Press Release

[Daejeon, Republic of Korea – Feb. 4, 2019] Bioneer announced that its AccuPower® HBV Quantitative PCR Kit for Hepatitis B virus has obtained CE-IVD, List A marking. Bioneer is the first Korean company having acquired three certifications for HIV (Human Immunodeficiency Virus), HCV (Hepatitis C virus), and HBV (Hepatitis B virus), which cover two-thirds of the world's USD 9.9 billion molecular diagnostics market.

The CE-IVD certification, according to the level of risks associated with the use of in-vitro diagnostic medical devices, is separated into four levels, with List A is being the highest level. Few global companies have CE-IVD, List A approved products, such as Roche, Hologic, and Qiagen, which account for about 60% of the infectious disease market. Especially, it is important to diagnose uncurable viruses such as AIDS, Hepatitis B, and Hepatitis C at early stages with high detection sensitivity molecular diagnosis for proper treatment.

In addition, the molecular diagnostic system ExiStation™ used in clinical trials is based on real-time PCR and gene extraction equipment, and can simultaneously diagnose Hepatitis B, Hepatitis C, HIV, Tuberculosis and Sexually Transmitted Infections. It can be expanded and configured according to the size of the laboratory, the number of specimens, and the type of inspection, and is equipped with an automated system to reduce the error of the inspector and derive quick and accurate inspection results.

Bioneer said that “with the certification of HBV quantitative analysis kit, we have completed marking of all three major items of molecular diagnostics. Based on this, we will increase our participation in national bidding and accelerate the expansion of distributors in overseas countries such as Europe, Southeast Asia, and Africa and supporting global funds.”

Meanwhile, hepatitis B virus can cause liver disease such as chronic hepatitis, cirrhosis and liver cancer, claiming 1 million deaths every year. More than 300 million people around the world are known to have been infected.


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About BIONEER Corporation

Established in 1992, BIONEER is the first Korean biotechnology company with aim of the complete localization of genetic technology and publicly traded at KOSDAQ since 2005.

BIONEER’s multiplex molecular diagnostics kit for the ZIKA, dengue and chikungunya viruses was listed in Emergency Use Assessment and Listing (EUAL) from WHO in 2016.

In 2018, BIONEER received its first CE-IVD, List A mark for HIV diagnosis kit and afterward, it was registered on the purchase list of international non-profit financing organization, Global Fund.

In 2019, BIONEER received its second CE-IVD, List A mark for HCV diagnosis kit.

[Daejeon, Republic of Korea – January 2, 2020] BIONEER announced that it has made an application for permission to the Ministry of Food and Drug Safety (MFDS) in Korea for candidate materials of functional cosmetics capable of alleviating hair loss, as those have shown excellent results during its clinical study.

Bioneer conducted a 24-week clinical trial on male and female patients diagnosed with androgenetic alopecia to be tested with 'COSMERNA', a highly efficient product containing siRNA applied with SAMIRNA ™, the next-generation RNAi therapeutic platform technology from Bioneer.

Quantitative analysis using phototrichogram technique showed that the total number of hairs in the test group, the ones that have used COSMERNA three times per week, showed an increase at week 16 and 24, while the total number of hairs for the control group showed a decrease. Comparing with the pre-test results, significant differences were shown after 16 weeks, and the gaps became more predominant over the time of the test.

The participants of the clinical study were also showed positive opinions during the survey.

In the part of the questionnaire asking about the thoughts on the efficiency, the test group answered positively on 'enriched hair', 'enriched hair loss area' and 'reduced hair loss' parts.

The mechanism of BIONEER’s candidate materials works by inhibiting the production of androgen receptors (AR), which attach with dihydrotestosterone (DHT) and induce hair loss. By reducing the number of androgen receptors, the side effect can also be drastically reduced compared with conventional hair-loss medications.

The successive results of this clinical study have shown that BIONEER’s candidate materials are effective in hair-loss caused by overexpression of androgen receptor or by the conversion of testosterone to DHT. With this, the development of Alopecia Areata therapeutics using SAMiRNA™ technology, also being currently under development, is expected to gain momentum.

While obtaining approval of functional cosmetics from the MFDS, BIONEER is also preparing to commercialize various products according to its plan.

Bioneer said “this is the first time to demonstrate the efficiency of our next-generation siRNA technology, SAMiRNA™, which is known to overcome the side effect of the innate immune response from the traditional siRNA therapies. This means a lot to us. We are going to be first in the world to release medications to alleviate hair-loss using our own, patented next-generation siRNA technologies, and open up a new era in functional cosmetics.” Bioneer also added, “with these results, we can accelerate the development of our ongoing new drug therapeutics pipelines using SAMiRNA™”.

COSMERNA’s safety was approved with the strict skin test, showing no irritation or any other symptoms, approved by gaining local patents, applying for PCT, and being registered on International Cosmetic Ingredient Dictionary and Handbook (ICID) and Korean Cosmetic Association (KCA) as a candidate material for functional cosmetics.


