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- 2025-12-19 21:01:11
- Policy
- Six strengths of obesity drug Mounjaro Quick Pen approved
- by Lee, Hye-Kyung Sep 08, 2025 06:16am
- Following its launch in Korea, Eli Lilly has expanded the product lineup of its obesity treatment Mounjaro (tirzepatide) by receiving approval for the Mounjaro QuickPen formulation. On September 5, the Ministry of Food and Drug Safety approved 6 QuickPen doses: 2.5 mg/0.6 ml, 5 mg/0.6 ml, 7.5 mg/0.6 ml, 10 mg/0.6 ml, 12.5 mg/0.6 ml, and 15 mg/0.6 ml. Mounjaro is a once-weekly injectable single molecule that selectively binds to and activates both the GIP and GLP-1 receptors. Treatment is initiated at 2.5 mg (step 1) and increased in increments after at least four weeks. Unlike Saxenda and Wegovy, which are only available as single-pen formulations, Mounjaro is offered in multiple formulations — beginning with pre-filled syringes, now QuickPens, and vials in the pipeline. In the case of the pre-filled formulation, one pen contains one dose, requiring four pens per month. In the case of the Quickpen that was approved this time, one pen now contains four doses, covering an entire month, similar to Saxenda and Wegovy. The vial formulation, which is pending approval, is administered via syringe and needle. While this is less convenient, it is expected to be more affordable. Meanwhile, Mounjaro has faced nationwide shortages within just three weeks of launch, particularly for the starter 2.5 mg dose. Lilly Korea is also pursuing reimbursement for its diabetes indication. In Korea, Mounjaro is approved for glood glucose control in adults with type 2 diabetes (monotherapy or combination therapy); chronic weight management in adults with obesity or overweight with at least one weight-related comorbidity; and adjunctive therapy to diet and exercise for obesity with moderate-to-severe obstructive sleep apnea in adults.
- Opinion
- [Reporter's View] Approval-to-reimbursement takes only 6 mth
- by Lee, Hye-Kyung Sep 08, 2025 06:15am
- The Ministry of Food and Drug Safety (MFDS) has been operating the 'Global Innovative products on Fast Track (GIFT)' since 2022. GIFT is a 'Program Supporting the Expedited Review of Global Innovative Products' launched by the MFDS, aiming to quickly launch medicines for life-threatening diseases, such as cancer, and rare diseases, as well as those demonstrating innovativeness. It is intended to deliver these medicines to patients quickly. According to the MFDS, 55 items have been designated as GIFT over the past three years. Significant achievements have been made; for example, 39 items among these were approved. Notably, GIFT-designated products, which are treatments for severe and rare diseases, are a good fit for the 'concurrent approval-evaluation-negotiation pilot program' led by the Ministry of Health and Welfare since 2023 and are generating synergistic effects. The 'concurrent approval-evaluation-negotiation pilot program' is a system that supports expedited National Health Insurance listing by conducting MFDS product approval, Health Insurance Review & Assessment Service (HIRA) reimbursement evaluation, and National Health Insurance Service (NHIS) drug price negotiation in parallel. Previously, the process from approval to reimbursement took over 300 days: 120 days for MFDS approval, 150 days for HIRA evaluation, and 60 days for NHIS negotiation. This pilot program has shown that such procedure was cut by about half. Candidates for the pilot program must meet specific criteria, such as treatments for cancer or rare diseases with a life expectancy of less than one year, a small patient population, the absence of alternative treatments, and demonstrated superior efficacy with over two years of survival. As such, GIFT-designated products are the optimal candidates. All five products selected for the pilot program so far have been GIFT products: Recordati Korea's Qarziba (dinutuximab beta), Ipsen Korea's Bylvay (Odevixibat), Curocell's LimKato (anbasel), UCB's Fintepla (fenfluramine), and MSD's Winrevair (sotatercept). Currently, Qarziba, Bylvay, and Winrevair have received expedited approval. Qarziba, in particular, was reimbursed from December 1, 2024, completing the process from approval to drug pricing in just six months. In terms of results, both the GIFT program and the 'concurrent approval-evaluation-negotiation pilot program' are welcome developments for the industry and for improving patient access. However, even though the systems have been in operation for two to three years, their scope remains limited, and there are concerns for broader implementation. While the GIFT program has established a preferential drug pricing regulation for new drugs developed by innovative pharmaceutical companies, only five products (2.6%) that received expedited review under GIFT have been approved. The selection criteria for the 'concurrent approval-evaluation-negotiation pilot program' are also so stringent that it is difficult to select more products, even from the GIFT list. Although the government is aware of the need for expanded operation based on the systems' records, there is a perception that many issues still need to be resolved regarding staffing and inter-ministerial communication. As the necessity of these systems is proven by their results, there may be a need to focus on expanding the expedited review and 'concurrent approval-evaluation-negotiation pilot program.'
