August 22, 2025 – TenNor Therapeutics (Suzhou) Limited announced that the New Drug Application (NDA) for its first-in-class drug product, Rifasutenizol (TNP-2198) capsules, for the treatment of Helicobacter pylori (H. pylori) infection, has been accepted by the National Medical Products Administration (NMPA) of China.

Rifasutenizol is the first new molecular entity (NME) specifically developed for H. pylori since the discovery of this pathogen. It features a multi-target synergistic mechanism of action, expected to overcome the resistance issues associated with traditional antibiotics and provide a new treatment option for patients with H. pylori infection. In a multicenter, randomized, double-blind, bismuth-containing quadruple therapy-controlled Phase III clinical trial conducted in China, the Rifasutenizol-based triple therapy regimen demonstrated multiple advantages compared to the currently used bismuth-containing quadruple therapy.

The successful acceptance of the Rifasutenizol NDA marks another significant milestone in TenNor Therapeutics' journey towards commercialization.

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About TenNor Therapeutics

Incorporated in 2013, TenNor Therapeutics is a near-commercial stage biotechnology company dedicated to the discovery, development and commercialization of differentiated therapies to address unmet medical needs in disease areas associated with bacterial infections and bacterial metabolism. Empowered by its proprietary multi-targeting conjugate molecule technology, TenNor Therapeutics aims to deliver the best therapeutic solutions to overcome the limitations of conventional treatments and improve patient outcomes. As of January 24, 2026, TenNor Therapeutics had built a pipeline of seven innovative programs, including two Core Products, namely, rifasutenizol (TNP-2198), a new molecular entity (“NME”) drug candidate used as part of a triple therapy in combination with amoxicillin and a proton pump inhibitor for the treatment of Helicobacter pylori (“H. pylori”) infection in China and U.S. as well as monotherapy for bacterial vaginosis and C. difficile infection in China; and rifaquizinone (TNP-2092 injection), a triple-targeting antibacterial drug candidate for the treatment of implant-associated bacterial infections, i.e. acute bacterial skin and skin structure infection (“ABSSSI”) and prosthetic joint infection (“PJI”), as well as left ventricular assist device infection (“LVADI”) and catheter-related bloodstream infection (“CRBSI”) in China and the U.S.

For more information, please visit: www.tennortherapeutics.com