- LOGIN
- MemberShip
- 2026-07-22 03:12:20
- Company
- "Era of precision therapy for lung cancer"… Leclaza-based treatment strategy
- by Cha, Ji-Hyun Jul 14, 2026 08:03am
- Professor Tae-Hwan Kim of Ajou University Hospital·Professor Ji-Youn Han of the National Cancer Center (from left)The therapeutic paradigm for epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) is shifting. While treatment was previously centered on third-generation EGFR tyrosine kinase inhibitor (TKI) monotherapy, the introduction of combination therapies such as Leclaza plus Rybrevant, alongside integrated local consolidative therapies like radiation, has shifted the clinical approach toward modulating treatment intensity based on individual patient risk profiles.In particular, as Leclaza expands its clinical utility from a frontline monotherapy to a foundational component of combination regimens, a personalized treatment paradigm is becoming established. This approach simultaneously addresses long-term survival, resistance mitigation, and the management of central nervous system (CNS) metastases. Professor Ji-Youn Han of the Department of Hematology-Oncology at the National Cancer Center and Professor Tae-Hwan Kim of the Department of Medical Oncology and Hematology at Ajou University Hospital shared their insights into the evolving dynamics of Leclaza-based treatment strategies, patient selection criteria, and optimal protocols for managing CNS metastases.Leclaza is a third-generation EGFR TKI that was approved as South Korea's 31st novel drug in January 2021. Subsequently, in August 2024, the combination of Leclaza + Rybrevant secured approval from the U.S. Food and Drug Administration (FDA) as a first-line treatment for adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations.The starting point of this shift in the EGFR-mutant lung cancer landscape is the use of multifaceted, customized therapeutic approaches in the first-line treatment setting. Previously, the clinical utility of third-generation agents was limited to patients who developed the T790M resistance mutation after progression on first- or second-generation targeted therapies. Today, clinicians can evaluate various combination strategies anchored by a third-generation EGFR TKI right from initial diagnosis.Professor Han stated, "The advanced care began when third-generation therapeutics became accessible as a first-line treatment for all patients confirmed with EGFR mutations," and added, "With the clinical efficacy of combination therapies now robustly validated, the current therapeutic approach focuses on stratifying treatment strategies based on specific patient risk factors.The introduction of third-generation EGFR TKIs has allowed clinicians to design therapeutic strategies aimed at long-term overall survival rather than merely extending progression-free intervals. Professor Kim said "Previously, many patients lost subsequent therapeutic opportunities before ever receiving a third-generation agent if they failed to demonstrate the T790M resistance mutation post-progression," and he emphasized that "Using third-generation agents as a first-line intervention reduces these treatment gaps and establishes a baseline survival expectation of over 3 years. It is a profoundly meaningful clinical advancement in real-world practice.Recently, the treatment paradigm has advanced further, moving away from using monotherapy approach for all patients toward differentiating between monotherapy and combination therapies based on baseline disease severity. This shift is supported by data from the MARIPOSA and FLAURA2 trials, which indicate that combination strategies have the potential to further optimize progression-free survival (PFS) and overall survival (OS) compared with third-generation EGFR TKI monotherapies.Professor Han said, "Third-generation EGFR TKIs should not be viewed as the definitive endpoint of EGFR-mutant lung cancer therapy, but rather as the foundational starting point," and added, "While monotherapy outcomes have improved, combination therapies must be actively considered for patient cohorts characterized by persistent unmet medical needs, such as those presenting with baseline brain or liver metastases and the EGFR L858R mutation.In real-world clinical settings, the primary criteria for prioritizing combination therapy are baseline brain and liver metastases, the EGFR L858R mutation, and a high baseline tumor burden. Patients with detectable circulating tumor DNA (ctDNA) in their blood profile are also stratified into the high tumor-burden category. Clinical consensus indicates that for patients presenting with these distinct risk factors, upfront combination regimens should take precedence over single-agent interventions.Rybrevant offers a distinct mechanistic advantage as a bispecific antibody simultaneously targeting EGFR and MET, concurrently inhibiting both downstream signaling pathways. Professor Han explained that "While the MARIPOSA study did not present a granular analysis stratified by specific EGFR co-mutations, separate literature identifies MET activation as a critical therapeutic target within the EGFR L858R mutant population," and added, "Despite the necessary financial considerations, the Leclaza + Rybrevant combination therapy represents a highly tailored clinical choice for patients in whom MET signaling plays a dominant pathological role, such as those with liver metastases or L858R mutations.Conversely, Leclaza monotherapy remains an essential standard of care for elderly patients, those with compromised performance status, or individuals facing a high baseline burden of comorbidities and potential adverse events. Professor Kim pointed out that "While combination therapy yields high efficacy, it requires patients to visit clinical sites every two to three weeks for intravenous infusions, expanding the overall toxicity management burden," and added, "In contrast, stable monotherapy allows clinicians to extend outpatient follow-up intervals up to 3-4 months, offering distinct advantages regarding patient quality of life and long-term treatment persistence."Then, how can cumulative toxicities be managed during long-term Leclaza monotherapy?Clinicians utilize dose titration to manage treatment-induced side effects. For instance, if a patient experiences severe peripheral neuropathy while on