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- 2026-06-06 10:09:38
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- Korean companies pursue tailored and muscle-preserving strategies
- by Cha, Ji-Hyun May 29, 2026 09:14am
- Korean pharmaceutical and biotech companies are steadily producing tangible results in obesity and metabolic disease. Rather than simply chasing Novo Nordisk and Eli Lilly, which dominate the global market, domestic firms are drawing attention with differentiated development strategies ranging from GLP-1 therapies tailored to Koreans to muscle-preserving obesity drugs and histology-improving MASH therapies.D&D Pharmatech achieves all three key mash biopsy endpoints…positive signal for global partneringAccording to the pharmaceutical and biotech industry on the 29th, D&D Pharmatech presented 48-week biopsy results from the U.S. Phase II trial of its MASH candidate “zabopegdutide” (DD01) at the EASL Congress 2026 held in Barcelona, Spain, on the 27th (local time).In this study, DD01 met all three key efficacy endpoints required for MASH treatment approval. The proportion of patients achieving “MASH resolution without fibrosis progression” reached 62.5%, far exceeding the placebo group’s 5.3%. The proportion achieving “fibrosis improvement without worsening MASH” was 50.0%, outperforming placebo by 34.2 percentage points (placebo: 15.8%). The composite endpoint achieving both criteria simultaneously was also significantly higher at 37.5% versus 5.3% in the placebo group.DD01 is a dual agonist targeting both the GLP-1 receptor, which promotes insulin secretion and appetite suppression, and the glucagon receptor, which increases energy metabolism. It is being developed as a once-weekly subcutaneous injection. Earlier interim 12-week results already showed that 75.8% of treated patients achieved at least a 30% reduction in fatty liver, meeting the primary endpoint. The latest results also confirmed improvement in actual liver tissue.Overview of D&D Pharmatech’s MASH candidate “zabopegdutide” (DD01) (Source: D&D Pharmatech)This announcement is considered medically and commercially meaningful because DD01 demonstrated histological evidence of fibrosis improvement rather than merely reducing liver fat. In MASH development, liver fat reduction serves as an early signal of efficacy, but biopsy data showing resolution of steatohepatitis and fibrosis improvement are more important for approval and licensing.Notably, DD01 reduced intrahepatic fat by 37.0% at Week 12, even among patients with body weight reductions of less than 5%. This has led to interpretations that DD01’s effect may not simply be a secondary effect of weight loss but may also involve direct hepatic metabolic improvement through glucagon receptor stimulation. In obesity drug candidates, a key differentiator for MASH expansion potential is whether the drug itself improves liver metabolism beyond weight reduction, and these results are viewed as evidence supporting DD01’s direct metabolic effect on the liver.Industry expectations are also rising for a large-scale licensing deal for DD01. Competition among big pharma companies to secure MASH pipelines has intensified globally. Last year, Roche acquired 89bio for up to USD 3.5 billion to obtain the MASH candidate pegozafermin, while Novo Nordisk acquired Akero Therapeutics for up to USD 5.2 billion to secure efruxifermin.GlaxoSmithKline (GSK) also invested up to USD 2 billion to acquire rights to Boston Pharmaceuticals’ FGF21-based MASH candidate efimosfermin alfa. Efimosfermin alfa failed to achieve statistical significance in the composite endpoint, simultaneously measuring MASH resolution and fibrosis improvement, yet still resulted in a major deal, making it a comparison case that highlights DD01’s asset value.D&D Pharmatech was co-founded in 2014 by Professor Seulgi Lee of Johns Hopkins University School of Medicine and others. The company develops therapies for obesity, MASH, and neurodegenerative diseases based on GLP-1 peptide technologies. It also possesses ORALINK, a platform for converting injectable drugs into oral formulations, as well as PEGylation technology. In May 2024, the company successfully listed on Korea’s KOSDAQ market through a technology-special listing.D&D Pharmatech has also attracted market attention after its partner company was acquired by a global big pharma company. In April 2023, D&D signed a technology transfer agreement with U.S. obesity treatment developer Metsera for an oral obesity treatment candidate, establishing a global development partnership. Metsera was later acquired by Pfizer in November last year and became a wholly owned subsidiary, with its obesity pipeline integrated into Pfizer’s portfolio. For D&D Pharmatech, the partnership established with an early-stage biotech effectively became linked to a global big pharma development network.Beyond DD01, D&D Pharmatech also possesses oral obesity treatment pipelines. Using its ORALINK peptide oral delivery platform, the company is developing oral GLP-1 obesity candidate “DD02S” and oral GLP-1/GIP/glucagon triple agonist candidate “DD03.” DD02S is currently being developed by Metsera as MET-224, and first patient dosing in a North American Phase I/II trial has already been completed. DD03 became part of Pfizer’s portfolio as an oral triple agonist candidate, though its specific development stage has not been disclosed.Hanmi seeks approval for efpeglenatide…also reveals muscle-increasing novel obesity drugHanmi Pharmaceutical recently unveiled its second muscle-increasing obesity drug candidate. The company plans to present 8 research results related to its next-generation obesity candidates ‘HM17321’ and ‘HM500197’ at the American Diabetes Association (ADA 2026) meeting to be held in New Orleans from June 5 to 8.Newly disclosed HM500197 is a peptide-based candidate that inhibits myostatin. Myostatin is a protein that suppresses muscle growth, and Hanmi believes controlling it could increase muscle mass and improve muscle function. Unlike existing myostatin inhibitors developed mainly as antibodies or Fc fusion proteins, Hanmi designed the candidate as a peptide-based therapy to increase the potential for combination or fixed-dose therapies.Hanmi is also developing another muscle-increasing obesity candidate, HM17321. Rather than targeting incretin receptors such as GLP-1, HM17321 is a urocortin-2 (UCN2) analog selectively targeting the corticotropin-releasing factor receptor 2 (CRF2 receptor). Hanmi believes HM17321 can simultaneously induce weight loss and muscle gain, addressing the muscle loss limitations often associated with existing GLP-1 obesity therapies.Hanmi Pharmaceutical's major pipeline overview (Source: Hanmi Pharmaceutical)Hanmi is accelerating new drug development in obesity and metabolic disease. The company has branded its obesity initiative as ‘H.O.P’ (Hanmi Obesity Pipeline) and is rapidly building a customized