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- 2026-04-21 06:21:32
- Company
- Huinno focuses on 'ECG monitoring device,' boosting monitoring competitiveness
- by Hwang, byoung woo Apr 14, 2026 12:04pm
- As the wearable patient monitoring market competition is centered around functional expansion, Huinno has unveiled a ward monitoring strategy focused on electrocardiogram (ECG) monitoring.Yeongjoon Gil, CEO of HuinnoOn the 10th, Huinno held a briefing to unveil its smart AI telemetry system, 'MEMO Cue,' emphasizing its safety features, including defibrillation protection circuits, AI interpretation technology, and a structure linked to health insurance reimbursement, as its competitive edge in ward monitoring.Existing ward patient monitoring devices are primarily wire-based. Patients must be attached to various sensors and cables, creating a structure that limits movement. This has been repeatedly pointed out for increasing fall risks, causing patient discomfort, and placing a management burden on medical staff.MEMO Cue addresses these issues with a chest-attached patch-based wearable ECG device. Using an ultra-lightweight patch weighing approximately 9g, patients can move freely while their ECG, respiration rate, and oxygen saturation are monitored in real time.Hospitals can remotely check multiple patients simultaneously through an integrated control system. The company explained that operational efficiency can be improved through a central monitoring system rather than the traditional approach of checking directly at the patient's bedside.In particular, increasing alarm accuracy and reducing false alarms were presented as major differentiators.CEO Yeongjoon Gil explained, "Existing equipment has many false alarms, so medical staff sometimes turn them off," adding that "MEMO Cue is focused on increasing alarm accuracy and reducing medical staff fatigue by applying learning-based AI."The explanation is that in clinical tests, an overall accuracy of approximately 98.5% was achieved, and the alarm precision indicator also exceeded that of competitive products worldwide.Emphasis on Defibrillation Protection Design... Differentiating Patient SafetyDuring the briefing, Huinno emphasized the defibrillation protection design.Defibrillators used in the treatment of cardiac arrest patients deliver high-voltage energy of up to 360J. General wearable ECG devices may be destroyed by this impact or pose a secondary risk to the patient.Huinno explained that MEMO Cue can operate normally even under the same conditions by applying a defibrillation protection circuit. In a field demonstration, while devices without a protective design were damaged, MEMO Cue maintained a normal signal after impact.MEMO Cue met the international medical device safety standard IEC 60601-1 and obtained the electrical grade 'Type CF Defib-proof.' FDA 510(k) approval is also in progress.Regarding this, CEO Gil explained that the defibrillation protection design is significant not only for patient safety but also for hospital operations. This is because equipment without a protective design must be removed in an emergency, but equipment with a protective design allows for continuous monitoring.CEO Gil stated, "Monitoring must be continuously possible without removing the equipment, even in a cardiac arrest situation," and added, "There is a need for ward monitoring equipment designed on the premise of patient safety."For MEMO Cue, both technical strength and the insurance reimbursement structure were emphasized. The product received the remote heart rate monitoring fee (EX871) from the Health Insurance Review and Assessment Service (HIRA), and it can be prescribed concurrently with existing Holter test fees.It was explained that hospital entry burdens can be reduced by performing real-time monitoring and post-analysis simultaneously with a single device.Huinno also presented integration with its existing ECG analysis service, 'Memo Care,' as a strength. It has been designed to conduct automated analysis reports based on data collected during ward monitoring.CEO Gil said, "We are building a platform that covers the entire medical lifecycle from diagnostic assistance and real-time monitoring to prediction. Our goal is to secure global competitiveness in the AI-based patient monitoring market."Early Stages of the Ward Monitoring Market...ECG-Centered Competition Begins in EarnestHuinno concluded that the wearable ward-monitoring market is in its early stages and that competition is rapidly expanding.The current number of beds in Korea subject to ECG monitoring is approximately 500,000. It was analyzed that the entire market has formed, including approximately 50,000 beds in advanced general hospitals, approximately 120,000 beds in general hospitals, nursing hospitals, and primary medical institutions.However, Huinno pointed out that competition is flowing toward simple functional expansion.CEO Gil said, "Recently, competitors have been emphasizing the expansion of various vital signs such as oxygen saturation, blood pressure, and body temperature, but the essence of the current fee is ECG monitoring," and that "Without ECG monitoring, it is difficult to bill for medical acts with other vital signs alone."Huinno's technology competitiveness: a chest-attached patch-based wearable ECG device; wearable lightweight design; AI-based false alarm reduction; defibrillation protection design; Holter record integration; Huinno's MEMO Cue received the remote heart rate monitoring fee (EX871) from the Health Insurance Review and Assessment Service (HIRA). (source: presentation)In other words, the recent view is that the core competitive axis of the wearable patient monitoring market is still ECG-based accuracy and reliability.Huinno plans to maintain its competitiveness in the ward monitoring market by leveraging its experience securing a high market share in advanced general hospitals through its existing Holter analysis service, MEMO Care. The company explained that the service has secured approximately 60% of the market share, based on HIRA data.Additionally, as differences from competitive products, the company presented ▲wearable lightweight design ▲AI-based false alarm reduction ▲defibrillation protection design ▲Holter record integration.Finally, CEO Gil added, "It is the beginning stage of the wearable ward monitoring market opening. We will compete with major global players with a product that ensures both hardware safety and AI software accuracy."
