Dannopharmaceutical-B (06872): Core products rifonidazole (TNP-2198) and rifuquinone (TNP-2092) have achieved a number of key developments in research and development
Zhitong Finance App News, Danno Pharmaceutical-B (06872) announced that the Group's two core products, rifonidazole (TNP-2198) and rifuquinone (TNP-2092), have made a number of key developments in research and development. Details are listed below.
rifonidazole (TNP-2198)
Since Helicobacter pylori was discovered in 1982, rifonidazole is the world's first novel molecular entity (NME) drug candidate developed for this pathogenic bacterial infection. It has a unique dual-target synergy mechanism - by inhibiting bacterial RNA polymerase and activating nitro-reductase to produce synergetic effects such as damaging bacterial DNA, it significantly enhances the bactericidal effect, overcomes drug resistance, and greatly reduces the risk of drug resistance.
The company has completed seven clinical trials of rifonidazole in China, including two phase I clinical trials, two clinical pharmacological trials, two phase II clinical trials, and one phase III clinical trial. Early clinical data on rifonidazole was published as one of the feature articles in “The Lancet Infectious Diseases” in 2024, drawing global attention. The results of the phase III clinical trial of rifonidazole were also published in “The Lancet Infectious Diseases” on September 11, 2025. Furthermore, the company reported the latest research results on rifonidazole at the 2025 Digestive Disease Week Conference (the world's largest international conference in the field of gastrointestinal diseases) held in the US, and was selected as an outstanding general conference report.
Due to its potential to treat Helicobacter pylori infections that may cause serious and life-threatening conditions, the US Food and Drug Administration has qualified rifonidazole as a qualified infectious disease product.
The company submitted a drug marketing license application for rifonidazole capsules to the China National Drug Administration in August 2025, and received a supplementary information notice from the Drug Evaluation Center of the State Drug Administration in June 2026. As of the date of this announcement, rifonidazole has completed the submission of all supplementary information.
rifuziquantel (TNP-2092)
Rifaquinone is the world's first novel drug under development with a three-target mechanism of action. It is specifically designed to address the major unmet clinical need for biofilm infections associated with implanted medical devices. Its unique three-target synergy can co-inhibit bacterial RNA polymerase, DNA rotase, and topoisomerase IV - a mechanism that not only shows strong antimicrobial activity against drug-resistant pathogens (including methicillin-resistant Staphylococcus aureus and quinolone-resistant Staphylococcus aureus), but also reduces the frequency of drug resistance to a very low level (<10-12).
In preclinical studies, rifoquinone showed strong biofilm bactericidal activity in both in vitro and in vivo models, and the effect was clearly superior to current standard antimicrobials. The company has successfully completed six phase I and phase I clinical trials in the US and China. Intravenous rifoquinone injections have shown good safety and excellent efficacy in acute bacterial skin and skin structure infections (ABSSSI). Indications developed include intravenous or intra-articular injection (IA) to treat artificial joint infections (PJI), ABSSSI, and left ventricular assist device infections (LVADI).
Rifaquinone's transformative potential has been highly recognized by regulators. The US Food and Drug Administration has granted rifaquinone certification as a qualified infectious disease product, fast track, and orphan drug. In addition, rifuquinone also won the first prize in the China National Disruptive Technology Innovation Competition.
As of the date of this announcement, the company has selected treatment of PJI through IA administration as a core priority development indication for rifuquinone. The phase IIa proof-of-concept clinical trial using IA administration to treat PJI through IA administration has achieved positive results, and a multi-center phase IIb clinical trial has also completed enrolling the first patient. The trial aims to further evaluate the efficacy, safety, and pharmacokinetic characteristics of rifaquinone in treating PJI without debridement or revision surgery, and marks a critical stage in clinical development of this potentially disruptive new drug product.