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- 2026-07-22 03:12:21
- InterView
- [Reporter's View] Healthcare bills should put patients first
- by Lee, Jeong-Hwan Jul 10, 2026 08:46am
- With negotiations between the ruling and opposition parties over the leadership of the second half of the 22nd National Assembly at a standstill, it remains unclear which party will chair the Health and Welfare Committee.Although the ruling Democratic Party of Korea (DPK) has agreed to relinquish the committee chairmanship it held during the first half of the Assembly to the People Power Party (PPP), the PPP rather insisted that the DPK must give up the chairmanship of the Legislation and Judiciary Committee, calling for renewed negotiations over committee assignments.According to political sources, the PPP is even considering giving up all seven committee chairmanships allocated to it unless the DPK reverses its unilateral appointment of chairs for 11 standing committees, including the Legislation and Judiciary Committee.As a result, there is now a possibility that the DPK, rather than the PPP, could ultimately retain the chairmanship of the Health and Welfare Committee during the second half of the Assembly.Because the committee chair has significant influence over the progress and outcome of major healthcare bills currently pending in the National Assembly, medical associations, pharmacists' organizations, and government agencies are closely monitoring the progress.One question naturally arises. Should we accept the current situation, where Korea’s healthcare legislation, which deeply affects the health and lives of the public and Korea’s healthcare environment as a whole, is determined by the political balance between the ruling and opposition parties or by the influence of particular professional groups such as physicians and pharmacists, as fate?Rather than functioning as a legislature centered on the public interest, the National Assembly often appears to operate according to the competing interests and lobbying power of political parties and professional organizations. Shouldn’t greater efforts be made to change this reality?Lawmakers and professional organizations alike should reflect on the fact that the fate of major healthcare legislation can turn 180 degrees depending on which party controls the Health and Welfare Committee or how many physicians and pharmacists sit on it.If a legislative proposal genuinely benefits public health and strengthens the financial sustainability of the National Health Insurance system, the National Assembly should function in a way that enables the most rational outcome regardless of political affiliation or professional background.The situation surrounding the ‘Limited INN Prescribing Bill (Generic Prescribing Bill),’ which was introduced to help address drug shortages, illustrates this concern, as its prospects are likely to depend on whether the ruling or opposition party chairs the Health and Welfare Committee during the second half of the current National Assembly.The PPP and physicians argue that even limited international non-proprietary name prescribing should never be permitted because it could undermine physicians' prescribing authority. In contrast, the DPK and pharmacists contend that limited INN prescribing should be introduced as soon as possible to address shortages of essential medicines and improve the financial sustainability of the National Health Insurance system.The National Assembly's legislative process is essentially being swayed by the political calculations of ruling and opposition parties and the vested interests of specific professional groups, such as doctors and pharmacists. As a result, genuine people-centered policymaking has become increasingly difficult to find.The National Assembly is the sanctuary of the people's will. Only when lawmakers move beyond partisan politics and professional self-interest to focus on protecting public health, improving Korea's healthcare system, and ensuring the sustainability of the National Health Insurance system will the Assembly truly fulfill its purpose.While politicians weigh the interests of the medical and pharmaceutical sectors and calculate political gains and losses, the voices of ordinary citizens, the practical beneficiaries of healthcare policy, are too often left out. The goal of legislation should never be measured by whether it strengthens or weakens a particular political party or professional group.Regardless of which party ultimately chairs the Health and Welfare Committee or how physicians and pharmacists are represented on the committee, legislative review should proceed in a manner that preserves consistency in national healthcare policy and upholds the principle of putting the public first.
- Policy
- Tecartus and Ianalumab receive GIFT designation
- by Lee, Tak-Sun Jul 10, 2026 08:45am
- AI-generated imageThe Ministry of Food and Drug Safety (MFDS) has designated two innovative rare disease therapies attracting global attention for its Global Innovative products on Fast Track (GIFT) program, accelerating efforts to expand treatment options for patients in Korea.According to the MFDS in July, Gilead Sciences Korea's CAR-T therapy Tecartus Inj (brexucabtagene autoleucel) and Novartis Korea's investigational Sjögren's disease treatment ianalumab have been designated as the 73rd and 74th GIFT products, respectively. The designation qualifies both products for expedited regulatory review during the marketing authorization process.‘Tecartus Inj,’ which has also been designated an advanced biopharmaceutical, is indicated for adults with relapsed or refractory mantle cell lymphoma (MCL) and B-cell acute lymphoblastic leukemia (ALL). The MFDS granted GIFT designation after determining that the therapy offers substantially improved efficacy and safety compared with existing treatment options. Tecartus received regulatory approval from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2020.Novartis Korea's ianalumab is a monoclonal antibody currently being developed for adults with moderate to severe Sjögren's disease. The drug targets the BAFF receptor, inhibiting B-cell survival. Given the lack of adequate treatment options for the disease, the MFDS granted GIFT designation on the basis that ‘no available therapy’ currently exists. The product has also received Fast Track designation from the US FDA.Both products have already been designated as orphan drugs in Korea and will undergo the MFDS's expedited review process for their approved indications and marketing authorization.Products designated under the GIFT program benefit from a review period approximately 25% shorter than that of the standard review process. Sponsors are also eligible for ‘rolling review,’ under which completed portions of the application are reviewed as they become available, as well as tailored consultations with dedicated reviewers before submitting a marketing application. These measures are expected to significantly accelerate the introduction of innovative therapies into the Korean market.An MFDS official said, "Through GIFT designation, we expect to accelerate the introduction of innovative medicines developed by both pharmaceutical companies in Korea and abroad, thereby providing patients with rare and intractable diseases with faster access to new treatment options."
