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- 2026-04-21 12:18:43
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- Hanmi's new drug licensed to MSD, greenlight for entering Phase 3 trial?
- by Chon, Seung-Hyun Feb 10, 2026 08:14am
- It is likely that 'efinopegdutide,' a novel treatment for metabolic dysfunction-associated steatohepatitis (MASH) licensed from Hanmi Pharmaceutical to MSD, would proceed to Phase 3 clinical trials. MSD concluded Phase 2 clinical trials at the end of last year and has significantly expanded its supply of clinical samples from Hanmi to prepare for Phase 3 studies. Improvements in export performance contributed to Hanmi Pharmaceutical recording an operating profit margin of nearly 20% in Q4 of last year.According to Hanmi Pharmaceutical, on the 6th, the company's Q4 exports last year reached KRW 54.2 billion, a 15.3% year-on-year increase. This represents an 83.0% jump from the KRW 29.6 billion recorded in Q3. While Hanmi's export volume had declined for two consecutive quarters after reaching KRW 68.2 billion in Q1 of last year, it rebounded sharply in Q4.Hanmi Pharmaceutical's Quarterly Export Performance (unit: KRW 1 million, source: Hanmi Pharmaceutical)The company explained that the export expansion was driven by a significant increase in the supply of efinopegdutide clinical samples to MSD, produced at Hanmi's Pyeongtaek Bio Plant.Efinopegdutide is a MASH treatment candidate that Hanmi Pharmaceutical licensed to MSD in August 2020. The deal was valued at up to $870 million, including a $10 million upfront payment.The drug is a dual agonist that simultaneously activates GLP-1, which aids insulin secretion and appetite suppression, and glucagon, which increases energy metabolism. It utilizes Hanmi's proprietary LAPSCOVERY technology to extend the drug's half-life.A Hanmi Pharmaceutical official stated, "Export volumes grew in Q4 as clinical samples were supplied to prepare for MSD's Phase 3 clinical trials."Following the licensing of efinopegdutide, MSD conducted Phase 2 trials comparing efinopegdutide with Novo Nordisk's semaglutide and a placebo. Results from a Phase 2a analysis presented at the 2023 European Association for the Study of the Liver (EASL) in Vienna showed that efinopegdutide reduced liver fat content by 72.7% relative to baseline at week 24. This significantly outperformed semaglutide, which showed a 42.3% reduction over the same period. Industry experts interpret MSD's purchase of clinical samples as a "green light" to enter Phase 3, suggesting that MSD is preparing for the next stage as positive outlooks were shown for Phase 2 results.MSD completed the Phase 2b trial for efinopegdutide in December last year and is expected to announce the results this year.According to ClinicalTrials.gov, the Phase 2b study began on June 23, 2023, and concluded on December 29, 2024, with 381 participants enrolled. MSD completed the Phase 2b trial for efinopegdutide in December 29 of last year. (source: ClinicalTrials.gov)In its recent Q4 earnings report, MSD listed efinopegdutide in its Phase 2 pipeline for cardiovascular, metabolic, and respiratory diseases. This report indicates that efinopegdutide is categorized as a core pipeline.Hanmi Pharmaceutical is showing a recurring pattern of surging exports tied to the supply of clinical samples of efinopegdutide. In Q1 of last year, exports rose 45.1% compared to the previous quarter. At that time, Hanmi announced that "Increased revenue from clinical samples delivered to MSD contributed to 'etc. regional volume' increases."Meanwhile, efinopegdutide is a candidate that was previously licensed to Janssen in December 2015 (as JNJ-64565111). The total contract volume amounted to $915 million with an upfront payment of $105 million. After Janssen returned the rights of JNJ-64565111 in 2019, Hanmi re-licensed it to MSD for NASH (now MASH) treatment within a year.The increase in exports of clinical samples significantly improved Hanmi's overall financial performance. In Q4 of last year, operating profit reached KRW 83.3 billion, up 173.4% year-on-year, while revenue grew 23.1% to KRW 433 billion. The operating profit margin for the quarter hit 19.2%, the highest in ten years since the 29.1% recorded in Q4 of 2015, when Hanmi secured a blockbuster licensing deals. In Q4 of 2015, Hanmi recorded sales of KRW 589.9 billion and an operating profit of KRW 171.5 billion.
- Company
- HanAll’s development of Imeroprubart on track
- by Choi Da Eun Feb 10, 2026 08:14am
- Clinical development of Imeroprubart, HanAll Biopharma’s autoimmune disease drug candidate, is progressing smoothly.Roivant Sciences, the parent company of HanAll’s partner Immunovant, disclosed the latest development updates on Imeroprubart (Immunovant development code IMVT-1402) during its earnings call on the 6th (U.S. time).Imeroprubart is one of the FcRn inhibitor candidates that HanAll Biopharma licensed to Roivant in 2017. Clinical programs are currently underway across six autoimmune indications: Graves’ disease (GD), difficult-to-treat rheumatoid arthritis (D2T RA), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), Sjögren’s disease (SjD), and cutaneous lupus erythematosus (CLE). The company estimates that the drug could offer a new treatment option to more than 600,000 patients in the U.S. alone.Notably, enrollment in the registrational trial for D2T RA progressed faster than anticipated, exceeding initial targets with 170 patients enrolled. Top-line results are expected in the second half of this year, and no major safety concerns have been reported to date.A proof-of-concept (PoC) trial in cutaneous lupus erythematosus (CLE) is also ongoing, with top-line data anticipated later this year. The upcoming clinical readouts are viewed as critical indicators of whether Imerofravat can establish itself as a first-in-class and best-in-class therapy.Roivant also outlined its future development timeline. It plans to sequentially release topline results from pivotal trials for Graves' disease and myasthenia gravis in 2027, followed by commercialization starting with the Graves' disease indication in 2028.In addition, Immunovant disclosed a single-patient case from an ongoing open-label study within the CLE PoC trial. CLE is an autoimmune condition characterized by chronic skin inflammation, presenting with erythema, pain, pruritus, burning sensations, and alopecia. In severe cases, it can lead to irreversible damage such as scarring, pigmentary changes, and permanent hair loss.According to the IR materials disclosed by Immunovant, a patient who received high-dose Imeroprubart (600 mg) for 12 weeks showed a greater than 60% reduction in the CLASI-A score (from 36 to 13), which measures the severity of skin inflammation. Clinically meaningful improvements were also observed in hair loss and skin lesions. Antibody (IgG) levels in the blood at week 12 showed a 78% reduction from baseline.Seungwon Jeong, President and CEO of HanAll Biopharma, said, “We are pleased to see Imeroprubart’s clinical development progressing faster than planned. We expect the data to be released in the second half of this year to more clearly demonstrate Imeroprubart’s differentiated therapeutic efficacy and competitiveness.”
