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- 2026-04-21 15:18:26
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- 'Expanded reimb for Keytruda…expected to improve solid cancer treatment performance'
- by Son, Hyung Min Jan 30, 2026 10:59am
- Professor Keun-Wook Lee of the Department of Hematology and Oncology at Seoul National University Bundang HospitalThe immune checkpoint inhibitor Keytruda is bringing a major shift in the oncology treatment landscape in Korea following expanded scope of reimbursement across major solid tumors.Of the 11 indications included in the reimbursement scope, evaluations suggest that the potential to improve patient access and survival outcomes has increased in areas where existing treatment options were limited.On the 29th, MSD Korea held a press conference at Seongam Art Hall in Gangnam-gu, Seoul, to commemorate the expansion of reimbursement for Keytruda (pembrolizumab).Starting from the 1st of this month, Keytruda's reimbursement in Korea has been expanded to a total of 11 indications, including metastatic HER2-positive and negative gastric cancer, recurrent and metastatic triple-negative breast cancer (TNBC), head and neck cancer, and endometrial cancer.As MSD's flagship immunotherapy targeting PD-1, Keytruda has proven clinical evidence across various solid tumors, and this reimbursement adjustment is drawing industry attention as it covers cancers with high unmet medical needs.Professor Keun-Wook Lee of the Department of Hematology and Oncology at Seoul National University Bundang Hospital emphasized the importance of expanding Keytruda's reimbursement for gastrointestinal cancers, including gastric and colorectal cancers.Patient access to Keytruda has improved, as reimbursement is now available for major gastrointestinal cancers, including HER2-positive gastric cancer, first-line treatment for HER2-negative gastric cancer with PD-L1 CPS 10 or higher, and microsatellite instability-high (MSI-H) colorectal cancer.Professor Lee evaluated, "Keytruda's accessibility has improved as it is now reimbursed for major gastrointestinal cancers," and added, "Considering the characteristics of these cancers, which are directly linked to eating, digestion, and bowel functions and cause great discomfort in life, this expansion is a crucial turning point for patients."Professor Min Hwan Kim of the Department of Hematology and Oncology at Severance HospitalProfessor Lee added, "Reimbursement to minority patient groups such as MSI-H is a meaningful achievement from both clinical and institutional perspectives."Professor Min Hwan Kim of the Department of Hematology and Oncology at Severance Hospital mentioned major clinical evidence in female cancers, such as breast and endometrial cancer.Professor Kim stated, "Keytruda demonstrated meaningful therapeutic effects in metastatic endometrial cancer for the first time in about 50 years, and clearly showed improvement in survival duration compared to conventional therapies even in triple-negative breast cancer, which has a very poor prognosis."Professor Kim explained, "Keytruda confirmed meaningful treatment outcomes in metastatic settings based on sustained responses, which can lead to prolonged survival and improved quality of life."Beyond immunotherapy toward ADCs and targeted therapies, MSD's R&D strategy is acceleratingImmune checkpoint inhibitor to ADC and targeted cancer drugSoo Jung Kim, Executive Director of the Medical Affairs Department at MSD KoreaMSD Korea is strengthening domestic access to cancer treatment and developing innovative new drugs, starting with this reimbursement expansion.MSD is also making efforts to improve administration convenience by developing a subcutaneous (SC) formulation of Keytruda, named 'Keytruda QLEX.'Soo Jung Kim, Executive Director of the Medical Affairs Department at MSD Korea, said, "Keytruda holds more than 40 indications across 18 cancer types. It has changed the paradigm of cancer treatment by improving survival duration in various cancers," and noted, "In the case of Keytruda QLEX, administration is possible in just two minutes. This will significantly increase patient convenience."Kim added, "More than 30 global Phase 3 clinical trials for new oncology drugs are underway. We are expanding our R&D portfolio not only in immunotherapy but also in the fields of targeted therapy and antibody-drug conjugates (ADC)."MSD entered into a joint ADC development agreement with Daiichi Sankyo in 2023 and secured global rights (excluding Japan) for three candidate materials ▲patritumab deruxtecan ▲ifinatamab deruxtecan ▲raludotatug deruxtecan.In particular, clinical research on the B7-H3-targeting ADC 'ifinatamab deruxtecan' is underway to establish a new combination for small cell lung cancer through combination strategies with MSD's bispecific antibody 'MK-6070.'MSD is also conducting global Phase 3 trials for the ADC 'MK-2870.' MK-2870 targets Trop-2 and is being developed with the goal of securing an indication for triple-negative breast cancer. This ADC is a candidate material that MSD in-licensed from China's Kelun-Biotech in 2022 for $1.41 billion.MSD is also actively pursuing next-generation combination strategies linking immunotherapies, targeted therapies, and cancer vaccines.Albert Kim, CEO of MSD Korea, said, "Keytruda's expanded reimbursement is the result of everyone's cooperation to create a healthy tomorrow for patients," and added, "We will continue to prioritize patient-centered treatment accessibility as our top value and actively participate in creating clinical evidence and discussions."
