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 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