Celltrion to expand COVID-19 testing portfolio to include both antigen and antibody testing kits

Celltrion Group today announced plans to expand its diagnostic portfolio for SARS-CoV-2, the virus causing COVID-19, in its efforts to improve access to COVID-19 testing and help prevent the further spread of coronavirus infection worldwide.

Celltrion has completed development of a point-of-care antigen testing (POCT) kit for COVID-19 together with South Korean healthcare company BBB, which specialises in blood testing and lab-on-a-chip technology. The POCT kit is a portable and highly sensitive device for use in rapid point of care testing to support early detection of COVID-19 positive patients in clinical settings.

Promising early results for a prototype of Celltrion’s POCT kit for COVID-19 showed more than 95% sensitivity. The kit uses lab-on-a-chip technology consisting of a microfluidic electrochemical biosensor which aims to give fast and accurate results. The kit is designed to show results within 15-20 minutes, and Celltrion anticipates receiving a CE mark in Europe later this month, ahead of the expected launch in July.

Celltrion has also entered into a distribution agreement with Humasis, a South Korean in-vitro diagnostic company, to distribute and sell a rapid diagnostic test globally this month. This test is a COVID-19 rapid antibody diagnostic test (RDT) kit, which could offer a cost-effective option and can be used by hospitals to confirm patients to be discharged. Celltrion and Humasis will also cooperate in the development of an upgraded rapid antibody diagnostic test and a rapid antigen diagnostic test, for which Celltrion will apply its proprietary COVID-19 antibody-antiviral technology to enhance detection sensitivity. Celltrion plans to leverage its advanced therapeutic technologies to expand the range of co-developed diagnostic devices beyond SARS-CoV-2 to a number of other infectious diseases as it progresses cooperation with Humasis.

“We are keen to drive early diagnosis of COVID-19 through the availability of our testing portfolio,” said Ki-Sung Kwon, Head of R&D Unit at Celltrion. “We have successfully built solid partnerships with local device companies that are prominent in the field of diagnostic testing. We are committed to providing flexibility for testing needs as the pandemic evolves, and are using our expertise and past experience developing antibody treatments and targeting coronaviruses to fight this pandemic.”

In addition to progress in diagnostic methods for COVID-19, Celltrion announced positive pre-clinical results for its antiviral antibody treatment last month.¹

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Notes to Editors:

About Celltrion Healthcare

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us

About COVID-19^2,3

Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak.

The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19.

There are currently no specific vaccines or treatments approved for COVID-19.

Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_1

FORWARD LOOKING STATEMENT

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.

These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion Healthcare's management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.

Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

References

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¹ Celltrion Announces Positive Pre-clinical Results for COVID-19 Antiviral Antibody Treatment, Showing Improvement in Recovery Time [Press Release] Retrieved from https://www.businesswire.com/news/home/20200531005014/en/Celltrion-Announces-Positive-Pre-clinical-Results-COVID--19 Last accessed: June 2020
² Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: June 2020
³ Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: June 2020

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