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- Epkinly, a new bispecific antibody for DLBCL, enters the drug negotiation stage
- by Eo, Yun-Ho Jan 29, 2026 08:17am
- Epkinly, new T-cell-engaging bispecific antibody drug, has entered the final stage for insurance reimbursement listing.According to industry sources, AbbVie Korea is currently conducting drug price negotiations with the National Health Insurance Service (NHIS) for the diffuse large B-cell lymphoma (DLBCL) treatment Epkinly (epcoritamab).Epkinly was approved in Korea in June 2024 and obtained designation as an orphan drug by the Ministry of Food and Drug Safety (MFDS).Epkinly is a humanized bispecific antibody (IgG1) that binds to specific extracellular epitopes of CD20 on B-cells and CD3 on T-cells.The drug induces specific T-cell activation and T-cell-mediated killing of CD20-expressing cells by simultaneously acting on cancer cells expressing CD20 and on T-cells expressing CD3.The efficacy of Epkinly was demonstrated in the EPCORE NHL-1 study, a non-randomized, single-arm clinical trial involving 167 patients with relapsed or refractory large B-cell lymphoma who had received 2 or more systemic therapies.Three-year follow-up results from the EPCORE NHL-1 study showed an overall objective response rate (ORR) of 59% and a complete remission (CR) rate of 41%, confirming that more than half of patients who achieved CR maintained their remission after three-years.Professor Deok-hwan Yang of the Department of Hematology at Chonnam National University Hwasun Hospital stated, "Epkinly, a bispecific antibody treatment, not only showed a complete remission rate similar to CAR-T treatments but can also be administered to patients immediately at medical institutions without a separate manufacturing period. As it targets a different antigen than CD19-targeting CAR-T treatments, the emergence of a new treatment option for patients who have failed CAR-T therapy is favorable."Meanwhile, the topline results of AbbVie's Phase 3 EPCORE DLBCL-1 study was disclosed recently. This study was conducted on 483 patients with relapsed or refractory DLBCL who had received one or more prior treatments and were ineligible for high-dose chemotherapy and autologous stem cell transplantation (HDT-ASCT).According to the topline results, Epkinly improved progression-free survival (PFS) by 26%. However, it failed to demonstrate an improvement in overall survival (OS), which was the primary endpoint.
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- First FRα-targeted ADC Elahere approved for ovarian cancer
- by Son, Hyung Min Jan 29, 2026 08:16am
- The antibody–drug conjugate (ADC) class has entered the ovarian cancer field, signaling a potential shift in the treatment paradigm.On the 28th, AbbVie Korea held a press briefing at the Plaza Hotel in Jung-gu, Seoul, to mark the approval of Elahere (mirvetuximab soravtansine) in Korea.Elahere was approved last month for the treatment of high-grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is folate receptor alpha (FRα) positive and resistant to platinum-based chemotherapy, in patients who have previously received one to three prior systemic therapies before the 19th of last month.Jung-yun Lee, Professor of Obstetrics and Gynecology, Severance HospitalElahere is an ADC targeting FRα-positive ovarian cancer. Its mechanism involves delivering the potent cytotoxic drug DM4 directly into cancer cells to destroy the tumor. The drug is drawing particular attention as a new option for patients with ovarian cancer who have developed resistance to platinum-based chemotherapy.Patients with platinum-resistant ovarian cancer often have compromised systemic health due to cumulative toxicity from repeated prior treatments and comorbidities. Therefore, effective later-line treatment options are crucial. However, existing standard treatments like non-platinum-based chemotherapy or certain targeted therapies have shown limited clinical benefits, with low response rates and no statistically significant improvement in survival.In clinical studies, Elahere reduced the risk of disease progression or death by 35% compared with standard non-platinum chemotherapy.The median progression-free survival (PFS) was 5.62 months, an improvement over 3.98 months in the control group. The objective response rate (ORR) reached up to 42.3%, significantly higher than 15.9% observed with standard therapy. The median overall survival (OS) was 16.85 months, versus 13.34 months in the control group, corresponding to a 32% reduction in the risk of death.From a safety perspective, the majority (88%) of adverse events observed in the Elahere treatment group were low-grade and manageable.The Korean Society of Gynecologic Oncology (KSGO) guidelines