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- 2026-05-11 12:54:00
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- Generics for NOAC will be released
- by Kim, Jin-Gu Aug 02, 2020 09:47pm
- In the oral anticoagulant (NOAC) market, which forms a market of ₩200 billion annually, the prescription performance of items other than Lixiana has decreased. Generics are gradually increasing sales. The competition in this market is expected to intensify if generics for Xarelto and Pradaxa are released next to generic for Eliquis next year. ◆Lyxiana's sales increased 6% over the same period last year According to UBIST, a pharmaceutical market research agency on the 28th, the total amount of NOAC outpatient prescriptions in the second quarter reached ₩46 billion. This is a 2% increase compared to ₩45.1 billion in the second quarter of 2019. Changes in NOAC The overall prescription size rose slightly, but the prescription amount of most of the original items decreased. Only Daiichi Sankyo's Lixiana increased 6% from ₩15 billion to ₩15.9 billion during the same period. Bayer's Xarelto decreased 4% from ₩13bn to ₩12.5bn, and BMS’ Eliquis fell 3% from ₩12.5bn to ₩11.2bn. Beringer Ingelheim's Pradaxa fell 21% from ₩4.6 billion to ₩3.6 billion. In the case of Eliquis, it was dropped due to the release of generics, but the BMS applied for suspension through administrative action and the court accepted it, and the disposition was postponed. In the future, The amount of prescriptions may decrease depending on the outcome of the lawsuit in the future. Outpatient ◆Generic sales are on the rise while original prescription performance is slow As the growth of original products in the NOAC market has stagnated since the second quarter of last year, generics are gradually increasing their influence. Generic for Eliquis 2nd Quarter of Rx Results (Unit: ₩1 million, Data:UBIST)Currently, only generics for Eliquis has been released on the market. Starting with Chong Kun Dang and Yuhan in the second quarter of last year, 12 pharmaceutical companies are currently selling generics. In the overall NOAC market, generics' prescription increased from 0.1% in the second quarter of 2019 to 0.8% in the third quarter, 1.7% in the fourth quarter, 3.0% in the first quarter of 2020, and 4.0% in the second quarter of 2020. Among the generic items in the second quarter of this year, Liquixia ranked first with ₩500 million of prescription results. It was followed by Samjin's Elxaban (₩400 million), Yuhan's Apixaban (₩300 million), and Aju's Eliban (₩200 million). ◆Generic for Xarelto and Pradaxa waiting to be released… Intensifying competition from next year Next year, generic for Xarelto and Pradaxa are on the way. Competition is expected to intensify from next year, when the trial period ends. The launch of generic for Pradaxa is the first. Huons, Aju, Introbiopharma, and Jinyang will take the right to generic exclusivity after July 2021, when the material patent expires. After April 2022, when the trial period ended, other pharmaceutical companies could also compete. Currently, the remaining items approved by the MFDS are 12 items from 6 companies. Xarelto’s patent expires in October 2021. SK Chemicals and Hanmi won the right. The remaining 28 pharmaceutical companies will be able to launch products after July 2022. In the case of Lixiana, which is currently the No. 1 item on the market, The patent expires in November 2026. Boryung, Samjin, HK inno.N, Chong Kun Dang, Kolmar, Hutex, Kolmar Korea, and Hanmi, which have succeeded in patent avoidance, are expected to compete for the launch of first generic.
