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- 2025-12-19 03:43:45
- Policy
- Reimbursement review is underway for 'Ozempic'
- by Lee, Tak-Sun Sep 15, 2025 06:02am
- Ozempic 'Ozempic (semaglutide, Novo Nordisk),' a diabetes treatment with the same active ingredient as the injectable Wegovy, has been reapplied for National Health Insurance reimbursement. Novo Nordisk submitted a reimbursement application for Ozempic to the Health Insurance Review & Assessment Service (HIRA) in the first half of this year, and the review is reportedly now underway. Ozempic is garnering attention regarding whether it will be successfully added to the reimbursement list this time, as its previous attempt in 2023 was halted just before it could be listed. According to industry sources on September 11, Novo Nordisk recently submitted supplementary documents related to Ozempic's reimbursement to HIRA. A review of Ozempic's reimbursement appropriateness is reportedly underway, and it is expected to be considered by the Drug Reimbursement Evaluation Committee (DREC) within the year. Ozempic had already passed the DREC in February 2023. At that time, the DREC recognized the appropriateness of sOzempic's reimbursement on the condition that the company accept a price below the evaluated amount, which the company agreed to. The Korean Diabetes Association and the Korean Endocrine Society had submitted their opinion to the PBEC, stating that it was appropriate for Ozempic, a long-acting GLP-1 receptor agonist, to have a reimbursement scope similar to that of Trulicity, which is in the same class and has also been the subject of a comparative clinical study. Subsequently, it entered drug price negotiation with the National Health Insurance Service (NHIS), but the reimbursement application was withdrawn due to the company's internal circumstances. Industry sources report that the company halted the reimbursement process at the time because the explosive demand for semaglutide products, such as Wegovy, in the global market made it difficult to supply the drug in Korea. The company's decision to re-pursue reimbursement this time is analyzed as being influenced by the full-scale entry of Mounjaro (tirzepatide, Lilly), Wegovy's competitor, into the Korean market. Mounjaro received domestic approval as an obesity treatment last September, and a reimbursement application for its diabetes indication was submitted in July. The Korean academic community also views the reimbursement of Ozempic and Mounjaro positively. This year's '2025 Diabetes Clinical Practice Guidelines' present both drugs as having a significant blood sugar-lowering effect. Currently, the only reimbursed product among drugs that bind to GLP-1 (Glucagon-like Peptide-1) receptors to lower blood sugar, like these two drugs, is Lilly's Trulicity (dulaglutide).
- Opinion
- [Reporter’s View] Real test begins for K-CDMOs
- by Son, Hyung Min Sep 15, 2025 06:01am
- In the midst of global supply chain restructuring, Korea’s CMO (Contract Manufacturing Organization) and CDMO (Contract Development and Manufacturing Organization) industries are emerging as new growth drivers for the biopharmaceutical sector. The shift away from China is acting as an opportunity factor, while independent achievements based on Korean firms’ technology and quality are also increasing. However, challenges such as potential overcompetition and global political and security risks still loom large. Samsung Biologics has been securing large-scale contracts since the beginning of this year. The company signed agreements worth more than USD 1 billion each with pharmaceutical firms in the U.S. and Europe. Its cumulative orders for the year have reached KRW 5.2435 trillion, nearly matching last year’s total of KRW 5.4035 trillion in just 8 months. Since its founding, the company’s cumulative orders have exceeded USD 20 billion. ST Pharm, though smaller in size, is also attracting attention with solid contracts. It secured a KRW 20.3 billion deal with a European pharmaceutical company for small-molecule APIs, and a KRW 18.3 billion supply contract with a U.S. biotech firm for oligonucleotide APIs. Its order backlog surged 76% from KRW 232 billion at the end of last year to KRW 407.9 billion as of date. Once considered a latecomer in RNA therapeutics manufacturing, ST Pharm has quickly increased its presence by signing consecutive deals with global companies. SK Pharmteco achieved a symbolic milestone in December last year with a KRW 2 trillion order for obesity drug APIs. At a time when global pharmaceutical firms are heavily investing in the development of GLP-1 class drugs, the fact that a Korean CDMO has actively joined this trend carries significance. At the same time, the company has also demonstrated diversification potential in cell and gene therapy (CGT), securing a contract with Switzerland’s Ferring Pharmaceuticals for a bladder cancer therapy. Smaller and mid-sized firms are also moving actively. ENcell signed a KRW 