Medigen Vaccine Biologics Corp’s (高端疫苗) phase 3 clinical trials for an enterovirus 71 vaccine completed the immunogenicity data “unblinding” on Saturday, with the results meeting Taiwan’s regulatory standard, the company said yesterday.
The vaccine has a high efficacy against the virus, which can cause hand, foot and mouth disease, Medigen said in a Taiwan Stock Exchange filing.
The trial results showed that antibody levels one month, six months and one year after two vaccine shots were higher than health authorities’ requirements, the company said.
Photo: Chen Yung-chi, Taipei Times
“The unblinded data showed the vaccine’s neutralizing antibody assay has qualified the Food and Drug Administration’s accelerated approval mechanism, and Medigen plans to file new drug applications for the vaccine after completing the clinical trial reports,” it said.
The phase 3 trials — conducted in Taiwan and Vietnam with 3,000 participants — evaluated the efficacy, safety, immunogenicity, cross protection and lot-to-lot consistency of the vaccine used for children under six years old.
The vaccine aims to reduce the risk posed by the virus, which causes one of the most prevalent infectious diseases in Taiwan, China and Southeast Asia, Medigen chief executive officer Charles Chen (陳燦堅) told a news conference at the Taipei Exchange yesterday.
The company plans to apply for local approval at the end of this quarter or early next quarter, Chen said, adding that he hopes that the vaccine would be regularly administered starting next year.
Medigen plans to produce 1 million doses annually for the domestic market, where the drug would be introduced first, Chen said.
For the Vietnamese market, 3 million to 5 million doses would be produced, as the virus is more widespread there, he said.
Among the rows of vibrators, rubber torsos and leather harnesses at a Chinese sex toys exhibition in Shanghai this weekend, the beginnings of an artificial intelligence (AI)-driven shift in the industry quietly pulsed. China manufactures about 70 percent of the world’s sex toys, most of it the “hardware” on display at the fair — whether that be technicolor tentacled dildos or hyper-realistic personalized silicone dolls. Yet smart toys have been rising in popularity for some time. Many major European and US brands already offer tech-enhanced products that can enable long-distance love, monitor well-being and even bring people one step closer to
TRANSFORMATION: Taiwan is now home to the largest Google hardware research and development center outside of the US, thanks to the nation’s economic policies President Tsai Ing-wen (蔡英文) yesterday attended an event marking the opening of Google’s second hardware research and development (R&D) office in Taiwan, which was held at New Taipei City’s Banciao District (板橋). This signals Taiwan’s transformation into the world’s largest Google hardware research and development center outside of the US, validating the nation’s economic policy in the past eight years, she said. The “five plus two” innovative industries policy, “six core strategic industries” initiative and infrastructure projects have grown the national industry and established resilient supply chains that withstood the COVID-19 pandemic, Tsai said. Taiwan has improved investment conditions of the domestic economy
Malaysia’s leader yesterday announced plans to build a massive semiconductor design park, aiming to boost the Southeast Asian nation’s role in the global chip industry. A prominent player in the semiconductor industry for decades, Malaysia accounts for an estimated 13 percent of global back-end manufacturing, according to German tech giant Bosch. Now it wants to go beyond production and emerge as a chip design powerhouse too, Malaysian Prime Minister Anwar Ibrahim said. “I am pleased to announce the largest IC (integrated circuit) Design Park in Southeast Asia, that will house world-class anchor tenants and collaborate with global companies such as Arm [Holdings PLC],”
MAJOR BENEFICIARY: The company benefits from TSMC’s advanced packaging scarcity, given robust demand for Nvidia AI chips, analysts said ASE Technology Holding Co (ASE, 日月光投控), the world’s biggest chip packaging and testing service provider, yesterday said it is raising its equipment capital expenditure budget by 10 percent this year to expand leading-edge and advanced packing and testing capacity amid strong artificial intelligence (AI) and high-performance computing chip demand. This is on top of the 40 to 50 percent annual increase in its capital spending budget to more than the US$1.7 billion to announced in February. About half of the equipment capital expenditure would be spent on leading-edge and advanced packaging and testing technology, the company said. ASE is considered by analysts