- Company
- Choline alfoscerate companies anxious of returning claims
- by Chon, Seung-Hyun Jul 31, 2020 06:34am
- Companies with cognitive enhancer choline alfoscerate products are to face another hurdle. Specifically, the companies are concerned of the clause stipulating the return of the claimed reimbursement when failing the clinical reevaluation during the pricing renegotiation for a product surging in sales. As South Korea’s Ministry of Food and Drug Safety’s (MFDS) clinical reevaluation process has been set, some companies are faced with marketing approval revocation and prescription sales return in the worst case scenario. According to pharmaceutical industry sources on July 30, the price-volume agreement (PVA) negotiation that National Health Insurance Service (NHIS) and pharmaceutical companies are to engage has included a number of choline alfoscerate generics. PVA allows an adjustment of pricing of a drug with a significant surge in use volume through a negotiation between pharmaceutical company and NHIS. Regardless of original or generic, a drug falling under the category of ‘making over 60 percent increase in claim amount compared to the year before, or making over 10 percent increase but increased by over 5 billion won,’ would be designated as a subject for PVA negotiation. Apparently ten choline alfoscerate products have been included for the coming PVA negotiation. As the medication market tends to expand rapidly every year, many generics in the market saw a sharp increase in prescription volume. A pharmaceutical market research firm UBIST found the choline alfoscerate’s outpatient prescription volume in the first half of the year reached 224.1 billion won, growing 19.6 percent from last year. The market volume has tripled in five years from 70.5 billion won in the first half of 2015. Quarterly outpatient prescription volume made in choline alfoscerate (Unit: KRW 1 million) Source: UBIST Regardless, the choline alfoscerate companies notified to participate in the PVA negotiation seems to be pressured about the sales return regulation. In accordance to NHIS drug pricing agreement, a company conducting a clinical trial for item approval renewal and pharmaceutical reevaluation by MFDS is stipulated to notify the details to NHIS. In case the company fails the reevaluation and loses approval, the responsible company has to pay NHIS back all reimbursement claimed from the date the MFDS ordered clinical trial through the date the listing was removed. Ultimately, if a company decides to withdraw its product from the market due to reevaluation outcome after agreeing on the choline alfoscerate’s pricing cut according to PVA negotiation, the company has to return all sales generated in between to NHIS. Choline alfoscerate is actually subjected to undergo clinical reevaluation. MFDS has recently demanded companies with choline alfoscerate products to submit clinical trial data. The relevant protocol has to be submitted by Dec. 23. The companies unable to prove efficacy of their choline alfoscerate during the clinical trial, the products may lose the government approval. And those companies that settled on the PVA would have to refund all prescription sales made from negotiation through approval revocation. And the product partially changing the indication due to clinical reevaluation would also have to return the prescription sales generated from the removed indication. Choline alfoscerate has been indicated to treat patients showing secondary symptoms of cerebrovascular insufficiency and degenerative brain-organic psychiatric syndrome— impairment of sense of direction, motivation, judgment and concentration due to confusion and degenerated memory, judgment and motivation; changes in emotions and behaviors—emotionally insecure, hypersensitive to stimulation, and indifferent to surrounding; and senile pseudo-depression. If any one of the indication gets removed, the pharmaceutical companies would have to pay back a part of their sales to NHIS. And the pharmaceutical industry experts predict the clinical reevaluation would likely to remove at least one of the indications. In fact, another cognitive enhancer acetyl-L-carnitine has lost one of indications after undergoing the clinical reevaluation. The original acetyl-L-carnitine Nicetile by Dong-A ST was indicated to treat patients with primary degenerative disease and secondary degenerative disease induced by cerebrovascular disease. However, the medication failed to demonstrate the efficacy of treating primary degenerative disease in the clinical reevaluation ordered by MFDS in 2015, the indication was removed in July last year. Acetyl-L-carnitine product that had PVA negotiation has to pay back all prescription sales made from the point of negotiation through indication removal. While the health authority has decided to apply selective reimbursement on choline alfoscerate, the companies with the medication subjected to PVA negotiation are heavily burdened. On July 24, MOHW convened the Health Insurance Policy Deliberation Committee (HIPDC) meeting and deliberated reimbursement reevaluation result and applying selective reimbursement on choline alfoscerate. The patient copayment rate on choline alfoscerate would be raised from 30 percent to 80 percent. MOHW preannounced the amendment and plans to enforce it from August. A pharmaceutical company insider complained, “When the market is unstable due to coverage reduction and clinical reevaluation, the company feels even more strained about the risk of returning prescription sales only because of making a significant growth in recent sales and clinical reevaluation result.”
