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- 2026-05-17 00:53:26
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- Moderna and BeiGene joined KRPIA
- by Eo, Yun-Ho Feb 25, 2022 05:57am
- According to related industries, U.S.-Moderna Korea and Chinese-BeiGene Korea recently joined as KRPIA members. As a result, the number of KRPIA member companies has increased to 46. Both Moderna and BeiGene are multinational pharmaceutical companies that established a Korean subsidiary last year, and promotional activities are expected to begin in earnest this year. Moderna, well-known as a developer of the COVID-19 vaccine, recruited Son Ji-young, former CEO of CSL Behring Korea, as the first corporate president at the end of last year. The company is currently taking three strategies: ▲ High-capacity booster shots ▲ New booster shots ▲ Omicron-specific booster shots to cope with some variations in Omicron and existing vaccines. The first alternative, the high-capacity booster shot, has doubled the existing vaccine to 100μg capacity, and has completed safety and immunogenicity tests on 306 adults. Vaccine candidate substance mRNA-1273.529 targeting Omicron is also being developed and will take about two to three months. BeiGene is a company owned by Amgen, a global pharmaceutical company. Amgen acquired about 20% of BeiGene's stake for $2.7 billion (about 3.1 trillion won) last year. The company is supplying three new drugs in China: Amgen's multiple myeloma treatment Kyprolis (Carfilzomib) and acute leukemia treatment Blincyto (Blinatumomab). PD-1 inhibitory immuno-cancer drug candidates such as Keytruda(Pembrolizumab) and Opdivo(Nivolumab) were technically exported to Celgene and obtained FDA approval from Brukinsa, a BTK inhibitory cell lymphoma treatment. Meanwhile, KRPIA includes Japanese companies such as Takeda, Daiichi Sankyo, Mitsubishi Tanabe Pharma, Santen Pharmaceutical, Astellas, Kowa, Kyowa Kirin Korea, and multinational companies such as Galderma, Sandoz, Fresenius Kabi, Fresenius Medical Care, and Baxter.
- Policy
- Voluntary price cuts of originals as ‘trade-offs’ an issue
- by Lee, Tak-Sun Feb 25, 2022 05:57am
- ‘Discounting the price of existing drugs to list high-priced new drugs.’ Recently, the pharmaceutical industry has been buzzing with speculations that some companies are voluntarily reducing the price of their original drugs as a fiscal sharing strategy to receive reimbursement. This strategy, which was considered unimaginable before, is raising concern among generic companies, as the price drop of an original drug will threaten the price competitiveness of its generic items. According to the industry on the 24th, prices of 15 MSD Korea’s Januvia products and 2 Astellas Korea’s Vesicare products will be discounted from the 1st of next month. All the pricing decisions were voluntarily made by the company. The price caps of the products will fall from 3.2% to 77% at the most. The industry speculates that the voluntary price cuts are the results of negotiating with the insurance authorities to list their high-priced drugs for reimbursement, as a kind of "trade-off" strategy. In other words, the analysis is that MSD made a “trade-off” to reimburse ‘Keytruda’ as first-line treatment of NSCLC, which will cost at least 170 billion won in insurance finances, and Astellas to reimburse its acute myeloid leukemia treatment ‘Xostapa.’ However, the parties involved are refraining from making official statements regarding the matter. However still, the strategy will ultimately be a ‘win-win’ for both the insurance authorities and pharmaceutical companies, as it would save NHI finances and allow companies to list high-price drugs. But this was not good news for the generic companies. Due to the voluntary price cut of Vesicare, the ceiling price of 75 generics became 16-18 won more expensive than Vesicare. Only 2 generic products will have a lower price than Vesicare. Some hospitals and clinics prescribe products with a lower price cap among the same ingredient drugs in consideration of the patient’s economic status, and generic companies will have lost this price competitiveness due to the voluntary discounts. Moreover, as the well-known originals became cheaper than the less known generics, the generic companies are now more disadvantaged than before. Generic versions of MSD Korea’s Januvia tab. And Janumet tab. may be released upon patent expiry in September 2023. However, the voluntary price cut of the original products has lowered the list price of its generics, increasing the cost burden. Due to such reasons, the industry is seeing that there is a problem in companies voluntarily lowering drug prices of patented drugs for the ‘trade-offs’. A domestic industry official said, “The trade-offs were made in agreement between the insurance authorities and the pharmaceutical companies, but it is unreasonable that this may affect the profitability of other drugs that will be released in the future. The subjects of the trade-offs should be limited to off-patent drugs at the very least.”