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About BIONEER Corporation

Established in 1992, BIONEER is the first Korean biotechnology company aiming for the complete localization of genetic technologies. It is also the first in Korea to develop and commercialize enzymes for PCR, oligos, primers, and real-time PCR instruments. With its continuous research and development, BIONEER has focused on supplying instruments and chemicals for researchers in the field of biotechnology and providing various services such as sequencing, NGS, gene/protein synthesis, and gene expression analysis. Thanks to those endeavors, BIONEER has acquired deep expertise in genetic technology to expand its field of business to molecular diagnosis and new RNAi drug development.


How phototrichogram analysis has been done

Shave the target area of the hair equally not exceeding 1 ㎠, then take the magnified photograph of the region for a fixed period and count the total number of hair. Analyze the data by comparing it with the results taken before and after the clinical trial.

[Daejeon, Republic of Korea - October 29, 2019] Bioneer specialized in molecular diagnostic instruments announced that it has additionally received List-A CE-IVD marking for AccuPower® HCV Quantitative RT-PCR Kit which used to diagnose the Hepatitis C virus – the first List-A CE marked product is AccuPower® HIV-1 Quantitative RT-PCR Kit.

The kit, called AccuPower® HCV Quantitative RT-PCR Kit, quantifies HCV viral RNA from blood samples using Bioneer’s semi-automated real-time qPCR molecular diagnostic system, ExiStation™.

The ExiStation™ instrument became eligible for procurement by the World Health Organization (WHO) and CE marked. It can analyze 16 samples at once in a basic mode and be expandable for 32 samples or 48 samples. It can detect early infections such as HIV and TB through simultaneous diagnosis and also provides users a molecular diagnostic system without heavy procurement spending.

Hepatitis C is a liver infection caused by the hepatitis C virus (HCV) which is blood-borne. Today, most people become infected with the hepatitis C virus by sharing needles or other equipment to inject drugs. For some people, hepatitis C is a short-term illness but for 70%–85% of people who become infected with the hepatitis C virus, it becomes a long-term, chronic infection. Chronic hepatitis C is a serious disease that can result in long-term health problems, even death. Many people might not be aware of their infection because they are not clinically ill.

There is no vaccine for hepatitis C. Therefore, it is more important to diagnose the disease early with an accurate and sensitive detection kit and have a proper medical treatment.

Bioneer said, “it is a pleasure that this additional certification can prove that Bioneer is a leader in molecular diagnostic instrument market in Asian area with the fact that two products take place in CE List-A and if our new HBV kit also certified and added to the list within this year, Bioneer will be the first company which has all three detection kits certified as List-A CE in Asia” Bioneer also added “we are planning to enter into European market and international procurement market for WHO preapproval so we can expect to increase its sales there”



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About BIONEER Corporation

Established in 1992, BIONEER is the first Korean biotechnology company with the aim of the complete localization of genetic technology.

BIONEER’s multiplex molecular diagnostics kit for the ZIKA, dengue and chikungunya viruses was listed in Emergency Use Assessment and Listing (EUAL) from WHO in 2016.

In 2018, its HIV diagnosis kit became the first in Asia to be in CE-IVD, LIST A, and afterward, in 2019, it was registered on the purchase list of international non-profit financing organization, Global Fund.

[Daejeon, Republic of Korea - February 8, 2019] Bioneer announced that it has become the first South Korean company to register the HIV-1 Quantitative RT-PCR Kit in the Global Fund purchase list. Furthermore, it obtains the approval of the Korea Food and Drug Administration (KFDA).

On January 29, Bioneer received the KFDA approval for its AccuPower® HIV-1 Quantitative RT-PCR Kit (HIV-1 Kit). Also, on January 31 Bioneer’s HIV-1 Kit and its molecular diagnostic system ExiStation™ were registered on the Global Fund purchase list together.

The global HIV diagnostics market is expected to grow at an average annual rate of 10.5% from 2016 to 2021, with the market expanding from $23.5 billion in 2016 to $38 billion in 2021. According to the KCDC (Center for Disease Control & Prevention, Korea), the number of AIDS patients in Korea was 12,320, with 1,191 new patients reported in 2017 alone.

Bioneer's HIV-1 Kit received the CE-IVD, List A (European In-Vitro Diagnostics Certification) in October last year, and currently is in the process for WHO PQ (Prequalification) application, whilst participating in the public bidding of the other international aid agencies. In addition, with the KFDA approval, Bioneer is negotiating to provide its technology not only in Korea but also in Southeast Asia, including Vietnam, Thailand, and Indonesia in the first half of this year. The HIV testing market in Southeast Asia is estimated at $ 300 million in 2019.

Bioneer official said that "molecular diagnostic products developed and produced from raw materials to equipment by using its patented technology are well recognized overseas". It was further added that "Bioneer products in terms of quality and price are competitive with other similar products of global companies in both local and international markets.”


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About The Global Fund fights AIDS, Tuberculosis and Malaria

A form of a public-private partnership with joint donors and beneficiaries from governments, international organizations, NGOs and the private sector.

Funding for the eradication of AIDS, tuberculosis, and malaria, which is a poverty-causing disease in developing countries. Since its establishment in 2002, nearly $39 billion has been spent on three major disease-related programs in more than 150 countries.


About WHO Recommendations for the Treatment of AIDS 

In order to check the progress after treatment with HIV antiviral agents, patients with AIDS need to check the amount of HIV-1 virus in the blood at least twice a year by HIV-1 virus quantitative testing using real-time PCR technology.

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