5.7 billion AAV gene therapy CDMO contract with the Korea Research Institute of Bioscience and Biotechnology in July, the largest single deal in the company’s history and equivalent to 80% of its annual revenue. Prestige Biologics landed a KRW 13.2 billion deal with an undisclosed pharma company, laying the groundwork for long-term CDMO operations. Medipost also entered the CDMO market in earnest with a KRW 2 billion deal for cell therapy manufacturing. However, viewing this trend solely as a ‘tailwind’ may raise issues. While it's true that global pharmaceutical companies are turning their attention to Korea, it also means the competitive arena has broadened and become more complex. Potential manufacturing bases like India and Eastern Europe are also rapidly expanding their scale. This is precisely why Korean CDMOs must differentiate themselves by emphasizing development capabilities and innovative technologies, moving beyond simple contract manufacturing. Moreover, the moment dependency increases, paradoxically, so does the risk. If revenue becomes concentrated on specific companies or products, the structure becomes entrenched, making it more vulnerable to external environmental changes. To avoid a ‘second China dependence’ incident, the contract portfolio needs to be diversified, and a mid-to-long-term investment roadmap supported. The surge in orders driven by the de-China effect is also sparking concerns of excessive competition among Korean companies. While the U.S. Biosecure Act may restrict Chinese firms, companies from Japan and Eastern Europe are also moving to capture opportunities in supply chain realignment. This makes it difficult to assume that Korea alone will enjoy a sustained boom. The recent contract wins are certainly encouraging signals. Yet, as the saying goes, true competitiveness lies not in winning contracts but in maintaining them. What is needed now is not celebration, but sober assessment.’ The boom Korean CDMOs are experiencing is only the beginning. The answer to whether they can lead the global market through ‘development’ and ‘innovation’ beyond mere ‘contract manufacturing’ will naturally emerge through the challenges ahead.
- Company
- MSD vs Medihelpline PMS contract dispute goes on trial
- by Eo, Yun-Ho Sep 12, 2025 06:19am
- A legal battle is looming between multinational pharmaceutical company MSD Korea and CRO firm Medihelpline over payment disputes related to a PMS outsourcing contract. According to Dailypharm coverage, MSD recently filed a lawsuit against Medihelpline, demanding the return of part of the advance payments made under a PMS outsourcing contract. However, the complaint was returned due to the recipient’s absence. Prior to this, Medihelpline had filed a “subcontract dispute mediation request” with the Subcontract Dispute Mediation Council of the Korea Trade Mediation Agency, claiming that MSD failed to pay approximately KRW 1.5 billion in subcontract fees. In other words, both sides are insisting that the other is responsible for the unsettled payments under the same outsourcing contract. PMS (Post-Market Surveillance) refers to the system of collecting data from 600 to 3,000 patients over four to six years after a new drug is launched, to report the usage results to the Ministry of Food and Drug Safety (MFDS). Medihelpline’s role under the contract was to visit medical institutions prescribing MSD’s drugs, collect PMS data, and prepare submission documents for the MFDS, in return for payment. Such outsourcing contracts are extremely common and are conducted countlessly in the pharmaceutical industry. The dispute can be summarized as follows: Between 2017 and 2022, the two companies entered into outsourcing contracts to conduct PMS for seven of MSD’s products, known collectively as the “MK Family.” Out of these, PMS services for 3 products were carried out smoothly. The problem arose with the remaining 4 products, where execution was insufficient. Among them were products that MSD had abandoned, and at the time, Medihelpline was also struggling with mass staff layoffs, making normal operations difficult. The conflict surfaced during the settlement process for this contract. According to the settlement data Medihelpline submitted in the first half of 2025, the work the company did for the 3 products exceeded the estimated amounts based on actual cases, meaning MSD owed an additional KRW 530 million. MSD accepted and agreed to this. The ‘estimated amount’ refers to the figure set at the time of the initial contract, since the exact number of actual cases cannot be predicted in advance due to the nature of PMS contracts. In other words, PMS projects inherently involve significant variability. However, for the four products where execution was lacking, the services naturally fell well short of the estimated amounts. MSD expressed its intent to settle payments based on the actual number of cases performed. Medihelpline rejected this, insisting that settlement should be based