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- 2026-07-20 10:02:02
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- MSD develops first oral PCSK9 inhibitor
- by Son, Hyung Min Jul 20, 2026 08:51am
- MSD's launch of the world's first oral PCSK9 inhibitor is expected to reshape the dyslipidemia treatment market.The arrival of an oral therapy is likely to intensify competition over treatment convenience in a market that has until now evolved primarily by extending dosing intervals of injectable therapies.Oral PCSK9 inhibitor LipfendraAccording to industry sources, the U.S. Food and Drug Administration (FDA) approved Lipfendra (enlicitide) on July 16 for reducing low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia and heterozygous familial hypercholesterolemia (HeFH).Lipfendra is an oral PCSK9 inhibitor taken once daily at a 20mg dose as an adjunct to diet and exercise.PCSK9 inhibitors are indicated for patients whose LDL-C levels remain inadequately controlled despite lipid-lowering therapy, including high-intensity statins and ezetimibe, or for those requiring additional LDL-C reduction because of a high risk of atherosclerotic cardiovascular disease (ASCVD).All currently marketed PCSK9 inhibitors are injectables. Amgen's ‘Repatha (evolocumab)’ and Sanofi/Regeneron's ‘Praluent (alirocumab)’ are monoclonal antibodies administered every two weeks.Novartis' ‘Leqvio (inclisiran)’ is an siRNA therapy that suppresses PCSK9 production in the liver. After the initial administration, the second dose is administered after three months, and then every six months.While the PCSK9 inhibitor market has focused on reducing injection frequency and extending dosing intervals, Lipfendra has differentiated itself with oral administration.Lipfendra is a macrocyclic peptide-based oral PCSK9 inhibitor. It inhibits PCSK9 to increase hepatic clearance of LDL cholesterol and targets the same pathway as injectable PCSK9 inhibitors as an oral formulation.However, there are certain restrictions during its intake. Lipfendra may be taken with water, coffee, or tea, but patients must avoid eating for at least 30 minutes afterward to ensure adequate drug absorption.Approval supported by two global Phase III trialsLipfendra's approval was based on results from the CORALreef Lipids and CORALreef HeFH studies, part of MSD's global Phase III CORALreef program.CORALreef Lipids was a multicenter, randomized, double-blind, placebo-controlled Phase III trial involving 2,904 patients with hypercholesterolemia.Participants were those receiving stable lipid-lowering therapy, including moderate- or high-intensity statins that still required additional LDL-C reduction.In the trial, Lipfendra reduced LDL-C by 56% versus placebo at Week 24. LDL-C fell 57% from baseline in the Lipfendra group, while it increased by 3% in the placebo group.In the CORALreef HeFH study, which involved 303 patients with heterozygous familial hypercholesterolemia, Lipfendra reduced LDL-C by 59% versus placebo at Week 24. LDL-C declined 58% from baseline in the Lipfendra group but increased by 3% in the placebo group.Beyond LDL-C reduction, Lipfendra also lowered non-high-density lipoprotein cholesterol (non-HDL-C) and apolipoprotein B (ApoB), both associated with ASCVD risk.Among patients with hypercholesterolemia, Lipfendra reduced non-HDL-C by an average of 54% and ApoB by 50%. In patients with HeFH, the corresponding reductions were 52% and 48%, respectively.Overall safety was comparable to placebo. In the hypercholesterolemia study, adverse event rates were similar between the two groups. In the HeFH study, however, diarrhea and dizziness occurred more frequently with Lipfendra.Diarrhea was reported in 7% of patients receiving Lipfendra versus 2% with placebo, while dizziness occurred in 9% and 4%, respectively. Treatment discontinuation due to adverse events was similar between groups.Although Lipfendra has demonstrated robust LDL-C lowering, it has yet to demonstrate reduction in major cardiovascular events such as myocardial infarction, stroke, or cardiovascular death.MSD is currently evaluating its effects on cardiovascular events and mortality in the CORALreef Outcomes trial involving more than 14,500 participants. Patient enrollment has been completed.The overall CORALreef clinical program includes more than 19,000 patients with hypercholesterolemia. In addition to the cardiovascular outcomes trial, MSD is conducting long-term extension studies as well as trials in pediatric patients and combination therapy with Lipfendra.Lipfendra is also expected to play an important role in MSD's long-term growth strategy. Its oral formulation and relatively lower price may act in favor when seeking to expand into the injectable-dominated PCSK9 inhibitor market.Lipfendra is priced at USD 315 per month in the United States. This is lower than some of the currently marketed PCSK9 therapies.The market expects Lipfendra to become one of MSD's key growth drivers following the loss of patent exclusivity for Keytruda (pembrolizumab), with peak annual global sales projected at up to USD 5 billion.