- Company
- LG Chem begins development of Zemiglo + SGLT-2 inhibitor
- by Kim, Jin-Gu Jul 31, 2020 06:33am
- LG Chem will develop a combination of DPP-4 inhibitor and SGLT-2 inhibitor. Currently, three items are permitted as a combination, but no drug has been developed by a domestic pharmaceutical company. According to the pharmaceutical industry on the 29th, the MFDS recently approved LG Chem's Phase I trial plan which comparing the pharmacokinetics, safety and tolerability when Gemigliptin 50mg and Dapagliflozin 10mg are administered respectively and together. ZemigloGemigliptin is a DPP-4 inhibitor developed by LG Chem itself. It is Zemiglo. Dapagliflozin is generic for AstraZeneca's SGLT-2 inhibitor Forxiga. Currently, there are three products approved in Korea for the combination of DPP-4 inhibitor and SGLT-2 inhibitor. No products have been developed by domestic companies yet. Beringer Ingelheim's Glyxambi (Empagliflozin-Linagliptin) and AstraZeneca's Qtern (Dapagliflozin-Saxagliptin) were each approved in March 2017. MSD's'Steagluzan (Citagliptin + Ertugliflozin)' was approved in September 2018. If LG Chem succeeds in developing complex drugs, it will be the fourth drug in the Zemiglo series. Currently, LG Chem possesses ▲DPP-4 inhibitor single ingredient Zemiglo ▲DM complex, Zemimet (Gemigliptin/Metformin) ▲DM and hyperlipidemia complex Zemiro (Gemigliptin/Rosuvastatin). The total prescription amount for the three products last year was ₩97.9 billion. This year, ₩56 billion worth was prescribed until the first half. The products are likely to exceed ₩100 billion annually. ◆The key is whether DPP-4·SGLT-2 combination therapy benefits are recognized. The Korean Diabetes Association submitted an opinion to the government in April that a combination of DPP-4 inhibitors and SGLT-2 inhibitors would require benefits. Prior to this, in 2018, the government tried to find a way to apply benefits. In February of this year, LG Chem and Dong-A ST launched in June, and in June, Handok launched clinical trials. In the case of LG Chem, it is to verify the combination therapy of Zemiglo and Dapagliflozin or Empagliflozin. Dong-A ST also entered a combination clinical trial of its DPP-4 inhibitor, Suganon (Evogliptin) and Dapagliflozin or Empagliflozin. Handok has also been approved for a clinical trial plan to verify the combination therapy of its DPP-4 inhibitor Tenelia (Teneligliptin) and SGLT-2 inhibitor. An official in the pharmaceutical industry said, "If the government recognizes the combination therapy of DPP-4 inhibitors and SGLT-2 inhibitors as reimbursed items, it will be possible to prescribe combination drugs as well as combination therapy."
- Company
- GC Pharma, applied for Phase II clinical trial of GC5131A
- by Kim, Jin-Gu Jul 31, 2020 06:31am
- GC Pharma announced on the 29th that it had applied to the MFDS for a clinical trial phase II plan for COVID-19 blood plasma tx, 'GC5131A'. Samsung Medical Center, Asan Medical Center, Chung-Ang University Hospital, Korea University Ansan Hospital, and Chungnam National University Hospital are targeting 60 people. 'GC5131A' is a Hyperimmune globulin made by extracting various effective immune antibodies from the plasma (liquid component of blood) of COVID-19 recovery patient. It has been reported that Hyperimmune globulin has been used in the human body for a long time, so it has been developed rapidly. If the MFDS approves the clinical trial plan, it will enter the Phase II clinical trial in Korea among the candidates for new drugs, excluding products that have initiated the clinical trial through drug re-creation. The GC Pharma explained that production of clinical trial preparations has been completed and that patients will be administered as approved by the MFDS. “We will do our best to put GC5131A into the medical field in a short period of time,” said Kim Jin, head of Medical division, GC PHarma. On the other hand, it is explained that the blood plasma treatment is different from convalescent plasma therapy, which is used to transfuse the plasma of patients in the recovery phase to severely ill patients. Blood plasma therapy is a kind of medical practice, and blood plasma treatment is a medicine made by fractionating only the immunoprotein containing antibodies from the plasma and concentrating it at a high concentration.
