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- 2026-07-22 03:12:20
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- Rinvoq reimbursement expanded to ankylosing spondylitis
- by Son, Hyung Min Jul 02, 2026 09:17am
- The expansion of Korea’s National Health Insurance reimbursement for ‘Rinvoq (upadacitinib)’ in ankylosing spondylitis (AS) will allow patients with no prior exposure to biologic therapies to opt for a new oral treatment early in the course of the disease.Experts said the revised reimbursement criteria will enable patients who fail to respond adequately to conventional therapy to continue treatment with oral medication without first transitioning to injectable biologics, thereby enhancing both treatment continuity and patient choice.On July 1, AbbVie Korea held a press briefing at The Plaza Seoul Hotel to commemorate the expansion of reimbursement for its Janus kinase (JAK) inhibitor Rinvoq in ankylosing spondylitis, and introduced the latest treatment strategies and the drug's clinical significance.Since last month, Rinvoq has been reimbursed for adults with severe active ankylosing spondylitis who have received treatment with two or more nonsteroidal anti-inflammatory drugs (NSAIDs) or disease-modifying antirheumatic drugs (DMARDs) for at least three months but experienced an inadequate response or were unable to continue therapy because of adverse events. Reimbursement is available regardless of whether patients have previously received biologic or targeted synthetic DMARDs.Previously, reimbursement was limited to patients who had already undergone biologic therapy; however, under the new expanded criteria, patients with no prior biologic treatment experience are now eligible for reimbursementProfessor Seung-Jae Hong, Division of Rheumatology, Kyung Hee University Medical CenterAnkylosing spondylitis is an autoimmune disease characterized by chronic inflammation of the spine and sacroiliac joints, causing lower back pain and morning stiffness. If treatment is delayed, the spine may progressively become fused, leading to restricted mobility, functional impairment, and various complications, highlighting the importance of early diagnosis and active treatment.Although the number of patients with ankylosing spondylitis continues to increase in Korea, clinicians note that significant unmet needs remain in achieving disease remission and controlling pain.Accordingly, treatment goals have expanded beyond symptom relief to include maintaining long-term remission or low disease activity, preventing structural damage, and improving patients' quality of life.Professor Hong said, "The goal of ankylosing spondylitis treatment is not only to control inflammation and disease activity but also to reduce the pain patients experience in their daily lives and help them maintain normal social functioning."He continued, "The ultimate objective is not simply pain reduction but preventing disability so patients can continue working and maintain social life. For this, maintaining long-term remission is therefore essential. Rinvoq has established itself as a valuable treatment option capable of helping achieve these goals through both pivotal clinical trials and real-world clinical experience."The clinical evidence supporting Rinvoq was confirmed through the SELECT-AXIS 1 trial in biologic-naïve patients with active ankylosing spondylitis and its long-term extension study.Patients receiving Rinvoq 15 mg demonstrated clinical improvement as early as Week 2. The ASAS40 response rate reached 16.7% at Week 2 and 54.0% at Week 14 (1.1% and 27.6%, respectively) in the placebo group. In the long-term extension study, more than 85% of patients in both the continuous Rinvoq group and those who switched from placebo maintained an ASAS40 response through Week 104.ASAS40 is a major clinical benchmark used to measure the effectiveness of treatments for ankylosing spondylitis established by the Assessment of SpondyloArthritis International Society (ASAS). It is at least a 40% improvement from baseline across four key domains, including spinal pain, disease activity, physical function and inflammation.Improvements in disease activity and pain were also observed early during treatment. Compared with placebo, patients receiving Rinvoq showed significantly greater reductions in high-sensitivity C-reactive protein (hsCRP), a marker of inflammation, from Week 2 onward. By Week 14, improvements in back pain scores were also significantly greater than those seen with placebo. These benefits were sustained through Week 104, while the safety profile remained consistent with previous studies.Prof. Hong noted, "Although oral therapies are often perceived as having a slower onset of action, Rinvoq is characterized by rapid improvements in both pain and inflammation soon after treatment begins. In routine clinical practice, many patients have also experienced these early benefits."He added that the greatest significance of the reimbursement expansion lies in improving treatment continuity."Under the revised reimbursement criteria, patients now have the option of continuing treatment with one oral therapy after NSAIDs or DMARDs without being required to receive biologic therapy first. For younger patients with active lifestyles, including those balancing school, work, or frequent business travel, Rinvoq provides advantages in both treatment convenience and long-term adherence."He concluded, "Improved patient access to a cost-effective treatment is also positive from the perspective of maintaining the sustainability of the National Health Insurance system. Going forward, clinicians will be better able to develop more flexible treatment strategies that take into account not only disease status but also patients' lifestyles and treatment preferences."