- Policy
- Lixiana generics to be reimbursed in 2H
- by Jung, Heung-Jun Jul 10, 2026 08:45am
- With the expiration of the compound patent for Lixiana (edoxaban) set for later this year, a large number of generic products are expected to enter Korea's reimbursement list in the second half of 2026. However, the government's new multi-product listing management policy, which takes effect next month, is expected to serve as a key variable.In addition, recent changes to pricing premiums for Innovative Pharmaceutical Companies, Quasi-Innovative Pharmaceutical Companies, and Supply Stability Leading Companies are expected to result in different reimbursement prices depending on each company’s designation status.According to industry sources on the 8th, the new multi-product listing management system, which is scheduled to take effect next month, will apply to Lixiana generics set to be listed for reimbursement in November.According to pharmaceutical market research institute UBIST, Daiichi Sankyo's anticoagulant Lixiana generated KRW 121.8 billion in sales last year, up approximately 4% from KRW 117.5 billion the previous year.A large number of follow-on manufacturers have already obtained marketing authorization in preparation for reimbursement listing immediately upon patent expiry.As of this month, 28 generic products from 14 companies containing the same active ingredient as the original Lixiana, ‘edoxaban tosilate,’ have received regulatory approval. Because these products are expected to enter the reimbursement market simultaneously, they will become subject to the multi-product listing management system one year later.The multi-product listing management policy is a new drug pricing mechanism introduced under the government's drug pricing reform. Under the system, once the number of products with the same formulation reaches 14 or more, reimbursement prices for products entering the market will be reduced after one year, with the pricing rate set to fall from 45% to 38.25%.However, reimbursement prices will also vary depending on whether a company is certified as an Innovative or Quasi-Innovative Pharmaceutical Company. Innovative companies receive a 60% pricing premium, while Quasi-Innovative companies receive a 50% premium. Companies designated as Supply Stability Leading Companies are also eligible for a 50% premium. The premium remains in effect for a total of four years (1+3 years)Accordingly, if an Innovative (or Quasi-Innovative) Pharmaceutical Company or a Supply Stability Leading Company is subject to the multi-product listing management policy, its 50–60% premium will be maintained for four years, after which the pricing rate will be adjusted to 38.25%.As a result, companies such as Boryung, HK inno.N, and Dongkook Pharmaceutical will be able to retain the 60% premium for a certain period, while companies that do not qualify as Innovative Pharmaceutical Companies or Supply Stability Leading Companies will see their pricing rate reduced to 38.25% after one year, widening the reimbursement price gap.An official at a domestic pharmaceutical company A said, "Apart from Lixiana, there are unlikely to be many cases subject to the multi-product listing management policy. It remains to be seen how companies will respond if the reimbursement price gap between products receiving premiums and those that do not becomes substantial."Another key uncertainty is the implementation schedule for the Quasi-Innovative Pharmaceutical Company certification program, which has yet to be finalized. The government has only indicated that the program will be introduced after revisions to the Innovative Pharmaceutical Company framework are completed, leading industry observers to only expect the certification criteria and procedures to be finalized soon.However, it will be physically impossible to complete the Quasi-Innovative certification process before the Health Insurance Policy Deliberation Committee decides on reimbursement listings for Lixiana generics at the end of October.Another industry official from domestic pharmaceutical company B commented, "The criteria for Quasi-Innovative Pharmaceutical Companies are somewhat simpler than those for Innovative Pharmaceutical Companies because they mainly focus on sales, R&D requirements, and rebate-related issues. Fewer than 20 companies are expected to qualify. If the government issues the necessary notification and moves quickly, certification could be completed by the end of the year."
