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- 2025-12-20 03:13:58
- Company
- Sanofi-MTPK sign exclusive sales agreement for Aubagio
- by Son, Hyung Min Sep 16, 2025 06:09am
- (From left), MI Youn Lee, Head of EP & Portfolio at Sanofi Korea and Australia/New Zealand; Won Kyu Lee, CEO of Mitsubishi Tanabe Pharma Korea) Mitsubishi Tanabe Pharma Korea (CEO Wonkyu Lee, MTPK) announced that it has entered into an exclusive domestic promotion and distribution agreement with the global biopharmaceutical company Sanofi Korea (General Manager Kyung Eun Bae), for the multiple sclerosis (MS) treatment Aubagio. The agreement officially took effect on September 1, 2025. Both companies aim to ensure stable product supply and patient-focused service through close collaboration. Through this partnership, MTPK has secured exclusive sales rights for Aubagio in Korea and will be responsible for local sales and marketing activities. Sanofi will continue to handle product importation, supply, regulatory affairs, and overall product management. Aubagio has demonstrated efficacy in reducing relapses and slowing disease progression in patients with relapsing multiple sclerosis. It is a once-daily oral therapy, offering convenience that is being used widely both in Korea and abroad. MI Youn Lee, Head of EP & Portfolio at Sanofi Korea and Australia/New Zealand, stated, “With this agreement, we expect that more Korean MS patients will gain stable access to the therapeutic benefits of Aubagio. Sanofi will continue to strive to build a sustainable treatment environment that allows patients to maintain better treatment and improve their quality of life.” Won Kyu Lee, CEO of MTBK also said, “Drawing on our extensive experience in the field of neurological diseases, we will do our utmost to ensure Aubagio reaches Korean MS patients more effectively. In line with our corporate philosophy, we will continue to enhance corporate value through the introduction of innovative new drugs and contribute to patients and society through ongoing activities.”
- Policy
- "Gov't actively supports the development of new drugs"
- by Lee, Jeong-Hwan Sep 16, 2025 06:08am
- Ministry of Health and Welfare (MOHW) The Ministry of Health and Welfare (MOHW) explained that its establishment of a first-ever 'Phase 3 Specialized Fund' as one of its budget projects for next year is the result of government's commitment to creating innovative new drugs in Korea. The MOHW also announced that it would first design a specific business model for the 'Loan System for New Drugs Based on Success' by next year through a research project, and then begin selecting pharmaceutical and bio companies to receive benefits from 2027. A MOHW official, in a recent meeting with the Korea Special Press Association, explained, "The establishment of a specialized fund by the government to support pharmaceutical companies with the will and capability to develop new drugs in Phase 3 is the first of its kind, and it holds significant meaning." The MOHW has allocated KRW 60 billion in new costs for the establishment of the Phase 3 specialized fund next year. The goal is to establish a total fund of KRW 150 billion by combining the MOHW's contribution and investment from a fund of funds. This fund will then be used to select and support pharmaceutical and bio companies that have innovative new drug and Bio-Better pipelines and the intention to pursue Phase 3 clinical trials. Once the fund is established, the MOHW will not be directly involved in the selection of pharmaceutical companies or new drug candidates, entrusting that responsibility to investment firms. The MOHW also allocated KRW 500 million for a research service budget to design a Korea model for the 'Loan System for New Drugs Based on Success.' Given that it is rare to invest such a large amount, such as millions of KRW, into a research budget, it demonstrates a strong will to design a proper loan model for Korea. The Loan System is a policy that exempts or partially reduces the loan repayment responsibility for pharmaceutical companies that receive government investment and support for new drug development, even if the new drug ultimately fails to be created. If next year's budget is approved by the National Assembly, the MOHW plans to do its utmost to ensure that domestically developed new drug and bio companies can receive tangible benefits. A MOHW official said, "The Phase 3 specialized fund requires consultation with policy banks and other institutions. It's difficult to proceed with just government contributions, so we need to raise external investment." He stressed that, "While a KRW 150 billion fund may not be large when you consider the costs required for Phase 3, the fact that this is the first time the government is establishing a specialized fund to provide customized support for Phase 3 clinical trials is what makes it meaningful." The official added, "This is a demonstration of the government's strong will to discover new drugs." He continued, "The fact that this is the first time we are providing such support is impressive, and if the project is successful, we can increase its size, which makes it a crucial budget." And added, "For the Loan System, we will only be conducting research next year. We've allocated KRW 500 million, which is a significant amount for a research budget." He added, "We will design a specific implementation plan and a practical loan model for new drugs. After completing the research next year, we plan to reflect the actual project support budget in the 2027 budget plan." Finally, He said, "The Loan System requires collecting many opinions from the pharmaceutical and biotech industry during the research process," and added, "We need to discuss details, including pharmaceutical companies willing to support, the number of new drugs, and the criteria for success. We decided that we need such a system to encourage challenging investments in new drug development, which has a high probability of failure, and the Ministry of Economy and Finance agreed to include it in the budget plan."
