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.
RUN IT BACK: A succesful first project working with hyperscalers to design chips encouraged MediaTek to start a second project, aiming to hit stride in 2028 MediaTek Inc (聯發科), the world’s biggest smartphone chip supplier, yesterday said it is engaging a second hyperscaler to help design artificial intelligence (AI) accelerators used in data centers following a similar project expected to generate revenue streams soon. The first AI accelerator project is to bring in US$1 billion revenue next year and several billion US dollars more in 2027, MediaTek chief executive officer Rick Tsai (蔡力行) told a virtual investor conference yesterday. The second AI accelerator project is expected to contribute to revenue beginning in 2028, Tsai said. MediaTek yesterday raised its revenue forecast for the global AI accelerator used
Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) has secured three construction permits for its plan to build a state-of-the-art A14 wafer fab in Taichung, and is likely to start construction soon, the Central Taiwan Science Park Bureau said yesterday. Speaking with CNA, Wang Chun-chieh (王俊傑), deputy director general of the science park bureau, said the world’s largest contract chipmaker has received three construction permits — one to build a fab to roll out sophisticated chips, another to build a central utility plant to provide water and electricity for the facility and the other to build three office buildings. With the three permits, TSMC
TEMPORARY TRUCE: China has made concessions to ease rare earth trade controls, among others, while Washington holds fire on a 100% tariff on all Chinese goods China is effectively suspending implementation of additional export controls on rare earth metals and terminating investigations targeting US companies in the semiconductor supply chain, the White House announced. The White House on Saturday issued a fact sheet outlining some details of the trade pact agreed to earlier in the week by US President Donald Trump and Chinese President Xi Jinping (習近平) that aimed to ease tensions between the world’s two largest economies. Under the deal, China is to issue general licenses valid for exports of rare earths, gallium, germanium, antimony and graphite “for the benefit of US end users and their suppliers
Dutch chipmaker Nexperia BV’s China unit yesterday said that it had established sufficient inventories of finished goods and works-in-progress, and that its supply chain remained secure and stable after its parent halted wafer supplies. The Dutch company suspended supplies of wafers to its Chinese assembly plant a week ago, calling it “a direct consequence of the local management’s recent failure to comply with the agreed contractual payment terms,” Reuters reported on Friday last week. Its China unit called Nexperia’s suspension “unilateral” and “extremely irresponsible,” adding that the Dutch parent’s claim about contractual payment was “misleading and highly deceptive,” according to a statement
RSS