obesity and metabolic disease portfolio unique to Hanmi. The goal is to establish differentiated obesity drug pipelines using its proprietary long-acting LAPSCOVERY platform and next-generation peptide design capabilities.Currently, Hanmi Pharmaceutical has established a related obesity and metabolic disease pipeline, which includes HM500197 and HM17321, as well as ▲ the GLP-1 agonist ‘Epfeglenatide’ ▲ , the next-generation triple-action agent ‘HM15275’, which simultaneously targets GLP-1, GIP, and glucagon, and ▲a combination therapy of HM15275 and HM17321.Among these, efpeglenatide is the most advanced asset in development. Efpeglenatide is a long-acting GLP-1 therapy utilizing Hanmi’s LAPSCOVERY technology and is being developed for both obesity and diabetes indications.Hanmi is specifically positioning efpeglenatide as a “Korean-style GLP-1 obesity drug” tailored to Korean obesity patients, who generally have a lower prevalence of severe obesity compared with Western populations. In a domestic Phase III trial involving 448 obese adults without diabetes, efpeglenatide achieved an average body weight reduction of 9.8% at week 40, compared with 1.0% in the placebo group. The proportion of patients achieving at least 5% weight loss was 79.4% versus 14.5% in placebo, while rates of at least 10% and 15% weight loss were 46.0% and 19.9%, respectively.Based on these Phase III results, Hanmi filed a marketing authorization application for Hanmi Efpeglenatide Auto Injector last December with the Ministry of Food and Drug Safety. Last month, it launched the company-wide “EFPE-PROJECT-Seosa” task force to unify development, clinical, manufacturing, and distribution strategies for commercialization. On the 18th, Hanmi also began dosing the first patient in a domestic Phase III trial aimed at expanding indications into diabetes treatment.The obesity drug war shifts to metabolic disorders and muscle preservation, with Korean latecomers joining the frayThe global market for metabolic disease treatments is rapidly restructuring around GLP-1 agonists, intensifying competition. While Novo Nordisk’s ‘Wegovy’ and Eli Lilly’s ‘Zepbound’ lead the obesity treatment market, competition is expanding beyond single-mechanism GLP-1 agonists to include dual- and triple-action agents that target GIP and glucagon.Eli Lilly’s triple-action drug ‘Retatrutide’ demonstrated an average weight loss of 28.3% over 80 weeks in Phase III clinical trials, re-emphasizing the direction for next-generation obesity drug development. According to global market research firm Research and Markets, the global obesity treatment market is projected to grow at an average annual rate of 22% from USD 12.8 billion (KRW 18 trillion) last year to reach USD 100 billion (KRW 130 trillion) by 2030.Against this backdrop, Korean companies are increasingly raising expectations for licensing deals and commercialization by generating concrete clinical results in obesity and metabolic disease. Notably, Korean firms are not simply attempting to imitate leading global products but are differentiating their strategies through Korean-specific GLP-1 therapies, muscle-preserving obesity drugs, histology-improving MASH therapies, oral peptides, and long-acting formulations.In addition to Hanmi and D&D Pharmatech, pipelines from other domestic latecomers are also drawing attention.MetaVia, the U.S. subsidiary of Dong-A ST, is developing ‘DA-1726,’ a dual agonist simultaneously targeting GLP-1 and glucagon receptors. MetaVia recently presented additional Phase I data at EASL Congress 2026. In a multiple-dose escalation study conducted in healthy obese adults, the DA-1726 48 mg group showed an average weight loss of 6.1% at Day 26 and 9.1% at Day 54, with waist circumference reductions of 5.8 cm and 9.8 cm, respectively.No serious adverse events or treatment discontinuations occurred, and no clinically meaningful changes were observed in cardiovascular indicators such as heart rate and QTcF. Non-invasive liver assessments also showed improvements in CAP, VCTE, and FAST scores, suggesting potential applications for obesity-related liver disease and MASH. MetaVia is currently conducting Phase I Part 3 to optimize safety and tolerability at higher doses. The company is also collaborating with ImmunoForge on developing a once-monthly long-acting formulation of DA-1726.ProGen is also considered one of the major players in the multi-agonist competition. Its candidate “PG-102” is a dual agonist targeting both GLP-1 and GLP-2 receptors. In addition to weight-loss effects through GLP-1, the therapy aims to leverage GLP-2’s role in intestinal mucosal recovery and nutrient absorption to promote healthy weight loss without muscle loss.Overview of Yuhan’s oral GLP-1 receptor agonist candidate ‘YH-GLP-1RA’ (Source: Yuhan Corp)Yuhan Corp has also entered the obesity and metabolic disease treatment race. The company has outlined three pillars for its obesity treatment development strategy: ▲ ultra-long-acting injectables ▲ oral synthetic new drugs ▲ next-generation mechanisms. The company states that it has confirmed superior oral bioavailability, as well as greater food intake reduction and weight loss effects compared to competitor drugs in an obese mouse model using its oral GLP-1 receptor agonist candidate ‘YH-GLP-1RA.’ Yuhan Corp aims to begin preclinical studies of this candidate in the third quarter of this year and enter Phase 1 clinical trials by the end of next year.Formulation technology companies are also moving quickly. As the obesity market shifts beyond simple weight-loss efficacy toward long-term maintenance and dosing convenience, once-monthly long-acting formulations are emerging as a major focus.Peptron signed a technology evaluation agreement with Eli Lilly in 2024 regarding its drug delivery platform ‘SmartDepot.’ Although the specific target products were not disclosed, the collaboration reportedly involves applying Peptron’s long-acting technology to Lilly’s peptide drugs.G2GBio plans to present preclinical data at the ADA meeting for one-month sustained-release formulations of CagriSema, tirzepatide, and retatrutide developed using its proprietary “InnoLAMP” platform. Although G2GBio has not directly signed a co-development agreement with Lilly, it aims to demonstrate platform competitiveness by using globally leading obesity candidates as validation models. Meanwhile, Inventage Lab is developing one-month sustained-release injections ‘IVL3021’ based on semaglutide and ‘IVL3024’ based on tirzepatide together with Yuhan.An industry official explained, “Competition in the obesity drug market is shifting from simple weight-loss rates toward safety, durability, muscle preservation, and improvement of accompanying metabolic diseases. Domestic companies are securing differentiated strengths such as MASH histological improvement and long-acting formulations, so future clinical results and partnering outcomes will be critical.”
