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- 2026-10-11 05:52:42
- Policy
- Preferential drug pricing not enough for emerging innovative pharmas
- by Jung, Heung-Jun Oct 08, 2026 09:00am
- During a National Assembly audit, calls have emerged for stronger support for “emerging (semi)” innovative pharmaceutical companies, a new intermediate category introduced below innovative pharmaceutical companies.The argument is that preferential drug pricing and government R&D support are not enough to help the semi-innovative companies advance to fully innovative pharmaceutical company status.In response, the Ministry of Health and Welfare (MOHW) said it would gather industry feedback through a public-private consultative body before implementing the new system and review whether additional support measures are needed.During the National Assembly audit of the MOHW on the 7th, People Power Party lawmaker Tae-ho Kim agreed to the government’s policy of dividing innovative pharmaceutical companies into “emerging (semi-innovative)” and “leading (innovative)” categories and providing support according to their stage of growth, but criticized the lack of support offered to the emerging category.Kim said, “I understand the government’s intention to build a growth ladder for pharmaceutical companies by dividing them into emerging and leading categories. But in practice, it seems as if several of the lower rungs of that growth ladder have been removed, then coined ‘emerging’ in name only.”“I’m not sure whether telling companies to jump higher after removing the footholds is really a policy designed to help them grow, or simply a test of how well they can jump,” he added.Support for companies in the emerging category is largely limited to government R&D programs and preferential drug pricing, while excluding benefits available to existing innovative pharmaceutical companies—including tax incentives, special provisions for the construction of research facilities and exemptions from certain charges.Kim said, “We should be helping these companies conduct more research so that they can grow into innovative companies, but this could instead reduce their capacity to invest in research. Can this really serve as a growth ladder?”Health and Welfare Minister Eun-kyeong Jeong responded that the emerging category is being newly introduced as an intermediate step toward full innovative pharmaceutical company status and that support measures would be refined as the program is implemented.Jeong said, “Since this is a new category, we first need to evaluate participating companies and then consider improvements to the system step by step. The emerging category is intended to serve as an intermediate stage toward innovative pharmaceutical company status, with certain forms of support helping companies grow along the way.”Jeong cited preferential treatment under the revised drug pricing system as one of the main reasons for introducing the new category. She nevertheless acknowledged the gap in support between emerging and fully innovative companies and said the government would consider additional measures as the program develops.Jeong said, “I understand that the point is that we need appropriate support measures tailored to different types of companies, creating a pathway from startups to emerging companies and ultimately innovative pharmaceutical companies. We will design the system more carefully and refine it based on industry feedback gathered through the public-private consultative body.”Kim asked the ministry to submit a comparative analysis before the comprehensive audit, including supplementary measures to support clinical development and research funding for emerging innovative pharmaceutical companies.
- Opinion
- [Reporter’s View] Rebate investigation expertise must survive system overhaul
- by Kim, Jin-Gu Oct 08, 2026 09:00am
- Korea’s criminal justice system has undergone a major overhaul with the abolition of the Prosecutors’ Office and the launch of the Public Prosecution Service and Serious Crimes Investigation Agency. Investigations in the healthcare sector have also been reorganized under the new framework.The Food and Drug Crime Investigation Division of the Seoul Western District Prosecutors’ Office, which had handled pharmaceutical and medical device rebate investigations, no longer exists. The joint investigation team that had focused on illegally operated hospitals and license-lending pharmacies has also been disbanded. Ongoing cases have been transferred to the police and other agencies.As the investigative system changed, the agency in charge of cases also changed. The key question is whether the investigative expertise accumulated over many years can be carried over into the new system.Healthcare crime investigations have undergone years of specialization. In 2011, the government established a joint investigative unit dedicated to pharmaceutical rebates. In 2013, the Seoul Western District Prosecutors’ Office was designated as a prosecution office specializing in food and drug safety. Its work later continued through the Food and Drug Investigation Division and the Food and Drug Crime Investigation Division, which handled rebate cases and a range of other healthcare crimes.In May this year, a joint investigation team targeting illegal medical and pharmaceutical practices was also established, led by prosecutors and police with participation from the Ministry of Health and Welfare, National Health Insurance Service, Health Insurance Review & Assessment Service, National Tax Service and Financial Supervisory Service. The team was designed to connect criminal investigations, administrative sanctions, recovery of health insurance funds and the tracing of criminal proceeds within a single coordinated framework.There was a clear reason for strengthening dedicated and joint investigations: criminal schemes are becoming increasingly complex.Recent cases have involved establishing paper companies, giving hospital officials equity stakes, and then paying rebates in the form of dividends. Other cases have involved payments disguised as research funding under the pretext of post-marketing surveillance. Rather than handing over cash or gift certificates directly, rebate schemes have evolved to resemble legitimate commercial transactions or research payments.Illegally operated hospitals and pharmacies have likewise moved beyond simple name-lending arrangements. Some schemes use multiple layers of corporate entities and contractual relationships to conceal the actual operator, while others transfer assets into third-party names to evade recovery. Identifying the true operator and tracing the flow of funds are becoming increasingly difficult.Such cases cannot be uncovered simply by examining the relevant laws. Investigators need to understand pharmaceutical sales practices and drug distribution structures, as well as how legitimate clinical trials are conducted and research funds are normally disbursed. They must also be able to trace National Health Insurance claims data, corporate relationships, and financial flows. Knowing which agency holds which information, and how those pieces of information can be connected, is equally important.Investigative expertise is built through layers of repeated cases being