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Celltrion receives EUA from FDA for its COVID-19 testing kit Sampinute

Celltrion receives EUA from FDA for its COVID-19 testing kit Sampinute
Celltrion receives EUA from FDA for its COVID-19 testing kit Sampinute

 

  • Celltrion Inc.’s shares surged by 4.6% following the announcement.
  • The company claims that its COVID-19 testing kit has a sensitivity of 94% and gives test results in 10 minutes.

Celltrion Inc., a biopharmaceutical firm headquartered in South Korea, has reportedly obtained the emergency use authorization (EUA) from the United States Food & Drug Administration (FDA) for Sampinute, a COVID-19 testing kit of the company.

Sources with relevant information stated that the emergency use authorization arrived three months after seeking approval since July end, even though the product had already been released in the U.S. in the month of August.

In fact, Celltrion reportedly intends to provide Sampinute with the help of local wholesalers across the U.S. owing to high demand for diagnostic kits, primarily among government agencies and large corporations that are likely to get back to work after working from home.

As per reliable sources, the recent development increased Celltrion’s shares as well as that of its partners. The company’s shares went up by 4.6%, whereas Celltrion Healthcare and Celltrion Pharma shares surged by 1.6% and 4.6% respectively.

It is to be noted that Celltrion Inc. had initiated commercial production of its potential COVID-19 antibody CT-P59 in September 2020. As a matter of fact, the company had initially planned to produce over 1 million doses before acquiring EUA for its drug.

With its wide product range of biologics and chemical drugs, Celltrion is expected to emerge as a major pharmaceutical company in the subsequent years, cite industry experts. Moreover, the results of its potential COVID-19 antibody drug CT-P59, which is presently in phase 2 and 3 clinical trials, are predicted to be released in the upcoming months.

According to the experts, the drug is likely to be released in the market by the year 2021.

Source- https://www.channelnewsasia.com/news/world/south-korea-pharma-celltrion-s-covid-19-test-gets-us-emergency-13373852

http://www.businesskorea.co.kr/news/articleView.html?idxno=53844

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Vinisha Joshi

Despite graduating with an engineering degree in electronics and communication, Vinisha Joshi chose the road less travelled, and decided to pursue her career in content writing . Currently, she pens down articles for cuereport.com and a few other distinguished news platforms, pertaining to business and finance.