- Policy
- NA Health and Welfare bill subcommittee schedule uncertain
- by Lee, Jeong-Hwan Apr 14, 2026 08:53am
- As negotiations between the ruling and opposition floor members over the schedule for the National Assembly Health and Welfare Committee’s April bill review subcommittee drag on, the prospects for the meeting remain uncertain.If the subcommittee does not convene due to a failure to reach an agreement, bills of interest to the medical and pharmaceutical sectors, including the bill mandating limited international nonproprietary name (INN) prescribing, will be delayed until after the June 3 local elections.On the 13th, a ruling-party official on the Health and Welfare Committee explained, “Since the beginning of this month, we have been continuing discussions with the opposition over the schedule for the April bill subcommittee, but we have not yet reached an agreement.”As an agreement between the ruling and opposition party floor leaders on the subcommittee schedule remains elusive, some are predicting that holding the meeting in April is practically impossible.This is because it would be difficult for the Democratic Party of Korea to convene the subcommittee unilaterally, given that opposition parties, including the People Power Party, are not showing much enthusiasm for the meeting.Moreover, the bill on the limited mandatory use of INN prescribing, which is one of the hottest issues in the healthcare sector, falls under the jurisdiction of the first legislation subcommittee, whose chair is Rep. Mi-ae Kim of the People Power Party, making it even less likely that the meeting will be held if a consensus between the ruling and opposition parties is not reached.This bill had already been placed on the agenda at the March subcommittee, but was postponed once after failing to secure an opportunity for review.If the subcommittee does not convene this month, the probability of it being held before the June 3 local elections is effectively close to zero.This is because scheduling for the subcommittee can only be coordinated through bipartisan consultations in late June, after the local election results are announced.Given the current state of negotiations between the ruling and opposition parties on the Welfare Committee, it seems unlikely that the bill on mandatory limited INN prescribing, a source of intense conflict within the medical community, will be reviewed by the subcommittee this month.In particular, the medical community, led by the Korean Medical Association, has stated that if the Welfare Committee subcommittee places the INN prescribing bill on April’s agenda, it will again stage an outdoor rally this month, following a similar protest last month. This appears to be having some effect on whether the subcommittee is convened.The medical community maintains that it will remain on constant standby to organize protests against the bill in accordance with the subcommittee’s schedule and agenda.Accordingly, some are questioning whether the parties would really choose to convene the subcommittee now, ahead of local elections, given that it could divert attention away from the election campaign.A ruling party official on the Welfare Committee stated, “The Democratic Party continues to appeal to the opposition, the need to convene the April bill subcommittee to expedite the review of bills related to people’s livelihoods. We are currently waiting as we have not yet received a clear response, so whether the meeting will be held remains undecided.”
- Company
- Nemluvio forms a new pillar in dermatitis treatment
- by Son, Hyung Min Apr 14, 2026 08:53am
- The arrival of a biologic with a new mechanism of action in the treatment fields of atopic dermatitis and prurigo nodularis is raising the possibility of a shift in treatment strategies.In particular, ‘Nemluvio (nemolizumab),’ which directly blocks IL-31 signaling in these two conditions where severe itching is a key symptom, is expected to emerge as a new treatment option based on its rapid symptom-relief effect.On the 13th, Galderma Korea held a media session at the Plaza Hotel in Jung-gu, Seoul, to commemorate the domestic approval of the biologic Nemlubio.Nemluvio media sessionNemluvio is a monoclonal antibody that inhibits the IL-31 signaling pathway, which is considered a major driver of itch. It received approval as a treatment for atopic dermatitis and prurigo nodularis in Korea last January. Among biologics targeting these diseases, Nemluvio is the first IL-31 inhibitor.IL-31 is known to be a key pathway in the ‘itch-scratch cycle,’ directly stimulating sensory nerves to transmit itch signals and triggering repetitive scratching behavior. Furthermore, it is identified as a major factor exacerbating the disease through a complex mechanism involving inflammatory responses, epidermal barrier dysfunction, and skin fibrosis.Nemluvio demonstrated statistically significant itch relief compared to the placebo group within 48 hours of administration in both atopic dermatitis and nodular prurigo patients. Additionally, when used in combination with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI), it met all primary endpoints.Specifically, in atopic dermatitis, the proportion of patients achieving at least a 75% improvement in the Eczema Area and Severity Index (EASI-75) was significantly higher than in the placebo group. In