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- 2025-12-17 20:28:08
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- 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.”
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- 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."
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- Greenlight for launching KRAS inhibitors for lung cancer
- by Son, Hyung Min Sep 11, 2025 06:10am
- Next-generation KRAS inhibitors are emerging as a new game-changer in the lung cancer treatment market. While first-generation KRAS inhibitors, such as Amgen's Lumakras and BMS's Krazati, have been commercialized, concerns have risen regarding their limitations in terms of resistance and restricted indications. As a result, global pharmaceutical companies are now jumping into the competition with their next-generation pipelines. KRAS is a protein that plays a key role in cell growth, differentiation, and survival, and it induces tumor formation through various mutations. Although it is frequently found in non-small cell lung cancer (NSCLC) and colorectal cancer, existing drugs have failed to provide a clear therapeutic benefit to most patients, except for specific types of lung cancer patients. Consequently, the development of 2nd-generation KRAS inhibitors is rapidly emerging as a key project in global oncology research. Lilly's olomorasib in Phase 3 Trials...Combination with Keytruda·Chemotherapy Eli Lilly unveiled the clinical results of its 2nd-generation KRAS inhibitor, olomorasib, at the World Conference on Lung Cancer (WCLC 2025), held in Barcelona, Spain, from September 6-9 of this month. Olomorasib is classified as a next-generation KRAS inhibitor candidate as it shows anti-tumor activity even in patients with a history of treatment with existing KRAS G12C inhibitors. It was also designated as a 'Breakthrough Therapy' by the U.S. Food and Drug Administration (FDA) earlier this month. The clinical results presented at WCLC 2025 are based on data from the Phase 1 (LOXO-RAS-20001) and the early cohort of the Phase 3 (SUNRAY-01) studies. The studies were conducted in first-line NSCLC patients stratified by their PD-L1 expression level. The goal of the SUNRAY-01 study is to prove superiority in first-line NSCLC treatment with a PD-L1 expression level of 50% or more, by comparing olomorasib + Keytruda with placebo + Keytruda. According to Lilly, 85 patients received the olomorasib and Keytruda combination therapy, and 17% of them had already started Keytruda treatment for one cycle before enrollment. The clinical results showed an objective response rate (ORR) of 71%. Notably, the patient group with PD-L1 expression of 50% or more who received 100mg of olomorasib (26 patients) showed an 85% response rate. The median duration of response (DOR) has not yet been reached. The progression-free survival (PFS) rate was 77% at 6-month. In terms of safety, diarrhea (29%) and elevated liver enzyme levels (AST/ALT 25-26%) were reported as the most common adverse events. Grade 3 or higher adverse events were elevated ALT (18%), AST (14%), and diarrhea (7%). Most adverse events were manageable through dose reduction (29%) or steroid treatment. Treatment discontinuation occurred in 9% of patients, but an overall manageable safety profile was maintained. Olomorasib also yielded notable results in the Phase 1 combination trial with chemotherapy (LOXO-RAS-20001). A total of 78 patients received olomorasib + Keytruda + chemotherapy combination therapy, with PD-L1 expression distribution of 35% for less than 1%, 40% for 1-49%, and 22% for 50% or more. A high proportion of high-risk patients was included. The ORR in this patient group was 59%, and it was 64% in patients who received a high dose (100mg). The median DOR was 10.5 months, and PFS was 11.6 months, showing a significant therapeutic effect even when combined with chemotherapy. The safety profile overlapped with the characteristics of chemotherapy. Anemia (35%), nausea (37%), fatigue (32%), and diarrhea (30%) were the most commonly reported symptoms. Grade 3 or higher adverse events included anemia (14%), neutropenia (12%), and elevated liver enzymes (12%). These were also manageable through dose adjustments (15%) and treatment discontinuation (6%). Based on this data, Lilly is accelerating Phase 3 studies such as SUNRAY-02. SUNRAY-02 is evaluating olomorasib + Keytruda + chemotherapy in the entire PD-L1 patient population. The industry is paying attention to the possibility of Lilly positioning olomorasib as a first-line NSCLC treatment regardless of PD-L1 expression levels. There are high expectations that it could become a new option for patient groups with limited treatment opportunities due to resistance issues. MSD Also Developing Next-Generation KRAS G12C for NSCLC Treatment MSDMSD is also aiming to enter the KRAS inhibitor market by putting MK-1084 at the forefront. MK-1084 is currently in Phase 1/2 trials for solid tumors, including NSCLC and CRC. MSD's strategy is to combine it with Keytruda for lung cancer and with Erbitux for colorectal cancer. To address the issues of resistance and limited duration of treatment