- Product
- Korea first to recommend cuffless blood pressure monitors,
- by Hwang, byoung woo Jul 20, 2026 08:51am
- Cuffless blood pressure monitors, which measure blood pressure without inflating a cuff around the arm, have been included in Korea's hypertension treatment guidelines for the first time. The Korean Society of Hypertension (KSH) has become the first in the world to recommend cuffless blood pressure monitors for out-of-office blood pressure measurement, establishing a clinical framework for their use.The move is expected to accelerate clinical adoption, which is already increasing following reimbursement coverage, by reducing patient discomfort associated with conventional ambulatory blood pressure monitors and easing equipment burdens on healthcare providers. The society also plans follow-up clinical studies to strengthen the recommendation.At a press briefing on July 17, the KSH introduced the major updates in its sixth edition of the 2026 Korean Society of Hypertension Guidelines and their clinical implications.(from the left) Seonghoon Choi, Director of Public Relations at KSH (Hallym University College of Medicine); Kwang-il Kim, Chairman of KSH (Seoul National University Hospital); Sang-Hyun Ihm, Chair of the KSH Guideline Committee (The Catholic University of Korea College of Medicine); Eun Mi Lee, Secretary of the KSH Guideline Committee (Dongguk University College of Medicine)First positive recommendation…opens door to clinical useThe updated guidelines retain the existing recommendation to use validated cuff-based blood pressure monitors for office, home, and ambulatory blood pressure measurement while newly adding cuffless monitors as an option for out-of-office monitoring.Its use received a Class IIb recommendation with Level B evidence, meaning it may be considered in practice. This differs from U.S. and European guidelines, which do not recommend cuffless devices for clinical use.The society emphasized that this is the world's first positive recommendation for cuffless blood pressure monitors. While international discussions continue regarding their accuracy and appropriate use, the recommendation reflects growing validation data and real-world clinical experience accumulated in Korea.Kwang-il Kim, Chairman of KSH and professor at Seoul National University College of Medicine, explained, "There were concerns from overseas academia that Korea might be moving too quickly, but others viewed it as taking the lead in a new field. This is the first positive recommendation for cuffless blood pressure monitors anywhere in the world."In Korea, Sky Labs' CART BP, a ring-type blood pressure monitor, has already undergone validation against conventional 24-hour ambulatory blood pressure monitoring and is being used in clinical practice. Moving beyond being just a simple wearable device, its use has broadened as a clinical tool for ambulatory blood pressure monitoring.Major changes in the KSH hyperlipidemia treatment guidelinesSang-Hyun Ihm, Chair of the KSH Guideline Committee (Catholic University of Korea), said, "Given that the device is already being used in Korean patients and supporting evidence has accumulated, we concluded it would not be appropriate to classify it as a technology that should not be used. Although it has not reached Class I or IIa, we introduced it as a Class IIb recommendation that may be considered in clinical practice."Adoption expands following reimbursement…use expands across primary care clinicsThe inclusion of cuffless monitors in the guidelines is also expected to support the growing use of the technology following reimbursement coverage.Eun Mi Lee, Secretary of the KSH Guideline Committee, said, "We understand that the use of cuffless blood pressure monitors has increased significantly since its reimbursement listing. The convenience for both patients and healthcare professionals serves as a clear advantage."She noted, however, that additional validation is needed in certain patient populations, including those with thick finger joints, improperly positioned sensors, arrhythmias, or pregnancy.The society attributed the increase in use partly to broader adoption by primary care clinics. Traditional 24-hour ambulatory blood pressure monitoring requires dedicated equipment and repeated cuff inflation, placing burdens on both providers and patients. This had limited its use in smaller clinics.Seonghoon Choi, Director of Public Relations at KSH (Hallym University College of Medicine), said, “The rate of ambulatory blood pressure monitoring using conventional cuff-based devices has remained around 0.5% in Korea. The growing use of cuffless monitors suggests that primary care physicians, not just tertiary hospitals, are now participating in out-of-office blood pressure monitoring."Choi added, "The society has long emphasized that treatment decisions should not rely on a single office blood pressure measurement. The expansion of ambulatory blood pressure monitoring in primary care is therefore a very encouraging development."Cuffless monitors were newly introduced in practiceCan monitor blood pressure at night and in daily life… expands treatment dataOne of the main advantages of cuffless monitors is their ability to measure blood pressure during sleep and daily activities without repeated arm compression.Conventional ambulatory monitors inflate every 15 or 30 minutes, allowing patients to anticipate measurements and complain about sleep disturbances or discomfort during the night.Ring-type cuffless monitors can measure blood pressure more frequently without compressing the arm, potentially enabling more comprehensive monitoring beyond nighttime to routine daily activities.KSH President Kim said, "Conventional ambulatory monitors measure blood pressure every 15 or 30 minutes, whereas cuffless devices can collect readings at many more time points. They also offer advantages for nighttime and prolonged monitoring that exceeds one day."The technology may also benefit patients who have difficulty wearing arm cuffs, such as those undergoing