Taipei-based TaiGen Biotech has won approval from the China FDA to sell its new antibiotic, Taigexyn (nemonoxacin), that successfully cleared a Phase III trial late last year in Taiwan and mainland China to treat pneumonia.
The approval marks a first for a Class 1.1 new drug from a Taiwanese company in mainland China. It's also the first approval since China FDA set a requirement for the self-inspection of drug clinical trial data in July 2015. The drug is already approved in Taiwan.
"This is the second market approval for Taigexyn and will further expand its commercial opportunity," Ming-Chu Hsu, chairman and CEO of TaiGen said in a statement. "Mainland China is the largest antibiotic market in the world with annual sales exceeding $12 billion. Taigexyn's excellent activity against drug-resistant bacteria and low propensity to resistance development is a valuable tool in fighting the problem of increasing antimicrobial resistance."
China and India are at the center of efforts in Asia to curb the over-prescription of antibiotics that has led to growing antibiotic resistance in the world's two most populous countries.
The TaiGen antibiotic will be marketed in China by Zhejiang Medicine with sales expected in the second half of 2016, according to the company.
Taigexyn is a non-fluorinated quinolone, broad spectrum antibiotic, with clinical trials demonstrating activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumonia (PRSP).
The U.S. FDA granted Taigexyn a Qualified Infectious Disease Product and fast-track designations for Community-Acquired Pneumonia and acute bacterial skin and skin structure infections.
- here's the release
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