- Company
- Statin + ezetimibe comb emerging as cashcows…33 over KRW 10B
- by Chon, Seung-Hyun Feb 10, 2026 08:14am
- In the Korean pharmaceutical industry, combination drugs containing statin + ezetimibe have become strong cash cows. Last year, 33 products surpassed KRW 10 billion in prescription sales, contributing to the company's firm performance. Notably, four products achieved annual prescriptions exceeding KRW 100 billion.Prescription sales of 20 combination drugs containing rosuvastatin‧ezetimibe surpassed KRW 10 billion. Hanmi Pharmaceutical, with Rosuzet as a key product, generated over KRW 200 billion in the statin + ezetimibe market, while Organon, Yuhan Corporation, and JW Pharmaceutical also gained high profits from these combinations.Last year, 33 statin+ezetimibe combination products recorded over KRW 10 billion…4 items surpassed KRW 100 billionAccording to pharmaceutical market research firm UBIST, 33 statin+ezetimibe combination products recorded over KRW 10 billion in prescriptions last year, an increase of six items from 27 in 2024.Statin + ezetimibe combination drugs exceeding KRW 10 billion in annual prescription sales (unit: KRW 100 million, source: UBIST). GRAY: simvastatin + ezetimibe, ORANGE: pitavastatin+ezetimibe, RED: atorvastatin+ezetimibe, BLUE: rosuvastatin+ezetimibeCurrently, four types of statin+ezetimibe combinations are available, ezetimibe + four tyeps of statin (simvastatin, rosuvastatin, atorvastatin, or pitavastatin). Last year, the rosuvastatin+ezetimibe market was the largest at KRW 809.6 billion, followed by atorvastatin+ezetimibe at KRW 380 billion and pitavastatin+ezetimibe at KRW 185.3 billion.Statin+ezetimibe combinations that generated over KRW 10 billion in prescription sales have tripled in five years, from 11 items in. The products in the '100 Billion KRW Club' continued to join every year, growing from 11 in 2020 to 13 in 2021, 18 in 2022, and 23 in 2023.Last year, there were four items with KRW 100 billion in prescription sales.Rosuzet by Hanmi Pharmaceutical, the first domestically developed statin + ezetimibe combination drug, recorded KRW 227.9 billion. Since its 2015 launch, Hanmi has secured an early lead by obtaining rights to ezetimibe usage from the patent holder, MSD. Currently, 50 domestic pharmaceutical companies have entered the statin + ezetimibe combination drug market.Atozet by Organon, the original atorvastatin + ezetimibe combination, reached KRW 127.3 billion in sales. This drug surpassed KRW 100 billion for the first time recording KRW 102.1 billion in 2023. It recorded sales above KRW 100 billion for three consecutive years, despite generic competition.LivaloZet by JW Pharmaceutical generated KRW 117 billion last year, becoming the second domestically developed product to join the '100 billion won club.' LivaloZet is a combination drug of pitavastatin + ezetimibe. LivaloZet achieved remarkable success in 2022, with prescription sales of KRW 31.8 billion. Sales skyrocketed to KRW 70.4 billion and KRW 93.3 billion in 2023 and 2024, respectively. LivaloZet showed notable growth last year, surpassing KRW 100 billion in sales for the first time.Yuhan Corporation's rosuvastatin + ezetimibe combination, Rosuvamibe, joined the '100 billion won club' with prescription sales of KRW 102.2 billion last year. Rosuvamibe surpassed KRW 100 billion in annual prescriptions in its 10th year since its launch in 2016. It is recording a high growth rate, expanding by 88.1% over five years from a prescription volume of KRW 54.3 billion in 2020.20 items with rosuvastatin + ezetimibe over KRW 10BLooking at the number of products with prescriptions over KRW 10 billion by ingredient for statin + ezetimibe combinations, rosuvastatin + ezetimibe accounted for more than half, with 20 items. This is more than double the nine items recorded in 2020.Following Rosuzet and Rosuvamibe, HK inno.N's Rovazet showed strength with a prescription volume of KRW 56.6 billion last year. Rovazet expanded more than twofold over five years, from KRW 27.5 billion in 2020, and last year's prescription volume increased by 19.6% compared