- Policy
- JW’s ‘Actemra’ reviewed for reimbursement as COVID-19 Tx
- by Lee, Tak-Sun Feb 25, 2022 05:57am
- The government is reviewing providing nsurance benefits to JW Pharmaceutical’s rheumatoid arthritis treatment ‘Actemra’ (tocilizumab)’ for the treatment of COVID-19. This is because the drug, which is being often used in Korea off-label to treat patients with severe COVID-19, is increasing patient burden due to its non-reimbursed cost unlike other insured COVID-19 treatments like Remdesivir or Regkirona. Also, due to its shortage in supply, the medical community has asked the government to purchase Actemra like other COVID-19 treatments. According to the NHIS webpage on the 23rd, the authorities have conducted negotiations with JW Pharmaceutical on providing health insurance coverage for ‘Actemra.’ The negotiation has been conducted to lower the burden borne by patients by reimbursing ‘Actemra,’ which is currently widely used in patients with severe COVID-19. However, the negotiation results have not been disclosed yet. An NHIS official said, “the NHIS had conducted negotiations for Actemra recently, but did not share details of the negotiation or its results. The industry believes that discussions on providing insurance support would have been conducted for Actemra for equity with other COVID-19 treatments as the drug is being widely used off-label for patients with severe COVID-19 without reimbursement. Off-label prescriptions of Actemra has increased for the treatment of severe cases of COVID-19 last year, to make YoY growth of 24.9% and record ₩20 billion in sales last year Other COVID-19 treatments such as Remdesivir, Regkirona, and Paxlovid have been fully purchased by the Korea Disease Control and Prevention Agency and are provided free for the patients’ use. However, in the case of Actemra, as the drug was not approved as a COVID-19 treatment, the cost needs to be solely borne by the patient. Actemra, which is used for the treatment of rheumatoid arthritis in adults, costs ₩345,682 per shot without reimbursement, bringing an immense burden on the patients. Regarding the matter, the Korean Society of Infectious Diseases and other medical societies have submitted an opinion to the government to ask for the use of Actemra as a treatment for severe COVID-19. The industry believes it is highly likely that the government would temporarily apply insurance benefits to Actemra until the drug is approved as a COVID-19 treatment in Korea. Actemra is already being used with temporary or official approval as a COVID-19 treatment abroad. The US FDA granted Actemra Emergency Use Authorization (EUA) as a treatment for COVID-19. The European Commission also approved the drug as a treatment for COVID-19 in December last year. The WHO had also recently added Actemra to the prequalified COVID-19 treatment list' for reference by low- and middle-income countries that may have difficulty conducting independent reviews. Recently, the community has been suffering a supply shortage of Actemra with its increased use in patients with severe COVID-19. Due to this, the company is working to change its license to expand manufacturers of the drug that is currently limited to Japan. Also, the authorities are known to be reviewing Actemra for emergency use in treating COVID-19.
- Company
- Shionogi COVID tx developed by Ildong has been approved
- by Kim, Jin-Gu Feb 25, 2022 05:56am
- Ildong Pharmaceutical announced on the 23rd that it has been approved by the MFDS to change the clinical trial plan of Shionogi's oral COVID-19 treatment candidate "S-217622" under development in Korea. Earlier, Ildong Pharmaceutical applied to change its clinical plan in the direction of confirming the results of each phase by modifying the existing plan to conduct phase 2b/3 clinical trials of S-217622 at once and dividing it into phase 2b and phase 3. Ildong Pharmaceutical plans to separate and check the validity and safety of Phase 2b and Phase 3 while continuing the existing clinical trials that have been conducted in Korea since the beginning of this year. This is to accelerate commercialization in line with changes in Shionogi's S-217622 development strategy and clinical plan. Shionogi is said to have recently confirmed significant results related to the COVID-19 virus suppression effect in phase 2a clinical trials. Ildong Pharmaceutical explained that it is planning to commercialize the EUA based on the interim results after completing the process up to phase 2b. The changed clinical trial plan is designed to be divided into a group (Cohort A) that conducts phase 2a, phase 2b, and phase 3 clinical trials for mild and moderate patients, respectively, and a group (Cohort B) that conducts phase 2a and phase 2b/3, respectively. The total size of the global clinical trial conducted by Shionogi is 1260 for cohort A and 600 for cohort B, of which 200 patients are eligible for clinical trials in Korea. S-217622 is a mechanism that inhibits the proliferation of viruses in the body by inhibiting the protease (3CL-protase) of the SARS-CoV-2 virus that causes COVID-19. Currently, global clinical trials are underway in Korea, Japan, Singapore, Vietnam, and Europe.
