Pharmadax Inc (法德生技藥品) yesterday said it has gained marketing approval in China for its generic schizophrenia drug and expects to grab 20 percent of the market within three years.
On Sunday, the company received approval from the Chinese National Medical Products Administration (NMPA) for the 50mg, 150mg, 200mg, 300mg and 400mg versions of its quetiapine fumarate ER tablets, Pharmadax said, adding that its drug is the generic version of AstraZeneca PLC’s Seroquel XR tablet.
The company obtained US Food and Drug Administration (FDA) approval for the antipsychotic drug in 2017.
The US approval helped the firm secure a priority review with the NMPA, which sped up the licensing process to less than two years, Pharmadax said.
While competition has become heated in the US, with a few companies producing generic versions of Seroquel, including Handa Pharmaceuticals Inc (漢達生技) and India’s Lupin Ltd, Pharmadax said that there would be less competition in China.
“Currently, only the original Seroquel is available in China, and we are the first generic drug company to obtain approval, while other companies are still waiting, so we are confident that we can stay ahead of our rivals,” a company official told the Taipei Times.
Sales of quetiapine fumarate tablets in China increased 32.13 percent year-on-year to 1.75 billion yuan (US$244.9 million) last year, Pharmadax said.
With the Chinese government paying more attention to mental health, more health programs or support services are expected to be launched in the country, which would likely boost sales of antipsychotic drugs, the company said.
Pharmadax has set a target of annual sales growth of 50 percent over the next three years, aided by China-based Coland Holdings Ltd (康聯控股), which is responsible for marketing the drug for the next five years.
Coland has set up distribution channels in more than 200 cities and at more than 3,500 hospitals in China, Pharmadax said.
The company said it would begin marketing the drug in China soon, declining to give an exact date.
Pharmadax has finalized the prices for Quetiapine Fumarate with Coland, which would be slightly lower than the original drug, it said.
The company would produce 800 million tablets per year at its two plants in Foshan, Guangdong Province, it added.
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