Suzhou, China, April 11, 2023 – TenNor Therapeutics (Suzhou) Limited announced that its investigational new drug Rifasutenizole (TNP-2198) for the treatment of Helicobacter pylori infection has been granted the Qualified Infectious Drug Product (QIDP) status by the US FDA. With the QIDP designation, Rifasutenizole will qualify for priority review, fast track and a 5-year extension of market exclusivity in the United States.
Rifasutenizole is a multi-targeting drug conjugate discovered and developed by TenNor. It has the potential to become the first new antibacterial product developed specifically for H. pylori infection in the world. So far TenNor has completed five clinical trials in China and is currently conducting a multi-center, randomized, double-blind, bismuth-containing quadruple therapy-controlled Phase III clinical trial. The product is also supported by the National Major New Drug Innovation grant in China.
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