to the previous year.Last year's prescriptions for Daewoong Pharmaceutical's Crezet reached KRW 47.7 billion, a 24.2% increase from the previous year. It has maintained a high-growth trend, more than doubling from KRW 20 billion in 2020 to KRW 45 billion over the past five years. GC Biopharma's Daviduo and Aju Pharmaceutical's Cretrol recorded prescriptions of KRW 34.4 billion and KRW 30.3 billion, respectively, last year, emerging as flagship medications for their companies.Huons, Jeil Pharmaceutical, Myungmoon Pharm, Mothers Pharmaceutical, and Abbott recorded over KRW 20 billion in prescriptions for rosuvastatin + ezetimibe combinations. Ahn-gook Pharmaceutical, Kyungdong Pharm, Dongkook Pharm, Hana Pharm, HLB Pharmaceutical, Kukje Pharma, Medica Korea, Daewoong Pharmaceutical, and Shinpoong Pharm recorded over KRW 10 billion.For atorvastatin + ezetimibe combinations, a total of 8 products recorded prescriptions totaling over KRW 10 billion last year. While five products each recorded over KRW 10 billion in 2023 and 2024, three additional products rose above KRW 10 billion last year.Jeil Pharmaceutical's Lipitor Plus recorded the highest domestic prescription volume at KRW 47.7 billion last year. Jeil Pharmaceutical is co-marketing Lipitor Plus with Viatris. Lipitor Plus grew nearly twofold from KRW 13.4 billion in 2022 to KRW 26.4 billion in 2023, and then reached KRW 38.4 billion in 2024, with an annual increase of about KRW 10 billion. Last year's prescriptions increased by 24.2% year-on-year.Yuhan Corporation's Atorvamibe surpassed KRW 20 billion last year with KRW 23.2 billion in prescriptions, a 45.2% increase from the previous year. Atorvamibe soared 157.8% in three years from KRW 9 billion in 2022. Daewoong Pharmaceutical's Litorvazet recorded KRW 20.1 billion in prescriptions last year. Both Yuhan Corporation and Daewoong Pharmaceutical achieved success in the atorvastatin + ezetimibe market, following the rosuvastatin + ezetimibe market. Ahn-gook Pharmaceutical, Boryung, HK inno.N, and KyungDong Pharm also saw their atorvastatin + ezetimibe combinations reach over KRW 10 billion in prescriptions.In the pitavastatin + ezetimibe combination market, a total of 4 products showed prescription performance of over KRW 10 billion last year.Following LivaloZet, products such as Ahn-gook Pharmaceutical's Pevarozet, Daewon Pharmaceutical's Tavalozet, Boryung's Lzerozet, Dongkwang Pharm's PZ, and Hanlim Pharm's Stazet have entered the market. Ahn-gook Pharmaceutical, along with Daewon Pharmaceutical, Boryung, DongKwang, and Hanlim Pharm, successfully invalidated the patents related to the pitavastatin + ezetimibe combination in April 2021. Following clinical trials, they obtained item approval in May 2023. Ahn-gook Pharmaceutical is responsible for the production of pitavastatin + ezetimibe combinations for all five of these companies.Ahn-gook Pharmaceutical's Pevarozet created a sensation last year, with prescription volume of KRW 29.2 billion, a 158.6% increase from the previous year. Pevarozet is aggressively targeting the market by highlighting its 46% smaller formulation size compared to LivaloZet, which significantly improves patient convenience with medication. Additionally, Daewon Pharmaceutical's Tavalozet and Boryung's Lzerozet recorded prescription performances of KRW 18.2 billion and KRW 13.4 billion, respectively, last year.In the pitavastatin + ezetimibe combination market, a total of 4 products recorded prescription sales of over KRW 10 billion last year.In the simvastatin + ezetimibe combination drug market, only one product, Organon's Vytorin, showed prescription performance of over KRW 10 billion last year.Looking at the prescription performance of statin + ezetimibe combinations by company, Hanmi Pharmaceutical maintained its lead with KRW 227.9 billion from a single item, Rosuzet. Organon, Yuhan Corporation, and JW Pharmaceutical demonstrated strength by recording sales exceeding KRW 100 billion. Jeil Pharmaceutical, HK inno.N, Daewoong Pharmaceutical, and Ahn-gook Pharmaceutical recorded over KRW 50 billion in the statin + ezetimibe market.