- InterView
- [Reporter's View] Disparity btwn approval·reimb criteria for cancer drugs
- by Son, Hyung Min May 29, 2026 09:14am
- Recently, there has been a discrepancy between the scope of approval and health insurance reimbursement criteria in cancer treatment. Consequently, there are growing cases in which patients who are technically eligible for treatment under the approved indication are unable to achieve therapeutic benefits.Critics point out that the widening gap among global clinical guidelines, real-world clinical practice, and domestic regulatory approval and reimbursement criteria is becoming yet another barrier to patient care.The aims of regulatory approval and reimbursement are inherently different. Approval is a process of evaluating therapeutic viability based on safety and efficacy, whereas reimbursement evaluates both cost-effectiveness and clinical necessity within a constrained healthcare budget. Consequently, the criteria of these categories are different. However, instances where the approved label, global guideline recommendations, and actual reimbursement scope diverge are increasingly common, aggravating confusion in clinical settings.One of these examples is the treatment of advanced renal cell carcinoma (RCC).Global clinical guidelines offer a broader range of therapeutic choices following first-line immuno-oncology therapy for RCC.Major international guidelines, including the National Comprehensive Cancer Network (NCCN), European Society for Medical Oncology (ESMO), and European Association of Urology (EAU), recommend various targeted therapies as key subsequent lines of therapy after immuno-oncology combination therapies. In particular, certain agents are highlighted as preferred choices after first-line therapy, suggested as a flexible, sequential treatment strategy depending on patient status and therapeutic response.However, real-world clinical practices in South Korea are quite different. The approved scope for several subsequent treatment options is limited to prior exposure to VEGF-targeted therapy. Consequently, for patient cohorts who received first-line immuno-oncology combination therapy, utilization is restricted, and reimbursement is entirely unavailable. While global guidelines are expanding therapeutic choices, a restrictive structure remains, where approval and reimbursement criteria narrow down the eligible patient population.This gap is also evident in the treatment of metastatic gastric cancer. Based on evidence of survival benefits, immune-oncology combination therapy has recently become a key pillar of treatment, with some agents securing regulatory approval for an all-comer patient population. At the reimbursement stage, however, the target patient population is redefined by reflecting the biomarker thresholds based on PD-L1 expression levels, such as Combined Positive Score (CPS) or Tumor Area Positivity (TAP).As a result, certain eligible patients are excluded from reimbursement coverage. In real-world clinical practice, even when a physician determines a clear clinical necessity for treatment, considering patients whose biomarker scores are near the cut-off threshold or who have an overall poor performance status, therapeutic choices are limited by rigid reimbursement rules. This indicates that the discrepancy between regulatory approval and reimbursement guidelines directly lead to disparities in patient access to treatments.Of course, it is challenging to extend reimbursement coverage to every therapy based on its approved scope. Balancing fiscal sustainability and cost-effectiveness in the national health insurance budget is necessary.Selecting specific patient populations and establishing prioritization within limited financial resources are necessary steps. The critical issue, however, is the degree of the gap between these criteria and actual clinical practice. If global guidelines and regulatory frameworks are designed to expand access to treatment while reimbursement criteria remain anchored in outdated patient-selection frameworks, the lag between shifting therapeutic paradigms and institutional policies will inevitably widen.If regulatory approval is the process of unlocking therapeutic potential, reimbursement is the process that translates that potential into clinical reality. A certain degree of variance between the two criteria can exist. However, when the gap widens to the point of gauging patient access to life-saving treatments, it is time to re-evaluate what the system is missing.
- Policy
- Lilly’s Verzenio passes CDDC review for reimbursement
- by Jung, Heung-Jun May 29, 2026 09:14am
- Eli Lilly Korea’s Verzenio Tab (abemaciclib) passed the Cancer Drug Deliberation Committee (CDDC), moving one step closer toward expanded reimbursement coverage for early breast cancer.Meanwhile, Curocell’s CAR-T therapy ‘Rimqarto Inj’ (anbalcabtagene autoleucel), which had attracted significant attention, failed to secure reimbursement criteria.On the 27th, the Health Insurance Review and Assessment Service released the results of the 5th Cancer Drug Deliberation Committee meeting. The committee reviewed reimbursement decisions and the expansion of reimbursement criteria for a total of 5 products. Among them, two products passed the initial reimbursement hurdle.AbbVie Korea’s ovarian cancer therapy ‘Elahere Inj’ (mirvetuximab soravtansine) was the only new drug to receive reimbursement criteria.The criteria apply to adult patients with folate receptor alpha (FRα)-positive, platinum-resistant high-grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received one to three systemic therapies.Lilly Korea’s Verzenio Tab was approved for reimbursement expansion for use ‘in combination with endocrine therapy as adjuvant treatment in adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, lymph node-positive early breast cancer at high risk of recurrence.’Outcomes diverged for early breast cancer reimbursement expansion. Novartis Korea’s Kisqali Tab (ribociclib succinate) attempted to expand reimbursement for HR-positive, HER2-negative Stage II and III early breast cancer patients at high risk of recurrence, but reimbursement criteria were not established.Roche Korea’s Alecensa Cap (alectinib hydrochloride) also attempted reimbursement expansion as adjuvant therapy following tumor resection in ALK-positive non-small cell lung cancer patients, but failed to pass the CDDC review.Among the new drugs, Curocell’s CAR-T therapy ‘Rimqarto Inj’ failed to establish secure reimbursement coverage for the treatment of adult B-cell lymphoma patients, leaving the company seeking reimbursement again in the future.