prurigo nodularis, at week 16, the proportion of patients achieving an Investigator’s Global Assessment (IGA) score of 0/1, meaning ‘clear or almost clear’ skin lesions, was more than three times higher than in the placebo group.Professor Jung Eun Kim, Department of Dermatology, Catholic University of Korea, Eunpyeong St. Mary's HospitalThe long-term follow-up studies also showed sustained efficacy and safety. According to interim analyses of the long-term extension studies in atopic dermatitis (ARCADIA LTE, 104 weeks) and prurigo nodularis (OLYMPIA LTE, 100 weeks), the improvements observed in skin lesions, itch, sleep, and overall quality of life remained consistent for more than 2 years, with no new adverse reactions observed.Based on this evidence, combination therapy with Nemluvio was also included in the 2025 U.S. atopic dermatitis treatment guidelines.Jung Eun Kim, Professor of Dermatology at Catholic University of Korea Eunpyeong St. Mary's Hospital, said, “Among approved biologics, Nemluvio showed the fastest effect in improving itch. It also offers safety advantages, as no increase in side effects like conjunctivitis, which has been a concern with existing treatments, was observed.”She continued, “The proportion of moderate-severity patients with atopic dermatitis is increasing compared to severe cases. This is especially meaningful as a treatment option in elderly patients, where safety is particularly important.”Galderma Korea plans to launch Nemluvio in the second half of this year and has already applied for reimbursement listing.Jai Hyuck Lee, General Manager of Galderma Korea, said, “Nemluvio directly inhibits IL-31, a key trigger of itch, and is expected to present a new treatment paradigm for patients who face limitations with existing therapies.”
- Policy
- Smoking-cessation drug varenicline continues to exit the market
- by Lee, Tak-Sun Apr 14, 2026 08:53am
- AI-generated imageThe market presence of varenicline-based smoking cessation treatments is steadily contracting. Following the withdrawal of the original Champix from the domestic market, CTC Bio’s “Nicobreak Oral Disintegrating Film” (active ingredient: varenicline), which had garnered attention as the country’s only film-type smoking cessation treatment, has also been removed from the list of approved products.According to the Ministry of Food and Drug Safety on the 13th, the approvals for two strengths of CTC Bio’s smoking-cessation aid ‘Nicobreak ODF,’ 0.5 mg and 1 mg, expired on that date and were removed from the list of approved medicines. This comes 5 years after the product became the first oral dissolving film (ODF) formulation of varenicline approved in Korea in April 2021.At the time of approval, Nicobreak positioned itself as a ‘dark horse’ capable of targeting a niche market, particularly among the elderly who have difficulty swallowing pills and smokers with active lifestyles, by highlighting its convenience of being able to take the medication without water, as a break away from Pfizer’s original varenicline, ‘Champix,’ which comes in tablet form.However, the actual market trend proved harsh. The industry points to several reasons behind the expiration of Nicobreak’s approval: ▲ failure to secure market share, ▲ contraction of government-supported smoking-cessation programs, ▲ the shrinking position for varenicline-based therapies overall, and cutthroat competition among generics.The domestic varenicline market is currently understood to be led by Jeil Health Science’s ‘Nicochamps,’ with Hanmi Pharmaceutical’s ‘Nocotin’ following behind. The assessment is that the ODT formulation lacked sufficient marketing force to break the tablet-centered prescription practice.Changes in the government’s anti-smoking policy also worked against it. The Ministry of Health and Welfare’s budget for the National Smoking Cessation Support Service has steadily declined each year, from approximately KRW 143.5 billion in 2015 to KRW 91.6 billion in 2025. These budget cuts led to reduced participation by medical institutions and a decline in patient referrals, which became a decisive factor in pharmaceutical companies losing interest in the smoking cessation treatment market.Furthermore, the market shrank even further when Champix faced a supply suspension due to the nitrosamine impurity issue that arose in 2021.After Pfizer Korea voluntarily withdrew the approval for its original product, ‘Champix,’ and exited the Korean market in 2024, major pharmaceutical companies such as Daewoong Pharmaceutical and Kwangdong Pharmaceutical have also been successively surrendering approvals for their varenicline generics.An industry official analyzed the situation as follows: “Although the market was reorganized after the varenicline impurity issue, the reduction in government support has made it difficult to attract new patients. For a specialized formulation like Nicobreak ODT, if sales are not sufficient, the practical benefit of maintaining the product would have been even lower.”With Nicobreak’s exit, the market for varenicline-based treatments is expected to become even more concentrated around a few leading products. In addition, with the disappearance of a specialized formulation that can be taken without water, the range of choices available to patients seeking smoking cessation treatment is likely to narrow somewhat.
