Enimmune Corp (安特羅生技) plans to apply to the Taiwan Food and Drug Administration for marketing approval for its enterovirus 71 (EV-71) vaccine next quarter after the treatment passed an interim analysis yesterday.
If approved, it would be the nation’s first vaccine for EV-71, which is a common pathogen that causes polio-like syndromes, and mostly infects infants and children aged five and younger.
Although the firm has developed three EV-71 vaccines in China, the latest treatment would have an advantage in the home market, as it is designed to act against genotype B4 of EV-71, which is more widespread in Taiwan and Vietnam, while Chinese vaccines target genotype C4, Enimmune general manager Vic Chang (張哲瑋) told the Taipei Times by telephone.
The interim analysis was conducted by the firm’s independent data monitoring committee comprised of external experts, Chang said.
The experts monitored vaccinated test subjects for at least six months to see if they developed any allergic reactions, but none of them had severe reactions to the vaccine, barring some mild side-effects, such as inflamed skin, he said.
The overall seroprotection rate for the subjects who were given a single dose in the phase-III clinical trial was about 90 percent, higher than the regulatory minimum, Chang added.
“That means that our vaccines had good efficacy,” Chang added.
Enimmune, a subsidiary of Adimmune Corp (國光生技), has over the past decade focused on researching and developing the EV-71 vaccine.
The firm said that it completed a phase-III randomized, double-blind and placebo-controlled trial in April last year with a 1,266 subjects.
Given that there is no medication for EV-71 infection in Taiwan except for supportive therapies, the vaccine would likely qualify to apply to the agency’s accelerated approval mechanism, in which review would be sped up for treatments that satisfy unmet medical needs and greatly advance treatment, Chang said.
“If everything goes smoothly, we anticipate gaining approval in the fourth quarter. Adimmune would help us manufacture the vaccines,” Chang said.
The government is also expected to consider including the vaccine in the National Health Insurance system, he added.
Meanwhile, Medigen Vaccine Biologics Corp (高端疫苗) said that it would conduct an interim analysis of its EV-71 vaccine later this year after enrolling 3,000 subjects for a phase-III trial in December last year, spokesman Leo Lee (李思賢) said.
“We concentrate on developing the world’s first EV-71 vaccine for protecting children two months to six months old, given all existing EV-71 vaccines would be administered to children older than six months,” Lee said.
Merida Industry Co (美利達) has seen signs of recovery in the US and European markets this year, as customers are gradually depleting their inventories, the bicycle maker told shareholders yesterday. Given robust growth in new orders at its Taiwanese factory, coupled with its subsidiaries’ improving performance, Merida said it remains confident about the bicycle market’s prospects and expects steady growth in its core business this year. CAUTION ON CHINA However, the company must handle the Chinese market with great caution, as sales of road bikes there have declined significantly, affecting its revenue and profitability, Merida said in a statement, adding that it would
MARKET LEADERSHIP: Investors are flocking to Nvidia, drawn by the company’s long-term fundamntals, dominant position in the AI sector, and pricing and margin power Two years after Nvidia Corp made history by becoming the first chipmaker to achieve a US$1 trillion market capitalization, an even more remarkable milestone is within its grasp: becoming the first company to reach US$4 trillion. After the emergence of China’s DeepSeek (深度求索) sent the stock plunging earlier this year and stoked concerns that outlays on artificial intelligence (AI) infrastructure were set to slow, Nvidia shares have rallied back to a record. The company’s biggest customers remain full steam ahead on spending, much of which is flowing to its computing systems. Microsoft Corp, Meta Platforms Inc, Amazon.com Inc and Alphabet Inc are
RISING: Strong exports, and life insurance companies’ efforts to manage currency risks indicates the NT dollar would eventually pass the 29 level, an expert said The New Taiwan dollar yesterday rallied to its strongest in three years amid inflows to the nation’s stock market and broad-based weakness in the US dollar. Exporter sales of the US currency and a repatriation of funds from local asset managers also played a role, said two traders, who asked not to be identified as they were not authorized to speak publicly. State-owned banks were seen buying the greenback yesterday, but only at a moderate scale, the traders said. The local currency gained 0.77 percent, outperforming almost all of its Asian peers, to close at NT$29.165 per US dollar in Taipei trading yesterday. The
The US overtaking China as Taiwan’s top export destination could boost industrial development and wage growth, given the US is a high-income economy, an economist said yesterday. However, Taiwan still needs to diversify its export markets due to the unpredictability of US President Donald Trump’s administration, said Chiou Jiunn-rong (邱俊榮), an economics professor at National Central University. Taiwan’s exports soared to a record US$51.74 billion last month, driven by strong demand for artificial intelligence (AI) products and continued orders, with information and communication technology (ICT) and audio/video products leading all sectors. The US reclaimed its position as Taiwan’s top export market, accounting for
RSS