- Company
- 'Latest data on anticancer drugs to be unveiled'…ASCO
- by Son, Hyung Min May 29, 2026 09:14am
- Major studies on next-generation oncology treatment strategies, including targeted therapies, antibody-drug conjugates (ADCs), and bispecific antibodies, will be unveiled at the world's largest cancer conference.At the American Society of Clinical Oncology Annual Meeting (ASCO 2026), which will be held in Chicago, USA, for five days starting on the 29th of this month, the latest data on various novel anticancer drugs will be presented, including long-term survival and treatment optimization data for the 'Leclaza (lazertinib)' + 'Rybrevant (amivantamab)' combination therapy, cancer type expansion strategies for TROP2-targeted ADCs, and novel bispecific antibody-based therapeutic approaches.With research presentations in gastric, liver, breast, and head and neck cancers involving Korean researchers scheduled, the role of Korean researchers will be confirmed as well as global trends in cancer treatment.At this year's ASCO, the attention in oncological strategies appears to be shifting beyond therapeutic efficacy competition toward long-term survival, convenience of administration, biomarker-based patient selection, and novel platform battles. In particular, EGFR-mutated lung cancer and the TROP2 ADC field are considered the most fiercely competitive arenas for next-generation treatment strategies.Leclaza and Rybrevant, from long-term survival to SC conversionNon-small cell lung cancer treatments Leclaza and RybrevantJanssen will present multiple studies on the Leclaza + Rybrevant combination strategy at this conference. In particular, the company will present full life-cycle data spanning long-term survival outcomes, subcutaneous (SC) conversion, adverse event management strategies, and cost-effectiveness, moving beyond mere improvements in historic therapeutic outcomes.Leclaza is a novel EGFR-positive non-small cell lung cancer drug developed by Yuhan Corp. This drug is a third-generation tyrosine kinase inhibitor (TKI) targeting exon 19 deletions and exon 21 (L858R) mutations.Janssen has secured the global commercial rights to Leclaza and has been conducting clinical studies evaluating its efficacy in combination with Rybrevant. This targeted therapeutic option targets exon 20 insertion and MET mutations. This combination therapy previously demonstrated the longest overall survival (OS) outcomes in the Phase III MARIPOSA study.At this year's conference, results from the CHRYSALIS-2 study will be unveiled. This clinical trial analyzed the long-term OS outcomes of the Leclaza/Rybrevant combination in patients with advanced non-small cell lung cancer harboring atypical EGFR mutations.Considering that patients with atypical EGFR mutations have been classified as a poor-prognosis subgroup with relatively low response rates to conventional EGFR-targeted therapies, these data will serve as a benchmark to assess the potential expansion of the scope of combination therapy.Furthermore, findings from the COPERNICUS study, which evaluated the initial safety of the Rybrevant SC and Leclaza combination, will be presented. The core focus is determining the extent to which administration time, infusion-related reactions (IRRs), thromboembolism, and dermatological toxicities (previously flagged as burdens in intravenous-based therapy) can be mitigated under concurrent prophylactic skin toxicity management and anticoagulation therapy. A key point is whether converting Rybrevant to a subcutaneous formulation can enhance treatment sustainability and patient convenience.For EGFR-positive lung cancer targeted therapies, most approved options, including Leclaza, 'Tagrisso (osimertinib)', and 'Giotrif (afatinib)', are oral medications, whereas Rybrevant is an injectable. This explains why focus is being placed on the commercialization of the Rybrevant SC formulation, which significantly reduces administration time.Furthermore, an economic analysis comparing the cost-effectiveness against Tagrisso-based therapeutic strategies will be disclosed. This research explores which strategy will provide a competitive edge, accounting for treatment costs and healthcare expenditures alongside clinical efficacy.TROP2 ADC competition intensifies following Trodelby…Expanded indication acceleratesView of ASCO 2025 (Source: ASCO).Competition among TROP2-targeted ADCs is also a key topic at ASCO. With Gilead's 'Trodelby (sacituzumab govitecan)' and Daiichi Sankyo·AstraZeneca's 'Datroway (datopotamab deruxtecan)' having preempted the market, MSD, Astellas, and Chinese biotechs are accelerating the development of next-generation candidates.MSD will present a digital pathology-based biomarker study for its TROP2-targeted ADC, 'sacituzumab tirumotecan'. The research explores whether using artificial intelligence (AI) can enhance the predictability of treatment response compared with legacy TROP2 expression assessment methodologies, suggesting the potential refinement of future patient stratification strategies.Currently, sacituzumab tirumotecan is being evaluated across a total of 17 global Phase III programs, including endometrial cancer, lung cancer, breast cancer, gastric cancer, cervical cancer, ovarian cancer, and bladder cancer. Among these, 10 Phase III trials are ongoing in gynecological and breast malignancies areas.Recently disclosed non-small cell lung cancer (NSCLC) data are regarded as a key example demonstrating the expansion potential of sacituzumab tirumotecan.According to the abstract released at ASCO, the combination of sacituzumab govitecan and Keytruda reduced the risk of disease progression or death by 65% compared with Keytruda monotherapy in treatment-naïve, PD-L1-positive advanced non-small cell lung cancer patients in the Chinese OptiTROP-Lung05 study.Additionally, move toward expanding scope of applicable cancer types are anticipated. With research analyzing TROP2 expression and exploring therapeutic targeting viability