for KRAS inhibitor monotherapies, MSD's goal is to improve response rates and survival by synergizing with PD-1 inhibitors and targeted therapies. In the Phase 1 KANDLELIT-001 study, MK-1084 demonstrated positive anti-tumor activity in both colorectal cancer and NSCLC as a monotherapy and in combination therapies. In the colorectal cancer patient group, MK-1084 monotherapy showed an ORR of 38%, 46% when combined with cetuximab, and 38% when combined with cetuximab + chemotherapy (mFOLFOX6). Including unconfirmed responses during the follow-up period, the ORR reached as high as 66%. The results were even more pronounced in lung cancer patients. MK-1084 monotherapy had an ORR of 38%, but it achieved a high response rate of 77% when combined with Keytruda, and 53% when combined with Keytruda + chemotherapy. The safety was also reported to be manageable. Elevated liver enzyme levels and hematological abnormalities were the main side effects, but most were controlled through dose adjustments and adjuvant therapy. MSD is accelerating the commercialization of MK-1084 through subsequent Phase 3 studies, KANDLELIT-004 (lung cancer) and KANDLELIT-012 (colorectal cancer).
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- ‘HIV Is No Longer a Target of Discrimination'
- by Hwang, byoung woo Sep 11, 2025 06:09am
- While advances in antiretroviral drugs have made human immunodeficiency virus (HIV) a manageable chronic disease, experts point out that social awareness remains stagnant. Amid the reality that the suicide risk among infected individuals in Korea is nearly twice as high as among non-infected individuals, academia, patient groups, and industry have joined forces to end the discrimination. Medical professionals, HIV organizations, industry, and academia have united to end discrimination against people living with HIV, launching the ‘RED Period Consultative Body’ and holding a roundtable discussion on the 10th. Professor Beom-sik Chiin of the Infectious Disease Division at the National Medical Center The event featured speakers and panelists from various sectors who highlighted the persistent stigma and prejudice faced by people with HIV despite advances in treatment technology, emphasizing the need for improved awareness and policy support. The RED Period Campaign derives its name from the red ribbon symbolizing AIDS, embodying the meaning of putting an end to prejudice. Professor Beom-sik Chiin of the Infectious Disease Division at the National Medical Center, who presented at the event, emphasized the need for a fundamental shift in perception of the disease under the theme ‘Proposals for Ending Social Prejudice/Stigma in Line with Scientific Advances in the HIV Treatment Environment’. According to Professor Chin, advances in antiretroviral therapy (ART) mean that with early diagnosis and treatment, people living with HIV now have an average life expectancy similar to that of non-infected individuals. When medication suppresses viral activity to the point where HIV is undetectable in blood tests, the risk of transmission to others is also eliminated. This signifies that HIV is now a manageable and preventable chronic disease. However, social perceptions still lag behind scientific progress, hindering the quality of life for people living with HIV. An analysis of five-year mortality rates among individuals diagnosed with HIV in Korea in 2017 revealed that people living with HIV had a 1.84 times higher risk of death by suicide compared to those without HIV. Professor Chin stated, “Letting aside situations like being refused surgery in medical settings, people living with HIV still experience frustration due to HIV. I hope we can put an end to this by educating and promoting that safe medical care is possible if access to post-exposure prophylaxis is strengthened and implemented and promote the availability of financial support measures. He further noted, “Overcoming the deep-rooted stigma associated with the term ‘AIDS’ won't be easy. A starting point could be changing legal terminology, such as replacing ‘AIDS Prevention Act’ with alternative terms in public domains. This could minimize prejudice and stigma within institutional frameworks.” The findings of the ‘2025 National Survey on HIV Awareness,’ conducted by the LGBTQ+ rights organization Sinnaneun Center and Korea Research, were also released at the meeting. This survey, targeting 3,000 people nationwide, consisted of questions regarding ▲ awareness and understanding of HIV disease ▲ quantitative data on social misunderstandings and prejudice ▲ public perception of institutional support programs for HIV. The survey results showed that while 8 out of 10 people had heard of HIV, only 25% demonstrated sufficient awareness to distinguish between HIV and AIDS. Furthermore, only 13% of all respondents believed Korean society holds an open and inclusive attitude toward HIV, while 80% of respondents stated that improving HIV awareness in Korean society is necessary. Notably, 81% agreed on the need for active government policy support to reduce HIV infections. Professor Chin stated, “The most notable aspect of this survey is that members of our society