recommend Elahere for the treatment of FRα-positive platinum-resistant ovarian cancer with the highest level of evidence (Level I) and strongest recommendation grade (Grade A).Jung-yun Lee, Professor of Obstetrics and Gynecology, Severance Hospital, who participated in the pivotal clinical trial, stated, “Elahere demonstrated meaningful improvements across key clinical endpoints in platinum-resistant ovarian cancer, an area with high unmet medical need. It also showed consistent efficacy across subgroups. With an ORR of 42.3%, which is higher than that of the control group, Elahere offers the possibility of improved outcomes even for patients who previously had limited expectations of response. It is the first FRα-targeted therapy to demonstrate an overall survival benefit.”Importance of biomarker testing rises in ovarian cancerProfessor Jae-kwan Lee, Korea University Guro Hospital, Department of Obstetrics and GynecologyWith the approval of Elahere, biomarker-driven personalized treatment strategies are now being more fully implemented in ovarian cancer, raising expectations for meaningful changes in the treatment paradigm.While targeted therapies in ovarian cancer were previously limited to those based on the expression of a few biomarkers like PARP and HER2, the emergence of Elahere has highlighted the importance of FRα biomarker testing.FRα is a protein involved in tumorigenesis and is minimally expressed in normal tissues but highly expressed in ovarian cancer.Approximately 35-40% of all ovarian cancer patients are reported to be FRα-positive. Its expression tends to remain consistent from diagnosis through recurrence, enabling personalized targeted therapy when the cancer progresses to platinum-resistant ovarian cancer.This biomarker is determined positive when membrane staining intensity of 2+ or higher is confirmed in at least 75% of tumor cells using Roche Diagnostics' immunohistochemistry (IHC)-based companion diagnostic assay.Professor Jae-kwan Lee of the Department of Obstetrics and Gynecology at Korea University Guro Hospital said, “Depending on tumor heterogeneity, even cases previously negative for FRα may become positive upon recurrence. For patients without treatment alternatives, retesting should be considered.”
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- 'Ozempic' prescriptions available at general hospitals
- by Eo, Yun-Ho Jan 28, 2026 08:12am
- Product photo of Ozempic'Ozempic,' the diabetes treatment containing the same active ingredient as the obesity drug Wegovy, is entering the general hospital prescription areas.According to industry sources, Novo Nordisk Korea's GLP-1 receptor agonist (GLP-1 RA) Ozempic has passed the drug committees (DC) of major tertiary general hospitals, including Samsung Medical Center and Seoul National University Hospital. Ozempic is currently securing its prescription area ahead of the implementation of insurance reimbursement in February.Ozempic, which will be listed next month, can be prescribed as part of a triple therapy including metformin and sulfonylurea (SU), or in combination with insulin. However, unlike existing GLP-1 analogs, the reimbursement criteria have been restricted to 'Type 2 diabetes patients whose glycated hemoglobin (HbA1C) levels remain at 7% or higher despite at least 2 to 4 months of combination drug therapy.'While analysis suggests that this is Ministry of Health and Welfare's measure to prevent misuse or abuse of Ozempic, some critics argue it limits patient access. It remains to be seen how much Ozempic, with many limitations, will demonstrate in the diabetes treatment market.Competition within the GLP-1 class is expected to intensify further, as Eli Lilly Korea’s GIP/GLP-1 dual receptor agonist 'Mounjaro (tirzepatide)' is also currently undergoing price negotiations with the National Health Insurance Service (NHIS) for diabetes reimbursement listing.Meanwhile, Ozempic demonstrated powerful blood sugar-lowering and weight loss effects compared to various diabetes medications, including DPP-4 inhibitor Januvia (sitagliptin), the exendin-4-based GLP-1 RA Byetta (exenatide), and the GLP-1 RA Trulicity (dulaglutide), through six Phase 3 studies (SUSTAIN 1–5 and 7). Notably, Ozempic showed superior blood sugar-lowering effects compared to insulin while maintaining a lower risk of hypoglycemia.The 'SUSTAIN 9' study confirmed additional blood sugar and weight reduction effects in Type 2 diabetes patients who did not achieve sufficient control following treatment with SGLT-2 inhibitors, a leading class of oral diabetes medications. In the 'SUSTAIN 6' Phase 3 trial, the drug reduced the risk of major adverse cardiovascular events (MACE) by 26% in adult patients with Type 2 diabetes and high cardiovascular risk.