in metastatic anal cancer, where subsequent treatment options are highly constrained, being unveiled, attention is focused on whether TROP2 ADCs can expand beyond breast and lung cancers into orphan malignancies. In thyroid cancer, research on TROP2-based PET imaging technology will be presented, demonstrating potential expansion into the diagnostic realm.Platform competitions among latecomers are also intensifying. Astellas will present initial clinical data for 'ASP2998', a TROP2 ADC conjugated with a stimulator of interferon genes (STING) agonist payload, showcasing a next-generation ADC strategy. Alphamab Oncology, a Chinese biotech, plans to present data on its TROP2·HER3 bispecific ADC (JSKN016), highlighting its potential to target HER2-negative breast cancer. The competitive landscape is broadening beyond cytotoxic payload delivery toward dual-targeting and immune-activation strategies.Presentations by several Korean researchers...Unveiling research in major solid tumorsNumerous presentations involving Korean researchers are also scheduled.Professor Hong Jae Chon of Bundang Cha Medical Center will unveil the first clinical data for BeOne Medicines' GPC3 × 4-1BB bispecific antibody 'BGB-B2033', which is currently under development primarily for hepatocellular carcinoma (HCC). The core endpoints focus on initial safety profiles and anti-tumor activity signals in a liver cancer cohort with limited options following prior immune checkpoint inhibitor therapy.Professor Sun Young Ra of Yonsei Cancer Hospital will present the PD-L1 subgroup analysis results of a BeOne Medicines' 'Ziihera (zanidatamab)'-containing combination therapy in the first-line treatment of HER2-positive advanced gastric cancer. This research examines whether the clinical benefit is sustained regardless of PD-L1 expression status, which could inform potential future expansions of the target patient population.Ziihera is a bispecific antibody that simultaneously binds to two distinct domains of the HER2 receptor, developed to enhance signal blockade and immune response induction concurrently compared to legacy monospecific antibodies.In particular, this strategy has the potential combination with BeOne Medicines' immuno-oncology agent, 'Tevimbra (tislelizumab)'. The approach aims to maximize therapeutic efficacy by proposing a triplet regimen combining HER2-targeted therapy and immune checkpoint inhibition.Professor Yeon Hee Park of Samsung Medical Center will present clinical outcome analysis based on treatment durability and response of an 'Enhertu (trastuzumab deruxtecan)' combination therapy. Professor Hye Ryun Kim of Yonsei Cancer Hospital will present a combination strategy combining Tiumbio's TGFβRI/VEGFR2 dual inhibitor 'tosposertib' with an immune checkpoint inhibitor. Lastly, Professor Han Sang Kim of Yonsei Cancer Hospital will introduce a study examining the predictability of biomarker-based response in second-line treatment for metastatic colorectal cancer.
- Company
- Korean firms circumvent 1 patent on neuropathic pain drug Taleaje
- by Kim, Jin-Gu May 29, 2026 09:14am
- Generic drug makers have succeeded in circumventing the salt and composition patent protecting the neuropathic pain treatment Taleaje Tab (mirogabalin). If they also succeed in bypassing the formulation patent they are separately challenging, they may be able to move the generic launch timing forward to June 2031.According to the pharmaceutical industry on the 28th, the Korean Intellectual Property Trial and Appeal Board ruled in favor of Huons, Dong-A ST, and JW Pharmaceutical in their passive scope confirmation trial against Daiichi Sankyo regarding Taleaje’s salt and composition patent (10-2142257).Taleaje is protected by 3 patents: a substance patent (10-1335784) expiring in June 2031, a salt and composition patent expiring in April 2034, and a formulation patent (10-2425821) expiring in 2036.Generic companies filed passive scope confirmation trials against the salt/composition patent in May last year. In addition to the 3 companies that won the first ruling, Kyongbo Pharmaceutical, Samjin Pharmaceutical, BC World Pharm, Dongwha Pharm, Daewoong Pharmaceutical, and HK inno.N also filed similar challenges. These companies additionally challenged the formulation patent as well.Among the challengers, BC World Pharm, Dongwha Pharm, and HK inno.N voluntarily withdrew their trials and exited the patent challenge race. The remaining 6 companies continue their challenges. Following the recent favorable ruling, the industry expects KyungDong Pharmaceutical, Samjin Pharmaceutical, and Daewoong Pharmaceutical to succeed in bypassing the salt/composition patent.If they additionally succeed in circumventing the formulation patent following their success with the salt and composition patents, the generic launch timing could be advanced to June 2031 when the substance patent expires.Taleaje is used for neuropathic pain treatment. Daiichi Sankyo received approval for four dosage strengths (2.5mg, 5mg, 10mg, and 15mg) in January 2020.However, the product failed to secure coverage under the National Health Insurance. It is currently being sold as a non-reimbursed medication. As of 2024, its sales revenue stood at approximately KRW 3.7 billion. Given that the product generates significant sales even without insurance coverage, analysts believe it is well worth the challenge for generic drug manufacturers.If companies challenging the patent successfully obtain generic approval and secure insurance coverage, they are expected to compete in the neuropathic pain treatment market against pregabalin (brand name Lyrica) and gabapentin (brand name Neurontin).Pregabalin and gabapentin are already covered by national health insurance and are reported to form a market worth KRW 200 billion annually. Additionally, potential competition exists with COX-2 inhibitor analgesics such as celecoxib (brand name Celebrex) and SNRI antidepressants such as duloxetine (brand name Cymbalta).
