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- 2026-03-17 07:03:49
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- Additional formulations of Abbvie’s Skyrizi were approved
- by Eo, Yun-Ho Apr 27, 2022 06:04am
- The approval of an additional formulation of the IL-23 inhibitor ' Skyrizi' has increased the drug’s versatility in the field of plaque psoriasis. On the 22nd, Abbvie Korea announced that the Ministry of Food and Drug Safety additionally approved its Skyrizi Prefilled Syringe 150mg and Prefilled Pen 150mg formulations of its IL-23 inhibitor ' Skyrizi Prefilled Syringe Injection (risankizumab)’ for the treatment of adult patients with moderate-to-severe plaque psoriasis. With the approval, Skyrizi may additionally be administered 4 times a year as maintenance therapy in two formulations - Skyrizi Prefilled Syringe 150mg and Prefilled Pen 150mg. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading the development and global sales of the drug. The 150mg formulation of Skyrizi is administered through a single shot of a 150mg injection. It is administered twice as a subcutaneous injection early on (at week 0, week 4), then every 12 weeks thereafter. The previously approved 75mg formulation was administered in two shots per visit. The approval of the new 150mg formulation would allow for the number of annual shots required by half. In other words, the newly approved dose of Skyrizi is 150mg (2 shots of 75mg prefilled syringe or 1 shot of Skyrizi Prefilled Syringe 150mg or Prefilled Pen 150mg) administered subcutaneously at week o and week 4, and every 12 weeks thereafter. Eun-Joo Park, Professor of Dermatology at Hallym University Sacred Heart Hospital said, “Skyrizi as a maintenance treatment demonstrated a consistent safety profile and a high skin improvement effect that can be maintained in the long-term with 4 doses a year in various clinical trials. The addition of the 150mg dose that allows for patients to receive the required dose with a single shot, would increase convenience among HCPs and patients as well as broaden their range of choices.” Skyrizi can be subcutaneously administered at hospitals or be administered at home after receiving training for subcutaneous injections. The new 150mg Prefilled Pen that was additionally approved was devised to improve the treatment experience for the patients. Abbvie explained that the additional approval of the new formulation was based on clinical results that demonstrated that a single shot of the Skyrizi Prefilled Syringe 150mg met the primary efficacy endpoint was bioequivalent to two shots of the existing 75mg formulation. The Prefilled Pen 150mg formulation also demonstrated its bioequivalence with the Prefilled Syringe 150mg. Skyrizi is an IL-23 inhibitor that selectively inhibits IL-23 by binding to its p19 subunit. IL-23 is involved in various chronic immune-mediated conditions including psoriasis. The 150mg formulation was approved by the European Commission in May 2021 to treat moderate to severe plaque psoriasis in adults after systemic or phototherapy. Phase III trials on Skyrizi in psoriasis, Crohn's disease, ulcerative colitis, and psoriatic arthritis are still ongoing. In Korea, the drug was approved in December 2019 as a treatment for adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy (including biological therapy). The drug then added the psoriatic arthritis indication on the 5th of last month. Skyrizi may be used to treat adult patients with active psoriatic arthritis who responded inadequately or were intolerant to disease-modifying anti-rheumatic drugs (DMARDs).
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- Benefit of Pfizer's Cibinqo is applied
- by Eo, Yun-Ho Apr 26, 2022 06:12am
- Another JAK inhibitor aims to enter the atopic dermatitis insurance benefit right. According to related industries, Pfizer Korea recently submitted an application for benefits of Cibinqo, a new drug for JAK1. As Lilly's Olumiant and AbbVie's Rinvoq are expected to be applied in May. Cibinqo was approved in Korea in November last year when the listing process of Olumiant and Rinvoq was underway. There was an observation that Cibinqo would also hurry to apply for registration and proceed with the registration process together, but the timing of Pfizer's application was later than expected. This drug acts as a mechanism to control the levels of IL 4, 13, 31, and 22 and TSLP on the thymus substrate, which are involved in the pathophysiological characteristics of atopic dermatitis. The permitted indication is the treatment of symptomatic atopic dermatitis in moderate cases of adults and adolescents aged 12 or older. Cibinqo proved its effectiveness through phase 3 clinical studies such as JADEMONO-1, MONO-2, and COMPARE. In the 12th week, the eczema severity evaluation index was lowered by more than 70%, and the treatment effect was proved in indicators such as relieving itching within two weeks of treatment. Among them, the JADE Mono-1 study randomly assigned and analyzed oral Cibinqo 100 mg, Cibinqo 200 mg, or placebo administration groups once a day for 12 weeks for patients with severe-moderate atopic dermatitis over the age of 12. In the Cibinqo 200m group, 63% of patients achieved a 75% improvement in Eczema Severity Index (EASI) at 12 weeks of treatment, compared to 12% in the placebo group, and 90% improvement in Eczema Severity Index (EASI-90) at 39%.