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- Oral PNH drug 'Fabhalta' available at general hospitals
- by Eo, Yun-Ho Feb 09, 2026 07:33am
- Oral drug 'Fabhalta' for PNH is cleared to be prescribed at general hospitals.According to industry sources, Novartis Korea's Fabhalta (iptacopan), an oral treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), has passed the drug committees (DC) of 'Big 5' tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, and Seoul St. Mary's Hospital, and medical institutes, including Kyungpook National University Hospital, Wonju Severance Christian Hospital, Chungnam National University Hospital, and Chonnam National University Hwasun Hospital.Prescription areas of Fabhalta have been consistently expanded since the insurance reimbursement listing in July of last year.PNH is a rare disease that is estimated to occur in approximately 1.5 out of 1 million people globally.The treatment of this disease has relied on C5 inhibitors. 'Soliris (eculizumab)' was approved for the first time in Korea in 2010. 'Ultomiris (ravulizumab)' was approved in 2022 and has been used as a treatment for PNH. Both treatment options fall into the category of C5 inhibitor, which work by inhibiting the terminal component C5 within the complement system's alternative pathway. They are also intravenous injectables.In April 2024, 'Empaveli (pegcetacoplan),' a subcutaneous injection that inhibits the complement cascade by binding to C3 and C3b, was approved. In August of the same year, Fabhalta, an oral treatment that inhibits Factor B, emerged.The unmet need in PNH, due to the mechanistic limitations of C5 inhibitors, is extravascular hemolysis (EVH). PNH begins with a genetic defect in red blood cells, leading to both intravascular hemolysis (IVH) and extravascular hemolysis (EVH).Such hemolysis soon causes thrombosis and bone marrow failure, making it life-threatening. Therefore, it is crucial to control hemolysis in PNH treatment. While the current standard of care, C5 inhibitors, significantly controls IVH, they have mechanistic limitations in controlling EVH.This is why attention is gathering around the reimbursement listing for the Factor B inhibitor Fabhalta. Factor B exists further upstream in the alternative pathway than C5, C3, and C3b. By inhibiting this factor, both IVH and EVH can be comprehensively controlled.In fact, Fabhalta demonstrated efficacy in treatment-naive patients. According to the APPOINT-PNH study of treatment-naïve PNH patients, 19 of 33 patients reached a hemoglobin level of 12 g/dL or higher without red blood cell transfusions.Additionally, 92% of patients showed a clinically significant increase in hemoglobin of 2 g/dL or more, and 63% of patients sustained a hemoglobin level of 12 g/dL or higher without transfusion. During the 24-week study period, hemoglobin levels showed a trend of continuous increase, reaching normalized levels from week 20 and sustaining them through week 24. Furthermore, 98% overcame transfusion dependence.Professor Jun Ho Jang of the Department of Hematology-Oncology at Samsung Medical Center stated, "When C5 inhibitors first emerged, experts analyzed that the paradigm of PNH treatment had shifted. However, C5 inhibitors still have limitations in controlling EVH."Jang emphasized, "Fabhalta is a new drug that will lead to another paradigm shift in PNH treatment. Since the mechanism of Factor B inhibition works by involving Factor B located at the top of the alternative pathway, this drug can control both intra- and extravascular hemolysis, and has shown encouraging results through clinical trials."
- Company
- "Dupixent reimb for severe asthma… access to targeted therapy"
- by Son, Hyung Min Feb 09, 2026 07:33am
- The biological agent 'Dupixent' has secured reimbursement for severe asthma, expanding patient access. Given that many patients did not respond to existing treatments, the field evaluates that this will be a therapeutic turning point that addresses long-standing unmet needs.On the 5th, Sanofi-Aventis Korea held a press conference at the Lotte Hotel in Seoul to commemorate the reimbursement of Dupixent (dupilumab) in Korea. Professor Ji-yong Moon of the Department of Pulmonary, Allergy and Critical Care Medicine at Konkuk University Medical Center Dupixent is the first biological agent to target the signaling of interleukin (IL)-4 and IL-13, which are major drivers of Type 2 inflammation.Various immunce disease indications for Dupixent has been added, including severe asthma, atopic dermatitis, prurigo nodularis, eosinophilic esophagitis, and chronic obstructive pulmonary disease (COPD). However, reimbursement had been limited to the treatment of atopic dermatitis.In December last year, patient accessibility was expanded as Dupixent became reimbursed for severe asthma. This comes about six years after the indication was added in 2020.The expanded reimbursement covers cases ▲where the blood eosinophil count is 150 cells/µL or higher, or fractional exhaled nitric oxide (FeNO) is 25 ppb or higher within 12 months before starting treatment, and at least four acute asthma exacerbations requiring systemic corticosteroids occurred within those 12 months ▲where oral corticosteroids equivalent to 5mg/day of prednisolone or higher have been continuously administered since six months before starting treatment.The evaluation method involves assessing the patient every year before and after drug administration (every six months for oral corticosteroid-dependent asthma), and the patient is approved if they meet one of the two conditions.Through the Phase 3 QUEST clinical study, Dupixent was confirmed to improve lung function and reduce exacerbation rates.The data show that the Dupixent group showed an annualized exacerbation rate reduction of more than 45% at 52-week compared to the placebo group. Additionally, significant improvement in lung function was observed from the second week of Dupixent administration. This effect was maintained throughout the 52 weeks.Notably, it significantly reduced the annualized severe asthma exacerbation rate compared with the placebo group in patients with baseline eosinophil (EOS) counts of 150 cells/µL or higher.Professor Moon stated, "Dupixent showed meaningful asthma control indicators and quality of life improvement in patients with increased Type 2 inflammatory biomarkers, and explained, "This reimbursement has opened the way for medical staff to select patients expected to respond to treatment based on clinical indicators such as blood eosinophil counts and FeNO, connecting them to targeted therapy at the appropriate time.""Symptom management is difficult to achieve with a single treatment…various options must be secured"An opinion was also presented that symptom control is difficult with a single treatment, necessitating the securing of various options. Type 2 inflammatory asthma is characterized by excessive cytokine activation, including IL-4, IL-5, and IL-13. It not only carries a high risk of repeated exacerbations and loss of lung function but also triggers various immune comorbidities, such as atopic dermatitis, chronic rhinosinusitis, and COPD, which generally diminish the patient's quality of life.Accordingly, various biological agents are being utilized for severe asthma, including interleukin-targeting Dupixent, Novartis's Xolair (omalizumab)', GSK's 'Nucala (mepolizumab)', and AstraZeneca's 'Fasenra (benralizumab)', as well as AstraZeneca's 'Tezspire (tezepelumab)', which targets thymic stromal lymphopoietin (TSLP).Unlike general asthma, severe asthma is difficult to control, and experts argue that more medications, such as oral steroids (OCS) or additional biological agents, must be secured. However, because OCS can cause various side effects, its use is currently declining.Biological agents have strengths in terms of safety and the ability to reduce dependence on oral steroids.Professor Moon stated, "Due to the characteristics of asthma, not all patients are treated with the same drug. Therefore, the Global Initiative for Asthma (GINA) guidelines recommend assessing for Type 2 inflammation when treating severe asthma and selecting the appropriate medication."Professor Moon added, "A significant number of patients undergoing treatments have a poor prognosis due to repeated acute exacerbations despite existing treatments," and emphasized, "The reimbursement of Dupixent, which targets the cause of disease, holds great clinical value in providing better treatment options to patients who experienced limitations of existing therapies."
