Shares in OBI Pharma Inc (台灣浩鼎) and PharmaEngine Inc (智擎) rallied yesterday as the biotechnology firms announced encouraging progress in their new drug development pipelines over the weekend.
OBI Pharma on Sunday announced that the US Food and Drug Administration has granted orphan drug designation for OBI-3424, the company’s hepatocellular carcinomas (HCC) drug.
The stock yesterday gained 5.7 percent to close at NT$157.5 in Taipei trading.
The designation, which is granted for rare diseases with fewer than 200,000 patients in the US, brings benefits upon marketing approval, including market exclusivity, reduced or waived regulatory fees and protocol assistance during the approval process.
The drug is designed to selectively release a potent DNA alkylating agent in patients with an overexpression of the AKR1C3 enzyme, whereas other traditional alkylating agents, such as cyclophosphamide and ifosfamide, are non-selective, the company said.
AKR1C3 is also a marker found in other treatment-resistant and difficult to treat cancers, such as castrate-resistant prostate cancer and T-cell acute lymphoblastic leukemia, it said.
The company has outlined plans to streamline the drug’s clinical development process by targeting patients with AKR1C3 overexpression.
PharmaEngine Inc (智擎) on Sunday announced that it would receive US$3 million in milestone payments as Onivyde, its new pancreatic drug, commences sales in its third EU market.
The windfall is expected to boost the company’s earnings per share by NT$0.61, it said.
The company last month reported that a global pivotal trial for PEP503, a soft tissue sarcoma drug it is developing with France’s Nanobiotix SA, has met its primary and secondary endpoints, which would aid the approval process ahead.
PEP503 is activated with radiotherapy via Nanobiotix’s NanoXray, a class III medical device, and is designed to promote patients’ immune system response against tumors, the company said.
Other indications being explored include head and neck cancer, as well as liver, colorectal and prostate cancer, the company added.
NO VIRUS BLUES: A SEMI Taiwan official said that the virus does not slow down the global semiconductor industry’s investment in manufacturing equipment The production value of the nation’s semiconductor industry is expected to grow 16.7 percent this year from last year, outpacing the global industry’s 3.3 percent growth, industry association SEMI said yesterday. That would help Taiwan safeguard its second spot in the global semiconductor market with a production value of more than NT$3 trillion (US$102.73 billion), SEMI Taiwan president Terry Tsao (曹世綸) told a media briefing in Taipei for the Semicon Taiwan trade show beginning today. The global semiconductor industry’s production value is expected to increase to US$426 billion this year, SEMI said. In terms of semiconductor equipment investment, equipment billings from Taiwanese firms
Intel Corp has received licenses from US authorities to continue supplying certain products to Huawei Technologies Co (華為), a company spokesman said yesterday. Washington has been pushing governments around to world to squeeze out Huawei, saying that the telecom giant would hand data to Beijing for espionage. From Monday last week, new curbs have barred US companies from supplying or servicing Huawei. This week, the state-backed China Securities Journal reported that Intel had received permission to supply Huawei. China’s Semiconductor Manufacturing International Corp (SMIC, 中芯國際), which uses US-origin equipment to make chips for Huawei and other companies, last week confirmed that it had sought
INVEST IN TAIWAN: A metal components casting firm and the world’s largest maker of aluminum bicycle rims also obtained approvals to join the program Solar Applied Materials Technology Co (SOLAR, 光洋應用材料), a part of Taiwan Semiconductor Manufacturing Co’s (TSMC, 台積電) “green supply chain,” has pledged to invest NT$1 billion (US$34.1 million) to build a new plant at the Tainan Technology Industrial Park (台南科技工業區), the Ministry of Economic Affairs said yesterday. SOLAR has been collaborating with TSMC to extract precious metals from waste and reuse them as “sputtering target” material in high-end semiconductor manufacturing, a TSMC press release issued in May said. Established in 1978, SOLAR also offers key materials and integrated services to customers in the optoelectronics, information and communications technology, petrochemicals and consumer electronics industries,
Swancor Renewable Energy Co (上緯新能源) yesterday announced plans for a 4.4 gigawatt (GW) offshore wind project off Miaoli County as part of its commitment toward Taiwan’s energy transformation, the company said in a statement. The “Formosa 4” project includes three deep-water wind farms 18km to 20km off the coast, Swancor Renewable CEO Lucas Lin (林雍堯) said, adding that planning for the project began last year. A proposal for Formosa 4 was this week submitted to the Environmental Protection Agency (EPA), the company said. Swancor Renewable jointly developed the Formosa 1 project, a 128 megawatt (MW) wind farm about 4km off Miaoli and the