- Company
- Olympus Korea sales rebound to KRW 230 billion
- by Hwang, byoung woo Jul 10, 2026 08:45am
- Olympus Korea has successfully rebounded from the previous year’s sales decline with sales amounting to approximately KRW 230 billion.The company recorded growth in both product sales and services, while a mitigated cost of goods sold (COGS) burden drove increases in both operating and net profit. Furthermore, the company is solidifying its foundation for future growth by shifting away from its focus on endoscopy instrumentation, toward artificial intelligence (AI) and therapeutic solutions. Returning to the KRW 230 billion sales…Strengthened financial positionAccording to Olympus Korea’s recently disclosed 26th fiscal audit report (April 1, 2025, to March 31, 2026), the company's annual revenue reached KRW 231.3 billion. This result carries significance as the company generated an KRW 8.9 billion expansion from the KRW 222.4 billion reported in the previous year, recovering the prior year's losses. Notably, this figure surpasses the KRW 230.1 billion recorded in the 24th term, the highest revenue performance among the last four fiscal terms.Olympus Korea had maintained stable revenues of KRW 231.0 billion in its 23rd term and KRW 230.1 billion in its 24th term, before dropping to KRW 222.4 billion in its 25th term. The sales drop in the 25th term coincided with operational disruptions at South Korean clinical sites due to the healthcare dispute between doctors and the government.The company's profitability also improved. Operating profit for the 26th term rose to KRW 20.9 billion, up KRW 5.0 billion from the previous term's KRW 15.9 billion. Net income also increased to KRW 17.1 billion, up KRW 4.4 billion from the previous term's KRW 12.7 billion. This turnaround signifies that Olympus Korea has restored both its top-line revenue scale and intrinsic profitability to levels achieved before the healthcare conflict. Olympus Korea Sales between 2021-2025 (PURPLE: SALES, GREEN: OPERATING PROFITS, BLUE: NET INCOME). Source: FSS, unit: KRW 100 millionCOGS for the 26th term decreased to KRW 141.0 billion from KRW 144.4 billion in the prior term. Despite rising sales, this cost reduction led to an expansion of gross profit from KRW 78.0 billion to KRW 90.3 billion. Consequently, the gross profit margin climbed from approximately 35.1% in the preceding term to around 39.0% in the 26th term. Selling, general, and administrative (SG&A) expenses rose to KRW 69.5 billion from KRW 62.1 billion in the prior year. Other metrics include increases across salaries and bonuses, retirement benefits, outsourced services, and sales promotion expenses. However, the positive impact of the improved COGS ratio successfully absorbed the expanded overhead, allowing operating profit to rebound compared to the previous year. Notably, the drastic drop in the interim dividend paid out to the parent company, Olympus Corporation.For the 26th term, Olympus Korea distributed a total interim dividend of KRW 9.5 billion (KRW 26,388,889 per share). This represents a 44.1% reduction compared to the interim dividend of approximately KRW 16.99 billion (KRW 47,202,441 per share) allocated during the 25th term. As a combined result of rising net income and optimized dividend sizing, retained earnings grew from KRW 78.1 billion in the prior term to KRW 85.0 billion. This indicates that, alongside top-line recovery, the company has reinforced its internal capital reserves. Growth in both products and services…expanding therapeutic portfolio expansionBy revenue category, both product sales and service provisions demonstrated stable upward trajectories. Product revenue for the 26th term amounted to KRW 193.8 billion, up KRW 4.5 billion from the previous term's KRW 189.3 billion. Concurrently, service revenue climbed to KRW 37.5 billion, a KRW 4.4 billion advance from the KRW 33.2 billion posted in the prior term. The overall top-line gains were evenly balanced between equipment commercialization and technical service lines. This trend aligns with Olympus Korea's strategic transition from a pure-play medical equipment supplier to an integrated provider of services and therapeutic solutions. Leveraging its established diagnostic leadership in gastrointestinal endoscopy imaging systems, the company is accelerating the construction of integrated therapeutic portfolios that fuse surgical instrumentation with advanced digital solutions. A primary example of this commercial blueprint is iTind, a minimally invasive therapeutic device designed for benign prostatic hyperplasia (BPH). Fabricated from nitinol, the device offers a non-incisional therapeutic option that can be performed under local anesthesia. Following its regulatory designation under South Korea's New Medical Technology assessment, the system has steadily expanded its market penetration across both tertiary hospitals and localized clinics. This year, portfolio diversification has accelerated across both the digital solution and surgical device sectors.In January, Olympus Korea executed a MOU with INEX Corporation to initiate the domestic commercialization of ENAD, an AI-powered endoscopy image analysis software. The strategic core of the partnership involves interfacing and deploying ENAD within Olympus's existing hardware ecosystems to broaden digital touchpoints in endoscopy diagnostics. Additionally, in April, the company officially launched its next-generation laparoscopic surgical instrument line, HICURA, into the Korean market. HICURA is a core surgical handpiece used in diverse minimally invasive procedures, including general surgery, gynecology, and urology, emphasizing operational efficiency in the operating room through a three-stage modular system and an extensive portfolio of jaw configurations. Olympus Korea's 26th-term performance is significant, as it boosted a clear recovery from the revenue volatility triggered by the domestic medical conflict. Annual revenue successfully rebounded to approximately KRW 230 billion, accompanied by expansions in operating profit and net income compared with the previous year.Currently, industry attention will center on whether the company can overcome its exterior growth beyond this KRW 230 billion range besides the 25th term. Given that the initial introduction of medical equipment inherently generates revenue streams, including clinical training, maintenance, repairs, and software upgrades, the expansion of the therapeutic portfolio, alongside high-margin service revenue, will be the primary pillars driving the company's long-term growth in South Korea.