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- US tariffs on pharmaceuticals forecast…K-bio closely monitors
- by Chon, Seung-Hyun Jan 28, 2026 08:12am
- U.S. President Donald Trump showed his intent to impose a 25% tariff on pharmaceuticals. Korea's major pharmaceutical companies devised countermeasures by acquiring U.S.-based manufacturing plants. The Korean pharmaceutical industry is also closely watching the continuously changing imposition of tariffs.ChatGPT-generated imageOn January 26, 2026, President Trump posted on Truth Social, "The South Korean National Assembly has failed to implement previously agreed trade measures," adding, "An immediate increase in tariffs on Korean woods, pharmaceuticals, and all other reciprocal goods from 15% to 25%.In October 2025, during the APEC summit in Gyeongju, Korea and the U.S. reached a Most Favored Nation agreement for pharmaceuticals. This deal detailed that tariffs on South Korean medicines would not exceed 15%.According to the details of the agreement disclosed last month, the White House released a South Korea-U.S. Summit Joint Fact Sheet (JFS) that includes an agreement to ensure that tariffs on South Korean pharmaceutical products do not exceed 15%. It was finalized that in any case where tariffs are imposed on pharmaceuticals, the rate will not exceed 15%. For generics, it was decided to apply zero tariffs.The KoreaBIO Association stated, "While it was agreed in the Korea-U.S. trade agreement to apply a maximum of 15% if Section 232 tariffs are applied to pharmaceuticals, it will be difficult to rule out the possibility of a tariff increase to 25% through future amendments to the trade agreement."President Trump has also mentioned the possibility of imposing 100% tariffs on branded pharmaceuticals since October of last year.Through Truth Social on September 25 last year, President Trump stated, "Starting the 1st of next month, a 100% tariff will be imposed on all branded and patented pharmaceuticals from companies that are not building pharmaceutical production plants within the United States." adding, "'IS BUILDING' means a state where groundbreaking has occurred or construction is underway," and "In cases where construction has started, no tariffs will be imposed on the corresponding pharmaceuticals." However, no official tariff measures regarding pharmaceuticals have been announced to date.Korean pharmaceutical and biotech companies with high export volumes to the U.S. are in a state of high alert regarding pharmaceutical tariff rates. Domestic pharmaceutical and biotech companies without local plants in the U.S. have no choice but to closely watch the trend, as U.S. pharmaceutical tariff rates can impact their market penetration.However, it has been suggested that even if tariff rates rise, the direct blow will not be significant for Celltrion and Samsung Biologics, which export the most pharmaceuticals from Korea to the U.S., as they have established countermeasures by acquiring local plants.Celltrion has shown the most preemptive movement in preparation for U.S. tariffs. In September last year, Celltrion's subsidiary, Celltrion USA, signed a formal contract to acquire a biopharmaceutical production plant located in Branchburg, New Jersey, from ImClone Systems Holdings, a subsidiary of Eli Lilly. The acquisition amount is approximately $330 million (about KRW 460 billion). Celltrion received approval from Irish competition authorities in October last year and finally completed the acquisition process in November after the finalization of the business combination review by the U.S. Federal Trade Commission (FTC).Celltrion USA production facility opening ceremony held in June (from left: Kee Woo-sung, Vice Chairman of Celltrion; Todd Winge, CEO of Celltrion Branchburg; Park Kyung-ok, Senior Vice Chairman of Celltrion Holdings; Seo Jung-jin, Chairman of Celltrion Group; U.S. Senator Andy Kim of New Jersey; U.S. Representative Thomas Kean Jr. of New Jersey; Thomas Young, Mayor of Branchburg Township; Seo Joon-seok, Head of Celltrion North America Headquarters).The U.S. production facility acquired by Celltrion is a large-scale campus equipped with a total of four buildings, including production facilities, logistics warehouses, a technical support building, and an operation building on a site of approximately 148,500㎡, capable of producing about 66,000 liters of drug substance (DS). Celltrion plans to enter into an immediate expansion process and invest an additional KRW 700 billion to expand production capacity to a total of 132,000 liters.A Celltrion official explained, "By securing the production facility in Branchburg, New Jersey, we have prepared a fundamental solution regarding tariffs and have structurally escaped from all risks.Samsung Biologics signed a contract last December with GlaxoSmithKline (GSK) to acquire the Human Genome Sciences (HGS) biopharmaceutical production facility located in Rockville, Maryland. This involves an investment of $280 million (approximately KRW 410 billion) by Samsung Biologics America, the U.S. subsidiary of Samsung Biologics, to acquire the plant. The asset acquisition process is scheduled to be