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- 2026-09-08 05:27:03
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- Obesity drugs mkt is expanding beyond GLP-1 to amylin and glucagon
- by Son, Hyung Min Sep 07, 2026 08:59am
- The obesity drug market, dominated by GLP-1 receptor agonists, is diversifying toward using novel hormonal pathways such as amylin and glucagon.In the future, rather than administering the same drug to everyone with obesity, treatment strategies could evolve into tailored approaches that select GLP-1-based therapeutics, amylin agonists, and dual or triple agonists based on comorbid complications, required weight-loss range, and tolerability.W. Timothy Garvey, Professor of the Department of Nutrition Sciences at the University of Alabama at Birmingham (UAB), attended the International Congress on Obesity and Metabolic Syndrome (ICOMES 2026) organized by the Korean Society for the Study of Obesity (KSSO) at the Conrad Hotel in Yeouido on the 4th, where he delivered a presentation titled "Incretin Targets to Multi-Hormonal Approaches: The Role of Amylin and Glucagon" and introduced future directions in the development of next-generation obesity therapies.Professor Garvey distinguished newly emerged obesity drugs such as 'Wegovy (semaglutide)' and 'Mounjaro (tirzepatide)' from conventional agents, calling them "second-generation therapies." While conventional obesity treatments showed an average weight-loss efficacy of 10% or less, recent therapeutics have achieved an average reduction of 15% or more.However, Professor Garvey noted that the significance of second-generation therapeutics does not lie merely in increasing weight-loss range. Professor Garvey explained that greater weight reduction expands the scope for preventing or improving various obesity-related complications. Therefore, obesity management should focus on improving patient health rather than body weight alone.W. Timothy Garvey, Professor of the Department of Nutrition Sciences at the University of Alabama at Birmingham (UAB), attended the International Congress on Obesity and Metabolic Syndrome (ICOMES 2026) organized by the Korean Society for the Study of Obesity (KSSO) at the Conrad Hotel in Yeouido on September 4.Expanding to amylin and glucagon…Diversification of targets for novel obesity drugsGlobal development of obesity treatments is broadening its targets beyond the single GLP-1 pathway to diverse hormones regulated by nutritional status, including amylin, GIP, glucagon, and PYY.In addition to single agonists, dual agonists targeting both GLP-1 ·glucagon triple agonists, are currently under development. This approach aims to maximize weight-loss efficacy by combining distinct mechanisms of action.Boehringer Ingelheim's GLP-1·glucagon dual agonist survodutide demonstrated a weight-loss rate of 16.6% at week 76 in the maximum-dose 6 mg cohort, based on the efficacy estimand (assuming treatment adherence), in the Phase 3 SYNCHRONIZE-1 trial. Based on the treatment-regimen estimand, which reflects treatment discontinuations and other variables, the rate was 13.0%.However, tolerability remains a challenge. The proportion of patients in the 6 mg group who discontinued the investigational drug due to adverse events was approximately 20%, and gastrointestinal adverse events such as nausea and vomiting were also relatively frequent.Professor Garvey pointed out, "A discontinuation rate of 20% is concerning," noting that the burden of gastrointestinal adverse events was greater than in prior GLP-1 clinical trials. Conversely, he attributed positive significance to the findings showing reductions in liver fat and liver stiffness.Eli Lilly's GLP-1·GIP·glucagon triple agonist retatrutide achieved a weight loss rate of 28.3% at the maximum dose of 12 mg based on the efficacy estimand in the Phase 3 TRIUMPH-1 trial. The 9 mg and 4 mg doses achieved reductions of 25.9% and 19.0%, respectively.Describing the extent of weight reduction observed at the maximum dose, Professor Garvey remarked that it was "comparable with bariatric surgery." However, because paresthesia and hypotension were also observed, he noted that adverse event management would be necessary for real-world clinical use.Amylin, potential differentiation in both weight loss efficacy and tolerabilityAt this presentation, Professor Garvey placed particular emphasis on amylin.Amylin is a hormone cosecreted with insulin from pancreatic beta cells; it acts on regions such as the brainstem and hypothalamus to increase satiety and reduce food intake while delaying gastric emptying.Preclinical studies have shown that amylin suppresses the decrease in energy expenditure during weight loss and reduces fat mass while potentially preserving muscle mass relatively well. Researchers are also investigating its potential to attenuate bone mass loss.However, Professor Garvey drew a line by stating that because these effects on muscle and bone are still based on preclinical evidence, further confirmation is required to determine whether they can be replicated in patients.In clinical settings, a relatively low incidence of gastrointestinal adverse events, along with robust weight loss efficacy, is cited as a major strength.The long-acting amylin analog petrelintide, under development by Roche and Zealand Pharma, demonstrated a weight reduction exceeding 10% in the Phase 2 ZUPREME-1 trial.Professor Garvey highlighted that nausea occurred in about 20% of patients, lower than levels typically reported in clinical trials of GLP-1-based agents, and that vomiting, diarrhea, and constipation were also relatively uncommon.Novo Nordisk's CagriSema, a co-formulation of the amylin analog cagrilintide and semaglutide, demonstrated a weight loss rate of 22.7% at week 68 based on the efficacy estimand in the REDEFINE 1 trial. This exceeded the 16.1% observed with semaglutide monotherapy and 11.8% with cagrilintide monotherapy.Eli Lilly's investigational selective amylin receptor agonist, eloralintide, also demonstrated weight loss of up to 20.1% based on the efficacy estimand in a 48-week Phase 2 study.Professor Garvey said long-acting amylin agents show weight-loss efficacy sufficient to anticipate health benefits in short-term clinical trials, while carrying a relatively lower burden of gastrointestinal adverse events. He explained that this underpins the pharmaceutical industry's heightened focus on developing the amylin class.Drug selection may vary depending on severe obesity and comorbiditiesProfessor Garvey anticipated that as the pipeline of obesity therapeutics expands, treatment algorithms will be established, much like those for hypertension or diabetes, where agents are tailored to patient conditions and additional medications are introduced as needed.However, Professor Garvey clarified that this is not currently an established recommendation, but rather a hypothetical treatment strategy grounded in early clinical evidence.Professor Garvey categorized patients broadly into three types. For patients with a high body mass index (BMI) accompanied by biomechanical complications such as impaired mobility, dual or triple agonists could be considered, as substantial weight reduction of 20% to 25% or more may be required.For patients with specific comorbidities such as cardiovascular disease or obstructive sleep apnea, Professor Garvey considered administering agents proven effective in improving those complications in clinical trials first.Conversely, for the broader population of individuals with obesity who do not have specific comorbidities, Professor Garvey mentioned the possibility of utilizing long-acting amylin agonists, which offer sufficient weight loss efficacy along with favorable tolerability, as an initial therapeutic option.Professor Garvey stated, "In obesity, as in hypertension or diabetes, management can evolve by starting with a well-tolerated drug and then adding other agents if clinical targets are not met," concluding that "as treatment options expand, a more individualized approach will become possible for each patient."
