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- 2025-12-22 13:08:38
- Company
- ABL licenses out its tech to big pharmas worth ₩350B
- by Cha, Jihyun Apr 08, 2025 05:57am
- ABL Bio has signed a licensing-out agreement worth KRW 70 billion in advance payments (upfront). This is the company's 7th licensing-out agreement and its first platform deal. Including this contract, the cumulative technology fee ABL Bio earned through technology exports is close to KRW 350 billion. According to the Financial Supervisory Service on the 7th, ABL Bio signed a technology export contract with the multinational pharmaceutical company GlaxoSmithKline (GSK) on the 5th for the BBB shuttle platform ‘Grabbody-B' for the development of new treatments for degenerative brain diseases. This is the first time that ABL Bio has exported a platform, not a candidate substance. This contract aims to develop multi-targeted therapeutics using various modalities, including siRNA, ASOs, oligonucleotides or polynucleotides, and antibodies. Under the terms of the agreement, GSK will receive exclusive rights to develop and commercialize multiple new target candidates using ABL Bio’s GrabBody-B. ABL Bio will transfer its GrabBody-B-related technology and know-how to GSK, and GSK will be responsible for preclinical and clinical development, manufacturing, and commercialization. With this contract, ABL Bio will receive an advance payment (upfront) of EUR 38.5 million (approximately KRW 73.9 billion) and short-term milestones of EUR 38.6 million (approximately KRW 74.1 billion) with no obligation of return. ABL Bio will also receive up to EUR 2.063 billion (approximately KRW 3.9623 trillion) in development, licensing, and commercialization milestones for multiple programs. The total contract value, including the amount above, is EUR 2.1401 billion (approximately KRW 4.1104 trillion). In addition, ABL Bio will also be entitled to receive a royalty based on net sales. This is ABL Bio's 7th licensing-out agreement. Previously, in 2022, ABL Bio exported the dual antibody candidate 'ABL301' for the treatment of degenerative brain diseases to the multinational pharmaceutical company Sanofi. The contract is worth a total of USD 1.06 billion (about KRW 1.47 trillion), including an upfront payment of USD 75 million (about KRW 100 billion). In 2018, ABL Bio signed a licensing-out contract with Yuhan Corp for a total of KRW 59 billion for 2 candidate substances for an immuno-oncology drug based on bispecific antibodies. In the same year, it transferred the rights to 'ABL001', a candidate substance for the treatment of biliary tract cancer, to Compass Therapeutics in the United States. The contract size is worth USD 410 million in the anticancer field and USD 185 million in the eye disease field. ABL Bio has licensed out the ROR1-targeted ADC pipeline 'ABL202', which it jointly researched with LegoChem Biosciences in 2020, to CStone Pharmaceuticals in China. The total contract value was worth KRW 363.5 million, excluding sales royalties after commercialization, and all payments, including upfront, milestone, and royalty payments, are to be shared with LigaChem Biosciences in a certain ratio. In addition, ABL Bio signed licensing-out agreements with TSD Life Sciences and Handok in 2019 and 2020, respectively. However, the company did not disclose the specific contract amount, such as advance payments or milestones, for these contracts. The cumulative contract amounts and milestones received by ABL Bio through the licensing out agreements, including the advance payment for the GSK contract, totals at KRW 349.1 billion. This is the sum of the four technology export contracts that the company has disclosed the detailed terms, including contract amounts and milestones. To date, ABL Bio has received a cumulative USD 125 million in payments from Sanofi. It received USD 75 million in advance payments at the time of the 2022 contract and an additional USD 20 million in milestone payments in the same year. In January 2023, the company received a milestone payment of USD 25 million for the first dose administered in the Phase 1 clinical trial and received an additional USD 5 million in milestone payments for the transfer of manufacturing technology last year. In addition, ABL Bio received an advance payment of KRW 1.4 billion from Yuhan Corp. The advance payment received by ABL Bio from Compass Therapeutics was USD 11 million. With the inflow of revenue from technology exports, ABL Bio also succeeded in turning a profit in 2022, posting KRW 900 million in operating profit on a consolidated basis. However, the company returned to the red the following year due to increased research and development (R&D) expenses. Last year, ABL Bio posted KRW 33.4 billion in sales and KRW 59.4 billion in operating losses on a consolidated basis. Sang Hoon Lee, CEO of ABL Bio, said, “This contract reflects our strong commitment to innovatively advancing the development of treatments for degenerative brain diseases through our leadership in the BBB shuttle market and forging strategic partnerships with global big pharma companies like GSK.” Lee added, “This contract will be a great opportunity to further solidify ABL Bio's position in the degenerative brain disease treatment market through the commercialization of GrabBody-B and expand the scope of modality applicable to GrabBody-B.”