themselves keenly recognize the lack of an open and inclusive attitude toward HIV.” He added, “I am confident that the survey results will serve as a crucial driving force for promoting activities to end prejudice and stigma surrounding HIV, alongside solid support for government policy support.” Following Professor Chin, Professor Jong-hyuk Lee of Kwangwoon University’s Department of Media & Communication introduced the campaign’s purpose and significance, emphasizing the need to build a healthier society by eradicating prejudice. The Red Period Campaign is not a one-off event but a long-term awareness project aimed at eliminating stigma around HIV. The council plans to lead continuous online and offline activities to engage broad sectors of society in collaboration. Finally, Dr. Tae-hyung Kim, Planning Director of the Korean Society for AIDS, said, “The Red Period campaign is a promise to end discrimination and stigma against people with HIV, and to build a society where everyone has equal access to treatment and prevention. HIV is no longer a target of stigma—it is a manageable chronic disease. We hope this message will reach both the public and the medical community, and that our efforts will contribute to Korea’s national goal of reducing new HIV infections by 50% by 2030.”
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- Could Spravato resolve treatment-resistant depression?
- by Hwang, byoung woo Sep 11, 2025 06:09am
- As Korea ranks first in suicide rates among OECD countries, the need for treatment support for ‘treatment-resistant depression’ is being emphasized. Experts stress the need for alternatives in treating treatment-resistant depression, a condition known to have a sevenfold higher risk of suicide attempts compared to general depression. On September 9, to mark World Suicide Prevention Day, Janssen Korea held a Masterclass to share the current state of TRD and the latest treatment insights. Professor Sung-jun Cho of Kangbuk Samsung Hospital’s Department of Psychiatry According to Statistics Korea's ‘2023 Cause of Death Statistics’, 13,978 people died by suicide in 2023. The suicide rate per 100,000 people in 2023 was 27.3, an 8.5% increase compared to 2022. This ranks Korea first among OECD countries in suicide rates, exceeding the OECD average by more than double. Depression is cited as one of the major factors for suicide. Psychological autopsy results from 1,099 suicide deaths over nine years from 2015 to 2023 (MOHW/Korea Foundation for Suicide Prevention, 2023 Psychological Autopsy Interview Results Report) estimated that 86.3% had suffered from mental illness prior to death, with 74.5% identified as having depressive disorder. Among those suspected of having a mental illness, 60.5% had received treatment or counseling for mental health issues before their death. Professor Sung-jun Cho of Kangbuk Samsung Hospital’s Department of Psychiatry noted, “In Korea, we can see that the prevalence of depression has surpassed the one million mark, which is significantly higher than in other countries. Because it is difficult to clearly define the presence or absence of depression, treatment is often challenging.” Major depressive disorder refers to a condition where persistent depressive mood and loss of interest lasting at least two weeks are accompanied by multiple physical symptoms and significant impairment of daily functioning. Among these patients, about 1 in 3 may have TRD, showing no response to various antidepressant treatments. TRD is generally defined as the ‘absence of a clinical response despite administration of at least two oral antidepressants at adequate doses for a sufficient duration.’ Professor Cho stated, “TRD patients incur over 40% more healthcare costs than patients with major depressive disorder. Not only is treatment difficult, but relapse rates are also higher compared to patients with major depressive disorder. Severe patients who struggle to maintain employment may experience a vicious cycle where their economic burden increases.” However, there is currently no universally standardized treatment for TRD. Treatment options for TRD include pharmacotherapy such as antidepressant optimization, switching or combination therapy, and augmentation therapy, as well as procedures like repetitive transcranial magnetic stimulation (rTMS) and electroconvulsive therapy (ECT). However, conventional pharmacotherapy takes time to achieve remission, making it difficult to expect an immediate response to suicidal impulses. Conventional depression treatments take approximately 37 to 51 days to achieve remission, making it easy to miss the golden window for treatment. Furthermore, the remission rate decreases sharply with each treatment failure. Amidst the growing need for rapid and effective treatments for TRD, attention is turning to the role Spravato (esketamine hydrochloride) could play in the field. It is the only drug approved in Korea for treatment-resistant depression. Unlike existing antidepressants targeting serotonin and norepinephrine, Spravato is a novel antidepressant acting on the NMDA receptor. Clinical studies have shown that Spravato produced clinically significant