- Company
- 'Brukinsa' aims to obtain CLL reimb for all age groups
- by Eo, Yun-Ho Jul 10, 2026 08:45am
- Product photo of BTK inhibitor 'Brukinsa'The second-generation BTK inhibitor 'Brukinsa' aims to expand its prescription areas to all age groups in the chronic lymphocytic leukemia (CLL) treatment.According to industry sources, BeOne Medicines Korea recently submitted an application to expand national health insurance reimbursement for Brukinsa (zanubrutinib). The application details include the first-line treatment of treatment-naïve CLL adult patients under the age of 65 who present with co-morbidities.Consequently, it is noteworthy to watch whether this strategy will successfully improve the treatment paradigm for CLL patients under 65. These age groups have been relying on conventional chemoimmunotherapy regimens such as FCR (fludarabine·cyclophosphamide·rituximab).While chronic lymphocytic leukemia is the most prevalent leukemia subtype in Western countries, it is a relatively rare disease in South Korea. Although reported figures vary across literature, the prevalence in South Korea is reported to be approximately 10 to 20 times lower than that observed in Western populations. This low disease prevalence is a shared epidemiological characteristic documented across East Asia, including Japan.A distinct clinical feature characterizing South Korean CLL patients is the age group. In Western cohorts, the median age at diagnosis typically falls in the 70s, whereas numerous domestic studies report a significantly lower median age of around 60 years, ranging from 60 to 65 years. Consequently, a substantial proportion of South Korean patients are diagnosed at a relatively younger age; in several cases, the under-65 patient group is reported.Brukinsa is currently recommended as Category 1 for the first-line treatment of CLL under the National Comprehensive Cancer Network (NCCN) Guidelines. Globally, it is being recommended as a primary treatment option without age-based restrictions. However, in South Korea, national health insurance reimbursement for Brukinsa is strictly limited to CLL patients aged 65 and older. Analysis suggests that this restrictive indication was established because Brukinsa's reimbursemnt has been tied to the listed indication set by the first-in-class BTK inhibitor, 'Imbruvica (ibrutinib)'. Both health professionals and patients have consistently pointed out the current situation and called for expanding Brukinsa's reimbursement criteria in the CLL treatment.Meanwhile, the clinical efficacy of Brukinsa in CLL was confirmed through the global Phase 3 SEQUOIA trial. This study evaluated patients with CLL or small lymphocytic lymphoma (SLL) who has no prior treatment history, comparing Brukinsa directly with a combination therapy of 'Symbenda (bendamustine)' + 'MabThera (rituximab)'.The study results showed that at 24-month, the primary endpoint of progression-free survival (PFS) was 85.5% in the zanubrutinib group versus 69.5% in the bendamustine + rituximab control group. Furthermore, Brukinsa demonstrated a substantial 58% reduction in the risk of disease progression or death compared to the active control group.
- Policy
- Exports of K-bios reach record $4.5 billion in 1H 2026
- by Lee, Tak-Sun Jul 09, 2026 08:55am
- South Korea's biopharmaceutical industry posted its highest-ever export performance for the first half of the year, once again demonstrating its growing presence in the global market. The expansion was driven primarily by increasing market share in Europe, supported by strong manufacturing competitiveness and growing contract development and manufacturing organization (CDMO) orders.According to the Ministry of Food and Drug Safety (MFDS, Minister: Yu-Kyoung Oh), Korea's biopharmaceutical exports totaled USD 4.5 billion during the first half of 2026, representing a 15.3% increase from the same period last year. This is the highest first-half export figure on record.Over the past three years, Korea's biopharmaceutical exports have grown by more than 20% annually on average, nearly doubling in size. During the first half of this year, biopharmaceuticals accounted for 86.5% of Korea's total pharmaceutical exports (USD 5.2 billion), reaffirming their role as the primary driver of Korea’s pharmaceutical exports.Growth was also evident on a quarterly basis. Exports reached USD 2.0 billion in the first quarter and USD 2.5 billion in the second quarter, representing year-over-year increases of 11.1% and 15.3%, respectively. Monthly exports also set new records throughout the period. In June alone, exports reached USD 1.02 billion, marking the first time monthly biopharmaceutical exports exceeded the USD 1 billion threshold.Switzerland is the top export destination…Netherlands and France record rapid growthDuring the first half of the year, Korean biopharmaceuticals were exported to 163 countries worldwide. By export value, Switzerland ranked first with USD 770 million (17.1%), followed by the United States with USD 610 million (13.6%) and Hungary with USD 600 million (13.3%).Exports to Switzerland increased 67.4% (US$310 million) compared with the same period last year, allowing the country to maintain the top position for both the first quarter and the first half of the year. The increase was attributed mainly to higher CDMO orders secured by Korean companies from global pharmaceutical firms based in Switzerland, along with growing demand for biosimilars.Other European markets also posted strong growth. Exports to the Netherlands rose 80% to USD 450 million, making it Korea's fourth-largest export destination, while exports to France reached USD 160 million, allowing the country to enter Korea's top ten export markets for the first time, ranking ninth.Recombinant biologics account for 88% of exports…toxins and antitoxins also show strong performanceBy product category, recombinant biologics led exports with USD 3.97 billion, accounting for 88% of total biopharmaceutical exports. This is an 18.4% year-over-year increase. Exports of recombinant DNA products grew particularly rapidly in major European markets, especially in France (+630%), Belgium(+184%), and Italy(+147%).Exports of toxins and antitoxins reached USD 280 million, up 47.4% from a year earlier. The United States (USD 70 million) and China (USD 60 million) were the largest export markets, while exports to Southeast Asian countries such as Thailand (+119%) and Vietnam (+112%) more than doubled year on year. In contrast, vaccine exports declined 27.4% year over year to USD 120 million, with shipments primarily exported to Southeast Asia and Africa, including Thailand and Bangladesh.MFDS to implement ‘CDMO Special Act’ in December…will support the act through regulatory reformTo sustain the current momentum through the second half of the year, the MFDS plans to provide additional regulatory support. ‘The Special Act on Regulatory Support for Biopharmaceutical Contract Development and Manufacturing Organizations (CDMO Special Act),’ enacted last December, will officially take effect this coming December.Once implemented, the legislation will introduce an ‘Export Manufacturing Registration System,’ allowing CDMO companies manufacturing products exclusively for export to enter global markets without first obtaining a separate pharmaceutical manufacturing license. The MFDS also plans to introduce certification programs aimed at enhancing the credibility of domestically produced biopharmaceutical APIs.Young-jin Ahn, Director of the Biopharmaceuticals and Herbal Medicines Bureau at the MFDS, said, "We will innovate the review and approval process for new drugs and biosimilars while providing regulatory support throughout the entire product lifecycle so that safe therapies can reach patients around the world as quickly as possible. We will also provide tailored information to support Korean companies' overseas expansion and actively strengthen regulatory cooperation with our major export markets."
