TaiGen Biopharmaceuticals Holdings Ltd (太景醫藥研發控股) on Monday said it would start selling the injectable formulation of its novel antibiotic Taigexyn in China next year after the manufacturer passed the Chinese regulators’ on-site inspection.
The Chinese National Medical Products Administration’s Center for Drug Evaluation began its inspection at Zhejiang Medicine Co Ltd’s (ZMC, 浙江醫藥) factory on Friday.
The Chinese pharmaceutical firm, a partner of TaiGen’s unit in Beijing, is to manufacture and market the injectable antibiotic in China.
The center finished its inspection yesterday, announcing that it had found no major errors after it examined the equipment, production process, quality control program, the ingredients and tested some samples, TaiGen said in a statement.
The center “gave us some suggestions to tweak production. Overall, it can be said that the factory passed the inspection,” TaiGen communication manager Grace Wang (王暄茹) said by telephone.
As on-site inspections marks the final stage of new drug application in China, the company is expected to receive marketing approval soon and launch sales next year, Wang said.
The approval would enable TaiGen to expand its Taigexyn production line, offering doctors an option besides the oral version of Taigexyn that it began selling in 2016, she said.
“We found that doctors prefer prescribing the oral versions of antibiotics for patients with less severe symptoms, as they can take the tablets themselves,” Wang said.
The injectable version of Taigexyn is forecast to be used for inpatient treatment or for patients with severe symptoms, she said.
The sales of oral Taigenxyn in Taiwan in the first nine months of the year surged 250 percent from a year earlier, while making an annual gain of 170 percent in China, the company’s data showed.
Sales of injectable version are expected to generate higher profits, as its price would be at least eight times more than the tablets, Wang said.
As it might take some time for the new drug to be included in China’s public health insurance program, Chinese might have to pay for the drug themselves, she added.
TaiGen said it is also seeking market approval for the intravenous formulation from Taiwan’s Food and Drug Administration and submitted a new drug application on Oct. 16.
It is difficult to forecast how long the agency’s review will take, the company said.
TaiGen shares yesterday fell 0.81 percent to NT$18.35 in Taipei trading. They have risen 7.94 percent this year.
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