symptom improvement within 24 hours in TRD patients, achieving a 52.5% remission rate after 28 days of treatment. Furthermore, patients who maintained remission after 16 weeks of Spravato treatment saw a 51% reduction in relapse risk when treatment was continued. Professor Cho stated, “After about a month of Spravato treatment—once the induction phase was complete—more than half of the patients not only responded but reached remission. The rapid onset of effect, sometimes as early as the day after administration, is particularly notable.” However, Spravato is known to cost approximately KRW 400,000 per administration as it is not covered by reimbursement. Typically, two doses are administered per treatment session, costing about KRW 800,000 per visit. In the early stages, treatment is usually given twice per week, resulting in a weekly cost of about KRW 1.6 million. This high cost inevitably creates barriers to patient access. Current domestic suicide prevention policies for high-risk groups are limited to supporting treatment costs for injuries resulting from suicide attempts, counseling, and case management for attempters and bereaved families. Professor Cho argues that providing integrated healthcare services extending to practical treatments that can lead to long-term suicide prevention is necessary. Professor Cho stated, “In the clinical setting, there is talk that Spravato could realistically contribute to lowering suicide rates. However, there inevitably exists a cost barrier preventing its actual prescription.” He added, “We are beginning to see changes, such as the Jeonbuk Mental Health Welfare Center’s support program covering Spravato treatment costs for major depressive disorder patients. We need more initiatives like this to ensure continuous, active treatment.
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- Will Balversa make progress toward reimb in Korea this year?
- by Eo, Yun-Ho Sep 10, 2025 06:14am
- Attention is focused on whether progress will be made in the insurance reimbursement listing process for ‘Balversa,’ the first targeted therapy for bladder cancer. According to industry sources, Janssen Korea’s FGFR inhibitor for urothelial carcinoma, Balversa (erdafitinib), passed review by the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service (HIRA) this past May. Discussions are now underway for its submission as an agenda to the Drug Reimbursement Evaluation Committee later this year. The specific indication under review for reimbursement is ‘treatment of adult patients with unresectable locally advanced or metastatic urothelial carcinoma with FGFR3 genetic alterations, whose disease has progressed during or after at least one prior systemic therapy including a PD-1 or PD-L1 inhibitor.’ At the time of its original domestic approval in 2022, Balversa’s indication was,“Treatment of adult patients with locally advanced or metastatic urothelial carcinoma harboring FGFR2 or FGFR3 alterations, whose disease has progressed during or after at least one platinum-based chemotherapy, or within 12 months of receiving neoadjuvant or adjuvant chemotherapy, including platinum-based chemotherapy.” However, immune checkpoint inhibitors targeting PD-1 and PD-L1 have been approved for use in the first- and second-line settings since then, creating a need to demonstrate Balversa’s efficacy in patients pretreated with these agents. This unmet need was addressed by the publication of results of the Phase III THOR trial, which compared Balversa to chemotherapy in patients with FGFR3/2-altered metastatic urothelial carcinoma who had progressed following 1–2 lines of therapy, including immunotherapy. The study demonstrated an overall survival (OS) benefit with Balversa. According to the THOR trial results, during a median follow-up period of 15.9 months, the median overall survival (mOS) in the Balversa treatment group was 12.1 months, representing a 36% reduction in the risk of death compared to 7.8 months in the chemotherapy group. Based on these results, the U.S. FDA approved the conversion of Valbessa's designation to full marketing approval in January, with the approval conditions set under more limited terms than the initial approval. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) also recently recommended expanding Valbessa's indications. Janssen Korea has additionally submitted the THOR study results to the Ministry of Food and Drug Safety (MFDS) in Korea. These developments culminated in the positive opinion from the Cancer Disease Deliberation Committee in May. Whether Balversa will secure reimbursement within the year and become an accessible treatment option for Korean patients remains to be seen. Meanwhile, bladder cancer has been one representative cancer that has had no targeted therapy options available. Balversa became the first targeted anticancer drug for bladder cancer through its novel mechanism that inhibits FGFR (Fibroblast Growth Factor Receptor). FGFR is one of the biological signals involved in cancer cell growth and is associated with multiple cancer types. FGFR alterations are particularly common in bladder cancer, observed in approximately 20-30% of patients.