- Policy
- Xeljanz frequently granted off-label use in lupus and dermatomyositis
- by Jung, Heung-Jun Sep 07, 2026 08:59am
- With the number of approved non-reimbursed off-label drug use applications increasing to 136 since the previous tally, Xeljanz (tofacitinib) was found to have been frequently approved for conditions including refractory dermatomyositis.Although Xeljanz is approved for rheumatoid arthritis and ulcerative colitis, it is also used in practice as salvage therapy for severe autoimmune diseases.According to HIRA’s data on ‘Approved and rejected applications for non-reimbursed off-label drug use’ that was issued on the 7th, a total of 2,594 cumulative applications have been approved as of this month.Since HIRA began disclosing the figures in October last year, 408 additional applications have been approved over approximately 1 year. Rejections increased by only 21 during the same period, putting the approval rate at approximately 95%.Since HIRA began disclosing the figures in October last year, 408 additional applications have been approved over approximately 1 year. AI-generated imageThe low rejection rate is interpreted as applications having already secured supporting evidence through review by hospital institutional review boards (IRBs) or medical societies.This month’s tally included 136 more approvals than the previous count in May. Xeljanz (tofacitinib) accounted for 11 of them, a particularly notable increase.Xeljanz is currently indicated for ulcerative colitis, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, among other conditions. Its approved off-label uses include treatment of patients with refractory dermatomyositis or systemic lupus erythematosus who have failed to respond to existing therapies.The cumulative number of approvals for Xeljanz has risen from 3 as of October last year to 20 this month.Plasma-derived products also continue to show frequent off-label use. GC Biopharma’s IV-Globulin SN Injection and SK Plasma’s Liv-Gamma SN Injection received 11 additional off-label approvals compared with May.The products are approved for ▲hypo- or agammaglobulinemia, ▲use in combination with antibiotics in severe infections, ▲idiopathic thrombocytopenic purpura, ▲Guillain-Barré syndrome and ▲Kawasaki disease.In clinical practice, they are prescribed off-label mainly for complications following organ transplantation and severe autoimmune diseases, generating continued demand.However, an application to use the products in patients with postural orthostatic tachycardia syndrome, which is not an autoimmune disease, was rejected due to insufficient medical evidence.
- InterView
- "SpaceOAR reduces rectal bleeding…major shift in radiation therapy"
- by Hwang, byoung woo Sep 07, 2026 08:59am
- Radiation therapy for prostate cancer is evolving in a way that enhances therapeutic efficacy while also reducing adverse events and the burden of hospital visits.As hypofractionated radiotherapy is expanding, protecting the rectum adjacent to the prostate has become a challenge. This is because radiation exposure to normal organs must be minimized to shorten the overall treatment duration.Professor Won Park of the Department of Radiation Oncology at Samsung Medical Center recently met with Daily Pharm to discuss shifts in prostate cancer radiotherapy and the SpaceOAR System's role in reducing rectal toxicity.Prostate cancer cases increase… Critical role of radiation in the elderlyAccording to the 2023 National Cancer Registry statistics from the Ministry of Health and Welfare (MOHW), prostate cancer was the most frequently diagnosed cancer among Korean men, with 22,640 cases recorded.Professor Won Park of the Department of Radiation Oncology at Samsung Medical CenterThe clinical setting has also changed. While urological cancers accounted for less than 10% of the patients Professor Park treated 15 to 20 years ago, that figure has now grown to approximately 80%. Among these, 70% to 80% are prostate cancer cases, reaching nearly 80% when looking solely at newly diagnosed patients.Prostate cancer treatment is chosen from active surveillance, surgery, radiation therapy, or hormone therapy based on disease stage, grade of malignancy, patient age, and comorbidities. For early-stage patients with low-grade disease, clinicians sometimes monitor progression through follow-up examinations.For localized prostate cancer requiring active treatment, surgery and radiation therapy are the primary options. In cases where the disease has progressed or exhibits high-grade malignancy, radiation therapy and hormone therapy may be administered concurrently.Professor Park explained, "For early-stage disease, patients can choose between surgery and radiation therapy. While the therapeutic outcomes are equivalent, the procedures and side-effect profiles differ, requiring patients to make an informed choice."Professor Park added, "Radiation can be applied from very early stages up to relatively contained prostate cancer without widespread metastases. As population aging continues, the role of radiation therapy will only expand."Reducing rectal toxicity has led to fewer treatment sessionsThe primary challenge of prostate cancer radiation therapy is that the prostate is located near the rectum and bladder. Delivering an adequate radiation dose to the tumor while avoiding exposure to adjacent normal organs is difficult, and rectal bleeding can occur post-treatment.According to Professor Park, an analysis conducted by Samsung Medical Center on patients who previously underwent 28 fractions of radiation therapy revealed that approximately 20% experienced Grade 2 or higher rectal toxicity requiring interventions such as hemostasis or blood transfusions. To reduce this risk, the Samsung Medical Center adopted the SpaceOAR System approximately four years ago.The SpaceOAR System creates a temporary separation by injecting a biodegradable hydrogel between the prostate and the rectum before radiation therapy. This decreases the radiation dose delivered to the rectum. However, patients whose cancer has invaded the rectum are excluded from this procedure.In a follow-up analysis of approximately 280 early-stage patients monitored for more than two years, only one or two patients had Grade 1 rectal bleeding requiring no medical intervention, and no cases of Grade 2 or higher bleeding were identified.Professor Park noted, "In the past, roughly two out of ten patients required additional intervention due to rectal bleeding," and added, "Since implementing