the standard 240mg dose, the daily intake is down-titrated to 160mg to maintain treatment continuity. Professor Kim said, "Retrospective data indicate limited evidence of significant efficacy loss following programmatic dose reductions", adding that "The clinical community has accumulated extensive experience in maintaining long-term therapeutic durability through customized dose adjustments.The CNS metastases is a critical variable in overall treatment intensity. Approximately 25% to 30% of EGFR-mutant lung cancer patients present with brain metastases at initial diagnosis, and even when successfully controlled via upfront therapy, a significant proportion experience intracranial disease progression during long-term follow-up. In a pooled analysis of 64 patients with baseline CNS metastases from the LASER201 and LASER301 trials, the median intracranial progression-free survival (iPFS) with Leclaza was 27.7 months. Among patients with measurable baseline CNS lesions, the intracranial objective response rate (iORR) reached 92%, accompanied by a disease control rate (DCR) of 96%.For patients presenting with limited metastases, a strategy combining Leclaza monotherapy with localized radiation is frequently deployed. Professor Kim explained that "For oligometastatic patients presenting with fewer than five intracranial lesions, clinicians can utilize a strategy that pairs oral Leclaza with stereotactic body radiotherapy (SBRT) rather than initiating systemic combination infusions," and adding that "This combined approach effectively sustains clinical efficacy while successfully mitigating the burden of frequent hospital visits and combination-induced systemic toxicities."The clinical scope of Leclaza-based treatment strategies is projected to broaden further through ongoing Investigator-Initiated Trials (IITs) within South Korea. These trials are actively validating the drug's therapeutic potential across niche clinical segments that were underrepresented in registration trials, including T790M-negative cohorts, active brain and leptomeningeal metastases, and uncommon atypical EGFR mutations. Professor Han said, "IITs have been a critical role in developing real-world clinical strategies and establishing standards of care, and they will continue to serve as the engine for advancing novel therapeutic pathways in populations with high unmet needs."Professor Han emphasized the necessity of optimizing clinical efficacy as well as expanding patient access to the market. Professor Han explained that even when a novel therapeutic demonstrates exceptional clinical value, patients cannot derive real-world benefits if health insurance reimbursement is delayed or if long-term treatment generates unsustainable financial toxicity. Yuhan Corporation operated a nationwide Early Access Program (EAP) to provide the drug compassionately before formal national reimbursement and has recently implemented price reductions to systematically lower the long-term economic burden on patients with chronic conditions.Professor Han concluded by noting that "Given the limited pipeline of innovative, domestically developed innovative oncology agents in South Korea, Yuhan Corporation’s successful development of Leclaza presents a highly significant milestone for the domestic pharmaceutical industry," and added, "We hope that the company will draw its century-long corporate legacy to continue evolving into a global biopharmaceutical leader, driving innovation in foreign drug discovery."
- Company
- Fabhalta submitted for expanded reimb for rare kidney disease
- by Eo, Yun-Ho Jul 14, 2026 08:03am
- Product photo of FabhaltaAn oral complement inhibitor 'Fabhalta' is under review for expanding national health insurance reimbursement for the rare kidney disease C3 glomerulopathy (C3G).According to industry sources, Novartis Korea recently submitted an application to expand reimbursement for its Factor B inhibitor, Fabhalta (iptacopan), targeting the indication. Fabhalta was approved last November as the first therapeutic option for C3G, a disease that had lacked targeted therapies for 12 years since its clinical definition was established in 2013. C3G is a rare chronic glomerulonephritis caused by abnormal overactivation of the alternative complement pathway. C3G causes excessive C3 cleavage and activation of the C3 protein in the bloodstream, resulting in the accumulation of its byproducts within the renal glomeruli and triggering subsequent inflammation and tissue injury. The most common symptoms include proteinuria, hematuria, edema, hypertension, and fatigue, with approximately 50% of diagnosed patients progressing to end-stage renal disease (ESRD) within 10 years. Even following kidney transplantation, recurrence rates reach up to 66.7%, and post-recurrence data indicate a median time to allograft loss of 6.4 years. Previously, the therapeutic approach has relied heavily on non-specific supportive care, such as managing proteinuria and blood pressure, alongside certain conventional immunosuppressive agents. As an oral complement inhibitor, Fabhalta is a first-in-class agent that selectively binds to Factor B, a critical protein in the alternative complement pathway. It blocks activation of the pathway cascade and effectively reduces glomerular C3 deposition. The clinical efficacy of this drug was confirmed through the Phase 3 APPEAR-C3G study. This trial evaluated biopsy-confirmed C3G patients receiving Fabhalta 200 mg orally twice daily, assessing its therapeutic capacity to reduce proteinuria via the 24-hour urine protein-to-creatinine ratio (UPCR) and to stabilize renal function, as measured by estimated glomerular filtration rate (eGFR). In the APPEAR-C3G study, the primary endpoint, change in UPCR at 6 months relative to baseline, was -30.2% in the Fabhalta cohort and +7.6% in the placebo group. The Fabhalta group demonstrated statistically significant 35.1% reduction compared to the control group. Furthermore, the proportion of patients achieving the composite renal endpoint at 6 months was markedly higher in the Fabhalta group (30%) than in the placebo group (6%). At 12 months, the success rate in the Fabhalta group escalated further to 45%.Meanwhile, Fabhalta was added to the national health insurance reimbursement list in July 2025 as a treatment for paroxysmal nocturnal hemoglobinuria (PNH).
