Drug maker TaiGen Biotechnology Co (太景生技) is expected to launch its first product across the Taiwan Strait in the next two years.
One of the company’s products, Nemonoxacin, which goes by the trade name Taigexyn and was developed as a treatment for pneumonia and skin infections, is expected to receive a drug permit for an oral formulation in the first half of next year from both the Taiwanese and Chinese food and drug administrations, TaiGen chairman and chief executive officer Hsu Ming-chu (許明珠) said at an investors’ conference on Thursday.
The oral antibiotic drug is likely to hit the Chinese market in the second half of next year and the Taiwanese market in the first half of 2015, Hsu added.
TaiGen last year licensed China-based Zhejiang Medicine Co (浙江醫藥集團) to make and sell Nemonoxacin in China.
TaiGen is expected to receive between US$1 million and US$5 million of milestone payments from Zhejiang Medicine, as well as royalties of 7 percent to 11 percent on future sales of the drug in China, the company said.
Citing the sales of two similar drugs in China, Hsu estimated that Nemonoxacin’s market value in China would be 1 billion yuan (US$165 million) a year.
The company is seeking to license Nemonoxacin to companies, with the intention of them filing third-phase clinical trials in Europe and the US and then selling the drug in those places, Hsu said.
TaiGen is also looking for partners to file second-phase clinical trials of cocktail treatments for hepatitis C using TG-2349, Hsu said.
“TG-2349 is used to inhibit protease in the hepatitis C virus, and we are looking for companies with polymerase inhibitor or inhibitors for nonstructural protein 5A,” Hsu said. “However, because we plan to enter China with the drug ourselves, we are seeking partners without operations in China.”
Lotus Pharmaceutical Co (美時化學製藥), which makes and distributes oral and injection medicines, will manufacture TaiGen’s Nemonoxacin on a contract basis for markets other than China, Europe and the US.
TaiGen said it plans to develop its own manufacturing capacity in China in the next two to three years.
“We will purchase a formulation factory in China as soon as we have enough money, because the Chinese government demands that we make drugs locally,” she said.
Nemonoxacin is the first drug from Taiwan to meet the requirements to be registered as a category 1.1 new drug in China, which will enable it to reap a higher price premium, the company said.
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Meanwhile, TaiGen plans to raise up to NT$1.1 billion (US$36.6 million) ahead of its TAIEX listing on Jan. 17, as the company will issue 22 million new shares at about NT$50 each, with 10 percent of the new shares to be reserved for its employees.
The company plans to use the proceeds as working capital for new drug development and to repay bank loans.
In the January to September period, the company posted losses of NT$271.86 million, or NT$0.42 per share.