2024, and the first quarter of 2025, the company achieved operating revenues of 4.34 million yuan, 0 yuan, 15.06 million yuan, and 1.69 million yuan respectively. During the same periods, net profits were approximately -429 million yuan, -446 million yuan, -515 million yuan, and -177 million yuan respectively.