- Policy
- Savings of KRW 32.6B expected from 2025 'Type-Da' PVA nego
- by Lee, Tak-Sun Sep 05, 2025 06:20am
- The National Health Insurance expenditure is expected to see a savings effect of approximately KRW 32.6 billion due to this year's negotiation for the 'Type-Da' Price-Volume Agreement. This year's negotiated items total 110, comprising 48 active ingredients. The ceiling price of these items has been adjusted as of September 1. Items subjected to one-time reimbursement instead of drug price reduction are also included in this list. According to the National Health Insurance Service (NHIS), on September 4, National Health Insurance expenditure is anticipated to be reduced due to the adjusted ceiling price (including one-time reimbursement cases) resulting from the successful negotiation of the 'Type-Da' Price-Volume Agreement. Items included in 'Type-Da' list are those that do not meet criteria for 'Type-Ga' or 'Type-Na.' When a drug has been listed for four years or more, its ceiling price is adjusted through negotiations with the National Health Insurance Service if the claim amount for the same product group increases by more than 60% compared to the previous claim amount, or by more than 10% and exceeds KRW 5 billion. This year, a total of 110 items comprising 48 ingredients were subject to negotiations. This includes several blockbuster products such as Hanmi Pharmaceutical's Rosuzet Tab, Yuhan's Rosuvamibe Tab, Celltrion's Remsima Inj, Organon's Atozet Tab, and Janssen's Concerta OROS Tab. Analysis suggests that the National Health Insurance finances are expected to see savings of approximately KRW 32.6 billion from this year's PVA negotiation. This figure decreased from last year's savings of KRW 52.1 billion, as last year's Type D negotiations included 207 items comprising 63 product types, which was more than this year. Meanwhile, eight drugs, including Daewon Pharmaceutical's Codaewon S Syrup, were signed up for one-time reimbursement instead of a price cut due to temporary usage increases resulting from unavoidable circumstances, such as the COVID-19 pandemic. The one-time refund contract was introduced to promote the stable supply of medicines. Additionally, 12 items from innovative pharmaceutical companies were selected as negotiation targets three or more times within a five-year period, resulting in a 30% reduction in the price cut rate. The NHIS has been implementing this reduction plan since last year to enhance the sustainability of the pharmaceutical ecosystem.
- Company
- Zynyz receives orphan drug designation in Korea
- by Eo, Yun-Ho Sep 05, 2025 06:20am
- The immuno-oncology drug Zynyz that Handok has decided to market in Korea has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety (MFDS) recently announced the designation through a public notice. Specifically, the drug is indicated for ▲Merkel cell carcinoma and ▲ squamous cell carcinoma of the anal canal (SCAC). Among these, the Merkel cell carcinoma indication had already been granted orphan drug status earlier in June. Zynyz (retifanlimab), which was developed by the US company Incyte, was also designated in July as a subject for the “Global Innovative Products on Fast Track (GIFT)” program. Since receiving approval from the U.S. FDA in May, the PD-1 inhibitor Zynyz has been gaining attention as the first first-line treatment for adult patients with unresectable locally recurrent or metastatic anal cancer, in combination with platinum-based chemotherapy (carboplatin, paclitaxel). The efficacy of Zynyz in anal cancer was demonstrated in the Phase III POD1UM-303 study. This study evaluated 308 patients with unresectable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) by comparing outcomes between the Zynyz + carboplatin + paclitaxel combination arm and the standard-of-care arm. Results showed that the median progression-free survival (PFS) was 9.3 months in the Zynyz arm, which is a 37% reduction in the risk of disease progression or death compared with the 7.4 months in the standard-of-care arm. In the interim analysis, the median overall survival (OS) was 29.2 months in the Zynyz arm and 23 months in the standard-of-care arm. The objective response rate (ORR) for the Zynyz arm was 56%, with 22% achieving complete response and 33% partial response—higher than the 44% observed in the standard-of-care arm. The median duration of response (DoR) was 14 months in the Zynyz arm, compared with 7.2 months in the standard-of-care arm. SCAC accounts for about 85% of all anal cancers and is classified as a rare cancer. The majority of cases are caused by human papillomavirus (HPV) infection, and HIV-positive individuals face a 25–35 times higher risk. Early symptoms often resemble hemorrhoids, leading to delayed diagnosis, with many patients visiting hospitals at advanced stages.
