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.
OUTSOURCING
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.
CAPITAL EXPANSION
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.
WASHINGTON’S INCENTIVES: The CHIPS Act set aside US$39 billion in direct grants to persuade the world’s top semiconductor companies to make chips on US soil The US plans to award more than US$6 billion to Samsung Electronics Co, helping the chipmaker expand beyond a project in Texas it has already announced, people familiar with the matter said. The money from the 2022 CHIPS and Science Act would be one of several major awards that the US Department of Commerce is expected to announce in the coming weeks, including a grant of more than US$5 billion to Samsung’s rival, Taiwan Semiconductor Manufacturing Co (TSMC, 台積電), people familiar with the plans said. The people spoke on condition of anonymity in advance of the official announcements. The federal funding for
HIGH DEMAND: The firm has strong capabilities of providing key components including liquid cooling technology needed for AI servers, chairman Young Liu said Hon Hai Precision Industry Co (鴻海精密) yesterday revised its revenue outlook for this year to “significant” growth from a “neutral” view forecast five months ago, due to strong demand for artificial intelligence (AI) servers from cloud service providers. Hon Hai, a major assembler of iPhones that is also known as Foxconn, expects AI server revenues to soar more than 40 percent annually this year, chairman Young Liu (劉揚偉) told investors. The robust growth would uplift revenue contribution from AI servers to 40 percent of the company’s overall server revenue this year, from 30 percent last year, Liu said. In the three-year period
LONG HAUL: Largan Energy Materials’ TNO-based lithium-ion batteries are expected to charge in five minutes and last about 20 years, far surpassing conventional technology Largan Precision Co (大立光) has formed a joint venture with the Industrial Technology Research Institute (ITRI, 工研院) to produce fast-charging, long-life lithium-ion batteries for electric vehicles, mobile electronics and electric storage units, the camera lens supplier for Apple Inc’s iPhones said yesterday. Largan Energy Materials Co (萬溢能源材料), established in January, is developing high-energy, fast-charging, long-life lithium-ion batteries using titanium niobium oxide (TNO) anodes, it said. TNO-based batteries can be fully charged in five minutes and have a lifespan of 20 years, a major advantage over the two to four hours of charging time needed for conventional graphite-anode-based batteries, Largan said in a
Taiwan is one of the first countries to benefit from the artificial intelligence (AI) boom, but because that is largely down to a single company it also represents a risk, former Google Taiwan managing director Chien Lee-feng (簡立峰) said at an AI forum in Taipei yesterday. Speaking at the forum on how generative AI can generate possibilities for all walks of life, Chien said Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) — currently among the world’s 10 most-valuable companies due to continued optimism about AI — ensures Taiwan is one of the economies to benefit most from AI. “This is because AI is