- Company
- ZP Therapeutics appoints Junghun Kim as new head
- by Eo, Yun-Ho Apr 08, 2025 05:57am
- Junghun Kim, General Manager of ZP Therapeutics The head of ZP Therapeutics has been replaced after about 3 months. According to industry sources, Zuellig Pharma Korea recently appointed Junghun Kim (50), former Country Manager of Takeda Pharmaceutical Malaysia and Singapore, as the new General Manager of its commercial division, ZP Therapeutics. Hyunjoo Lee (48), the former CEO who took office at the end of last year, recently moved to the position of head of the Oncology BU at AstraZeneca Korea after leaving the company. The new General Manager, Junghun Kim, has been in the pharmaceutical industry for about 20 years. Kim is a seasoned expert who has served various roles, including registration and approval (RA) work, sales branch manager, and marketing manager. Since joining Takeda Pharmaceutical Korea in 2015, Kim has served as the marketing manager and Franchise Head of the Internal Medicine division, which has GI and hematology products, and as the head of the Oncology Business Unit since 2019. He also served as the Country Manager of Takeda Malaysia and Singapore. Meanwhile, ZP Therapeutics Korea has established itself as a preferred commercial solution partner for pharmaceutical clients by providing integrated solutions that cover marketing, sales promotion, product launch, medical e-detailing, registration and approval, market access, digitalization, and data-driven sales excellence in line with the needs and changes in the pharmaceutical market. Currently, it licenses several specialty and generic drug brands and supports major pharmaceutical companies with its sales and marketing services.
- Opinion
- [Reporter's View] Why clinical outcomes require deliberation
- by Son, Hyung Min Apr 08, 2025 05:57am
- Even small differences in clinical outcomes can be highly meaningful. Especially for refractory diseases. Recent top‐line results from Compass Therapeutics’ Phase 2/3 COMPANION-002 trial for cholangiocarcinoma have sparked considerable debate within the industry. According to Compass Therapeutics, the treatment of bispecific antibody tovecimig in combination with the cytotoxic agent paclitaxel resulted in the objective response rate (ORR) of 17.1%, which is nearly three times higher than the 5.3% observed with paclitaxel monotherapy. However, some suggested that the 17.1% ORR is considerably lower than the 37.5% ORR recorded in a previous domestic Phase 2 study conducted by Handok. In a domestic Phase 2 trial, tovecimig+paclitaxel combination therapy had a 37.5% ORR. The latest clinical trial's ORR is less than half of the Phase 2 study. It is important to note that it is too early to make a definitive conclusion on the clinical trial outcomes. The patient populations differed significantly, 24 patients in the domestic Phase 2 trial versus 111 patients of varying races and ages in the global Phase 2/3 study. COMPANION-002 trial is still ongoing, and data on secondary endpoints such as progression-free survival (PFS), overall survival (OS), and duration of response (DOR) have yet to mature. Furthermore, the unique characteristics of cholangiocarcinoma must be taken into account. Although the overall patient numbers are relatively small, cholangiocarcinoma is notoriously difficult to diagnose early and is characterized by rapid metastasis and recurrence, leading to a 5-year relative survival rate of only 28.9% (2017–2021). In fact, seven out of ten cholangiocarcinoma patients eventually die. Another primary reason for the low survival rate is ineffective treatment options. In cases of locally advanced or metastatic cholangiocarcinoma where it is inoperable and first-line therapy has failed, there has been no approved targeted therapy available in Korea. Targeted drug studies have been challenging because of early diagnosis and a small population of patients. Although some targeted therapies for cholangiocarcinoma have shown less than a 1-month improvement in PFS compared to placebo, they have surpassed regulatory hurdles. FOLFOX-based regimens yield a median PFS of 4.0 months and an OS of 6.2 months. Some cancer types have many patients and easily detected in early phases. Clinical studies of those types rarely have data recording over ten digits of months of PFS and OS. However, in challenging fields such as cholangiocarcinoma and triple-negative breast cancer, where the development of targeted therapies is complex, even slight numerical differences can be highly significant. Therefore, it would be premature to draw definitive conclusions about Compass Therapeutics' cholangiocarcinoma treatment without waiting for the final data. As the pharmaceutical industry gradually overcomes long-standing challenges in developing effective therapies for cholangiocarcinoma, a range of new treatments is emerging. Recent developments include the addition of immunotherapies such as AstraZeneca's Imfinzi and MSD's Keytruda as first-line options, as well as the emergence of targeted therapies like Pemazyre and Tibsovo for second-line treatment, along with various agents including, tovecimig and rivoceranib. Experts emphasize that, given the scarcity of treatment alternatives for cholangiocarcinoma, even slight differences in efficacy relative to existing therapies can be significant. When interpreting clinical outcomes, it is essential to consider each cancer type's specific clinical context and biological characteristics. Ultimately, understanding the differences in clinical results between cancers with limited treatment options and those with a wide array of available therapies is critical for accurate data interpretation.