on the estimated figures stated in the original contract. Issue 1: Estimated amounts in the contract vs. the unique nature of PMS agreements The dispute centers on two key points: whether payments should be made for actual work performed or strictly according to the contract's estimated figures, and to what extent the contract allows for flexibility in dealing with the inherent variability of PMS projects. Medihelpline argued that this dispute represents “abuse of power over a subcontractor in a hierarchical relationship,” and stated, “If MSD simply pays according to the original contract, there would be no issue. We will fight this to the end.” Thus, the key issue becomes whether it is valid for a PMS outsourcing contract between a pharmaceutical company and a CRO to be settled based on the estimated figures written in the contract. MSD’s stance is “No.” According to the company, the core of PMS is tracking the outcomes of individual patients’ treatments, and outsourcing contracts are by definition based on the number of cases. The estimated figures in the contract are merely references to approximate the expected scale at the outset, written with the understanding that settlement would be based on actual cases. In fact, Medihelpline demanded an additional KRW 530 million beyond the estimated amounts specified in the contract for 3 successfully completed products, citing extra costs incurred from conducting sub-analyses of the collected data. Medihelpline also informed MSD in November 2023 that the advance payments it had already received exceeded the actual work performed by KRW 800 million KRWand requested suspension of further advance payments as well as offsetting against payments for other projects. Medihelpline sought extra payment for over-fulfilled work and requested suspension where less was done, implicitly acknowledging the contract's case-based nature. An MSD representative stated, “This is not the first time we’ve worked with Medihelpline on PMS outsourcing. In all past contracts, settlement has always been based on actual cases performed. The advance payments for the 4 projects clearly exceed the services delivered. We filed the refund claim lawsuit not merely to recover the advance, but to put an end to the CRO’s accusations and this settlement dispute through civil litigation.” In response, a Medihelpline representative responded, “The email sent to MSD in 2023 was sent unilaterally by an individual without management’s approval, at a time when the company was experiencing major internal changes, including mass resignations. There is a signed contract, and it is proper to honor it as written. MSD is exploiting a single mistake as a weakness.” Issue 2. Whether PMS contracts fall under the scope of the Subcontracting Act Another key issue is the Subcontracting Act. Medihelpline claims that MSD Korea’s failure to pay violates Articles 11 and 13 of the Subcontracting Act, and has filed a dispute mediation request with the Fair Trade Commission. The alleged violations are Article 11(2) of the Act, which states that “a principal contractor shall not reduce subcontract payments once agreed upon,” and Article 13, which requires that “when the principal entrusts manufacturing, the subcontract payment must be made within 60 days of receiving the deliverables, or within the shortest period possible.” The Subcontracting Act was established to correct unfair trade practices between large corporations and small or medium-sized enterprises, and to protect subcontractors as the economically weaker party. If Medihelpline’s claims are true and a global corporation like MSD abused its position to exploit a small domestic CRO, then such conduct deserves to be sanctioned. Thus, the issue lies in whether settlement based on actual cases performed in PMS contracts constitutes abuse of power, and whether such contracts fall within the scope of subcontracting arrangements. The law lists specific industries—such as engineering, transportation, construction, and security—as falling under subcontracting, while leaving other activities to be designated by the Fair Trade Commission. Therefore, the customary practices of PMS contracts between multinational pharmaceutical companies and domestic CROs, as well as precedents and the legitimacy of such arrangements, are likely to become key criteria in the court’s judgment. A Medihelpline representative stressed, “The company is facing severe financial difficulties due to MSD’s non-payment along with other factors, and we will confront MSD’s actions head-on beyond the mediation request. We are confident this is a clear violation of the Subcontracting Act.” An MSD representative lamented, “For over a year, we have made continuous efforts to pay costs in accordance with the proper contractual procedures. Nevertheless, Medihelpline has refused to cooperate in settling the service fees, instead making groundless accusations that damage our reputation and credibility. We regret this deeply.”
