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- 2026-04-29 06:35:14
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- K-medical devices sweep CES2026…'Physical AI'
- by Hwang, byoung woo Dec 31, 2025 07:49am
- Korea's medical device companies will participate in world's largest IT and consumer electronics show 'CES2026,' scheduled to kick off on January 6 (local time) next year.Source: CES websiteAnalysis suggests that the emergence of 'Physical AI', where AI integrates with physical bodies and medical procedures rather than remaining a mere hardware display, is evaluated to have elevated the status of K-medical devices to a new level.According to the 'CES 2026 Preview' report published by the Korea Trade-Investment Promotion Agency (KOTRA), the core shift in this year's CES is the evolution of AI toward combining with physical environments beyond the virtual world. The digital health and medical device industries are at the forefront of this trend.Digital health, Ranked No. 1 in CES trends... The transformation of a 'Consumer Electronics Show'CES is the world's largest tech exhibition, visited by over 180,000 people from 170 countries annually. It serves as a global stage that concentrates the flow of future technologies, including AI, digital healthcare, mobility, and smart homes.In particular, this year's CES is expected to feature medical AI with high utility in clinical settings, automation-based diagnostic technologies, and innovations in women's health as major themes.According to KOTRA's analysis of industry trends for CES 2026, the digital health sector recorded the highest growth rate among all industry groups, with the number of participating companies increasing by approximately 7.4% year-over-year. This is a signal that CES, which once centered on smartphones and TVs, is shifting its center of gravity toward the medical and healthcare sectors.Furthermore, 'Clinical Decision Support Systems (CDSS)', where AI assists in diagnosis and treatment decision-making beyond simple monitoring, and precision medicine have emerged as key keywords. Analysis suggests that the expansion of data infrastructure and the advancement of AI have brought personalized medical solutions into the reality.Korea accounts for 60% of Innovation Award Winners, with the second-largest number of participating companiesThe progress of Korean companies is particularly outstanding in CES 2026.Among the 284 companies receiving Innovation Awards, 168 are Korean companies, accounting for approximately 60% of the total. After maintaining the status as the country with the most awards for three consecutive years, Korea has further expanded its market share.At CES 2026, KOTRA will operate a unified Korea Pavilion comprising 470 companies in cooperation with 38 related organizations and local governments.This is highly regarded as a 'practical export platform' aimed at connecting with global medical institutions, insurers, and partners, moving beyond a simple exhibition.'Non-invasive·Personalized' treatment areas..focus on the expansion of diagnostic technologyFirst, in the field of treatment, non-invasive and personalized were presented as core trends.Gbrain, a two-time Innovation Award winner, highlighted its competitiveness in the invasive Brain-Computer Interface (BCI) field with a fully implantable brain stimulation system for treating brain diseases such as Parkinson's.The device, in which AI analyzes brainwaves in real-time to adjust stimulation, is cited as an example demonstrating the clinical applicability of BCI technology.The keywords for this year's CES are artificial intelligence (AI), robotics, and digital health.EverEx, a digital rehabilitation solution company, drew attention with its 'MORA' platform, which supports rehabilitation based on smartphone cameras without requiring separate equipment. Currently, predictive AI-based rehabilitation is being evaluated as a potential alternative to address medical personnel shortages and cost issues.In the diagnostic field, liquid biopsy and on-device AI technology have emerged.Exopert will showcase an automated early-stage multi-cancer detection platform based on exosome analysis, while Noul plans to present the possibility of automating field diagnostics through its cervical cancer Point-of-Care (PoC) diagnostic solution.By participating in CES, Noul expects to accelerate business development in North America and Latin America, its current areas of focus.Additionally, technologies such as SevenPointOne's voice-based brain health check 'AlzWIN' and WIRobotics' walking assist robot 'WIM S' will showcase technologies that accelerate 'digital transformation' by extending the scope of diagnosis from hospitals to daily life.Wontech presented a total healthcare strategy combining non-contact vital sign measurement and pain treatment devices, while An&Luck proposed an aging response model through a community-integrated care platform. This demonstrates that strategies combining services and platforms are becoming full-scale, moving beyond individual hardware products.The industry views CES 2026 as a turning point where Korean medical devices transition from manufacturing competition to a software- and solution-centered industry.A medical device industry official stated, "The growth indicators for digital health identified at CES are a signal of the competition for global leadership. The next task is to translate these achievements into results through North American regulatory approvals and entry into insurance reimbursement."
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- Adoption of pulsed field ablation gains momentum in Korea
- by Hwang, byoung woo Dec 30, 2025 07:22am
- PFA at Asan Medical CenterThe treatment paradigm for atrial fibrillation (AF) is rapidly shifting from conventional thermal ablation techniques to the non-thermal approach of pulsed field ablation (PFA).Global medical device companies are sequentially entering the Korean market, signaling the beginning of an intense competition for market share.According to a report released by the Korea Health Industry Development Institute (KHIDI) on the 29th, the global PFA market size is projected to grow from approximately USD 1.5 billion (KRW 2.15 trillion) in 2024 to USD 9.2 billion (KRW 13.20 trillion) by 2029, representing a compound annual growth rate (CAGR) of around 41.1%.PFA emerges as the game changer... strengths in safety and procedure efficiencyPFA utilizes the principle of ‘irreversible electroporation (IRE)’, which uses a high-voltage electric field to create microscopic pores in cell membranes.Unlike radiofrequency ablation (RFA) or cryoballoon ablation (CBA), which rely on thermal energy and carry risks such as esophageal injury and phrenic nerve palsy, PFA is evaluated as reducing major complications associated with conventional ablation, such as esophageal injury, phrenic nerve damage, and pulmonary vein stenosis.Clinical data also support this. Results from the ADVENT clinical trial involving 607 patients demonstrated PFA's 12-month treatment success rate of 73.3%, demonstrating non-inferiority compared with conventional thermal ablation techniques (71.3%).Notably, the incidence of pulmonary vein stenosis was just 0.9% in the PFA group, compared with 12% in the conventional ablation group, and no cases of esophageal damage were reported.Building on these strengths, market penetration in Korea is expected to accelerate. The domestic PFA market is projected to grow at an average annual rate of 11.1%, expanding from approximately USD 31 million (KRW 42 billion) in 2024 to USD 53 million (KRW 72 billion) by 2029.Market size and growth rate of PFA in KoreaGlobal “Big 3” secure Korean approvals… adoption accelerates at tertiary hospitalsThe Korean PFA market is currently shaping up as a three-way competition among Boston Scientific, Medtronic, and Johnson & Johnson (J&J).Boston Scientific took the