- Company
- Amvuttra listed for reimbursement in Korea
- by Son, Hyung Min May 28, 2026 10:28am
- The treatment landscape for hereditary transthyretin amyloid polyneuropathy (hATTR-PN), a rare inherited disease, is beginning to show signs of change.Given the nature of the disease, which takes several years from symptom onset to diagnosis and leads to rapid functional decline, the importance of early diagnosis and intervention is growing. Expectations are also rising for improved treatment access following reimbursement coverage for the RNA interference (RNAi)-based therapy ‘Amvuttra (vutrisiran).’On the 27th, Medison Pharmaceuticals held a press conference at the Plaza Hotel in Jung-gu, Seoul, to commemorate the domestic launch of Amvuttra for the treatment of hATTR-PN.(From left: Professor Jeeyoung Oh (Department of Neurology, Konkuk University Hospital), and Professor Gyeongmo Sohn (Department of Neurology, Haeundae Paik Hospital)Hereditary transthyretin amyloid polyneuropathy (hATTR-PN) is a rare disease in which structurally abnormal transthyretin (TTR) proteins transform into amyloid forms and accumulate in various organs, including peripheral nerves, autonomic nerves, and the heart, causing nerve damage and organ dysfunction.This disease is characterized by a complex combination of systemic symptoms, including not only peripheral sensory and motor neuropathy but also autonomic dysfunction, cardiovascular abnormalities, and gastrointestinal symptoms. A substantial number of Korean patients reportedly present with mixed phenotypes involving both neurologic and cardiac symptoms.Delayed diagnosis is considered one of the biggest challenges. Early symptoms such as numbness in the hands and feet, sensory abnormalities, and gastrointestinal symptoms are relatively nonspecific and are often mistaken for other diseases. In Korea, the average time from symptom onset to diagnosis is reported to be 3.7 years.Professor Gyeongmo Sohn of Haeundae Paik Hospital said, “hATTR-PN often begins with early sensory abnormalities, gastrointestinal problems, or weakness of finger muscles. It is important to recognize so-called ‘red flags’ such as family history, vitreous opacity, carpal tunnel syndrome (CTS), and autonomic symptoms at an early stage.”He continued, “Autonomic symptoms such as dizziness caused by orthostatic hypotension, gastrointestinal motility disorders, and sexual dysfunction often appear even before motor nerve damage occurs. Early suspicion and diagnosis have a significant impact on patient prognosis.”The disease also progresses rapidly. According to Professor Sohn, the median survival after diagnosis for hATTR-PN patients is approximately 4.7 years, shortening to about 3.4 years when cardiomyopathy is present.RNAi-based Amvuttra added to reimbursement list… “Goal is to suppress disease progression”Treatment of hATTR-PN in Korea broadly involves gene silencers and protein stabilizers. Currently approved treatments include the RNAi-based gene silencer Amvuttra and Pfizer’s TTR stabilizer Vyndamax (tafamidis).Amvuttra is a therapy that suppresses the production of abnormal TTR proteins via RNA interference. It is considered a disease-modifying treatment because it fundamentally lowers production of the disease-causing protein and slows disease progression. Another key feature is that it can be administered as a subcutaneous injection once every three months.After receiving Korean approval in November 2024, Amvuttra additionally gained approval in March this year for reducing cardiovascular death, hospitalization, and urgent heart failure visits in adult patients with wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM).Furthermore, as of April 1, health insurance coverage was extended to include Stage 1 patients with hATTR-PN for whom Vyndamax was insufficiently effective or difficult to administer, as well as all Stage 2 patients regardless of prior treatment status.Amvuttra’s clinical efficacy was confirmed through the global Phase III HELIOS-A study. This study was conducted on 164 hATTR-PN patients across 22 countries.Trial results showed that at 18 months, the Amvuttra treatment group exhibited a 0.46-point reduction in the Modified Neuropathy Impairment Score +7 (mNIS+7) compared to baseline, whereas the external placebo control group showed a 28.1-point increase.Improvements were also observed in the quality of life and physical function. The treatment group showed statistically significant improvements in the Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QoL-DN) score compared to the external placebo group, and preservation of function was also seen in the 10-meter walk test assessing ambulatory ability.Professor Jeeyoung Oh, Department of Neurology at Konkuk University Hospital, said, “Amvuttra has demonstrated data showing improvements in neurologic function and quality of life in clinical studies. Because both physicians and patients have long faced significant unmet needs due to limitations in treatment accessibility, we hope reimbursement coverage will allow patients to receive treatment benefits at more appropriate stages.”
