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- 2025-12-22 16:21:09
- Policy
- Bill for vaccinating 'shingles for elderly·HPV for males'
- by Lee, Jeong-Hwan Mar 05, 2025 06:00am
- The Democratic Party of Korea Rep. issues a bill The Democratic Party of Korea is pursuing changes to the law to expand the free-of-charge vaccination program, requiring the government to cover the costs of shingles vaccines for adults 65 and above and human papillomavirus (HPV) vaccination for males below 17 years. Given that the Yoon Suk Yeol government's pledges during the candidacy to expand the National Immunization Program (NIP) to include shingles and HPV vaccines fell through, the National Assembly aims to implement this with the legislation to protect national health. On March 4, the Democratic Party of Korea Rep. Park Heeseong announced the bill to make partial revision to the 'Infectious Disease Control and Prevention Act.' Rep. Park Heeseong pointed out that the government made a candidacy pledge to provide shingles vaccinations for adults aged 65 and above and HPV vaccines for boys aged 12 and above. However, it was not included in the government budget, suggesting that the pledge has fallen through. Rep. Park Heeseong said that shingles vaccinations have high preventative effects, but since they are still non-reimbursed, this poses a substantial financial burden for individuals facing cost differences. Rep. Park Heeseong highlighted that HIP infection is part of the NIP, but the law limits the range of free-of-cost vaccination to females aged 12 or between 12 and 26. Rep. Park Heeseong believes that the government is not implementing vaccination despite proven evidence, including cost-effectiveness and disease burden, for introducing single vaccinations for older people free-of-cost and HPV vaccinations for males at no cost. Therefore, Rep. Park Heeseong drafted a bill to add shingles vaccination to the NIP and expand the HPV vaccination NIP to include males. The bill newly added·established Clause 18 to Article 24 of the NIP to include 'shingles.' The bill amended the current law to include a new 'Article 24-2 on human papillomavirus (HPV) infection vaccination.' The bill's amendment details that the mayor of a special self-governing city, governor of a special self-governing province, or the mayor·governor·head of Gu is now required to administer HPV vaccinations through local public health centers for females aged 26 or younger and males aged 17 or younger, as a measure to prevent HPV infection. Additionally, the bill's amendment to Article 64 (expenses paid by special self-governing provincess, cities, Gun, and Gu) now includes HPV vaccination. This change establishes the basis for local governments to cover vaccination costs, ensuring that patients can receive the vaccine free of charge.
- Opinion
- [Desk's View] Regulatory changes disrupt the generic mkt
- by Chun, Seung-Hyun Mar 05, 2025 06:00am
- The strategies of Korean pharmaceutical companies for entering generic markets have significantly changed over the past few years. Pharmaceutical companies made entries and withdrawals indiscriminately because of the government's regulatory changes. According to the Ministry of Food and Drug Safety (MFDS) report, prescriptions with approval declined by 35.6%, with 589 items. Compared to 4,195 counts in 2019, it shrunk by 86.0% over 4 years. The number of prescription drug approvals was 1,618 counts and 1,562 counts in 2017 and 2018, respectively. In 2019, it surged more than two-fold, with 4,195 counts. In 2020, it increased by 67.5% than two years before, with 2,616 counts. In 2021 and 2022, it decreased to 1,600 counts and 1,118 counts, respectively. In 2023 and last year, it was less than 1,000 counts. Although it may seem that pharmaceutical companies' motivation for entering the prescription drug business has decreased, the reality is that government has created regulatory confusion. In 2018, there was a ban on the sale of 175 pharmaceutical products containing the active ingredient valsartan, used to treat high blood pressure, due to excessive impurities. In response, the Ministry of Health and Welfare (MOHW) and the MFDS established the "Committee for Improving of Generic Drugs Policies" to formulate measures to control the excessive production of generics. The revised drug pricing system, implemented in July 2020, is one of the major policies by the government to suppress the overabundance of generic drugs. The revised drug pricing system requires generic products to meet both bioequivalence testing and the use of registered raw materials to maintain a maximum reimbursement price of 53.55% compared to the current patent-expired original drugs. The revised drug pricing system includes a stepwise pricing system, which involves a lower maximum reimbursement price for drugs that are newly listed for reimbursement. Pharmaceutical companies attempted to secure as many generics as possible before the government strengthened its regulations on generic drugs. It has been reported that most generics eligible for approval had already been obtained before implementing the new drug pricing system. However, many indiscriminately introduced