hemodialysis or those who experience discomfort from repeated cuff inflation.For now, KSH sees the primary clinical role of cuffless monitoring in the follow-up of patients already diagnosed with hypertension, using the devices to assess treatment response, nighttime blood pressure, and diurnal variation while establishing interpretation criteria specific to cuffless measurements.Large clinical study involving over 1000 patents planned…. To prepare data to elevate the recommendation levelThe KSH is preparing an investigator-initiated clinical trial to strengthen the recommendation in future guideline updates.Chairman Kim said, “Whereas previous studies focused mainly on whether cuffless devices produced measurements comparable to cuff-based monitors, the next phase will evaluate whether treatment guided by cuffless blood pressure readings improves blood pressure control and patient outcomes."The evidence showing that cuffless monitors can generate values comparable to conventional ambulatory monitors supported the current Class IIb recommendation. Going forward, we need to demonstrate whether treatment based on cuffless measurements leads to better outcomes and predicts prognosis more accurately than existing methods."He added, "A single meaningful study could support a Class IIa recommendation, and consistent findings from both domestic and international studies could eventually lead to a Class I recommendation. Class IIb does not indicate a problem with the device -- it marks the beginning of a new clinical field."The planned study is expected to enroll more than 1,000 patients, with the final sample size depending on participating institutions and whether primary care clinics are included. The KSH aims to launch the study later this year after completing institutional reviews and protocol evaluations.The recommendation is not limited to any specific product. According to the KSH, any cuffless monitor that demonstrates sufficient accuracy and clinical evidence may receive the same level of recommendation.The updated guidelines also introduce isolated diastolic hypertension as a new category, strengthen blood pressure targets for high-risk patients, classify single-pill combination therapies, establish diagnostic and treatment algorithms for resistant hypertension, and emphasize more proactive management of hypertensive disorders of pregnancy. In particular, hypertensive disorders of pregnancy were identified as an area requiring efforts to bridge the gap between the guidelines and clinical practice, as the number of patients continues to increase while treatment options available in Korea remain limited.Chairman Kim said, "Gestational hypertension not only impacts maternal health but also the health of the child. The society will continue exploring policy solutions and providing the information needed to improve care."
- Policy
- Reimb expansion for Tevimbra’s five indications under drug price negotiations
- by Jung, Heung-Jun Jul 20, 2026 08:51am
- Product photo of Tevimbra BeOne Medicines Korea’s immunotherapy, Tevimbra Inj (tislelizumab), has entered drug price negotiations with the National Health Insurance Service (NHIS) to expand reimbursement coverage for five indications.Additionally, Roche Korea’s immunotherapy Tecentriq Inj (atezolizumab) has also entered negotiations for adjuvant therapy in non-small cell lung cancer (NSCLC).According to industry sources, on July 19, the Ministry of Health and Welfare (MOHW) issued price negotiation orders to the NHIS for Tecentriq and Tevimbra. These medications were recognized for their appropriateness for reimbursement expansion during the recent 5th and 6th Pharmaceutical Reimbursement Evaluation Committee (PREC) meetings.Tevimbra is the product that has secured the highest number of approved indications among the pharmaceuticals reviewed for reimbursement expansion during the 1st to 7th PREC meetings this year.The company is seeking to expand reimbursement across five indications, including monotherapy and combination therapy for non-small cell lung cancer, as well as first-line combination therapies for gastric cancer and esophageal cancer.Currently, the only reimbursed indication for Tevimbra is second-line combination therapy for esophageal cancer. In April last year, it successfully secured its initial reimbursement listing for esophageal cancer ahead of other immunotherapies with the same mechanism of action, such as Keytruda and Opdivo.Once this indication expansion is implemented, competition with blockbuster drugs like Keytruda and Opdivo is expected to intensify. Patient access to treatment is anticipated to strengthen as additional therapeutic options become available.However, price negotiations for multi-indication immunotherapies, which pose a heavy burden on the national health insurance budget, are rarely easy. Given that the share of oncological drugs within overall pharmaceutical expenditures is rising substantially, detailed negotiations regarding the application of complex Risk Sharing Agreements (RSAs) and refund rates will be the key determining factors.Yet, during its initial reimbursement listing last year, Tevimbra was well-received for enhancing patient access to a reasonably priced drug. As market competition intensifies, it can positively impact the insurance budget, a favorable factor in upcoming price negotiations.Product photo of TecentriqIf BeOne successfully clears the hurdle of NHIS negotiations, it is expected to proceed with a listing in the fourth quarter of this year.Roche Korea’s immunotherapy Tecentriq has also recently commenced price negotiations. In May, the PREC approved reimbursement expansion appropriateness as an "adjuvant therapy following resection and platinum-based chemotherapy in patients with early-stage non-small cell lung cancer."Tecentriq garnered significant attention in 2022 as the first immunotherapy to receive regulatory approval for adjuvant therapy in early-stage non-small cell lung cancer. It is now awaiting a reimbursement expansion after approximately four years.