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- RET targeted therapy Retevmo opens era of precision medicine
- by Apr 26, 2022 06:12am
- Lilly Korea’s RET targeted therapy Retevmo(selpercatinib) has landed in Korea. The drug is expected to become a new treatment option in RET fusion-positive patients with non-small-cell lung cancer and thyroid cancer. Lilly Korea held an online press conference to celebrate the approval of Retevmo on the 25th. Professor Min Hee Hong of Oncology at Yonsei Cancer Center and Professor Won Gu Kim of Endocrinology and Metabolism at Asan Medical Center attended the virtual event to explain the significance of Retevmo’s approval. Retevmo was approved by the Ministry of Food and Drug Safety in March last year as a treatment for RET fusion-positive NSCLC and thyroid cancer patients. More specifically, the drug is indicated for the treatment of▲ adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); ▲adults and pediatric patients 12 years of age or older with advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; and ▲ adult patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or lenvatinib treatment, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy. At the press conference, Professor Hong said, “Lung cancer patients with RET mutations are twice more likely to experience CNS metastasis, but had to be treated with chemotherapy, which is less effective and more prone to toxicity due to the lack of RET targeted therapies. Retevmo demonstrated significant response in the LIBRETTO-001 trial, as well as an 82% ORR in patients with CNS metastasis. 23% of these patients achieved complete response.” Kim added, “Although the survival rate for thyroid cancer is known to be high patients with RET point mutated medullary thyroid cancer have a poor prognosis and low survival rate. Also, patients with thyroid cancer who are refractory to radioactive iodine therapy have a low survival rate and life expectancy. Retevmo has shown a 79% and 69% ORR in the abovementioned patient groups, opening a new era of precision medicine.” RET mutations occur in 2 to 6 % of all NSCLC cases and are more often found in adenocarcinomas and younger patients under 60 years of age and non-smokers. In NSCLC, RET fusions occur more than RET mutations. In thyroid cancer, RET fusions are reported in up to 40% of the cases. RET fusions can be identified through rest such as NGS, FISH, RT-PCR, etc. Among the tests, NGS is known to be the most effective diagnostic method for identifying RET fusions. However, it takes around one month to receive results after NGS testing, and as ‘Keytruda,’ a reimbursed immunotherapy option already exists for NSCLC in the first line, it is highly likely that Retevmo will not be selected as a first-line treatment in these patients. Professor Hong said, “As RET fusion is not a common mutation, we cannot idly just wait for the test results, therefore it is likely that we will use immunotherapies first. However, using immunotherapies before Retevmo may reduce the response rate to Retevmo, this is why it is important for us to receive the NGS results as quickly as possible.”
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- President-elect Yoon visits SK Bioscience HQ
- by Kim, Jin-Gu Apr 26, 2022 06:12am
- President-elect Suk-yeol Yoon visited SK Bioscience headquarters in Seongnam, Gyeonggi-do, and promised “We will spare no effort in the development of vaccines so no one can say they could not develop vaccines due to lack of money.” Transition team chair Cheol-soo Ahn and members of the Social Welfare subcommittee of the transition team accompanied Yoon to the site, and Tae-won Chey, Chairman of SK Group, and Jae-Yong Ahn, CEO of SK Bioscience were also present at the site. According to SK Bioscience, president-elect Yoon observed the entire vaccine R&D process, from the extraction of animal cells used for vaccine development and production to culturing, fermentation, purification, and analysis. Yoon said, “I will visit more R&D sites in the future. Korea’s economy, security, and health all depend on this.” Yoon said, “In my administration, I plan to spare no support for companies that develop vaccines and treatments for the pandemic, including SK Bioscience. If companies ask for loosening of some regulations in the R&D process, I will actively review it and make sure that the companies are not inconvenienced." Jae-Yong Ahn, CEO of SK Bioscience, said, “We need steady support from the government to continue on our hard-earned vaccine development capabilities." Transition team chair Cheol-soo Ahn said, “The new virus is an important national crisis that requires continued management. Using this as an opportunity, it is the new administration’s task to create a data-driven disease control and prevention system. To SK Bioscience, transition team chair Cheol-soo Ahn said,” The NA had always deferred making decisions on vaccine-related budgets as a low priority agenda, but the new administration’s goal is to secure vaccine sovereignty in Korea by investing in vaccine development so Korea could gain vaccine development capabilities.” On the morning of the same day, SK Bioscience had announced that its own synthetic antigen COVID-19 vaccine candidate’GBP510’ had shown superior immune response to its comparator in a Phase III clinical trial. After securing safety data on GBP510 within the month, the company plans to apply for domestic and overseas approvals for its drug as a vaccine used for COVID-19 prevention after basic vaccination .