generics failed to sell and eventually vanished from the market. In November last year, 1,000 drug items were removed from the National Health reimbursement list due to a lack of production or claims. Health authorities have recently been deleting drugs from the reimbursement list if there have been no insurance claim records in the past two years or if there has been no production or import data for three years. Among these 1,000 removed items, those approved in 2000 and 2019 were the most prevalent, accounting for 334 and 187 items, respectively. In other words, over half of the deleted drugs were new products on the market for less than five years. On May 1, 2023, 322 drug items were removed from the reimbursement list, with those approved in 2019 and 2020 were 221 items, which accounted for 68.6% of the total. The government’s regulatory strengthening encouraged pharmaceutical companies to obtain generic approvals indiscriminately, accelerating market saturation. Ultimately, many of these generics failed to sell, disappearing from the market while only losing unnecessary approval costs. Since 2021, the number of prescription drugs withdrawn from the market has exceeded the number of new approvals. Between 2015 and 2020, the annual approvals of new prescription drugs consistently outnumbered the products withdrawn. In 2015, there were 2,406 newly approved prescription drugs, more than twice the 977 canceled or withdrawn products. In 2016, new approvals were more than three times the number of withdrawals. In 2019, however, canceled or withdrawn products reached 1,283, amounting to only 30.6% of new approvals, and in 2020, new approvals exceeded market withdrawals by 691 products. In 2021, the number of canceled or withdrawn prescription drugs increased to 1,687, surpassing the 1,600 new approvals, and this gap gradually expanded. Last year, market withdrawals increased to 2,432, more than four times the 589 newly approved products. Analysis suggests that pharmaceutical companies indiscriminately secured generics in response to the government’s regulatory strengthening without thinking of countermeasures, disappearing in mass quantity from the market after a certain period, ultimately leading to significant social and economic cost waste. Additionally, critics point out that the government’s frequent regulation changes have exacerbated the abundance of generics and caused strategic confusion among pharmaceutical companies. In 2012, the MOHW abolished the stepwise drug pricing system through a revision. After that, it allowed pharmaceutical companies to actively launch generics, even in markets long past patent expiration, on the premise that they could still receive high prices despite a late market entry. However, due to the ongoing issue of the abundance of generics, the stepwise pricing system was reinstated after 8 years. Moreover, the mandatory production requirements for contract-manufactured generics have been repeatedly reversed. In 2014, the MFDS introduced the 'GMP Compliance Certificate' system, which exempted contract-manufactured generics from the requirement to submit GMP evaluation data for approval purposes. Then, starting in October 2022, the requirement for submitting GMP evaluation data for contract-manufactured generics was reinstated to strengthen quality and safety management. Yet, in October of last year, the requirement for GMP evaluation data covering the manufacturing process for outsourced drugs was waived again under regulatory relaxation. In response to the government's regulatory changes, pharmaceutical companies strategized to maximize profits, further disrupting the market. The government is partially responsible for failing to anticipate the market impact of these regulatory changes. Implementing policies aimed solely at suppressing the overabundance of generics without understanding market dynamics has resulted in unnecessary social costs. Government policies do not always yield favorable market outcomes. We want to ask whether the government has considered reviewing the generic-related policies implemented over the past few years. Their efforts failed to identify any positive outcomes from these regulatory changes. It has been reported that the government is considering a new system to cut generic drug prices. The government reviews the proposal to lower domestic drug prices by comparing them with those in eight major countries (the United States·Japan·Germany, the United Kingdom·France·Switzerland·Italy·Canada). They plan to adjust domestic prices to match the adjusted average price derived from six countries after excluding the highest and lowest figures among the so-called A8 nations. The pharmaceutical industry has strongly opposed this. The rationale is it's reasonable to consider market entry timing when comparing generic drug prices internationally. However, whether the government will hear the industry's concerns remains uncertain. There is a growing fear that, once again, a one-sided policy will be imposed, ignoring the warnings from the pharmaceutical industry. To minimize the failure of the government's policy, the government should at least listen to the voices of the industry.