- Company
- Obesity·COVID-19 drugs change multinational pharma performance
- by Son, Hyung Min Apr 14, 2026 08:53am
- There was no outstanding player. The performance of multinational pharmaceutical companies' Korean subsidiaries last year diverged sharply by product portfolio.While some companies recorded high growth driven by expanded obesity treatments, those that saw sales boosts from COVID-19 showed a clear downward trend in growth following the transition to the endemic phase.According to the Financial Supervisory Service on the 14th, sales by the Korean subsidiaries of 30 major multinational pharmaceutical companies increased by 8.0% from KRW 8.7417 trillion in 2024 to KRW 9.4453 trillion last year. Among the 30 Korean subsidiaries, revenue increased for 24 companies, including Novartis Korea, Novo Nordisk, Sanofi-Aventis Korea, and AstraZeneca Korea.Novartis Korea recorded the highest sales among the Korean subsidiaries of multinational pharmaceutical companies. The company's sales last year amounted to KRW 721.3 billion, up 6.3% from the previous year.In terms of operating profit, Otsuka Korea was the highest. Otsuka Korea recorded an operating profit of KRW 49.9 billion last year, a 6.2% increase from KRW 47.0 billion in 2024.Janssen Vaccine recorded sales of KRW 78.4 billion last year, a sharp 52.7% increase from KRW 51.3 billion in the previous year.However, the company faced changes in terms of business continuity. According to the public disclosure, the management of the parent company of Janssen Vaccine decided to cease business activities in November 2025, and last year's financial statements were prepared on a liquidation basis without applying the going-concern assumption.Accordingly, despite the increase in sales, Janssen Vaccine continues to reflect uncertainty about the continuity of its future business.Sales Trend of Multinational Pharmaceutical Companies' Korean Subsidiaries: (from top) Novartis Korea, Novo Nordisk, Sanofi-Aventis Korea, AstraZeneca Korea, Pfizer, MSD Korea, Merck, Roche Korea, Eli Lilly Korea, Janssen Korea, GSK, Viatris Korea, AbbVie Korea, Boehringer Ingelheim Korea, Bayer Korea, Otsuka Korea, BMS Korea, Amgen Korea, Gilead Sciences Korea, Janssen Vaccine, Lundbeck Korea, Ferring Korea, UCB Korea, Menarini Korea, Ipsen Korea, BeOne Medicines, Teva Handok, Leo Pharma, and Kyowa Kirin Korea.Major shifts with obesity drugs… Explosive growth for Lilly and Novo NordiskCompanies selling obesity drugs posted the highest growth rates.Eli Lilly Korea's sales last year was KRW 482.1 billion, a 193.6% increase from the previous year. Operating profit also surged 259.2%, from KRW 10.3 billion to KRW 37.1 billion. Eli Lilly Korea showed the highest sales growth rate among major multinational companies.Previously, Lilly maintained stable sales with oncology drugs such as 'Verzenio (abemaciclicb)' and 'Cyramza (ramucirumab),' as well as the SGLT-2 inhibitor 'Jardiance (empagliflozin)' and the biological agent 'Taltz (ixekizumab),' but it showed a stagnant trend, recording approximately KRW 200 billion sales from 2021 to 2024.This structure changed completely after the launch of the obesity treatment 'Mounjaro (tirzepatide).' Mounjaro, launched in Korea last August, quickly settled in the market, becoming a core growth pillar in a short period.According to the market research firm IQVIA, Mounjaro surged from KRW 28.4 billion in the third quarter of last year to KRW 187.1 billion in the fourth quarter, surpassing KRW 100 billion in quarterly revenue for a single product. Market presence was expanded by overtaking the competing drug 'Wegovy (semaglutide).'This demand expansion was reflected directly in the financial indicators. Eli Lilly Korea's inventory assets increased by 279.3% from KRW 49.4 billion to KRW 187.3 billion, and cash and cash equivalents also increased by 88.6% from KRW 82.1 billion to KRW 154.8 billion. This reflects both the improvement in cash generation following the revenue expansion and a strategy to preemptively secure volume.Novo Nordisk gained effects from 'Wegovy (semaglutide).' The company's sales increased by 85.6% from KRW 308.5 billion to KRW 613.6 billion, and operating profit also increased by 77.1% from KRW 13.7 billion to KRW 24.2 billion.Novo Nordisk, which had maintained stable growth centered on insulin, hemophilia treatments, and Saxenda, saw its performance structure change completely after the launch of Wegovy.Last year, Wegovy's revenue was KRW 467.0 billion, accounting for more than 70% of the total, creating an unusual structure where a single product led the growth of the legal entity. Every quarter, it showed rapid market dominance, surpassing KRW 100 billion in revenue within one year of its launch.Companies with COVID-19 boost see sales decrease… Kyowa Kirin -80% following business saleCompanies that relied on the special boost from COVID-19 entered a clear phase of negative growth following the transition to the endemic phase.MSD Korea's sales decreased 14.2% from KRW 667.8 billion in 2024 to KRW 573.2 billion last year. During the same period, operating profit decreased 13.0% from KRW 24.9 billion to KRW 21.6 billion.The main reason for the sales decrease was the supply void of the COVID-19 treatment 'Lagevrio (molnupiravir).' MSD Korea explained that the absence of a supply contract with the Korea Disease Control and Prevention Agency last year affected the revenue decrease.In fact, MSD Korea's sales have been highly volatile, driven by demand for COVID-19 treatments. Revenue peaked at KRW 820.4 billion in 2022 when demand reached its peak, but subsequently decreased to KRW 760.9 billion in 2023 and KRW 667.8 billion in 2024 following the endemic transition. Compared with last year's revenue of KRW 573.2 billion, revenue has shrunk by 30.1% over the past three years.While performance decreased due to the revenue shortfall from