- Company
- MenQuadfi’s indication includes infants as young as 6 weeks
- by Hwang, byoung woo Sep 05, 2025 06:19am
- On the 4th, Sanofi Kore announced that its fully liquid quadrivalent meningococcal vaccine, MenQuadfi, received expanded indication approval from the Ministry of Food and Drug Safety (MFDS) on August 26. The new approval allows MenQuadfi’s vaccination for infants from 6 weeks to under 2 years of age. With the indication extension, MenQuadfi has become the first quadrivalent meningococcal conjugate vaccine in Korea that can be administered to infants as young as 6 weeks. This approval allows a broader age range to have preventive options against invasive meningococcal disease. MenQuadfi contains 10μg of antigen each for the four meningococcal serogroups (A, C, W, and Y) and is formulated as a fully liquid formulation that requires no reconstitution or mixing, enhancing ease of use. It utilizes tetanus toxoid (TT) as a protein carrier to induce a strong T cell–mediated immune response. Following the indication extension, MenQuadfi now offers flexible vaccination schedules to those 6 weeks to 55 years of age. Infants aged 6 weeks to under 6 months may receive a 4-dose series, with the initial three doses given at minimum 8-week intervals, and a fourth booster at least 6 months after the third dose, administered at ≥12 months of age. For infants aged 6 to less than 24 months with no prior meningococcal vaccination, a 2-dose schedule is recommended, with a minimum 3-month interval between doses and the second dose administered after 12 months of age. For individuals aged 2 to 55 years, a single dose is sufficient for protection. MenQuadfi’s indication extension was based on results from the MET42 and MET61 studies. The Phase III MET42 trial enrolled about 2,627 infants and toddlers aged 2 to 18 months to evaluate the immunogenicity and safety of MenQuadfi versus an existing quadrivalent meningococcal vaccine. After just three doses starting at 2 months of age, MenQuadfi demonstrated strong immune responses across all 4 meningococcal serogroups: A (64.4%), C (96.4%), W (92.8%), and Y (88.7%). These results were higher compared to the comparator vaccine (A: 50.6%, C: 82.8%, W: 85.6%, Y: 81.8%). The MET61 study assessed infants aged 6 to 23 months with a 2-dose schedule, comparing the immunogenicity and safety of MenQuadfi against control vaccines, including Sanofi’s own Menactra. The results confirmed that MenQuadfi induced non-inferior immune responses across all serogroups (A, C, W, Y) compared with control vaccines, with a safety profile comparable with existing vaccines. Hee-kyung Park, Director of Sanofi’s Vaccines Business Unit, said, “With the indication extension of MenQuadfi in Korea, we are pleased to be able to protect infants as early as 6 weeks of age from invasive meningococcal disease. Sanofi will continue to work closely with health authorities to strengthen preventive strategies and secure protection against meningococcal infections across various age groups.”