- Company
- Ocrevus is reimbursed for relapsing multiple sclerosis
- by Whang, byung-woo Mar 05, 2025 06:00am
- Pic of Ocrevus On March 4, Roche Korea announced that its multiple sclerosis treatment drug Ocrevus (ocrelizumab) will be reimbursed by Korea’s National Health Insurance from March 1. According to the new announcement, Ocrevus will be covered as a monotherapy for patients with relapsing multiple sclerosis, which includes ▲patients with relapsing-remitting multiple sclerosis (RRMS) who are ambulatory and have failed or had insufficient response to first-line treatment (e.g., interferon beta-1b) and ▲patients with secondary progressive multiple sclerosis (SPMS). As a result, Ocrevus will be reimbursed for the relapsing-remitting type as a second-line treatment and the secondary progressive type as a first-line treatment. Relapsing multiple sclerosis (RMS) includes both relapsing-remitting and secondary progressive multiple sclerosis. Relapsing-remitting multiple sclerosis (RRMS) is the most common type of multiple sclerosis. The reimbursement application of Ocrevus was based on a wealth of clinical evidence on its utility, including the results of large-scale global Phase III clinical trial OPERA I & II and the 10-year analysis of the open-label extension study in patients with relapsing multiple sclerosis. In the OPERA I & II studies, the Ocrevus group showed a 40% improvement in the risk of confirmed disability progression (CDP) compared to the control group over 12 weeks and maintained a consistent effect over 24 weeks. The annual recurrence rate (ARR) was reduced by nearly half compared to the control group, and the average number of brain lesions per MRI scan was also significantly improved, confirming clinical efficacy. The clinical efficacy of Ocrevus was maintained even after 10 years of dosing. A 10-year follow-up analysis conducted in the open-label extension study of OPERA I & II showed that the Ocrevus-treated group achieved a steady decline in ARR over 10 years, with the 10-year ARR (0.017) being equivalent to approximately 1 relapse in 60 years. In particular, in both clinical studies, patients who received early treatment with Ocrevus in the early stages of the clinical trial showed more effective disease progression control and lower risk of disability compared to patients who started treatment later. No new adverse reactions or unexpected side effects were observed in patients who received Ocrevus for 10 years, confirming an overall favorable safety profile. “Recently, treatment for multiple sclerosis has been shifting to a strong initial treatment strategy that actively prevents disability by using high-potency drugs from the early stages,” said Professor Ho-jin Kim of the Department of Neurology at the National Cancer Center. ”With the reimbursement of Ocrevus increasing the treatment options, more patients can effectively prevent disease progression and disability from the early stages, ultimately improving treatment outcomes.” “Ocrevus, which has risen to record number one in global drug sales at Roche, is a representative multiple sclerosis treatment that has benefited more than 350,000 patients worldwide,” said Ezat Azem, General Manager of Roche Korea. “We expect that the reimbursement application will strengthen the accessibility of treatment for patients with relapsing multiple sclerosis in Korea and provide more patients with the therapeutic benefits of Ocrevus, which have been confirmed through a large number of clinical data and prescription experiences.” Meanwhile, in Korea, Ocrevus was approved by the Ministry of Food and Drug Safety in May 2024 for two types of patients: relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
- Company
- Pfizer’s sales fall 76% in 2 yrs with the end of pandemic
- by Son, Hyung Min Mar 05, 2025 06:00am
- Pfizer Korea’s sales are on a downward trend. The company's sales have plummeted by 76% in 2 years. The analysis is that the demand for COVID-19 vaccines and treatments has fallen sharply, which has affected the decline in sales. Pfizer Korea aims to make a rebound in sales with new products such as Prevnar 20, a new pneumococcal vaccine, and a COVID-19 vaccine that can respond to new variants. According to the Financial Supervisory Service on the 4th, sales of Pfizer Korea fell 51% from KRW 1.6018 trillion in 2023 to KRW 783.7 billion last year. Operating profit fell 57% from KRW 63.8 billion to KRW 27.2 billion over the same period. This is the first time in 4 years since 2020 that Pfizer Korea has recorded sales of less than KRW 1 trillion. Prizer Korea suffered a direct hit to its sales in the endemic. The company entered the KRW 1 trillion club in sales in 2021 with its COVID-19 vaccine, Comirnaty Inj, and its COVID-19 treatment, Paxlovid, but its sales have dropped sharply with the stabilization of the COVID-19 pandemic. Pfizer Korea Pfizer joined forces with BioNTech in March 2020, when COVID-19 began to spread around the world, to develop a messenger ribonucleic acid (mRNA) vaccine. BioNTech, which owned the mRNA technology, and Pfizer, which has extensive experience in large-scale global clinical