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- Blenrep may be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Jul 02, 2026 09:16am
- 'Blenrep,’ a novel antibody-drug conjugate (ADC) for multiple myeloma, may be prescribed at general hospitals in Korea.According to industry sources, GSK Korea’s first-in-class anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) Blenrep (belantamab mafodotin) has been approved by the Drug Committees (DCs) of several leading medical institutions, including Seoul National University Hospital, Asan Medical Center, Konkuk University Medical Center, Kyungpook National University Hospital, Pusan National University Hospital, and Ewha Womans University Mokdong Hospital.The therapy was designated under Korea's Global Innovative products on Fast Track (GIFT) program and received marketing authorization in December last year. It was launched as a non-reimbursed treatment in April.GSK has since submitted an application for National Health Insurance reimbursement. Attention is now focused on whether Blenrep will secure reimbursement listing and establish itself as a practical treatment option on site.Specifically, Blenrep is indicated for use ▲in combination with bortezomib and dexamethasone in adults with multiple myeloma who have received at least one prior line of therapy, and ▲in combination with pomalidomide and dexamethasone in adults who have received at least one prior therapy including lenalidomide.The drug demonstrated its efficacy in the open-label Phase III DREAMM-7 and DREAMM-8 studies.In DREAMM-7, the median progression-free survival (PFS) was 36.6 months in the Blenrep combination arm (BVd: belantamab mafodotin, bortezomib and dexamethasone), compared with 13.4 months in the control arm (DVd: daratumumab, bortezomib and dexamethasone), representing a statistically significant improvement. At a median follow-up of 39.4 months, the regimen also demonstrated a significant improvement in overall survival (OS), reducing the risk of death by 42%.Results of the interim analysis of DREAMM-8 (median follow-up of 21.8 months) showed that median PFS had not yet been reached in the Blenrep combination arm. Still, the study demonstrated a statistically significant improvement in PFS compared with the 12.7 months observed in the control group.Meanwhile, multiple myeloma is a hematologic malignancy in which malignant plasma cells proliferate within the bone marrow, replacing normal plasma cells. These malignant cells produce an abnormal protein known as M protein, which can lead to osteolytic bone lesions accompanied by multiple sites of pain as well as anemia. In Korea, approximately 1,961 new cases of multiple myeloma are reported annually (as of 2022, Korea National Cancer Incidence Database), accounting for about 0.7% of total cancer occurrences
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- "Lorviqua has suggested new long-term trt standard for ALK-positive NSCLC"
- by Son, Hyung Min Jul 01, 2026 09:17am
- "Lorviqua," a treatment for ALK-positive non-small cell lung cancer (NSCLC), has demonstrated long-term effectiveness in inhibiting disease progression in a 7-year long-term follow-up analysis, establishing a new treatment standard in ALK-targeted therapy. Notably, Lorviqua reduced the risk of disease progression or death by 81% compared to conventional therapy. It achieved long-term suppression of central nervous system (CNS) metastasis, which is the most significant clinical challenge in ALK-positive lung cancer. Analysis suggests that this drug is leading a paradigm shift in treatment.Professor Ji-Youn Han of the National Cancer CenterOn June 30, Pfizer Pharmaceuticals Korea hosted a press conference at the Conrad Seoul Hotel in Yeouido to showcase the clinical value of Lorviqua (lorlatinib). Pfizer recently announced the 7-year follow-up results from the global Phase 3 CROWN study, confirming the long-term efficacy of Lorviqua. ALK-positive NSCLC is a rare oncogenic driver mutation in NSCLC, accounting for approximately 3% to 5% of all NSCLC cases. It frequently occurs in a relatively younger patients and exhibits a high incidence of brain metastasis during the disease course; thus, long-term disease control and the suppression of CNS metastasis are considered critical determinants of clinical outcomes. In fact, the development of ALK-targeted therapies has evolved continuously to address these specific unmet medical needs.The first-generation ALK inhibitor, 'Xalkori (crizotinib),' established the foundation for treating ALK-positive lung cancer but faced limitations in sufficiently suppressing CNS metastasis due to restricted blood-brain barrier (BBB) penetration. Subsequently, second-generation ALK inhibitors such as 'Alecensa (alectinib)' and 'Alunbrig (brigatinib)' emerged, improving intracranial control. However, the development of therapeutic agents to achieve more potent ALK inhibition and overcome resistance mechanisms continued. Lorviqua is a third-generation ALK inhibitor designed to overcome these limitations. Unlike existing drugs, it incorporates a macrocyclic structure engineered to bind more selectively and potently to the ALK protein, and it is characterized by its ability to effectively penetrate the blood-brain barrier (BBB) to maintain high intra-CNS drug concentrations. Professor Ji-Youn Han of the National Cancer Center explained, "Because brain metastasis is highly prevalent in ALK-positive lung cancer, how effectively an agent crosses the BBB to control intracranial disease is the linchpin of long-term therapy. Lorviqua is a drug specifically developed to address this requirement."The CROWN study is a global, randomized, open-label Phase 3 clinical trial comparing Lorviqua versus