completed within the first quarter of this year.View of the Human Genome Sciences biopharmaceutical production facility located in Rockville, Maryland. The Rockville production facility is a drug substance production plant with a total capacity of 60,000 liters located in the center of the Maryland bio-cluster, consisting of two manufacturing buildings. The facility is equipped with infrastructure capable of supporting the production of antibody drugs at various scales, from clinical stages to commercial production.This is Samsung Biologics' first acquisition of an overseas plant. Samsung Biologics operates five plants in Songdo, Incheon. All five plants were constructed using internally procured funds.It appears that biotech companies with large U.S. export volumes have completed preparations for tariff risks by investing a total of over KRW 1 trillion to acquire local plants.According to the Ministry of Food and Drug Safety, South Korea's pharmaceutical export volume to the U.S. in 2024 was $1.49117 billion (approximately KRW 2 trillion), accounting for 16.1% of the $9.28987 billion total export volume of domestically produced pharmaceuticals. Among pharmaceutical exports to the U.S. in 2024, finished pharmaceutical products accounted for $1.29899 billion, or 87.1%, while active pharmaceutical ingredients (API) were only $192.19 million, or 16.9%. Samsung Biologics and Celltrion in the U.S. export of domestically produced pharmaceuticals occupy the most.For Samsung Biologics, U.S. regional sales accounted for KRW 1.1741 trillion, or 25.8% of its KRW 4.5473 trillion total revenue in 2024. Samsung Biologics' U.S. revenue share recorded 28.5% and 26.3% in 2022 and 2023, respectively. Samsung Biologics calculates regional revenue based on the location of its CDMO clients. Samsung Biologics' cumulative U.S. revenue for the third quarter reached KRW 1.6482 trillion, surpassing last year's export volume. U.S. sales accounted for 38.8% of Samsung Biologics' KRW 4.2484 trillion cumulative revenue through the third quarter. For Celltrion, biopharmaceutical sales in the North American market reached KRW 1.0453 trillion in 2024. Celltrion's North American market sales decreased 11.3% from KRW 709.5 billion in 2022 to KRW 629.2 billion in 2023, but increased by 66.1% in 2024 compared to the previous year, surpassing KRW 1 trillion for the first time.
- Company
- New AML drug Vanflyta approved in Korea
- by Son, Hyung Min Jan 28, 2026 08:12am
- Daiichi Sankyo Korea (CEO Jeong-tae Kim) announced on the 26th that its acute myeloid leukemia (AML) targeted therapy Vanflyta (quizartinib) has been approved in Korea.With this approval, Vanflyta can now be used in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation therapy, and as a maintenance mono therapy following consolidation therapy, for adult patients with newly diagnosed acute myeloid leukemia that is FLT3-ITD-positive.AML accounts for approximately 23.1% of all leukemia cases worldwide, and around 2,000 adults are newly diagnosed with AML each year in Korea. FLT3 mutations are the most commonly reported genetic alterations in AML, with approximately 25% of newly diagnosed AML patients harboring the FLT3-ITD mutation. The FLT3-ITD mutation is associated with a high disease burden and poor prognosis, including shortened overall survival.The efficacy and safety of Vanflyta were evaluated over a long-term period of more than five years in the Phase III QuANTUM-First trial, a randomized, double-blind, placebo-controlled study involving 539 patients with newly diagnosed FLT3-ITD–positive AML.Patients enrolled in the study received induction and consolidation combination therapy followed by up to 3 years of maintenance monotherapy with Vanflyta, regardless of whether they underwent allogeneic hematopoietic stem cell transplantation.Results showed a 22% reduction in the risk of death in the Vanflyta group compared with the placebo group. At a median follow-up of 39.2 months, the median overall survival (mOS) was 31.9 months in the Vanflyta group, an extension compared with 15.1 months in the placebo group.Jeong-tae Kim, CEO of Daiichi Sankyo Korea, stated, “We are very pleased to be able to provide a new first-line treatment option for patients with poor prognosis FLT3-ITD mutation-positive AML with the approval of Vanflyta. Following solid tumors, we are now introducing a therapy that can improve treatment outcomes in hematologic malignancies as well. We will continue our endeavors to make meaningful progress to expand treatment access for more patients in Korea.”Byung-sik Cho, Chair of the Acute Myeloid Leukemia/Myelodysplastic Syndrome Working Group of the Korean Society of Hematology (Professor of Hematology at Seoul St. Mary’s Hospital), said, “Vanflyta has been confirmed to extend both complete remission duration and overall survival when administered as maintenance therapy following induction and consolidation therapy, added to standard chemotherapy in newly diagnosed FLT3-ITD mutation-positive AML patients based on its mechanism that selectively targets the FLT3-ITD mutation. This is expected to bring an important change to AML treatment strategies in Korea.”