trials, have produced synergy. Pfizer succeeded in developing the vaccine Comirnaty, which has a 95% preventive effect, in less than a year after the spread of COVID-19. In December 2020, the US Food and Drug Administration (FDA) granted emergency use authorization, and emergency use authorization was granted in Korea as well in March of the following year, after which the vaccine was supplied through the Korean subsidiary in earnest. Afterward, Pfizer succeeded in developing the COVID-19 treatment Paxlovid, which the Korean government also procured to use as a treatment. As a result, sales at Pfizer Korea also increased significantly. The company's sales reached KRW 1.694 trillion in 2021, surpassing the KRW 1 trillion mark, and then rose sharply to KRW 3.2254 trillion in 2022. Compared to the sales in 2020, sales increased by 723% in 2 years. However, sales began to decline in 2023 as governments around the world declared an end to the COVID-19 pandemic. Sales of Pfizer Korea in 2023 fell 50% year-on-year to KRW 1.6018 trillion, and the company failed to secure sales of KRW 1 trillion last year, at KRW 783.7 billion. Last year's sales were down 76% from 2022 when the company made the highest performance ever. Operating profit was also struggling. After recording an operating loss of KRW 7.2 billion in 2020, the company succeeded in turning a profit in 2021 with KRW 59.2 billion. After that, its sales jumped to KRW 120.1 billion in 2022 but decreased 47% to KRW 63.8 billion in 2023. Last year, it decreased by 57% from the previous year to KRW 27.2 billion. Aims to boost sales with the new product launch PfizerPfizer Korea is aiming to boost sales with the launch of a new product. The company launched a new pneumococcal vaccine, ‘Prevnar 20,’ in November last year. Prevnar 20 is a new pneumococcal vaccine that Pfizer introduced 14 years after the release of Prevnar 13. This vaccine adds seven serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) to the 13 serotypes in the existing Prevnar 13. In clinical trials, Prevnar 20 demonstrated immunogenicity and tolerability against 20 serotypes when administered to healthy infants four times. These results were similarly shown in clinical trials conducted on adults. Sales growth is also expected for the non-small cell lung cancer drug Lorviqua. Currently, Pfizer Korea is in negotiations with the National Health Insurance Service to expand the reimbursement coverage of Lorviqua as a first-line treatment. Lorviqua is Pfizer’s third-generation ALK-positive non-small cell lung cancer targeted therapy. Currently, Takeda's Alunbrig and Roche's Alecensa, along with Lorviqua, have been fiercely competing in the second-generation ALK-positive non-small cell lung cancer targeted therapy. It will be interesting to see if the company can stay ahead of the competition in the first-line treatment environment, as the company confirmed Lorviqua’s efficacy with the latest data from the 5-year trial. Pfizer also plans to launch new vaccines that can respond to new variants to defend its sales. Pfizer introduced Comirnaty JN.1, a COVID-19 vaccine that can respond to new variants, including JN.1 last year. The company is also aiming to rebound sales by recently launching Comirnaty JN.1 0.033, a COVID-19 vaccine for infants, to make a rebound in sales.
- Policy
- MFDS designates etomidate a psychoactive drug
- by Lee, Hye-Kyung Mar 04, 2025 05:57am
- The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) announced on February 28 that it will preannounce an amendment to the Enforcement Decree of the Narcotics Control Act that will designate 7 substances, including hexahydrocannabinol, which is scheduled to be designated as a controlled substance by the United Nations, as narcotics or psychotropic substances. The amendment is open for opinion collection until April 10. Five substances (4 narcotics and 1 psychotropic drug) that will be newly designated as narcotics this time are those designated as narcotics or psychotropic drugs at the 68th United Nations Commission on Narcotic Drugs (CND) and two psychotropic drugs including etomidate that have been designated as narcotics by the Narcotics Safety and Risk Management Deliberative Committee. Substances newly designated as narcotics by the United Nations Commission on Narcotic Drugs are new narcotics synthesized by changing the structure of existing narcotics. The Ministry of Food and Drug Safety is quickly identifying international narcotics trends and has already designated and managed some drugs as temporary narcotics. The proposed revision also includes etomidate, a general anesthetic induction agent. Since there were cases of illegal administration or abuse of etomidate in some medical institutions, it will be designated as a narcotic drug in advance and actively managed for their safe use in Korea. The Ministry of Food and Drug Safety said, “We expect that this designation of narcotics will be in harmony with international drug regulations and will actively respond to the problem of domestic drug abuse. We will continue to do our best to safely manage narcotics for the health and safety of the people.”