- Company
- Big 5 green lit another CDK4/6 inhibitor Verzenio
- by Eo, Yun-Ho Jul 30, 2020 06:18am
- General hospitals in South Korea are entering prescription code for anticancer treatment Verzenio. According to pharmaceutical industry sources on July 28, drug committees at the Big Fives including Seoul National University Hospital, Severance Hospital and Samsung Medical Center, and other major general hospitals like National Cancer Center, Ajou University Hospital, and Chonnam National University Hwasun Hospital have passed Lilly’s Verzenio (abemaciclib) for prescription. From last month, the treatment was listed for healthcare reimbursement as a combination therapy with an aromatase inhibitor for treating perimenopausal women with HR+/HER2- advanced or metastatic breast cancer for first-line endocrine therapy, or as a combination therapy with fulvestrant for treating women with HR+/HER2- advanced or metastatic breast cancer. All doses of 50 mg, 100 mg, and 150 mg of the medication are priced at 49,587 per tablet. The medication has settled a risk sharing agreement (RSA) to receive reimbursement to treat patients with HER2- advanced breast cancer in combination with AstraZeneca’s Faslodex (fulvestrant). As the major general hospitals green lit Verzenio, the cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor prescription war would get escalated. A CDK4/6 inhibitor Verzenio can be prescribed to perimenopausal women with HR+/HER2- advanced or metastatic breast cancer either for first-line endocrine therapy combined with an aromatase inhibitor, or for combination therapy with Faslodex after receiving endocrine therapy. The first-in-class CDK4/6 inhibitor Ibrance by Pfizer requires seven days of off treatment after 21 consecutive days of once-daily 125 mg administration, whereas Verzenio can be administered every day. Ibrance has also expanded the coverage as a fulvestrant combination therapy along with Verzenio. Ibrance’ efficacy of significantly improving progression-free survival (PFS) as a second-line therapy has been confirmed during PALOMA-3 study. Besides patients with early stage breast cancer, the CDK4/6 inhibitor also showed consistent effect in patients with stage 4 metastatic breast cancer that affected their lungs and bones. Verzenio has recently attracted the industry’s interest, when it completed MONARCH2 study that showed improved PFS as well as overall survival (OS). The achievement was unprecedented for a CDK4/6 inhibitor. As a part of secondary endpoints, the OS of both pre and postmenopausal women was observed.
- Company
- 2,000 reimbursed items were registered for 3 months
- by Chon, Seung-Hyun Jul 29, 2020 06:34am
- Pharmaceuticals have launched generic products enormously ahead of the new drug price system. In the last three months, about 2000 generics have been licensed and listed. It is to receive upper limit price before applying cascading drug price system that the later it is registered, the lower the price. The government's restrictions on generics have led to the release of many generics. According to the MOHW's announcement on the 28th, “The Amendment of the Pharmaceutical reimbursed list and the upper limit price table”, from August 1st, a total of 836 products will be newly added to the health insurance reimbursement list. Most of the new drugs listed are generics. Products listed in August are Pregabalin (14), Gabapentin (13), Aceclofenac (6), and Celecoxib (7). More than 100 eye drops have been newly registered, and it is identified as newly registered products by dose among previously approved products. For eye drops, the upper limit price should be separately listed in the reimbursed list by dose. In particular, small and medium-sized pharmaceutical companies were actively launching generic products. Kims Pharma registered 48 generics in August. Union Korea Pharm (40), SCD Pharm (36), Reyon (36), Mothers Pharm (31), Kukje pharm (27), Korea United Pharm (22), DHP Korea (20) ), Lite pharm (20), Pharvis Korea (20) have newly registered eye drops, and many small-sized companies have registered generics. Number of new monthly registered drugs (unit: # of Drug, data: The MOHW) The number of new drugs listed in August is the highest this year. From January to May of this year, about 300 medicines were newly added to the reimbursed list every month. Following the list of 558 in June and 653 in July, the number of products on the list is increasing rapidly. In the last three months, more than 2000 generics have been newly registered. The intention is to receive upper limit price before the new price system is implemented. The new generic drug price system, which has been in effect since last month, includes cascading drug price system that lowers the upper limit as the registration period is delayed. If more than 20 generics are listed in a particular generic market, the upper limit for new listed items will be up to 85% of the existing lowest price. According to the MOHW, the previous drug price system is applied to the products that were registered in May. Most products listed in August are products that have been registered in May. This means that generic drugs that have been registered for benefits since June will receive a lower price than existing products due to the cascading drug price system. Since there are more than 20 generics