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- 2026-04-15 00:55:06
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- 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.
- 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.
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