- Company
- Keytruda expands bladder and ovarian cancer indications
- by Son, Hyung Min Jul 13, 2026 09:28am
- Immuno-oncology drug KeytrudaMSD's immuno-oncology therapy Keytruda (pembrolizumab) has secured additional approvals in South Korea for the treatment of muscle-invasive bladder cancer (MIBC) and platinum-resistant ovarian cancer.The approval carries significance as it provides a new perioperative treatment option for bladder cancer patients who are ineligible for cisplatin-based chemotherapy, as well as an additional immunotherapy option for patients with platinum-resistant ovarian cancer, where treatment choices have been limited.MSD Korea announced on July 8 that the Ministry of Food and Drug Safety (MFDS) expanded Keytruda’s indication to muscle-invasive bladder cancer (MIBC) and platinum-resistant ovarian cancer.First, Keytruda was approved as neoadjuvant therapy in combination with enfortumab vedotin prior to surgery, followed by adjuvant therapy after radical cystectomy, for patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy.The drug also received approval, with or without bevacizumab, in combination with paclitaxel for patients with PD-L1-positive (CPS ≥1), platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received one or two lines of systemic therapy.According to data released by the Korea Central Cancer Registry (KCCR) in 2026, bladder cancer predominantly affects older adults, with more than half of patients aged 70 years or older.Among these patients, muscle-invasive bladder cancer is particularly aggressive, with nearly half eventually developing metastatic disease. Once distant metastasis occurs, the five-year relative survival rate falls to 13.2%, compared with 86.3% for localized disease.Although cisplatin-based chemotherapy before radical cystectomy remains the recommended standard of care, many elderly patients and those with impaired renal function are not eligible for the therapy, creating a substantial unmet need for new perioperative treatment strategies.Keytruda demonstrated clinical benefit in this population when administered as perioperative immunotherapy before and after radical cystectomy.The approval was based on the Phase III KEYNOTE-905 study, in which patients received neoadjuvant Keytruda plus enfortumab vedotin, underwent radical cystectomy, and then received adjuvant treatment with the same combination. After a median follow-up of 25.6 months, the regimen demonstrated statistically significant improvements in event-free survival (EFS), overall survival (OS), and pathological complete response (pCR) compared with the control group.The combination reduced the risk of an event by 60% in the EFS analysis and lowered the risk of death by 50% in the OS analysis compared with the control arm. It also achieved a 48.3 percentage-point higher pathological complete response rate than the control arm.KEYNOTE-B96 expands Keytruda as a treatment option in platinum-resistant ovarian cancerOvarian cancer remains an aggressive disease for which neither a definitive cause nor an effective screening method has been established. Even after appropriate first-line chemotherapy, approximately 70% to 80% of patients experience relapse.Platinum-based chemotherapy is the standard first-line treatment. However, approximately 25% of patients are platinum-refractory, showing little or no response to platinum-based chemotherapy from the outset. Even patients who initially respond often experience recurrence and eventually develop platinum-resistant disease. Until now, treatment for these platinum-resistant patients has largely consisted of non-platinum chemotherapy, with or without bevacizumab, but these regimens have not demonstrated a meaningful reduction in mortality.Keytruda demonstrated efficacy in the Phase III KEYNOTE-B96 trial involving patients with PD-L1-positive (CPS ≥1), platinum-resistant recurrent ovarian cancer (n=643) who had previously received one or two lines of systemic therapy.Participants were randomized 1:1 to receive either Keytruda or placebo, in combination with paclitaxel, with or without bevacizumab. In a PFS analysis of patients with CPS ≥1, the Keytruda regimen reduced the risk of disease progression or death by 28%. The regimen also reduced the risk of death by 24% in the OS analysis, demonstrating a statistically significant benefit. Median OS was 18.2 months.Heesung Lee, Oncology Business Unit Director at MSD Korea, said, “This indication expansion is particularly meaningful in that it provides new treatment options for patients with platinum-resistant ovarian cancer and muscle-invasive bladder cancer, two areas with significant unmet medical needs. We will continue working to expand treatment possibilities for even more patients through Keytruda."With these approvals, Keytruda now holds 5 approved indications in bladder cancer and 2 in ovarian cancer, bringing its total to 37 approved indications across 18 different cancer types in South Korea.
- Company
- Generic Equfina entry intensifies…high-dosage·unlisted patent challenge
- by Kim, Jin-Gu Jul 13, 2026 09:28am
- Product photo of 'Equfina'Review of generic approval applications for Eisai Korea’s Parkinson’s disease therapeutic, Equfina (safinamide) has officially commenced. Given that administrative issues do not arise during the Ministry of Food and Drug Safety (MFDS)'s marketing authorization review process, the filing companies are expected to secure a Prioritized Marketing Authorization.As the commercialization timeline draws closer, industry interest is focusing on the distinctive differentiation strategies deployed by Bukwang Pharmaceutical, Myung In Pharmaceutical, and Samil Pharmaceutical, the three domestic players competing in the Equfina generic market. The companies have played completely different strategic cards, including introducing a high-dose formulation that is absent from the innovator product portfolio and preemptively overcoming unlisted patents.Four products submitted to notified drug registry…'100mg high-dose' variable emerges According to the MFDS list of notified drug applications released on the 10th, four products containing safinamide mesylate have been submitted for marketing authorization. The three domestic companies finalized their regulatory filings within just two days after the innovator's Post-Marketing Surveillance (PMS) block expired on the 23rd of last month.Notably, a 100mg high-dose formulation has emerged as a major variable. The original product, Equfina, is currently commercialized exclusively as a single 50mg dosage strength. While three of the four filings on the notified drug list match the reference product's 50mg strength, the remaining application seeks authorization for a 100mg formulation. Analysis suggests that one of the three manufacturers filed for an expanded dosage strength to differentiate itself from the original drug by offering enhanced dosing convenience and improved patient compliance. Bukwang, Myung In, and Samil previously secured victories in negative scope-of-right confirmation trials targeting an Equfina formulation patent (Patent No. 10-1491541) slated to expire in 2028. Having already satisfied two key regulatory prerequisites for First Generic Exclusivity, namely the "first-to-file trial claim" and "trial victory", the companies will secure a 9-month market exclusivity period once the current review of their "first-to-file marketing authorization applications" is finalized.Samil successfully overcomes unlisted patent…preemptively disarms patent riskIndependent of the generic exclusivity timeline, one specific manufacturer has explored a distinct competitive pathway by preemptively mitigating its legal risk and patent exposure. Among the three generic competitors, Samil Pharmaceutical acted independently to file separate patent challenges against Equfina’s unlisted patents, securing an affirmative trial decision in April. Through this move, Samil became the first player to dismantle potential post-launch patent litigation risks.Equfina is known to have two underlying patents that are not registered in the MFDS Drug Patent List. While unlisted patents do not impede marketing authorization or the acquisition of First Generic Exclusivity, launching a generic product without invalidating or evading them exposes the generic sponsor to future patent infringement lawsuits or substantial damages claims from the innovator company.These three companies include CNS portfolios…target post-launch portfolip synergiesBecause all three companies undergoing regulatory review have commercial expertise within the Central Nervous System (CNS) therapeutic area, the market battle is expected to center on driving portfolio synergies with their existing neurodegenerative disease pipelines post-launch.This strategic interplay stems from Equfina's clinical positioning as an adjunctive therapy to 'levodopa'-containing therapy for Parkinson's disease patients experiencing end-of-dose motor fluctuations.In its existing portfolio, Myung In Pharmaceutical has a comprehensive portfolio of levodopa-based Parkinson’s therapies, including 'Myungdopar' (levodopa·benserazide), 'Perkin (levodopa·carbidopa)', and 'Trilevo (levodopa·carbidopa·entacapone)'. At the same time, Samil Pharmaceutical markets 'Onedopa (levodopa·benserazide)'. Conversely, Bukwang Pharmaceutical lacks a direct levodopa formulation. Still, it has aggressively invested in its CNS portfolio following the domestic commercial launch of its novel atypical antipsychotic 'Latuda (lurasidone)' for schizophrenia and bipolar disorder last year.Meanwhile, Equfina is a third-generation MAO-B (monoamine oxidase type B) inhibitor with a dual mechanism of action targeting both dopaminergic and non-dopaminergic signaling pathways. Since its launch as a reimbursed drug by Eisai Korea in February 2021, the product's domestic import volume has grown more than fourfold over three years, rising from $770,000 (approximately KRW 1.2 billion) in 2021 to $3.28 million (approximately KRW 5 billion) in 2024.