accumulated through trial and error. Judgment about which transactions warrant suspicion, how to distinguish legitimate contracts from sham transactions, and which records should be examined first becomes more refined with each case. The experience accumulated in this process is itself one of the most valuable investigative assets.Under the new system, these functions are divided among multiple agencies. Rebate cases are investigated by the police and, depending on the nature of the case, may fall to the Serious Crimes Investigation Agency. The Major Crimes Prosecution Division within the Prosecution Office is responsible for prosecuting healthcare cases and maintaining prosecutions. Cases previously handled by the joint investigation team are being distributed among police units.More important than the new division of responsibilities is preserving the expertise built up over the years. The investigative judgment gained through years of casework, along with established channels of cooperation among relevant agencies, must be carried forward into future investigations.Expertise does not come simply from an establishment of an organization. It gains strength through people, cases and time. It is sharpened by digging through countless cases, revisiting missed clues and keeping pace with new criminal methods. Healthcare crime continually changes shape as offenders exploit gaps in the system. The investigative framework can change. But the chain of expertise built over many years must not be broken.
- Company
- Drug price cuts push pharma to tighten workforce spending
- by Lee, Seok-Jun Oct 08, 2026 09:00am
- Drug price cuts are beginning to take a toll on pharmaceutical employment. Faced with mounting pressure on profitability, companies are scaling back new hiring and leaving positions vacated through natural attrition unfilled, while tightening performance management and overhauling compensation and pay structures. What began as a one-time “workforce expense diet” is increasingly becoming a permanent approach to labor-cost management.Under the drug pricing reform implemented in August, the maximum pricing rate for off-patent drugs and generics was lowered from 53.55% to 45%. The government has decided to apply the new standard to previously listed drugs as well, with prices for 13,958 products in the first reassessment round set to be adjusted from next April.AI-generated imageAccording to industry sources, some pharmaceutical companies have recently all but suspended entry-level recruitment or reduced hiring to a minimum. Companies are also leaving positions vacated through retirement and other natural attrition unfilled, instead redeploying existing employees.Rather than resorting to large-scale restructuring, companies are managing overall labor costs by restricting recruitment and not replacing departing employees. The trend is seen as an effort to reduce fixed costs as the risk of declining profitability from drug price cuts increases.Performance management of existing employees is also becoming more stringent. Industry sources say some companies are grading employees on scales such as A through D and subjecting those receiving lower ratings to closer management. Repeated low ratings can also have the effect of inducing voluntary retirement among employees, according to industry officials.The approach allows companies to gradually adjust workforce levels through performance evaluation and compensation systems rather than sharply reducing headcount through short-term restructuring. For employers, it offers a way to pursue continued workforce efficiency while reducing the burden associated with formal restructuring.Standards for incentive payments are also becoming tighter. In some cases, bonuses that had initially been expected have been eliminated, while employees who achieve as much as 95% of their targets receive no incentive if they fail to meet the 100% threshold.In other words, coming close to a target may no longer be enough to earn a reward. Cost controls are expanding beyond recruitment and headcount to compensation for existing employees.Wages are no exception. As pressure on earnings and profitability grows, companies may respond by limiting salary increases or revising their wage structures. The focus of cost management is thus broadening from the number of employees to the cost of each individual employee.Retirement plans are also emerging as a means of cost management. According to industry sources, some pharmaceutical companies have begun encouraging employees to switch from defined benefit (DB) retirement plans to defined contribution (DC) plans.Under a DB plan, the employee’s retirement benefit is determined in advance, with the employer responsible for managing the plan assets and paying the benefit. Under a DC plan, the employer pays a predetermined annual contribution into the employee’s account, while the eventual retirement benefit varies according to investment performance. From the employer’s perspective, a DC plan can make long-term retirement benefit obligations relatively easier to forecast and manage.However, because wage structures and retirement plan arrangements differ from company to company, a shift from DB to DC plans cannot necessarily be characterized as a direct cost-saving response to drug price cuts. It is more appropriately viewed as one of several changes occurring at some companies as they seek to manage labor costs and long-term financial obligations.Cutting ‘spending on people’...prolonged trend could weigh on competitivenessChanges in pharmaceutical workforce management illustrate where the cost burden from lower drug prices may ultimately be transferred. Lower prices may benefit patients and National Health Insurance finances, but pharmaceutical companies facing reduced profitability inevitably begin reviewing their internal costs.Labor is one of the most readily adjustable cost categories. What begins with reduced recruitment and unfilled vacancies is now extending to performance evaluations, incentives, wages, and retirement plans.The concern is what happens if the trend persists. A prolonged decline in entry-level recruitment could slow generational turnover within organizations. Repeated workforce adjustments and increasingly stringent performance management could also affect job security and employee engagement.The impact could be greater still if investment in core pharmaceutical personnel, including R&D and sales staff, is reduced. Efforts to protect profitability from drug price cuts could lead to lower investment in personnel, which in turn could weaken companies’ R&D and sales competitiveness.An industry official said, “When profitability declines because of drug price cuts, costs are ultimately the first thing companies tend to control. Practices such as reducing new hiring, leaving vacancies from natural attrition unfilled and improving the efficiency of the existing workforce will likely continue.”The official added, “The impact of drug price cuts does not end with drug prices. If reduced hiring, tighter performance management, workforce redeployment and changes to compensation and wage structures continue, it means pharmaceutical companies have begun reassessing even how much they spend on their people in order to protect profitability.”