- Policy
- HIRA to disclose all off-label drug approval/disapprovals
- by Lee, Tak-Sun Sep 12, 2025 06:19am
- All approval decisions regarding off-label drugs will be disclosed on the official website from now on. Currently, only non-approved general drugs are listed publicly, but going forward, both approved and non-approved cases will be made available in order to reduce the administrative burden on medical institutions submitting applications. On the 10th, the Health Insurance Review and Assessment Service (HIRA) pre-announced a partial amendment to its regulations governing the approval of non-reimbursed off-label use of drugs beyond their authorized or reported indications, and will collect industry opinion until the 16th. Applications for non-reimbursed off-label drug use must first be reviewed by a hospital or academic society with an Institutional Review Board (IRB). Among these, general drugs are referred by HIRA to the Ministry of Food and Drug Safety (MFDS) for evaluation of safety and efficacy, while anticancer drugs are reviewed monthly by the Cancer Disease Deliberation Committee. The issue has been that for off-label general drugs, only non-approved cases were published on the website, making it difficult for medical institutions to prepare applications due to a lack of information. By contrast, for off-label cancer drugs, both approved and non-approved cases are disclosed, raising concerns over fairness when only non-approved cases were listed for general drugs. A HIRA official stated, “With the disclosure of both approvals and non-approvals for all off-label drugs, we expect that medical institutions will face less administrative burden when preparing applications.” Industry voices are also calling for the relaxation of current approval criteria. In particular, they argue that the IRB review requirement should be abolished and the clinical data requirements eased. One industry insider pointed out, “For infectious disease treatments like COVID-19, it is difficult to conduct clinical trials due to the nature of the disease. Yet, off-label non-reimbursed use requires clinical literature similar to that for general drugs. This is an unreasonable measure that fails to account for the urgent characteristics of infectious disease treatments.” HIRA has also shown willingness to improve the system, having commissioned an external research project last year on “Improvement Measures for the Use of Drugs and Medical Devices Beyond Approved Indications,” and hosting an international symposium on the issue on the 29th of last month. This regulatory amendment marks the first step toward system improvement,, with further reforms are expected to be discussed in the future.
- Company
- Anticipation for the survival-extending effects of Fruzaqla
- by Hwang, byoung woo Sep 12, 2025 06:18am
- A new option has emerged for fourth-line metastatic colorectal cancer (CRC) treatment. Previously, there were no more drugs available to use, increasing expectations in clinical practice. In Korea, the survival-extending effect of Fruzaqla (fruquintinib) is evaluated as a potential solution to the unmet needs of CRC patients. The number of patients with CRC is rapidly increasing, making it the number one cancer in Korea, excluding thyroid cancer. DailyPharm met with Professor Jin Won Kim of Seoul National University Bundang Hospital's Division of Hematology and Medical Oncology and Professor Dirk Arnold of Asklepios Tumorzentrum Hamburg's Division of Hematology and Oncology to discuss Fruzaqla's potential as a standard of care for fourth-line treatment. Young patients with colorectal cancer surging...20% still diagnosed at stage 4 Approximately 20% of colorectal cancer patients are first diagnosed at the metastatic Stage 4, and even half of those diagnosed with early localized disease develop distant metastasis during treatment. While the 5-year survival rate drops to about 20% when metastasis occurs, there were virtually no treatment options available after the third line, leading to high unmet needs for patients. Professor Jin Won Kim of Seoul National University Bundang HospitalCurrent standard treatments for metastatic colorectal cancer are mainly concentrated on first- and second-line treatments, primarily consisting of combinations of conventional chemotherapy and targeted therapies. In later lines, such as the third line and beyond, effective drugs are rare, and development is slow. Professor Arnold said, "In the typically-defined first- and second-line treatments, anti-VEGF or anti-EGFR monoclonal antibodies are used in combination with chemotherapy based on fluoropyrimidine, oxaliplatin, and irinotecan." He added, "In later lines, maintaining quality of life becomes the main goal. Third-line and later treatments require a balanced approach that simultaneously considers both prognosis improvement (life extension) and maintaining quality of life." According to Professor Kim, chemotherapy is the key treatment for Stage 4 colorectal cancer. If the diseases are concentrated in a localized area, such as a liver-only metastasis, surgery is attempted after chemotherapy to reduce