- Company
- HK Inno.N and Pfizer partner to distribute COVID-19 vaccine
- by Lee, Seok-Jun Sep 05, 2025 06:18am
- HK inno.N (CEO Dal-Won Kwak) announced on the 4th that it has signed a co-promotion agreement with Pfizer Korea (CEO Dong-Wook Oh) for the 2025–2026 season distribution of the new COVID-19 variant vaccine, Comirnaty LP.8.1 Prefilled Syringe (SARS-CoV-2 mRNA Vaccine), as part of the National Immunization Program (NIP). Last year, HK inno.N was responsible for the private distribution of Comirnaty JN1 Injection (single-dose, bretobameran, SARS-CoV-2 mRNA vaccine). More recently, the company has also been in charge of distribution for the government-funded NIP program, which targets high-risk groups such as seniors aged 65 and older and immunocompromised individuals, a market valued at approximately KRW 200 billion. Through this co-promotion agreement, HK inno.N and Pfizer Korea have expanded their partnership to include promotional activities for those included in the National Immunization Program. Comirnaty® LP.8.1 Prefilled Syringe received approval from the MFDS on January 29 for the prevention of COVID-19 caused by SARS-CoV-2 in individuals aged 12 years and older. The vaccine is administered as a single 0.3 mL intramuscular injection, regardless of previous COVID-19 vaccination history. For individuals who have received prior COVID-19 vaccination, the new shot should be given at least three months after the last dose. HK inno.N CEO Dal-Won Kwak said, “Based on our sales and distribution capabilities, we will contribute to the stable supply of Comirnaty® LP.8.1 Prefilled Syringe and to the improvement of public health in Korea.
- Company
- Fruzaqla may be prescribed at general hospitals in KOR
- by Eo, Yun-Ho Sep 04, 2025 06:12am
- ] The new colon cancer drug Fruzaqla is may now be prescribed at general hospitals in Korea. According to industry sources, Fruzaqla (fruquintinib), a colorectal cancer therapy from Takeda Korea that selectively inhibits vascular endothelial growth factor receptors (VEGFR)-1, 2, and 3, has passed the drug committees (DC) of 41 major medical institutions nationwide, including Samsung Medical Center, Seoul National University Hospital, and Severance Hospital. Prior to its approval in Korea this June, Fruzaqla had been designated as an orphan drug in February and as a “Global Innovative products on Fast Track” (GIFT) in November of last year. Specifically, Fruzaqla is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti-VEGF therapy; an anti-EGFR therapy (for RAS wild-type); and trifluridine/tipiracil and/or regorafenib, but have progressed on or are intolerant to these therapies. Fruzaqla demonstrated efficacy in the Phase III FRESCO-2 trial. Results showed that the median overall survival (mOS) for the Fruzaqla arm was 7.4 months compared with 4.8 months in the placebo arm, reducing the risk of death by 34%. In addition, the median progression-free survival (mPFS) was 3.7 months (95% CI: 3.5–3.8) with Fruzaqla, more than doubling the placebo group’s 1.8 months, and reducing the risk of disease progression or death by 68%. Moreover, Fruzaqla is an oral therapy that can be taken once daily without complicated dietary restrictions, the convenience of which is expected to improve not only treatment outcomes but also patients’ quality of life. Professor Sang-Cheul Oh, Department of Oncology, Korea University Guro Hospital (Chair of the Colorectal Cancer Subcommittee, Korean Cancer Study Group) said, “Fruzaqla’s mechanism of action that selectively inhibits VEGFR-1, 2, and 3 provides strong efficacy with lower toxicity, making it a very meaningful option for later-line patients in the 4th line or beyond who have already received long-term treatment.”