Xalkori in 296 treatment-naive patients with advanced ALK-positive NSCLC. At 7-year follow-up, the median progression-free survival (PFS) in the Lorviqua group was not reached (NR), compared with 9.1 months in the Xalkori group. The PFS rates at 7 years were 55% and 3%, respectively. The risk of disease progression or death was reduced by 81% compared to Xalkori (HR 0.19). The risk reduction efficacy previously validated in the 5-year follow-up has been sustained seamlessly through the period of 7-year.Notably, among the patients who were free of disease progression at 24 months after treatment initiated, 79% maintained their progression-free status at the 7-year mark. This indicates that a vast majority of patients who maintain therapeutic efficacy during the first 2 years go on to achieve durable, long-term disease control. Professor Han evaluated, "An HR of 0.19 in advanced lung cancer is an unprecedented level of benefit," and added, "It is highly significant that a degree of risk reduction typically observed only in the adjuvant targeted therapy setting for early-stage lung cancer has been sustained long-term in the advanced-stage setting."Professor Han added, "It is also noteworthy that most patients who did not progress within the first two years maintained durable long-term disease control thereafter".In this updated analysis, the intracranial control efficacy was reconfirmed as a foundational mechanism supporting Lorviqua's prolonged systemic PFS.No new intracranial progression events were reported in the Lorviqua group after 30 months of treatment. The median time to intracranial progression was also not reached with Lorviqua, compared to 16.4 months in the Xalkori group. Furthermore, durable CNS disease control was consistently maintained over the long term, both in patients with baseline brain metastases and in those without. Professor Han explained, "The primary reason for the sustained PFS in this long-term follow-up ultimately is the continuous protection of the CNS," and added, "This can be interpreted as the effective suppression of brain metastases in highly ALK-dependent patients, translating into remarkable long-term survival and disease control outcomes."The safety profile was consistent with the previously reported 5-year follow-up results. All-cause Grade 3 or 4 adverse events occurred in 77% of the Lorviqua group and 57% of the Xalkori group; however, permanent treatment discontinuations due to treatment-related adverse events (TRAEs) remained low at 5% and 6%, respectively. No new permanent treatment-related discontinuations were observed in the Lorviqua group after the first 26 months of therapy. An additional analysis on dose reductions was also presented. Patients who underwent dose reductions due to adverse events successfully maintained both systemic PFS and intracranial disease control, providing robust evidence that dose adjustments during toxicity management do not compromise long-term therapeutic efficacy.However, overall survival (OS) data have not yet reached the protocol-specified analysis endpoints, and further follow-up is ongoing. The industry anticipates that since these outcomes have re-confirmed Lorviqua's long-term disease-modifying capabilities, significant focus will remain on the upcoming definitive OS datasets.
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- Intuitive, expanding to a platform beyond surgery
- by Hwang, byoung woo Jul 01, 2026 09:17am
- Landscape of Intuitive Surgical Korea media dayRobotic-assisted surgery is no longer a mere piece of surgical equipment; it is expanding to a platform that connects pre-, intra-, and postoperative data. Marking its 20th anniversary of introduction in South Korea, the da Vinci robotic surgical system is widening its scope of application into gynecological diseases, complex pediatric surgeries, and essential healthcare sectors, establishing an intersection between precision treatment and the standardization of surgical techniques.On the 30th, Intuitive Surgical Korea held a media day titled 'Connect Intuitive' to introduce the clinical and social value of robotic-assisted surgery and the prospect of the future surgical environment. 20 years since its introduction to South Korea…expanding surgical involvement and societal valueOn this day, Yongbum Choi, General Manager of Intuitive Surgical Korea, explained that robotic-assisted surgery has shifted the open-surgery-centric paradigm toward a focus on minimally invasive and precision surgery.Yongbum Choi, General Manager of Intuitive Surgical Korea"We believe that minimally invasive care is a treatment that improves patients' lives," Choi said. "The aim of Intuitive is to expand the possibilities for healthcare providers to treat patients through ingenious ideas and intelligent technology."In South Korea, since da Vinci robotic surgery commenced at Severance Hospital in 2005, its fields of application have steadily expanded. Based on an analysis combining the Health Insurance Review and Assessment Service (HIRA) Open API and proprietary company data, Intuitive presented that the proportion of robotic-assisted surgery among all surgeries rose from approximately 6% in 2019 to approximately 16% in 2025.Choi also explained robotic-assisted surgery's value beyond clinical outcomes to include patient experience, the operational environment for medical staff, healthcare cost reduction, and improvements in accessibility.Based the COMPARE Study published in 2025, choi explained that compared to open surgery, the blood transfusion rate decreased by 75% and the 30-day mortality rate decreased by 46%, and even when compared to laparoscopy, differences were demonstrated in terms of conversion rates to open