tumor size, or surgery is performed immediately depending on the situation. Professor Kim said, "The pace of new drug development for colorectal cancer is very slow compared to other cancer types, and options remain limited, with treatments used 10 years ago still holding a major position," and added, "Colorectal cancer patients can survive for a little over two years with basic treatment alone, which makes it difficult to prove a 'definite improvement' over existing therapies, often leading to clinical trial failures." He pointed out that various pharmaceutical companies were reluctant to develop fourth-line treatments for colorectal cancer because profits are uncertain. As a result, the launch of new drugs has been slow compared to other cancer types, forcing patients to continue treatment with drugs that have been in use for over 10 years. Professor Kim also said, "The first and second-line treatments are well-covered by insurance in Korea. However, third-line and beyond have limited coverage, which significantly reduces treatment options." He added, "Because of this, treatment options decrease, and drug efficacy tends to diminish as the treatment line advances." VEGFR-targeting Fruzaqla effective after anti-VEGF treatment Takeda Pharmaceutical Korea's oral targeted anti-cancer drug, Fruzaqla, is expected to shed light on the fourth-line treatment landscape for metastatic colorectal cancer in Korea. Fruzaqla is a tyrosine kinase inhibitor (TKI) that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3, which are essential for tumor angiogenesis. Notably, this drug demonstrated effectiveness even in patients who have become resistant to prior anti-VEGF treatment. Professor Dirk Arnold of Asklepios Tumorzentrum HamburgProfessor Arnold said, "While bevacizumab (a conventional anti-VEGF antibody treatment) binds to VEGF somewhat non-specifically, Fruzaqla has a very high specificity and binding affinity for all known VEGF receptors. It has been reported to be effective even in patients who have failed prior anti-VEGF treatment." In other words, this drug maximizes drug exposure while minimizing toxicity by precisely targeting only the VEGF pathway and not attacking unnecessary targets. Professor Arnold explained that in real-world clinical settings, a survival-prolonging effect was confirmed with Fruzaqla administration even in a patient group that had already received various anti-VEGF drugs. The efficacy and safety of Fruzaqla were proven in the large-scale global Phase 3 FRESCO-2 study. This randomized controlled trial included 691 metastatic colorectal cancer patients who had received treatments such as trifluridine/tipiracil (TAS-102) or regorafenib after failing standard therapy. Professor Arnold said, "Even in some patients who had received both TAS-102 and regorafenib, Fruzaqla's effect was at a level almost identical to the original study." He added, "This is a very encouraging result that shows Fruzaqla provides patients with a consistent and robust therapeutic effect." Professor Kim also commented, "Fourth-line treatment refers to treatment administered after all existing treatments have been used. Considering this, Fruzaqla is noteworthy for showing a significant therapeutic effect in a patient group with no other alternatives." Non-reimbursed status·reimbursement listing present challenges...advantage of oral formulation gains attention Meanwhile, Fruzaqla as an oral formulation is considered a major advantage in terms of patient convenience. Professor Kim said, "Most colorectal cancer patients have no difficulty with oral intake, and oral drugs can be more effective and convenient for colorectal cancer patients compared to gastric cancer or other cancer types." In Korea, Fruzaqla was officially launched in June after receiving approval from the MFDS in March, but it has not yet been approved for insurance reimbursement. Currently, drugs for third-line and later stages of colorectal cancer are not covered by insurance due to concerns about their cost-effectiveness relative to efficacy, resulting in a high burden on patients. Professor Kim emphasized, "While there are a few drugs that can be used for third-line and later treatments for colorectal cancer, none of them are covered by insurance," and added, "If a new drug comes out and helps patients, we believe it should definitely be covered by insurance." However, since the requirement for a health-economic evaluation for reimbursement listing is high, it appears that Fruzaqla will also need to undergo subsequent procedures to be included in the reimbursement list, just like other non-reimbursed drugs. Finally, the experts shared the opinion that it is most important not to give up on treatment for metastatic colorectal cancer. Professor Kim said, "Colorectal cancer is not a disease that can be completely resolved at once. Continuously pursuing treatment and using every drug available is key to prolonging a patient's survival," and added, "It is important not to give up even during difficult times in the treatment process and to continue with it."
- 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.”