- Policy
- Fast-track listed rare disease drugs need to demonstrate performance
- by Jung, Heung-Jun May 28, 2026 10:27am
- The government will lower drug prices starting in the fourth year if rare disease treatments fail to meet their targets following post-marketing evaluation, following fast-track listing.Evaluations will be based on real-world evidence (RWE), but if pharmaceutical companies fail to collect and submit the required data, the drugs may be removed from reimbursement coverage altogether.Sook-hyun Lee, Director of New Pharmaceutical Benefits Listing Division at the Health Insurance Review and Assessment Service (HIRA)On the 27th, Sook-hyun Lee, Director of the New Drug Listing Division at the Health Insurance Review and Assessment Service (HIRA), explained specific operational plans for the system during a public hearing on “Fast-Track Listing Strategies to Improve Access to Rare Disease Treatments.”Until now, rare disease treatments underwent a 150-day approval negotiation process at HIRA and a 60-day process at the National Health Insurance Service (NHIS) following approval by the Ministry of Food and Drug Safety (MFDS) before official notification by the Ministry of Health and Welfare.Under the revised drug pricing system, the review periods at both HIRA and the NHIS will be shortened to one month each. Instead, post-listing management will be strengthened through follow-up evaluations after reimbursement listing.A general scope for drugs eligible for the fast-track listing pilot program has also been established. Drugs will be selected based on: ▲availability of alternative treatments ▲severity of the disease ▲need for rapid introduction ▲fiscal impact. The pilot project plans to begin by selecting two to three items based on these criteria.Director Lee explained, “The primary criteria for selecting target drugs are treatments for rare diseases that have already received approval or are listed in at least three of the A8 countries.”A performance-based evaluation model will be operated using real-world evidence (RWE) and linked to electronic medical records (EMR). Before reimbursement, pharmaceutical companies must submit clinical outcome evaluation plans for review by HIRA. The plan must include details such as ▲target patients and drugs ▲outcome measures ▲evaluation cycle and duration ▲reimbursement adjustment plan ▲methods for calculating clinical performance evaluation results ▲data collection procedures and quality control methods.Afterward, pharmaceutical companies will be required to collect annual data during years one through three, and evaluations will be conducted based on those results. The findings will then be reported to the Drug Reimbursement Evaluation Committee.Data collection and validation will continue for three years after fast-track listing, and reimbursement adjustments will begin in year four according to evaluation outcomes. Data collection and verification will be conducted for three years following fast-track listing, and reimbursement will be adjusted starting in the fourth year based on the evaluation results.Lee stated, “If pre-established targets are not achieved, drug prices will be reduced, and if data are not submitted, we are reviewing measures to convert reimbursement to full out-of-pocket payment.” Obligations related to post-evaluation plans and follow-up measures based on results will also be included in fast-track reimbursement contracts.The National Health Insurance Service will apply expenditure cap agreements to fast-track listed drugs. Negotiations will be conducted based on total expenditure figures proposed by pharmaceutical companies, and after one year of listing, actual claims will serve as the benchmark.The expenditure cap mechanism is expected to prevent rapid increases in financial burden caused by the expansion of fast-track reimbursement listings.Pricing standards are expected to be stricter than those applied to drugs exempt from pharmacoeconomic evaluations. Drug prices are expected to be negotiated at around 90% of the lowest price among the A8 countries.
- Policy
- Bayer's new antifungal cream Canesten wins nod…"once-daily"
- by Lee, Tak-Sun May 28, 2026 10:27am
- Bayer Korea is expanding its market presence by introducing a new product projected to shift the over-the-counter (OTC) anti-fungal market in South Korea.In contrast to existing Canesten products, the new product is a topical formulation that requires only once-daily application.On the 27th, Bayer Korea secured marketing authorization from the Ministry of Food and Drug Safety (MFDS) for 'Canesten Once Daily Cream', a once-daily topical anti-fungal. This new product differs from Bayer's existing anti-fungal product, 'Canesten Cream', in both its active pharmaceutical ingredient (API) and its usage.Differentiation from existing products...Re-entering the Korean Market with the API 'bifonazole'The key feature of 'Canesten Once Daily Cream' is its updated API. While existing Canesten products utilize clotrimazole, this new product features bifonazole as its primary API. Although both substances are classified as azole-based anti-fungals, products containing bifonazole have vanished from the domestic market. Bayer's strategy is to successfully re-establish bifonazole in the Korean market through this approval.The usage has also been dramatically improved. While the existing Canesten Cream required application 2 to 3 times a day, the new product is effective with just a single daily application (preferably before bedtime), thinly applied and rubbed onto the affected area.However, a pharmaceutical industry employee said, "Because the name includes 'Once,' it is easy for consumers to confuse it with single-application athlete's foot treatments that have high brand awareness, such as 'Lamisil Once External Solution' (terbinafine hydrochloride)," and added, "'Canesten Once Daily Cream' is not a single-application treatment. It is a product that must be applied consistently once every day throughout the designated treatment duration."Currently, the domestic topical anti-fungal market involves market competition between the traditional powerhouse 'Lamisil' series and 'single-application (Once) formulations' driven by domestic pharmaceutical companies.Amid this competition, Bayer Korea's introduction of 'Canesten Once Daily Cream' is interpreted as a strategic move to aggressively expand the Canesten brand equity into the traditional tinea (dermatomycosis) market. The Canesten brand currently spans vaginal tablets, powders, and other formulations, utilized not only for tinea but also for vulvovaginal candidiasis and vaginitis.In particular, the enhanced convenience of a 'once-daily' application is expected to improve treatment adherence (the degree to which a patient follows prescribed medication guidelines) among busy modern consumers. Analysis suggests that the product has an advantage in capturing male tinea patients, where the penetration rate of existing products has been low.It is important to note that the treatment duration varies depending on the specific clinical indication. For dermatomycosis and cutaneous candidiasis, treatment lasts 2 to 3 weeks, whereas for tinea versicolor and erythrasma, it lasts 2 weeks. Therapy must be continued even if symptoms subside mid-treatment to prevent fungal recurrence.An industry insider stated, "Bayer has reintroduced bifonazole, which had vanished from the domestic market, with its 'once-daily' product. It will be interesting to see whether Canesten, with its powerful brand recognition, can shift the landscape of the domestic tinea treatment market with this new product."
