TaiGen Biotechnology Co (太景生技) shares yesterday surged by the 10 percent daily limit to NT$29.8, after the company announced that the oral formulation of Taigexyn, its novel antibiotic, has been approved by China’s Food and Drug Administration (CFDA).
China is the largest antibiotic market in the world, with annual sales surpassing US$12 billion, the company said.
The Chinese market for antibiotics in the same category as Taigexyn was estimated at about 6.4 billion yuan (US$972.56 million) last year, with five antibiotics manufacturers dominating the market with a 4.9 billion yuan share, the company said, citing the findings of US-based industry research firm IMS Health.
Manufacturing, sales and marketing of Taigexyn in China are to be overseen by Zhejiang Medicine Co (浙江醫藥), which inked an exclusive 20-year licensing deal with the firm in 2013, TaiGen said.
Under the terms of the deal, TaiGen is to receive royalty payments from its Chinese partner of 7 to 11 percent of annual sales, TaiGen said in a filing to the Taiwan Stock Exchange.
Taigexyn is the first Class 1.1 drug developed by a Taiwanese company that has received market approval in China, the company said in a statement.
The CFDA in March launched a new drug classification system.
Under the new scheme, innovative drugs that contain new chemical entities that have never been marketed anywhere else in the world are granted Class 1 status, which entitles them to benefits including expedited reviews and a more favorable standing in post-approval tendering and reimbursement, industry experts said.
The firm expects to file an intravenous formulation with the CFDA in the second half, it said.
Based on nemonoxacin, Taigexyn is a non-fluorinated quinolone broad-spectrum antibiotic.
The drug has completed clinical trials on efficacy and safety for treating community-acquired pneumonia (CAP), as well as studies on treating drug-resistant bacteria such as methicillin resistant Staphylococcus aureus, and penicillin-resistant streptococcus pneumonia, the company said.
In the US, authorities have granted fast-track designations for Taigexyn to treat CAP and acute bacterial skin and skin structure infections, the company said.
TaiGen said that the designations would provide an additional five-year extension to the new chemical entity market exclusivity and priority review when it applies for market approval in the US.
The drug was submitted to Taiwan’s Food and Drug Administration in 2013, and received approval in the domestic market in the following year.
TaiGen reported sales last month dipped 12.34 percent annually to NT$5.9 million (US$182,166), and aggregate sales in the first five months of this year dropped 12.27 percent to NT$28.93 million.
DECOUPLING? In a sign of deeper US-China technology decoupling, Apple has held initial talks about using Baidu’s generative AI technology in its iPhones, the Wall Street Journal said China has introduced guidelines to phase out US microprocessors from Intel Corp and Advanced Micro Devices Inc (AMD) from government PCs and servers, the Financial Times reported yesterday. The procurement guidance also seeks to sideline Microsoft Corp’s Windows operating system and foreign-made database software in favor of domestic options, the report said. Chinese officials have begun following the guidelines, which were unveiled in December last year, the report said. They order government agencies above the township level to include criteria requiring “safe and reliable” processors and operating systems when making purchases, the newspaper said. The US has been aiming to boost domestic semiconductor
Nvidia Corp earned its US$2.2 trillion market cap by producing artificial intelligence (AI) chips that have become the lifeblood powering the new era of generative AI developers from start-ups to Microsoft Corp, OpenAI and Google parent Alphabet Inc. Almost as important to its hardware is the company’s nearly 20 years’ worth of computer code, which helps make competition with the company nearly impossible. More than 4 million global developers rely on Nvidia’s CUDA software platform to build AI and other apps. Now a coalition of tech companies that includes Qualcomm Inc, Google and Intel Corp plans to loosen Nvidia’s chokehold by going
ENERGY IMPACT: The electricity rate hike is expected to add about NT$4 billion to TSMC’s electricity bill a year and cut its annual earnings per share by about NT$0.154 Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) has left its long-term gross margin target unchanged despite the government deciding on Friday to raise electricity rates. One of the heaviest power consuming manufacturers in Taiwan, TSMC said it always respects the government’s energy policy and would continue to operate its fabs by making efforts in energy conservation. The chipmaker said it has left a long-term goal of more than 53 percent in gross margin unchanged. The Ministry of Economic Affairs concluded a power rate evaluation meeting on Friday, announcing electricity tariffs would go up by 11 percent on average to about NT$3.4518 per kilowatt-hour (kWh)
OPENING ADDRESS: The CEO is to give a speech on the future of high-performance computing and artificial intelligence at the trade show’s opening on June 3, TAITRA said Advanced Micro Devices Inc (AMD) chairperson and chief executive officer Lisa Su (蘇姿丰) is to deliver the opening keynote speech at Computex Taipei this year, the event’s organizer said in a statement yesterday. Su is to give a speech on the future of high-performance computing (HPC) in the artificial intelligence (AI) era to open Computex, one of the world’s largest computer and technology trade events, at 9:30am on June 3, the Taiwan External Trade Development Council (TAITRA) said. Su is to explore how AMD and the company’s strategic technology partners are pushing the limits of AI and HPC, from data centers to