TENNOR THERAP-B (06872): Core products rifasutenizol (TNP-2198) and rifaquizinone (TNP-2092) achieve multiple key R&D milestones

TENNOR THERAP-B (06872) announced that its two core products, rifasutenizol (TNP-2198) and rifaquizinone (TNP-2092), have achieved multiple key R&D milestones, details of which are set out below. Rifasutenizol (TNP-2198) Rifasutenizol is the world's first new molecular entity (NME) candidate drug developed against Helicobacter pylori infection since the bacterium was discovered in 1982. It features a unique dual-target synergistic mechanism of action by inhibiting bacterial RNA polymerase to block the transcription process, and through nitroreductase activation to generate free radicals that damage bacterial DNA, among other synergistic effects, it significantly enhances bactericidal efficacy, overcomes drug resistance, and substantially reduces the risk of resistance development. The Company has completed seven clinical trials of rifasutenizol in China, including two Phase I clinical trials, two clinical pharmacology trials, two Phase II clinical trials, and one Phase III clinical trial. Early clinical data of rifasutenizol were published as one of the featured articles in The Lancet Infectious Diseases in 2024, attracting global attention. The Phase III clinical trial results of rifasutenizol were also published in The Lancet Infectious Diseases on September 11, 2025. In addition, the Company reported the latest research findings of rifasutenizol at the 2025 Digestive Disease Week (the world's largest international conference in the field of gastrointestinal diseases) held in the United States, and was selected for a distinguished plenary presentation. In view of its potential in treating Helicobacter pylori infection, which can lead to serious and life-threatening conditions, the U.S. Food and Drug Administration has granted rifasutenizol Qualified Infectious Disease Product designation. The Company submitted a New Drug Application for rifasutenizol capsules to China's National Medical Products Administration in August 2025, and in June 2026 received a supplementary information notice issued by the Center for Drug Evaluation of the NMPA. As of the date of this announcement, rifasutenizol has completed the submission of all supplementary information. Rifaquizinone (TNP-2092) Rifaquizinone is a globally first-in-class investigational new drug with a triple-target mechanism of action, specifically designed to address the significant unmet clinical need of biofilm infections associated with implanted medical devices. Its unique triple-target synergistic action simultaneously inhibits bacterial RNA polymerase, DNA gyrase, and topoisomerase IV a mechanism that not only demonstrates potent antibacterial activity against drug-resistant pathogens (including methicillin-resistant Staphylococcus aureus and quinolone-resistant Staphylococcus aureus), but also reduces the frequency of resistance to an extremely low level (<10-12). In preclinical studies, rifaquizinone demonstrated potent biofilm bactericidal activity in both in vitro and in vivo models, with efficacy markedly superior to current standard-of-care antibacterial drugs. The Company has successfully completed six Phase I and Phase II clinical trials in the United States and China, with intravenous rifaquizinone showing a favorable safety profile and excellent efficacy in acute bacterial skin and skin structure infections (ABSSSI). Indications under development include: intravenous or intra-articular (IA) administration for the treatment of prosthetic joint infection (PJI), ABSSSI, and left ventricular assist device infection (LVADI). The transformative potential of rifaquizinone has been highly recognized by regulatory authorities. The U.S. Food and Drug Administration has granted rifaquizinone Qualified Infectious Disease Product, Fast Track, and Orphan Drug designations. In addition, rifaquizinone won the Excellence Award at China's National Disruptive Technology Innovation Competition. As of the date of this announcement, the Company has selected IA administration for the treatment of PJI as the core priority development indication for rifaquizinone. The Phase IIa proof-of-concept clinical trial of rifaquizinone administered via IA for the treatment of PJI as an alternative to surgery has achieved positive results, and the first patient has been enrolled in the multicenter Phase IIb clinical trial. The trial is designed to further evaluate the efficacy, safety, and pharmacokinetic profile of rifaquizinone in treating PJI without debridement or revision surgery, marking a critical stage in the clinical development of this potentially disruptive new drug product.