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- Samsung Biologics signs KRW 1.8T contract deal
- by Chon, Seung-Hyun Sep 10, 2025 06:13am
- Samsung Biologics announced on September 9 that it has signed a Contract Manufacturing Organization (CMO) agreement worth $1.294 billion (approximately KRW 1.800 trillion) with a U.S.-based pharmaceutical company Samsung BiologicsThis contract is the second-largest one in the company's history, following a deal worth approximately KRW 2 trillion with a European pharmaceutical company in January. The contract is set to run until December 31, 2029. The client and product name have not been disclosed due to confidentiality clauses. Samsung Biologics' cumulative contract value for this year has reached KRW 5.2435 trillion. In just eight months, the company has nearly matched its total contract value from last year (KRW 5.4035 trillion). Its total cumulative contract value since its founding has now exceeded $20 billion. Samsung Biologics said, "Even as business uncertainties for the entire bio-industry, such as a global economic slowdown and tariff impacts, continue to grow, our consecutive large-scale contracts once again prove our competitiveness and the market's trust in us." Samsung Biologics is expanding its production capacity to meet the increasing demand for biopharmaceuticals. Its fifth plant, a 180,000-liter production facility that integrates the best practices from plants 1-4, began full-scale operation in April. With this, Samsung Biologics has secured a total production capacity of 784,000 liters, making it the world's largest. Samsung Biologics has obtained a total of 382 manufacturing approvals from major global regulatory agencies in the U.S., Europe, and Japan. The company stated that the number of approvals continues to increase with its expanding production capacity, and its pass rate for regulatory audits remains among the highest in the industry. Samsung Biologics added, "We are continuously expanding our customer base by securing numerous new contracts across the globe this year, including in the U.S., Europe, and Asia, based on our core competitiveness of overwhelming production capacity, quality, and various track records."
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- Will 'Tibsovo' be listed for reimbursement in H2?
- by Eo, Yun-Ho Sep 10, 2025 06:13am
- Product photo of Tibsovo As 'Tibsovo' seeks insurance reimbursement for cholangiocarcinoma, a disease with limited treatment options, attention is being paid to whether it will achieve results in the second half of this year. According to industry sources, Servier's Tibsovo (ivosidenib) is currently under discussion for the review schedule for the Drug Reimbursement Evaluation Committee (DREC). Tibsovo is a targeted cancer drug for cholangiocarcinoma and acute myeloid leukemia (AML), and it has passed the Health Insurance Review & Assessment Service (HIRA)'s Cancer Disease Review Committee. This is the second attempt for Tibsovo to be listed for cholangiocarcinoma indication. Tibsovo's AML indication passed the Cancer Disease Review Committee in October of last year. Tibsovo's indication is specified as follows: If a patient tests positive for IDH1 mutation, Tibsovo can be used as a ▲Monotherapy in patients with locally advanced or metastatic AML who have had prior therapy ▲Combination therapy with 'azacitidine' in adult patients over 75 years with accompanying disease that cannot be treated with chemotherapy. Cholangiocarcinoma is a cancer with a poor prognosis. The five-year relative survival rate is only 28.9%. 65% of the patients with cholangiocarcinoma of the liver are found be non-operable when diagnosed. Tibsovo is the only targeted drug recommended as a Category 1, the highest grade, by the National Comprehensive Cancer Network (NCCN) for a second-line treatment for cholangiocarcinoma. According to ClarlDHy Phase 3 clinical trial, Tibsovo reduced the disease progression by 63% compared to a placebo and had a median progression-free survival (PFS) of 2.7 months (placebo 1.4 months). Also, patients treated with Tibsovo had a median overall survival (OS) of 10.3 months, which was longer over twice than 5.1 months of those treated with a placebo. Meanwhile, in the AGILE Phase 3 trial involving patients with AML, Tibsovo was demonstrated to improve event-free survival (EFS) when combined with azacitidine, and the overall survival (OS) was significantly improved. The patients treated with Tibsovo had a median OS of 24.0 months (placebo 7.9 months). In a long-term follow-up study, the median OS of Tibsovo combination therapy was 29.3 months, over 3.7-fold longer than that of placebo combination therapy. Professor Kyu-Pyo Kim of Asan Medical Center's Department of Oncology said, "Tibsovo is indicated to treat IDH1 mutation-positive cholangiocarcinoma and AML. The efficacy and safety of this drug were confirmed in clinical trials. Notably, considering that both studies have been designed to allow switching regimen, a significant improvement in OS indicates a very meaningful outcome." Professor Kim added, "Since a new targeted drug that is effective for cholangiocarcinoma and AML, diseases with limited treatment options, has emerged, it is expected to contribute to improving treatment outcomes and quality of life in patients with cholangiocarcinoma and AML in Korea."