surgery, complication rates, and the length of hospital stay. "Last year, approximately 85,000 da Vinci surgeries were performed domestically," Choi stated. "Without da Vinci, an estimated 5,100 patients might have experienced conversions to open surgery during laparoscopic procedures, and the length of hospital stay is projected to have increased by approximately 43,000 days."Choi added, "Even if we convert only the reduction in open conversions into financial terms, a societal cost savings effect of approximately 10 billion KRW can be inferred. Robotic surgery is drawing closer as a therapeutic option that reduces societal healthcare costs beyond the scope of the surgery itself."da Vinci 5, a surgical platform incorporating surgical sensation and dataAt the event, advancements in the next-generation robotic surgical system, the da Vinci 5, were also highlighted as a primary topic. The core features are 'Force Feedback' and digital intelligence. Force feedback is a feature that measures the physical resistance applied to instruments during surgery, allowing the operating surgeon to feel it haptically.Jung Ryeol Lee, a professor in the Department of Obstetrics and Gynecology at Bundang Seoul National University Hospital, stated, "Legacy robotic systems lacked haptic feedback transmitted to the hands, forcing surgeons to rely on visual changes to perceive tactile sensations indirectly. Force feedback is a hardware innovation in that it implements a sense that had previously been lost in robotic surgery."Real-world surgical cases were also introduced. It was explained that although a specific lesion was not clearly visible on ultrasound, the difference in internal tissue resistance was confirmed via force feedback, leading to the discovery of a concealed fibroid upon incision. Professor Lee said, "Force feedback enhances safety by restraining excessive force, and it can be utilized to discover hidden lesions through direct tactile information. This carries significant weight in the gynecological field, where lesions must be resected while maximizing the preservation of normal tissue."Digital functionalities were also emphasized. The da Vinci 5 integrates surgical video storage, analysis of force and instrument movement data, AI-driven video analysis, real-time video streaming, and simulation-based training. Professor Lee noted, "Previously, operating surgeons had to learn through an apprenticeship-based model and accumulate experience over a long period to reach a certain level of proficiency. Now, integrated education is possible, combining preoperative simulation, intraoperative remote mentoring, and postoperative data and video review."(from left) Jung Ryeol Lee, a professor in the Department of Obstetrics and Gynecology at Bundang Seoul National University Hospital; Professor Jonghoon Lee of the Department of Pediatric Urology at Samsung Medical CenterPotential of precision treatment has been validated in gynecological diseases·pediatric surgeriesIn presentations by medical professionals, the clinical value of robotic-assisted surgery for gynecological diseases and highly complex pediatric surgeries was highlighted.Professor Jung-Ryul Lee identified the clinical significance of gynecological robotic surgery in 'precision tissue preservation' and 'fertility preservation'. Professor Lee explained that the objective of gynecological surgery is shifting from simple lesion removal toward maximizing the preservation of normal physiological functions and fertility.Professor Lee said, "The robot provides good eyes and delicate hands, which are the two virtues required for an outstanding operating surgeon," and added, "When utilized by individuals of equal skill, advanced equipment enhances surgical performance." In the field of obstetrics and gynecology, myomectomy, ovarian cystectomy, conservative surgery for women of childbearing age, and oncologic surgery were presented as key application areas for robotic surgery.Patient perception is also shifting. Professor Lee stated, "In the early days of introduction, many patients questioned whether robotic surgery was necessary due to cost concerns. Recently, an increasing number of patients come in specifically requesting robotic surgery, or naturally accept it when it is explained as the appropriate approach."Professor Jonghoon Lee of the Department of Pediatric Urology at Samsung Medical Center explained the potential of robotic-assisted surgery in pediatric urology."Because pediatric patients have extremely small surgical spaces and delicate tissues, a high level of precision is required," Professor Lee said. "Since these patients will live for another 70 to 80 years or more, more precise and safer surgeries are necessary." Furthermore, "Open surgery presents challenges regarding scarring, recovery timelines, and pain, while laparoscopy is highly complex because it requires intricate suturing within a small space without tremor filtration. The robot, through magnified vision, articulated instruments, and tremor filtration capabilities, allows the needle to be accurately inserted and sutured at the desired target location." Professor Lee also highlighted the current reality of pediatric urologic surgery in South Korea. Given that the number of dedicated pediatric urologists is limited, robotic surgery can be an effective tool for surgical skills education and standardization.Professor Lee added, "Although cases considering robotic surgery to pediatric patients are not yet highly prevalent in South Korea, force feedback, 3D high-definition vision, and tremor filtration technologies are far more critical in pediatric surgery where spaces are small, and tissues are fragile. This is a prospective field with high expectations."
