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 is a clinical-stage company specialized in the discovery and development of differentiated new drug products in diseases associated with bacterial infection and metabolism. TenNor possesses a unique multi-targeting drug conjugate technology platform and a strong new drug development pipeline with global IP protection. Several products are currently in late-stage of clinical development targeting H. pylori infection, implanted medical device infections, hepatic encephalopathy and irritable bowel syndrome with diarrhea. The company is committed to address the unmet needs in the disease area and provide safe and effective therapies for patients in China and around the world.
For more information, please visit: www.tennorx.com