- InterView
- [Reporter’s View] Paradox of Korea's drug pricing reform
- by Kim, Jin-Gu Jul 09, 2026 08:55am
- As Korea prepares for a sweeping overhaul of its drug pricing system, pharmaceutical and biotech companies are increasingly seeking advice not in Sejong, the nation's administrative capital, but at major law firms in Seocho-dong and Gwanghwamun in Seoul. Domestic pharmaceutical companies are assessing whether they qualify as Innovative or Quasi-Innovative companies under the new pricing framework in an effort to minimize financial losses. Meanwhile, Korean affiliates of multinational drugmakers are busy identifying legal gray areas surrounding the Flexible Pricing Agreement system and post-listing management rules.Given the scale of the reforms, many companies say it is virtually impossible to respond adequately relying solely on internal capabilities. The industry broadly agrees on the need for mid- to long-term improvements to the drug pricing system. However, reforms introduced at a pace the market struggles to absorb are also producing unintended consequences. Ironically, large law firms are the only ones reaping the benefits between the government, which sets the policies, and the pharmaceutical and biotech companies, which are subject to them.Over the past several years, law firms have evolved beyond simply providing legal advice to become key players in the pharmaceutical industry. As regulations grow more complex and policy predictability declines, their influence has expanded accordingly. They help develop legal arguments to ensure industry perspectives are reflected during legislative and regulatory revisions, interpret increasingly complicated regulations, and formulate compliance strategies. They also design defense strategies against administrative actions such as drug price cuts or marketing authorization revocations. In areas where regulation and administrative enforcement intersect, it has become difficult to find issues in which law firms are not involved.In this context, it is somewhat disheartening to see major law firms aggressively recruiting former officials from the Ministry of Health and Welfare and other government agencies.From the industry's perspective, there is an undeniable need for experts who understand the rationale behind complicated regulatory changes and can provide response measures. Likewise, it is only natural for law firms to recruit professionals with the expertise demanded by the market. Nor should individuals be criticized simply for pursuing post-retirement careers that make use of their professional experience. If they have passed the required government ethics reviews, there is no legal issue.However, looking beyond legal formalities reveals a troubling contradiction. Officials who only recently designed the framework of these policies, emphasized the public interest of the pharmaceutical industry, and tightened regulatory standards are now, after retirement, standing on the opposite side and advising companies on how to circumvent or defend against those very same regulations.The government announces new policies, and individuals who directly or indirectly helped design those policies later develop legal defense strategies at private law firms. Companies then pay substantial fees to purchase that expertise. As policy changes become more frequent, this unusual ecosystem only becomes more firmly entrenched.An even greater concern is how companies allocate their resources. Money and manpower that should be invested in research and development or productivity are repeatedly diverted to regulatory compliance and legal reviews. This is hardly beneficial for strengthening the competitiveness of Korea’s pharmaceutical and biotech industry. If government policy encourages companies to compete over regulatory strategy rather than innovation, then the fundamental design of those policies also deserves renewed scrutiny.The ultimate goal of drug pricing reform is to ensure the long-term sustainability of Korea's National Health Insurance system while fostering a healthy pharmaceutical and biotech ecosystem. However, if the greatest beneficiaries of these reforms are not pharmaceutical companies' R&D organizations but large law firms, it is worth asking once again whether both the design of the reform and the manner in which it has been implemented are truly appropriate.
- Policy
- MFDS warns against misuse of GLP-1 obesity drugs
- by Lee, Tak-Sun Jul 09, 2026 08:55am
- The Ministry of Food and Drug Safety (MFDS) has warned against the misuse and abuse of GLP-1-based obesity treatments, urging consumers not to use products purchased through overseas direct purchases. The agency also announced plans to intensify inspections of misleading advertisements by pharmacies and medical institutions.On July 8, the MFDS announced so following media reports on the growing misuse of GLP-1 obesity medications. The agency emphasized that these products should be used only in patients who meet the approved indications for obesity treatment and strictly in accordance with the approved prescribing information under the supervision of a healthcare professional.GLP-1 class obesity drugs contain glucagon-like peptide-1 (GLP-1), which increases glucose-dependent insulin secretion, suppresses glucagon release, delays gastric emptying, and promotes weight loss.These medicines are indicated for: ‘adults with obesity and an initial body mass index (BMI) of 30 kg/m² or higher,’ or ‘overweight adults with a BMI between 27 kg/m² and less than 30 kg/m² who have at least one weight-related comorbidity, such as hypertension.When GLP-1 obesity medications approved for adolescents are prescribed, special caution is also required because adolescents are still growing. Healthcare providers should closely monitor for insufficient nutritional intake and excessive weight loss that could affect growth, as well as gastrointestinal adverse events leading to dehydration and acute pancreatitis.The MFDS also noted that these products are often mistakenly perceived as simple "diet pills," leading to inappropriate use. The agency stressed that obesity treatments are prescription-only medicines and must be used only after being prescribed by a physician and accompanied by proper medication counseling from a pharmacist.In particular, products obtained through overseas direct purchases have not been approved in Korea, meaning their safety and efficacy have not been adequately verified. Also, because their manufacturing and distribution history cannot be confirmed, such products may be counterfeit or substandard medicines, posing significant health risks. Furthermore, consumers who experience harm after using these products may have difficulty obtaining legal protection, including product recalls or compensation.To promote the safe use of obesity medications and improve public understanding, the MFDS plans to produce card news materials and short-form videos for distribution through social media. The agency will also work with the Ministry of Education and the Ministry of Gender Equality and Family to provide information on the safe use of obesity medications through websites frequently visited by adolescents and parents.In addition, in cooperation with local governments, the MFDS plans to conduct intensive inspections and follow-up actions on medical institutions and pharmacies regarding off-label promotion and false or misleading advertising of obesity treatments.An MFDS official said, "We will continue making every effort to improve users' understanding of obesity treatments and actively provide information on their safe use within the approved indications, fostering an environment that supports the safe use of medicines."