COVID-19 treatments, MSD Korea is seeking a rebound by reorganizing its portfolio around oncology, vaccines, and rare diseases.Pfizer Korea showed a similar trend. The company's sales decreased 25.2% from KRW 783.7 billion in 2024 to KRW 586.1 billion last year.The company's overall performance shrank as demand for the COVID-19 vaccine 'Comirnaty' and the treatment 'Paxlovid' plummeted. This is the result of reflecting the base effect from the significant decrease in public supply volume, which had surged during the pandemic.Gilead also saw sales decrease 26.8% from KRW 319.8 billion in 2024 to KRW 234.0 billion last year due to the supply void of the COVID-19 treatment 'Veklury.'For Kyowa Kirin Korea, the sales decline continued due to the sale of its business. The company's sales last year amounted to KRW 13.8 billion, a sharp 79.9% decrease from the previous year.Kyowa Kirin Korea sold its Asia-Pacific business unit after conducting a restructuring in Korea in 2024. The company sold its China business to Hong Kong's Winhealth Pharma Group. Kyowa Kirin Korea transferred its promotion and distribution units in major Asian countries, such as Korea and Taiwan, to the pharmaceutical distributor DKSH.In addition, sales decreased slightly for Amgen Korea (-6.2%) and Teva Handok (-3.9%).
- Opinion
- [Desk’s View] Unmet needs remain in immuno-oncology
- by Eo, Yun-Ho Apr 13, 2026 09:12am
- Immuno-oncology has now become quite a fairly common term. It is a term even ordinary people are likely to have heard at least once. More than a decade has already passed since the term was first introduced to Korea. At present, immuno-oncology drugs have expanded their indications across various cancer types and established themselves as a major pillar of cancer treatment. Whether the growing number of indications receive coverage has become an important gateway that determines treatment access.The extent to which the clinical value of new treatment options should be reflected during reimbursement review remains a persistent concern. For the government, it is a matter of striking a balance between the financial burden and the clinical benefits offered by new drugs.The upcoming Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service is one place where this question constantly comes up for debate. At this month’s meeting, reimbursement for the ‘Opdivo (nivolumab)’ and ‘Yervoy (ipilimumab)’ combination as first-line treatment for hepatocellular carcinoma and non-small cell lung cancer will be presented for deliberation. At the meeting held last October, the combination was rejected for both liver and lung cancers.In hepatocellular carcinoma, following Tecentriq (atezolizumab) plus Avastin (bevacizumab), Imfinzi (durvalumab) plus Imjudo (tremelimumab) have also been added to the reimbursement list. In non-small cell lung cancer as well, an immuno-oncology-based treatment strategy has already taken hold, with ‘Keytruda (pembrolizumab)’ already reimbursed as monotherapy and combination therapy for 4 years.With immuno-oncology drug combinations already reimbursed, attention is now turning to whether reimbursement criteria will be set for the new Opdivo-Yervoy combination, as the addition must be more than simply another treatment option to pass review.In this regard, hepatocellular carcinoma remains a cancer type with frequent recurrence, poor prognosis, and high mortality rates, and many patients begin treatment with impaired liver function. Due to these disease characteristics, key evaluation criteria include whether the treatment option can provide deep and durable responses, long-term survival, and long-term survival benefit regardless of liver function status.The Opdivo and Yervoy combination is the treatment option that has demonstrated the longest survival data in first-line treatment for hepatocellular carcinoma. In clinical trials, it recorded a median overall survival (mOS) of 23.7 months, with a survival rate of 31% at 48 months. In addition, in an Asian patient subgroup analysis, a median overall survival (mOS) of 34.0 months, a 3-year survival rate of 49%, an objective response rate of 37%, and a complete response rate of 10% were reported. Compared with existing immuno-oncology combinations, whose mOS typically does not exceed 20 months, these are significant results.In particular, the Opdivo-Yervoy combination significantly reduced the risk of death by 25% versus the control arm, even in patients with impaired liver function classified as ALBI grade 2/3, demonstrating a degree of mortality risk reduction comparable to that seen in patients with preserved liver function.Its use in non-small cell lung cancer also warrants attention. Although Keytruda-based regimens have effectively become the cornerstone of first-line treatment, it is difficult to say that they fully address the treatment needs of all patient subgroups. In practice, there are still patient groups, such as those with PD-L1-negative tumors or squamous histology, for whom long-term survival benefit under existing immuno-oncology treatment settings has been reported only to a limited extent.As the Opdivo-Yervoy combination demonstrates consistent survival improvements in these patient groups, regardless of PD-L1 expression or histology, it has been discussed as a viable alternative.Ultimately, the core of the Cancer Disease Deliberation Committee review should not be on whether another option should be added to the reimbursement list. Real deliberation should be made on whether the current reimbursement system is offering a sufficient range of treatment choices in practice, and to what extent unmet treatment needs in specific patient groups should be reflected in deliberations. It would be difficult to accept a conclusion that the current system is sufficient merely because options already exist. When it comes to immuno-oncology drugs, unmet needs remain.