- Company
- Reimbursement possible for Long-acting HIV treatment in KOR
- by Whang, byung-woo Mar 04, 2025 05:57am
- Expectations are growing in the clinical field with the imminent reimbursement of the long-acting HIV (human immunodeficiency virus) treatment ‘Vocabria+Rekambys’ combination in Korea. It has been more than two years since the combination was approved in Korea, but it has not yet been released on the market due to hurdles including costs. As patients have been waiting for its release, it is expected to quickly gain influence with reimbursement coverage. Pic of VocabriaAccording to industry sources, GSK Korea concluded drug price negotiations with the National Health Insurance Service for the combination therapy of the new HIV drugs Vocabria (cabotegravir) and Rekambys (rilpivirine). Rekambys Janssen Korea’s product and GSK was in charge of its reimbursement listing process in Korea. Both drugs were originally developed as oral medications and then developed into injectable drugs. Long-acting injectable drugs cannot cure HIV infection, but they are therapeutic agents that target white blood cells to help lower and maintain the level of the AIDS virus. In February 2022, it was approved by the Ministry of Food and Drug Safety as a combination therapy for the treatment of HIV-1 infection in adult patients who are virologically suppressed, have no history of virological failure, and have no known or suspected resistance to cabotegravir or rilpivirine. Currently, the market is divided between the three-drug combination therapy, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide, B/F/TAF) and the two-drug combination therapy, Dovato (dolutegravir/lamivudine). Although many prescriptions have been made before Biktarvy and Dovato, like Gemvoya and Triumeq are still being prescribed, the weight has shifted to using the later released treatments. According to the pharmaceutical research institution IQVIA, Biktarvy’s sales in 2023 had been KRW 54.5 billion, the highest among HIV treatments. This is an 11% increase compared to the KRW 49.1 billion in sales in 2022. Dovato also has a growth curve of KRW 13.2 billion in 2021, KRW 20.3 billion in 2022, and KRW 26 billion in 2023, after generating KRW 1.8 billion in sales at the time of its reimbursement approval in 2020. The biggest strength of the Vocabria+Rekambys combination that has emerged in this situation is its convenience. While existing HIV treatments are oral drugs that must be taken every day for 365 days a year, the combination therapy that includes Vocabria can reduce the frequency of administration to a maximum of six times a year with intramuscular injections administered once a month or once every two months. This strength is regarded to be effective in alleviating the anxiety of social stigma, which is considered a challenge for people living with HIV. According to a survey conducted by Love for One, an organization for people living with HIV, 73% of people living with HIV in Korea said they were afraid that taking HIV medication would reveal their infection to others and the surrounding environment. As there are already inquiries from patients about the combination therapy Vocabria+Rekambys in the clinical setting, experts believe that there will be a lot of switching of treatments. “The existing treatment requires taking one pill every day, so people have to take it in the middle of work or face stressful situations such as business trips or travel,” said Jin-nam Kim, a professor of infectious diseases at Hanyang University Hospital. ”Even before its release, there were patients who inquired about the treatment because they could avoid having to think about their daily lives if they could just get a shot at the hospital once a month.” As the number of treatments that require periodic injections, such as rheumatism and atopic dermatitis, has increased, it is believed that this may reduce the burden of social stigma felt by patients. However, the combination therapy of Vocabria+Rekambys is not all-encompassing, so the influence of existing treatments is expected to remain. Conventional treatments are usually prescribed at a hospital visit every 3 months, and in some cases, every 6 months. However, since the combination therapy is an injectable, the patient must follow the dosing cycle, and if it is difficult to shorten this cycle according to individual circumstances, it may be a burden to visit the hospital more frequently. Professor Kim said, “Adherence to medication is important, and in the case of oral medications that are taken daily, if the patient has the existing medication, they can take it daily and maintain the drug concentration. However, although there is a seven-day margin before and after the administration date for injections, there are indeed limitations depending on the patient.” The combination therapy of the two drugs is expected to be reimbursed by the National Health Insurance soon after it is approved by the Health Insurance Policy Deliberation Committee. In response, Professor Kim said that he could not make a definite statement as no treatment has been released yet, but based on patient inquiries, he expected that at least 10% of patients would switch. He added, “Injectable drugs cause pain at the injection site, and there are new drugs, so I don't think many will change at once. Still, the number of patients who inquired was in the double digits (more than 10%), and since the efficacy has already been proven through various studies, some patients will switch when provided with more options.”