- Company
- Active treatment needed for childhood·adolescent obesity
- by Eo, Yun-Ho Sep 15, 2025 06:03am
- With interest in obesity management becoming higher than ever with the introduction of Mounjaro and Wegovy, attention is also gathering to neglected areas. In particular, the rising prevalence of childhood obesity and the limited treatment options have raised the need for improved treatment environments. Globally, obesity has become the most common nutritional disorder among children, leading to physical problems such as growth hormone deficiency, precocious puberty, and polycystic ovary syndrome, as well as psychosocial issues including low self-esteem, depression, and anxiety. Since children and adolescents are continuously growing in height and weight, obesity is diagnosed using body mass index (BMI) percentiles based on sex and age. According to the Korean Society for the Study of Obesity’s Clinical Practice Guidelines (2022, 8th edition), children aged two years and older should be assessed using the 2017 growth chart: BMI at or above the 85th percentile is considered overweight, and at or above the 95th percentile is considered obese. ◆Childhood and adolescent obesity is on a continuous rise...Korea is also at risk The problem is the sharp increase in the childhood and adolescent obesity population. According to a pooled analysis by the World Health Organization (WHO) and Imperial College London, the number of obese children and adolescents has increased by more than tenfold over the past 40 years. By analyzing BMI and obesity prevalence trends from height and weight measurements in populations aged 5 and older across 200 countries between 1975 and 2016, the prevalence of childhood obesity rose from less than 1% in 1975 to 6% among girls and 8% among boys in 2016. This indicates a steady global rise in both the number and proportion of children affected by obesity, with particularly sharp increases in regions such as the Middle East and North Africa, South Asia, East Asia, and high-income English-speaking countries. Prevalence of Pediatric and Adolescent Obesity in Korea In line with global trends, obesity prevalence among Korean children and adolescents has also been on the rise. According to the “2021 National Health Statistics” published by the Korea Disease Control and Prevention Agency, obesity prevalence among boys aged 6–18 increased to 19.5% in the 8th survey period from 11.1% in the 5th (a 1.76-fold increase), while among girls it rose to 12.7% from 9.2%, which is a 1.38-fold increase. Also, a sample survey of elementary, middle, and high school students released by the Ministry of Education in April showed that 29.3% of students fell into the overweight or obese category last year—which is roughly one in three. ◆Academic community aligns with clinical guidelines...recommends drug therapy Given this situation, clinical guidelines for childhood and adolescent obesity are also evolving. Notably, the necessity for more direct treatment approaches, including previously conservative drug therapy, is increasingly being raised. According to the guidelines released on January 9, 2023, by the American Academy of Pediatrics (AAP) for the evaluation and treatment of childhood obesity, pharmacological therapy is recommended for children aged two and older, and surgical interventions are permitted from age 13 onward—emphasizing active intervention from the early stages of diagnosis. The recommended medications include Saxenda (liraglutide), Wegovy (semaglutide), Xenical (orlistat), and Qsymia (phentermine/topiramate). This has sparked debate by overturning the tendency to prioritize traditional dietary and behavioral therapies in children and adolescents, but it also underscores the urgent need for obesity management in severely obese children and adolescents. Korea has also recognized the need for pharmacotherapy. In 2022, the Korean Society for the Study of Obesity recommended considering drug therapy under the supervision of experienced specialists if intensive diet, exercise, and behavioral therapy fail to control ongoing weight gain and obesity-related comorbidities in children Furthermore, the first guidelines on childhood obesity that was published in Asia, which was in 2019, covered the ▲definition and diagnosis of overweight and obesity in children, ▲treatment principles of pediatric obesity, ▲behavioral therapy (including diet, exercise, lifestyle, and mental health), ▲pharmacological treatment, and ▲surgical treatment. For each area, they established recommendations and their respective levels of evidence (Level A–D). Professor Hye-Woon Jung of Kyung Hee University Hospital’s Department of Pediatrics said, “Lifestyle intervention is important for severely obese children and adolescents, but it may not be enough. In such cases, active pharmacological treatment should be considered. Although some medications are approved for severe pediatric obesity, treatment options remain limited in Korea.”