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- Tremfya reimbursed for inflammatory bowel disease
- by Son, Hyung Min Jul 01, 2026 09:17am
- As treatment goals for inflammatory bowel disease (IBD) continue to evolve beyond symptom control toward endoscopic and histologic healing, reimbursement for the interleukin (IL)-23 inhibitor Tremfya has expanded therapeutic options for patients.Despite the introduction of various biologic therapies, experts noted that many patients still fail to achieve optimal disease control, underscoring the need for new treatment strategies aimed at achieving deep remission and long-term disease control.On June 30, Janssen Korea held a press briefing to commemorate the reimbursed launch of Tremfya(guselkumab), an IL-23-targeting biologic, for the treatment of IBD.Since the 1st, Tremfya has been reimbursed under the National Health Insurance system for patients with moderately to severely active Crohn's disease and ulcerative colitis. The therapy can now be used as a first-line biologic treatment option in patients who have shown an inadequate response or intolerance to conventional therapy, or for whom standard treatment is contraindicated.Professor Sung Ae Jung, Department of Gastroenterology and Hepatology, Ewha Womans University Seoul HospitalIL-23 is a cytokine known to play a key role in the inflammatory processes underlying both Crohn's disease and ulcerative colitis. As a result, several antibody therapies have been developed to block IL-23 activity, all of which target IL-23’s p19 subunit.Tremfya’s strength lies in its dual-action mechanism, which adds additional immune cell targeting to its existing mechanism of action.It is the only IL-23 inhibitor that directly targets CD64-positive immune cells, which produce IL-23. The antibody's Fab region binds to the p19 subunit of IL-23 to block inflammatory signaling, while its Fc region binds to receptors on CD64-positive immune cells, suppressing their activation and function.In other words, Tremfya not only blocks the inflammatory signaling molecule itself but also inhibits the activity of the cells responsible for producing it. According to experts, this dual mechanism represents a unique advantage not shared by other IL-23 p19 inhibitors.Inflammatory bowel disease, which includes Crohn's disease and ulcerative colitis, is a chronic inflammatory disorder of unknown cause affecting the gastrointestinal tract. The disease is characterized by chronic and recurrent relapses, and due to the nature of the disease, it presents in various forms and severities.Although advances in medical technology have improved the treatment landscape through the introduction of multiple biologic therapies, the chronic nature of IBD and its need for long-term management means that a substantial need for new therapeutic options remains.Sung Ae Jung, Professor of Gastroenterology and Hepatology at Ewha Womans University Seoul Hospital (President, Korean Association for the Study of Intestinal Diseases), said, "Treatment goals for IBD have evolved from simply improving symptoms to achieving deep remission, including endoscopic and histologic healing, and ultimately modifying the course of the disease. However, despite the introduction of various therapies, approximately half of patients still fail to reach optimal treatment outcomes."She added, "Novel therapies with new mechanisms of action like Tremfya are expected to play a significant role in addressing these unmet medical needs."Professor Seong Noh Hong, Department of Gastroenterology, Samsung Medical CenterIn the Phase II/III GALAXI study, Tremfya demonstrated superiority over Stelara (ustekinumab) across multiple endoscopic endpoints in patients with Crohn's disease. In particular, the therapy achieved deep remission, meeting both clinical remission and endoscopic remission endpoints.In the Phase III QUASAR study, Tremfya also demonstrated clinical value in ulcerative colitis by achieving not only endoscopic remission but also histologic healing.Tremfya also demonstrated durable efficacy in the long-term results of both studies.Specifically, in the QUASAR study, approximately 95% of patients remained on treatment through Week 92. At that time, clinical remission rates were 74% in the Tremfya 200 mg group and 71% in the 100 mg group. Endoscopic remission rates were 34% and 35%, respectively, while histologic remission rates reached 66% and 67%.The long-term GALAXI extension study also confirmed a safety profile consistent with that observed in the drug's previously approved indications.Seong Noh Hong, Professor of Gastroenterology at Samsung Medical Center (Chair, IBD Research Committee, KASID), said, "Tremfya achieved deep remission by simultaneously demonstrating meaningful endoscopic and clinical remission rates in Crohn's disease. It has also met key efficacy endpoints in ulcerative colitis, garnering attention as a promising new treatment option for IBD."Hong added, “The recently reported long-term extension data also demonstrated consistent efficacy over time. These findings suggest that Tremfya could contribute to treatment strategies aimed at achieving deep remission from the early stages of disease management."
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- Kim & Chang attorney Kwon-Eui Park named as one of the 'Top Lawyers'
- by Eo, Yun-Ho Jun 30, 2026 09:21am
- Attorney Kwon-Eui ParkKwon-Eui Park (40), an attorney at Kim & Chang, has been named as one of the top attorneys in the legislative response field within the '2026 Korea Law Firm Consumer Report.'Recently published by The Law Times Korea, the '2026 Korea Law Firm Consumer Report' is the first report tracking the premier attorneys across various practice areas based on evaluations from corporate legal counsel and executives, who are the end-users of legal services. The report is drawing substantial industry attention because it shifts away from traditional brand awareness surveys and relies exclusively on evaluations from clients with legal service experiences.In the report, there were 3,605 responses to 'Top Lawyers' including duplicate nominations, with 1,443 individual attorneys mentioned at least once. Notably, a selective group of 374 attorneys received three or more votes.When categorized by firm, Kim & Chang had the highest volume of listings, with 251 attorneys (17.4% of the total). Within the healthcare practice sector, Attorney Kwon-Eui Park gained the highest number of votes, while three other colleagues, Inje Kang, Gyu Won Choi, and Jae-ha Lee, were also named to the list.Meanwhile, Attorney Park has a background as a licensed pharmacist. Upon graduating from the Sahmyook University College of Pharmacy, he was admitted to Chonnam National University Law School. However, he immediately deferred his initial law school enrollment for one year to gain practical experience in the field, spending six months as a hospital pharmacist and another six months as a community (retail) pharmacist.After graduating from law school, Park completed his military service as a public interest legal officer, serving one year at the Seoul Central District Prosecutors' Office, one year at the Ministry of Food and Drug Safety (MFDS), and one year at the Ministry of Justice. Following his service, Park built deep, specialized domain expertise at the Health Insurance Review and Assessment Service (HIRA) from October 2016 to March 2020 before joining Kim & Chang.