lead with its FARAPULSE platform, obtaining catheter approval in April 2024 and generator approval in September.Following Korea’s first successful PFA procedure at Severance Hospital in December last year, the number of adopting hospitals is rapidly increasing.J&J’s VARIPULSE system received catheter approval in August 2024 and emphasizes its fully integrated workflow with its proprietary 3D mapping system, CARTO 3, as a key competitive advantage.Medtronic's ‘PulseSelect’ followed suit, entering the fray in January 2025 with Class III medical device approval for its integrated catheter and generator system.The company has further strengthened its lineup with the Sphere-9 catheter, capable of high-density mapping and dual RF/PF ablation.Major global medical device companies' PFA approval status“Clear clinical value”…but reimbursement remains the key to wider adoptionClinicians have expressed positive views on PFA adoption.Professor Boyoung Joung of the Cardiology Department at Severance Hospital stated, “PFA cuts procedure time by nearly half compared to conventional methods while significantly reducing complication risks, leading to high satisfaction among both physicians and patients. Currently, about 35% of atrial fibrillation ablation procedures at Severance Hospital are performed using PFA, and this proportion is expected to continue rising.”According to an analysis of real-world data (RWD)-based cost outcomes collected from hospitals in Belgium, Germany, and the Netherlands, the direct costs per patient during the initial procedure (including personnel, time, anesthesia, tests, hospitalization, etc.) were 22% lower than CBS and 35% lower than RFA.From the patient perspective, while immediate cost savings were modest, cumulative reductions were observed over time due to fewer repeat procedures and lower complication management costs.However, regulatory hurdles remain. Although PFA passed the New Health Technology Assessment in December last year, it has yet to be listed for reimbursement, pending inclusion in the National Health Insurance reimbursement list. Currently, whether a patient has indemnity health insurance significantly influences their choice.An industry insider commented, “In markets such as the U.S., PFA already accounts for over 70% of all ablation procedures and has effectively become the standard of care. Given its proven efficiency and safety, reimbursement and other institutional support in Korea would significantly accelerate the pace of market transition.”
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- Bimzelx indication expanded to inflammatory diseases
- by Son, Hyung Min Dec 30, 2025 07:22am
- The inflammatory disease treatment market, which had long been dominated by biologics such as Humira (adalimumab) and Cosentyx (secukinumab), is showing signs of significant change. Competition is intensifying as not only biologics but also Janus kinase (JAK) inhibitors and next-generation targeted therapies are successively expanding their indications.UCB Pharma's ‘Bimzelx’According to industry sources on the 30th, the Ministry of Food and Drug Safety (MFDS) has approved Bimzelx (bimekizumab) for 3 additional indications: ▲psoriatic arthritis, ▲axial spondyloarthritis, and ▲hidradenitis suppurativa.Bimzelx is the first and only biologic that simultaneously inhibits interleukin-17A and interleukin-17F. It received its initial domestic approval in August last year for the treatment of plaque psoriasis.This approval for psoriatic arthritis is based on results from two Phase III clinical trials: the BE OPTIMAL study in biologic-naive patients and the BE COMPLETE study in patients who had inadequate response or intolerance to TNF-α inhibitors.In the BE OPTIMAL study, 44% of the Bimzelx group achieved the primary endpoint of ACR50 at week 16, showing a significant improvement compared to the placebo group (10%). In the BE COMPLETE study, 43% of the Bimzelx group achieved ACR50, and 27% achieved ACR70. No new safety signals were observed in either study.The axial spondyloarthritis indication was approved based on the results of two parallel Phase III clinical trials: BE MOBILE 1 in non-radiographic patients and BE MOBILE 2 in radiographic patients.In the studies, the 16-week ASAS40 response rates in the Bimzelx group were 48% and 45%, respectively, significantly higher than in the placebo group (21% and 23%). Responses were observed within 1 to 2 weeks after the first dose, and the response rate continued to increase through week 24. Patients who switched from placebo to Bimzelx also showed similar response rates at week 24. No new adverse reactions were identified in terms of safety.The hidradenitis suppurativa indication was approved based on two Phase III clinical trials, BE HEARD 1 and 2, conducted in moderate-to-severe patients. The proportion achieving HiSCR50 at week 16 was 48% and 52% in the Bimzelx groups, respectively, significantly higher than the placebo groups (29%, 32%).The more stringent HiSCR75 responses were also higher in the Bimzelx group at 33% and 36%, respectively, compared to placebo. These benefits were maintained or further improved through 48 weeks, with meaningful improvements observed in quality-of-life measures such as DLQI. An integrated long-term extension analysis confirmed sustained efficacy and safety over two years.New competitors enter the field… Potential of TYK2-targeted novel drugs draws attentionWith the expansion of Bimzelx’s indications, competition with existing biologics and JAK inhibitors has become inevitable. Current competitors with overlapping indications include major biologics and JAK inhibitors like Novartis’s Cosentyx, AbbVie’s Humira and Rinvoq (upadacitinib), and Johnson&Johnson’s Stelara (ustekinumab).BMS’s ‘Sotyktu’The rapid advancement of new TYK2 inhibitors is also noteworthy. Currently, BMS's ‘Sotyktu (deucravacitinib)’ has only secured approval for plaque psoriasis in Korea. BMS has completed clinical trials for psoriatic arthritis and is awaiting regulatory review in the US.Unlike JAK inhibitors, TYK2 inhibitors selectively suppress the TYK2 protein, blocking only signaling in the IL-12, IL-23, and Type I interferon pathways. This allows for safer treatment while regulating immune responses, making them a point of interest.Among existing biologics, IL-17 inhibitors have faced concerns about exacerbating inflammatory bowel diseases like ulcerative colitis or Crohn's disease and causing oral candidiasis. While IL-23 inhibitors showed no prominent adverse reactions, concerns exist regarding injection site pain or discomfort and upper respiratory tract infections. This is one reason new treatment options are gaining attention.Competition among latecomers is also inevitable.Takeda’s zasocitinib is regarded as one of the most advanced TYK2 inhibitors following Sotyktu. Its commercial potential was confirmed in a Phase IIb clinical trial published last year in the medical journal JAMA.This study randomly assigned 259 participants to receive one of four daily oral doses of zasocitinib (2mg, 5mg, 15mg, or 30mg) or placebo for 12 weeks.Clinical results showed a dose-dependent response to zasocitinib. The proportion of patients achieving a Psoriasis Area and Severity Index (PASI) 75 (75% or greater improvement in skin condition) was 18%, 44%, 68%, and 67% in the respective dose groups, significantly higher than the 6% in the placebo group. Furthermore, no serious safety concerns were reported in this study, indicating that zasocitinib has a favorable safety profile.Takeda is actively developing zasocitinib for indications beyond psoriasis and is also pursuing approval for psoriatic arthritis. Furthermore, Takeda is conducting Phase II studies for moderate-to-severe active Crohn's disease and ulcerative colitis, and is planning studies for systemic lupus erythematosus, exploring the potential of zasocitinib in other immune-mediated diseases.