- Company
- Domestic approval of 'Vanrafia' is imminent…new IgAN drug entries expected
- by Son, Hyung Min Oct 07, 2026 04:20pm
- Novartis’ new IgA nephropathy (IgAN) drug, Vanrafia, is nearing regulatory approval in South Korea, signaling anticipated shifts in the treatment landscape.As regulatory approval for Vanrafia, which targets the disease's pathogenic and progression pathways, nears, the reimbursement status of the previously approved Nefecon is expected to become a critical factor shaping prescribing competition.Novartis’ VanrafiaAccording to industry sources on the 7th, Novartis Korea is currently pursuing domestic approval for Vanrafia (atrasentan). The company anticipates an approval decision as early as this month.Vanrafia selectively antagonizes endothelin A (ETA) receptors involved in renal damage, aiming to reduce proteinuria and slow declines in kidney function.Vanrafia is formulated for oral administration at 0.75 mg once daily and can be taken with or without food.Last year, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Vanrafia based on clinical evidence of reduced proteinuria in patients with primary IgAN.In the Phase 3 ALIGN trial, which was the basis for approval, Vanrafia demonstrated significant proteinuria reduction, and subsequent long-term follow-up evaluated its nephroprotective effects.In the final analysis, Vanrafia demonstrated a 38.3% reduction in proteinuria compared with placebo at 9 months. In an analysis tracking patients over approximately 2.5 years, it reduced the rate of kidney function decline by approximately 34% versus placebo.Nefecon enters the Korean market first… Reimbursement status as the key variableAfter Vanrafia receives domestic approval, a new competitive landscape is expected to emerge in the IgAN therapeutic market alongside the previously approved Nefecon.Everest Medicines Korea’s Nefecon (micronized budesonide) secured approval from the Ministry of Food and Drug Safety (MFDS) in November 2024 for adult patients with primary IgAN who have a 24-hour urine protein excretion of ≥1 g/day or a urine protein-to-creatinine ratio (UPCR) of ≥0.8 g/g.Nefecon is a targeted-release formulation designed to deliver budesonide to specific regions of the distal ileum. Its mechanism of action differs from Vanrafia, which targets ETA receptors, by modulating the mucosal immune response implicated in IgAN pathogenesis.Dosing regimens also differ. Nefecon is indicated for 16 mg once-daily for 9 months, followed by a dosage taper before discontinuation.Because no direct head-to-head clinical trials exist between Nefecon and Vanrafia, a simple comparison of comparative efficacy remains challenging. However, because they target distinct pathophysiological pathways, clinical options can broaden based on individual patient characteristics.Reimbursement will determine actual market uptake.Everest Medicines Korea’s new IgA nephropathy (IgAN) drug, NefeconEverest Medicines suffered a setback last year in its initial bid for Nefecon’s reimbursement. In May of this year, the company submitted supplemental data to reapply, which is currently under review by the Health Insurance Review and Assessment Service (HIRA).Once Vanrafia is approved, the insurance coverage status and reimbursement criteria for each agent will directly govern real-world prescribing patterns.IgAN is a chronic, progressive disease requiring long-term clinical management. Even if therapeutics are approved, high out-of-pocket costs inevitably pose significant barriers to real-world patient access.The non-reimbursed price of Nefecon disclosed across major medical institutions stands at approximately KRW 50,000 to 60,000 per capsule. Converted to monthly treatment costs, this amounts to around KRW 7 million.The reimbursement outcome for Nefecon could serve as an initial benchmark for defining the future reimbursement scope of novel IgAN therapies. However, given the differing mechanisms of action and clinical evidence profiles between the two drugs, their reimbursement criteria and pharmaco-economic evaluation frameworks may diverge.Successive entry of novel therapeutics… Treatment options diversifyIgA nephropathy is characterized by the glomerular deposition of immunoglobulin A (IgA), which triggers progressive inflammation and renal damage. As renal function continually declines, a subset of patients progresses to end-stage renal disease (ESRD).Previously, standard of care centered on supportive therapy utilizing renin-angiotensin system (RAS) inhibitors to manage proteinuria and blood pressure. Recently, the successive emergence of therapies like Nefecon and Vanrafia, which directly target specific pathways involved in disease onset and progression, is transforming the therapeutic paradigm.Beyond Vanrafia, Novartis also holds Fabhalta (iptacopan), a complement pathway inhibitor, in its IgAN pipeline.Fabhalta received regular FDA approval in July of this year as a treatment to slow the decline of kidney function in adult patients with primary IgAN. In the Phase 3 APPLAUSE-IgAN trial, Fabhalta demonstrated an approximate 48% reduction in the rate of kidney function decline compared with placebo over two years.Additionally, novel mechanism-based therapies such as Filspari (sparsentan), a dual endothelin-angiotensin receptor antagonist, have already secured approval and utilization in the United States. Furthermore, with investigational candidates targeting the APRIL signaling pathway entering development, IgAN management is progressively shifting from conventional proteinuria mitigation toward precision targeting of underlying disease progression mechanisms.In contrast, few novel therapies have entered the domestic market to date. With Nefecon securing the initial approval and Vanrafia now preparing for subsequent market entry, clinically available options remain limited compared with the global market.