- Company
- Multiple myeloma indication added to 'Darzalex'
- by Son, Hyung Min Jul 13, 2026 09:28am
- Multiple myeloma treatment 'Darzalex'The scope of use of 'Darzalex' has expanded in multiple myeloma treatments.Following the expansion of combination therapy indications, from first-line treatment to relapsed·refractory settings, clinically validated Darzalex-based therapeutic strategies can now be utilized more broadly.According to industry sources, the Ministry of Food and Drug Safety (MFDS) recently approved expanded indications for combination therapy containing Darzalex (daratumumab) subcutaneous (SC) Inj. Developed by Johnson & Johnson, Darzalex is a targeted monoclonal antibody that binds to the CD38 glycoprotein, highly expressed on the surface of multiple myeloma cells.Following this regulatory approval, the DVRd quadruple combination therapy, which adds Darzalex SC into the conventional standard-of-care VRd triple combination therapy (bortezomib + lenalidomide + dexamethasone), has secured first-line therapeutic indications for both transplant-eligible (TE) and transplant-ineligible (TIE) patients.Additionally, the DPd triple combination therapy, combining Darzalex with pomalidomide and dexamethasone, has been newly authorized for patients with relapsed or refractory multiple myeloma (RRMM) who have received prior therapies including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD).First-line DVRd quadruple combination therapy confirmed improved progression-free survival (PFS) The clinical efficacy of the DVRd therapy was validated through the pivotal Phase 3 PERSEUS clinical trial.The PERSEUS trial evaluated and compared the efficacy and safety profiles of the DVRd therapy versus the standard VRd therapy in patients with newly diagnosed multiple myeloma (NDMM) aged 18 to 70 years.The study was designed so that following DVRd induction and consolidation therapy, patients in the experimental group transitioned to a maintenance therapy combining lenalidomide and Darzalex SC. In contrast, the control group received lenalidomide monotherapy maintenance.Trial results at 48-month analysis showed that the progression-free survival (PFS) rate was 84.3% in the DVRd group whereas 67.7% in the VRd control group. The data demonstrated a statistically significant reduction in the risk of disease progression or death with the DVRd therapy compared with the VRd group. The most prevalent Grade 3 or higher adverse events reported in the DVRd group were neutropenia (62.1%), followed by thrombocytopenia (29.1%), diarrhea (10.5%), pneumonia (10.5%), and febrile neutropenia (9.4%). Overall, the incidence of severe toxicities was higher in the DVRd group than in the baseline VRd control group.In a PFS extrapolation analysis using data from the PERSEUS trial and another Phase 3 study, CEPHEUS, the best-fit model projected a median progression-free survival of approximately 17.1 years for the transplant-eligible group (PERSEUS) receiving the DVRd therapy. Currently, the National Comprehensive Cancer Network (NCCN) Guidelines designate the Darzalex SC-containing quadruple combination therapy (DVRd) as a preferred option for the first-line treatment of newly diagnosed, transplant-eligible (TE) multiple myeloma patients.Effectiveness of first-line DVRd therapy in transplant-ineligible multiple myelomaThe therapeutic utility of the DVRd therapy in transplant-ineligible (TIE) patients, or those for whom first-line autologous stem cell transplantation is not planned, was robustly established in the Phase 3 CEPHEUS clinical trial.This study evaluated multiple myeloma patients with no prior treatment history, as well as those who were either transplant-ineligible or did not intend to undergo upfront transplantation, and directly compared the long-term clinical benefits of DVRd therapy versus VRd therapy under a continuous treatment strategy.At a median follow-up of 58 months, the DVRd group demonstrated a significantly reduced risk of disease progression or mortality compared to the VRd control group.The primary endpoint of overall minimal residual disease (MRD) negativity rate (10⁻⁵) was significantly higher in the DVRd group (60.9%) than in the VRd group (39.4%).Furthermore, the proportion of patients who achieved a sustained MRD-negative response lasting 12 months or longer was substantially higher in the DVRd group (48.7%) than in the VRd control group (26.3%).The safety profile of the DVRd group reported in the CEPHEUS clinical trial was consistent with the established parameters previously documented for these individual agents.The NCCN Guidelines recommend Darzalex-containing combination therapies, such as DVRd, as a preferred first-line treatment option for transplant-ineligible patient populations, contingent upon individual patient performance status.Relapsed·refractory patients experiencing two or more incidences, expanded therapeutic options via the DPd RegimenAdditionally, regulatory approval was granted for a Darzalex SC-based triple combination therapy combining pomalidomide and dexamethasone (DPd). This therapy is designated for patients with relapsed or refractory multiple myeloma whose disease progressed following a first-line treatment and who have exposure to prior lines of therapy containing both a proteasome inhibitor and an immunomodulatory drug.Consequently, treatment options have expanded to consider this Darzalex SC-containing combination therapy as a primary therapeutic alternative for relapsed or refractory multiple myeloma patients previously managed with PIs and IMiDs.The clinical efficacy and safety of the DPd therapy were established through the Phase 3 APOLLO trial. This APOLLO trial is a Phase 3 clinical trial evaluating the therapeutic outcomes of the DPd therapy versus the Pd in patients with relapsed or refractory multiple myeloma who had received at least one prior line of therapy, including previous exposure to lenalidomide and a proteasome inhibitor.Primary analysis at a median follow-up of 16.9 months demonstrated that the median progression-free survival in the DPd group was 12.4 months, compared with 6.9 months in the Pd control group, indicating a significantly lower risk of disease progression or mortality.The current NCCN Guidelines recommend the DPd therapy as a preferred therapy for patients who have relapsed or become refractory following prior lines of therapy consisting of lenalidomide and a proteasome inhibitor.As Darzalex SC-based combination therapies secure indications in first-line and second- or later-line settings, calls to broaden therapeutic access are intensifying within the medical community.Professor Sung-Hoon Jung of the Department of Hematology at Chonnam National University Hwasun Hospital remarked, "The MFDS approval of these Darzalex-based combination therapies allows the domestic clinical community to align their multiple myeloma treatment strategies directly with established global guidelines. Given the high demand among clinicians for access to modern standards of care, it is imperative to initiate policy discussions to enhance patient access through national health insurance reimbursement or co-payment support frameworks."