- Policy
- Jardaince patent expires Oct 23…over 400 generics expected
- by Lee, Tak-Sun Sep 15, 2025 06:02am
- Product photo of Jardiance As the substance patent for Jardiance (empagliflozin, Boehringer), an SGLT2 inhibitor for the treatment of diabetes, is expiring next month (October 23), over 400 generic drugs are expected to be introduced to the market. Notably, domestic pharmaceutical companies in Korea have developed empagliflozin + metformin extended-release tablets and are launching the first type of combination therapies, such as empagliflozin + sitagliptin. They are expected to revitalize the sales market. According to industry sources on September 14, Korean pharmaceutical companies announced the launch of Jardiance generic drugs next month and began pre-marketing. Along with Forxiga, which was withdrawn from the Korean market, Jardiance is among the top two SGLT inhibitors for the treatment of diabetes. Based on last year's UBSIT, outpatient prescription sales for Jardiance monotherapy amounted to KRW 66.3 billion and for Jardiance Duo (empagliflozin + metformin) recorded KRW 41.8 billion, accounting for a market exceeding KRW 100 billion. Esgliteo, a combination of empagliflozin and linagliptin, also recorded KRW 12.1 billion and became a blockbuster drug. Domestic pharmaceutical companies that seized the opportunity for the Forxiga patent expiration in April 2023 are also entering the Jardiance market, which is a KRW 100 billion market, with their generic drugs. A total of 412 empagliflozin monotherapy and combination products have been approved so far. Pharmaceutical companies like Hanmi Pharmaceutical and Daewon Pharmaceutical are expected to receive higher prices by entering the generic drug market with their independently developed data-submission drugs. Several generic products were developed before the implementation of the joint bioequivalence test regulation, which meant they could not meet the self-developed bioequivalence test conditions. Among the generic monotherapies, only Dongkoo Bio & Pharma and Huons have met the requirements. Consequently, Dongkoo Bio & Pharma, which contract-manufactures generic drugs for over 20 pharmaceutical companies, is expected to receive the highest price among generics due to the innovative pharmaceutical company premium. With this premium, a cost of KRW 396 for the 10mg dose and KRW 518 for the 25mg dose is set, which corresponds to a 68% markup of the highest-priced drug. Among the generic drugs for the empagliflozin + metformin combination, there is also an extended-release film-coated tablet formulation that is taken once daily. The original product does not have an extended-release formulation. Additionally, Chong Kun Dang and Daewon Pharmaceutical have developed combination therapies that combine empagliflozin with the DPP-4 inhibitor sitagliptin, which they will be the first to introduce to the Korean market. An unprecedented level of competition is expected due to the entry of these generic drugs, which circumvented the joint bioequivalence test regulation. In addition, there are also drugs from pharmaceutical companies like Hanmi Pharmaceutical and Daewon Pharmaceutical, which have developed their products using in-house technology and new extended-release formulations. Related to this, a fierce competition is anticipated to create new prescriptions, with pharmaceutical companies pursuing independent sales and numerous CSOs joining in, offering high commission rates. In response, Boehringer Ingelheim, which holds the original Jardiance that recently succeeded in obtaining expanded reimbursement to cover chronic kidney disease, is expected to defend its existing accounts while also actively expanding into new ones for a year, during which it will be granted a 70% premium on the highest price. Jardiance is co-promoted in Korea with Yuhan Corporation.
- Company
- NIP inclusion of Beyfortus sparks discussion
- by Hwang, byoung woo Sep 15, 2025 06:02am
- The results of a study on the cost-effectiveness of Sanofi’s RSV preventive antibody injection for infants, Beyfortus (nirsevimab), have been published, sparking debate around including Beyfortus in Korea’s National Immunization Program (NIP). Pic of BeyfortusA research team led by Professor Hae-Sun Suh from Kyung Hee University College of Pharmacy recently published Beyfortus’s cost-effectiveness when introducing it to Korea. This study is the first in Korea to analyze the cost-effectiveness of Beyfortus and was published in the international journal ‘Human Vaccines & Immunotherapeutics’. The study compared two strategies: administering Beyfortus to all infants under 12 months and to high-risk children under 24 months, versus the current strategy of administering a preventive antibody injection (palivizumab) only to high-risk infants. Using claims data from the Health Insurance Review and Assessment Service (HIRA), the team conducted a cost-utility analysis (CUA) from a societal perspective. This included outpatient and inpatient treatment, management of complications, caregiver productivity loss, and socioeconomic costs from premature death. Results showed that using the Beyfortus strategy on all infants under 1 year of age and high-risk groups under 2 years of age reduces unnecessary medical costs associated with RSV infection and alleviates the burden of productivity loss for caregivers. In particular, it was confirmed that over 90% of the overall health improvement effect originated from the group of full-term infants under one year of age, supporting the validity of a universal RSV prevention strategy for all infants. Furthermore, the incremental cost-effectiveness ratio (ICER) for introducing the Beyfortus prevention strategy compared to the existing strategy was USD 33,071 per