- Policy
- MFDS cases find new home...but where will rebate probes go?
- by Jung, Heung-Jun Oct 07, 2026 08:52am
- Food and drug cases previously handled by the Seoul Western District Prosecutors’ Office’s Food and Drug Crime Investigation Division will now largely be handled by the Serious Crimes Prosecution Division of the Seoul Western District Public Prosecution Office. AI-generated image.The investigative framework for Korea’s healthcare sector is taking different paths across different areas following the abolition of the Prosecutors’ Office and the launch of the Public Prosecution Service on October 2.Some ongoing cases have been dispersed to police following the dissolution of joint investigation teams, while in other areas, it remains unclear which body will take over from the specialized investigative units that previously handled them.Food and drug cases investigated by the Ministry of Food and Drug Safety’s Criminal Investigation Office will now be referred to the Seoul Western District Public Prosecution Service instead of the former Seoul Western District Prosecutors' Office..For pharmaceutical and medical device rebate cases, however, the successor investigative authority remains unclear following the dissolution of the Food and Drug Crime Investigation Division of the Seoul Western District Prosecutors’ Office, which had previously led such investigations.A separate joint investigation team focused on illegally operated hospitals and pharmacies operating under borrowed pharmacist licenses has also been disbanded, with its existing cases transferred to different police units.According to relevant agencies on the 6th, the transition to the new prosecution system and dissolution of the Seoul Western District Prosecutors’ Office’s Food and Drug Crime Investigation Division have also reshaped investigative and prosecutorial functions in food and drug cases.The referral system for food and drug cases directly investigated by the MFDS Criminal Investigation Office, however, remains largely unchanged.A Serious Crimes Prosecution Division that has been established within the Seoul Western District Public Prosecution Service will handle food- and drug-related cases. As a result, cases completed by the MFDS unit will continue to be referred to the Seoul Western District Prosecution Service.An MFDS Criminal Investigation Office official said, “The Seoul Western District Public Prosecution Service has established a Serious Crimes Prosecution Division, and its responsibilities include food and drug cases. As before, all cases investigated by our unit will be referred to the Seoul Western District Public Prosecution Service.”The official added, “Since we previously referred all food and drug cases investigated by the unit to the Seoul Western District Prosecutors’ Office, there is little practical change on our part.”The greater uncertainty surrounds investigations into pharmaceutical and medical device rebates. These had largely been conducted through joint investigations led by the Food and Drug Crime Investigation Division of the Seoul Western District Prosecutors’ Office, with police, the Ministry of Health and Welfare, the MFDS and other agencies providing personnel and specialized information under prosecutor-led investigations.The Seoul Western District Public Prosecution Service is still determining how individual cases previously handled by the Food and Drug Crime Investigation Division will be reassigned.An official from the Seoul Western District Public Prosecution Service said. “The work previously handled by the Food and Drug Crime Investigation Division is expected to fall under the Serious Crimes Prosecution Division, but the division of responsibilities has not yet been fully settled.”Regarding where cases from the former investigative areas would be transferred, the official said, “Cases are being handled individually, so it is difficult to provide details on the specific transfers.”The Serious Crimes Prosecution Division is responsible for indictments and maintaining prosecutions in food and drug cases but does not conduct investigations itself.The police can investigate rebate cases, while the Serious Crimes Investigation Agency may also become involved depending on the nature of a case. However, it remains unclear whether the dedicated investigative framework previously led by the Food and Drug Crime Investigation Division will be maintained.The joint investigation team on illegally operated hospitals and license-lending pharmacies, established at the Seoul Western District Prosecutors’ Office in May, was also disbanded ahead of the launch of the new prosecution system.The task force was dissolved as of the 1st, and personnel seconded from agencies including the Ministry of Health and Welfare, the National Health Insurance Service and HIRA have returned to their respective organizations.An official from the task force said, “The team was disbanded as of Oct. 1, and all seconded personnel returned to their original organizations,”.Cases being investigated by the team were also transferred to police. “We handed existing cases over to the police, including some that went to the Seoul Metropolitan Police Agency. Previously, cases were consolidated in one place for investigation, but they have now been split up.”Investigations into illegally operated hospitals and license-lending pharmacies have therefore shifted from a centralized model that brought personnel together in a single task force to a