- Policy
- K-Bio Q1 sales hit record high…tops $2 billion
- by Lee, Tak-Sun Apr 13, 2026 09:12am
- Exports of Korean biopharmaceuticals in the first quarter of this year were at a record high. In particular, exports of biosimilars to Europe increased significantly.The Ministry of Food and Drug Safety (MFDS, Minister Yu-kyoung Oh) announced on the 10th that the export volume of South Korea's biopharmaceuticals in the first quarter of 2026 reached an unprecedented record of $2 billion (estimated), an 11.1% increase compared to the export value of the first quarter of last year.The MFDS explained that this is driven by an increase in the market share of K-biopharmaceuticals and by the expansion of competitiveness among biopharmaceutical Contract Development and Manufacturing Organizations (CDMOs).According to export value by year for the first quarter, it recorded $1.5 billion in 2024, followed by $1.8 billion in 2025 (a 20% increase from the previous year), and $2 billion this year (an 11.1% increase). Biopharmaceuticals accounted for 71% of the total pharmaceutical export value of $2.8 billion in the first quarter of this year."Export value by year for Q1": $1.5 billion in 2024, followed by $1.8 billion in 2025 (a 20% increase from the previous year), and $2 billion this year (an 11.1% increase). "Top 5 countries for exports in Q1": The country with the largest exported value in the first quarter of 2026 was Switzerland, recording $340 million (17.0% of total exports). Source: Korea Customs Service HS code and Korea Trade Statistics Promotion InstituteBy month, exports in January and February increased by 11.9% and 25.4% year-on-year to $660 million and $690 million, respectively. March exports were similar to the same period last year at $650 million, showing steady export figures from January through March.The country with the largest exported value in the first quarter of 2026 was Switzerland, recording $340 million (17.0% of total exports). The United States followed this at $330 million (16.5%) and Hungary at $300 million (15.0%). Exports to the top five countries accounted for 68.4% of the total.Exports to Switzerland increased by 70% (+$140 million) compared to the same period last year, rising from the 4th largest export destination in the first quarter of last year to 1st place this year.Exports to the United States decreased by $40 million (-12.6%) year-over-year, accounting for 16.5% of the first quarter export value. Exports to Hungary increased by $50 million (+20.2%) year-over-year.Analysis suggests that the increase in exports to Europe is due to a combination of cooperation with global pharmaceutical companies, technology exports, and a favorable environment for biosimilars.The MFDS explained that it is strengthening the global competitiveness of domestic biopharmaceuticals and helping them enter overseas markets by advancing rational regulatory innovation and providing customized information, as well as by actively pursuing regulatory diplomacy with major exporting countries.Aligning with the rapid growth of the biopharmaceutical CDMO market, the 'Special Act on Regulatory Support for Biopharmaceutical CDMO Companies' was enacted. By introducing a registration system for export manufacturing, an institutional foundation was established, enabling CDMO companies for export purposes to enter the global market without a pharmaceutical manufacturing license.Furthermore, the MFDS is advancing innovations in the biopharmaceutical approval and review process and in full-cycle regulatory support, enabling safe treatments to be launched faster than anywhere else in the world.To enable domestic biotech companies to enter the international market quickly, the MFDS has simplified the documents required for a preliminary GMP evaluation (from 11 to 4). It has preemptively promoted the 'Raw Material Manufacturing Site Certification Pilot Project' to support the entry of domestic biopharmaceutical raw materials into the global market.In addition, to respond to varying licensing systems and regulatory environments by country, the "Click! Global Biopharmaceutical Information Service" is operated to systematically provide regulatory information for 24 major countries, including the U.S., Europe, and Southeast Asia, along with the latest guidelines and translations to address local regulatory changes.An official from the MFDS stated, "We will continue to strengthen the international competitiveness of our biopharmaceuticals through rational regulatory improvement and institutional and technical support. We will also create an environment where the public can use them with safety management of biopharmaceuticals."