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- Cancer immunotherapy are being applied to expand benefits
- by Eo, Yun-Ho Apr 26, 2022 06:11am
- Tecentriq will apply primary therapy benefits for liver and non-small cell lung cancer from May According to related industries, Roche Tecentriq will be applied to liver cancer and non-small cell lung cancer indicators from May as Merck and Pfizer Bavencio (Avelumab) passed the Cancer Drugs Benefit Appraisal Committee. The benefit standards were set as the first solo maintenance therapy in adult patients with local progressive or metastatic urinary tract epithelial cell cancer that did not progress in platinum-based chemotherapy treatment. If benefit adequacy is recognized by the HIRA's Drug Benefit Evaluation Committee and drug price negotiations are concluded with the NHIS, it will be eligible for insurance benefits. In the case of Tecentriq, benefits will be applied in the first monotherapy if it is a metastatic non-small cell lung cancer with positive PD-L1 expression and no EGFR or ALK mutation from the 1st of next month. It succeeded in applying liver cancer benefits for the first time among immuno-cancer drugs. Combination therapy of Tecentriq and Avastin (Bevacizumab) can be given first-line benefit if both 3 or higher, Child-Pugh class A grade, and ECOG PS) 0 to 1 point are satisfied among patients with advanced hepatocellular carcinoma that cannot be operated or treated locally. MSD's Keytruda has expanded its standards for primary therapy for non-small cell lung cancer since last month. Benefits are also applied to patients with recurrent or refractory Hodgkin lymphoma and children aged 2 or older who have failed at least two previous treatments, patients with progressive (stage 4) non-small cell lung cancer with positive PD-L1 expression and no EGFR or ALK mutation, patients with metastatic non-flat non-small cell lung cancer without EGFR or ALK mutation, patients with metastatic squamous non-small cell lung cancer, and if autologous hematopoietic stem cell transplantation fails, or autologous stem cell transplantation is not a treatment option. Benefits are also applied to patients with recurrent or refractory Hodgkin lymphoma and children aged 2 or older who have failed at least two previous treatments, patients with progressive (stage 4) non-small cell lung cancer with positive PD-L1 expression and no EGFR or ALK mutation, patients with metastatic non-flat non-small cell lung cancer without EGFR or ALK mutation (combined with chemotherapy), patients with metastatic squamous non-small cell lung cancer (combined with anticancer chemotherapy), and if autologous hematopoietic stem cell transplantation fails, or autologous stem cell transplantation is not a treatment option.
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- JAKi options added to Dupixent for atopic dermatitis
- by Eo, Yun-Ho Apr 25, 2022 06:07am
- Two new treatment options were added to the field of atopic dermatitis that had only Dupixent as an option. The new options are both JAK inhibitors. The Ministry of Health and Welfare had issued a pre-administrative notice on the ‘Details on the standard and methods for applying long-term care benefits (pharmaceuticals)’ and announced it will expand the scope of reimbursement for two types of JAK inhibitors – Lilly Korea’s ‘Olumiant (baricitinib),’ and Abbvie Korea’s ‘Rinvoq (upadacitinib)’ – in atopic dermatitis. With the approval, JAK inhibitors have entered the field of atopic dermatitis in just one year since applying for reimbursement (for Olumiant). By reimbursement standards, the drugs may be used for the treatment of patients with severe chronic atopic dermatitis whose condition has lasted for over 3 years and whose symptom is not adequately controlled despite the use of topical treatment (corticosteroids and/or calcineurin inhibitors) and does not respond to over 3 months of systemic immunosuppressants (cyclosporine or methotrexate) (which is measured by a 50% or more reduction of EASI) or is not eligible for their use due to side effects, and whose EASI score is 23 or higher before starting treatment. As both drugs are relatively cheaper than Dupixent, the drugs are expected to become major options in the field of atopic dermatitis in the future. Dupixent selectively inhibits IL-4, and IL-13, which are known as key cytokines that cause atopic dermatitis. The drug is highly effective as it targets specific cytokines, but may not be as effective in some patients. On the other hand, JAK inhibitors including Rinvoq are involved in a relatively broader set of cytokines. The cytokines deliver signals through various pathways including the JAK-STAT pathway by binding to their receptors on the cell surface, and JAK inhibitors target the JAK enzyme that orders proteins that play a key role in Immune-inflammation regulation. The differences in MOA also bring other differences. The biologic agent Dupixent is an injection type of drug whereas JAK inhibitors are small-molecule drugs that can be taken orally. Oral drugs like Rinvoq can be a good alternative that can increase convenience for patients who have trouble receiving regular injections in clinics. Meanwhile, the insurance authorities are discussing extending reimbursement of Dupixent to pediatric and adolescent patients with atopic dermatitis.
