Shares in newly listed Anxo Pharmaceutical Co Ltd (瑩碩生技) yesterday made modest gains on the Emerging Stock Board of the Taipei Exchange as the drug developer makes headway in the Chinese market. The stock rose 0.6 percent to NT$45.
Anxo on Monday announced that it had signed an agreement with a Chinese company based in Shenzhen to commercialize a generic psychoactive drug.
The two firms would work together to bring the drug through the regulatory approval process in China, Anxo said, without revealing further details due to confidentiality terms.
The generic drug is a treatment for depression that has already been approved for sale in Taiwan, Anxo spokesperson Hank Chen (陳志賢) said by telephone.
The drug would be manufactured in Taiwan and distributed in China by the company’s Chinese partner, Chen added.
Although the depression treatment has already been approved by Taiwanese authorities and could be eligible for China’s fast track status as a generic drug, it would still have to complete a full set of clinical trials in China, Chen said.
It is still too early to give a time table for the approval process and the company would monitor China’s regulations for changes, he said.
Anxo said China does not have a drug that equals its depression drug, so the product is expected to command a high price there.
The drug would have an estimated market value of US$150 million, and sales in China alone could reach 350 million yuan (US$51.23 million), the company said.
The company aims to take advantage of a new set of rules for evaluating generic drugs that was implemented by the China Food and Drug Administration in 2015.
The rules have cleared up China’s once chaotic queue for approving new drugs as developers with lower-quality clinical studies have withdrawn their applications to facilitate efforts to push through better-prepared companies, who are able to meet US and European standards regarding research, development and manufacturing capabilities, industry analysts have said.
Anxo in early May announced that it had signed a partnership with another Chinese company that would allow it to out-license a drug known only as NXR-606 in China.
Founded in 2003, Anxo reported a pre-tax income of NT$53.41 million in the first four months of the year, with its bottom line bouncing back into the black. Earnings per share as of the end of April were NT$0.98.
Sales in the first half of the year rose 27.02 percent year-on-year to NT$437 million, company data showed.
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