- Company
- Early diagnosis and personalized therapy are key
- by Son, Hyung Min Sep 10, 2025 06:12am
- Hong-Ki Min, Division of Rheumatology, Konkuk University Medical Center “The treatment options for rheumatoid arthritis (RA) have become far more diverse than in the past. Contrary to the past when management focused primarily on alleviating symptoms, today, with early diagnosis and tailored treatment strategies, it is possible to maintain long-term remission. Patients can now continue their daily lives with fewer limitations, marking a major paradigm shift in their care.” This was the assessment shared by Professor Hong-Ki Min of Konkuk University Medical Center’s Division of Rheumatology in a recent interview with Dailypharm. Rheumatoid arthritis is a common autoimmune disease diagnosed in Korea, where the immune system attacks the joints, causing inflammation that often begins in small joints such as the wrists and fingers, and may progress to larger joints throughout the body, such as the knees and ankles. In its early stages, it is often mistaken for simple joint pain and neglected. However, missing the optimal treatment window can lead to joint deformity and loss of function, significantly restricting daily life. Furthermore, the risk of systemic complications like cardiovascular and pulmonary diseases increases, classifying it as a systemic disease beyond a simple joint disorder. The cornerstone of RA treatment is pharmacotherapy, including disease-modifying antirheumatic drugs (DMARDs) such as methotrexate (MTX). Professor Min explained, “During treatment, it is crucial to monitor not only inflammation suppression but also long-term side effects, infections, and the occurrence of cardiovascular disease. Depending on the patient’s needs, therapy may be switched to biologics or Janus kinase (JAK) inhibitors.” Currently, various treatment options for rheumatoid arthritis have emerged, including not only immunosuppressants but also biologics and JAK inhibitors. Notably, JAK inhibitors like Eisai’s Jyseleca and AbbVie’s Rinvoq have gained attention because they are oral therapies, offering an alternative to injections and significantly improving convenience. Professor Min stated, “JAK inhibitors are evaluated as being equivalent to biologics in terms of efficacy. They represent an important alternative for patients with significant aversion to injections.” “Cross-switching between JAK inhibitors now permitted... expanding treatment options” Previously, patients who switched from biologics to a JAK inhibitor and failed to respond had no choice but to return to biologics, as switching between different JAK inhibitors was not permitted under Korea’s reimbursement regulations. However, following advocacy by physicians and the Korean College of Rheumatology and patient requests, the government approved reimbursement for switching between JAK inhibitors as of December 2023. This has reduced the burden associated with switching between biologics to JAK inhibitors. Professor Min explained that while the expansion of treatment options enables personalized therapy, institutional limitations still exist. Under Korea's health insurance system, switching to a specific drug requires at least six months of use. Even if the effect is insufficient, maintaining the drug for that period is necessary before switching to another option. Professor Min stated, “The rheumatoid arthritis treatment environment has significantly improved compared to the past. New drugs with diverse mechanisms have emerged, and treatment strategies have become more specialized, leading to an increase in patients maintaining remission for extended periods.” He added, “This can be particularly challenging for patients who show resistance to multiple drugs. Some patients cannot revert to their previous medication even if the effect diminishes after switching, leaving physicians in a difficult position.” With treatment options becoming diversified and personalized care made possible, early diagnosis has become more important than ever. Because RA directly attacks the joints, failure to diagnose and treat early can lead to irreversible joint deformities and functional impairment. The Korean College of Rheumatology is running a nationwide campaign under the theme “Early Diagnosis, Specialist Care.” This goes beyond a simple recommendation for medical care and is an academic-level message aimed at preventing long-term complications and preserving patients' quality of life. Professor Min concluded, “RA patients who are not treated in time risk joint damage, deformity, and disability, which significantly reduce quality of life. But today, with more therapeutic options available, patients should not lose hope. With regular specialist care, patients can fully maintain their daily social activities.”
