TAIPEI, Taiwan, August 28, 2022－TaiGen Biotechnology Company, Limited (“TaiGen”) announced today that Russian Federation MoH (Ministry of Health) has approved the new drug application (NDA) for Nemonoxacin IV formulation (500 mg/250 ml) for the treatment of community-acquired bacterial pneumonia (CAP). Along with this marketing authorization, Nemonoxacin has accumulated a total number of 5 marketing authorizations worldwide.
Nemonoxacin is a novel non-fluorinated quinolone available in both oral and intravenous formulations. TaiGen has completed multi-national and multi-center trials of both forms. Clinical data showed it is active against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumonia. Two formulations of Nemonoxacin are approved and marketed in Taiwan and mainland China. And they have been proven to offer effective, safe, and comprehensive treatment to fulfill unmet medical needs to local patients.
“Antimicrobial resistance is a silent pandemic estimated to kill 10 million people each year after 2050; and we are delighted to see the introduction of nemonoxacin to Russian people, by R-Pharm, to battle against it.” – says Mr. Kuo-Lung Huang, Chairman and CEO at TaiGen.
This marketing authorization is also a milestone for Nemonoxacin to enter other CIS (Commonwealth of Independent States) markets. The authorized medicine in Russian Federation is recognized by other CIS countries. Therefore, Nemonoxacin is eligible for NDA filing in these countries. The whole market of CIS countries and Turkey is licensed to R-Pharm by TaiGen as the R-Pharm Territory.
R-Pharm is a leading Russian pharmaceutical company with commercial operations in Russian Federation, CIS, and Turkey. In 2021, it has over 6500 employees with sales revenue of US$3.1 billion. Key business areas of R-Pharm include manufacturing, sales and marketing of prescription drugs, laboratory diagnostics, medical equipment, and venture investment.
About TaiGen Biotechnology
TaiGen Biotechnology is a leading research-based and market-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, China. In addition to Nemonoxacin, TaiGen has an in-house discovered key NCEs: TG-1000, a novel pan-influenza antiviral effective against influenza-A, influenza-B, avian flu H7N7, and Tamiflu-resistant viruses. TG-1000 is currently in Phase 2 clinical study in China and is ready to file phase 3 trial.