QALY (approximately KRW 43 million per QALY), demonstrating its cost-effectiveness. QALY, the cost-effectiveness indicator used in this study, is a health outcome measure that reflects health-related quality of life by applying a weight. It quantifies ‘how long and how healthily one can live’ through treatment and prevention. Although a cost-effectiveness threshold is not explicitly defined in Korea, analysis using commonly accepted standards—ranging from approximately USD 35,000 (per capita GDP) to USD 50,000 (1.5 times per capita GDP)—showed this study demonstrated cost-effectiveness within that range. Professor Suh said, “This study confirmed that a prevention strategy utilizing Beyfortus is not only effective for preventing RSV in infants and young children in Korea, but also provides a valid basis for its inclusion in a nationwide universal vaccination program. We hope these results will serve as key policy data for the future introduction of Beyfortus into the National Immunization Program, thereby contributing to protecting infant and young child health and reducing the social burden.” Beyfortus demonstrates cost-effectiveness …Will it synergize with the revised legislation? The published research on Beyfortus is expected to bolster future discussions regarding the National Immunization Program (NIP). Given the NIP's inherent goal of maximizing the vaccination effect through universal immunization, cost-effectiveness remains a critical consideration alongside efficacy. This aspect is included in the ‘Bill for the Partial Amendment to the Infectious Disease Prevention and Management Act’ proposed by Representative Yong-ki Jeon of the Democratic Party of Korea last August, which addresses RSV's inclusion in the NIP. While the legislative intent stated that it aims to contribute to public health improvement through infectious disease prevention by mandating essential vaccinations for acute respiratory infections, the inclusion of provisions regarding the submission of cost estimation requests implies that future submission of vaccine cost-effectiveness evaluation data is a prerequisite. Particularly, it is analyzed that the fact that the Korea Disease Control and Prevention Agency (KDCA) has not established clear guidelines for the preventive antibody Beyfortus within the NIP program, which has primarily focused on vaccines, could positively influence its potential inclusion in the universal vaccination program. Hee-kyung Park, Head of Sanofi’s Vaccine Division, said, “While 90% of infants under 2 years old are infected with RSV, there are no available treatments for RSV, making prevention crucial. Hospitalizations due to infant RSV infection place a significant burden on parents and families raising children. Therefore, establishing an effective prevention strategy accessible to all infants is paramount.” Park added, “Sanofi will continue to protect infant health and reduce the medical and economic burdens faced by families and society through innovative preventive solutions.”
- Policy
- Reimbursement review is underway for 'Ozempic'
- by Lee, Tak-Sun Sep 15, 2025 06:02am
- Ozempic 'Ozempic (semaglutide, Novo Nordisk),' a diabetes treatment with the same active ingredient as the injectable Wegovy, has been reapplied for National Health Insurance reimbursement. Novo Nordisk submitted a reimbursement application for Ozempic to the Health Insurance Review & Assessment Service (HIRA) in the first half of this year, and the review is reportedly now underway. Ozempic is garnering attention regarding whether it will be successfully added to the reimbursement list this time, as its previous attempt in 2023 was halted just before it could be listed. According to industry sources on September 11, Novo Nordisk recently submitted supplementary documents related to Ozempic's reimbursement to HIRA. A review of Ozempic's reimbursement appropriateness is reportedly underway, and it is expected to be considered by the Drug Reimbursement Evaluation Committee (DREC) within the year. Ozempic had already passed the DREC in February 2023. At that time, the DREC recognized the appropriateness of sOzempic's reimbursement on the condition that the company accept a price below the evaluated amount, which the company agreed to. The Korean Diabetes Association and the Korean Endocrine Society had submitted their opinion to the PBEC, stating that it was appropriate for Ozempic, a long-acting GLP-1 receptor agonist, to have a reimbursement scope similar to that of Trulicity, which is in the same class and has also been the subject of a comparative clinical study. Subsequently, it entered drug price negotiation with the National Health Insurance Service (NHIS), but the reimbursement application was withdrawn due to the company's internal circumstances. Industry sources report that the company halted the reimbursement process at the time because the explosive demand for semaglutide products, such as Wegovy, in the global market made it difficult to supply the drug in Korea. The company's decision to re-pursue reimbursement this time is analyzed as being influenced by the full-scale entry of Mounjaro (tirzepatide, Lilly), Wegovy's competitor, into the Korean market. Mounjaro received domestic approval as an obesity treatment last September, and a reimbursement application for its diabetes indication was submitted in July. The Korean academic community also views the reimbursement of Ozempic and Mounjaro positively. This year's '2025 Diabetes Clinical Practice Guidelines' present both drugs as having a significant blood sugar-lowering effect. Currently, the only reimbursed product among drugs that bind to GLP-1 (Glucagon-like Peptide-1) receptors to lower blood sugar, like these two drugs, is Lilly's Trulicity (dulaglutide).
