TaiGen Biopharmaceuticals Holdings Ltd (太景醫藥研發控股) yesterday said that the intravenous formulation of its new antibiotic Taigexyn (nemonoxacin) has been granted fast-track designation by China’s Center for Drug Evaluation and could gain marketing approval in the country before the end of this year.
It is the company’s second new drug to receive fast-track designation from Chinese authorities, after its new hepatitis C drug, Furaprevir (TG-2349), received the designation in April 2016, it said.
The oral formulation of the antibiotic had gained marketing approval in China in June 2016.
Intravenous formulations make up 80 percent of the Chinese antibiotics market, said Huang Kuo-lung (黃國龍), president of TaiGen’s Beijing-based subsidiary.
Once approved in China, the intravenous formulation of Taigexyn is expected to bring considerable sales contribution to the company, Huang said.
Non-fluorinated quinolone antibiotics, such as Taigexyn, are the second-most prescribed medicine against infections, Huang said, adding that the market was estimated to be worth about NT$30.3 billion (US$1.03 billion) as of the end of 2016.
Demand for antibiotics in China is expected to see continued growth of 8 to 10 percent annually, Huang said.
The company would receive an additional milestone payment from its Chinese licensee, Zhejiang Medicine Co (浙江醫藥集團), and it is eligible to receive 7 to 11 percent of Taigexyn revenue generated in China, Huang added.
New drugs typically see their sales peak three to five years after receiving marketing approval, Huang said.
Zhejiang Medicine Co is planning to market Taigexyn as a replacement for Levofloxacin and Moxifloxacin, which are the most prescribed antibiotics in China, with about 60 percent and 34 percent market shares respectively, Huang said.
TaiGen shares yesterday fell 1.08 percent to NT$22.95, outperforming the TAIEX, which fell 4.95 percent to 10,404 points.
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