- Company
- Roche Diagnostics bets on mass spectrometry for lab automation
- by Hwang, byoung woo Feb 09, 2026 07:32am
- Roche Diagnostics Korea has positioned its ‘automated mass spectrometry solution’ as the final piece of the laboratory automation puzzle.The vision is to extend the laboratory efficiency gained through existing core lab automation to mass spectrometry, delivering the most accurate results precisely when patients need them.The company particularly emphasized a strategy to organically connect automated and digital platforms within the clinical setting, which is in line with Korea’s trend of seeking infrastructure expansion.On February 6, Roche Diagnostics Korea hosted a media session titled “Beyond Data, To Certainty,” where it shared its vision for next-generation automated mass spectrometry solutions designed to maximize laboratory efficiency, alongside AI-driven digital insights.(from the left) Sungho Cho, Head of Core Lab & POC at Roche Diagnostics Korea; Muhwan Yoon, Head of Digital Insights at Roche Diagnostics KoreaFrom ‘isolated islands’ to automated tracks... the evolution of mass spectrometryAccording to Roche, mass spectrometry has traditionally functioned as an “isolated island” within diagnostic laboratories. While recognized as the gold standard for analytes requiring precise quantification, such as hormones and vitamin D metabolites, its complex process has necessitated highly skilled personnel performing manual processes in dedicated spaces.Sungho Cho, Head of Core Lab & POC at Roche Diagnostics Korea, who led the presentation at the event, said, “Until now, mass spectrometry testing was inevitably conducted in batch mode. Samples were collected and analyzed only on specific days or outsourced to external laboratories, which meant patients sometimes had to wait a full week for results.”Roche’s proposed solution is to integrate this ‘island’ into the automated laboratory track. From sample receipt and pre-analytical processing to analysis and result reporting, all steps are unified into a single automated workflow, seamlessly connecting mass spectrometry to core lab automation.At the forefront of this strategy is the company's newly introduced ‘cobas pro i 601 analyzer’. Its core feature is the direct connection of the mass spectrometry equipment to the same track as standard automated immunoassay/biochemistry analyzers, integrating the entire process from sample loading to result generation.Cho emphasized, “The era has arrived where random access (Anytime Testing) is possible for even mass spectrometry, allowing results to be confirmed on the day of testing and immediately reflected in treatment. This is the realization of Roche’s vision for a seamless, uninterrupted patient journey.”NAVIFY's smart lab vision… adding ‘certainty’ to dataWhile mass spectrometry completes the hardware connection, Roche’s digital insights brand, ‘NAVIFY’ aims to create clinical value by analyzing the data flowing across the infrastructure.Muhwan Yoon, Head of Digital Insights at Roche Diagnostics Korea, described NAVIFY as a comprehensive digital ecosystem encompassing diagnostics, clinical care, pathology, and molecular diagnostics. Roche’s digital strategy centers on AI-driven 3P principles: Prediction, Performance, and Personalization.Specifically, AI algorithms identify patients' chronic disease risks early and provide recommendations to clinicians, while predicting laboratory workload to optimize staffing and reagent allocation. The core objective is to connect this to deriving personalized treatment options tailored to each individual patient.NAVIFY-based solutions initially focused on clinical laboratories but have since expanded to include clinicians, pathology, and molecular diagnostics.Yoon emphasized, “NAVIFY integrates not only diagnostic testing but also clinical, pathology, and molecular diagnostic data into a single ecosystem. It will become the tool for delivering a ‘true smart lab,’ which reduces the time medical staff spend on administrative tasks and allows them to focus solely on patient care.”Cost and regulation remain challenges…but automation is inevitableLooking ahead, cost and regulatory barriers remain key challenges for the adoption of innovative technologies in real-world clinical settings.On this, Cho said, “Traditional manual workflows involve hidden costs such as high labor expenses for specialized personnel and management costs associated with human error. Roche’s automation systems reduce reliance on manual labor, significantly improving operational efficiency. In the long term, this represents a strategic investment that enhances both hospital profitability and diagnostic accuracy.”Kit Tang, General Manager of Roche Diagnostics KoreaYoon also stated, “We are lowering entry barriers by offering various options tailored to hospital situations, such as subscription models.”He added that the company is actively engaging with regulators to address challenges arising from the intersection of digital technologies and traditional medical device approval frameworks. There is a growing consensus in the field that digitalization is a matter of survival.In closing, Kit Tang, General Manager of Roche Diagnostics Korea, emphasized, “Roche’s mission is ‘Doing now what patients need next.’ Automating mass spectrometry and digitally connecting diagnostics are not merely for product launches. They represent our commitment to eliminating diagnostic uncertainty and providing confidence to patients.”He added, “True patient-centered care is achieved not by introducing individual technologies, but by ensuring those technologies are organically connected in the clinical setting and translated into tangible benefits for patients.”