- Opinion
- [Reporter’s View] Real test begins for K-CDMOs
- by Son, Hyung Min Sep 15, 2025 06:01am
- In the midst of global supply chain restructuring, Korea’s CMO (Contract Manufacturing Organization) and CDMO (Contract Development and Manufacturing Organization) industries are emerging as new growth drivers for the biopharmaceutical sector. The shift away from China is acting as an opportunity factor, while independent achievements based on Korean firms’ technology and quality are also increasing. However, challenges such as potential overcompetition and global political and security risks still loom large. Samsung Biologics has been securing large-scale contracts since the beginning of this year. The company signed agreements worth more than USD 1 billion each with pharmaceutical firms in the U.S. and Europe. Its cumulative orders for the year have reached KRW 5.2435 trillion, nearly matching last year’s total of KRW 5.4035 trillion in just 8 months. Since its founding, the company’s cumulative orders have exceeded USD 20 billion. ST Pharm, though smaller in size, is also attracting attention with solid contracts. It secured a KRW 20.3 billion deal with a European pharmaceutical company for small-molecule APIs, and a KRW 18.3 billion supply contract with a U.S. biotech firm for oligonucleotide APIs. Its order backlog surged 76% from KRW 232 billion at the end of last year to KRW 407.9 billion as of date. Once considered a latecomer in RNA therapeutics manufacturing, ST Pharm has quickly increased its presence by signing consecutive deals with global companies. SK Pharmteco achieved a symbolic milestone in December last year with a KRW 2 trillion order for obesity drug APIs. At a time when global pharmaceutical firms are heavily investing in the development of GLP-1 class drugs, the fact that a Korean CDMO has actively joined this trend carries significance. At the same time, the company has also demonstrated diversification potential in cell and gene therapy (CGT), securing a contract with Switzerland’s Ferring Pharmaceuticals for a bladder cancer therapy. Smaller and mid-sized firms are also moving actively. ENcell signed a KRW 5.7 billion AAV gene therapy CDMO contract with the Korea Research Institute of Bioscience and Biotechnology in July, the largest single deal in the company’s history and equivalent to 80% of its annual revenue. Prestige Biologics landed a KRW 13.2 billion deal with an undisclosed pharma company, laying the groundwork for long-term CDMO operations. Medipost also entered the CDMO market in earnest with a KRW 2 billion deal for cell therapy manufacturing. However, viewing this trend solely as a ‘tailwind’ may raise issues. While it's true that global pharmaceutical companies are turning their attention to Korea, it also means the competitive arena has broadened and become more complex. Potential manufacturing bases like India and Eastern Europe are also rapidly expanding their scale. This is precisely why Korean CDMOs must differentiate themselves by emphasizing development capabilities and innovative technologies, moving beyond simple contract manufacturing. Moreover, the moment dependency increases, paradoxically, so does the risk. If revenue becomes concentrated on specific companies or products, the structure becomes entrenched, making it more vulnerable to external environmental changes. To avoid a ‘second China dependence’ incident, the contract portfolio needs to be diversified, and a mid-to-long-term investment roadmap supported. The surge in orders driven by the de-China effect is also sparking concerns of excessive competition among Korean companies. While the U.S. Biosecure Act may restrict Chinese firms, companies from Japan and Eastern Europe are also moving to capture opportunities in supply chain realignment. This makes it difficult to assume that Korea alone will enjoy a sustained boom. The recent contract wins are certainly encouraging signals. Yet, as the saying goes, true competitiveness lies not in winning contracts but in maintaining them. What is needed now is not celebration, but sober assessment.’ The boom Korean CDMOs are experiencing is only the beginning. The answer to whether they can lead the global market through ‘development’ and ‘innovation’ beyond mere ‘contract manufacturing’ will naturally emerge through the challenges ahead.