decentralized, police-led system.For areas such as rebates, illegally operated hospitals and license-lending pharmacies, where investigations had been led jointly by prosecutors and other agencies, maintaining specialized investigative capabilities and continuity hereon will be a key challenge under the new system.Meanwhile, the Prosecutors’ Office, which had held both investigative and prosecutorial authority, closed after 78 years, with the Serious Crimes Investigation Agency and Public Prosecution Service launched on the 2nd of this month. The change marks a major restructuring of Korea’s criminal justice system, with investigative and prosecutorial functions formerly exercised by prosecutors now assigned to separate agencies.Under the revised Criminal Procedure Act, Public Prosecution Service Act, and Serious Crimes Investigation Agency Act that took effect on Oct. 2, police are responsible for investigating general criminal cases, while the Serious Crimes Investigation Agency handles serious crimes. The Public Prosecution Service will determine whether to indict cases referred by investigative agencies and conduct prosecutions in court. As a result, criminal complaints and accusations can no longer be filed with the Public Prosecution Service. General cases must be filed with police, while crimes under the jurisdiction of the Serious Crimes Investigation Agency must be filed with that agency.The Serious Crimes Investigation Agency investigates major crimes including corruption, economic crimes, defense procurement offenses, narcotics, national security offenses, cybercrime and abuse of law. It also conducts supplementary investigations into seven categories of crimes involving socially vulnerable victims, including child abuse, domestic violence and sexual offenses. Crimes committed by senior public officials in connection with their duties remain under the jurisdiction of the Corruption Investigation Office for High-ranking Officials.With the abolition of the Prosecutors’ Office, cases previously investigated by prosecutors are also being transferred to the Serious Crimes Investigation Agency or police according to jurisdiction. Prosecutors at the new Public Prosecution Service may, however, continue investigating certain cases for up to 90 days when the statute of limitations is approaching or when consistent handling is required for matters such as warrant applications.
- Policy
- JW Pharma begins developing triple therapy combining Livalozet + SGLT-2 inhibitors
- by Lee, Tak-Sun Oct 07, 2026 08:52am
- JW Pharmaceutical has officially begun developing a next-generation fixed-dose combination (FDC) triple therapy, combining an SGLT-2 inhibitor-class antidiabetic agent into its dyslipidemia treatment, 'Livalo.'The company's strategy aims to solidify its leadership in the chronic multimorbidity market by merging the potent lipid-lowering efficacy of the existing 'Livalozet (pitavastatin + ezetimibe)' with glycemic control.According to the Ministry of Food and Drug Safety (MFDS), JW Pharmaceutical secured Investigational New Drug (IND) approval on the 2nd for a Phase 1 clinical trial of its investigational FDC triple therapy candidate, 'JW0113.'This clinical study will enroll 64 healthy adult volunteers and is scheduled to run from December 2026 to December 2027. The trial is designed as an open-label, randomized, 2-sequence, 4-period, fasting, single-dose, oral, replicated crossover study. The objective is to demonstrate bioequivalence by comparing the pharmacokinetic (PK) profiles and safety of the FDC candidate 'JW0113' administered alone versus co-administration with the corresponding reference listed drugs.Notably, as the primary pharmacokinetic endpoints specify the area under the plasma concentration-time curve from time zero to the last measurable concentration (AUCt) and peak plasma concentration (Cmax) for pitavastatin, total ezetimibe, and empagliflozin, it was confirmed that this pipeline candidate is an FDC triple therapy combining the active pharmaceutical ingredients of Livalozet with empagliflozin, a flagship SGLT-2 inhibitor.The chronic disease FDC market pioneered by 'Zemiglo' and 'Rosumet'… now advancing to 'triple combination therapy'With more than 70% to 80% of domestic diabetic patients concurrently presenting with dyslipidemia, the two conditions represent a quintessential multimorbidity. Due to the clinical nature of these diseases, patients often face a high pill burden, which tends to compromise medication adherence. Consequently, the pharmaceutical industry moved early to introduce combination therapies to manage both conditions simultaneously.In the domestic market, products such as LG Chem's 'Zemiglo (gemigliptin + rosuvastatin, a DPP-4 inhibitor + statin)' and Yuhan's 'Rosumet (rosuvastatin + metformin, a statin + first-line antidiabetic agent)' opened the era of 'diabetes + dyslipidemia' FDCs and are recognized as benchmark cases that enhanced patient dosing convenience.However, as recent cardiovascular disease prevention guidelines have adopted more stringent LDL cholesterol targets, the mainstream paradigm in lipid management has shifted from 'statin monotherapy' to 'statin + ezetimibe combination therapy.' Concurrently, combination regimens involving 'SGLT-2 inhibitors,' which have demonstrated cardiovascular and renal protective benefits, have become the standard of care in diabetes management. Accordingly, as market demand moves beyond existing dual therapies (one statin + one