the SpaceOAR System, observing bleeding that requires clinical intervention has become exceedingly rare."Rectum protection also provided the clinical foundation for reducing treatment fraction frequency. Samsung Medical Center currently delivers radiation therapy in five fractions over a single week for a substantial proportion of early- to intermediate-stage patients. For patients who do not receive the SpaceOAR System or are ineligible because of rectal invasion, the dose per fraction is lowered, and the total number of treatment sessions is extended.Professor Park explained that "Creating space between the prostate and the rectum allows the rectum to be protected even when administering high radiation doses per fraction," and added, "Patients can reduce their hospital visits, and the hospital can treat a larger volume of patients utilizing the same equipment."Experience built based on 1,000 cases…Expanding application to complex casesSamsung Medical Center recently surpassed 1,000 cumulative SpaceOAR System procedures. After acquiring dedicated equipment, weekly procedural volume increased from an initial two cases to up to 15 cases.Professor Park attributed the significance of the 1,000-case milestone to gaining experience across a broad spectrum of patient profiles, accumulating clinical indications and limitations. The procedure was attempted even in patients presenting with tissue adhesions from recurrence following previous radiation therapy, adhesions posterior to the prostate following rectal cancer surgery, and recurrence after High-Intensity Focused Ultrasound (HIFU) therapy.If adhesions are severe, the space between the prostate and rectum may fail to expand sufficiently, leading to procedural failure. Accumulated clinical experience now allows clinicians to assess feasibility accurately and counsel patients on procedural limitations beforehand.Regarding the milestone of 1,000 cases, he reflected, "Extensive and varied experience has been established. It has instilled the confidence to attempt the procedure even when presented with highly challenging cases."The SpaceOAR Vue System, introduced last year, incorporates an iodine tracer that allows hydrogel visualization via computed tomography (CT) and MRI. Unlike the conventional product, it enables more precise demarcation between the prostate and rectal boundaries and facilitates pre-treatment alignment.Regarding this, Professor Park noted, "Patients do not need to undergo the insertion of gold fiducial markers, and clinicians can precisely target treatment areas," and added, "Verifying target positioning during actual treatment sessions has also become significantly more streamlined."Equipment, interdisciplinary collaboration, and guidelines are the keyPatient access improved after National Health Insurance reimbursement for biodegradable material injection for prostate cancer radiotherapy was granted in 2023. However, reimbursement eligibility alone does not guarantee that every medical institution can implement the procedure.The procedure requires transrectal ultrasound (TRUS) to visualize the trajectory of the needle relative to the prostate, along with a skilled clinical team. Samsung Medical Center also used equipment and procedural suites in the Department of Urology while acquiring specialized ultrasound techniques through the Department of Radiology.Depending on the hospital, either the Department of Urology or the Department of Radiology may perform the procedure. Rather than which clinical department leads, wider adoption is dependent on securing the requisite equipment and expertise and building a multidisciplinary collaborative effort.To increase introduction, Professor Park suggested, "It is challenging for a radiation oncology department to launch this program independently without equipment and prior procedural experience," adding, "Proactive efforts must be made to introduce the system through collaboration with urology or radiology departments."Establishing standardized domestic clinical guidelines remains an unmet need. Although relevant procedural guidelines have been incorporated into international treatment standards and textbooks, this procedure was introduced in Korea approximately four years ago.Professor Park emphasized, "Once clinical guidelines are firmly established in Korea, the number of adopting institutions will expand significantly," adding, "Expectations are high, as clinicians can alleviate concerns regarding rectal toxicity, while patients can complete their courses of treatment more rapidly with minimized adverse effects."
- InterView
- Treatment options for renal anemia become more diverse
- by Son, Hyung Min Sep 07, 2026 08:59am
- Treatment of anemia associated with chronic kidney disease is moving beyond simply adjusting doses of erythropoiesis-stimulating agents (ESAs) toward selecting an appropriate mechanism based on each patient’s iron metabolism, inflammatory status, and treatment response.ESAs, which have led the treatment of anemia in dialysis patients for decades, remain the standard of care. More recently, however, oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), which stimulate endogenous erythropoietin (EPO) production by harnessing the body’s response to hypoxia, have entered clinical practice in Korea and broadened the range of options.The use of the new mechanisms is deemed to be useful in patients who struggle to reach their target hemoglobin level despite ESA therapy or who have sufficient iron stores, as measured by ferritin, but cannot effectively use that iron for erythropoiesis.At a recent interview with Dailypharn, Dong Ki Kim, Professor of Nephrology at Seoul National University Hospital, said, “For the past 30 years, anemia treatment in dialysis patients has essentially revolved around setting the ESA dose and determining when to supplement iron.”Anemia common among dialysis patients…linked to cardiovascular riskDong Ki Kim, Department of Nephrology, SNUHAnemia is a common complication in dialysis patients. Declining kidney function reduces production of EPO, which stimulates red blood cell production. Uremic toxins, chronic inflammation, impaired iron utilization, repeated blood sampling, and blood loss during dialysis also contribute to the condition.The burden on patients can also be substantial. As anemia worsens, it may cause not only shortness of breath and fatigue but also a broad decline in quality of life, affecting exercise capacity, concentration, sleep and social activities.Kim noted that anemia management is closely linked to the long-term prognosis of dialysis patients and goes beyond relieving symptoms.He said, “Cardiovascular disease is one of the primary causes of death in dialysis patients. When anemia occurs, heart rate and cardiac output increase to compensate for it, which increases the burden on the heart and can raise the risk of cardiovascular complications such as left ventricular hypertrophy.”