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- COVID-19 Tx Lagevrio lands in tertiary hospitals in Korea
- by Eo, Yun-Ho Apr 25, 2022 06:07am
- The oral COVID-19 treatment ‘Lagevrio’ has officially landed for prescriptions at general hospitals in Korea. According to industry sources, MSD Korea’s Lagevrio (molnupiravir) has passed the drug committees of tertiary hospitals including the Seoul National University Hospital in Korea. With the approval, the drug may be prescribed for in-hospital dispensing at tertiary hospitals and for in-hospital and out-hospital dispensing at general hospitals. Lagevrio, which is directly supplied by the Korea Disease Control and Prevention Agency through direct contracts, has been prescribed at dispensed at frontline convalescent hospitals, medical institutions, and designated pharmacies until now. The World Health Organization had issued conditional recommendations for the use of Lagevrio for patients at very high risk of hospitalization such as ▲those who haven’t received vaccinations for COVID-19, ▲those severely immunocompromised due to immunotherapy, etc., and ▲those with chronic diseases such as diabetes and published this revised COVID-19 treatment guideline in the British Medical Journal in March. Lagevrio is a ribonucleoside analog that is inserted in the place of the normal RNA needed in the viral replication process to induce lethal mutagenesis. As the first oral antiviral to be included in the WHO’s COVID-19 treatment guideline, the metanalysis of 6 clinical trials on Lagevrio in 4,827 patients showed that the drug reduced the rate of hospitalization by 36% compared to its comparator and showed a 3.4 day faster symptom improvement. Also, an interim and full analysis of a Phase III trial on Lagevrio showed that the drug demonstrated a reduction in the risk of hospitalization and death in outpatients with mild-to-moderate COVID-19 who were at risk of progressing to severe disease. In the planned interim analysis at 29 days after treatment, 14.1% (53/377) of the randomized patients had been hospitalized or died (8 cases) in the placebo group, whereas 7.3% (28/385) of the randomized patients were hospitalized with no deaths recorded in the Lagevrio group. The absolute risk reduction between the Lagevrio and placebo group was 6.8%, in which Lagevrio reduced the risk of hospitalization or death by around 50% by Day 29. Meanwhile, Lagevrio was approved for use in the UK as the first oral antiviral treatment for COVID-19 in November last year and then received emergency use authorization from the US Food and Drug Administration in December of the same year. MSD has signed supply agreements for the drug in 30 countries including Korea, the US, the UK, Germany, Australia, and Japan, and has been supplying Lagevrio to the countries.