- Company
- MSD vs Medihelpline PMS contract dispute goes on trial
- by Eo, Yun-Ho Sep 12, 2025 06:19am
- A legal battle is looming between multinational pharmaceutical company MSD Korea and CRO firm Medihelpline over payment disputes related to a PMS outsourcing contract. According to Dailypharm coverage, MSD recently filed a lawsuit against Medihelpline, demanding the return of part of the advance payments made under a PMS outsourcing contract. However, the complaint was returned due to the recipient’s absence. Prior to this, Medihelpline had filed a “subcontract dispute mediation request” with the Subcontract Dispute Mediation Council of the Korea Trade Mediation Agency, claiming that MSD failed to pay approximately KRW 1.5 billion in subcontract fees. In other words, both sides are insisting that the other is responsible for the unsettled payments under the same outsourcing contract. PMS (Post-Market Surveillance) refers to the system of collecting data from 600 to 3,000 patients over four to six years after a new drug is launched, to report the usage results to the Ministry of Food and Drug Safety (MFDS). Medihelpline’s role under the contract was to visit medical institutions prescribing MSD’s drugs, collect PMS data, and prepare submission documents for the MFDS, in return for payment. Such outsourcing contracts are extremely common and are conducted countlessly in the pharmaceutical industry. The dispute can be summarized as follows: Between 2017 and 2022, the two companies entered into outsourcing contracts to conduct PMS for seven of MSD’s products, known collectively as the “MK Family.” Out of these, PMS services for 3 products were carried out smoothly. The problem arose with the remaining 4 products, where execution was insufficient. Among them were products that MSD had abandoned, and at the time, Medihelpline was also struggling with mass staff layoffs, making normal operations difficult. The conflict surfaced during the settlement process for this contract. According to the settlement data Medihelpline submitted in the first half of 2025, the work the company did for the 3 products exceeded the estimated amounts based on actual cases, meaning MSD owed an additional KRW 530 million. MSD accepted and agreed to this. The ‘estimated amount’ refers to the figure set at the time of the initial contract, since the exact number of actual cases cannot be predicted in advance due to the nature of PMS contracts. In other words, PMS projects inherently involve significant variability. However, for the four products where execution was lacking, the services naturally fell well short of the estimated amounts. MSD expressed its intent to settle payments based on the actual number of cases performed. Medihelpline rejected this, insisting that settlement should be based on the estimated figures stated in the original contract. Issue 1: Estimated amounts in the contract vs. the unique nature of PMS agreements The dispute centers on two key points: whether payments should be made for actual work performed or strictly according to the contract's estimated figures, and to what extent the contract allows for flexibility in dealing with the inherent variability of PMS projects. Medihelpline argued that this dispute represents “abuse of power over a subcontractor in a hierarchical relationship,” and stated, “If MSD simply pays according to the original contract, there would be no issue. We will fight this to the end.” Thus, the key issue becomes whether it is valid for a PMS outsourcing contract between a pharmaceutical company and a CRO to be settled based on the estimated figures written in the contract. MSD’s stance is “No.” According to the company, the core of PMS is tracking the outcomes of individual patients’ treatments, and outsourcing contracts are by definition based on the number of cases. The estimated figures in the contract are merely references to approximate the expected scale at the outset, written with the understanding that settlement would be based on actual cases. In fact, Medihelpline demanded an additional KRW 530 million beyond the estimated amounts specified in the contract for 3 successfully completed products, citing extra costs incurred from conducting sub-analyses of the collected data. Medihelpline also informed MSD in November 2023 that the advance payments it had already received exceeded the actual work performed by KRW 800 million KRWand requested suspension of further advance payments as well as offsetting against payments for other projects. Medihelpline sought extra payment for over-fulfilled work and requested suspension where less was done, implicitly acknowledging the contract's case-based nature. An MSD representative stated, “This is not the first time we’ve worked with Medihelpline on PMS outsourcing. In all past contracts, settlement has always been based on actual cases performed. The advance payments for the 4 projects clearly exceed the services delivered. We filed the refund claim lawsuit not merely to recover the advance, but to put an end to the CRO’s accusations and this settlement dispute through civil litigation.” In response, a Medihelpline representative responded, “The email sent to MSD in 2023 was sent unilaterally by an individual without management’s approval, at a time when the company was experiencing major internal changes, including mass resignations. There is a signed contract, and it is proper to honor it as written. MSD is exploiting a single mistake as a weakness.” Issue 2. Whether PMS contracts fall under the scope of the Subcontracting Act Another key issue is the Subcontracting Act. Medihelpline claims that MSD Korea’s failure to pay violates Articles 11 and 13 of the Subcontracting Act, and has filed a dispute mediation request with the Fair Trade Commission. The alleged violations are Article 11(2) of the Act, which states that “a principal contractor shall not reduce subcontract payments once agreed upon,” and Article 13, which requires that “when the principal entrusts manufacturing, the subcontract payment must be made within 60 days of receiving the deliverables, or within the shortest period possible.” The Subcontracting Act was established to correct unfair trade practices between large corporations and small or medium-sized enterprises, and to protect subcontractors as the economically weaker party. If Medihelpline’s claims are true and a global corporation like MSD abused its position to exploit a small domestic CRO, then such conduct deserves to be sanctioned. Thus, the issue lies in whether settlement based on actual cases performed in PMS contracts constitutes abuse of power, and whether such contracts fall within the scope of subcontracting arrangements. The law lists specific industries—such as engineering, transportation, construction, and security—as falling under subcontracting, while leaving other activities to be designated by the Fair Trade Commission. Therefore, the customary practices of PMS contracts between multinational pharmaceutical companies and domestic CROs, as well as precedents and the legitimacy of such arrangements, are likely to become key criteria in the court’s judgment. A Medihelpline representative stressed, “The company is facing severe financial difficulties due to MSD’s non-payment along with other factors, and we will confront MSD’s actions head-on beyond the mediation request. We are confident this is a clear violation of the Subcontracting Act.” An MSD representative lamented, “For over a year, we have made continuous efforts to pay costs in accordance with the proper contractual procedures. Nevertheless, Medihelpline has refused to cooperate in settling the service fees, instead making groundless accusations that damage our reputation and credibility. We regret this deeply.”
