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- 2025-12-20 08:35:05
- Policy
- MOHW will reform system for certifying innovative companies
- by Lee, Jeong-Hwan Sep 12, 2025 06:18am
- The Ministry of Health and Welfare (MOHW) plans to announce a legislative notice in October for reforms to the Korea Innovative Pharmaceutical Company certification system, aiming to implement the changes in January next year. The reform plan includes converting the certification system into a point-based structure and establishing separate certification criteria for multinational pharmaceutical companies. Regarding whether to abolish the current penalty clause—which bars companies whose certification has been canceled from reapplying for three years—the MOHW responded that it is “under review.” An MOHW official explained so during a meeting with the MOHW press corp on the 10th. The delay in announcing and implementing the reform plan that was originally scheduled earlier, appears to have been influenced in part by the change of administration and the launch of the new government. At the core of the reforms is a shift from the current system—where certification is immediately revoked if illegal practices such as pharmaceutical rebates are uncovered—to a point-based system. The ministry aims to enforce the anti-rebate rule while moving to a flexible, point-based certification system. The MOHW official stated, “The reform plan for Korea Innovative Pharmaceutical Company Certification includes converting to a point-based system covering acts such as illegal rebates, and establishing separate certification criteria for domestic versus multinational pharmaceutical companies. We are aiming to publish the legislative notice in October and implement it in January next year.” The official added, “We are still reviewing whether to lift the rule that prevents companies whose certification was canceled due to illegal rebates from reapplying for certification for three years.”
- Policy
- Improvement to the post-marketing management for pharma
- by Lee, Tak-Sun Sep 11, 2025 06:11am
- A comprehensive discussion regarding the post-marketing management program of pharmaceuticals, including actual transaction price-based drug price reduction and re-evaluation of pharmaceutical reimbursement, is anticipated once research results become available at the end of this year. Improvement plans to the actual transaction price-based drug price reduction and re-evaluation of pharmaceutical reimbursement programs have already been discussed with the pharmaceutical industry. However, with the release of the 'Research on a Unified Mechanism for Post-marketing Drug Price Management,' commissioned by the Ministry of Health and Welfare, scheduled for the end of this year, the policy is to conduct a comprehensive discussion based on results. On September 9, the Ministry of Health and Welfare officially announced the detailed operational guidelines for adjusting the ceiling price based on its actual transaction price survey, which is conducted once every two years. The survey will target 19,588 drugs and inspect 104,275 medical institutions from July 1 of last year to June 30 of this year. However, as before, public and national hospitals will be excluded from the survey. Additionally, low-priced drugs, discontinuation-prevention drugs, narcotics, orphan drugs, radiopharmaceuticals, artificial perfusion solutions, and oxygen·nitrous oxide are excluded. Oxygen and nitrous oxide were added to the list of excluded items this time. Discussions on improving the actual transaction price reduction program began late last year. Based on the 'Research on Improving the Actual Transaction Price-Based Drug Price Reduction System' (led by Professor Kim Jinhyun of Seoul National University), which was commissioned by the Health Insurance Review & Assessment Service, a consultative body was formed with the pharmaceutical industry to gather opinions until the first half of this year. The consultative body discussed issues such as abolishing the 10% price reduction cap and including public and national hospitals in the survey. The proposal to include public and national hospitals in the survey is a matter that the pharmaceutical industry strongly opposes, as drug dumping is a structural problem in public hospital bidding, where drugs are often awarded for as low as KRW 1. Although the process of gathering opinions from the pharmaceutical industry has been completed, the actual transaction price survey will proceed as before, excluding public and national hospitals. Only oxygen and nitrous oxide were included in the list of excluded items. An industry official said, "We understand that the improvement plan for the actual transaction price-based drug price reduction program will be discussed as part of a discussion with other post-marketing management programs after the unified post-market mechanism research is released at the end of the year." He added, "At that time, the issue of including public and national hospitals may be re-discussed." The improvement plan for the re-evaluation of drug reimbursement appropriateness is also scheduled for re-discussion after the unified post-market management research. The plan was discussed at a subcommittee meeting of the Health Insurance Policy Deliberation Committee last month, but it was not included on the review agenda for the main session. The details of the re-evaluation improvement plan are to change the selection criteria from the existing average claim amount of 0.1% or more over three years (approx. KRW 20 billion) to KRW 10 billion or more, and to expand the condition for not being listed in other countries from fewer than two A8 countries to fewer than three countries. Notably, seven ingredients, including ginkgo leaf extract, were selected for next year, which is the first year of the second re-evaluation phase under the comprehensive health insurance plan. However, with the discussion delayed, the progress of the re-evaluation next year itself is now uncertain. An industry official said, "If the confirmation of the re-evaluation targets is delayed, it may be difficult to proceed next year, considering the time needed to prepare materials like textbooks," and added, "It will be necessary to wait and see how the discussion proceeds after the post-marketing unified mechanism research is released at the end of the year."