- Company
- Olympus Korea sales rebound to KRW 230 billion
- by Hwang, byoung woo Jul 10, 2026 08:45am
- Olympus Korea has successfully rebounded from the previous year’s sales decline with sales amounting to approximately KRW 230 billion.The company recorded growth in both product sales and services, while a mitigated cost of goods sold (COGS) burden drove increases in both operating and net profit. Furthermore, the company is solidifying its foundation for future growth by shifting away from its focus on endoscopy instrumentation, toward artificial intelligence (AI) and therapeutic solutions. Returning to the KRW 230 billion sales…Strengthened financial positionAccording to Olympus Korea’s recently disclosed 26th fiscal audit report (April 1, 2025, to March 31, 2026), the company's annual revenue reached KRW 231.3 billion. This result carries significance as the company generated an KRW 8.9 billion expansion from the KRW 222.4 billion reported in the previous year, recovering the prior year's losses. Notably, this figure surpasses the KRW 230.1 billion recorded in the 24th term, the highest revenue performance among the last four fiscal terms.Olympus Korea had maintained stable revenues of KRW 231.0 billion in its 23rd term and KRW 230.1 billion in its 24th term, before dropping to KRW 222.4 billion in its 25th term. The sales drop in the 25th term coincided with operational disruptions at South Korean clinical sites due to the healthcare dispute between doctors and the government.The company's profitability also improved. Operating profit for the 26th term rose to KRW 20.9 billion, up KRW 5.0 billion from the previous term's KRW 15.9 billion. Net income also increased to KRW 17.1 billion, up KRW 4.4 billion from the previous term's KRW 12.7 billion. This turnaround signifies that Olympus Korea has restored both its top-line revenue scale and intrinsic profitability to levels achieved before the healthcare conflict. Olympus Korea Sales between 2021-2025 (PURPLE: SALES, GREEN: OPERATING PROFITS, BLUE: NET INCOME). Source: FSS, unit: KRW 100 millionCOGS for the 26th term decreased to KRW 141.0 billion from KRW 144.4 billion in the prior term. Despite rising sales, this cost reduction led to an expansion of gross profit from KRW 78.0 billion to KRW 90.3 billion. Consequently, the gross profit margin climbed from approximately 35.1% in the preceding term to around 39.0% in the 26th term. Selling, general, and administrative (SG&A) expenses rose to KRW 69.5 billion from KRW 62.1 billion in the prior year. Other metrics include increases across salaries and bonuses, retirement benefits, outsourced services, and sales promotion expenses. However, the positive impact of the improved COGS ratio successfully absorbed the expanded overhead, allowing operating profit to rebound compared to the previous year. Notably, the drastic drop in the interim dividend paid out to the parent company, Olympus Corporation.For the 26th term, Olympus Korea distributed a total interim dividend of KRW 9.5 billion (KRW 26,388,889 per share). This represents a 44.1% reduction compared to the interim dividend of approximately KRW 16.99 billion (KRW 47,202,441 per share) allocated during the 25th term. As a combined result of rising net income and optimized dividend sizing, retained earnings grew from KRW 78.1 billion in the prior term to KRW 85.0 billion. This indicates that, alongside top-line recovery, the company has reinforced its internal capital reserves. Growth in both products and services…expanding therapeutic portfolio expansionBy revenue category, both product sales and service provisions demonstrated stable upward trajectories. Product revenue for the 26th term amounted to KRW 193.8 billion, up KRW 4.5 billion from the previous term's KRW 189.3 billion. Concurrently, service revenue climbed to KRW 37.5 billion, a KRW 4.4 billion advance from the KRW 33.2 billion posted in the prior term. The overall top-line gains were evenly balanced between equipment commercialization and technical service lines. This trend aligns with Olympus Korea's strategic transition from a pure-play medical equipment supplier to an integrated provider of services and therapeutic solutions. Leveraging its established diagnostic leadership in gastrointestinal endoscopy imaging systems, the company is accelerating the construction of integrated therapeutic portfolios that fuse surgical instrumentation with advanced digital solutions. A primary example of this commercial blueprint is iTind, a minimally invasive therapeutic device designed for benign prostatic hyperplasia (BPH). Fabricated from nitinol, the device offers a non-incisional therapeutic option that can be performed under local anesthesia. Following its regulatory designation under South Korea's New Medical Technology assessment, the system has steadily expanded its market penetration across both tertiary hospitals and localized clinics. This year, portfolio diversification has accelerated across both the digital solution and surgical device sectors.In January, Olympus Korea executed a MOU with INEX Corporation to initiate the domestic commercialization of ENAD, an AI-powered endoscopy image analysis software. The strategic core of the partnership involves interfacing and deploying ENAD within Olympus's existing hardware ecosystems to broaden digital touchpoints in endoscopy diagnostics. Additionally, in April, the company officially launched its next-generation laparoscopic surgical instrument line, HICURA, into the Korean market. HICURA is a core surgical handpiece used in diverse minimally invasive procedures, including general surgery, gynecology, and urology, emphasizing operational efficiency in the operating room through a three-stage modular system and an extensive portfolio of jaw configurations. Olympus Korea's 26th-term performance is significant, as it boosted a clear recovery from the revenue volatility triggered by the domestic medical conflict. Annual revenue successfully rebounded to approximately KRW 230 billion, accompanied by expansions in operating profit and net income compared with the previous year.Currently, industry attention will center on whether the company can overcome its exterior growth beyond this KRW 230 billion range besides the 25th term. Given that the initial introduction of medical equipment inherently generates revenue streams, including clinical training, maintenance, repairs, and software upgrades, the expansion of the therapeutic portfolio, alongside high-margin service revenue, will be the primary pillars driving the company's long-term growth in South Korea.