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- Rhapsido soon to be launched in Korea
- by Son, Hyung Min Jan 28, 2026 08:11am
- A shift in the treatment landscape for chronic spontaneous urticaria (CSU) is imminent. With Novartis positioning an oral BTK inhibitor as a successor to Xolair, competition over treatment options for antihistamine-refractory patients is entering a new phase.Novartis’s Rhapsido (remibrutinib)According to industry sources on the 28th, Novartis Korea has recently completed its regulatory submission for Rhapsido (remibrutinib). Approval is expected within the first half of this year.Rhapsido is an oral targeted therapy that inhibits Bruton’s tyrosine kinase (BTK), a key pathway in the pathophysiology of CSU, thereby blocking the release of histamine and inflammatory mediators. The drug was approved in the United States last September for the treatment of adult CSU patients whose symptoms persist despite second-generation H1 antihistamines.One of Rhapsido’s most notable features is its oral formulation, taken twice daily. Until now, treatment options for patients unresponsive to first-line antihistamines have been largely limited to the injectable biologic Xolair (omalizumab). The arrival of Rapsido opens a new option, an oral targeted therapy.According to the Phase III REMIX-1·2 clinical trial results, which formed the basis for its U.S. FDA approval, Rhapsido demonstrated superiority over placebo in improving itch severity (ISS7), hive severity (HSS7), and total urticaria activity score (UAS7) starting from Week 2. Approximately one-third of patients achieved complete remission (defined as zero itch and zero hives) by Week 12.In terms of safety, the drug showed a favorable profile, being stable enough not to require laboratory monitoring. Common adverse events were mild and included nasopharyngitis, headache, and abdominal pain.Following the US approval, Novartis has submitted Rhapsido for approval in major markets, including the EU, Japan, and China, where it has received priority review status. With formal submission completed in Korea as well, the entry of the first oral targeted therapy for CSU is imminent.Beyond CSU, Novartis is also expanding clinical development of Rhapsido across a range of immune-mediated diseases, including chronic inducible urticaria (CIndU), hidradenitis suppurativa (HS), food allergy, and multiple sclerosis.BTK inhibitors emerge as a successor to biologics in CSUCompetition in the CSU treatment market is rapidly intensifying around BTK inhibitors.BTK inhibition was first established in hematologic malignancies such as B-cell lymphomas and leukemia. Starting with the first-generation agent Janssen’s Imbruvica (ibrutinib), second-generation drugs BeiGene’s Brukinsa (zanubrutinib) and AstraZeneca’s Calquence (acalabrutinib), and third-generation Lilly’s Jaypirca (pirtobrutinib), have rapidly expanded their market share as later entrants.With the mechanistic advantages of BTK inhibition having also been confirmed in autoimmune diseases, later entrants are increasingly targeting these indications in drug development.Sanofi’s WayrilzNotably, Sanofi is strengthening its BTK inhibitor lineup in addition to its IL-4/13 inhibitor Dupixent (dupilumab).In September last year, Sanofi received US approval for the BTK inhibitor Wayrilz (rilzabrutinib) for immune thrombocytopenia (ITP). The drug has now advanced into Phase III trials for chronic inducible urticaria(CIU) and CSU.While Rhapsido achieves sustained BTK inhibition through irreversible binding, Wayrilz employs a hybrid mechanism combining reversible and irreversible binding.Sanofi is also developing another BTK inhibitor, tolebrutinib. However, development has recently been put to a stop after the FDA issued a Complete Response Letter (CRL).This treatment had garnered expectations for its mechanism of action, which selectively suppresses the immune response in multiple sclerosis by regulating B lymphocytes and disease-associated microglia. However, the requirement for additional data has rendered the approval timeline uncertain.