- Product
- Generic substitutions and INN-based prescriptions on track
- by Kim JiEun Sep 04, 2025 06:12am
- The prolonged instability in drug supply has fueled momentum in the pharmacy community, with both streamlined generic substitutions and limited mandatory international nonproprietary name prescriptions gaining traction in the National Assembly. On September 2, Democratic Party of Korea lawmaker Jong-Tae Jang introduced amendments to the Medical Service Act and the Pharmaceutical Affairs Act. The proposed bill would create a legal definition for supply-unstable medicines and mandate ingredient name-based prescriptions for such drugs on a limited basis. This follows the passage of the so-called “Generic Substitution Activation Act,” recently approved by the National Assembly’s Health and Welfare Committee, adding yet another long-pursued initiative of the pharmacy sector to the legislative agenda. The shift began with revisions to the enforcement regulations of the Pharmaceutical Affairs Act, which simplified the notification process for generic substitutions. Despite strong opposition from physicians, the Ministry of Health and Welfare pushed through the revision, allowing the HIRA (Health Insurance Review and Assessment Service) online portal as one of the means for post-notifications. Even with doctors voicing concerns of “infringement of prescribing rights,” the government and the National Assembly have continued to push for regulatory revisions and legislation due to the persistent issue of drug shortages. The issue, which first emerged during the early COVID-19 period, have remained unresolved even 5 years after the pandemic subsided. Critics argue the government has failed to present a clear solution. As a result, consensus between the government and the National Assembly on the need to address drug shortages has directly driven attempts at systemic reform. During the last presidential election, the Democratic Party of Korea pledged to implement limited INN-based prescriptions for essential medicines as part of its project to secure a stable drug supply. This confirmed the Lee Jae Myung administration’s commitment to addressing the shortage issue. In its May policy platform, the Democratic Party of Korea included “promoting generic substitutions and limited ingredient-name prescriptions for essential drugs with unstable supply” under its measures to ensure stable access to essential medicines. The pharmacist community believes the streamlining generic substitution law will pass smoothly, given that regulatory changes have already been enacted. However, they remain cautious on mandatory INN-based prescriptions, anticipating fierce resistance from physicians. The Korean Medical Association is likely to intensify its opposition and pressure the government. A pharmacy association representative commented, “We welcome the fact that bills addressing drug shortages are being introduced and advanced with a sense of urgency. For years, responses to shortages have been nothing more than post-hoc measures. Now is the time for preventive and systemic solutions. Although past attempts at generic substitution and INN-based prescriptions repeatedly collapsed due to opposition from the medical community, we are hopeful that with shortages now recognized as a societal issue, this time will be different.”
- Policy
- Pilot Drug Approval·Review Coordination Committee extended
- by Lee, Hye-Kyung Sep 04, 2025 06:10am
- The pilot operation period for the Pharmaceutical Approval and Review Coordination Committee will be extended by one year. According to the pharmaceutical industry on September 3, the Ministry of Food and Drug Safety (MFDS) decided to extend the pilot period for the Coordination Committee by one year, starting from August 29. The committee had been operating on a trial basis for one year since June 17 of the previous year. This extension is based on a revision of the committee's operational guidelines. For the past year, applications for adjustment were limited to cases involving safety and efficacy review data, quality review data, and documentation related to data protection. However, starting this year, the scope has been expanded to include 'all matters' for which the Pharmaceutical Approval Management Division has requested supplementary data. The scope of applications for adjustment following the Pharmaceutical Approval and Review Coordination Committee extension. The Coordination Committee was established last June to make the drug product approval and review process more transparent and rational. It allows applicants to request an adjustment when supplementary data is asked for during the drug product approval and review process. The committee, chaired by the Director of the Drug Safety Bureau, includes the Head of the Pharmaceutical Review Department, the Director of the Pharmaceutical Policy Division, the Director of the Pharmaceutical Approval Management Division, relevant review department heads, and experts from the Central Pharmaceutical Affairs Council. They proceed with adjustments through a majority vote. With the pilot program extended for another year, it will apply to applications submitted to the Pharmaceutical Approval Management Division. The MFDS plans to evaluate the operational results at the end of this period to decide whether to terminate the pilot program, transition it to a full-scale operation, or further expand the scope of adjustment applications. The scope of applications for adjustment includes ▲Review data specified in Article 5 of the 'Regulations on Drug Product Approval, Notification, and Review' ▲Data related to the eligibility for clinical trial data protection, as per Article 31-6 of the 'Pharmaceutical Affairs Act' and Article 21-2 of the 'Rules on the Safety of Pharmaceuticals, etc.' ▲Other matters for which adjustment is deemed necessary in response to a request for supplementary information (excluding requests for supplementary data needed for evaluating the implementation status of Good Manufacturing Practice (GMP) and clinical trials). An applicant wishing to request an adjustment must submit an application form, as specified in Annex No. 1 of the guidelines, to the Pharmaceutical Approval Management Division within 30 days of the request for supplementary information. The committee plans to process the adjustment applications, in principle, within the 60-day supplementary request period. Only the applicant listed on the application form can request an adjustment; an agent cannot make this request. Meanwhile, once an application is selected for adjustment, it will be thoroughly discussed at a Coordination Committee meeting, which is composed of both internal and external experts. A two-thirds majority vote of the committee members present decides on the supplementary requirements. The results of the adjustment are then communicated to the relevant divisions and the applicant.