“Because anemia is closely associated with outcomes such as hospitalization and death, it should not be viewed simply as an adjunctive treatment aimed at relieving symptoms,” he added.Excessively raising hemoglobin or correcting it too rapidly must also be avoided. Management within an appropriate range requires a comprehensive assessment of not only the patient’s hemoglobin and iron status but also inflammation, bleeding, cardiovascular disease and ESA responsiveness.Patients with poor ESA response and iron deficiency…intensify treatment gapsESAs have transformed the treatment of renal anemia. By reducing the frequent transfusions previously required and improving anemia and quality of life, they have remained the mainstay of treatment for many years.However, not every patient responds to ESA therapy.In patients with chronic inflammation, levels of hepcidin—the hormone that regulates iron metabolism—increase, preventing the body from effectively using iron even when sufficient stores are present. This is commonly seen in patients with diabetes, infections, vascular access problems, peritonitis, chronic wounds, or autoimmune diseases.Patients with functional iron deficiency, characterized by those who have adequate serum ferritin but low transferrin saturation (TSAT), may also fail to achieve the desired response despite receiving ESAs and iron supplementation.Kim explained, “In these patients, continually increasing the ESA dose may offer limited efficacy, and the risk of adverse effects must also be considered. This has led to a rising, constant demand for treatment options that control anemia through mechanisms other than ESAs.”HIF-PHIs are one new option that may help address these limitations. They inhibit the prolyl hydroxylase enzymes responsible for degrading hypoxia-inducible factor, thereby activating the body’s hypoxia-response pathway and stimulating endogenous EPO production. Their effects on pathways involved in iron absorption, transport, and utilization also distinguish them from conventional ESAs.“While ESAs stimulate red blood cell production by supplying EPO from outside the body, HIF-PHIs use the patient’s own hypoxia-adaptation system. An important distinction is that they affect iron metabolism, including hepcidin, helping mobilize stored iron for erythropoiesis.”“Who to use HIF-PHIs”…specifying subject patientsIn Korea, the oral HIF-PHI Vadanem (vadadustat) is used to treat anemia associated with chronic kidney disease in adults receiving dialysis. It is available in 150 mg and 300 mg strengths and can be taken orally once daily.In the global INNO2VATE 1 and 2 trials in dialysis patients, Vadanem demonstrated noninferiority to the conventional ESA darbepoetin alfa in improving hemoglobin levels.Based on his clinical experience, Kim identified several patient groups in whom HIF-PHI treatment may be considered: patients newly starting dialysis; patients with functional iron deficiency or inflammation who respond poorly to ESAs; and peritoneal dialysis patients for whom injections are burdensome.“Patients beginning dialysis may retain a relatively greater degree of residual kidney function and, in some cases, have less severe inflammation. For these patients, an HIF-PHI that stimulates endogenous EPO production may be an option.”He added, “HIF-PHIs may also be considered in patients with functional iron deficiency, whose ferritin is sufficient but whose low TSAT indicates that iron is not being properly mobilized, or in patients whose response to ESAs is impaired by inflammation.”However, closer management is needed when patients with poor response who had been receiving high-dose ESAs switch to an HIF-PHI. Their previous ESA requirements and changes in hemoglobin levels must be monitored until the appropriate HIF-PHI dose is established.“In patients switched to an HIF-PHI, I have generally seen hemoglobin remain within the target range or rise gradually during the first 4-8 weeks, rather than changing abruptly. It is important to monitor both hemoglobin and iron-related parameters regularly during treatment.”Their oral route of administration is another reason HIF-PHIs may be considered in clinical practice.“What patients mention most often is that they appreciate not having to receive injections. For healthcare professionals, replacing the management of injection schedules and doses with once-daily administration allows greater focus on maintaining the patient’s hemoglobin at a stable level.”Reimbursement remains a challenge…”Treatment should match the patient”Kim also pointed to the need for policy improvements. Under the current reimbursement framework, restrictions on combining HIF-PHIs with ESAs make it difficult to use flexible treatment strategies during the transition between therapies.Kim said, “It is encouraging that reimbursement for the new drug has improved patient access. However, greater flexibility is needed when transitioning between treatments, and the hemoglobin target range may also need to be reconsidered based on individual patient conditions.”He added that the narrow hemoglobin range recognized for reimbursement during maintenance therapy and the restriction of eligible use to dialysis patients may warrant discussion as further clinical evidence emerges.He said, “It is disappointing that the hemoglobin range eligible for reimbursement during maintenance therapy is rather narrow. There may be room for adjustment, particularly when compared with the target ranges recommended in international guidelines.”Kim added, “As Korean real-world clinical data accumulate, more specific criteria for the use of HIF-PHIs may be developed to better reflect the characteristics of Korean dialysis patients.”He emphasized, “Going forward, treatment decisions will increasingly focus on determining which mechanism of action is most appropriate for each patient and which therapy can maintain stable hemoglobin levels. With more options available, anemia treatment can become more individualized and precise.”
- Company
- Will the MM drug Tecvayli finally be reimbursed in Korea?