- Policy
- HIRA to disclose all off-label drug approval/disapprovals
- by Lee, Tak-Sun Sep 12, 2025 06:19am
- All approval decisions regarding off-label drugs will be disclosed on the official website from now on. Currently, only non-approved general drugs are listed publicly, but going forward, both approved and non-approved cases will be made available in order to reduce the administrative burden on medical institutions submitting applications. On the 10th, the Health Insurance Review and Assessment Service (HIRA) pre-announced a partial amendment to its regulations governing the approval of non-reimbursed off-label use of drugs beyond their authorized or reported indications, and will collect industry opinion until the 16th. Applications for non-reimbursed off-label drug use must first be reviewed by a hospital or academic society with an Institutional Review Board (IRB). Among these, general drugs are referred by HIRA to the Ministry of Food and Drug Safety (MFDS) for evaluation of safety and efficacy, while anticancer drugs are reviewed monthly by the Cancer Disease Deliberation Committee. The issue has been that for off-label general drugs, only non-approved cases were published on the website, making it difficult for medical institutions to prepare applications due to a lack of information. By contrast, for off-label cancer drugs, both approved and non-approved cases are disclosed, raising concerns over fairness when only non-approved cases were listed for general drugs. A HIRA official stated, “With the disclosure of both approvals and non-approvals for all off-label drugs, we expect that medical institutions will face less administrative burden when preparing applications.” Industry voices are also calling for the relaxation of current approval criteria. In particular, they argue that the IRB review requirement should be abolished and the clinical data requirements eased. One industry insider pointed out, “For infectious disease treatments like COVID-19, it is difficult to conduct clinical trials due to the nature of the disease. Yet, off-label non-reimbursed use requires clinical literature similar to that for general drugs. This is an unreasonable measure that fails to account for the urgent characteristics of infectious disease treatments.” HIRA has also shown willingness to improve the system, having commissioned an external research project last year on “Improvement Measures for the Use of Drugs and Medical Devices Beyond Approved Indications,” and hosting an international symposium on the issue on the 29th of last month. This regulatory amendment marks the first step toward system improvement,, with further reforms are expected to be discussed in the future.
- Company
- Anticipation for the survival-extending effects of Fruzaqla
- by Hwang, byoung woo Sep 12, 2025 06:18am
- A new option has emerged for fourth-line metastatic colorectal cancer (CRC) treatment. Previously, there were no more drugs available to use, increasing expectations in clinical practice. In Korea, the survival-extending effect of Fruzaqla (fruquintinib) is evaluated as a potential solution to the unmet needs of CRC patients. The number of patients with CRC is rapidly increasing, making it the number one cancer in Korea, excluding thyroid cancer. DailyPharm met with Professor Jin Won Kim of Seoul National University Bundang Hospital's Division of Hematology and Medical Oncology and Professor Dirk Arnold of Asklepios Tumorzentrum Hamburg's Division of Hematology and Oncology to discuss Fruzaqla's potential as a standard of care for fourth-line treatment. Young patients with colorectal cancer surging...20% still diagnosed at stage 4 Approximately 20% of colorectal cancer patients are first diagnosed at the metastatic Stage 4, and even half of those diagnosed with early localized disease develop distant metastasis during treatment. While the 5-year survival rate drops to about 20% when metastasis occurs, there were virtually no treatment options available after the third line, leading to high unmet needs for patients. Professor Jin Won Kim of Seoul National University Bundang HospitalCurrent standard treatments for metastatic colorectal cancer are mainly concentrated on first- and second-line treatments, primarily consisting of combinations of conventional chemotherapy and targeted therapies. In later lines, such as the third line and beyond, effective drugs are rare, and development is slow. Professor Arnold said, "In the typically-defined first- and second-line treatments, anti-VEGF or anti-EGFR monoclonal antibodies are used in combination with chemotherapy based on fluoropyrimidine, oxaliplatin, and irinotecan." He added, "In later lines, maintaining quality of life becomes the main goal. Third-line and later treatments require a balanced approach that simultaneously considers both prognosis improvement (life extension) and maintaining quality of life." According to Professor Kim, chemotherapy is the key treatment for Stage 4 colorectal cancer. If the diseases are concentrated in a localized area, such as a liver-only metastasis, surgery is attempted