Drug maker Golden Biotechnology Corp (國鼎生技) yesterday said that its new lung cancer drug has received approval from the US Food and Drug Administration (FDA) to enter second-stage clinical trials, paving the way for the medicine to hit the world market in 2017.
Hocena is the first chemical drug developed by the company. It has a higher profit margin than the other botanical drugs in the pipeline, the company said.
The company yesterday signed an agreement to outsource the second-phase clinical trials to global contract research organization Icon Holdings Corp. Icon will conduct the trials in the US and Taiwan first, based on the agreement.
Golden Biotechnology plans to spend US$10 million on clinical trials, company chairman Alex Liu (劉勝勇) told a media briefing yesterday.
“We expect the drug to hit the market within 20 months, as the US government has allowed the drug to enter the fast track,” meaning it can skip third-phase clinical trials, he said.
There is currently no drug that can cure lung cancer, but the new approach offered by Hocena to treat the disease could give new hope to lung cancer patients, Liu said.
OTHER CANCER TYPES
Aside from lung cancer, Golden Biotechnology also plans to test Hocena for treatment of pancreatic cancer, colorectal cancer and leukemia when the drug passes the first part of phase two clinical trials within the next six to 10 months, said Chen Chih-ming (陳志銘), director of the company’s research and development department.
The market for lung cancer and pancreatic cancer drugs is estimated at about US$6.5 billion a year, according to Golden Biotechnology. That is less than a 10th of the overall market for cancer drugs last year, at US$80 billion.
The company plans to expand its capital to about NT$1 billion (US$33.7 million) from NT$700 million now by the end of this year to fund the clinic trials.
Farglory Group (遠雄集團), which has a 20 percent stake in the company, is its largest shareholder, followed by three companies set up by Global Mixed-mode Technology Inc (致新科技) chairman Hsieh Nan-chiang (謝南強), which own 10 percent of the shares.
Golden Biotechnology expects to narrow its loss to NT$64.44 million in the first half of this year, from a loss of NT$83.39 million in the same period last year.
Chief financial officer Jackson Huang (黃士旗) said the company is unlikely to turn a profit by the end of next year because it has to spend money on clinical trials.
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