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- Fist instance ruling for 5 out of 7 Jardiance unlisted patent disputes
- by Kim, Jin-Gu Jun 30, 2026 09:21am
- Product photo of JardianceThe dispute surrounding the unlisted patents for the SGLT-2 inhibitor diabetes treatment 'Jardiance (empagliflozin)' is nearing its end.As generic companies have recently succeeded in invalidating another unlisted method-of-use patent, first-instance decisions have been closed for five of the seven complexly unlisted patents. A resolution for the remaining two patents is also expected in the near future.Consequently, the focus in this dispute is projected to shift to the Patent Court. Both the original drug company and generic companies have already appealed a first-instance decision each after contesting the initial rulings.Invalidating use patent set to expire in 2034…5 out of 7 unlisted patents received a first instance rulingAccording to pharmaceutical industry sources on June 26, the Intellectual Property Trial and Appeal Board (IPTAB) issued a favorable ruling on June 25 in an invalidation trial petitioned against Boehringer Ingelheim by Genewone Sciences, Chong Kun Dang, Korea Prime Pharm, Boryung, Huons, and Hanmi Pharm regarding a Jardiance use patent (10-2138213).This patent is set to expire in April 2034 and is not listed in the Ministry of Food and Drug Safety (MFDS) Patent List. It covers the treatment and prevention of diabetes or prediabetes using empagliflozin in patients with renal disease.Generic companies petitioned for an invalidity trial against Boehringer Ingelheim in January 2024 and secured a first-instance victory after 2.5 years.With this ruling, disputes over five out of the seven unlisted Jardiance patents received a first-instance ruling. Between 2023 and 2024, generic companies targeted these seven unlisted Jardiance patents by filing invalidation trials or passive scope confirmation trials.At the time, pharmaceutical companies had to individually identify and respond to patents that were not listed in the official patent registry. Although overcoming unlisted patents is not a prerequisite for obtaining generic marketing authorization, the presence of these patents posed a significant risk of patent infringement liability and subsequent damages claims upon product launch.Notably, analysis suggests that the existence of these unlisted patents continues to pose a risk for generic manufacturers, even as generic versions were launched concurrently following the expiration of the Jardiance substance patent in October last year.The remaining unlisted formulation patent and use patent are expected to receive ruling soonJardiance has two listed patents and seven unlisted patents. Generic companies successfully avoided one of the listed patents in 2019. The other listed patent was the substance patent, which expired in October last year. The remaining unlisted patents include ▲three use patents for empagliflozin monotherapy ▲one use patent and one formulation patent for empagliflozin+metformin combination ▲one use patent for empagliflozin+linagliptin combination ▲one use patent for empagliflozin+linagliptin+metformin triple combination therapy.Among these, a conclusion was reached first regarding a Jardiance use patent (10-2318207) expiring in April 2034. Generic companies won the first instance in November last year, and Boehringer Ingelheim has appealed the decision.In February of this year, the original drug company emerged victorious in the composition and use patent dispute (expiring in August 2028) for Esgliteo (empagliflozin+linagliptin). IPTAB issued a ruling dismissing the generic companies' arguments regarding the passive scope confirmation and invalidation. Dissatisfied with the outcome, three generic manufacturers chose to appeal to the Patent Court.In April, generic companies won a dispute over the use patent (expiring in November 2027) for Jardiance Duo (empagliflozin + metformin). Following this, generic manufacturers have now also secured a favorable first-instance ruling in the Jardiance use patent dispute. Separately, the use patent dispute concerning the empagliflozin+linagliptin+metformin triple combination therapy was concluded when Genewone Sciences voluntarily withdrew its trial petition.The remaining patents include unlisted formulation patent expiring in October 2030 and another concerning a use patent expiring in April 2034.The pharmaceutical industry anticipates that first-instance decisions for both remaining disputes will be made within the second half of this year. In this regard, IPTAB designated administrative patent judges to formulate patent cases in May. On the first of this month, judges were also assigned to the use patent case. Given that rulings are typically issued within 4 to 6 months of judge designation, a decision this year is highly probable.Once the remaining two trials are completed, the dispute is expected to narrow and shift into a legal battle over a few core patents in the Patent Court.Boehringer Ingelheim has already appealed to the Patent Court against the favorable decision that generic companies secured for the Jardiance use patent (10-2318207). Conversely, the domestic generic alliance that lost the Esgliteo patent (10-1491554) dispute due to a dismissal ruling has also filed an appeal, indicating an upcoming higher-court battle. Meanwhile, Boehringer Ingelheim has not yet decided whether to appeal its June 25 first-instance defeat in the other Jardiance use patent case.