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- Galderma 'Nemluvio' for atopic dermatitis·PN wins nod in KOR
- by Son, Hyung Min Jan 27, 2026 06:55am
- Product photo of NemluvioGalderma Korea (CEO Jaihyuk Lee) announced that Nemluvio (nemolizumab), a biologic that selectively blocks the interleukin (IL)-31 receptor, received domestic approval on the 23rd for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis.With this approval, Nemluvio has become the only treatment option for moderate-to-severe atopic dermatitis that allows the dosing interval to be extended to every eight weeks, reducing the treatment burden on patients by reducing the frequency of administration.Nemluvio is the world's first monoclonal antibody that selectively blocks IL-31 receptor alpha, thereby inhibiting the IL-31 signaling pathway. IL-31 ia primary cause of itching.IL-31 is a neuro-immune cytokine that induces repetitive scratching behavior by directly stimulating nerves and activating sensory neurons that transmit itch signals. In addition to triggering itch, it serves as a quadruple trigger deeply involved in the fundamental pathophysiology of atopic dermatitis and prurigo nodularis, including inflammatory expression, epidermal dysregulation, and skin fibrosis.The basis of Nemluvio approval was the results of the Phase 3 ARCADIA and OLYMPIA clinical trials.ARCADIA 1 and 2 were randomized, double-blind, placebo-controlled, global Phase 3 clinical studies conducted in 941 and 787 patients, respectively, aged 12 and older with moderate-to-severe atopic dermatitis, to evaluate the efficacy and safety of Nemluvio over 48 weeks.The clinical results showed that Nemluvio+topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI), met all endpoints compared to the placebo group.The proportion of patients achieving at least 75% improvement in the Eczema Area and Severity Index (EASI-75) was 43.5% and 42.1% in the Nemluvio+TCS/TCI treatment groups in the ARCADIA 1 and 2 studies, respectively, compared to 29% and 30.2% in the placebo groups, demonstrating a statistically significant difference between the two groups.In particular, a statistically significant difference in pruritus compared to the placebo group was observed starting from 48 hours after administration, confirming Nemluvio's rapid itch-relief effect. At weeks 4 and 16, more than twice as many patients in the Nemluvio+TCS/TCI group experienced clinically meaningful itch relief (PP-NRS improvement of 4 points or more) compared to the placebo group.OLYMPIA 1 and 2 were conducted on 286 and 274 adult patients, respectively, aged 18 and older, with moderate-to-severe prurigo nodularis. In these trials, Nemluvio monotherapy met all endpoints compared to the placebo group.Nemluvio demonstrated a consistent safety profile across all clinical programs. The incidence of serious adverse events (SAE) was similar to that of the placebo group, and most adverse events were mild to moderate and manageable.Yang Won Lee, President of the Korean Atopic Dermatitis Association (Department of Dermatology, Konkuk University Hospital), explained, "Atopic dermatitis and prurigo nodularis are chronic inflammatory neuro-immune diseases where symptoms such as 'itching' cause chronic insomnia, fatigue, and various psychological stresses, seriously degrading the quality of life for patients."Lee added, "With the introduction of a new biologic targeting the IL-31 receptor, a key pathway for itching, to the domestic market, we hope to alleviate the suffering of patients with moderate-to-severe atopic dermatitis and prurigo nodularis and see another meaningful advancement in long-term disease management."CEO Jaihyuk Lee, stated, "Based on our long-standing expertise in the field of dermatology, Galderma has introduced a new biological treatment option that can meet the unmet medical needs of patients with atopic dermatitis and prurigo nodularis. We expect Nemluvio, the first to directly inhibit the interleukin-31 pathway, to provide patients with more effective and sustainable treatment opportunities and bring substantial changes to their daily lives."Galderma Korea plans to launch Nemluvio in the second half of this year. The company has completed the application for health insurance reimbursement listing to secure faster access to treatment for patients with atopic dermatitis and prurigo nodularis.