- Policy
- Pfizer COVID-19 vaccine for children has been approved
- by Lee, Hye-Kyung Feb 25, 2022 05:56am
- Pfizer's COVID-19 vaccine "Cominatiju 0.1mg/mL," which is subject to vaccination for children and adolescents aged 5 to 11, has obtained an item license. The MFDS (Minister Kim Kang-rip) announced on the 23rd that Pfizer Pharmaceutical Korea has approved "Comirati 0.1mg/mL" applied for permission as an imported item. Depending on the design of the clinical trial, different doses were allocated at the age of 11 and 12, and in the case of 5 to 11 years old, the dose was selected in consideration of the results of the immune response obtained from the clinical trial (phase 1). The vaccine is an mRNA vaccine jointly developed by Pfizera of the U.S. and Bioentech of Germany and imported by Pfizer Pharmaceutical of Korea, which will be diluted with 0.9% sodium chloride injection. According to clinical data submitted by pharmaceutical companies, the overall safety information was similar to those aged 16 to 25 (1064 people) when comparing safety and evaluating 3,109 people aged 5 to 11. The most frequent abnormal cases after vaccination were pain at the injection site, fatigue, headache, redness and swelling at the injection site, muscle pain, and chills, and most of the symptoms were mild to moderate. The probability of redness and swelling at the injection site was 26.4% and 20.%, respectively, higher than 10.3% and 11.4% seen at the age of 16-25 years old. The abnormal cases appeared more in the second inoculation than in the first inoculation, but were reported to have disappeared within three days of the outbreak. There were no deaths, myocarditis, pericarditis, or anaphylaxis, and it was confirmed that no serious adverse drug reactions such as drug-related hospitalization or death occurred. COVID-19 immune responses were compared and evaluated at the ages of 5 to 11 (264) and 16 to 25 (253), and the preventive effect was evaluated as the proportion of patients infected with COVID-19 after administering vaccines (1305 patients) and contrast drugs (663 patients) at the ages of 5 to 11. As a result of comparing the immune responses of ages 5 to 11 and 16 to 25 at one month after the completion of the second inoculation, it was found that both the ratio of neutralizing antibodies and the serum response rate were proven effective. As a result of analyzing the preventive effect seven days after the completion of the second inoculation of 1968 people (1305 in the test group and 663 in the control group) who were not infected with COVID-19, the preventive effect of vaccination was 90.7%. Based on this data, experts agreed that the safety and effectiveness confirmed in clinical trial data can be recognized as a result of consultation by the Central Pharmaceutical Review Committee on the 14th. However, although it did not occur in clinical trials as a risk management plan after approval, it was decided to observe the safety of myocarditis and pericarditis as a preventive measure, and to collect and evaluate abnormal cases arising from clinical trials and post-authorization use. Comernaty 0.1mg/mL (for ages 5 to 11) is a vaccine developed and produced separately by Pfizer of the United States for the purpose of preventing COVID-19 aged 5 to 11, and has the same type of additive, usage, and capacity (tojinameran) as previously approved by the Ministry of Food and Drug Safety. The specific vaccination plan will be announced separately by the Korea Centers for Disease Control and Prevention, taking into account the burden of children's diseases (severe rate, etc.), the epidemic of Omicron mutations, and the schedule of introduction of vaccines for children in Korea. In the future, the Ministry of Food and Drug Safety plans to analyze the manufacturing and test results of manufacturers for each manufacturing unit of Comirati 0.1 mg/mL (5-11 years old) and check the quality once again with national shipping approval.