- Policy
- PVA discount for innovative companies to increase to 50%
- by Jung, Heung-Jun Apr 13, 2026 09:12am
- With the reduction rate for price cuts under the price-volume agreement (PVA) for innovative pharmaceutical companies raised to 50%, the outlook for pharmaceutical companies is expected to diverge depending on whether the existing conditions related to repeated cuts remain in place.This is because the number of beneficiaries would decrease significantly if an additional condition requiring 3 price cuts within 5 years were imposed. This is expected to be a major point of contention during discussions over detailed requirements.According to the industry and relevant institutions on the 10th, while the increase in the PVA reduction rate for innovative companies has been decided, the detailed conditions have not yet been finalized.AI-generated ImageIn March, the Health Insurance Policy Deliberation Committee approved strengthened post-listing management preferential treatment for innovative companies by increasing the reduction rate for PVA-driven price cuts. The plan involves raising the reduction rate for price cuts from 30% to 50% when price reductions occur due to increased usage volume.For example, if usage increases and the drug price reduction rate is set at 4%, the cut rate for innovative companies would be lowered to 2%.Under current guidelines for PVA negotiations, a condition is attached for drugs that have undergone repeated cuts. To qualify for the reduction, a drug must have reached an agreement in negotiations at least twice over a five-year period, and the manufacturer must be either an innovative pharmaceutical company or a company recognized by the Health Insurance Review and Assessment Service (HIRA) as having R&D expenses accounting for 10% or more of its revenue.If a drug currently under negotiation has received a third negotiation order within 5 years prior to the end of the analysis period, the pharmaceutical company may submit documents to receive a 30% reduction.The key issue is whether these additional conditions will also apply under the new 50% reduction rate scheme. If eligibility is limited to products whose usage has increased enough to warrant 3 rounds of negotiations, the number of eligible items will decrease significantly.According to the NHIS, 17 items received a 30% reduction in the negotiations 2 years ago because they had been subject to price reductions 3 or more times within 5 years.The industry is hopeful that the specific conditions may change, as the Health Insurance Policy Deliberation Committee approved the 50% increase in the reduction rate without specifying any concrete conditions.In particular, the industry maintains that a 50% reduction should be granted without additional conditions to incentivize innovative companies and R&D investment.An official from a domestic pharmaceutical company expressed concern, stating, “If this does not apply to the third round of negotiations, specific implementation methods must be determined, such as whether it applies only to the first round or whether reductions will also apply to the second and third rounds. However, limiting it to the third round would significantly reduce the number of eligible items.”
- Company
- Final Zemiglo use patent invalidated in Korea
- by Kim, Jin-Gu Apr 13, 2026 09:11am
- The dispute surrounding the use patent for LG Chem’s diabetes treatment Zemiglo (gemigliptin) has ended with a final victory for generic companies. With this ruling, generic companies will be able to launch generic versions of Zemiglo after the substance patent expires in January 2030.Supreme Court issues discontinuance of trial on LG Chem’s appeal… use patent finally invalidatedAccording to the industry sources on the 10th, the Supreme Court issued a discontinuance of trial in the final appeal of the Zemiglo use-patent invalidation case filed by LG Chem against Celltrion Pharm, Dongkoo Bio & Pharma, Daehwa Pharmaceuticals, Jeil Pharmaceutical, and Boryung.A discontinuance of trial means that the Supreme Court affirms a lower court’s ruling without reviewing the merits of the case, having determined that the grounds for the appeal do not meet legal requirements. Consequently, the second-instance ruling, in which LG Chem lost, has been finalized. The use patent for Zemiglo has therefore been invalidated.LG Chem and generic drug companies had been in dispute over the use patent, which expires in October 2039. This patent covers the combined administration of gemigliptin and insulin. Celltrion Pharm and others filed a petition for invalidation in 2023, arguing that the patent lacked inventive step.The Intellectual Property Trial and Appeal Board (first instance) and the Intellectual Property Court (second instance) both ruled in favor of the generic companies. The Supreme Court then reached the same conclusion, putting an end to a legal battle that had lasted nearly 3 years.Impact of the final invalidation ruling… scope-confirmation litigation previously won by LG Chem also heading toward closureThis ruling is expected to influence a separate litigation regarding the scope of rights currently underway concerning the same use patent.Until now, disputes over Zemiglo’s use patent had proceeded along two separate tracks - the ‘invalidity lawsuit’ and the ‘scope of rights confirmation lawsuit.’ While the generic company won both disputes in the first instance, the rulings diverged in the second instance. While the generic drug companies prevailed in the invalidity suit regarding the use patent, the original manufacturer, LG Chem, won the dispute over the scope of rights.Because of those conflicting second-instance rulings, uncertainty grew over the timing of the early generic launch. At the time, there were concerns that if LG Chem ultimately succeeded in defending the patent, a generic launch could be delayed until after 2039.However, the situation has now reversed with the Supreme Court ruling. Legally, once a patent is definitively invalidated, the rights associated with it are deemed to have never existed from the outset. That means the favorable ruling LG Chem obtained in the scope-confirmation litigation loses legal effect, because the patent in question, which served as the basis for comparison, is now interpreted as “non-existent.”From the perspective of generic drug companies, this ruling effectively allows them to bring forward the launch of Zemiglo generics by 9 years, to a date after January 2030, when the substance patent expires. Although Zemiglo has a salt and hydrate patent set to expire in October 2031, generic drug companies have already successfully circumvented it.Zemiglo is LG Chem’s flagship drug. According to market research firm UBIST, the combined prescription sales of the ‘Zemiglo family’, which includes Zemiglo, Zemimet, Zemidapa, and Zemiro, totaled KRW 159.1 billion last year, a 4% increase from the previous year. Among these, Zemiglo alone recorded KRW 41.4 billion in prescription sales, accounting for 26% of the total family product prescriptions.