antidiabetic agent), there is rapid emerging demand for a generational transition to 'triple FDCs' that fuse the most potent lipid-lowering combination, 'statin + ezetimibe', with next-generation antidiabetic agents.Evolution of the 'Livalo Family'… Expanding from hypertension and mixed dyslipidemia into 'diabetes'JW Pharmaceutical has continuously diversified its product portfolio, anchored by its pitavastatin monotherapy, 'Livalo Tab.' The company has established a comprehensive cardio-cerebrovascular and chronic disease therapeutic portfolio, spanning 'Livalo V (pitavastatin + valsartan)', the statin + ezetimibe combination 'Livalozet' introduced in 2021, the fenofibric acid combination 'Livalo Feno' approved in 2025, and the triple-combination antihypertensive 'Livalo Hi (valsartan/amlodipine/pitavastatin).'The development of "JW0113" is regarded as a pivotal strategic bridge linking the Livalo family directly to the "diabetes space."In particular, empagliflozin is a benchmark SGLT-2 inhibitor with established efficacy not only in robust glycemic reduction but also in lowering the risk of heart failure and renal complications. Furthermore, compared to other statins, pitavastatin demonstrates a lower risk of new-onset diabetes mellitus (NODM), driving strong prescribing preferences for diabetic patients or individuals at high risk of diabetes. By combining these two agents with ezetimibe, which inhibits intestinal cholesterol absorption, the regimen will provide an optimal therapeutic option in a single pill for patients who have concurrent dyslipidemia and diabetes.A pharmaceutical industry official said, "While conventional dual-combination therapies like Zemiglo and Rosumet improved dosing convenience, JW0113 is an evolved model that brings three key drugs aligned with the latest clinical treatment guidelines into a single pill," and added, "If JW Pharmaceutical successfully commercializes this triple FDC alongside Livalo in the market, it is expected to secure an unmatched competitive edge across the chronic disease sector."
- Policy
- MOHW opposes bill requiring proof for CSO registration
- by Lee, Jeong-Hwan Oct 07, 2026 08:52am
- The Ministry of Health and Welfare (MOHW) has effectively opposed a proposed amendment to the Pharmaceutical Affairs Act that would explicitly stipulate in law the requirements for CSOs to maintain a place of business and require the submission of supporting documents, arguing that the change would offer little practical administrative benefit.On the 2nd, the ministry was found to have submitted its position on the bill proposed by Democratic Party lawmaker Jin-sook Jeon, which is pending in the National Assembly.Jeon’s bill would require CSOs, when reporting their pharmaceutical promotional sales activities to local governments, to meet requirements prescribed by Ministry of Health and Welfare regulations, including maintaining at least one business premises, and submit documents demonstrating compliance. The measure is intended to prevent the proliferation of so-called “ghost CSOs” that operate without an actual place of business.While agreeing with the bill’s aim of improving transparency in pharmaceutical distribution, the ministry stopped short of supporting the legislative change, citing its limited practical effect. Its position is that the existing framework already provides sufficient means to verify and enforce the requirements, reducing the need for a statutory amendment.The MOHW explained, “The current Enforcement Rule of the Pharmaceutical Affairs Act already stipulates that a CSO must have a business address as a reporting requirement, and local governments do not accept reports if the address cannot be verified.”“Competent authorities can already sufficiently verify the existence of an actual place of business through official documents submitted with the report, such as a business registration certificate or corporate registry. Since the requirements can already be enforced under the current rules, there is little practical benefit to amending the law.”The National Assembly’s Expert Advisory Office also lent support to the ministry’s position, noting that while elevating provisions currently contained in subordinate regulations into the parent statute could improve legal clarity, the practical benefit of the amendment would be limited because compliance can already be verified through checklists and official documents.The advisory office further noted that simply verifying the existence of business premises would do little to prevent illegal or evasive practices by disguised businesses, and suggested that more substantive measures are needed, such as mechanisms to identify ownership structures or new authority to investigate pharmaceutical sales and distribution practices.The Korean Pharmaceutical Association (KPA), however, strongly supported the amendment, calling for its swift passage to address problems associated with ghost CSOs.KPA said, “The recent increase in CSOs operating without business premises has made pharmaceutical distribution channels and lines of accountability increasingly unclear, worsening blind spots in oversight and contributing to disruptions in distribution practices, including illegal rebates and unfair sales practices. The amendment would clearly establish in law the basic infrastructure and reporting requirements for pharmaceutical sales representatives, thereby improving transparency in distribution channels and strengthening accountability.”