- Company
- Access to later-line therapy for kidney cancer remain unchanged
- by Son, Hyung Min May 28, 2026 10:27am
- Although treatment for advanced renal cell carcinoma (kidney cancer) is rapidly shifting toward immuno-oncology-based combination therapies, Korea’s treatment environment still lags behind global guidelines.In particular, even after immunotherapy combinations became established as first-line standard treatments, access to second-line therapies following disease progression remains limited. As a result, advances in treatment outcomes are not being fully translated into continuity of care for actual patients.On the 26th, Ipsen Korea held a press conference at the JW Marriott Hotel in Seocho-gu, Seoul, in celebration of World Kidney Cancer Day in June, highlighting the current treatment environment and patient access challenges in renal cell carcinoma. At the event, quality-of-life issues faced by kidney cancer patients and their families, along with the limitations of the domestic second-line treatment environment following immunotherapy, were presented as key topics.In Ho Kim, a professor of Medical Oncology at Seoul St. Mary’s Hospital, explained, “Renal cell carcinoma is one of the cancer types that has seen the most rapid advancements in treatment over the past decade. Thanks to advances in immunotherapy and targeted therapy, treatment environments now allow not only long-term disease control but also long-term survival in some patients.”Renal cell carcinoma is the most common type of kidney cancer, accounting for approximately 90% of all cases. While it often presents with no specific symptoms in the early stages, as the disease progresses, symptoms such as hematuria, flank pain, and fatigue may appear. In advanced stages, a cure through surgery alone is difficult, making drug therapy the cornerstone of treatment.Shift toward immunotherapy combination strategies…changes in first-line treatment strategiesProfessor In Ho Kim, Department of Medical Oncology, Seoul St. Mary’s HospitalCurrent treatment strategies for advanced renal cell carcinoma are selected based on patient risk categories. In clinical practice, physicians use the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk classification to divide patients into favorable-, intermediate-, and poor-risk groups. In intermediate- and poor-risk groups, immunotherapy-based combinations have effectively become the global standard.Professor Kim stated, “In the past, treatment focused on targeted therapy monotherapy, but immunotherapy combinations have changed the treatment paradigm. Particularly in the intermediate and poor-risk groups, the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) has demonstrated survival benefits and established itself as a major first-line treatment strategy.”Currently, the first-line immunotherapy combinations approved in Korea for renal cell carcinoma include: ▲Opdivo + Yervoy ▲Opdivo + Cabometyx (cabozantinib) ▲Keytruda (pembrolizumab) + Lenvima (lenvatinib) ▲Keytruda + Inlyta (axitinib). Combinations involving immunotherapy plus immunotherapy or immunotherapy plus targeted therapy have improved survival rates and disease control compared to conventional targeted therapy monotherapy approaches, driving major changes in renal cell carcinoma treatment strategies.However, Korea’s reimbursement environment is considered insufficient to keep pace with treatment advances. Currently, the only reimbursed immunotherapy combination is Opdivo + Yervoy for IMDC intermediate- and poor-risk patients. Insurance coverage is also limited to a maximum of 2 years. In contrast, immunotherapy plus targeted therapy combinations widely recommended in global treatment guidelines are not reimbursed.Limitations in access to follow-up therapy highlightedThe problem lies in the period following first-line immunotherapy. While many patients in Korea currently use the Opdivo plus Yervoy combination therapy, which is covered by insurance, the options available for subsequent treatment after disease progression are limited.In Korea, reimbursable drugs for second-line renal cell carcinoma treatment are limited to certain VEGF-targeted anticancer agents, such as Sutent (sunitinib), Votrient (pazopanib), and Inlyta. Meanwhile, Cabometyx, which is recommended as a key subsequent therapy option in international guidelines, is not only non-reimbursed but also limited in actual use.International guidelines from the NCCN, ESMO, and EAU recommend cabozantinib as a major follow-up treatment option after first-line immunotherapy-based therapy. However, Korean approval is limited to ‘advanced renal cell carcinoma patients previously treated with VEGF-targeted therapy.’ As a result, patients who received immunotherapy combinations in the first line face structural barriers to using Cabometyx under the current label.Cabometyx demonstrated improvements over everolimus in progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) in the METEOR study. Median PFS reached 7.4 months, OS was 21.4 months, and ORR was 24%, confirming clinical efficacy across all three major endpoints in second-line renal cell carcinoma treatment.Kim stated, “While patients in Korea frequently use the Opdivo plus Yervoy combination therapy as first-line treatment, there remains a structural gap that makes it difficult to naturally transition to evidence-based follow-up treatment afterward.”He further emphasized, “To translate the treatment outcomes of renal cell carcinoma into real-world patient care, we need to discuss improving access not only to first-line treatment but also to subsequent lines of therapy to ensure continuity in treatment.”
- Company
- Immunotherapy Tevimbra's five indications to be reviewed
- by Eo, Yun-Ho May 28, 2026 10:27am
- Product photo of 'Tevimbra'Five additional indications for 'Tevimbra' are anticipated to enter the final review stage of the Health Insurance Review and Assessment Service (HIRA) for expanded reimbursement.According to industry sources, Tevimbra (tislelizumab), a PD-1 inhibitor cancer immunotherapy from BeOne Medicines Korea, is expected to be considered by the HIRA Pharmaceutical Reimbursement Evaluation Committee in June.After obtaining successful reimbursement for esophageal cancer in April last year, which was a first as an immunotherapy, Tevimbra has added five indications for solid tumors, including esophageal cancer, gastric cancer, and non-small cell lung cancer (NSCLC). While expanding Tevimbra's indications, BeOne Medicines applied for expanded reimbursement, which subsequently passed the final Cancer Disease Review Committee (CDRC) meeting of 2025.The specific indications submitted for review include ▲first-line combination therapy for patients with unresectable, locally advanced, or metastatic esophageal cancer ▲first-line combination therapy for patients with unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma ▲two types for first-line combination therapy and one type for second-line monotherapy in non-small cell lung cancer (NSCLC).If Tevimbra secures expanded reimbursement this time, its role is expected to expand across various cancer types in South Korea in the future.Since BeOne Medicines has a record of finalizing negotiations with the government by advocating for a 'reasonable drug price' at its initial listing, anticipation is growing for the reimbursement review on the additional indications.It is to be watched whether BeOne Medicines can once again maintain its corporate philosophy of 'providing innovative new drugs at reasonable prices to ensure no patient is left behind.'Meanwhile, Tevimbra has confirmed efficacy and safety across diverse indications through the RATIONALE clinical trial series (RATIONALE-303, 304, 305, 306, 307).Notably, clinical benefits were confirmed in overall patient populations in study groups of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (GEJ) adenocarcinoma. In addition, consistent results were also observed in prespecified subgroups based on PD-L1 expression.