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- K-made new drug production reached KRW 800B
- by Chon, Seung-Hyun Dec 30, 2025 07:01am
- Last year, the production amount of domestically developed new drugs in South Korea was the highest in history. With a variety of hit products having been introduced to the prescription market, the production growth rate has neared 50% over the past two years. Annual production for HK inno.N's K-CAB, Daewoong Pharmaceutical’s Fexuclue, and Yuhan Corporation’s Leclaza each surpassed KRW 100 billion. Additionally, three domestically developed new drugs passed commercialization hurdles this year. This year has seen the highest output of new drugs in four years since 2021.Korea-made new drug production amounted to KRW 794.6B, up 47% in 2 years...K-CAB first to surpass KRW 200BAccording to the Ministry of Food and Drug Safety (MFDS) on December 30, domestically developed new drugs combined for a total production value of KRW 794.6 billion last year. This represents a 16.1% increase from the KRW 684.6 billion recorded in 2023, the highested in history. Compared to the 2022 production figure of KRW 540.5 billion, the sector has expanded by 47.0% in just two years.2024 Production Amount of Domestically Developed New Drugs in South Korea(unit: number of items, sources: MOHW, MFDS): (from top) K-CAB, Fexuclue, Leclaza, Pelubi, Kanarb, Zemiglo, Noltec, Duvie, Suganon, Envlo, Supect, Rolontis, Zydena, Pyramax, Mvix, Jaqbo, Besivo, Factive, Easyef SOLN, RG-Q, RevanexK-CAB, Fexuclue, and Leclaza represent key commercial successes among Korea-made drugs, each recording annual production exceeding KRW 100 billion.HK inno.N's K-CAB recorded the highest production last year at KRW 231.0 billion. K-CAB is the first potassium-competitive acid blocker (P-CAB) developed by a Korean company for the treatment of gastroesophageal reflux disease (GERD). K-CAB recorded production performance of KRW 171.9 billion in 2022 and KRW 173.9 billion in 2023. Last year, its production increased by 32.8% year-on-year, surpassing the KRW 200 billion mark. K-CAB is the first domestically developed new drug to exceed KRW 200 billion in annual production.K-CAB continues its high growth by highlighting advantages such as a faster onset of action compared to conventional proton pump inhibitor (PPI) products and the ability to be taken regardless of mealtime. In addition to the tablet form, two types of orally disintegrating tablets (ODT) have also been approved. KRW 28.2 billion-worth ODT formulation was produced last year.The production of Daewoong Pharmaceutical's GERD treatment, Fexuclue, reached KRW 118.1 billion last year, a 66.0% increase from the previous year. Fexuclue is a P-CAB class treatment similar to K-CAB. It received marketing authorization in December 2021 and began full-scale sales in July 2022 upon being listed on the national health insurance (NHI) reimbursement list.Fexuclue rapidly penetrated the market by demonstrated excellence in areas such as ▲rapid onset of action ▲fast and superior symptom improvement ▲ effective nighttime symptom relie ▲dosing convenience ▲low drug-drug interactions and consistent efficacy. Fexuclue's production was KRW 27.4 billion in its launch year (2022), then rose sharply to KRW 71.2 billion in 2023, and surpassed KRW 100 billion last year.Yuhan Corporation's Leclaza recorded a production value of KRW 105.8 billion last year. Leclaza is a treatment for non-small cell lung cancer (NSCLC) approved in January 2021 as Korea's 31st domestically developed new drug. Leclaza entered the prescription market following its listing on the NHI reimbursement list in July 2021.Leclaza's initial production in 2021 was KRW 9.8 billion, which expanded to KRW 39.3 billion in 2022. It surpassed the KRW 100 billion in 2023 with KRW 112.2 billion in production, only three years after launch, and has maintained production levels above KRW 100 billion for two consecutive years.Analysis suggests that the surge in demand is due to the expanded scope of NHI reimbursement for Leclaza as a first-line treatment. Leclaza was initially approved as a second-line treatment for locally advanced or metastatic NSCLC with specific gene (T790M) resistance following the administration of 1st or 2nd generation EGFR Tyrosine Kinase Inhibitors (TKIs). In June 2023, the MFDS approved changes of approval for Leclaza to include the 'first-line treatment of NSCLC'. Since January of last year, scope of reimbursement was expanded to include the 'first-line treatment of locally advanced or metastatic NSCLC with specific genetic mutations'.These three new drugs, K-CAB, Fexuclue, and Leclaza, combined for a total production of KRW 454.9 billion last year. They accounted for 57.3% of the total production value of all domestically developed new drugs, leading the commercial success of the sector.The production of Daewon Pharmaceutical's analgesic drug Pelubi reached KRW 76.9 billion last year, a 58.3% increase year-on-year. Approved in 2007 as Korea's 15th new drug, Pelubi is a non-steroidal anti-inflammatory drug (NSAID) with indications for osteoarthritis, rheumatoid arthritis, low back pain, and fever reduction in acute upper respiratory infections. Pelubi’s production surged as its prescription volume expanded significantly through the COVID-19 pandemic and endemic phases.Boryung's hypertension treatment Kanarb, LG Chem's diabetes treatment Zemiglo, and Il-Yang Pharm's anti-ulcer agent Noltec all recorded production values exceeding KRW 50 billion last year.Products recording over KRW 10 billion in production last year included Chong Kun Dang's diabetes treatment Duvie, Dong-A ST's diabetes treatment Suganon, Daewoong Pharmaceutical's diabetes treatment Envlo, Il-Yang Pharm's leukemia treatment Supect, and Hanmi Pharmaceutical's neutropenia treatment Rolontis. Of the 38 new drugs approved through last year, 21 products recorded production figures. Approximately half of the new drugs approved by the MFDS were found to have no production.Three Korea-made new drugs approved this