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- 2026-10-11 06:04:06
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- 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
- 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."
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