- Company
- MSD Korea sales 30%↓ in three years
- by Son, Hyung Min Apr 13, 2026 09:11am
- MSD Korea's performance continued to decline due to lower demand for COVID-19 treatments. As sales from treatments that drove performance during the pandemic have rapidly shrunk, existing core products have failed to offset the loss.According to the Financial Supervisory Service's electronic disclosure system on the 13th, MSD Korea's sales decreased by 14.2%, from KRW 667.8 billion in 2024 to KRW 573.2 billion last year. During the same period, operating profit dropped 13.0%, from KRW 24.9 billion to KRW 21.6 billion.MSD Korea Sales Trend by Year (unit: KRW 100 million). MSD Korea's sales decreased by 14.2%, from KRW 667.8 billion in 2024 to KRW 573.2 billion in 2025.The primary reason for the sales decline is the lack of supply of the COVID-19 treatment 'Lagevrio (molnupiravir).' MSD Korea explained that the absence of a supply contract with the Korea Disease Control and Prevention Agency (KDCA) last year affected the sales decrease.In fact, MSD Korea's sales have shown significant volatility, reflecting demand for COVID-19 treatments. Revenue peaked at KRW 820.4 billion in 2022 when demand was the highest, but subsequently decreased to KRW 760.9 billion in 2023 and KRW 667.8 billion in 2024 following the transition to the endemic phase. Compared with last year's sales of KRW 573.2 billion, revenue has shrunk by 30.1% over the past three years.Despite having a strong lineup of major products, including the immunotherapy 'Keytruda (pembrolizumab),' the cervical cancer vaccine 'Gardasil,' and the pneumococcal vaccines 'Vaxneuvance' and 'Capvaxive,' it was not enough to fill the void left by the end of the COVID-19 sales.However, the company continued investing in its Research and Development (R&D).According to data released by MSD Korea, the company invested 78 billion KRW in R&D last year, accounting for approximately 14% of its revenue, and has consistently invested over KRW 70 billion annually for the past five years. Despite the short-term performance decline, the company appears to be continuing its strategic investments to secure a foundation for medium- to long-term growth.New Indications·Pipeline Additions…Seeking a Rebound in PerformanceWhile performance has declined due to the sales void from COVID-19 treatments, MSD Korea is seeking a rebound opportunity by reorganizing its portfolio around oncology, vaccines, and rare diseases.The scope of Keytruda was rapidly expanded this year, with 11 additional indications, including triple-negative breast cancer and endometrial cancer, added to the reimbursement list. Furthermore, reimbursement for combination therapy with 'Padcev (enfortumab vedotin)' in urothelial carcinoma is also imminent.RSV preventive antibody injection 'Enfloncia (clesrovimab)' Keytruda has become a pillar of treatment with expanded reimbursement scope as a standard of care (SOC) across major solid tumors. This treatment has the most indications among drugs authorized in Korea.At the same time, efforts to develop new growth engines for infectious diseases are underway. MSD Korea has applied for the authorization of 'Enfloncia (clesrovimab),' an RSV preventive antibody injection for neonates and infants, and there is talk of possible approval in the second half of this year.Enfloncia is a long-acting monoclonal antibody that, in Phase 2b/3 clinical studies, demonstrated reductions of 60.5% in the occurrence of RSV-related lower respiratory tract infections and 84.3% in the risk of hospitalization.In addition, the reimbursement process for 'Winrevair (sotatercept),' a treatment for pulmonary arterial hypertension (PAH), is accelerating following its inclusion in the pilot project for concurrent authorization, evaluation, and negotiation.Winrevair is the first approved activin signaling inhibitor (ASI) in pulmonary arterial hypertension and offers a new mechanism of action after 20 years. This treatment works by blocking excessive activin signaling. This protein complex promotes cell proliferation in pulmonary arterial vessels, and restores the balance with anti-proliferation signals to induce reverse remodeling, normalizing altered vascular structures.As the impact from the termination of the COVID-19 special demand is being reflected, the expanded reimbursement for major products and the introduction of new drugs are expected to be key drivers of a future performance rebound.