- Policy
- Enactment of the Digital Healthcare Act begins in earnest
- by Lee, Jeong-Hwan Feb 24, 2022 05:59am
- With the National Assembly moving to enact a law specifically for the digital healthcare industry, attention is focused on whether the non-face-to-face treatment and drug delivery platform may gain momentum and make growth. The non-face-to-face and drug delivery platforms have been operating based on the non-face-to-face treatment that was temporarily allowed due to the COVID-19 pandemic and lacks specific legal and institutional grounds or support. If a law is enacted to foster the digital healthcare industry, the law and institutional support for the industry will be improved while the industry may enjoy benefits from the new various special provisions that would be set. NA member Tae-ho Jung of the Democratic Party of Korea recently submitted a bill as representative for the ‘Foster and Support of the Digital Healthcare Industry.’ The law aims to foster and support the digital healthcare industry and stipulate the basic matters necessary for development to strengthen industry competitiveness. The bill defines the Digital Healthcare Industry, subjects for support, and also contains provisions that require a comprehensive plan for foster and support be established every 5 years. Also, the bill will provide the basis for support such as certification, preferential treatment, tax exemptions, and prepurchase approvals for best companies while also providing support for training and employment of professionals and the establishment of a Digital Healthcare Business Association. The healthcare industry has started collecting opinions related to the proposed enactment of the bill. The Korean Hospital Association is collecting opinions from its member countries, and groups related to digital healthcare are expressing their agreement to the enactment of the bill. 7 associations including the Korea Medical Devices Industry Association, Korea Digital Health Industry Association, and the Korea Medical Device Industry Cooperative Association have issued a joint statement welcoming the bill. Digital healthcare is essential for responding to the post-COVID-19, data economy, and non-face-to-face society. In particular, if enacted, the bill will directly influence the management of the non-face-to-face treatment and drug delivery platform. Companies that have jumped into telemedicine and prescription drug delivery service due to COVID-19 have made remarkable growth despite the temporarily approved environment. If the regulations are lifted, industry analysis is that the telemedicine and prescription drug delivery platforms will grow explosively. The enactment of the Digital Healthcare Act is being evaluated as the trigger that will speed up such regulatory reform. In addition, there is a high possibility that dinosaur companies such as Naver and Kakao will enter the non-face-to-face treatment and drug delivery business in addition to IT venture companies. Tae-ho Jung, who submitted the bill said, “The COVID-19 pandemic has rapidly changed our living environment, and the limited amount of medical resources have been greatly affecting public health and the industry in general. It is imperative that we develop the digital healthcare technology to solve chronic problems such as aging and the upsurge of chronic disease patients."
- Policy
- Phase 3 of SK Biopharm's Cenobamate is approved
- by Lee, Hye-Kyung Feb 24, 2022 05:58am
- Clinical trials have been approved at six hospitals, including Seoul National University, for children with partial epilepsy attacks. SK Biopharm will enter phase 3 of clinical trials for pediatric test takers of Xcopri (Cenobamate), a treatment for epilepsy. On the 23rd, the MFDS approved a phase 3 clinical trial plan for Cenobamate (YKP3089) for pediatric testing patients with partial expression attacks submitted by SK Biopharm. This clinical trial will be conducted at six locations, including Yonsei Severance Hospital, Chungbuk National University Hospital, Korea University Guro Hospital, SNU Boramae medical center, Ajou University Hospital, and Seoul National University Hospital. Cenobamate is SK Biopharmate's new drug released in the U.S. in May 2020 after being approved by the U.S. Food and Drug Administration (FDA) in November 2019 for epilepsy partial seizures. Phase 3 clinical trials in the U.S. for adults aged 18 or older with systemic seizure symptoms began in September 2018, and clinical trials in China, Japan, and Korea for adults aged 18 or older were preparing to launch in the U.S., Europe and other Asian regions as patient registration began in March last year. It is known that the registration of phase 3 clinical trials in the United States has recently begun for children and adolescents aged 2 to 17 with partial epilepsy attacks, and Korea will enter phase 3 clinical trials at the same time. SK Biopharm announced on February 8 that its operating profit last year turned into a surplus year-on-year at 95.3 billion won. It recorded a surplus for the first time in five years due to the influx of new drug technology fees, and Cenobamate played a significant role. When Cenobamate transferred its technology to Angelini Pharma (formerly Arvelle Therapeutics), it received $123.22 million worth of technology fees last year. In addition, Cenobamate, which has been released in the U.S. since last year, has generated 78.2 billion won in sales, reflecting its operating profit as it is.