- Policy
- Celltrion seeks Cosentyx biosimilar approval without pediatric indication
- by Lee, Tak-Sun Jul 20, 2026 08:51am
- AI-generated imageCelltrion has adopted an “independent strategy” to circumvent the original drug’s exclusivity as it prepares to launch a biosimilar of the blockbuster autoimmune disease therapy, Cosentyx (secukinumab), in Korea.Rather than seeking approval for all of the original Cosentyx's approved indications, the company has applied only for the core adult indications, excluding pediatric indications and hidradenitis suppurativa (HS).According to the Ministry of Food and Drug Safety (MFDS), a marketing authorization application for a secukinumab biosimilar that references Cosentyx products registered in Korea (Cosentyx SensoReady Pen and Cosentyx Prefilled Syringe, etc) was submitted on June 26. The reference product is believed to be a Cosentyx biosimilar in development by Celltrion.A notable aspect of the filing is Celltrion's move immediately prior to the application. On June 25, one day before submitting its application, Celltrion filed a scope confirmation trial with the Patent Court against Novartis, the holder of Cosentyx's patents.The move is viewed as a strategic step to secure first generic exclusivity under Korea's drug approval-patent linkage system. To obtain an exclusive sales period for a biosimilar, a company must both be the ‘first to challenge the patent’ and be the ‘first to submit a marketing authorization application.’The most notable aspect is the company’s decision to omit several of the original drug’s approved indications. The original Cosentyx is approved for adults with plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and hidradenitis suppurativa, as well as for pediatric plaque psoriasis and juvenile idiopathic arthritis.However, the biosimilar application includes only three core adult indications: ▲Plaque psoriasis, ▲Psoriatic arthritis, and ▲Axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis). The application excludes adult hidradenitis suppurativa and all pediatric indications of the original drug.The move is regarded as an effort to avoid the original drug's remaining patents. The hidradenitis suppurativa and pediatric indications were added relatively recently, meaning their re-examination periods or patent terms still have considerable time remaining. Celltrion therefore appears to have opted to target the core adult indications that would enable the earliest market entry in Korea.Instead of seeking approval for a broader range of indications, Celltrion is taking the remaining key patents head-on. The patents Celltrion challenged on June 25 are Cosentyx's core patents.Cosentyx currently holds a method-of-use patent for the "treatment of psoriasis using an IL-17 antagonist," which is set to expire on October 7, 2031, and a formulation patent for "pharmaceutical products and stable liquid formulations of IL-17 antibodies," which is set to expire on December 21, 2035.In particular, the liquid formulation patent expiring in 2035 is considered a barrier that must be overcome to produce an injectable biosimilar. Through the scope confirmation trial, Celltrion plans to focus on demonstrating that its independently developed protein composition and formulation technology do not fall within the scope of the original drug’s patent.An industry official said, "Celltrion's application filing suggests that it intends to work around the patents essential to launching the product (psoriasis treatment method and formulation patents) through the patent trial, and launch the product immediately after the original’s substance patent expires on February 27, 2028, in an effort to gain a first-mover advantage in the Korean market."