- Company
- Launch of K-new drugs in the Chinese market is accelerated
- by Chon, Seung-Hyun Sep 10, 2025 06:12am
- New drugs developed in Korea are successively entering the Chinese market. Based on their commercial success in the Korean market, new P-CAB (Potassium-Competitive Acid Blocker) drugs for gastroesophageal reflux disease are quickly entering the approximately KRW 3 trillion-worth Chinese market. Fexuclue has become the second P-CAB to enter the Chinese market after K-CAB. Zaqubo is also in the approval process. Improvement is expected in the massive pharmaceutical trade deficit with China, which has exceeded KRW 5 trillion over the past 10 years. Fexuclue Launches in the Chinese Market, following K-CAB...Zaqubo Also Enters Approval Process According to industry sources on September 8, Daewoong Pharmaceutical received product approval for Fexuclue 40mg from China's National Medical Products Administration (NMPA) on September 5. Fexuclue obtained approval in China for the treatment of gastroesophageal reflux disease. Daewoong Pharmaceutical applied for Fexuclue approval in China in June 2023, and obtained the product approval in two years. Fexuclue is a 'P-CAB' gastroesophageal reflux disease treatment developed by Daewoong Pharmaceutical. It was approved as the 34th domestically developed new drug in December 2021. Fexuclue is a new Korean drug that Daewoong Pharmaceutical successfully developed with proprietary technology over 13 years, starting in 2008. P-CAB anti-ulcer drugs work by competitively binding to the proton pump and potassium ions, which are located in the final stage of acid secretion in parietal cells, thereby inhibiting gastric acid secretion. P-CAB new drugs have proven their commercial value in Korea by proven advantages such as a faster onset of action and the ability to be taken regardless of meals, unlike conventional PPI (Proton Pump Inhibitor) class products. According to global market research firm IMS data, the size of China's anti-ulcer drug market is approximately KRW 3 trillion, making it the largest in the world. With its 1.4 billion population adopting more Westernized dietary habits, the number of gastroesophageal reflux disease patients is rapidly increasing, and treatment demand is expected to expand. Daewoong Pharmaceutical projected, "Fexuclue is expected to rapidly increase market share in the Chinese anti-ulcer drug market by improving upon the drawbacks of existing PPIs, such as slow onset of action, short half-life, and the need for pre-meal administration." Fexuclue is highly regarded for its long half-life, which enables sustained acid suppression and provides excellent relief for nocturnal heartburn. Among drugs in the same class, Fexuclue is the only one to have clinically proven its effect in 'alleviating chronic cough' caused by acid reflux. Daewoong Pharmaceutical has set the second half of 2026 as the goal for Fexuclue's launch. The company plans to deploy a full-scale market entry strategy that reflects the characteristics and demand of the local Chinese market. Park Seong-soo, CEO of Daewoong Pharmaceutical, said, "This Chinese product approval will be a very important turning point for Fexuclue's leap to becoming a global blockbuster drug." Park added, "We will strive to ensure that Fexuclue becomes the most trusted treatment option for patients and medical professionals in China, the world's largest anti-ulcer drug market." Fexuclue is the second Korea-developed new P-CAB drug to enter the Chinese market, following K-CAB. In April 2022, HK inno.N's K-CAB was approved in China for the treatment of erosive esophagitis. The local product name was decided as 'Taisinzan (泰欣赞),' meaning 'carrying great joy.' HK inno.N pursued K-CAB's overseas expansion in 2015 by signing a technology export agreement with Chinese pharmaceutical company Luoxin Group and passed the Chinese hurdle in seven years. The agreement with Luoxin Group includes a total of $18.5 million in milestone payments based on upfront payment, clinical development, approval, and commercialization stages. K-CAB has been approved for three indications in China: erosive esophagitis, duodenal ulcer, and Helicobacter pylori eradication therapy. Since January of this year, K-CAB's scope of reimbursement has been expanded with the addition of the duodenal ulcer indication to the China's National Reimbursement Drug List (NRDL). Product photo of K-CAB (left) and Zaqubo (right) Onconic Therapeutics, a subsidiary of Jeil Pharmaceutical, is also accelerating the entry of its new P-CAB drug, Zaqubo, into the Chinese market. In March 2023, Onconic Therapeutics signed a technology