2023-04-13

Rifasutenizole for H. pylori Received FDA QIDP Designation

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

TenNor Therapeutics (6872.HK), incorporated in 2013, 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 June 30, 2026, TenNor Therapeutics had built a pipeline of eight innovative programs, including two Core Products, namely: rifasutenizol (TNP-2198), a multi-targeted conjugated new molecular entity (“NME”) candidate for the treatment of Helicobacter pylori infection when used in combination with amoxicillin and a proton pump inhibitor, as well as monotherapy for bacterial vaginosis and Clostridioides difficile (C. difficile) infection; and rifaquizinone (TNP-2092) injection, a triple-targeting NME candidate for the treatment of acute bacterial skin and skin structure infection and implant-associated bacterial infections (such as prosthetic joint infection, left ventricular assist device infection and catheter-related bloodstream infection).

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