- Policy
- Generic dispensing, collusion ban pass legislative committee
- by Lee, Jeong-Hwan Sep 11, 2025 06:11am
- On September 10, the National Assembly’s Legislation and Judiciary Committee passed two amendments to the Pharmaceutical Affairs Act. One expands the post-notification method for generic substitution at pharmacies to include information systems operated by the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service; the other expands the scope of essential medicines and elevates the legal basis for operating the Stable Supply Council from presidential decree to law. The National Assembly's Legislation and Judiciary Committee has also passed an amendment to the National Health Insurance Act, which allows for the reduction of drug prices or the suspension of reimbursement for unfairly traded drugs when reverse payment agreements are detected. These agreements involve originator and generic drug companies colluding to delay the launch of generics, thereby avoiding price reductions for the original drug. Once these bills are passed in the plenary session, they will complete the necessary legislative process and take effect on the enforcement date stipulated in the addenda following government promulgation. Bill to simplify the post-notification of generic substitution notifications#eB (Partial Amendment to the Pharmaceutical Affairs Act) establishes a new Article 27-2 (Establishment and Operation of a Substitution Information System) in the Pharmacuetical Affairs Act, enabling the MOHW to establish and operate an information system to support post-substitution notification. Specifically, the bill allows the Minister of Health and Welfare to delegate this task to the Health Insurance Review and Assessment Service (HIRA), with the necessary details to be stipulated by MOHW ordinance. The bill retains the existing obligation that when a pharmacist substitutes a drug listed on a prescription with an item recognized by the Ministry of Food and Drug Safety as having bioequivalence, the pharmacist must inform the patient of this fact and notify the prescribing physician or dentist within one day (or three days if unavoidable circumstances exist). National Essential Medicines definition expansion bill(Partial Amendment to the Pharmaceutical Affairs Act) allows medicines without substitutes or facing supply instability to be designated as National Essential Medicines. The basis for the composition and operation of the National Essential Medicines Stable Supply Council, previously established by Presidential Decree, has been elevated to the Pharmaceutical Affairs Act. The chairmanship of the council was revised: instead of appointing a single Vice Minister of MFDS as chair, it now requires adding one ‘senior public official designated by the Minister of Health and Welfare of the MOHW’. Generic drug collusion prohibition bill (Partial Amendment to the National Health Insurance Act) mandates that if the Fair Trade Commission detects collusive reverse payment agreements between originator and generic drug companies, the prices of the unfairly traded drugs must be reduced or their reimbursement suspended. Specifically, it stipulates that cases violating Article 40(1) or Article 45(1) of the Monopoly Regulation and Fair Trade Act, where the violation was committed “for the purpose of increasing or maintaining the upper limit of drug reimbursement costs,” the insurance drug price can be reduced or reimbursement suspended. When a reverse payment agreement violation is first detected, drug prices can be reduced by up to 20%. If another reverse payment agreement is detected within five years of the price reduction, drug prices can be reduced by up to 40%. If another illegal reverse payment agreement is detected within five years after the second price reduction, drug reimbursement can be suspended for up to one year.
- Company
- 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).
- Company
- ‘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.”
- Company
- 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.
- Company
- 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.
- Company
- 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."
- Company
- 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."
- Policy
- DREC members’ term extended due to delayed nominations
- by Lee, Tak-Sun Sep 10, 2025 06:13am
- The term of office for members of the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA), which is responsible for the final drug reimbursement adequacy evaluations, has been extended. Although their term was originally scheduled to end on the 7th, the extension was explained as due to delays in the candidate recommendation process for the next committee members. According to HIRA, the terms of both the 9th DREC and its subcommittee members have been extended. The 9th committee began its term on September 8, 2023, and was set to end on September 7, 2025. Each term lasts two years, and the current committee has 75 members in total. Accordingly, HIRA has been accepting nominations for candidates for the 10th-term DREC from various organizations since last month. DREC members are appointed based on recommendations from academic societies and organizations, with medical and pharmaceutical-related professional societies recommending around 70 members. The Korean Pharmaceutical Association can recommend one expert. However, due to delays in candidate recommendations, the composition of the 10th DREC could not be completed before the expiration of the 9th DREC's term. Consequently, the terms of the 9th DREC members have been extended. DREC’s operating regulations also stipulate that members whose terms have expired shall continue to perform their duties until their successors are appointed. HIRA explained that it plans to promptly finalize the recommendation process and complete the composition of the 10th committee. It maintains that there will be no changes to the DREC's schedule. The next DREC meeting is scheduled for October 2nd, which is likely to be attended by the existing 9th committee members. Once the 10th committee is formed, its subcommittees—including those for reimbursement standards, pharmacoeconomic evaluation, risk-sharing agreement, budget impact assessment, herbal medicines, and post-listing evaluation—will also be reconstituted. The DREC generally consists of around 105 members. The 31 medical societies eligible to recommend candidates include the Korean Society of Cardiology, Korean Society of Gastroenterology, Korean Academy of Tuberculosis and Respiratory Diseases, Korean Endocrine Society, Korean Pediatric Society, Korean Neurological Association, Korean Neuropsychiatric Association, Korean Surgical Society, Korean Cancer Association, Korean Academy of Family Medicine, Korean Dermatological Association, Korean Urological Association, Korean Ophthalmological Society, Korean Society of Otorhinolaryngology – Head and Neck Surgery, Korean Association for the Study of the Liver, Korean Diabetes Association, Korean Society of Nuclear Medicine, Korean Society of Infectious Diseases, Korean College of Rheumatology, Korean Society for Transplantation, Korean Society of Hematology, Korean Association for Lung Cancer, Korean Breast Cancer Society, Korean Gastric Cancer Association, Korean Society of Gynecologic Oncology, Korean Society of Pediatric Hematology-Oncology, Korean Urological Oncology Society, Korean Orthopedic Association, Korean Society of Coloproctology, Korean Society of Medical Oncology, and Korean Society of Surgical Oncology. At each monthly meeting, 20 committee members are randomly selected to participate. In July, HIRA revised its regulations, granting the HIRA President the authority to appoint the committee chairperson and to determine the composition of subcommittees and appoint subcommittee chairs. HIRA explained this as a measure to enhance the effectiveness of the DREC's composition and operation. However, some in the industry have expressed concerns that this could undermine the committee's fairness and neutrality.