in the majority of patent expiration drug markets, generics listed from September are forced to receive lower drug prices than before. Since the cascading drug price system does not apply only to generic products listed in August, the application in May is the last chance to receive the previous high price. In fact, until May, generic approval has been increased significantly. There were an overwhelming number of products that were approved by other companies as a consignment method without direct production. According to the MFDS, a total of 1399 generics were approved in the first half of this year through a full-process consignment method. This is the number of generics licensed through another company's bioequivalence study data. In January and February, 161 and 206 consigned generics were approved, respectively, and exceeded 300 in April and May. In 2013, the number of consigned generic licenses began to increase, but since the government's generic license and drug price regulation policies began to be established last year, the consigned generics are approved. In 2012, 50 licensed generics were licensed, but in 2013, the number was 500, a 10-fold increase in a year. In 2015 and 2016, there were more than 1,000 generics licensed for consignment. In 2017 and 2018, 681 and 751 commissioned generics were approved, respectively. Last year, 3,173 consignment generics were approved. It was more than twice as many as 1,306 cases in 2016. From last year to the first half of this year, there were 4,572 consigned generics. According to the HIRA, the total number of registered drugs in August this year is 26,328. It is the largest for 8 consecutive months. It increased by 3,066 from 27,754 in December last year, and more than 3,000, up from 20,689 in November 2018, a year and nine months ago. Despite the government's movement to regulate generics, many generics were released. However, starting in September, the number of new generics are expected to drop significantly. It is analyzed that pharmaceutical companies are equipped with as many generics as possible prior to the implementation of the cascading drug system. In fact, there were 12 licensed generics in June with the cascading drug price system, less than a tenth of the previous month.
- Company
- HCV drug Mavyret prescription goes down by 31% amid COVID-19
- by Kim, Jin-Gu Jul 29, 2020 06:33am
- Although Mavyret (glecaprevir) dominated the hepatitis C treatment market as soon as it was launched, the treatment took a steep fall in prescription volume. The pharmaceutical industry sources argue the 31-percent drop compared to last year would have been impacted by decreased number of patients and COVID-19. According to the pharmaceutical market research firm UBIST on July 27, Mavyret’s outpatient prescription sales from last January through June marked 16.4 billion won. Still the treatment is accounted for 74 percent of the Korean hepatitis C treatment market, but the situation is not exactly rosy. Compared to last year, the prescription sales have gone by down 31 percent. In the first half of 2019, Mavyret generated 23.7 billion won. In 12 months time, the figure plummeted by 7.3 billion won. The fall has continued for five consecutive months. After peaking at 13.1 billion won in the second quarter of 2019, the prescription has been sliding down from 12 billion won in third quarter last year, 8.8 billion won in fourth quarter last year, 8.8 billion won in last first quarter, and 7.7 billion won in last second quarter. Hepatitis C treatment prescription volume in 2020 H1 and Mavyret’s quarterly prescription volume (Source: UBIST) The research firm claims two complicated causes have affected the state. First, the hepatitis C patient size has shrunk. Direct-acting antiviral (DAA) medications treating hepatitis C, such as Mavyret, demonstrates high cure rates and has short therapy duration. Naturally, the overall patient size is constantly narrowing as increasing number of patients are cured. Korea’s Health Insurance Review and Assessment Service (HIRA) reported the number of hepatitis C patients last year was at 44,483, which went down by 10 percent in three years from 49,569 in 2016. The hepatitis C treatment market has been following the descending curve since the third quarter in 2016. The market volume valued at 68.5 billion won has dwindled to 10.3 billion won in the last second quarter. The current market is now at about one-seventh of its peak. The last quarter actually hit the historic low since the DAA medication entered the market. In last month, Bristol Myers Squibb (BMS) that first opened the hepatitis C treatment market withdrew ‘Daklinza plus Sunvepra’ combination therapy from the Korean market. The company explained it was because the competition has gotten increasingly intense, while the demand lessened. Yearly count of hepatitis C patients (Source: HIRA) and quarterly trend in hepatitis C treatment market volume (Source: UBIST) Moreover, this year has been rough for the market amid COVID-19. As patients have been refraining from visiting hospitals and clinics due to COVID-19, they were less exposed to the main cause of hepatitis C like infection through blood transfusion and syringe. Regardless of blood borne infection, the hepatitis C infection transmission was apparently impacted by social distancing.