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- Shingrix dominates herpes zoster vaccine market…66% share
- by Chon, Seung-Hyun Jun 29, 2026 09:42am
- The herpes zoster vaccine market, now worth approximately KRW 100 billion a year, continues to be led by ‘Shingrix.’ Despite being the newest entrant, the vaccine has captured nearly two-thirds of total market revenue. Meanwhile, Korea-developed vaccine SKYZoster has also maintained steady growth, accounting for nearly half of total vaccine doses sold.According to IQVIA, Korea's herpes zoster vaccine market reached KRW 30.9 billion in Q1, up 25.9% YoY. Quarterly sales exceeded KRW 30 billion for the first time, marking the largest quarterly market size ever recorded. Compared with KRW 8.9 billion in Q1 2022, the market has expanded more than threefold over the past four years.The rapid expansion is attributed to growing public awareness of the need for shingles prevention. GSK's recombinant vaccine Shingrix is widely regarded as the primary driver of market growth. AI-generated imageDuring Q1, Shingrix generated KRW 20.4 billion in sales, a 32.5% increase YoY. Since its launch in December 2022, the vaccine has enjoyed strong market acceptance thanks to its superior preventive effect.Shingrix's greatest strength lies in its high efficacy. In the ZOE-50 trial involving adults aged 50 years and older, it demonstrated 97.2% efficacy over a median follow-up of 3.2 years. In the ZOE-70 study involving adults aged 70 years and older, efficacy remained 89.8% after 3.7 years of follow-up. By comparison, Zostavax showed efficacy of 51% in adults aged 50 years and older and 41% in those aged 70 years and older. SKYZoster has demonstrated efficacy comparable to that of Zostavax.Shingrix has also confirmed its safety profile through 5 clinical studies involving immunocompromised adults aged 18 years and older. Based on these data, vaccination is indicated for high-risk immunocompromised populations, including recipients of autologous hematopoietic stem cell transplants, patients with solid tumors or hematologic malignancies, and solid organ transplant recipients.After immediately taking the top spot in the market with quarterly sales of KRW 11.1 billion in Q2 2023, Shingrix has maintained its lead and strong growth trajectory.Initially, some observers argued that Shingrix's premium price could hinder early market adoption. The two-dose regimen costs approximately KRW 400,000-500,000, more than twice the KRW 150,000-200,000 price of conventional vaccines at the time. Nevertheless, its superior efficacy has enabled rapid expansion of market share despite the higher price.As of Q1, Shingrix accounted for 66.2% of total market revenue, representing roughly two-thirds of the entire shingles vaccine market.Meanwhile, the Korean SKYZoster has also posted encouraging growth.SK Bioscience reported KRW 10.4 billion in Q1 sales for SKYZoster, representing a 47.3% YoY increase and marking the vaccine's first-ever quarterly sales exceeding KRW 10 billion.SKYZoster is a live attenuated shingles vaccine developed using SK Bioscience's proprietary technology. In a domestic clinical trial conducted at eight medical institutions involving adults aged 50 years and older, the vaccine demonstrated non-inferiority to the reference product, Zostavax.SK Bioscience received approval from the Ministry of Food and Drug Safety in October 2017 for the ‘prevention of herpes zoster in adults aged 50 years and older.’ At that time, the market had been dominated by MSD's Zostavax, but it has shifted to a competitive system with the introduction of SKYZoster.After posting sales of KRW 9.5 billion in Q1 2023, SKYZoster’s quarterly revenue dropped below half that level to KRW 3.9 billion in Q1 2024 before recovering its growth. Sales exceeded KRW 7 billion in Q1 last year, and this year, it has broken a new record for the first time in three years.AI-generated imageAlthough SKYZoster generated only about half the sales of Shingrix during Q1, thanks to its relatively lower price, it showed a comparable market share in terms of sales volume.SKYZoster accounted for 49.7% of total vaccine doses sold during Q1, compared with 50.3% for Shingrix. SKYZoster’s share has risen dramatically from 28.5% in Q1 2024, an increase of more than 20 percentage points over two years.Industry observers believe SKYZoster has absorbed a substantial portion of demand left behind following the withdrawal of Zostavax from the market.MSD Korea decided to discontinue Zostavax supply in June 2024 and voluntarily withdrew its marketing authorization in October of the same year.Approved in Korea in 2009, Zostavax was the country's first homegrown shingles vaccine that effectively opened the domestic market. It reached peak annual sales of KRW 83.7 billion in 2017. However, its position gradually weakened after the launch of domestically developed vaccines in 2018, and Shingrix further accelerated the decline. No sales have been recorded since Q3 last year.