year…highest since 2021This year, three domestically developed new drugs, GC Biopharma's Barythrax, Medytox's Nuviju, and Dong-A ST's Xcopri, received marketing authorization.List of Newly Approved Domestically Developed Drugs: 1. Sunpla Inj (SK Chemicals) 2. Easyef SOLN (Daewoong Pharmaceuticals) 3. Milican inj (Dong Wha) 4. Q-roxin Tab (JW Pharmaceutical) 5. Factive Tab (LG Chem) 6. Apitoxin Inj (BCWORLD PHARM) 7. Pseudobaccine (CJ CheilJedang) 8. Camtobell (Chong Kun Dang Pharm) 9. Revanex (Yuhan Corp) 10. Zydena (DONG-A ST) 11. Levovir (Bukwang Pharm) 12. Pelubi (Daewon Pharm) 13. Mvix (SK Chemicals) 14. Noltec Tab (IL-YANG PHARM) 15. Kanarb Tab (Boryung) 16. Pyramax Tab (SHIN POONG PHARM) 17. Zepeed Tab (JW Pharmaceutical) 18. Supect Capsule (IL-YANG PHARM) 19. Zemiglo (LG Chem) 20. Duvie Tab (Chong Kun Dang Pharm) 21. RIAVAX (GemVax & KAEL) 22. Acelex Cap (CrystalGenomics) 23. Zaborlante Tab (Dongwha Pharm) 26. Suganon tab (DONG-A ST) 27. Olita Tab (Hanmi Pharm) 28. Besivo Tab (Ildong Pharmaceutical)29. Alzavue Inj (Future Chem) 30. K-CAB (HK inno.N) 31. Leclaza (YUHAN Corp) 32. Regkirona Inj (CELLTRION) 33. Rolontis (Hanmi Pharm) 34. Fexuclue Tab (Daewoong Pharmaceuticals)35. SkyCovione Multi Injection (SK bioscience) 36. Envlo (Daewoong Pharmaceuticals)37. JAQBO Tab (Onconic Therapeutics) 38. Unafra Inj (VIVOZON PHARMACEUTICAL)39. Barythrax (Green Cross) 40. NUVIJU Inj (Medytox) 41. Xcopri tab (DONG-A ST).In April, GC Biopharma's recombinant anthrax vaccine, Barythrax, was approved as Korea's 39th new drug. Barythrax is a vaccine designed for the pre-exposure prophylaxis of anthrax in adults. It uses recombinant technology to manufacture the protective antigen (PA) protein, a major component of the anthrax toxin, to induce antibodies that prevent infection. Barythrax was co-developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA) and was approved 18 months after the application was filed in October 2023.In September, Medytox's Nuviju was approved as the 40th domestically developed new drug. Nuviju is a treatment that reduces submental subcutaneous fat by inducing adipocyte lysis through the disruption of the cell membrane's lipid bilayer via surfactant action. It is approved for adult patients seeking to improve moderate to severe submental fullness or excessive fat. Nuviju is Medytox's first chemical drug and the world's first next-generation fat-dissolving injectable developed with cholic acid as the main ingredient. Cholic acid is a type of bile acid synthesized in the liver and secreted into the bile.This year, the highest number of domestically developed new drugs reached the commercialization stage in four years, following the four drugs approved in 2021. In 2021, Yuhan Corporation's oncology drug Leclaza, Celltrion's COVID-19 treatment Regkirona, Hanmi Pharmaceutical's neutropenia treatment Rolontis, and Daewoong Pharmaceutical's GERD treatment Fexuclue obtained new drug approval.
- Company
- Introduction of new PNH drugs…expanding competition landscape
- by Son, Hyung Min Dec 30, 2025 07:00am
- The competition landscape for Paroxysmal Nocturnal Hemoglobinuria (PNH) treatment market in South Korea has intensified with the introduction of a new C5 complement inhibitor.The market, which was dominated by AstraZeneca's C5 inhibitors 'Soliris (eculizumab)·Ultomiris (ravulizumab)', is expected to see full-scale competition from new mechanism treatments, including C3·Factor B·Factor D inhibitors. Industry observers anticipate that the key criteria for selecting PNH treatments will shift from mechanism alone to factors such as administration convenience, including dosing intervals and formulations.Roche's PNH treatment 'Piasky (crovalimab)'According to industry sources on December 27, the Ministry of Food and Drug Safety (MFDS) approved Roche's PNH treatment, 'Piasky (crovalimab)', on December 24. Piasky is a C5 complement inhibitor developed by Roche. This drug works by administering a low dose subcutaneously (SC) every 4 weeks, which then recirculates in the blood to inhibit complement activity continuously.Piasky obtained U.S. FDA approval in June last year and was commercialized in Europe in August of the same year. In South Korea, it was designated as an orphan drug in February of last year.The basis of approval is the results of the Phase 3 COMMODORE 2 study. COMMODORE 2 was a randomized, open-label, active-controlled non-inferiority trial comparing Piasky directly with the current standard of care, AstraZeneca's Soliris, in PNH patients aged 13 and older weighing at least 40 kg.The primary endpoints of the trial were transfusion avoidance and hemolysis control rates. The secondary endpoints included breakthrough hemolysis, hemoglobin stabilization, changes in fatigue, and safety.In the studies, the hemolysis control rate from week 5 to week 25 was 79.3% in the Piasky group and 79.0% in the Soliris group, successfully meeting the criteria for non-inferiority.The proportion of patients who avoided red blood cell transfusions from baseline to week 25 was also similar, at 65.7% and 68.1%, respectively. The incidence of breakthrough hemolysis tended to be lower in the Piasky group (10.4%) than in the control group (14.5%), and there was no significant difference between the two groups in the proportion of patients maintaining stable hemoglobin levels.In terms of safety, the Piasky group had an approximately 6% incidence of serious adverse events, with epistaxis, pneumonia, and infusion-related reactions as the primary reports. The overall adverse event profile was similar to that of existing C5 inhibitors.C3 and Factor B...Competition over 'Mechanism + Convenience' begins in full-scaleFollowing the domestic approval of Piasky, the PNH treatment market is expected to shift from the existing C5-inhibitor-dominated structure into a phase of competitive diversification in mechanisms.PNH is a rare disease caused by acquired genetic mutations. While multiple mutations in hematopoietic stem cells can lead to blood cancers, PNH occurs when a mutation develops in the