- Policy
- Preferential framework ahead of certification?...drug pricing reform
- by Jung, Heung-Jun Jul 09, 2026 08:55am
- The Ministry of Health and Welfare (MOHW) is implementing preferential pricing benefits in August. Yet, the criteria for certifying Innovative and Semi-Innovative companies are incomplete. (AI-generated image)The South Korean government is being called for failing to account for newly certified Innovative·Semi-Innovative Pharmaceutical Companies as it pushes ahead with a reform of drug pricing calculations and price reductions for prior-listed drugs. Critics point out that the policy reform is not being processed in an appropriate sequence, given that the preferential pricing benefits are scheduled to take effect as early as next month, even though official applications for this year's Innovative and Semi-Innovative certifications have not yet opened. Furthermore, price reductions for baseline-listed drugs are set to begin in November, based on the September drug formulary registry, triggering widespread confusion about how the exemptions for Innovative and Semi-Innovative companies will be applied in practice. For the current year, the plan is to cut prices from 53.55% to 51% exclusively for medications listed before 2012, creating an administrative bottleneck in which products eligible for special exemptions must be reclassified retrospectively. According to industry sources on the 7th, generic drug pricing calculation and premium mechanisms, including the newly established "Semi-Innovative" company list, are set for an extensive restructuring next month. However, the certification process for Semi-Innovative companies has not even commenced. Similarly, new designations for Innovative Pharmaceutical Companies are not scheduled until December, meaning that structural revisions to the pricing and premium systems will precede the actual certifications. Consequently, pharmaceutical companies seeking Semi-Innovative status or aiming for new Innovative designations are effectively forced to delay their health insurance reimbursement listings to secure preferential pricing benefits. Because the Semi-Innovative and Innovative tiers receive a 50% and 60% pricing premium, respectively, missing out on these certifications results in a 5% to 15% financial penalty compared to the baseline calculation rate of 45%. An official from domestic pharmaceutical company said, "The government seems to force the timeline forward, but they simply need to let go of the rigid notion that it must be launched this year," and added, "From a regulatory coherence standpoint, postponing the implementation by just a few months would resolve everything. We intend to submit our formal feedback during the administrative notice period." The Ministry of Health and Welfare (MOHW) is currently collecting public and industry feedback on the partial amendment draft of the 'Criteria for Determination and Adjustment of Drugs' through an administrative notice period ending on the 13th. The pharmaceutical industry strongly maintains that the implementation timeline must be recalibrated to minimize operational confusion on the ground. The same structural misalignment applies to price cuts for prior-listed drugs, in which Innovative and Semi-Innovative enterprises are legally entitled to a 3-4 year grace period or a special exemption. The government is reportedly planning to categorize products according to the September Drug Reimbursement List and enforce price reductions in November. However, because no company has been certified as Semi-Innovative yet, it is impossible to identify which drugs qualify for exemptions under the prior-listed price cuts. Ultimately, eligibility for these exemptions can only be determined through a retrospective reclassification after the certification applications and evaluations are finalized.An official from another pharmaceutical company expressed frustration, stating, "This policy reform was originally intended to incentivize R&D innovation through pricing premiums. The logical sequence should be to finalize company certifications before altering the system. It appears the government is simply sticking to its original schedule regardless of the logical workflow."