- Company
- Tibsovo finally receives DREC review for reimbursement
- by Eo, Yun-Ho Jun 29, 2026 09:42am
- Tibsovo, a novel therapy for cholangiocarcinoma for which reimbursement has remained stalled for more than a year, is finally set to clear the last hurdle of the Health Insurance Review and Assessment Service (HIRA).According to Dailypharm coverage, Servier Korea's IDH1-targeted therapy Tibsovo (ivosidenib) for patients with IDH1 mutation-positive cholangiocarcinoma will be reviewed by HIRA's Drug Reimbursement Evaluation Committee (DREC) on July 2.Tibsovo was first approved as an orphan drug in Korea in April 2024. After passing the Cancer Drug Deliberation Committee on its second attempt in April 2025 for the cholangiocarcinoma indication, the product has spent more than a year under pharmacoeconomic evaluation.Recently, the government announced plans to improve access to innovative medicines for severe and rare diseases by raising the acceptable ICER threshold and revising the evaluation framework to better reflect disease severity and therapeutic value. As a result, whether Tibsovo will receive a flexible ICER application is expected to be the key issue at the upcoming reimbursement committee meeting.Cholangiocarcinoma is a representative high-risk cancer. Korea is known to have the world's highest mortality rate from biliary tract cancer, while the five-year survival rate for metastatic disease is only 4.1%. In the pivotal ClarIDHy trial, which served as the basis for the approval of Tibsovo, the median overall survival (mOS) of the control group was just 5.1 months.Its treatment landscape has recently improved somewhat in recent years. In the first-line setting, the 'Imfinzi (durvalumab)' combination therapy, and for second-line treatment, 'Pemazyre (pemigatinib)' for patients with FGFR2 fusion and 'Keytruda (pembrolizumab)' for MSI-H/dMMR patients have been granted reimbursement in Korea.However, patients with IDH1 mutations still have no reimbursed targeted treatment option, leaving a significant therapeutic gap.The socioeconomic burden of the disease is also substantial. Because cholangiocarcinoma is difficult to detect early, many patients are diagnosed at an advanced stage. Experts note that disparities in treatment access driven by socioeconomic status directly translate into disparities in survival rates in the disease.In the Phase III ClarIDHy trial, Tibsovo improved median overall survival to 10.3 months, nearly doubling survival compared with 5.1 months in the placebo group (HR 0.49). Median progression-free survival (PFS) also improved significantly to 2.7 months, versus 1.4 months with placebo. Based on these results, Tibsovo became the only second-line treatment for cholangiocarcinoma to receive a Category 1 recommendation in the NCCN Guidelines.More recently, findings from the Phase IIIb real-world ProvIDHe study also drew attention. Median overall survival reached 15.5 months in the overall study population, while the Korea-Australia subgroup, which included Korean patients, reported an mOS of 19.7 months.Meanwhile, Tibsovo has received reimbursement recommendations in seven of the eight A8 countries. The UK's NICE concluded cholangiocarcinoma is a severe condition as patients lose most of their expected life expectancy and quality of life, and applied the maximum severity modifier of 1.7. Scotland's SMC and Australia's PBAC also recommended reimbursement, citing the high unmet medical need and lack of alternative therapies.
- Company
- Nucala Autoinjector to soon enter Korean COPD market
- by Eo, Yun-Ho Jun 26, 2026 09:45am
- The monoclonal antibody ‘Nucala’ is seeking to expand its reach into the treatment of chronic obstructive pulmonary disease (COPD).According to industry sources, GSK Korea recently submitted an application to the Ministry of Food and Drug Safety (MFDS) to expand the indication of the Nucala Autoinjector (mepolizumab) to include COPD. Regulatory approval is expected in the second half of this year.Nucala is an IL-5-targeting biologic that received U.S. FDA approval for COPD last year. The drug was subsequently approved by the European Medicines Agency (EMA) in February.Specifically, the indication is for the treatment of COPD with elevated blood eosinophil counts in patients already receiving combination therapy with inhaled corticosteroids (ICS), long-acting beta2-agonists (LABA), and long-acting muscarinic antagonists (LAMA).Nucala's efficacy in COPD was demonstrated in the Phase III MATINEE trial.In the study, Nucala reduced the annual rate of moderate or severe exacerbations by 21% compared with placebo. It also reduced exacerbations that lead to hospitalization or emergency department visits by 35%. The incidence of adverse events was comparable to that observed in the placebo group.In Korea, Nucala is currently approved not only for the treatment of severe eosinophilic asthma in adults and adolescents aged 12 years and older, but also for ▲eosinophilic granulomatosis with polyangiitis (EGPA) in adults; and ▲hypereosinophilic syndrome (HES) in adults.Meanwhile, Nucala’s reimbursement was expanded to eosinophilic asthma in May. The revised reimbursement criteria now cover patients aged 12 years and older whose disease remains inadequately controlled despite treatment with ICS-LABA and LAMA.