X-linked PIGA gene.PNH is reportedly a disease without a fundamental cure. However, with scientific advances, the development of treatments that inhibit complement activation is changing the therapeutic approach. The complement system is a core element of innate immunity, a robust defense that directly attacks and destroys pathogens. This system consists of various pathways, such as C3 and C5, and ultimately forms the membrane attack complex (MAC) to destroy red blood cells.Until now, treatments inhibiting C5, located at the terminal pathway of the complement system, have been primarily used. The treatment environment improved with the introduction of Soliris, an injectable administered every two weeks, followed by Ultomiris, which can be administered every eight weeks. Many patients still manage the disease based on these treatments.Recently, the competitive axis has widened with the addition of Handok's C3 inhibitor 'Empaveli (pegcetacoplan)', Novartis's Factor B inhibitor 'Fabhalta (iptacopan)', and AstraZeneca's Factor D inhibitor 'Voydeya (danicopan)'. Each drug targets a different stage in the complement system. They have been designed to employ strategies to address unmet needs, such as extravascular hemolysis (EVH), may persist even after C5 inhibition.From left, PNH treatments 'Empaveli (pegcetacoplan)', 'Fabhalta (iptacopan)', 'Voydeya (danicopan)'Analysts suggest that the future market landscape will likely be driven more by administration convenience than by differences in efficacy.The dosing structure of Voydeya is complex requiring co-administration with a C5 inhibitor. However, it offers the advantage of potentially easier compliance management.For Fabhalta, its oral formulation is a strength, offering greater dosing convenience than injectables. This treatment is particularly effective for treating anemia and EVH.Empaveli poses burden of twice-weekly subcutaneous injections, but it remains an option for patients who can expect clinical effects from direct inhibition at the C3 stage. Experts evaluate it as a sufficiently effective option for patients who do not have a strong aversion to injections.Empaveli was developed by the U.S. company Apellis Pharmaceuticals, while Swedish Orphan Biovitrum (Sobi) holds the rights outside the United States. Handok signed a strategic partnership agreement with Sobi in 2023 to introduce Empaveli into the Korean market.
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- Merz selected as SDGBI ‘Excellent Group’
- by Hwang, byoung woo Dec 30, 2025 07:00am
- Merz Aesthetics Korea announced on the 29th that it has been selected as an ‘Excellent Group’ in the ‘2025 Sustainable Development Goals Business Index (SDGBI).’Following its entry into the ‘Outstanding Group’ of the domestic SDGBI last year, the company advanced one step further this year to be named in the ‘Excellent Group.’The SDGBI is a management analysis index based on the UN SDGs (United Nations Sustainable Development Goals), published by the UN SDGs Association since 2016. It is a sustainable management analysis index used to measure corporate implementation of SDGs.The index evaluates companies across four sectors—social, environmental, economic, and institutional—using 12 criteria and 48 indicators. These include environmental initiatives, socioeconomic impact, governance and institutional improvements, ESG-related financial activities, and the establishment of innovative infrastructure.Reflecting the characteristics of the medical aesthetics industry, Merz has developed its own ESG Index, aligned with the UN SDGs, and practices ESG management from a structured, long-term perspective.The UN SDGs Association annually evaluates ESG management performance based on the ESG Index. Its results showed that Merz has solidified its ESG management foundation, achieving an overall ‘A’ rating in the environmental, social, and institutional categories for 2 consecutive years since 2023. This year, such an achievement led to its nomination in the SDGBI Excellent Group.In particular, Merz is known to have received high scores for strengthening supply chain sustainability and creating social value tailored to the medical aesthetics sector.Merz practices ESG management throughout its supply chain, including carbon emission reduction and waste management. By obtaining approval for room-temperature storage (1–25°C) of its products, Merz reduced energy consumption associated with cold-chain logistics while enhancing product stability during distribution.In addition, Merz introduced eco-friendly packaging, reducing box size by 34% to conserve resources and improve shipping efficiency, thereby lowering carbon emissions during transportation.The removal of plastic trays is expected to reduce global plastic usage by approximately 12.77 tons annually.To prevent medical device reuse and strengthen waste management, Merz has also operated the Ultherapy PRIME™ / Ultherapy ESG-Certified Clinic Campaign. This initiative expanded an existing used tip disposal campaign, implemented since 2018, into a broader ESG-driven program to encourage wider participation among hospitals and clinics.In the social domain, Merz has carried out various social contribution activities based on its corporate mission, “Look Better, Feel Better, Live Better.”From an organizational perspective, the company fosters an employee-centric culture and supports work–life balance through diverse internal programs. Structured capability development initiatives are provided to promote continuous growth, while the Merz Employee Council (MEC) plays a central role in strengthening employee-driven organizational culture, embedding ESG principles throughout the entire organization.Su-Yeon Yu, General Manager of Merz Aesthetics, said, “This nomination is the result of the responsible management practices Merz has consistently pursued, as well as the collective efforts of all our employees. We will continue to lead the medical aesthetics industry toward sustainability through differentiated ESG management as a trusted company.”