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- Sales of Expectants & antibiotic have increased
- by Chon, Seung-Hyun Apr 25, 2022 06:07am
- Sales in the outpatient prescription market have been rising sharply this year. Sales in the prescription market have been rising as the number of COVID-19 confirmed cases has soared since late last year. The Expectant and antibiotic prescription market, which is used for colds and infectious disease diseases, recovered to the level before the outbreak of COVID-19 as it emerged from the sluggishness of the past two years. According to UBIST, a pharmaceutical research institute, on the 20th, the amount of outpatient prescriptions for medicines in the first quarter was 4.1248 trillion won, up 6.5% from the same period last year. This is the second time after 4.22 trillion won in the fourth quarter of last year. The outpatient prescription market showed a pattern of slowing growth after the spread of COVID-19. The prescription amount in 2019 was 15.2318 trillion won, up 8.2% from the previous year, but the growth rate in 2020 and last year was only 2.7% and 3.0%, respectively. In the first quarter of last year, the prescription amount increased 2.0% from the previous year to 3.8746 trillion won, but this year is the first time since the third quarter of 2019 that the quarterly prescription growth rate exceeded 6% compared to the same period last year. In more than two years, the growth before the outbreak of COVID-19 has recovered. The slowdown in the prescription market growth over the past two years is pointed out as the direct cause of COVID-19. After the spread of COVID-19, the market for related treatments also shrank significantly as the number of patients with infectious diseases such as flu and colds plunged due to strengthening personal hygiene management such as washing hands and wearing masks. This year, if there are many COVID-19 confirmed cases, hundreds of thousands of people poured out a day, and the demand for COVID-19 symptom-relieving treatments such as cold medicine surged. The government also encouraged pharmaceutical companies to increase production as the supply of cold medicines and anti-inflammatory analgesics failed to keep up with demand. In the first quarter, the amount of outpatient prescriptions for expectorants was 53.3 billion won, up 116.6% from 24.6 billion won during the same period last year. It is the first time in more than two years that the quarterly prescription performance of expectorants has exceeded 50 billion won since the fourth quarter of 2019 Prescription market of expectorants has been on the decline since recording KRW 54.5 billion in the fourth quarter of 2019. In the second quarter of 2020, the amount of prescription for expectorants was 26.5 billion won, down 43.8% from the previous year, and remained at 20 billion won for six consecutive quarters until the third quarter of last year. After the spread of COVID-19, the prescription market was directly hit by a sharp drop in cold patients. However, in the fourth quarter of last year, the prescription amount of expectorants began to rebound to 33.8 billion won, and this year, the market size recovered to the level before the spread of COVID-19. The amount of prescriptions for expectants in the first quarter was 33.2 billion won, up 164.4% from a year-on- Expectants decreased from 37.1 billion won in prescriptions in the fourth quarter of 2019 to 14.3 billion won in the second quarter of 2020, when COVID-19 began to spread in earnest. The amount of outpatient prescriptions for oral cephalosporin drugs in the first quarter was 65.1 billion won, up 49.6% from the previous year. Cephalosporin drugs, also called "Cepha antibiotics," are antibiotics widely used for pneumonia, sore throat, tonsillitis, and bronchitis. The amount of oral cephalosporin prescription in the first quarter is the largest since it recorded 75.6 billion won in the fourth quarter of 2019. Sales of Cephalosporin drugs have also shrunk significantly over the past two years due to a sharp drop in flu or cold patients due to the prolonged COVID-19. In recent years, it has recovered to the level of previous years due to a surge in the number of COVID-19 confirmed patients. In the case of oral PCN preparations, it recorded 52.7 billion won in the fourth quarter of 2019, but it was reduced by more than half to 20 billion won from the second quarter of 2020 to the third quarter of last year. It recorded 34.3 billion won in the fourth quarter of last year and showed a higher increase in recent years.
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- LDL-C target for cardiovascular dz will be lowered in Korea
- by Apr 25, 2022 06:07am
- The LDL-C target figure for South Korea's ultra-high-risk group for cardiovascular diseases is expected to be lowered to a similar level to global guidelines. The Korean Society of Lipid and Atherosclerosis held the Spring Cardiovascular Integration Academic Conference online and offline at the HICO on the 15th and 16th and unveiled some of the latest revised versions of the Dyslipidemia Treatment Guidelines. This amendment (the 5th edition) is the first revision of the guidelines for treating dyslipidemia in 4 years since 2018. In the meantime, in the United States and Europe, LDL-C targets for ultra-high-risk groups for cardiovascular diseases were lowered simultaneously. The ESC recommended lowering the target LDL-C level of the ultra-high-risk group for cardiovascular disease to 55 mg/dL, and considering less than 40 for extreme risk groups, such as patients who have experienced a second cardiovascular event. The AACE also recommends the LDL-C target value of the extreme risk group for cardiovascular disease at 55. This is because the premise that "the lower the LDL-C level, the higher the cardiovascular disease-related benefits" is accepted internationally. Korea, which remained in the 2018 guidelines, still sets the LDL-C target value for the