after chemotherapy to reduce tumor size, or surgery is performed immediately depending on the situation. Professor Kim said, "The pace of new drug development for colorectal cancer is very slow compared to other cancer types, and options remain limited, with treatments used 10 years ago still holding a major position," and added, "Colorectal cancer patients can survive for a little over two years with basic treatment alone, which makes it difficult to prove a 'definite improvement' over existing therapies, often leading to clinical trial failures." He pointed out that various pharmaceutical companies were reluctant to develop fourth-line treatments for colorectal cancer because profits are uncertain. As a result, the launch of new drugs has been slow compared to other cancer types, forcing patients to continue treatment with drugs that have been in use for over 10 years. Professor Kim also said, "The first and second-line treatments are well-covered by insurance in Korea. However, third-line and beyond have limited coverage, which significantly reduces treatment options." He added, "Because of this, treatment options decrease, and drug efficacy tends to diminish as the treatment line advances." VEGFR-targeting Fruzaqla effective after anti-VEGF treatment Takeda Pharmaceutical Korea's oral targeted anti-cancer drug, Fruzaqla, is expected to shed light on the fourth-line treatment landscape for metastatic colorectal cancer in Korea. Fruzaqla is a tyrosine kinase inhibitor (TKI) that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3, which are essential for tumor angiogenesis. Notably, this drug demonstrated effectiveness even in patients who have become resistant to prior anti-VEGF treatment. Professor Dirk Arnold of Asklepios Tumorzentrum HamburgProfessor Arnold said, "While bevacizumab (a conventional anti-VEGF antibody treatment) binds to VEGF somewhat non-specifically, Fruzaqla has a very high specificity and binding affinity for all known VEGF receptors. It has been reported to be effective even in patients who have failed prior anti-VEGF treatment." In other words, this drug maximizes drug exposure while minimizing toxicity by precisely targeting only the VEGF pathway and not attacking unnecessary targets. Professor Arnold explained that in real-world clinical settings, a survival-prolonging effect was confirmed with Fruzaqla administration even in a patient group that had already received various anti-VEGF drugs. The efficacy and safety of Fruzaqla were proven in the large-scale global Phase 3 FRESCO-2 study. This randomized controlled trial included 691 metastatic colorectal cancer patients who had received treatments such as trifluridine/tipiracil (TAS-102) or regorafenib after failing standard therapy. Professor Arnold said, "Even in some patients who had received both TAS-102 and regorafenib, Fruzaqla's effect was at a level almost identical to the original study." He added, "This is a very encouraging result that shows Fruzaqla provides patients with a consistent and robust therapeutic effect." Professor Kim also commented, "Fourth-line treatment refers to treatment administered after all existing treatments have been used. Considering this, Fruzaqla is noteworthy for showing a significant therapeutic effect in a patient group with no other alternatives." Non-reimbursed status·reimbursement listing present challenges...advantage of oral formulation gains attention Meanwhile, Fruzaqla as an oral formulation is considered a major advantage in terms of patient convenience. Professor Kim said, "Most colorectal cancer patients have no difficulty with oral intake, and oral drugs can be more effective and convenient for colorectal cancer patients compared to gastric cancer or other cancer types." In Korea, Fruzaqla was officially launched in June after receiving approval from the MFDS in March, but it has not yet been approved for insurance reimbursement. Currently, drugs for third-line and later stages of colorectal cancer are not covered by insurance due to concerns about their cost-effectiveness relative to efficacy, resulting in a high burden on patients. Professor Kim emphasized, "While there are a few drugs that can be used for third-line and later treatments for colorectal cancer, none of them are covered by insurance," and added, "If a new drug comes out and helps patients, we believe it should definitely be covered by insurance." However, since the requirement for a health-economic evaluation for reimbursement listing is high, it appears that Fruzaqla will also need to undergo subsequent procedures to be included in the reimbursement list, just like other non-reimbursed drugs. Finally, the experts shared the opinion that it is most important not to give up on treatment for metastatic colorectal cancer. Professor Kim said, "Colorectal cancer is not a disease that can be completely resolved at once. Continuously pursuing treatment and using every drug available is key to prolonging a patient's survival," and added, "It is important not to give up even during difficult times in the treatment process and to continue with it."