- Company
- Oral Wegovy enters market...prompts change in market strategy
- by Choi Da Eun Dec 29, 2025 08:54am
- The emergence of ‘oral Wegovy’ in the global obesity treatment market, which has long been dominated by injectable GLP-1 therapies, is expected to intensify competition for companies in Korea and abroad. Domestic pharmaceutical and biotech firms are shifting their development focus beyond simple formulation competition, eyeing niche strategies like muscle loss improvement.According to industry sources, Novo Nordisk's oral obesity treatment, Wegovy (semaglutide), received approval from the U.S. Food and Drug Administration (FDA) on the 22nd (local time).The oral version converts the company’s injectable GLP-1 class obesity therapy into a once-daily pill, eliminating key drawbacks of the injectable version, such as the need for refrigerated storage and the hassle of self-injection. Novo Nordisk plans to launch the product in the U.S. market in early January next year.Eli Lilly, which developed the GLP-1/GIP dual receptor agonist obesity drug Mounjaro, is also preparing to commercialize its oral GLP-1 therapy orforglipron. The company recently submitted a new drug application to the FDA, and industry observers expect a full-scale duopoly to emerge starting next year.The introduction of oral obesity drugs is widely seen as a potential game-changer for a market previously dominated by injectables. This is because it could significantly improve patient accessibility by reducing the psychological aversion to injections. Indeed, competition to develop oral GLP-1s is accelerating, particularly among global big pharma.Korean pharmaceutical companies are also developing GLP-1–based obesity drugs, but their commercialization timelines are likely to lag behind global frontrunners. As a result, incremental formulation improvements, as well as strategies aimed at reducing side effects associated with injectable or oral therapies, are gaining prominence. Approaches targeting multiple mechanisms beyond GLP-1 alone, such as inhibiting muscle loss and improving comorbid metabolic disorders, are also drawing attention.Daewoong Pharmaceutical is pursuing a non-injectable competitive edge with a microneedle patch-based obesity therapy. The microneedle patch reduces pain and needle phobia, allows room-temperature storage, and offers logistical advantages in distribution and handling. The absence of syringe waste is also cited as an additional benefit.A key feature of the microneedle patch is its potential to overcome the low bioavailability that has been a limitation of oral formulations. Oral drugs suffer significant peptide loss during passage through the digestive tract, requiring larger doses of active ingredients to achieve weight loss effects, which can increase the risk of side effects.According to human pharmacokinetic data released by Daewoong Pharmaceutical in August last year, the bioavailability of its microneedle patch was over 80% compared to injectables. This represents a significant improvement compared to the absorption rate of conventional patch formulations, which was around 30%.Hanmi Pharmaceutical has adopted a strategy to simultaneously improve muscle loss and gastrointestinal side effects, which are considered major limitations of GLP-1 class obesity drugs. The company is developing new drug candidates such as ‘HM15275’, which minimizes muscle loss while achieving weight loss effects, and ‘HM17321’, a muscle-increasing obesity treatment.Development of oral treatments is also active in Korea. However, as oral formulations are already well established in the global market, Korean companies are increasingly prioritizing early-stage technology licensing over direct competition with finished products. Some companies are concurrently pursuing joint development or license-out strategies targeting global pharmaceutical companies from the early clinical stages.Ildong Pharmaceutical's GLP-1 oral obesity treatment candidate ‘ID110521156’ showed an average weight loss of 9.9% and a maximum of 13.8% in the 200mg dose group in its Phase I clinical trial topline results. Weight loss effects of 5.5% and 6.9% on average over 4 weeks were also confirmed in the 50mg and 100mg dose groups, respectively. Based on these results, Ildong Pharmaceutical is preparing to enter global Phase II clinical trials and is targeting technology transfer to offset rising development costs at later clinical stages.DND Pharmatech is developing the oral GLP-1 drug ‘MET-002o’ based on its proprietary oral drug delivery platform ‘ORALINK’. Its partner company, Metsera, is conducting a Phase I clinical trial in North America.Industry expectations are growing for next-generation obesity therapies that go beyond simple weight-loss metrics to comprehensively address long-term use, side-effect management, and post-treatment weight regain.An industry official commented, “Convenience in administration has long been considered a key competitive factor in obesity therapies requiring long-term administration. The launch of oral Wegovy goes beyond a simple formulation change and improvements in efficacy and side effects. It is prompting Korean companies to fundamentally reassess their technology-licensing approaches and development strategies.”
- Company
- Reimb for Eylea expanded to 8mg formulation in KOR
- by Hwang, byoung woo Dec 29, 2025 08:54am
- Chong Kun Dang is expected to gain additional momentum in its clinic-focused sales strategy for Bayer’s macular degeneration treatment Eylea (aflibercept) following the expansion of its reimbursement coverage.According to Bayer Korea on the 26th, Eylea pre-filled syringe 8 mg (Eylea PFS 8mg) will be reimbursed by national health insurance starting January 1.Under the Ministry of Health and Welfare notification, reimbursement for Eylea PFS 8 mg applies to ▲ patients with subfoveal choroidal neovascularization due to age-related macular degeneration (AMD), ▲ diabetic macular edema (DME) patients with hemoglobin A1C (HbA1C) ≤10% and a minimum central retinal thickness ≥300µm.Eylea 8mg is a formulation with a molar dose four times higher than the existing Eylea 2mg, enhancing the duration of efficacy. It is administered monthly for the initial three months, after which the dosing interval can be extended up to 20 weeks based on the patient's condition.Notably, Eylea PFS 8mg incorporates the pre-filled syringe device ‘OcuClick’ technology. OcuClick is mechanically designed to precisely deliver the recommended dose (0.07ml) into the vitreous cavity, reducing procedure time for healthcare providers and minimizing administration errors.The reimbursement expansion is expected to positively impact Chong Kun Dang’s penetration into the clinic-level ophthalmology market.On the 16th, Chong Kun Dang and Bayer Korea signed a domestic distribution and sales agreement for Eylea. Under the agreement, Chong Kun Dang will exclusively handle sales, marketing, and distribution of the entire Eylea 2mg and 8mg product line in clinics.This partnership reflects the two companies’ aligned strategic interests.Chong Kun Dang aims to expand its existing lineup of ophthalmic products by leveraging the strong market position of Eylea, while Bayer expects synergies from Chong Kun Dang’s sales and marketing capabilities amid intensifying competition due to the emergence of biosimilars.Currently, three Eylea biosimilars are approved in Korea: ▲Samsung Bioepis' Afilivu, ▲Celltrion's Eydenzelt, and ▲Sam Chun Dang Pharm’s Vgenfli.Although Samsung Bioepis' Afilivu was the first to enter the market, its expansion stalled temporarily due to the aftermath of patent disputes. However, it recently won its appeal in the second trial and has now entered full-scale competition preparation.Celltrion's Eydenzelt is known to have gained a first-mover advantage in the market during Samsung Bioepis's patent dispute. Latecomer Sam Chun Dang Pharm is pursuing a lower drug pricing strategy compared to the other two companies.While Sam Chun Dang Pharm is adopting a direct sales strategy, Samsung Bioepis and Celltrion are targeting the domestic market through collaborations with Samil Pharmaceutical and Kukje Pharm, respectively.Chong Kung Dang – Bayer Korea’s Eylea co-promotion agreement signing ceremonyAgainst this backdrop, Bayer appears to have determined the need to partner with a domestic pharmaceutical company to strengthen its presence beyond tertiary hospitals and into clinics.Existing partnerships, including Bayer’s collaboration with Chong Kun Dang for Kerendia in chronic kidney disease with type 2 diabetes, likely influenced the decision.High-dose Eylea’s ability to extend dosing intervals up to 20 weeks may significantly reduce treatment burden for both physicians and patients in clinic settings.Young-joo Kim, CEO of Chong Kun Dang, stated, “Chong Kun Dang has already accumulated sales and marketing capabilities in ophthalmology based on a diverse product lineup. Leveraging our expertise and sales strength in ophthalmic diseases, we will actively promote Eylea's proven efficacy and safety to further expand its market presence.”JinA Lee, CEO of Bayer Korea, remarked, “Through our partnership with Chong Kun Dang, we aim to further enhance patient access to Eylea, which has led the anti-VEGF market for over a decade. Building on our strong collaboration, we will continue to deliver reliable treatment options to patients with retinal diseases and healthcare professionals in Korea, and consistently contribute to improving patients' quality of life.”