- Company
- Biologics for atopic dermatitis, 'four-way race'
- by Son, Hyung Min Feb 06, 2026 06:43am
- The biologic market for atopic dermatitis is experiencing a new shift. Competition among interleukin (IL)-13 inhibitors has been previously centered around 'Dupixent.' As treatments with new mechanisms enter the race, multi-layer competition is intensifying, with drugs that differ in their immune pathways. (clockwise from left) Nemluvio, Dupixent, Adtralza, EbglyssAccording to industry sources on the 4th, Galderma Korea has recently received domestic approval for its biologic agent 'Nemluvio (nemolizumab).' The indication is for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis (PN). With the addition of Nemluvio to the previously approved treatments, including Sanofi and Regeneron's Dupixent (dupilumab), LEO Pharma's Adtralza (tralokinumab), and Eli Lilly's Ebglyss (lebrikizumab)—the therapeutic options in the Korean atopic dermatitis market have expanded to four.Nemluvio is the only IL-31 receptor inhibitor among the drugs approved in Korea, targeting a distinctly different immune axis compared to existing treatments that inhibit the Th2 axis related to IL-13.IL-31 is a neuro-immune cytokine that induces itch signals, sitting at the center of a vicious cycle in which it directly stimulates sensory nerves, exacerbating scratching behavior.Unlike existing drugs like Dupixent (IL-4/13) and Adtralza or Ebglyss (IL-13), which focus on inflammation control, Nemluvio's mechanistic differentiation lies in its direct blockage of itching, the core symptom of the disease burden.In clinical trials, Nemluvio, when combined with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI), met all endpoints compared with placebo.Notably, the speed of itch improvement is rapid. In the global Phase 3 ARCADIA study, Nemluvio showed a statistically significant reduction in itching compared to placebo starting from 48 hours after administration, and at the 4-week and 16-week marks, more than twice as many patients compared to the placebo group experienced a clinically meaningful level of itch relief (PP-NRS improvement of 4 points or more).Regarding inflammation and lesion improvement, the Eczema Area and Severity Index 75% improvement (EASI-75) was 43.5% and 42.1% in ARCADIA-1 and ARCADIA-2, respectively, indicating a level of inflammation suppression similar to that of existing Th2 inhibitors.Administration convenience is also a strength. For atopic dermatitis, Nemluvio is administered at an initial dose of 60mg followed by 4-week intervals up to 16 weeks, and it is the only drug in Korea that can be switched to an 8-week dosing interval once a clinical response is confirmed.Considering that Dupixent and Ebglyss are both administered every 2 weeks, and Adtralza is administered every 2 or 4 weeks, Nemluvio is the first drug to provide a dosing interval optimization model based on clinical response.Analysis suggests that, given the essential role of long-term treatment for moderate-to-severe patients, this can significantly enhance market competitiveness by improving patient convenience and compliance.Clinical safety also showed no significant difference compared to existing treatments. Adverse events reported relatively frequently with existing biologics, such as conjunctivitis and herpes, showed no significant difference between the Nemluvio and placebo groups, and most adverse events were manageable at mild to moderate levels.New target competition intensifies… IL-22·IL-18 inhibitors are being developedAs atopic dermatitis is recognized as a multi-immune network disease that is difficult to explain by the inhibition of a single cytokine, new drug development is rapidly shifting from a Th2-centric approach to a multi-mechanism competition targeting various immune axes, such as IL-31, IL-22, and IL-18.Among these, the IL-22 inhibitor 'temtokibart,' being developed by LEO Pharma, is considered one of the most notable next-generation candidates.IL-22 is a key cytokine that induces epidermal proliferation, decreased barrier function, and chronic inflammation. IL-22 inhibition offers a distinct approach to existing Th2 inhibitors by simultaneously promoting skin barrier recovery and relieving inflammation.Temtokibart binds to IL-22RA1 (IL-22 receptor α1) to block IL-22 signaling and has the potential to inhibit the IL-20 and IL-24 pathways that share the same receptor. Thus, its strength lies in its upstream signal-inhibition mechanism, which regulates the entire epidermal barrier function and inflammatory pathways rather than blocking a single cytokine.In a Phase 2a study, temtokibart achieved EASI-90 in 30.8% of patients and EASI-100 in 20.9%, with broad reductions in systemic inflammatory proteins.Additionally, temtokibart was evaluated as the first mechanistic candidate to directly regulate epidermis-immune interactions, as it was shown to simultaneously inhibit the Th17/22, Th2, and Th1 axes and restore the expression of barrier genes such as KRT and CLDN.Another new drug candidate, camoteskimab from the U.S. biotech company Apollo Therapeutics, showed an 80% improvement in EASI scores in Phase 2a and maintained clinical responses even in the patient group that failed Dupixent.Since IL-18 is known as an upstream regulator of Th1, Th2, Th17, and Th22, it is expected to be a meaningful alternative for patients who did not respond to existing treatments. Korean company AprilBio and the U.S. drug development company Evommune have also entered Phase 2 clinical trials with this same mechanism.