- Policy
- MFDS allocates KRW 812.2 billion for next year's budget plan
- by Lee, Hye-Kyung Sep 04, 2025 06:09am
- The Ministry of Food and Drug Safety (MFDS; Minister, Yu-Kyoung Oh) has announced that its budget for 2026 has been set at a total of KRW 812.2 billion, an increase of KRW 63.3 billion (8.4%) from this year's budget of KRW 748.9 billion. This budget plan was focused on facilitating the smooth execution of the new government's national tasks and restructuring expenditure to ensure efficient financial management. The 2026 MFDS budget plan includes four areas: enhancing safety and expanding the foundation for innovative growth in the pharmaceutical and bio-health sectors, strengthening customized safety support for food and medicine, considering the regulatory environment, creating a safe food and healthy dietary environment, and building a proactive food and drug safety management system for the future. A total of KRW 170.4 billion has been allocated to enhance safety and expand the foundation for innovative growth in the pharmaceutical and biotech sectors. The Fund for the Korea Orphan & Essential Drug Center will increase from KRW 4.5 billion this year to KRW 6.7 billion next year. To resolve the unstable supply of rare and essential medicines, MFDS will strengthen the stable supply foundation by expanding contract manufacturing of discontinued products and the emergency import of self-administered medicines with minimal demand. For supporting and building a management system, such as innovative medical devices, KRW 2 billion will be invested. A newly allocated budget of KRW 15 billion will be invested next year to fund the rapid commercialization of AI-driven products. MFDS will assist in the swift commercialization of promising AI-based products in the food and medical device sectors, thereby shortening Korean companies' development timelines and accelerating their market entry. The budget for the Korean Association Against Drug Abuse has been increased from KRW 16.5 billion this year to KRW 17.1 billion next year. A total of KRW 105.4 billion has been allocated for strengthening customized safety support for food and medicine, taking into account the regulatory environment. With the biohealth industry continuing to grow and the demand for systematic regulatory support from industries with limited experience and expertise increasing, MFDS plans to expand regulatory support by building an integrated consultation platform and securing customized consultation personnel for advanced and next-generation biopharmaceuticals. The budget for this will be significantly increased from KRW 500 million this year to KRW 11.4 billion next year. To lead the development of the pharmaceutical industry, MFDS will create review guidelines for new technologies and concepts, such as AI-driven products, and establish review standards that consider the characteristics of advanced and next-generation biopharmaceuticals. This will secure approval and review capabilities at the level of developed countries. To counter non-tariff barriers, such as country-specific approval regulations that hinder the export of Korean pharmaceuticals, MFDS will operate export approval support hubs. These hubs will analyze and provide case studies of approvals by product and offer regulatory consultations for export countries, thereby supporting the swift acquisition of overseas drug approvals. A new budget of KRW 5.5 billion has been allocated for operating a regulatory science talent development program in which universities, industries, and research institutes participate. The goal is to cultivate regulatory science professionals who can scientifically evaluate the safety of advanced bio-health products. A total of KRW 187.1 billion has been allocated for creating a safe food and healthy dietary environment, and a total of KRW 146.9 billion has been allocated for building a food and drug safety management system for the future. Next year, MFDS plans to build an automated drug approval and review system. This system will verify submitted document requirements, handle repetitive and routine tasks, and generate data summaries and reports. The system is intended to address the shortage of review personnel and expand patients' treatment opportunities through a faster drug approval process. The automation system will be expanded from generic drugs next year to active pharmaceutical ingredients (APIs) in 2027 and new drugs in 2028. To respond to the changing environment, such as online food distribution and the development of artificial intelligence, MFDS will establish an Information Strategy Plan (ISP) to build an "Integrated Food Safety Information Network." This network will consolidate 15 food-related information systems and automate public service and administrative tasks. In addition, as the scope of narcotics investigations expands, MFDS will secure digital forensics personnel and equipment dedicated to investigating medicinal narcotics. It will also broaden the synthesis of standard materials for new psychoactive substances and the evaluation of dependence on temporary narcotics. MFDS stated, "Once the 2026 budget plan is finalized through the National Assembly's deliberation process, we will do our best to execute the new government's national tasks and key projects without delay and protect the health and safety of the public."