- Company
- ADC shows new potential in lung cancer
- by Son, Hyung Min Dec 29, 2025 08:54am
- An antibody-drug conjugate (ADC) targeting TROP-2 has confirmed new potential in non-small cell lung cancer. Amid repeated setbacks in lung cancer clinical trials involving major ADC candidates such as Trodelvy and Datroway, attention is focused on whether this achievement could mark a turning point for reevaluating TROP-2 ADCs.According to industry sources on the 29th, China's Sichuan Kelun Biotech, a partner of MSD, recently secured significant results in a Phase III clinical trial for first-line treatment of non-small cell lung cancer (NSCLC) using the TROP-2-targeted antibody-drug conjugate (ADC) ‘sasituzumab tirumotecan’ in combination with the immunotherapy drug 'Keytruda (pembrolizumab).MSD previously licensed the ADC candidate sacituzumab tirumotecan from Kelun Biotech in 2022.Sacituzumab tirumotecan consists of a ▲TROP-2–targeting monoclonal antibody, a ▲ topoisomerase-1 (TOP1) inhibitor payload, and a ▲ novel hydrolyzable linker. The ADC has a relatively high drug-to-antibody ratio (DAR) of approximately 7.4, designed to enhance intratumoral drug delivery.These results were derived from an interim analysis of the ongoing Phase III OptiTROP-Lung05 study conducted in China.OptiTROP-Lung05 compared the combination therapy of satisutuzumab tirumotecan and Keytruda versus Keytruda monotherapy in previously untreated non-small cell lung cancer (NSCLC) patients with a PD-L1 tumor proportion score (TPS) ≥1%.According to Kelun, the study met its primary endpoint of improved progression-free survival (PFS), with a positive trend also observed in overall survival (OS). The company plans to discuss regulatory approval for the lung cancer indication with Chinese regulatory authorities.This achievement is significant as it represents the first instance where a combination therapy of an ADC and an immuno-oncology drug has met the primary endpoint in a Phase III clinical trial for first-line non-small cell lung cancer. However, some note that caution is needed in its interpretation due to the study design, as Keytruda monotherapy, rather than the current global standard of Keytruda plus chemotherapy, was used as the control arm.The current global standard of care primarily involves Keytruda combined with chemotherapy, leading to an analysis suggesting that direct comparison data with combination chemotherapy is needed to clearly define its clinical position.Kelun and MSD are aggressively pursuing the expansion of sacituzumab tirumotecan’s lung cancer indications. In China, the ADC has already received approval for second-line treatment of EGFR-mutated NSCLC, marking its third approved indication within China alone. This approval was supported by Phase III data showing improvements in both PFS and OS versus chemotherapy. Nevertheless, because OptiTROP-Lung05 enrolled only Chinese patients, its applicability to global first-line lung cancer practice remains limited. MSD is therefore advancing a broader global development strategy, currently conducting over 10 registrational trials for sacituzumab tirumotecan, 5 of which are global Phase III studies. To date, MSD has not announced any official plans for a first-line NSCLC trial using Keytruda plus chemotherapy as the comparator.More refined patient-selection strategies are also underway. MSD’s TroFuse-007 trial is evaluating sacituzumab tirumotecan plus Keytruda versus Keytruda monotherapy in PD-L1 TPS ≥50% NSCLC patients. This patient group has historically been classified as having limited additional benefit from combination chemotherapy, making this trial a key test of the ADC combination strategy's distinctive benefit.MSD and Kelun aim to position sacituzumab tirumotecan as a “workhorse” within the TROP-2 ADC class. To support its development, MSD recently secured up to USD 700 million in funding through a royalty agreement with Blackstone.A history of setbacks for TROP-2 ADCs in lung cancerDespite the recent success, the prevailing industry view remains that TROP-2 ADCs still need to prove they can deliver consistent survival benefits in lung cancer.Indeed, given that TROP-2 ADCs from Gilead and AstraZeneca/Daiichi Sankyo previously suffered consecutive setbacks in lung cancer trials, whether sacituzumab tirumotecan can fully overcome this history of failure will be a key question moving forward.Gilead’s ‘Trodelvy’TROP-2 is a cell surface protein overexpressed in various epithelial-derived solid tumors, including triple-negative breast cancer. It is known to be involved in tumor proliferation, invasion, and metastasis. TROP-2 ADCs induce anticancer effects by selectively binding to cancer cells expressing this protein and delivering cytotoxic agents into the cells.However, unlike TROP-2 ADCs that have demonstrated efficacy and gained approval in breast cancer, they have repeatedly failed to prove effectiveness in lung cancer.Gilead’s Trodelvy (sacituzumab govitecan) achieved blockbuster status in triple-negative breast cancer but failed to replicate this success in lung cancer.The Phase III EVOKE-01 trial compared Trodelvy with docetaxel in patients with stage IV metastatic NSCLC who had received prior treatment. The primary endpoint was overall survival (OS).Ultimately, Trodelvy failed to achieve statistical significance in OS, only showing a trend toward efficacy in some secondary endpoints. Based on these results, Gilead halted its strategy to expand the indication into lung cancer.AstraZeneca and Daiichi Sankyo also faced similar challenges. Their jointly developed ‘Datroway (datopotamab deruxtecan)’ was seen as Daiichi Sankyo's second ambitious project after ‘Enhertu (trastuzumab deruxtecan),’ which reshaped the ADC market, but it failed to deliver expected results in lung cancer trials.ADC therapy ‘Datroway’The Phase III TROPION-Lung01 study compared datopotamab and docetaxel in a 1:1 ratio in patients with previously treated advanced or metastatic non-squamous NSCLC.The results showed improvement in progression-free survival (PFS) in some patient subgroups, but failed to demonstrate a significant difference in overall survival (OS). Notably, only limited efficacy was observed in the non-squamous patient subgroup, revealing limitations for expanding the indication.Based on these results, both companies withdrew their marketing applications in Europe following the withdrawal in the US. This decision followed pre-submission discussions with regulatory authorities, who determined the clinical significance