On December 12, 2025, exciting news emerged from the 7th China Biopharmaceutical Industry Chain Innovation Leaderboard and Transformation Forum held in Hongqiao, Shanghai: Siltartoxatug Injection, independently developed by Zhuhai Trinomab Pharmaceuticals Co., Ltd. (hereinafter referred to as "Trinomab"), was honored with a place on the " China Biopharmaceutical Industry Chain Innovation Leaderboard " under the category of “Global first innovative drug”(Biologics).
China Biopharmaceutical Industry Chain Innovation Leaderboard
The " China Biopharmaceutical Industry Chain Innovation Leaderboard”, where Siltartoxatug Injection was recognized, is organized and selected by the China Biopharmaceutical Industry Chain Innovation Leaderboard and Transformation Alliance (CBIITA). This year's selection is based on objective quantitative analysis from authoritative data platforms, combined with comprehensive evaluations by the review committee composed of senior experts in the field. Through dual verification of data and expert evaluation opinions, the final results are determined by third-party institutions to ensure scientificity and credibility. One of the award-winning drugs is Siltartoxatug Injection that is a first-in class recombinant monoclonal antibody drug against tetanus toxin. The drug is a fully human monoclonal antibody developed by Trinomab utilizing the fourth-generation human monoclonal antibody technology platform, HitmAb , and has completely broken through the limitations of traditional blood-derived products. Compared with clinically commonly used Human Tetanus Immunoglobulin (HTIG) and Equine Tetanus Antitoxin (TAT), Siltartoxatug Injection represents a qualitative leap: no skin test required, single injection administration, rapid onset of action, and long-lasting protection. It fundamentally addresses industry pain points such as shortage of plasma supply and potential pathogen transmission, driving the upgrading and replacement of tetanus passive immunization agents.
Anti-tetanus monoclonal antibody market in China boasts broad prospects and high growth potential. According to a report by Frost & Sullivan, the applicable cases for tetanus passive immunization agents exceeded 30 million doses in China in 2024. It is projected that the market size of tetanus passive immunization agents in China will grow at a Compound Annual Growth Rate (CAGR) of 15.31% from 2024 to 2028, reaching RMB 4.71 billion. Meanwhile, the market size of anti-tetanus monoclonal antibody in China is expected to increase to RMB 2.13 billion by 2028. The launch of Siltartoxatug Injection provides a superior option for prevention.
Original Innovative Drug Benefits Patients Nationwide
The clinical value of Siltartoxatug Injection has garnered broad recognition from global authoritative institutions. As early as 2024, its research findings were presented at the American College of Emergency Physicians (ACEP) Annual Meeting and the European Society for Emergency Medicine (EUSEM) Congress, capturing significant attention from the international emergency medicine community. In July 2025, the full Phase III clinical trial results were published in Nature Medicine, a premier international journal with an impact factor of 50.0. The trial demonstrated that within 12 hours of administration, 95.4% of participants receiving Siltartoxatug achieved protective antibody levels—far surpassing the 53.2% observed in the HTIG group—and on day 90 post-administration, 91.5% of patients receiving Siltartoxatug maintained protective antibody levels, compared to only 10.1% in the HTIG group. Supported by robust clinical evidence, the drug received rapid marketing approval from China’s National Medical Products Administration (NMPA) in February 2025 and was successfully included in the updated National Reimbursement Drug List (NRDL) in December 2025—achieving “approval-to-reimbursement” within one year and enabling nationwide patient access to this cutting-edge therapy.
“Global First-in-Class” Showcases International Competitiveness
In terms of global strategy, Siltartoxatug Injection has been demonstrated having strong “global first-in-class” competitiveness. It was granted Fast Track designation by the U.S. FDA as early as 2022. Furthermore, Trinomab has engaged in discussions with the FDA regarding the regulatory pathway for Siltartoxatug Injection in the United States and plans to further align with the agency on the design and protocol of a U.S.-based Phase III clinical trial.
Dr. Jing Li, Founder and Chairman of Pharmadigger, Deputy Director of CBIITA, and Chair of the Innovation Leaderboard Jury, commented:
“The launch of Siltartoxatug Injection embodies the very purpose of our ‘Innovation Leaderboard’—not only does it resolve critical clinical shortcomings of existing therapies, but it also earns the trust of international regulators through solid, China-originated clinical data, charting a viable path for ‘data-driven global translation.’ In this sense, its inclusion on the Leaderboard is not merely an honor for Trinomab, but a vivid reflection of collaborative innovation and self-reliance across China’s biopharmaceutical ecosystem.
We hope this forum and the Leaderboard will inspire more ‘global first-in-class’ breakthroughs like Siltartoxatug Injection, rallying more innovation-driven companies and experts to collectively advance the high-quality development of China’s biopharma industry and contribute ‘Chinese wisdom’ and ‘Chinese solutions’ to global health.”
About the China Biopharmaceutical Industry Chain Innovation Leaderboard
The China Biopharmaceutical Industry Chain Innovation Leaderboard (the “Leaderboard”) is organized by the China Biopharmaceutical Industry Innovation & Translation Alliance (CBIITA). Now in its seventh consecutive year, the Leaderboard has become a widely recognized and influential benchmark within the industry, playing a positive role in guiding the aggregation of innovation resources, showcasing industrial achievements, and fostering an innovation-oriented ecosystem.
The 2025 edition further refined its evaluation mechanism, adhering to principles of fairness and impartiality. Leveraging authoritative data platforms for objective quantitative analysis and engaging senior experts for comprehensive assessment—with dual validation by data and expert judgment and final confirmation by an independent third party—the selection process ensured scientific integrity and public credibility.
Statement
1. Trinomab does not promote the use of any drug outside its approved indications.
2. The medical information in this press release is intended for informational and news reporting purposes only and is not intended for promotional use, nor should it be considered as healthcare or diagnostic advice.
Forward-Looking Statements
This press release contains information that is current as of the date of release. It may include certain forward-looking statements regarding future events or the Company’s future performance. These statements are subject to risks and uncertainties. Words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” and similar expressions are intended to identify such forward-looking statements. Trinomab undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.