- Company
- Biogen seeks to expand reimb for high-dose Spinraza
- by Eo, Yun-Ho Oct 07, 2026 08:52am
- The spinal muscular atrophy therapy Spinraza is seeking expanded reimbursement with its high-dose regimen.Dailypharm has found that Biogen Korea filed an application in July to expand National Health Insurance coverage for a high-dose regimen of its spinal muscular atrophy drug Spinraza (nusinersen), which consists of a 50 mg loading dose and 28 mg maintenance doses. The regimen has now entered a full reimbursement review by the Health Insurance Review & Assessment Service (HIRA).Korea’s SMA treatment landscape has diversified as gene therapies and oral treatments have gained reimbursement alongside Spinraza. However, reimbursement criteria for existing treatments remain restrictive, prompting continued calls to address gaps in care, including concerns over treatment discontinuation and improved patient access.More recently, SMA treatment goals have moved beyond simply prolonging survival or preserving function. Treatment is increasingly aimed at achieving meaningful improvements in quality of life and helping patients reach normal developmental milestones, creating demand for a more proactive approach that seeks to maximize recovery of neuromuscular function rather than merely slow disease progression. The high-dose Spinraza is designed to address these unmet clinical needs.High-dose Spinraza has demonstrated its clinical value in the global Phase II/III DEVOTE trial and the ONWARD long-term extension study.In DEVOTE, high-dose Spinraza produced a mean 15.1-point improvement from baseline on the Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) in patients with Type 1 SMA whose symptoms emerged before six months of age, compared with an 11.1-point decline in untreated controls, demonstrating a significant improvement in motor function. It also reduced plasma neurofilament light chain (NfL), a marker of neuronal injury, by as much as 93%, indicating a reduction in neuronal damage.Positive findings were also reported in ONWARD, a multicenter long-term extension study evaluating the effects of switching patients from the conventional 12 mg dose to the high-dose regimen. After 302 days of follow-up, Hammersmith Functional Motor Scale–Expanded (HFMSE) scores improved in both ambulatory patients (mean 2.5 points from baseline) and non-ambulatory patients (mean 1.1 points). Revised Upper Limb Module (RULM) scores also showed clear overall improvement.Clinical experts view high-dose Spinraza not simply as a higher-dose formulation, but as a treatment option that could more strongly suppress neuronal damage and help optimize treatment for patients with SMA.As a result, some expect discussions on setting reimbursement criteria to be completed as early as this month, with the regimen potentially reaching the Drug Reimbursement Evaluation Committee within the year. Therefore, attention is now rising on whether the clinical benefits demonstrated with high-dose Spinraza will translate into timely reimbursement and broader patient access.
- Policy
- MFDS moves to speed finished drug approvals
- by Lee, Tak-Sun Oct 06, 2026 08:48am
- The Ministry of Food and Drug Safety (MFDS) is changing how it communicates requests for supplementary information on active pharmaceutical ingredients (APIs) during the approval process for finished pharmaceutical products, sending them directly to API manufacturers rather than through finished-drug companies.The change is expected to reduce review delays and improve technical communication by eliminating the multi-step process in which reviews have traditionally been delayed at the finished-drug company stage.The MFDS Drug Approval Policy Division said on the 30th that it will launch a pilot program, starting with applications for new or amended approvals filed from Oct. 1, under which API manufacturers will be directly notified of requests for supplementary information arising from linked reviews of APIs and finished products.‘Too much time lost going through finished-drug companies’...addresses industry communication difficultiesThe linked ‘API-finished product review’ is a system under which the quality and safety of the active ingredient registered under the Drug Master File (DMF) system are reviewed in conjunction with the marketing authorization application for the finished pharmaceutical product.Problems first arose when technical questions or requests for additional information concerning the API emerge during the review. Because the finished-drug company is the formal applicant, the MFDS has traditionally sent API-related requests only to that company, which then has to forward them to the API manufacturer and relay its response back to the agency.The industry has repeatedly raised concerns that this multi-step process can distort highly technical questions involving areas such as synthesis processes and impurity control. Companies have also reported difficulty meeting submission deadlines when API manufacturers are reluctant to share sensitive trade secrets with finished-drug companies.New drugs and data-submission drugs first...pilot limited to domestic API manufacturersThe key change is that the MFDS will notify API manufacturers directly by official letter, allowing the companies that actually generate the data and possess the relevant technical expertise to immediately identify and respond to requests for supplementary information.The pilot will cover new drugs, data-submission drugs, and follow-on drugs (generics), as well as applications for changes to their approvals handled by the Pharmaceutical Approval Management Division. It will apply when a finished-drug applicant submits a data-sharing consent form from a DMF holder (Korean API company, including the original registrant and APIs registered through a letter of authorization).The MFDS will send the relevant API manufacturer an official letter specifying the API name and DMF registration number, along with requests for “supplementary information related to Section 3.2.S, Drug Substance,” of the Common Technical Document (CTD).The pilot will not apply to products for which a data-sharing consent form has been submitted by an overseas API manufacturer, or where the DMF holder and finished-drug company are the same legal entity. Products under the jurisdiction of regional food and drug safety offices are also outside the scope of the current pilot.An MFDS official said, “By sending requests for supplementary API information directly to the API manufacturers responsible for preparing the data, we expect to improve review efficiency and support faster approval. We will closely assess the results of the pilot program before deciding how long to continue it and whether to expand its scope.”