- Company
- Yuhan’s ‘Leclaza’ makes ₩4.1 billion in 6 months
- by Chon, Seung-Hyun Feb 24, 2022 05:58am
- Yuhan Corporation's new drug ‘Leclaza’ has made ₩4.1 billion in its first year of release. In only 6 months since its sales began in earnest with reimbursement listing in July, Leclaza rose to the top among homegrown anticancer drugs, raising expectations on its potential for commercial success. According to the pharmaceutical research institution IQVIA on the 22nd, Leclaza recorded ₩4.1 billion in sales last year. After raising ₩1.5 billion in Q3, sales rose to ₩2.6 billion in Q4. Leclaza is the 31st homegrown new drug that was approved for the treatment of non-small cell lung cancer in January last year. It is indicated for patients with locally advanced or metastatic non-small cell cancer who have developed resistance to the T790 mutation after using 1st or 2nd generation EGFR TKIs. Before ‘Leclaza,’ the treatment options available for prescription in Korea were first-generation EGFR-TKIs ‘Iressa (gefitinib)’ and ‘Tarceva(erlotinib),’ and second-generation EGFR-TKIs ‘Giotrif (afatinib) and ‘Vizimpro (dacomitinib),’ and third-generation EGFR-TKI ‘Tagrisso (Osimertinib).’ Yuhan Corp made its debut in the market in July last year after being listed for reimbursement. The drug received the reimbursement approval only 165 days since its authorization using the ‘approval-benefit appraisal linkage system.’ The drug was approved its reasonableness of receiving medical care benefits was recognized in the cost-effectiveness aspect, as the drug ‘is therapeutically equivalent to Tagrisso (osimertinib) while being cheaper. Leclaza’s sales exceeded expectations, making ₩4.1 billion in the first 6 months. In general, anticancer drugs used in large hospitals may only be prescribed after passing reviews of drug committees in each hospital, therefore it takes a considerable amount of time for such drugs to generate sales after their release. Leclaza rose to the ranks and took the lead among domestically developed anticancer drugs as the most sold product during the past 6 months. Other homegrown anticancer drugs approved before Leclaza in Korea include Supect, Dongwha Pharm’s Milican, Chong Kun Dang’s Camtobell, Sam Sung Pharmaceutical’s Riavax, Hanmi Pharmaceutical’s Olita. Among the drugs, Supect’s sales recorded ₩7.4 billion last year, but its sales in the second half of the year were ₩4.1 billion, similar to Leclaza. Supect is the 18th homegrown novel drug that was approved in January 2012 for the treatment of chronic myeloid leukemia. Camtobell’s only made ₩3.8 billion last year, and other products have been revoked their licenses or withdrawn from the market. Therefore, Leclaza is the first to demonstrate the possibility of commercialization among homegrown anticancer drugs. Leclaza had started being prescribed at a rapid pace after landing in large hospitals with reimbursement. Leclaza can be prescribed in the ‘Big 4’ tertiary hospitals in Korea - the Seoul National University Hospital, Sinchon Severance Hospital, Samsung Seoul Medical Center, and the Seoul Asan Medical Center - and 30 other medical institutions including the National Cancer Center, Seoul National University Bundang Hospital, Seoul St. Mary's Hospital, Chonnam National University Hwasun Hospital, Kyungpook National University Chilgok Hospital, and the Pusan National University Hospital. In Yuhan Corp’s IR data that was recently released, the company presented its mid-to-long-term goal of “rising to the ranks in the global market by becoming the first homegrown new drug to earn over $1 billion (₩1.2 trillion) in annual sales with Leclaza.”