- Company
- 'Brukinsa' aims to obtain CLL reimb for all age groups
- by Eo, Yun-Ho Jul 10, 2026 08:45am
- Product photo of BTK inhibitor 'Brukinsa'The second-generation BTK inhibitor 'Brukinsa' aims to expand its prescription areas to all age groups in the chronic lymphocytic leukemia (CLL) treatment.According to industry sources, BeOne Medicines Korea recently submitted an application to expand national health insurance reimbursement for Brukinsa (zanubrutinib). The application details include the first-line treatment of treatment-naïve CLL adult patients under the age of 65 who present with co-morbidities.Consequently, it is noteworthy to watch whether this strategy will successfully improve the treatment paradigm for CLL patients under 65. These age groups have been relying on conventional chemoimmunotherapy regimens such as FCR (fludarabine·cyclophosphamide·rituximab).While chronic lymphocytic leukemia is the most prevalent leukemia subtype in Western countries, it is a relatively rare disease in South Korea. Although reported figures vary across literature, the prevalence in South Korea is reported to be approximately 10 to 20 times lower than that observed in Western populations. This low disease prevalence is a shared epidemiological characteristic documented across East Asia, including Japan.A distinct clinical feature characterizing South Korean CLL patients is the age group. In Western cohorts, the median age at diagnosis typically falls in the 70s, whereas numerous domestic studies report a significantly lower median age of around 60 years, ranging from 60 to 65 years. Consequently, a substantial proportion of South Korean patients are diagnosed at a relatively younger age; in several cases, the under-65 patient group is reported.Brukinsa is currently recommended as Category 1 for the first-line treatment of CLL under the National Comprehensive Cancer Network (NCCN) Guidelines. Globally, it is being recommended as a primary treatment option without age-based restrictions. However, in South Korea, national health insurance reimbursement for Brukinsa is strictly limited to CLL patients aged 65 and older. Analysis suggests that this restrictive indication was established because Brukinsa's reimbursemnt has been tied to the listed indication set by the first-in-class BTK inhibitor, 'Imbruvica (ibrutinib)'. Both health professionals and patients have consistently pointed out the current situation and called for expanding Brukinsa's reimbursement criteria in the CLL treatment.Meanwhile, the clinical efficacy of Brukinsa in CLL was confirmed through the global Phase 3 SEQUOIA trial. This study evaluated patients with CLL or small lymphocytic lymphoma (SLL) who has no prior treatment history, comparing Brukinsa directly with a combination therapy of 'Symbenda (bendamustine)' + 'MabThera (rituximab)'.The study results showed that at 24-month, the primary endpoint of progression-free survival (PFS) was 85.5% in the zanubrutinib group versus 69.5% in the bendamustine + rituximab control group. Furthermore, Brukinsa demonstrated a substantial 58% reduction in the risk of disease progression or death compared to the active control group.
- Company
- Biogen Korea appoints Chul Woong Kim as new GM
- by Eo, Yun-Ho Jul 08, 2026 08:54am
- The leadership vacancy at Biogen Korea, which had remained unfilled since the resignation of former GM Se-Eun Hwang, is finally set to be filled.According to industry sources, Biogen Korea has recently appointed Chul Woong Kim, Director of the Rare Disease Business Unit at AstraZeneca Korea, as its new General Manager. He is expected to officially join Biogen later this month.Biogen Korea has operated without a head for approximately four months following Hwang's sudden resignation in February. The former GM subsequently joined CSL Korea as its new head in March.Kim earned his bachelor's degree in International Trade from Dongguk University and completed an MBA at Yonsei University's Graduate School of Business. He is a seasoned rare disease expert with more than 20 years of experience across domestic and global pharmaceutical companies, spanning sales, marketing, brand strategy, and business unit management.Kim began his pharmaceutical career at Eli Lilly Korea before leading the hemophilia and rare disease business at Pfizer Korea. He later assumed a regional leadership role based in Hong Kong, overseeing rare disease strategy across Emerging Markets in Asia. Since 2022, he has served as Business Unit Director of AstraZeneca Korea's Rare Disease Business Unit, leading the company's rare disease operations in Korea.