- by Eo, Yun-Ho Sep 07, 2026 08:58am
- Tecvayli, a novel treatment for multiple myeloma, has completed the Health Insurance Review and Assessment Service stage of the reimbursement process nearly 3 years after receiving marketing authorization in Korea.According to industry sources, Janssen Korea’s bispecific antibody Tecvayli (teclistamab) recently passed HIRA’s Drug Reimbursement Evaluation Committee.The decision follows the drug’s Korean approval in July 2023 and its passage through the Cancer Drug Deliberation Committee in May. Tecvayli’s progress is being welcomed in the field, as reimbursement of new therapies has been particularly slow in multiple myeloma.Multiple myeloma remains an incurable disease, but in the past, survival rates were very low due to limited treatment options.In recent years, however, innovative treatments such as monoclonal antibodies, CAR-T therapies, and bispecific antibodies have expanded treatment options and improved survival.In fact, over the past 20 years, the five-year survival rate for multiple myeloma patients has increased from 29.8% in 2001-2005 to about 50.1% in 2017-2021. However, this remains below the 60% survival rate in developed countries such as the United States, and limited access to care is widely regarded as a major contributing factor.In Korea, only 13 (52%) of the 22 drugs recommended in the NCCN guidelines for multiple myeloma are covered by reimbursement (based on the NCCN guidelines 2024 v2).For example, Darzalex (daratumumab) was approved in 2019 as a first-line combination therapy for multiple myeloma, but was only granted reimbursement as a fourth-line monotherapy in Korea.It was not until October last year, roughly five years later, that the DREC recognized the appropriateness of expanding the reimbursed use of Darzalex under its risk-sharing agreement. Also, Xpovio (selinexor) was granted reimbursement in July 2024, after 4 reimbursement attempts since its approval in 2021.Bispecific antibody therapies for multiple myeloma simultaneously bind a target antigen on myeloma cells and CD3 on T cells. While some BCMA×CD3 bispecific antibodies are IgG2 kappa antibodies derived from two monoclonal antibodies, Tecvayli is a full-size IgG4-PAA bispecific antibody that redirects T cells to BCMA-expressing myeloma cells, offering a novel therapeutic approach.Despite their high clinical utility, Tecvayli and other bispecific antibodies, including Elrexfio (elranatamab) and Talvey (talquetamab), all remain unreimbursed in Korea. Therefore, attention is now focused on whether Tecvayli can clear price negotiations with the National Health Insurance Service and complete the final stretch of its reimbursement journey.Tecvayli was approved based on results from the Phase 1/2 MajesTEC-1 study. In the trial, which evaluated the efficacy and safety of the drug in a total of 165 patients, Tecvayli achieved an overall response rate (ORR) of 63% in patients with relapsed or refractory multiple myeloma (RRMM) who have received three or more therapies, including triple-class exposure to a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Also, 32.7% of the patients achieved a stringent complete response (sCR).Also, 6.7% and 19.4% of patients showed complete response (CR) and very good partial response (VGPR), respectively. The median time to first response was 1.2 months, and the duration of response (DOR) was analyzed to be 18.4 months (14.9-not estimable).
- Policy
- Shing Poong Pharm’s Prolia biosimilar approved in Korea
- by Lee, Tak-Sun Sep 04, 2026 08:47am
- Shin Poong Pharm has secured marketing authorization for Denovon, a biosimilar version of Amgen’s blockbuster osteoporosis treatment Prolia (denosumab), bringing the product one step closer to launch. Given the usual timetable for health insurance pricing and listing, Denovon is expected to enter the market around the end of the year.With 7 Prolia biosimilars now approved in Korea, competition in the market is expected to intensify further.On the 3rd, the Ministry of Food and Drug Safety approved Shin Poong’s Denovon Prefilled Syringe Injection, a denosumab treatment for osteoporosis.Denovon is supplied as a 60 mg/1 mL prefilled syringe formulation. Like the reference product Prolia, it is indicated for ▲the treatment of osteoporosis in postmenopausal women, ▲increasing bone mass in men with osteoporosis, ▲glucocorticoid-induced osteoporosis, and ▲bone loss in patients with nonmetastatic prostate cancer or breast cancer. Shin Poong acquired exclusive rights to develop and market the product in Korea from India’s Enzene Biosciences in 2021.Seven biosimilars vie for market…first 4 biosimilars already secure reimbursement listingThe approval of Denovon brings the total number of Prolia biosimilars authorized in Korea to seven. Shin Poong is the latest company to join a field that already includes Celltrion, Samsung Bioepis, LG Chem, HK inno.N, Daewon Pharmaceutical and Alvogen Korea.Four of the products have already secured reimbursement and are competing in the market. According to the national health insurance reimbursement list, four 60 mg Prolia biosimilars – Samsung Bioepis’ Obodence, Celltrion’s Stoboclo, HK inno.N’s Izambia and Daewon Pharmaceutical’s Junode – are already listed and are being sold in Korea.Samsung Bioepis (Xbryk), Celltrion (Osenvelt) and HK inno.N (Denbrace) have also received reimbursement approval for their biosimilar versions of Xgeva 120 mg, which is used to treat skeletal complications in patients with cancer.Shin Poong’s newly approved Denovon will now undergo the reimbursement process alongside LG Chem’s Jubbonti and Alvogen Korea’s Ducolia, neither of which has yet been listed.Late entrants seek foothold in KRW 170 billion blockbuster marketAmgen’s ProliaThe Korean Prolia market generates approximately KRW 170 billion in annual prescriptions, making Prolia the largest product in the osteoporosis treatment market. Its convenient once-every-six-month dosing regimen and continued coverage under national health insurance criteria have helped it establish a solid prescription base.In the existing market, early biosimilar entrants are leveraging approvals from drug committees at hospitals and clinics to carve out market share against the sales force of Chong Kun Dang, which holds the domestic marketing rights to the originator Prolia.Later entrant Shin Poong recently revised its agreement with originator Enzene to strengthen its competitive position. Ahead of the launch, Shin Poong secured ▲adjusted the supply price, ▲added sublicensing rights, and ▲a technology transfer option to the agreement.The adjusted supply price is expected to improve both pricing competitiveness and distribution margins. The sublicensing rights also open the door to co-promotion partnerships with pharmaceutical companies that have strong sales networks among local clinics (orthopedics, obstetrics and gynecology, and internal medicine), which account for a large share of prescriptions.An industry official said, “Four biosimilars have already secured reimbursement and are moving to establish an early lead, so an attractive price and a comprehensive sales network encompassing local clinics will be essential for any later entrant. With Shin Poong gaining greater flexibility by restructuring its agreement, the key question will be what kind of partnership it uses to establish itself in the market after securing reimbursement, which is expected around the end of the year.”