- Company
- Imdelltra can be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Feb 06, 2026 06:43am
- The bispecific antibody anticancer drug Imdelltra is entering major hospital prescription lists in Korea.According to industry sources, Amgen Korea's Imdelltra (talatamab), a treatment for relapsed or refractory extensive-stage small cell lung cancer (SCLC), has passed the Drug Committee (DC) reviews at leading general hospitals, including Samsung Medical Center, Asan Medical Center, and Severance Hospital.However, Imdelltra has not yet been listed for reimbursement. In January, during the Health Insurance Review and Assessment Service’s first Cancer Drug Review Committee meeting of the year, the drug received a decision of “reimbursement criteria not established.”Therefore, it remains to be seen whether Imdelltra will secure reimbursement status and emerge as a treatment option in the underserved small-cell lung cancer field.Approved in Korea in May last year, Imdelltra is a bispecific antibody targeting delta-like ligand 3 (DLL3), which is expressed in approximately 85–96% of patients with small cell lung cancer. DLL3 is typically localized intracellularly in normal cells but is aberrantly expressed on the surface of tumor cells in SCLC and other neuroendocrine cancers.Imdelltra binds to both the DLL3 antigen on cancer cells and the CD3 antigen on T cells, redirecting T cells to induce tumor cell death. Crucially, it acts directly on the antigens of T cells and cancer cells, independent of Major Histocompatibility Complex Class I (MHC-1) expression, one of the key pathways cancer cells use to evade the immune system, making it effective even against immune-evading cancer cells.The efficacy of Imdelltra was demonstrated in the DeLLphi-301 clinical trial, a phase 2 study conducted in adult patients with extensive-stage SCLC whose disease had progressed after at least two prior lines of therapy, including platinum-based chemotherapy.In the study, Imdelltra showed a clinically meaningful objective response rate (ORR). Among 100 patients treated with Imdelltra 10 mg, the ORR was 40%, and 58% of responders (n=23/40) maintained their response for six months or longer.Furthermore, the median overall survival (OS) in the Imdelltra 10mg group was 14.3 months, and the median progression-free survival (PFS) was 4.9 months. Treatment-related adverse events in the Imdelltra 10mg group were mostly low grade, with grade 3 or higher adverse events occurring in 29% of patients in the clinical Parts 1-2 and 15% of patients in Part 3.Based on these results, the National Comprehensive Cancer Network (NCCN) recommends Imdelltra monotherapy as a preferred regimen for platinum-resistant patients and as another recommended regimen for platinum-sensitive patients. In addition, the American Society of Clinical Oncology (ASCO) has issued a strong recommendation for Imdelltra monotherapy in patients with recurrent disease after chemotherapy.Small cell lung cancer (SCLC) accounts for approximately 10-15% of all lung cancer patients and is characterized by rapid cancer cell proliferation, leading to widespread metastasis within a short period. It is known that 6 to 7 out of 10 patients are diagnosed at the extensive stage, where cancer cells have metastasized to the contralateral lung or distant organs.Current treatment options for extensive-stage SCLC are limited, primarily consisting of chemotherapy and immunotherapy. Therapeutic choices become even more restricted beyond third-line treatment. Although initial response rates to chemotherapy are relatively high, responses are often short-lived, with rapid disease progression. Particularly in refractory or resistant patients whose disease progressed within 6 months after the last chemotherapy treatment, the response rate to conventional chemotherapy drops below 10%, underscoring the substantial unmet need for new treatment options.
- Company
- 'Fintepla' reduces seizure freq…treating Dravet syndrome"
- by Son, Hyung Min Feb 06, 2026 06:43am
- Changes are emerging in the treatment landscape for Dravet syndrome, an ultra-rare pediatric refractory disease. With the domestic approval of a serotonin-based novel drug that has demonstrated efficacy in reducing seizure frequency, expectations are high for a shift in the treatment paradigm for an area with significant unmet medical needs.On the 4th, UCB Korea held a press conference at the Plaza Hotel in Jung-gu, Seoul, to celebrate the approval of 'Fintepla (fenfluramine),' a treatment for Dravet syndrome, in Korea.Professor Hunmin Kim of Seoul National University Bundang Hospital Fintepla was designated as a drug for the second pilot project of the 'Approval-Evaluation-Negotiation Linkage System' in December 2024. This drug was officially approved in Korea last December, one year after its designation.The specific indication is an add-on therapy for the treatment of seizures in patients with Dravet syndrome aged 2 years and older. Given the nature of pediatric patients who may have difficulty swallowing pills, Fintepla is formulated as a syrup.Fintepla is a treatment that reduces seizures by stimulating multiple 5-HT receptor subtypes through serotonin release. It can decrease a patient's seizures through a dual mechanism that simultaneously activates serotonin receptors and sigma-1 receptors.Fintepla's clinical value was demonstrated in three randomized Phase 3 trials (STUDY 1–3).The analysis results of STUDY 1, which initially enrolled 119 patients, and STUDY 3, which included subsequently recruited patients, showed that the monthly average convulsive seizure frequency (MCSF) in the Fintepla-treated groups decreased by 62.3% and 64.8%, respectively. Notably, near-complete seizure freedom was confirmed only in the Fintepla-treated group.In STUDY 2, which consisted of a 6-week baseline, 3-week titration, and 12-week maintenance period for a total of 15 weeks, patients were randomly assigned 1:1 to either Fintepla or a placebo as an add-on to the existing standard of care, stiripentol (+ clobazam and/or valproate).In that study, the proportion of patients who showed a 50% or greater reduction in MCSF from baseline was 53.5% in the Fintepla combination group, compared with only 2% in the placebo group.In a 3-year open-label extension study, the reduction in seizure frequency with Fintepla was maintained. 