- Policy
- Health and Welfare Committee meeting may not be held in APR
- by Lee, Jeong-Hwan Apr 08, 2025 05:57am
- The Constitutional Court sentenced former President Suk Yeol Yoon to dismissal at 11:22 a.m. on the 4th, setting the stage for an early presidential election. The election date must be announced by Acting President Duck-Soo Han within 10 days of the president's impeachment. This means that the date of the early presidential election will be confirmed before the 14th of this month. The National Election Commission announced that it would begin accepting registrations for the 21st presidential election on the 4th, immediately after the Constitutional Court decided to cite the impeachment motion. The dismissal of the president has made it difficult for the National Assembly's standing committees to hold meetings. The secretaries of the ruling and opposition parties of the NA’s Health and Welfare Committee are likely not to hold a standing committee meeting in April. First, the National Election Commission announced the method of registering as a preliminary candidate, the campaigning method, and the taboo acts. A person who wants to become a preliminary candidate must submit to the National Election Commission documents certifying eligibility, such as a family relationship certificate, a document certifying criminal record, and a certificate of formal education, and pay a deposit of KRW 60 million (20% of the KRW 300 million deposit required of candidates). Assuming that all 60 days of the early presidential election period are used, the official candidate must register by the 10th to 11th of next month. The winner of the early presidential election will immediately begin his or her term without going through the Presidential Transition Committee. A prospective candidate may set up an ▲election office, ▲distribute campaign business cards, ▲create and send out promotional materials to no more than 10% of the total number of households in the country, ▲wear or carry a sash or sign, and ▲publish and sell (except through door-to-door sales) one copy of a prospective candidate's campaign pledge book in the usual way. Even if they are not a candidate or an election official, those who are allowed to campaign can do so at any time by sending text messages, posting on websites, or sending e-mails, and can campaign by phone or in person on days other than the election day. However, in order to conduct election campaigns by sending text messages through automatic mass communication or by entrusting an email transmission agency to send emails, one must register as a candidate or a candidate-to-be. Automatic mass communication is a method of sending messages to more than 20 recipients at the same time or to fewer than 20 recipients by automatically selecting recipients using a program. As the grounds for the presidential impeachment election confirmed, in accordance with Article 90 of the Public Official Election Act, it is not possible to install or post banners or other facilities that specify the name of a political party or the name, photo, or content that can be inferred from the name of a candidate (including a person who is seeking to be a candidate) to influence the election. The National Assembly is also likely to refrain from holding standing committee meetings this month. This is because the early presidential election has a greater weight than the holding of a standing committee meeting for the examination or processing of the bills under its jurisdiction. First of all, the Health and Welfare Committee is likely to not hold a Legislative Subcommittee and plenary session on its bills in April. An opposition member of the Health and Welfare Committee said, “With the early presidential election confirmed, there is a high probability that the bill review under the jurisdiction of the Health and Welfare Committee will be delayed. Although an agreement between the ruling and opposition party secretaries is necessary, I don't think the subcommittees on bills that were normally held during peacetime will be held.”