- Company
- Samsung Bioepis gains edge in Keytruda biosimilar race
- by Hwang, byoung woo Jul 08, 2026 08:53am
- Samsung Bioepis’ headquartersSamsung Bioepis has taken the lead in the race to develop a biosimilar to the blockbuster immuno-oncology drug Keytruda, becoming the first company to disclose Phase III clinical data.With the patent expiration of Keytruda, which has exceeded $30 billion in global sales, approaching, it is assessed that Samsung Bioepis has established the foundation for a follow-up approval strategy targeting the large-scale immuno-oncology biosimilar market by leveraging its extensive clinical data.Secures ‘Phase III data… differentiates regulatory positioningSamsung Bioepis recently announced that SB27, its Keytruda biosimilar candidate, met the primary efficacy endpoints in both global Phase I and Phase III clinical studies, demonstrating equivalence to the original product.The Phase I trial enrolled 163 participants across four countries, including South Korea. The company reported that pharmacokinetic analyses of the area under the plasma level-time curve (AUC) met the predefined equivalence criteria.The Phase III trial enrolled 555 patients in 14 countries. In patients with non-small cell lung cancer (NSCLC), SB27 demonstrated efficacy equivalent to the reference product based on the objective response rate (ORR) at Week 24, the study's primary endpoint. Comparable safety and immunogenicity profiles were also observed.The significance of these findings lies in Samsung Bioepis becoming the first developer to present topline results from a global Phase III study in the Keytruda biosimilar race, thereby securing clinical evidence that could strengthen its regulatory competitiveness. By completing both global Phase I and Phase III studies, the company has assembled a comprehensive clinical package expected to enhance its position during future regulatory review and commercialization.According to the company, both clinical studies are scheduled to be fully completed within this year. However, completion of the trials does not necessarily mean regulatory submissions or product launch will occur within the same timeframe.Even after clinical completion, biosimilar approval requires additional steps, including data collection and analysis, preparation of regulatory data, and development of country-specific submission strategies.USD 31.7 billion market fuels intensifying competitionThe fierce competition surrounding Keytruda biosimilars reflects the enormous size of the original’s market. According to MSD's 2025 financial results, combined annual sales of Keytruda and the subcutaneous formulation Keytruda Qlex reached USD 31.7 billion (approximately KRW 46 trillion), making it one of the world's highest-selling pharmaceutical products.Keytruda is a PD-1 immuno-oncology drug indicated for a wide range of cancers, including non-small cell lung cancer, melanoma, and head and neck cancer, giving it a broad treatment base and substantial prescribing volume.Given the product's commercial value, multiple developers are racing to develop biosimilars. The compound patent is scheduled to expire sequentially beginning in 2028 in Korea, 2029 in the United States, and 2031 in Europe, intensifying global competition to secure early market entry.Celltrion is conducting a global Phase III trial of its Keytruda biosimilar CT-P51, while China's Bio-Thera Solutions has initiated an integrated Phase I/III study of BAT3306. Other global biosimilar developers, including Formycon and Sandoz, are also pursuing pembrolizumab biosimilars.Samsung Bioepis' key advantage lies in having completed both global Phase I and Phase III studies, providing a robust clinical evidence package that goes beyond the minimum regulatory requirements and is expected to strengthen physician trust.MSD’s KeytrudaThis is particularly meaningful because large immuno-oncology biosimilars require complex trial designs and extensive patient recruitment. Demonstrating success in both Phase I and Phase III studies is expected to carry significance in future regulatory submissions and partnership discussions.Another noteworthy development is the evolving regulatory strategy among competitors. As the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) move toward streamlining biosimilar approval requirements, companies such as Sandoz and Formycon have discontinued Phase III trials and are instead pursuing regulatory approval based solely on Phase I data.While Samsung Bioepis benefits from having completed conventional global Phase I and Phase III studies, some competitors may seek approval through these alternative regulatory pathways under the evolving framework.Nevertheless, because Samsung Bioepis adopted an overlapping strategy by initiating Phase I and Phase III studies simultaneously, its extensive efficacy and safety data from a large-scale Phase III trial are expected to serve as a major competitive advantage in the prescription conservative oncology market, building physician trust and supporting future market penetration.Another challenge will be overcoming MSD's evergreen strategy aimed at extending the commercial life of Keytruda. To defend against biosimilar competition, MSD is actively transitioning patients from the intravenous (IV) formulation to a more convenient subcutaneous (SC) formulation, pursuing regulatory approvals in major markets in an effort to contain as many patients as possible before biosimilars become available.For Samsung Bioepis, successful commercialization will depend not only on regulatory approval timelines but also on product differentiation, manufacturing and supply capabilities, reimbursement and tender strategies in individual markets, and commercial partnership capabilities.The company stated that it is still too early to disclose specific launch plans or commercialization strategies for SB27.However, because patent expiry is expected earlier in Korea than in many other markets, industry observers believe the product could potentially be launched first in Korea in 2028. However, the actual launch timing will ultimately depend on regulatory review, patent litigation, and market conditions in each country.Dong-hoon Shin, Executive Vice President of Clinical Science at Samsung Bioepis, said, "Demonstrating equivalence between SB27 and the reference product represents a meaningful achievement that showcases Samsung Bioepis' global biosimilar development capabilities. Building on our rigorous quality management system, we will continue to strive to improve patient access to immuno-oncology therapies through biosimilars."
