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 July 24, 2025, TenNor Therapeutics had built a differentiated pipeline of seven innovative assets, including three Core Products, namely, rifasutenizol (TNP-2198), the world’s first and only new molecular entity (“NME”) drug candidate developed for the treatment of Helicobacter pylori (“H. pylori”) infection; rifaquizinone (TNP-2092) injection, a potential first-in-class, triple-targeting antibacterial drug candidate for the treatment of implant-associated bacterial infections; and TNP-2092 oral, the world’s first multi-targeting antibacterial drug candidate for the treatment of diseases associated with gut bacterial metabolism.

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