- Company
- Eight generic companies for Lixiana are expected to compete
- by Kim, Jin-Gu Jul 29, 2020 06:31am
- LixianaHanmi and Boryung overcome the patent of oral anticoagulant (NOAC) 'Lixiana' (Edoxaban). Eight generic companies, including those, are expected to compete after the patent expires in November 2026. The Intellectual Property Trial and Appeal Board recently decided on 'claims established'' at a trial to confirm the passive scope of rights to Lixiana composition patent claimed by Hanmi Pharmaceutical and Boryeong Pharmaceutical. As a result, eight companies have overcome Lixiana composition patent. Previously, in April, Samjin, HK inno.N, Chong Kun Dang, Kolmar pharma Hutecs Kolmar Korea received the same trial. However, they failed to overcome Lixiana's material patent. Accordingly, eight companies can enter the generic competition after November 10, 2026, when the material patent expires. They met two of the three requirements for generic for exclusivity right. If the requirements are met until the first application for permission, it is expected that there will be no difficulty in winning generic exclusivity. Lixiana is the representative product of the NOAC market. It was the latest release compared to other items, but It is superior to the results of JXarelto (Rivaroxaban), Eliquis(Apixaban), and Pradaxa (Dabigatran). According to UBIST, Lixiana's outpatient prescription amounted to ₩59.9 billion last year. This year, only ₩31.7 billion was prescribed in the first half.
- Company
- [Photo]“Dismissal is a murder” Sanofi Labor Union protests
- by An, Kyung-Jin Jul 29, 2020 06:30am
- On July 27, the Sanofi-Aventis Korea Labor Union Chapter of Federation of Korean Chemical Workers' Unions (FKCU) was gathered in front of the company’s Seoul headquarters to denounce the management’s unfair disciplinary action Sanofi-Aventis Korea’s Disciplinary Committee meeting was scheduled in the afternoon to deliberate a salesperson, who made false reports of calls and received a ‘letter of recommended dismissal.’ Two other salespeople who were accused the same have reportedly ‘resigned by recommendation.’ The labor union claims the two employees have been intervened by the management unjustly. And the union plans to continue their protest against the company to defend the job security of the other one employee that refused the management’s offer and received a letter of dismissal. The chief of Sanofi-Aventis Korea Labor Union, Park Young stated, “An unfair treatment by the Disciplinary Committee is as cruel as committing a murder. Hopefully, the committee would make a fair decision,” while “we would fight against the management until it stops repeating the same action of imposing excessive penalty and dismissing employees.”
- Company
- Generics for Betmiga competition gets fierce
- by Kim, Jin-Gu Jul 28, 2020 06:37am
- BetmigaFull-fledged competition began in the generic market of “Betmiga (Mirabegron),” which has annual outpatient prescriptions of ₩65 billion. Hanmi and Chong Kun Dang, which received generic for exclusivity, recently released generics. The two companies plan to focus on expanding the market until February next year when the trial period expires. According to the pharmaceutical industry on the 24th, Chong Kun Dang has released "Selebeta", which is a generic for Betmiga, from the 1st of this month. Hanmi has been launching and selling “Mirabek” since June, a month earlier. The overall prescription amount is a little higher than that of Hanmi, which was released a step ahead, but the two companies are said to be very similar. As the original market was so large, the officials said that the prescription performance was good. Since the launch of Betmiga, more than 40 domestic companies have filed for patent evasion. Since 2015, invalidity trials and passive judgments on the scope of rights have been requested for material patents, formulation patents, crystalline patents, and use patents. As a result, 11 companies succeeded in overcoming formulation patents, crystalline patents, and use patents excluding material patents. These are Hanmi, Chong Kun Dang, JW Pharma, Daewoong, Ildong, Intropharm, Alvogen Korea, Kyung Dong, Sinil, Hanwha, and Shinpoong. Only Chong Kun Dang and Hanmi have won the right of generic for exclusivity. They received the right of copyright in April. As the material patent expired on May 3, the two companies launched a series of products. Other pharmaceutical companies that have evaded patents are said to have been disrupted in bioequivalence tests. It is expected that the generic competition will get hotter after February next year. Other generic companies such as Kyung Dong, Sinil, and Shinpoong, which are currently undergoing bioequivalence testing, are predicting to join after February 3, next year, when the trial period ends. According to UBIST, Betmiga's outpatient prescription amounted to ₩65.7 billion last year. Betmiga became a blockbuster drug shortly after its release in October 2015. In 2016, it posted sales of ₩28.8 billion, ₩41.7 billion in 2017, and ₩54.8 billion in 2018.