- Company
- Lynparza secures long-term survival evidence in ovarian cancer
- by Son, Hyung Min Jul 08, 2026 08:53am
- PARP inhibitor 'Lynparza (olaparib)' The evaluation criteria for first-line maintenance therapy in ovarian cancer is shifting.Delaying disease recurrence, progression-free survival (PFS), and overall survival (OS) improvements are now included as primary endpoints for assessing therapeutic efficacy, underscoring the growing importance of initiating early-stage treatment strategies optimized for long-term prognosis.According to biopharmaceutical industry sources, recent global clinical guidelines are increasingly prioritizing biomarker-based personalized medicine for the ovarian cancer therapy.As treatment strategies become increasingly subdivided, targeting patients with BRCA mutations to those with homologous recombination deficiency (HRD), the clinical value of first-line maintenance therapies backed by long-term survival data has increased. Consequently, the therapeutic strategy is shifting toward subdividing treatment pathways based on patient-specific biomarker profiles to maximize the likelihood of modifying long-term prognosis from the initial maintenance therapy. Amid these clinical shifts, the PARP inhibitor 'Lynparza (olaparib)' is being assessed as a therapeutic option with long-term follow-up data across both BRCA-mutated and HRD-positive patients from the SOLO-1 and PAOLA-1 trials, respectively.Ovarian cancer has the highest mortality rate among all gynecological malignancies. A significant majority of patients are diagnosed at an advanced stage. Despite high initial response rates to frontline interventions, the clinical course is characterized by frequent recurrences, followed by sequential rounds of subsequent lines of therapy. Given these clinical challenges, real-world oncology practice is rapidly shifting toward maintenance strategies that prioritize overall survival (OS) outcomes alongside progression-free survival. The SOLO-1 study has proved Lynparza's effectiveness as a first-line maintenance therapy for BRCA-mutated ovarian cancer. At the 3-year follow-up analysis, the progression-free survival rate was 60% in the Lynparza group, compared with 27% in the placebo arm, demonstrating a 70% reduction in the risk of disease progression or death. Subsequent 7-year follow-up data provided evidence of long-term survival. The overall survival rate in the Lynparza group was confirmed at 67%, a 45% reduction in the risk of death compared to the placebo control (mOS: NR vs. 75.2 months). This indicates that 2 of 3 patients survived to the 7-year mark, validating that the survival benefit of frontline Lynparza maintenance therapy is sustained over extended follow-up. In addition to the BRCA-positive patients, Lynparza demonstrated a consistent overall survival benefit in patients with HRD-positive status.In the 5-year follow-up analysis of the PAOLA-1 clinical trial, the 5-year overall survival rate among HRD-positive patients was 65.5% in the Lynparza + bevacizumab combination therapy group versus 48.4% in the bevacizumab monotherapy group, translating to a 38% reduction in the risk of death. Within the same analysis, the median progression-free survival reached 46.8 months and 17.6 months, respectively, representing a 59% reduction in the risk of disease progression or death. The significance of the PAOLA-1 5-year data extends beyond merely securing additional long-term tracking points. Demonstrating a statistically significant overall survival benefit in the first-line maintenance setting is difficult in ovarian cancer clinical trials, as the data are highly susceptible to confounding by multiple sequential lines of subsequent therapies administered after recurrence. This trial demonstrated that the Lynparza + bevacizumab combination therapy maintains a highly consistent clinical benefit for HRD-positive patients over an extended long-term follow-up period, consistent with the efficacy seen in the initial primary analyses.Notably, the long-term follow-up study results of sustained PFS, alongside enhanced 5-year survival rates and reduced mortality risk, provides significant evidence supporting the clinical value proposition of this therapeutic strategy. This outcome confirms that frontline maintenance product selection directly correlates with downstream long-term prognostic outcomes. Homologous recombination deficiency represents a critical biomarker detected in approximately half of all patients with high-grade serous ovarian cancer, the primary histological subtype of the disease. As the ovarian cancer treatment paradigm transitions into biomarker-based precision oncology, the clinical weight of mature long-term survival evidence generated within the HRD-positive population has risen substantially.This clinical evidence is firmly reflected in international therapeutic standards. The National Comprehensive Cancer Network (NCCN) Guidelines recommend Lynparza following platinum-based chemotherapy in both BRCA-mutated and HRD-positive cohorts. Notably, within the HRD-positive population, the Lynparza plus bevacizumab combination therapy is the only PARP inhibitor-based therapy designated as a Category 1 recommendation.Despite strong clinical evidence and inclusion in standard global guidelines, patient market access bottlenecks persist in South Korea. While health insurance coverage is active for the BRCA-mutated cohort, the Lynparza-bevacizumab combination based on the PAOLA-1 trial for HRD-positive patients remains non-reimbursed. Although the therapy cleared the initial regulatory hurdle at the Cancer Disease Review Committee (CDRC) in September of last year, final implementation of the expanded reimbursement criteria has been delayed for nearly a year. Consequently, oncologists emphasize that even when companion diagnostic HRD screening identifies patients who would derive clinical benefit, financial barriers prevent the deployment of this optimized first-line maintenance strategy in real-world clinical practice.Discussions about the need to expand reimbursement for Lynparza have intensified recently. "The 2nd National Health Insurance Comprehensive Plan," finalized in March, includes provisions to review expanded reimbursement criteria for oncology therapeutics utilized in ovarian cancer care. Simultaneously, calls for improving patient access continue to gain traction across regulatory policy forums and academic symposia. Professor Se Ik Kim of the Department of Obstetrics and Gynecology at Seoul National University Hospital said, "Given that ovarian cancer carries a high recurrence rate requiring repetitive lines of sequential therapy, it is imperative to establish frontline strategies focused on maximizing long-term survival probability from the outset. Rather than simply delaying time-to-recurrence, clinical management must increasingly prioritize therapeutic strategies that optimize long-term prognosis by integrating patient-specific biomarker characteristics."Professor Kim added that Lynparza is a PARP inhibitor with mature, long-term survival data across both BRCA-mutated and HRD-positive populations from the SOLO-1 and PAOLA-1 trials. He emphasized that it is highly clinically meaningful because it demonstrates that frontline maintenance product selection in the HRD-positive population can significantly dictate downstream, long-term therapeutic outcomes. Professor Kim concluded by emphasizing that "While clinicians can now screen and identify patients expected to benefit clinically via companion HRD testing, patient access to treatment remains restricted. We expect that discussions on patient access advance rapidly so that clinically validated therapeutic strategies can be applied to real-world patient care. "