ultra-high-risk group below 70. As the revision was made for the first time in four years, Korea also included changes in global guidelines in the new revision. The main focus of the amendment is a stronger LDL-C treatment strategy than before. Kim Sang-hyun, a professor of circulatory internal medicine at Seoul National University Hospital, introduced the framework and direction of the revision being prepared this year under the theme of "the goal of LDL-C treatment for ultra-high-risk/high-risk groups for cardiovascular diseases." According to the revised bill released by Professor Kim, the society classified the clinical situation into five according to the patient's risk level by judging the presence or absence of cardiovascular risk factors, and recommended lowering the LDL-C target overall by risk group. If the existing guidelines consisted of four groups: ultra-high-risk, high-risk, medium-risk, and low-risk, the revision is characterized by more detailed groups. Among the five groups according to the clinical situation, the highest risk group is coronary artery disease and diabetes (with targeted organ damage or three or more major cardiovascular disease risk factors). The amendment presented the group with the lowest LDL-C target of less than 55. The second group is a case of atherosclerosis ischemic stroke/daily cerebral ischemic stroke, carotid artery disease, peripheral artery disease, abdominal aneurysm, diabetes (with risk factors for cardiovascular disease over 10 years of illness or one or two). It was recommended that the group be targeted below LDL-C 70. The third group is a group of patients with less than 10 years of diabetes and no major risk factors for cardiovascular disease, with a target figure of less than 100. The other two groups were moderate risk groups (more than two major risk factors) and low risk groups (less than one major risk factor), respectively, with LDL-C targets of less than 130 and 160. It is noteworthy that LDL-C target values of coronary artery disease patients who have experienced myocardial infarction and angina were adjusted to be less than 55 and at least 50% lower than the baseline (Recommended grade 1, Evidence level A). Existing medical guidelines recommended reducing the LDL-C target for these patients by less than 70 or 50% or more. The association plans to unveil the final revision within the first half of this year. It is because it is still judged that expert discussion is necessary. In the case of diabetic patients, it was agreed that more discussion is needed on what to do with the LDL-C target value depending on the risk. A domestic data base to be used in determining patient risk should also be established.
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- Samsung BioLogics acquired all of its shares in Epis
- by Chon, Seung-Hyun Apr 24, 2022 06:33pm
- View of Samsung Bioepis buildingSamsung BioLogics will incorporate Samsung Bioepis as a 100% subsidiary and operate a separate management system. Samsung BioLogics announced on the 20th that it has completed the first payment of $1 billion in the acquisition of Epis shares to Biogen. From the day the first payment was completed under the contract between the two companies, Epis was officially converted into a 100% subsidiary of Samsung BioLogics. Earlier in January, Samsung BioLogics signed a contract with Biogen to acquire 10,341,852 shares of Epis (50%-1 share) for 2.7655 trillion won. Of the total amount, $50 million is equivalent to an additional "Earn-out" cost if certain conditions are met, and the remaining $2.25 billion will be paid in installments over the next two years. Samsung BioLogics raised a total of 3.2008 trillion won through a paid-in capital increase in shareholders' allocation to raise the cost of acquiring Epis shares. It achieved a high subscription rate of more than 100% in the paid-in capital increase public subscription for shareholders. The public offering of 400 billion won worth of shares for executives and employees recorded a subscription rate of nearly 100%, while existing shareholders such as Samsung C&T and Samsung Electronics made 100% subscriptions. As a result, Samsung BioLogics ended its partnership with Biogen for the first time in 10 years. Samsung BioLogics established Epis in 2012 in the form of a joint venture with Biogen. Epis was launched in February 2012 with a capital of 164.7 billion won. At this time, Biogen invested 24.7 billion won, or 15% of its capital. In 2018, Biogen raised its stake to 50% when it exercised its call option for Samsung Epis. Initially, Biogen established Samsung Biologics and signed a call option contract to transfer shares of Samsung Bioepis up to 50% - 1 share by June 29, 2018. Biogen decided to acquire shares when the call option contract expired. In June 2018, Samsung BioLogics took over 9,226,068 shares of Epis 19,567,921 shares for $700 million (748.6 billion won). Samsung BioLogics said, "As the joint management system with Biogen is transformed into Samsung BioLogics' sole management system, independent and rapid decision-making on Epis is expected to be possible. Through this, we believe that we will be able to push for mid- to long-term growth strategies such as the development of new pipelines, open innovation, and new drugs more quickly and flexibly." Starting with the acquisition of Epis, Samsung BioLogics plans to take a leap forward toward global bio companies. It is expected to internalize Epis' R&D capabilities in biopharmaceutical and expand its business portfolio to the development of new drugs in the long run. Samsung BioLogics plans to continue its bold and preemptive investment to secure future growth engines by using the investment funds secured by the paid-in capital increase to build its fourth plant and purchase additional sites. John Lim, president of Samsung Biologics, said, "Epis' capabilities and know-how will as an opportunity to making Samsung's bio business a global top tier."