- Company
- Potential blockbuster drug Kerendia…1yr since reimbursement
- by Whang, byung-woo Mar 04, 2025 05:57am
- The prescription performance of Kerendia (finerenone), Bayer’s treatment for chronic kidney disease in adults with type 2 diabetes, has been increasing since it was granted reimbursement last year. With its monthly sales recording KRW 1 billion in the last month of last year, the drug is rapidly building up its performance, and given its growth, it is likely to become a blockbuster treatment in Korea this year. Pic of Kerendia Tab Kerendia is a first-in-class, selective, non-steroidal mineralocorticoid receptor antagonist(MRA) that inhibits the overactivation of mineralocorticoid receptors, which can cause inflammation and fibrosis in the kidneys, kidneys, and blood vessels. Kerendia, which was approved in Korea in May 2022, was approved for insurance reimbursement benefits on February 1 of last year, about a year and a half after its approval in Korea. The standards for Kerendia’s reimbursement are as follows: Adult patients with type 2 diabetes who have been taking angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) for more than four weeks, but have ▲a urinary albumin-to-creatinine ratio (uACR) over 300 mg/g or a urine dipstick test result of 1+ or higher, and ▲an estimated glomerular filtration rate (If eGFR is between 25 and 75, the drug may be administered together with ACE inhibitors and ARBs). Kerendia gained the spotlight as diabetes accounts for the highest proportion (38.6%) among the causes of end-stage renal disease. Until now, drugs to control blood pressure and reduce the burden on the kidneys were used with GLP-1 and SGLT-2 inhibitors to control blood sugar, but there was an unmet need. In particular, as there had been no drug that could directly suppress chronic inflammation or fibrosis of the kidneys, Kerendia, which has a new mechanism of action that can directly target these, is expected to play a greater role. “So far, GLP-1 receptor agonists, SGLT-2 inhibitors, and RAS inhibitors, which are blood pressure medications, have been used to treat patients with diabetes and kidney disease, but the risk of chronic kidney disease persisted in the patients,” said Yong-Ho Lee, Professor of endocrinology at Severance Hospital and Director of General Affairs of the Korean Diabetes Association. “As Kerendia has proven its efficacy in various clinical trials, it will become an important treatment option for patients with chronic kidney disease,” he said. Monthly Sales of Bayer In fact, Kerendia‘s sales have been growing since its reimbursement in Korea. After being granted reimbursement last year, Kerendia’s monthly sales started at KRW 30 million in March and continued to rise, reaching KRW 100 million in April. In particular, the company recorded monthly sales of KRW 1 billion in December, the last month of last year, and is expected to continue to increase its influence this year. Looking at the quarterly figures, the company showed twofold growth each quarter, posting KRW 800 million in the second quarter, KRW 1.7 billion in the third quarter, and KRW 2.7 billion in the fourth quarter. Taking this into account, sales are expected to easily exceed the KRW 10 billion mark which is the threshold for a blockbuster drug in Korea, within this year. The expansion of the prescription of Kerendia seems to have been influenced by its characteristics as a treatment for chronic kidney disease patients with Type 2 diabetes. According to UBIST, prescriptions increased significantly in the early days after the reimbursement was applied, mainly in the field of nephrology, but the number of prescriptions in the field of endocrinology also increased from September, and in December, when monthly sales reached KRW 1 billion, the number of prescriptions in the field of nephrology and endocrinology did not differ significantly. Quarterly Sales of Bayer In this situation, the drug’s influence in the market is expected to continue to grow as Bayer Korea announced plans to expand Kerendia’s indications. On November 20, 2019, the Ministry of Food and Drug Safety approved a randomized clinical trial to determine the efficacy and safety of finerenone on the morbidity and mortality of heart failure patients with a left ventricular ejection fraction of 40% or more who were hospitalized due to an acute non-reversible episode of heart failure. It can be regarded as a domestic version of the Phase III FINEARTS-HF trial, which evaluated Kerendia in patients with heart failure with a left ventricular ejection fraction of 40% or more, which was announced at the European Society of Cardiology's annual conference (ESC 2024) in September last year. As Kerendia has already been shown to prevent heart failure-related secondary events in patients with heart failure with reduced ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF), which have ejection fraction 40% or higher, the indication expansion in Korea is not expected to be difficult if there are no major variables.