- Company
- Biologic for asthma, 'Nucala' autoinjector can be prescribed
- by Eo, Yun-Ho Jan 27, 2026 06:54am
- Product photo of Nucala Auto-InjectorThe injectable formulation of the antibody medicine Nucala is entering the prescription area of general hospitals.GSK's Nucala Auto-Injector (mepolizumab), a treatment for severe neutrophilic asthma, has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center Seoul and Seoul National University Hospital, as well as medical institutes, including Kangdong Sacred Heart Hospital, Soon Chun Hyang University Hospital Cheonan, Jeonbuk National University Hospital, and Ajou University Hospital. Nucala Auto-Injector was approved in Korea in March of last year and was launched as a non-reimbursed drug in November of the same year after securing a distribution channel and quantity of stocks. Nucala Auto-Injector conditionally passed the Drug Benefit Evaluation Committee (DBEC) of the Health Insurance Review and Assessment Service (HIRA) on the 15th. Attention is focused on whether Nucala would succeed in obtaining reimbursement listing following the launch of the new formulation and the expansion of areas.Indications for the new autoinjector formulation have been added beyond the treatment of severe eosinophilic asthma in ▲existing adult and adolescent patients aged 12 and older to include eosinophilic granulomatosis with polyangiitis (EGPA) in adults and ▲hypereosinophilic syndrome (HES) in adults.Nucala is a self-administered injectable used to treat eosinophilic diseases. It is indicated as an add-on maintenance therapy for severe eosinophilic asthma (SEA) in patients aged 12 and older, for adult patients with EGPA, and for adult patients with HES, excluding those who are FIP1L1-PDGFRα-positive.The autoinjector formulation offers patients the convenience of self-administering the drug at home. This has been demonstrated through a self-administration success rate of over 96%, high patient preference, and ease of use.Meanwhile, Nucala is demonstrating increased competitiveness by securing an indication for chronic obstructive pulmonary disease (COPD). This medication received additional approval from the U.S. FDA this May as an 'add-on maintenance treatment for adult COPD patients with an eosinophilic phenotype.'The approval was granted based on the results of the Phase 3 MATINEE and METREX studies. In these studies, among a broad spectrum of COPD patient groups with an eosinophilic phenotype, the Nucala-administered group showed a significantly lower annual rate of moderate to severe exacerbations compared to the placebo group.
- Company
- Janssen enters price negotiations for Opsynvi’s reimb in KOR
- by Eo, Yun-Ho Jan 27, 2026 06:54am
- Attention is growing over whether a newly reimbursed treatment option will emerge in the underserved field of pulmonary arterial hypertension (PAH).According to Dailypharm coverage, Janssen Korea accepted the ‘price below the assessed amount’ proposed by the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee last December and recently began price negotiations with the National Health Insurance Service for the pulmonary arterial hypertension (PAH) treatment ‘Opsynvi (macitentan/tadalafil).’The final approved indication for Opsynvi that passed DREC is “long-term treatment of adult patients with WHO Functional Class II–III pulmonary arterial hypertension.”Opsynvi, which received approval in the United States in March 2024 and in Korea in July last year, is a fixed-dose combination of the PDE5 inhibitor Cialis (tadalafil) and the endothelin receptor antagonist (ERA) Opsumit (macitentan). Its key advantage lies in improved dosing convenience.The efficacy of Opsynvi was demonstrated in the Phase III A DUE trial, which compared the efficacy and safety of the Opsynvi combination therapy with monotherapy using either Opsumit or Cialis.After 24 months of follow-up, Opsynvi showed up to a 29% greater reduction in pulmonary vascular resistance (PVR), the primary endpoint, compared with either Opsumit or Cialis monotherapy.As of 2023, the number of PAH patients in Korea is estimated at approximately 3,600, with the average patient profile being women in their 40s, who often play central roles in both society and family life. While the 5-year survival rate has significantly improved compared to the past, 3 out of 10 pulmonary arterial hypertension patients in Korea still die within 5 years.PAH is a rare, intractable, and progressive disease, in which delaying disease progression has a direct impact on patients’ quality of life and survival. To date, no curative pharmacologic treatment has been established, and existing therapies primarily aim to relax thickened pulmonary arteries to alleviate symptoms.Meanwhile, the emergence of new drugs is expected to transform the domestic PAH treatment landscape.In June 2025, Bayer’s Adempas (riociguat) was added to the reimbursement list nearly 10 years after its initial approval. Winrevair (sotatercept) by MSD Korea, selected for the ‘Approval-Evaluation-Negotiation Parallel Review Project, is currently undergoing reimbursement procedures.