- Opinion
- ADC option for HR+ breast cancer...'Datroway' garners attention
- by Son, Hyung Min Sep 04, 2026 08:47am
- Which therapeutic options to choose from following CDK4/6 inhibitor treatment in the course of hormone receptor-positive (HR+)/HER2-negative (HR-) metastatic breast cancer treatment is becoming a major issue.The establishment of a combination therapy of endocrine therapy and a CDK4/6 inhibitor as the first-line standard therapy has significantly improved early-stage therapeutic outcomes and quality of life. However, therapeutic options that secure both therapeutic effects and tolerability are relatively limited when drug resistance occurs.Professor Kyung Hwa Park of the Division of Medical Oncology at Korea University Anam Hospital In South Korea, due to limited follow-up endocrine-based therapeutic options, patients whose disease has progressed often move on to chemotherapy. Industry experts view this process as increasing patient burden, such as hair loss, accumulated toxicity, and daily life struggles.'Datroway (datopotamab deruxtecan),' a TROP2-directed antibody-drug conjugate (ADC) recently approved in South Korea, is drawing attention as a novel treatment option distinct from conventional chemotherapy for patients with HR+/HER2- metastatic breast cancer.In a recent interview with Daily Pharm, Professor Kyung Hwa Park of the Division of Medical Oncology at Korea University Anam Hospital stated, "Patients treated with CDK4/6 inhibitors have high expectations for maintaining a high quality of life and sustaining daily routines for a prolonged period," and added, "However, patients feel frustrated because there are not enough subsequent treatment options to continue that."Professor Park continued, "In this situation, the approval of Datroway and availability of a new ADC treatment option is highly meaningful, as it allows patients to expect a relatively long progression-free survival (PFS) while maintaining their quality of life."Shortened survival following CDK4/6 inhibitor use… Subsequent treatment is not availableFor HR+/HER2- metastatic breast cancer, combination therapy of endocrine therapy and a CDK4/6 inhibitor is generally used as first-line treatment.The issue arises after resistance develops. Among patients whose disease progressed after CDK4/6 inhibitor use, the median PFS is less than 4 months;. In comparison, median PFS with chemotherapy is 6.4 months in the first-line setting, but drops to about 4.1 months in the third-line setting. In practice, only 31% of all patients proceeded to third-line therapy.Professor Park pointed out that this issue can be even more pronounced in Korea's domestic treatment landscape.Professor Park stated, "In Korea, subsequent endocrine therapies that can realistically be used are limited to fulvestrant monotherapy or the combination of everolimus plus exemestane," adding, "For patients with ESR1 gene mutations, there are no available drugs, leaving them at a stage where they must consider participating in clinical trials."Ultimately, a substantial number of patients transition to chemotherapy, but the reluctance felt by patients is considerable.Professor Park added, "Rather than financial reasons, many patients who have maintained their daily lives while undergoing treatment with CDK4/6 inhibitors do not want to switch to chemotherapy, which causes hair loss and makes daily living difficult."Datroway improves PFS… Safety is the benefitLast March, Datroway was approved in Korea for the treatment of patients with HR+/HER2- metastatic breast cancer who have received prior endocrine-based therapy and systemic chemotherapy in the advanced setting.In the TROPION-Breast01 study, the basis for approval, Datroway reduced the risk of disease progression or death by 37% compared with investigator's choice of chemotherapy.The median PFS was 6.9 months in the Datroway group and 4.9 months in the control group, with a hazard ratio (HR) of 0.63. The objective response rates (ORR) were 36.4% and 22.9%, respectively.The therapeutic effect demonstrated a consistent pattern regardless of prior lines of therapy, prior CDK4/6 inhibitor use, or HER2-low versus IHC 0 status.Professor Park viewed this as a case where, rather than focusing solely on the absolute PFS difference of two months, one must consider the limitations of existing therapies alongside patient characteristics.Professor Park noted, "While it is a difference of about two months, a PFS of approximately seven months is a considerably meaningful figure," adding, "Even when cytotoxic chemotherapies are effective, it can be difficult to maintain treatment for a long time due to cumulative toxicities such as peripheral neuropathy, hand-foot syndrome, and edema."Professor Park further added, "A major advantage of ADCs is that patients can sustain treatment with a relatively lower burden of cumulative toxicity."Considering both quality of life and Toxicity… "Maintaining daily life Is also a treatment outcome"In TROPION-Breast01, differences from conventional chemotherapy were also confirmed in terms of patient-reported outcomes (PROs) and safety.Analysis of time to confirmed deterioration showed a time to deterioration in quality of life of 9 months in the Datroway arm versus 4.8 months in the control group. Time to pain deterioration also differed, at 9 months versus 5.5 months, respectively.The incidence of Grade 3 or higher treatment-related adverse events was 20.8% in the Datroway group and 44.7% in the control group. Neutropenia was recorded in 1.1% and 30.8% of patients, respectively.Professor Park said, "Previsously, what mattered to metastatic cancer patients was how many more months they could live, but nowadays they ask whether they can travel abroad or go to a swimming pool during treatment," adding, "As more patients view cancer as a condition to live with while receiving treatment, maintaining quality of life and extending meaningful time have become essential."While adverse events such as stomatitis and ocular toxicities can occur with Datroway treatment, Professor Park's view is that many of them are preventable and manageable.Based on Professor Park's involvment in clinical trials, she explained, "There were low-grade cases of stomatitis that were managed using steroid mouthwashes, and patients with blurred vision were managed without major issues through appropriate ophthalmologic care and treatment," adding, "The incidence of high-grade adverse events that lead patients to visit hospitals or emergency rooms due to neutropenia or interstitial lung disease was very low."Switching to an ADC considering tumor burden and comorbiditiesThen, which HR+/HER2- patients should clinicians consider first for Datroway?Professor Park identified patients whose disease progresses rapidly despite CDK4/6 inhibitors, or those unlikely to respond to subsequent endocrine therapy, as primary candidates.She said, "Some patients experience disease progression within six months of using first-line therapies. For such patients, switching promptly to an ADC can be considered as the next treatment," adding, "The same applies to patients whose disease was controlled for a relatively long period with CDK4/6 inhibitors, but who have a high tumor burden or lack suitable subsequent endocrine therapy."Switching to an ADC can also be considered when targeted therapies such as PI3K or AKT inhibitors are difficult to use because of the patient's physical condition or underlying comorbidities.Patients with HER2 IHC (immunohistochemistry) 0 are also a population for whom Datroway can be considered. This is because they can leverage TROP2 as an independent target, even when existing HER2-targeted ADCs are restricted.Professor Park suggested, "Datroway can be considered for patients with HER2 0 status, patients who have HER2-low disease but face difficulties using HER2 ADCs due to cardiac function or other comorbidities, and vulnerable patients for whom safety is paramount.""Diversity of treatment options is crucial for patients"However, the issue of insurance reimbursement remains to enhance real-world access to treatment in Korea.Aside from clinical need, Professor Park anticipated that securing reimbursement for Datroway will not be simple. This is because evaluation standards have been raised as other ADCs demonstrated high clinical achievements and even improvements in overall survival (OS).Nevertheless, Professor Park emphasized the need to secure treatment options with diverse mechanisms and modes of administration, as every patient differs in organ function, comorbidities, susceptibility to toxicity, and hospital accessibility.Professor Park stated, "From a clinician's perspective, because each patient's condition, comorbidities, and organ function status are entirely different, it is essential to secure diversity in treatment options in terms of toxicity and tolerability."In conclusion, Professor Park said, "Continuing treatment while maintaining quality of life is an extension of meaningful time that is hard to measure in monetary terms," emphasizing that "As patients with metastatic breast cancer can maintain their daily routines and sustain their roles in their families and society while undergoing treatment, such benefit must also be viewed as an important aspect of care."