- Opinion
- "Kerendia for integrated management of kidney and heart health"
- by Son, Hyung Min Jul 09, 2026 08:55am
- "Chronic kidney disease associated with diabetes must be treated from the moment proteinuria is confirmed. Intervening early while kidney function is still sufficiently intact can make a difference in a patient's long-term lifetime prognosis."Professor Brendon Neuen, a nephrologist at Royal North Shore Hospital in Australia, shared this clinical insight during a recent meeting with DailyPharm, emphasizing that the management of chronic kidney disease (CKD) is rapidly shifting toward an integrated approach that simultaneously protects both the heart and the kidneys.Professor Brendon Neuen, a nephrologist at Royal North Shore Hospital in AustraliaAccording to Professor Neuen, the emergence of novel therapeutic options, such as 'Kerendia (finerenone),' has expanded therapeutic goals beyond merely slowing the decline of renal function to managing cardiovascular risk. From now, he anticipates that personalized, risk-based strategies that modulate treatment intensity according to individual patient risk profiles will establish themselves as the new standard of care.The therapeutic landscape for CKD has evolved over recent years. Previously, management relied on renin-angiotensin system (RAS) inhibitors to regulate systemic blood pressure and manage proteinuria. The subsequent introduction of SGLT2 inhibitors introduced a new paradigm, establishing concurrent renal protection and cardiovascular risk reduction as primary clinical endpoints.The emergence of Kerendia, a non-steroidal mineralocorticoid receptor antagonist (MRA), has enabled clinicians to directly target and modulate both inflammation and fibrosis. Overactivation of the mineralocorticoid receptor is known to drive pathological changes across the heart, vasculature, and kidneys. Kerendia is particularly effective in disrupting this cascade by actively suppressing inflammation and fibrotic progression.The paradigm shift is driven by high disease burden associated with diabetic kidney disease. Diabetes remains the leading etiology of CKD worldwide, and its clinical complications extend far beyond progressive renal decline. Patients who have concurrent diabetes and CKD face elevated risks of cardiovascular events, such as heart failure and myocardial infarction, alongside the risk of end-stage renal disease (ESRD). Notably, a significant proportion of this patient cohort succumbs to cardiovascular mortality before ever progressing to maintenance dialysis.Consequently, the Cardiovascular-Kidney-Metabolic (CKM) framework has emerged as a dominant therapeutic paradigm, treating renal decline and cardiovascular risk as interconnected pathologies.Because diabetes, CKD, and heart failure affect once another, accelerating disease progression and elevating mortality risk, clinical consensus strongly favors integrated, multi-organ management over isolated, organ-specific interventions. Reflecting this trend, major international clinical practice guidelines have shifted toward holistic cardio-renal protection and risk-stratified therapeutic intensification.Meanwhile, Kerendia is expanding its clinical areas. Based on the FIDELIO-DKD and FIGARO-DKD trials, which demonstrated significant reductions in renal decline and major adverse cardiovascular events (MACE) in patients with CKD and type 2 diabetes, the FIDELITY analysis further confirmed the drug's consistent therapeutic efficacy. More recently, Kerendia has expanded its clinical application into broader fields, including heart failure, non-diabetic CKD, and combination therapy paradigms, through ongoing and subsequent trials such as FINEARTS-HF, FIND-CKD, and CONFIDENCE.As a leading investigator in the CKM field, Professor Neuen has served as a co-author on the core FIDELIO-DKD, FIGARO-DKD, and FIDELITY trials and currently serves on the Steering Committee for the FIND-CKD trial.He is recognized as an expert leading the CKM paradigm shift through his extensive research into integrated cardio-renal management and risk-based treatment strategies.Professor Neuen said, "Recently presented clinical data have significantly broadened both the target patient populations and the strategic boundaries of CKD management," and added "The future standard of care will center on risk-stratified, personalized medicine that manages both the heart and kidneys.Q. What is the optimal stage for initiating early therapeutic intervention in patients with diabetic kidney disease?The ideal window for early detection and intervention occurs when the estimated glomerular filtration rate (eGFR) is maintained above 90, or at the very least above 60, signifying relatively well-preserved baseline renal function. The critical objective is to identify and treat patients at this early, preserved stage when kidney function remains intact but the initial signal of structural damage, such as proteinuria, is detected.A vast number of patients globally, including in South Korea, remain unaware that they present with persistent proteinuria despite showing normal standard serum creatinine or eGFR metrics. An elevation in proteinuria represents the definitive primary biomarker of progressive renal injury. If a patient is diagnosed only at an advanced stage, when renal function is largely depleted, and eGFR drops below 30, the residual functional nephron mass is severely diminished, meaning that even optimal therapeutic interventions will have significantly limited clinical utility.Q. Could you elaborate on the clinical necessity of integrated management across cardiovascular, renal, and metabolic diseases?The physiological interconnectedness of cardiovascular, renal, and metabolic pathologies is not a new concept. The co-occurrence of cardiac abnormalities in patients with established renal disease was first documented over two centuries ago. However, this axis has recently entered mainstream clinical discourse due to two major developments. First, our understanding of shared pathophysiological pathways and reciprocal mechanisms has deepened significantly, and second, we now possess therapeutic agents capable of modifying multiple disease pathways simultaneously. For example, GLP-1 receptor agonists and SGLT2 inhibitors. Most recently, Kerendia has demonstrated the capacity to simultaneously mitigate the risk of heart failure hospitalizations and renal progression, while additionally lowering the incidence of new-onset type 2 diabetes. The emergence of these multi-disease therapeutics allows clinicians to diagnose and treat patients from a more systemic perspective. This requires specialists across nephrology, cardiology, and endocrinology to break down clinical siloes, evaluate patient risk profiles through a broader lens, and deploy integrated treatment regimens.Crucially, these organ systems affect one another. An