was insufficient. Subsequently, AstraZeneca and Daiichi Sankyo are re-evaluating biomarker-based patient selection strategies and exploring potential combination therapies with targeted agents.Industry analysts attribute these failures to the limitation of directly applying the success formula that the companies experienced with breast cancer to lung cancer. Key factors cited include the high intratumoral heterogeneity in lung cancer and the less clear correlation between TROP-2 expression levels and treatment response compared to breast cancer. Additionally, managing cumulative toxicity with repeated dosing was also seen as a burden.Consequently, contrary to initial expectations that TROP-2 ADCs would be a universal platform expandable to all solid tumors, it is becoming clear that success varies dramatically depending on the specific indication. Against this backdrop, the recent confirmation of efficacy for sasituzumab tirumotecan in China is being viewed as a meaningful proof-of-concept that may reopen the door for TROP-2 ADCs in lung cancer.
- Company
- Preventive RSV antibody shot poised for NIP inclusion
- by Son, Hyung Min Dec 26, 2025 08:41am
- The need to include the RSV preventive antibody injection Beyfortus, which began immunization in Korea this February for infants and young children, in the National Immunization Program (NIP) is being raised.As the inclusion of a new category, ‘preventive antibodies,’ within the traditionally vaccine-focused NIP system emerges as a key policy issue, economic evaluation and cost-effectiveness have emerged as key decision-making criteria.According to industry sources on the 26th, a recent policy discussion forum held at the National Assembly to improve management measures for respiratory infections in infants and young children highlighted cases from major countries that have already incorporated RSV preventive antibodies for infants into their NIP frameworks. The discussions emphasized the significant disease burden RSV imposes on infants and young children.At the forum, Young-rae Sohn, Director General of the Department of Healthcare Safety and Immunization at the Korea Disease Control and Prevention Agency (KDCA), stated, “We plan to review its support in Korea based on economic evaluation and cost-effectiveness analysis. As this could become the first case of including a preventive antibody as a new category within the National Immunization Program, we are discussing it with particular caution.”This stance was reaffirmed during the National Assembly audit in October. Seung-kwan Lim, Commissioner of the KDCA, noted that there is growing social demand and academic support for RSV preventive antibodies, adding that the agency plans to assess priorities and the necessity of introducing such preventive measures into next year’s immunization program.To this end, the KDCA has secured research funding to generate scientific evidence evaluating RSV disease characteristics, efficacy of preventive antibodies, and cost-effectiveness, with results expected by the end of next year.A consistent theme across these discussions is the importance of economic evaluation and cost-effectiveness analysis. Such assessments are essential for allocating limited NIP budgets efficiently and serve as foundational evidence for policy decisions aimed at protecting all newborns and infants from RSV. The need for rigorous analysis is particularly pronounced when considering the inclusion of new preventive modalities in a national program.The RSV preventive antibody currently under consideration for NIP inclusion is Sanofi’s Beyfortus (nirsevimab), which began administration in Korea earlier this year. Beyfortus is a monoclonal antibody indicated for all newborns and infants entering their first RSV season, as well as high-risk children up to 24 months of age, offering broad preventive coverage. A single injection provides protection for at least five months, effectively covering an entire RSV season.Results from research evaluating the cost-effectiveness of Beyfortus have already been reported in Korea.According to the study, the Beyfortus prevention strategy for infants entering or in their first RSV season and for infants and young children during their second RSV season (up to 24 months of age) proved more efficient than existing prevention strategies in terms of reducing healthcare costs and caregiver productivity loss.Notably, over 90% of the overall health improvement benefits were observed in full-term infants under 1 year of age, providing evidence supporting the validity of a universal RSV prevention strategy for all infants. This economic evidence is expected to serve as a key resource in future discussions regarding the introduction of Beyfortus into the National Immunization Program (NIP).Internationally, countries that have already introduced Beyfortus into their NIPs have reported reductions in the risk of RSV-related hospitalizations.Chile, the first country in the Southern Hemisphere to adopt Beyfortus into a nationwide NIP, published real-world evidence based on data from 157,709 infants. The study showed a 76.41% reduction in hospitalization risk due to RSV lower respiratory tract infection and an 84.94% reduction in ICU admission risk. Importantly, while 13 RSV-related infant deaths were recorded during the same period in the previous year, no RSV-related deaths occurred among infants who received Beyfortus.Similar outcomes were confirmed in Galicia, Spain, the first region globally to introduce Beyfortus into its NIP. Interim analysis results published in The Lancet medical journal last May found that the RSV hospitalization rate among infants under 6 months who received Beyfortus decreased by 82% compared to the unvaccinated group.Regarding this, Professor Soo-han Choi of the Department of Pediatrics at Pusan National University Hospital stated, “While the World Health Organization (WHO) has previously issued vaccination policy recommendations centered on vaccines, in May 2025, it proposed that all countries adopt prevention strategies including preventive antibodies for infant RSV prevention.”He added, “While Korea's National Immunization Program (NIP) policies have primarily focused on vaccines, the recent initiation of discussions on incorporating RSV preventive antibodies into the NIP is highly encouraging. If RSV preventive antibodies are included in the NIP, universal preventive benefits will be provided to all infants, leading to a substantial reduction in the national burden of RSV disease.”