export agreement for Zaqubo with Chinese pharmaceutical company Livzon Pharmaceutical Group. The contract value is up to $127.5 million. Onconic Therapeutics received a non-refundable upfront payment of $15 million and is set to receive up to $112.5 million in technology fees based on development, approval, and commercialization milestones. Livzon Pharmaceutical Group began patient dosing for Zaqubo's Chinese Phase 3 clinical trial at the end of last year and successfully completed the trial last month, submitting a product approval application to the China's National Medical Products Administration. Expectations are high for the success of Korea-developed new P-CAB drugs in the Chinese market, building on their commercial success in the Korean market. In the Korean market, K-CAB's prescription sales surpassed KRW 100 billion in 2021, its third year since launch, and has recorded over KRW 100 billion in prescription sales for four consecutive years. In the first half of this year, its prescription sales increased by 14.0% year-on-year to KRW 104.7 billion, possibly leading to an annual prescription sales of KRW 200 billion. Fexuclue, launched in Korea in July 2022, recorded KRW 12.9 billion in prescription sales in its first year, and its sales soared over six times in two years, reaching KRW 78.8 billion last year. Its prescription amount in the first half of this year was KRW 43.2 billion, a 22.5% increase from the same period last year. Zaqubo, which entered the prescription market in earnest after receiving health insurance reimbursement in October of last year, recorded KRW 17.2 billion in outpatient prescription sales in the first half of this year. Last year's pharmaceutical trade deficit with China amounted to KRW 630B...Expectation for improving 'deficit of KRW 5T over 10 years' If Korea-developed new P-CAB drugs achieve commercial success in China, an improvement in the trade balance with China is also expected. The performance of Korean companies' pharmaceuticals in the Chinese market has been low. According to the Ministry of Food and Drug Safety, the value of pharmaceutical exports to China last year was $407.27 million, less than half of the import value of $865.61 million. Last year's pharmaceutical trade deficit with China amounted to $457.34 million (approximately KRW 630 billion). Pharmaceutical Exports and Imports to China (unit: $1,000, source: MFDS). Light Blue-Exports, Blue-Imports Over the past 10 years, from 2015 to last year, the total pharmaceutical trade deficit with China reached $3.66939 billion (approximately KRW 5.1 trillion). The pharmaceutical trade deficit with China expanded by $115.78 million over the past 10 years, from $341.56 million in 2014. During this period, pharmaceutical exports to China increased by $299.88 million, from $107.39 million to $407.27 million. However, imports increased by a significantly larger amount, $415.67 million, from $448.94 million to $864.61 million. This sluggish performance in exporting finished pharmaceutical products from Korea, coupled with the accelerated penetration of Chinese raw materials into the Korean market, is identified as a key factor in the worsening trade balance. Last year, the value of finished pharmaceutical product exports to China was $138.98 million. While this represents a 59.7% increase over 10 years from $87.01 million in 2014, it is a 45.8% decrease compared to the $256.44 million recorded in 2020. The slow progress of Korean companies in the Chinese market is pointed out as a reason for the worsening trade balance. In contrast, imports of Chinese active pharmaceutical ingredients (APIs) reached $816.32 million last year, a 110.2% jump from $388.31 million 10 years ago. Finished pharmaceutical product exports to China (unit: $1,000, source: MFDS) The continuous increase in imports from China is analyzed to be due to Korean pharmaceutical companies' preference for cheaper imported APIs for cost reduction. In 2014, China was the 6th largest country of origin for pharmaceutical imports, but it has now jumped to the 3rd position last year. In 2014, China was the second-largest country in terms of pharmaceutical exports, following Japan, but it fell to 9th place last year. An industry official said, "The continuous decrease in the cost structure of finished pharmaceutical products due to the government's sustained drug price reduction policy inevitably leads to a higher demand for cheaper imported APIs for cost reduction," and added, "If Korean companies' efforts into entering the Chinese finished pharmaceutical product market are initiated, an improvement in the trade balance can be expected."