- Policy
- Generic for Revlimid was listed as the lowest price
- by Lee, Tak-Sun Feb 24, 2022 05:58am
- Boryung Pharmaceutical is launching a generic drug called Revlimid (Renalidomide) for multiple myeloma treatment after four years of approval. With three general companies targeting the market since 2018, Boryung has thrown a winning move at the lowest price. According to the contents of the "Partial revision of the drug benefit list and upper limit table" released by the MOHW on the 21st, four capacities of Boryung Pharmaceutical's generic for Revlimid will be listed from March 1. It has been about four years since it was first approved in June 2018 with 25 mg. Generic for Revlimid has been on the market since January 2018. Currently, Chong Kun Dang's Lenaloma, Kwang Dong Pharmaceutical's Lenaldo, and Samyang Holdings' Lenalid are competing with the original drug Revlimid of Celgene. Generic drugs have yet to exert much power in the market. Quarterly sales of original products are around 8 billion won, but generic drugs alone maintain around 1 billion won. According to IQVIA in the second quarter of last year, Celgene's Revlimid recorded 8.8 billion won, Chong Kun Dang's Lenaloma recorded 1 billion won, Kwang Dong's Lenaldo 75.42 million won, and Samyang's Lenalid recorded 143.41 million won. Generic drugs are showing price competitiveness as a weapon against their original status, but it is not easy. Comparing the upper limit based on the 10mg formulation, Samyang's Lenalid costs 51,472 won, Chong Kun Dang's Lenaloma costs 71,874 won, Celgene's Revlimid costs 84,975 won, and Kwang Dong's Lenaldo costs 86,000 won. Compared to the original, Samyang's Lenalid is 20,000 won cheaper, and Chong Kun Dang's Lenaloma is 10,000 won cheaper. Boryung also chose the lowest price. Leblikin10mg is 51,471 won, 1 won cheaper than the current lowest price, Lenalid in Samyang. In particular, it is expected that it will be able to show competitiveness because it is 20,000 won to 30,000 won cheaper than existing products among capsule formulations. Boryung is preparing a variety of new products with generic for Revlimid to target the market for treating multiple myeloma. It is on the verge of developing the first generic of the latest version of Celgene's Pomalyst following Revlimid, and plans to introduce a new drug called Aplidin (Plitidepsin), Aplidin signed a contract with Spanish pharmaceutical company PharmaMar in 2016 to secure domestic copyright. Only Janssen's generic for Velcade(Bortezomib) Velkin was sold. Attention is focusing on whether Boryung will show the power of domestic pharmaceutical companies in the anticancer drug market with the lowest price strategy put forward along with various product lines.
- Policy
- Combination indication for Entresto has changed
- by Lee, Hye-Kyung Feb 24, 2022 05:58am
- The range of patients who can use Entresto (Sacubitril/Valsartan), a treatment for chronic heart failure of Novartis Korea, has become a little clearer. Until now, there has been a debate over the normal range of left ventricular ejection rates, with "chronic heart failure patients with decreased left ventricular contraction function." On February 14, the MFDS changed the effectiveness of Enresto, a heart failure treatment of Sacubitril/Valsartan drugs, and Xnepri by Sandoz. The efficacy at the time of Enresto approval in 2016 were ▲ chronic heart failure: decreased risk of death due to cardiovascular disease and hospitalization due to heart failure in patients with left ventricular contractile function (NYHA class II-IV), and ▲ angiotensin receptor antagonists (ARB) or angiotensin conversion enzymes (ACE) instead of other treatments. In combination therapy, patients with chronic heart failure were specifically specified, and patients with chronic heart failure with reduced left ventricular contraction function were specified as patients with chronic heart failure with a left ventricular ejection rate of 40% or less. The reason for this change was confirmed through the minutes of the central summary released by the MFDS. At the meeting, opinions on 40% and 60% were divided over the range of left ventricular ejection rates. As the left ventricular ejection rate showed consistent effects in the lower 60% group, there were opinions that the left ventricular ejection rate should be clearly described as 60%, and that the existing ejection rate could limit use in clinical sites or make it difficult to determine treatment targets. Some suggested that efforts and procedures to expand the standards for medical care benefits should be carried out together after changing efficacy and effectiveness. In response, the MFDS said, "Among the unauthorized matters, the phrase that this drug is administered in combination with other heart failure treatments instead of ARB or ACE inhibitors was established based on clinical trials and was suitable for existing treatment guidelines." The MFDS suggested, "The domestic guidelines for heart failure have not been changed at the moment, but considering that there is no standard therapy for patients with a 40% or more ejection rate, the phrase should be described only for patients with reduced ejection rate." The committee members generally agreed to the MFDS' change (proposal) saying that the definition of the left ventricular ejection rate is not accurately divided into figures, and finally decided to change the efficacy and effect. Meanwhile, according to UBIST, Enresto's outpatient prescription amount last year was 32.3 billion won, up 37.3% from 23.5 billion won last year.