- Company
- Commercialization of PAH drug 'Winrevair' imminent
- by Eo, Yun-Ho Mar 04, 2025 05:57am
- Product photo of Winrevair The new drug 'Winrevair' for pulmonary arterial hypertension (PAH) is anticipated to land in South Korea. According to industry sources, MSD Korea's Winrevair (sotatercept), the world's first inhibitor therapy to treat PAH, has passed the secondary evaluation for the approval-reimbursement linkage process and now enters the last phase of the review. Considering that a typical review time for drug candidates submitted to the 'Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations' has shortened to 81.5 days, the approval for Winrevair will be made soon. Since the reimbursement review has also started, it is to be closely watched whether Winrevair will gain presence as a treatment option in South Korea. Winrevair was designated an orphan drug by the Ministry of Food and Drug Safety (MFDS) in January and designated as the Global Innovative products on Fast Track (GIFT) in April. Additionally, the U.S. Food and Drug Administration (FDA) officially approved Winrevair as a subcutaneous injection administered once every 3 weeks to treat PAH. Winrevair is designed to bind the protein complex activitin and transforming growth factor-β (TGF-β). This drug works by inbiting abnormal signaling bewteen pulmonary vascular endothelial cells and reversing the disease progression. PAH is caused by narrowing of pulmonary arteries, leading to an increase in pulmonary artery pressure, and ultimately resulting in cardiac failure. In South Korea, almost half of the patients with PAH die within 5 years. More than 10 drugs have been approved to treat PAH, including phosphodiesterase type 5 (PDE5) inhibitors and endothelin receptor antagonists. However, many patients suffer from serious symptoms despite undergoing 2-3 combination therapies. Meanwhile, the effectiveness of Winrevair compared to the placebo was confirmed in the Phase 3 study of Winrevair named STELLAR. The clinical study evaluated the effectiveness and safety of the drug, assigning patients to the Winrevair treatment group and the placebo group on 1:1 ratio. The clinical study results have shown that Winrevair extended 6 Minute Walk Distance (6MWD), the primary efficacy endpoint, by 40.1m. The placebo reduced the 6MWD by 1.4m. 38.9% of the patients treated with Winrevair had significantly improved multiple endpoints, including improvement in the secondary endpoint increase in 6MWD over 30m. This was about four-fold longer than 10% of the placebo group.
- Company
- Will COVID-19 vaccines be included in the NIP?
