TaiGen Biopharmaceuticals Holdings Ltd (太景醫藥研發控股) yesterday said that it expects rapid revenue growth next year after it receives approval to sell an injectable formulation of its novel antibiotic in China.
The company hopes that Taigexyn (nemonoxacin) will follow the same path in China as Bayer AG’s moxifloxacin, as the German pharmaceutical giant saw rapid sales growth after an injectable formulation was introduced to the market.
“Patients in China simply prefer the needle, as they think it is far more potent and effective than oral formulations,” TaiGen Asia chief commercial officer Philip Huang (黃國龍) told an investors’ conference in Taipei, adding that injectables make up 85.5 percent of China’s annual antibiotic sales.
While the oral formulation of Taigexyn received marketing approval from the China Food and Drug Administration in 2016, the company has yet to see significant growth from the drug, as it is still building its brand and networks of hospitals and physicians, he said.
The oral formulation would help make Taigexyn a known name among patients and physicians as the company awaits approval for the injectable formulation, Huang said, adding that unit sales of the antibiotic surged 562.7 percent in the first nine months of this year, with unit sales in the past quarter alone skyrocketing 651.1 percent.
In February, the injectable formulation was granted fast-track designation by Chinese regulators, saving it from a long line to be reviewed that would have added two to three years to the approval process, he said.
Chinese regulators have begun inspecting clinical trial data and the company expects the intravenous formulation to receive marketing approval before the end of next year, he added.
Bayer’s moxifloxacin sales first exceeded 100 million yuan (US$14.4 million at the current exchange rate) in 2005, one year after its intravenous formulation was approved, Huang said.
Since then, moxifloxacin sales had jumped to 1.89 billion yuan as of the end of last year, with its injectable formulation contributing 1.44 billion yuan, he said.
Moxifloxacin has maintained robust growth, despite the emergence of two Chinese-developed generic and biosimilar injectables, Huang added.
“As China’s income levels and medical insurance coverage continue to rise, the overall market will continue to grow for all drugmakers,” Huang said.
TaiGen said it has also been gearing up to submit a new drug application to regulators in the US and China for its next-generation antiviral, which is designed to block replication and transmission of the influenza A and B viruses.
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