- Company
- Trajenta generics capture just 20% market share after 2 years
- by Kim, Jin-Gu Jul 16, 2026 08:52am
- Although more than 2 years have passed after generic versions of the DPP-4 inhibitor ‘Trajenta (linagliptin)’ entered the Korean market, the generics continue to account for only about 20% of prescriptions.The sluggish uptake contrasts with the intense interest shown around the time of the original drug’s patent expiry, when 68 companies obtained approval for 293 generic products. 2 years after launch, the average quarterly prescription value per company remains around KRW 100 million, while 87 products from more than 30 companies have been voluntarily withdrawn due to poor commercial performance.Trajenta and Trajenta Duo post KRW 19 billion in Q2 prescriptions…down 9% year over yearAccording to market research institution UBIST on the 16th, the combined outpatient prescription market for Trajenta and its generics totaled KRW 23.7 billion in Q2 2026, down 3% from a year earlier.The decline was driven primarily by lower sales of the original products. Prescriptions for Trajenta monotherapy fell 19%, from KRW 9.1 billion in Q2 2025 to KRW 7.4 billion in Q2 this year. Prescriptions for Trajenta Duo, the metformin combination, fell from KRW 11.7 billion to KRW 11.6 billion.The decline reflects both generic competition and reimbursement price reductions following the expiration of pricing premiums. The reimbursement price for Trajenta monotherapy was cut by 30% (from KRW 750 to KRW 525) when generics were launched in July 2024. Following the expiration of the one-year pricing premium in June 2025, the reimbursement price was further reduced to KRW 402. Prices for the fixed-dose combination Trajenta Duo were also reduced, depending on strength, from KRW 387 to KRW 338–344, then to KRW 259.Trajenta generics account for only 20% of market 2 years into launch….slowest penetration among DDP-4 inhibitorsSince the expiry of Trajenta's composition patent in June 2024, generic manufacturers have gradually increased prescription volumes. Combined prescriptions for Trajenta and Trajenta Duo generics reached KRW 4.8 billion in Q2, up 28% year-on-year.However, the prevailing industry assessment is that the penetration rate of Tradjenta generics has fallen short of expectations. The gap becomes even more pronounced when compared to the progress of other DPP-4 inhibitor generics whose patents expired earlier.For example, generics of ‘Tenelia (teneligliptin)’ had already captured 60% of the market 2 years after launch, and overtook the original drug.Generics of ‘Galvus (vildagliptin),’ the first DPP-4 inhibitor to lose patent protection, achieved a 48% market share within 2 years. Meanwhile, generics of ‘Januvia (sitagliptin),’ whose patent expired in September 2023, had reached a 23% market share after 2 years, three percentage points higher than Trajenta generics at the same stage (20%).Although the first generic exclusivity period expired in March last year, allowing many additional manufacturers to enter the market, the influx failed to lead to a rebound in the overall generic market.Average quarterly prescriptions remain around KRW 100 million per company…87 products withdraw from the market after ‘no-questions-asked generic approvals’Commercial performance has also been disappointing at the company level. As of Q2, no manufacturer had generated more than KRW 1 billion in combined quarterly prescriptions for Trajenta and Trajenta Duo generics. Only KyungDong Pharm (KRW 970 million) and Kyongbo Pharmaceutical (KRW 810 million) exceeded KRW 500 million in quarterly prescriptions.Most companies have failed to reach KRW 100 million in quarterly prescriptions. Among the 32 companies currently marketing Trajenta generics, 22 (68%) generated less than KRW 100 million in combined quarterly prescriptions. On average, quarterly prescriptions amount to just over KRW 100 million per company.The situation stands in sharp contrast to the enthusiasm seen during the approval stage. Following successful patent challenges in 2018, generic manufacturers aggressively pursued marketing authorizations. A total of 68 companies obtained approval for 293 generic products of Trajenta monotherapy and Trajenta Duo.In reality, however, only about half of the approved products were eventually launched. Instead, more companies have chosen to exit the market by voluntarily withdrawing approvals or declining to renew marketing authorizations upon expiration. To date, 87 products from 31 companies have been removed from the approval list.Industry observers attribute the trend to indiscriminate approval filings timed around the patent expiry of a blockbuster diabetes drug, resulting in excessive competition. As promotional costs to secure prescriptions have risen while profit margins have fallen short of expectations, many small and mid-sized pharmaceutical companies have entered a phase of portfolio rationalization by abandoning unprofitable products.Another factor behind the slow uptake is that Trajenta was the last major DPP-4 inhibitor to lose patent protection. By the time Trajenta generics entered the market, generics of Galvus, Tenelia, and Januvia had already established themselves, leaving late-arriving Trajenta generics struggling to compete for market share.
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