exacerbation of heart failure accelerates the progression of underlying kidney disease, while a deterioration in renal function conversely destabilizes cardiac output and worsens heart failure. Ultimately, these conditions form a pathological feedback loop, driving mutual deterioration through shared metabolic and hemodynamic risk factors.Q. What are your primary criteria for patient selection, and how do you evaluate therapeutic response?In terms of patient selection, my primary focus centers on whether a patient exhibits persistent residual albuminuria or proteinuria despite receiving optimized, maximum-tolerated background therapy with a standard RAS inhibitor and an SGLT2 inhibitor. Persistent protein excretion serves as an objective sign that progressive renal injury is actively continuing despite standard intervention. Therefore, if a patient continues to demonstrate elevated urine albumin-to-creatinine ratios under an optimized baseline regimen, I proactively initiate combination therapy by adding Kerendia.The reason for prioritizing combination therapy is that complex, multifaceted, and redundant biological pathways drive CKD progression. Effectively disrupting this disease process and securing optimal patient outcomes requires the simultaneous blockade of these distinct pathogenic streams.In fact, data from the FIND-CKD trial demonstrate that this combination approach can be the standard of care even in non-diabetic CKD populations, where historical therapeutic options have been highly constrained. Synthesizing recent FIND-CKD data with data from the CONFIDENCE trial, which evaluates the upfront combination of Kerendia and an SGLT2 inhibitor in patients with CKD and type 2 diabetes, makes it clear that combination regimens will assume a pivotal role in concurrently managing both renal attrition and systemic cardiovascular risk.Q. As a researcher for the FIND-CKD trial, could you explain the core findings of the study?The FIND-CKD trial was a randomized clinical study that enrolled 1,584 patients with non-diabetic chronic kidney disease to evaluate the efficacy of Kerendia in suppressing renal progression. While Kerendia's ability to delay renal decline and reduce cardiovascular events in patients with type 2 diabetes was already firmly established, whether these precise clinical benefits would translate to a non-diabetic CKD cohort had remained unverified.The trial data revealed that patients randomized to the Kerendia group experienced a significant deceleration in the chronic eGFR slope, with the annual rate of decline slowing from 4.0 mL/min per year in the control arm to 3.3 mL/min per year. While an absolute difference of 0.7 mL/min per year might appear modest on the surface, it culminated in a substantial 23% risk reduction in the primary composite endpoint, which aggregated the incidence of kidney failure, a sustained eGFR decline of 57% or greater, hospitalization for heart failure, and cardiovascular mortality.Notably, this therapeutic benefit remained remarkably consistent regardless of the underlying etiology of kidney disease, baseline renal function metrics, or concurrent baseline use of SGLT2 inhibitors. From a safety perspective, although the incidence of laboratory-monitored hyperkalemia was higher in the Kerendia cohort compared to the placebo group, clinically significant hyperkalemia events resulting in permanent treatment discontinuation or acute hospitalization were exceptionally rare.It is significant that approximately half of the total cohort across the 24 participating nations consisted of Asian patients, with South Korean patients accounting for roughly 10% of the overall study population. This substantial regional representation provides highly actionable, high-value evidence directly generalizable to real-world clinical practice across Asia and South Korea.Q. How do you evaluate the overall clinical value proposition of these findings?It is significant that Kerendia's established efficacy in diabetic kidney disease extends consistently into the non-diabetic CKD patients.It demonstrates that Kerendia can effectively address a broad patient demographic characterized by a severe, historical lack of treatment options. Anchored by the findings of FIND-CKD alongside the broader clinical trial portfolio, the molecule has demonstrated its potential to solidify its position as an essential, foundational therapeutic axis for both diabetic and non-diabetic CKD management.Kerendia's renal-protective benefit was consistently demonstrated across diverse clinical etiologies and baseline sub-segments, and the safety profile confirmed excellent overall tolerability that aligned with investigator expectations. When these findings were officially unveiled at the international congress, the atmosphere among the attending delegates reflected a shared consensus that we were witnessing a milestone advancement in renal medicine. It was the moment the medical community collectively recognized that Kerendia could serve as a core cornerstone of long-term kidney disease management.Q. What direction should chronic kidney disease management take?Personally, I believe the management of kidney disease is systematically transitioning toward a strict "risk-based approach." Under this paradigm, when a patient presents with heavily elevated baseline proteinuria and is stratified into a high-risk category, clinicians must initiate intensive combination therapy as early as possible within the treatment algorithm.Data from the CONFIDENCE trial provide strong evidence for an upfront, simultaneous initiation strategy using both an SGLT2 inhibitor and Kerendia on top of a foundational RAS inhibitor. For patients identified as high risk, our clinical mandate should be to deploy the full complement of validated, disease-modifying therapeutics with the utmost clinical urgency.Q. How are real-world prescribing trends shifting, and how do you project the future of the CKM integrated framework?There has been a rapid escalation in the clinical adoption and real-world uptake of GLP-1 receptor agonists, SGLT2 inhibitors, and Kerendia. For example, in recent clinical trial settings, the baseline utilization rate of SGLT2 inhibitors has climbed to 50%-60%. Compared with the 10% to 15% adoption rate observed when we initiated the FIND-CKD trial in 2020, clinical penetration within controlled study environments has progressed at an impressive pace.There has been a rapid escalation in the clinical adoption and real-world uptake of GLP-1 receptor agonists, SGLT2 inhibitors, and Kerendia. For example, in recent clinical trial settings, the baseline utilization rate of SGLT2 inhibitors has climbed to 50%-60%. Compared with the 10% to 15% adoption rate observed when we initiated the FIND-CKD trial in 2020, clinical penetration within controlled study environments has progressed at an impressive pace.