- Policy
- “Drug pricing reform relies on collaboration btwn Korea-multinational companies”
- by Jung, Heung-Jun Sep 04, 2026 08:47am
- From left, Policy Director of the Democratic Party of Korea, Hye Young Lee, Country Manager of BMS Korea, Christian Rodseth, Managing Director of Johnson & Johnson Korea, Kang Joonhyuk, Director of the Division of Pharmaceutical Benefits at the Ministry of Health and Welfare, Youngjoo Song, Senior Advisor at Bae, Kim & Lee LLC.The National Assembly and the Ministry of Health and Welfare (MOHW) evaluated that an innovation alliance between multinational and domestic pharmaceutical companies will determine the success of the drug pricing system reform.This indicates that outcomes from innovation must accumulate for the drug pricing reform, primarily pursued to restructure the domestic generic-centric pharmaceutical industry, to advance to its next phase.At the Healthcare Innovation Seminar hosted by the American Chamber of Commerce in Korea (AMCHAM) at the Shilla Hotel on the 3rd, Cho Won Jun, Policy Director of the Democratic Party of Korea, and Kang Joonhyuk, Director of the Division of Pharmaceutical Benefits at the Ministry of Health and Welfare (MOHW), emphasized the importance of fostering an innovation ecosystem.Cho stated, "From the perspective of domestic companies, because the National Health Insurance pie is fixed, there is a negative perception that expanding access to new drugs might reduce their own profits," adding, "Civil society organizations also harbor skepticism over whether profits are appropriately reinvested domestically. We can only move toward the next innovation when perceptions change in favor of shared value".Director Cho stated, "When the perception spreads that both sides are creators of shared profit through innovation and joint global expansion, the relationship inevitably becomes interdependent," and emphasized the importance of open innovation, "Trust is essential for policy shifts. We can only move forward once concerns over polarization diminish. We must forge an innovation alliance."Multinational pharmaceutical companies also agreed on the growth potential of the Korean market. However, they pointed out that the policies aimed at expanding drug access contained within the pricing reform must take firm root to create a predictable business environment.Furthermore, their position is that shared performance target metrics between the government and industry, alongside the swift expansion of drug access, are critical.Christian Rodseth, Managing Director of Johnson & Johnson Korea, positively evaluated the access expansion measures, remarking, "Initiatives such as the ICER threshold and flexible drug pricing agreements are outstanding because their purpose is to reward innovation".However, Rodseth added that the actual implementation of the institutional reform is crucial. Rodseth stated, "What matters is whether the reform plan is clear, whether it is genuinely implemented, and whether companies have experienced tangible benefits from it."Hye Young Lee, Country Manager of BMS Korea, emphasized performance measurement metrics, rapid expansion, and consistent execution through communication.Lee stated, "In the United Kingdom, a policy target was established to double expenditure on innovative new drugs from 0.3% to 0.6% of GDP. Having clear indicators enables transparent monitoring," adding, "Moreover, the fast-track listing pilot program is being implemented within a limited scope. While we agree with the necessity of a pilot project, a swift expansion is needed."Lee further stated, "If the government and industry fail to reach consensus on ambiguous areas or differing perspectives regarding policy interpretation, it could become a roadblock to execution and goal attainment," and suggested active communication.The government noted that it is deliberating on how to implement new drug access expansion measures while addressing regulatory gaps, and requested industry cooperation to ensure the completeness of the drug pricing system reform.Kang Joonhyuk, Director of the Division of Pharmaceutical Benefits at the Ministry of Health and Welfare, stated, "The system reform was conducted in a way that adjusts generics, which account for the largest share of pharmaceutical expenditures, to appropriate price levels while expanding access to innovative new drugs. We are finding a balance between appropriately rewarding the value of new drugs and maintaining the fiscal soundness of National Health Insurance".Kang continued, "There are various opinions regarding the expansion of flexible pricing agreements and institutionalizing the fast-track listing pilot program," and "We view policies concerning new drugs in the second half of the year as critically important."Lastly, Director Kang stressed industry efforts, stating, "The pharmaceutical industry is a vital partner in expanding policies with speed. Fast-track listing also requires the active participation of many companies," concluding that "Companies that have relied primarily on generics lack significant know-how in new drug development. We hope to see many collaboration models emerge with multinational pharmaceutical companies."