- Product
- Keytruda’s bladder cancer expansion expected to fill treatment gap
- by Son, Hyung Min Oct 06, 2026 08:48am
- A new perioperative treatment option has become available for patients with muscle-invasive bladder cancer (MIBC) who are unable to receive cisplatin-based chemotherapy.With the combination of Keytruda (pembrolizumab) and Padcev (enfortumab vedotin) approved for use before and after radical cystectomy, a systemic treatment option aimed at reducing the risk of recurrence became available for cisplatin-ineligible patients who previously had to rely largely on surgery.On the 2nd, MSD Korea held a press conference at JW Marriott Hotel Seoul to mark the approval of perioperative Keytruda in MIBC and present results from the Phase III KEYNOTE-905 trial and their implications for clinical practice in Korea.In July, the Ministry of Food and Drug Safety approved Keytruda in combination with Padcev for neoadjuvant treatment before surgery and adjuvant treatment following radical cystectomy in patients with MIBC who are ineligible for cisplatin-containing chemotherapy.Cisplatin-ineligible MIBC patients lacked perioperative treatment optionsInKeun Park, Professor of Oncology at Asan Medica CenterMIBC is a stage of bladder cancer in which the tumor has invaded the muscular layer of the bladder, with radical cystectomy forming the cornerstone of treatment. Cisplatin-based chemotherapy has been recommended before surgery to reduce the risk of recurrence.However, bladder cancer disproportionately affects older patients, many of whom have comorbidities such as impaired renal function, hearing loss, or peripheral neuropathy that make cisplatin unsuitable.Systemic treatment options before surgery have been particularly limited for cisplatin-ineligible patients. With the risk of recurrence persisting even after radical surgery, there has been a longstanding unmet need for treatment strategies spanning both the pre- and postoperative settings. This perioperative treatment gap in cisplatin-ineligible MIBC patients was also cited as a key clinical consideration when the indication was approved in Korea.Inkeun Park, professor of oncology at Asan Medical Center, said, “Radical cystectomy is critical in MIBC, but surgery alone cannot eliminate all risk of recurrence. Treatment options before surgery have been particularly limited for patients who cannot receive cisplatin-based neoadjuvant chemotherapy because of advanced age or impaired renal function.”“These patients needed a treatment strategy that could reduce tumor burden before surgery and provide systemic control of micrometastatic residual disease through the postoperative period,” he added.Risk of recurrence, progression, or death falls 60%...overall survival also improvedKEYNOTE-905 is a Phase III trial involving 344 patients with MIBC who were either ineligible for or declined cisplatin-based chemotherapy. The trial compared perioperative Padcev plus Keytruda with radical cystectomy alone.Patients in the combination arm received 3 cycles of Keytruda plus Padcev before radical cystectomy, followed by 6 cycles of Keytruda plus Padcev after surgery and subsequent Keytruda monotherapy.The combination reduced the risk of an event in event-free survival (EFS) by 60% compared with surgery alone. In the overall survival (OS) analysis, it also reduced the risk of death by 50%.A marked difference was also observed in pathological complete response (pCR), which was achieved in 57.1% of patients in the combination arm compared with 8.6% in the surgery-alone arm.Park said, “What is meaningful is not only the higher pathological complete response rate with preoperative treatment, but that the study also demonstrated improvements in the long-term clinical endpoints of EFS and OS. The findings provide evidence that perioperative systemic therapy can reduce the risks of recurrence and death even in patients who cannot receive cisplatin.”Combination therapy moves from metastatic disease into curative-intent settingPadcev plus Keytruda first demonstrated efficacy in locally advanced or metastatic urothelial carcinoma. Its development has since moved earlier into resectable MIBC, extending the combination from the metastatic setting into curative-intent treatment.In MIBC in particular, evidence for Padcev plus Keytruda continues to build in both cisplatin-ineligible and cisplatin-eligible patients.In KEYNOTE-B15, which enrolled cisplatin-eligible patients, perioperative Padcev plus Keytruda reduced the risk of an EFS event by 47% and the risk of death by 35% compared with conventional neoadjuvant gemcitabine plus cisplatin. The combination is currently under regulatory review in Korea for this indication.Treatment options for MIBC are therefore becoming increasingly differentiated according to patients’ cisplatin eligibility and risk of recurrence, moving beyond a treatment paradigm centered on radical cystectomy toward one that incorporates perioperative systemic therapy.Park said, “Since systemic therapy is administered both before and after surgery, drug treatment and surgery need to be planned as a single continuum of care. Treatment plans should take into account the patient’s renal function and overall condition, with close monitoring of adverse events during treatment and postoperative recovery to ensure that perioperative therapy can be continued appropriately.”