- by Moon, sung-ho Feb 28, 2025 05:58am
- The final results are gaining attention as the Korean government considers including COVID-19 vaccine to the National Immunization Program (NIP). The news presents a favorable opportunity for global pharmaceutical companies with vaccines. Consequently, these companies are focusing on publicizing the socioeconomic losses of COVID-19. According to the pharmaceutical industry on February 26, it was confirmed that the Korea Disease Control and Prevention Agency (KDCA) has begun research to evaluate the validity of COVID-19 vaccine inclusion to the NIP since last year and started the final review. Considering that the research began at the end of April last year, the result will likely be finalized in May. Based on the final result, it is possible that COVID-19 vaccines, along with influenza vaccines, will be included in the NIP in the second half. Therefore, the consideration for including in the NIP has brought attention the COVID-19 vaccine market. The global and Korean markets are dominated by Pfizer and Moderna. Recently, Moderna has been focusing on messaging the socioeconomic effects of the COVID-19 vaccine. Moderna Korea recently held the mRNA media insight event, announcing the importance of the COVID-19 vaccine. At the event, Dr. Hankil Lee of Ajou University Hospital College of Pharmacy, who presented "The Socioeconomic Impact of COVID-19 Losses and the Effects of Vaccination," noted that COVID-19 infections continue to cause significant socioeconomic damage. According to a Korean study (based on big data from the Health Insurance Review & Assessment Service) estimating productivity losses and medical expenses among the employed population, the societal losses attributable to COVID-19 reached approximately KRW 7 trillion in 2023. Specifically, among 25.16 million employed individuals aged 18 to 64, about 9.8 million sought outpatient care, roughly 140,000 required hospitalization, and 1,539 died. Based on these figures, the estimated direct medical costs amounted to approximately KRW 1.4 trillion, including KRW 540 billion for outpatient services, KRW 220 billion for inpatient treatment, and KRW 450 billion for post-illness care. Dr. Lee said, "It is the first study to estimate the national socioeconomic costs of COVID-19 infections using the latest domestic data sources," adding that "COVID-19 infections continue to impose a serious socioeconomic burden, and employee vaccination is evaluated as an effective strategy to reduce corporate losses and lower costs." Clinical settings have assessed that if COVID-19 vaccines are newly included in the NIP, they could help establish a new vaccine market. Inclusion in the NIP is deemed essential for stable market formation. Dr. Kwak Kyung-geun, President of the Seoul Physicians Association, stated, "In the case of COVID-19 vaccines, high-risk groups such as those aged 65 and older were supported by the government last year, and some COVID-19 vaccines were distributed privately. The procurement price was around KRW 100,000 per dose. I recall that not a single patient received the vaccine on a non-reimbursable basis, resulting in returns to the pharmaceutical companies." Dr. Kwak said, "If COVID-19 vaccines are included in the NIP, high-risk groups will be automatically covered, and, similar to influenza vaccines, the vaccination rate among these groups is expected to be high as the vaccine is perceived as essential," adding that "However, it is questionable whether relatively younger patients, excluding the high-risk groups, would choose to receive the vaccine on a non-reimbursable basis, despite potential global policy influences."
- Company
- Lunit presents AI breast cancer Dx results at ECR 2025
- by Whang, byung-woo Feb 28, 2025 05:58am
- On the 27th, Lunit, a medical artificial intelligence (AI) company, announced that it has presented 15 latest research achievements in the field of breast cancer diagnosis at the European Congress of Radiology 2025 (ECR 2025), which is being held in Vienna, Austria until the 2nd of next month. At the conference, Lunit presented 13 oral presentations and two poster presentations using the AI-based breast imaging analysis solution, Lunit INSIGHT MMG. In particular, it gained attention for presenting the clinical value of AI-based breast cancer diagnosis through collaborative research with prestigious European medical institutions. The most noted study presented by Lunit at ECR 2025 is a large-scale study conducted in collaboration with the Cancer Registry of Norway. The researchers analyzed more than 1 million mammography data from the Norwegian national breast cancer screening program (BreastScreen Norway) to explore whether Lunit Insight MMG could perform the role of one of two radiologists required for the current double reading system. The study found that when AI determined that there was a 10% or greater chance of breast cancer, it detected 79.9% of breast cancers found during actual screening, and when the chance of cancer was 5% or greater, it detected 75.5% of breast cancers found during actual screening. In particular, it demonstrated the effectiveness in early detection by finding an additional 5.7% of interval cancers that were missed during existing screenings. This proved empirically that the introduction of AI can significantly reduce the workload of specialists while maintaining the cancer detection rate. In addition, Lunit has collaborated with researchers at the Norwegian Institute of Public Health to evaluate the ability of AI to detect cancer at an early stage by applying Lunit Insight MMG to mammography data from more than 116,000 women who participated in the Norwegian National Breast Cancer Screening Program from 2004 to 2018. As a result, the AI detected the risk of future cancer six years before the final diagnosis. In addition, the AI analyzed cases of breast cancer detected during the screening process, and the cancer risk score increased significantly from 19.2 to 82.7, identifying lesions suspected of being breast cancer with high accuracy. On the other hand, women who did not have cancer maintained a consistently low AI risk score, and AI also smoothly detected an early risk increase in interval cancer. “The research presented at ECR 2025 once again demonstrated the high reliability and stability of Lunit's AI solutions,” said Beomseok Brandon Suh, CEO of Lunit. ”It is especially significant in that it has presented solutions to 2 key challenges: solving the shortage of specialists and early diagnosis.”