- Policy
- No cap set for semi-innovative pharma company designations
- by Lee, Jeong-Hwan Sep 04, 2026 08:47am
- The Ministry of Health and Welfare plans to designate an unlimited number of semi-innovative pharmaceutical companies, provided they meet the required ratio of research and development investment and are not subject to any disqualifying conditions.Like innovative pharmaceutical companies, semi-innovative companies will be designated through an absolute assessment rather than ranked against other applicants.Some pharmaceutical companies had questioned whether the ministry might impose an overall cap—such as 60 companies—on the combined number of innovative and semi-innovative pharmaceutical companies, given that 47 companies currently hold innovative pharmaceutical company certification. Such questions were resolved, as the ministry has formally confirmed that applicants will be assessed against fixed criteria with no numerical cap on designations.“A ministry official told Dailypharm by phone, ‘As with innovative pharmaceutical companies, there will be no cap on the number of semi-innovative companies certified, provided they meet the R&D investment thresholds and have no grounds for disqualification, such as illegal rebates.’”MOHW held the inaugural meeting of the Public-Private Council for Pharmaceutical Industry Innovation on the 2nd to discuss how the semi-innovative pharmaceutical company certification program will be established and operated.The ministry aims to create a growth ladder under which pharmaceutical startups can receive government support as they progress through semi-innovative and innovative status and ultimately grow into globally competitive pharmaceutical companies.It plans to establish the necessary legal basis by November and begin accepting applications for the new designation in December.To qualify as a semi-innovative pharmaceutical company, an applicant must meet the ministry’s required ratio of R&D expenditure to pharmaceutical sales.Companies with average annual sales of less than KRW 100 billion over the preceding three years must maintain an R&D-to-sales ratio of at least 7% and invest at least KRW 5 billion in R&D.The required ratio is at least 5% for companies with sales of KRW 100 billion or more and at least 3% for companies meeting cGMP or EU GMP standards.Each threshold is 2 percentage points lower than the corresponding requirement for innovative pharmaceutical company certification. To qualify for an innovative status, companies with sales below KRW 100 billion must invest at least 9% of sales and a minimum of KRW 7 billion in R&D. The required ratios are 7% for companies with sales of KRW 100 billion or more and 5% for companies meeting cGMP or EU GMP standards.In addition to meeting the R&D requirements, applicants must also be free of disqualifying conditions such as illegal pharmaceutical rebates and unethical conduct by executives or employees.A company will be disqualified over rebates if it has received two or more administrative sanctions or if the amount provided was at least KRW 5 million. However, violations that occurred more than five years before the assessment will be excluded. Also, cases in which a director or auditor receives a criminal fine or a more severe penalty for offenses such as embezzlement, breach of trust, stock price manipulation, assault, or sexual crimes will be disqualified.Like innovative pharmaceutical companies, semi-innovative companies will receive preferential pricing for both newly listed and already-listed generics. Specifically, new generics will be eligible for a price level of 50% for an initial one-year period plus an additional three years. Already-listed drugs will be allowed to retain a price level of 47% for three years when they undergo reassessment.The ministry categorizes innovative pharmaceutical companies as “leading” companies and semi-innovative pharmaceutical companies as “growth” companies. Under the detailed certification assessment, companies scoring at least 65 points, which is the minimum passing score set in the ministry’s public notice, will receive leading-company certification, while those scoring below 65 will be certified as growth companies. Because quasi-innovative companies will be assessed only on basic eligibility requirements, including their R&D investment ratio and the absence of disqualifying conditions, they will not be required to submit documentation for a separate detailed assessment.The ministry does not plan to limit the number of innovative or semi-innovative pharmaceutical companies certified, to encourage greater R&D investment across the industry. In effect, drug pricing incentives will be awarded through an absolute assessment rather than a competitive ranking.Pharmaceutical companies seeking either innovative or semi-innovative status will therefore need to prepare sufficient evidence to fully satisfy the ministry’s documentation requirements.
- Company
- IPF drug Jascayd to enter the Korean market
- by Eo, Yun-Ho Sep 04, 2026 08:46am
- Jascayd, the first new treatment for idiopathic pulmonary fibrosis (IPF) in a decade, is set to enter the Korean market.According to industry sources, Boehringer Ingelheim Korea has submitted a marketing authorization application for Jascayd (nerandomilast), a treatment for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis (PPF), and the Ministry of Food and Drug Safety is now reviewing it.Jascayd's final approval may come as early as this year. When approved, the company would be able to secure an additional asset in its pulmonary fibrosis portfolio alongside Ofev (nintedanib).Jascayd is an oral, selective phosphodiesterase 4B (PDE4B) inhibitor that exerts antifibrotic and immunomodulatory effects through a mechanism distinct from those of existing treatments. The drug is already approved in the United States, China, Japan, the United Kingdom, and Brazil.Its safety and efficacy were demonstrated in the global Phase III FIBRONEER-IPF trial.The study enrolled 1,177 patients with idiopathic pulmonary fibrosis. Its primary endpoint was the change from baseline in forced vital capacity (FVC) at Week 52. FVC, the volume of air that can be forcibly exhaled after taking the deepest possible breath, is a key measure of lung function.The results showed that Jascayd significantly slowed lung function decline compared with placebo. At Week 52, mean FVC had declined by 106 mL in the Jascayd 18 mg group and 122 mL in the 9 mg group, compared with 170 mL in the placebo group. In particular, the 18 mg group began to separate from the placebo group just 2 weeks after treatment initiation, and the difference was maintained through Week 52.Meanwhile, Ofev is currently reimbursed in Korea only for its PPF indication. Boehringer Ingelheim is seeking to expand its reimbursement to IPF, but discussions have made little progress.Meanwhile, IPF has the highest mortality rate among rare diseases in Korea. It is a rare, intractable disease in which interstitial tissue in the lungs progressively becomes fibrotic and stiffens without a known cause. As the lung structures responsible for oxygen exchange are damaged, patients develop chronic cough and shortness of breath, eventually progressing to respiratory failure.The disease also progresses rapidly. While lung function in healthy adults declines by around 10–20 cc per year, patients with IPF lose 150–250 cc annually, equivalent to roughly 10% of their lung function each year.