64.2% of all patients showed a 50% or greater decrease in MCSF from baseline.In terms of safety, 216 patients with Dravet syndrome who received Fintepla showed a similar adverse event profile. The most commonly reported adverse events were decreased appetite (34.7%), diarrhea (19.9%), fatigue (19.0%), fever (18.7%), reduced blood glucose (14.4%), and somnolence (13.9%).Professor Hunmin Kim of Seoul National University Bundang Hospital explained, "Fintepla is a treatment that has consistently proven its seizure control effect and therapeutic value in multiple clinical trials, despite the difficult environment for patient recruitment due to the nature of ultra-rare pediatric severe refractory diseases."Professor Kim added, "Not only the mortality rate due to sudden death but also the all-cause mortality rate appeared lower in the Fintepla-treated group compared to values reported in existing literature."Limited treatment environment for Dravet Syndrome... Expectations↑ with new treatment optionProfessor Hoon-Chul Kang of the Department of Pediatric Neurology at Severance Children's HospitalDravet syndrome is a type of pediatric epilepsy that occurs in infancy. According to experts, the majority (80%) of this disease is caused by a mutation in the SCN1A gene.The disease develops around 12 months of age, and up to 15% of patients die during early childhood or adolescence. Dravet syndrome patients are at high risk for physical and mental comorbidities, such as physical stiffness, language development disorders, autism, intellectual disability, and ADHD.Caregivers also endure high caregiving stress and low quality of life due to 24-hour care burdens, career interruptions, and loss of income.Frequent long-term seizures in Dravet syndrome patients not only lower the quality of life for both patients and caregivers but also carry a risk of Sudden Unexpected Death in Epilepsy (SUDEP). Therefore, the primary goal of treatment is to reduce or stop seizures.However, existing anti-epileptic drugs have limitations in controlling seizures, and some medications can even worsen them, leaving a significant unmet need in the domestic treatment environment.Professor Hoon-Chul Kang of the Department of Pediatric Neurology at Severance Children's Hospital stated, "Treatment for Dravet syndrome should aim beyond reducing seizure frequency to managing non-seizure comorbidities and minimizing drug side effects, but this has been difficult to achieve in the current treatment environment."Professor Kang emphasized, "There is an unmet need for treatment options that can more effectively control seizures, reduce cognitive decline and long-term disability, and improve the quality of life for patients and caregivers. Fintepla functions to prevent seizures. Seizure-freedom effects can also be expected. As it works differently from existing drugs, expectations are high."
- Company
- Kwangdong and MSD form pneumococcal vaccine alliance
- by Hwang, byoung woo Feb 05, 2026 07:48am
- The vaccine alliance between Kwangdong Pharmaceutical and MSD Korea is expanding into the adult pneumococcal market. Beyond their HPV vaccine collaboration, the partnership now includes the adult-specific 21-valent pneumococcal vaccine, marking an evolution in the companies' preventive portfolio partnership.Kwangdong Pharmaceutical is shifting its business focus toward prescription pharmaceuticals and vaccines by extending its existing vaccine sales infrastructure into the adult preventive care domain.On the 4th, Kwangdong Pharmaceutical announced that it had entered into a domestic co-promotion agreement with MSD Korea for Capvaxive, an adult-only 21-valent pneumococcal protein-conjugated vaccine. The two companies will jointly handle domestic marketing and distribution of Capvaxive starting from its launch in the first quarter of 2026.This collaboration builds on the partnership established through the co-promotion of the HPV vaccines Gardasil and Gardasil 9, which the two companies have jointly marketed and distributed in Korea since 2024.Given their existing cooperative relationship, the combination of Kwangdong’s sales infrastructure and MSD’s global vaccine portfolio is expected to generate significant synergies in the adult prevention market.Adult-only 21-valent design… broader serotype coverage expands protectionCapvaxive is a newly designed vaccine aimed at preventing invasive pneumococcal disease (IPD) and pneumococcal pneumonia in adults. It reflects the latest epidemiological characteristics of adult pneumococcal disease to address unmet needs.It prominently features the addition of eight unique serotypes—15A, 15C (deOAc15B), 16F, 23A, 23B, 24F, 31, and 35B—providing the broadest serotype coverage among currently approved pneumococcal protein-conjugated vaccines in Korea.According to the Ministry of Food and Drug Safety (MFDS) approval, Capvaxive is indicated for the prevention of invasive disease and pneumococcal pneumonia caused by pneumococcal serotypes (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) in adults aged 18 years and older.Having accumulated over 25 years of experience supplying pneumococcal vaccines to adults in Korea, MSD Korea plans to fully implement adult-tailored prevention strategies through this partnership.The company stated that it will work with Kwangdong Pharmaceutical to ensure that more adults benefit from expanded serotype-based protection.The current direct competitor is Pfizer's 20-valent pneumococcal protein-conjugated vaccine, Prevnar 20.With Chong Kun Dang handling domestic sales for Prevnar 20 for adults, marketing competition between the co-promotion partners is expected to intensify.For Kwangdong Pharmaceutical, the agreement represents more than a simple product addition, as it represents part of its broader effort to build experience in the vaccine business.Having already established preventive vaccine sales and marketing systems through the co-promotion of Gardasil and Gardasil 9, the company is now positioned to extend that infrastructure to adult pneumococcal vaccines.Sung-won Choi, CEO of Kwangdong Pharmaceutical, said, “This collaboration will further strengthen our vaccine portfolio and establish a foundation to address broader preventive healthcare needs. Leveraging our differentiated sales infrastructure and expertise, we will support the successful market entry of Capvaxive and continue to enhance our competitiveness in the domestic vaccine market.”Industry observers view this collaboration as an extension of Kwangdong Pharmaceutical’s ongoing strategic shift.While maintaining stable cash flows from its beverage and OTC businesses, the company is increasingly expanding its portfolio into high-value-added areas such as prescription drugs and vaccines.According to the recently disclosed quarterly report (cumulative for Q3 2025), Kwang Dong Pharmaceutical's sales structure is gradually shifting toward a pharmaceutical-centric portfolio.Reviewing sales and order status, the combined sales of prescription drugs (ETC) and vaccines reached KRW 140.5 billion. This represents approximately 18.3% of the company’s total revenue (KRW 768.5 billion).