- Policy
- Pemzayre, high-priced drug post-management system candidate
- by Lee, Tak-Sun Apr 08, 2025 05:56am
- Handok 'Pemzayre Tab,' Handok's bile duct cancer (cholangiocarcinoma) treatment, is expected to be subjected to the post-management system for high-priced drugs. Pemzayre Tab is likely to be added to the reimbursement list in May. Consequently, a submission system for evaluating treatment outcomes as part of the post-management evaluation will be established. According to industry sources on the 7th, Pemzayre passed the Health Insurance Review and Assessment Service (HIRA's) Drug Reimbursement Evaluation Committee (DREC) in January. The company is negotiating with the National Health Insurance Service (NHIS) for drug pricing negotiations. Considering the 60-day drug pricing negotiations period, Pemzayre will likely to be added to the reimbursement list in May. This drug is the first targeted drug in South Korea with cholangiocarcinoma indication. Pemazyre is indicated for patients with locally advanced or metastatic who have FGFR2 gene fusions. Pemzayre has been in used the United States, Europe, and Japan. If it is reimbursed, this drug will be used in adult patients with locally advanced or metastatic cholangiocarcinoma who have FGFR2 gene fusions or rearrangements and have undergone one or more systemic therapy. Based on its anatomical origin, cholangiocarcinoma is classified into intrahepatic cholangiocarcinoma (iCCA), arising from bile ducts within the liver, and extrahepatic cholangiocarcinoma, developing from bile ducts outside the liver. Because this cancer is frequently diagnosed at an advanced stage with a poor prognosis, there is a critical unmet need for targeted therapies. FGFR2 fusion or rearrangements are known to be found in 10-16% of patients with iCCA. In recognition of this urgency, the Korean Ministry of Food and Drug Safety (MFDS) designated this as an orphan drug in November 2021. The MFDS granted marketing approval via expedited review in April 2023. Following approval, the drug quickly entered the reimbursement procedure. After successfully establishing reimbursement criteria in August last year and passing the DREC review in January this year, its chances of inclusion in the National Health Insurance system have markedly increased. However, pricing remains a significant issue. The product, which contains 14 tablets per package, has a supply cost of approximately US$19,000 per product. Given that the treatment course may extend for up to 42 days, its reimbursement could significantly burden health insurance expenditures. Accordingly, the government is expected to manage this drug under the "High-Priced Drugs Reimbursement Management Criteria." Currently, six drugs, Kymriah, Zolgensma, Spinraza, Yescarta, Luxturna, and Tecartus, are subject to these criteria. The criteria for high-priced drugs include ▲Newly listed with high prices and uncertain cost-effectiveness that require further verification ▲Incur substantial annual per capita expenditures, or generate annual health insurance claims that could severely impact the national health insurance budget ▲Expected to provide long-term benefits from a single administration, necessitating additional safety confirmation and long-term evaluation ▲Based on their impact on healthcare, deemed necessary for management. Once a drug is designated as a target under the high-priced drug post-management system, a post-administration response evaluation must be conducted, and the resulting data must be submitted. Based on this data, the HIRA will then perform performance evaluations and ongoing monitoring of treatment effectiveness. If a drug is under patient-based performance risk-sharing agreements, the NHIS will use it to calculate drug reimbursement amounts.
- Company
- China's mAb 'Hetronifly' secures orphan drug designation
- by Eo, Yun-Ho Apr 07, 2025 05:51am
- Product photo of Hetronifly China-made immune checkpoint inhibitor has been designated as an orphan drug in South Korea. The Ministry of Food and Drug Safety (MFDS) recently announced on a notification board that it has granted Shanghai Henlius Biotech's 'Hetronifly (serplulima)' an orphan drug designation (ODD). The drug is indicated for 'use in combination with carboplatin and etoposide as a first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).' Hetronifly was initially approved in China in 2023 under the product name 'Hansizhuang.' This drug also secured approval recommendations in Europe. Hetronifly has gained attention as the first immunotherapy for cancer as a first-line treatment of ES-SCLC. Hetronifly demonstrated efficacy through the multicenter Phase 3 'ASTRUM-005' study. The study was randomized, double-blind, placebo-controlled, and global multicenter. The results showed that the patient group administered with Hetronifly had an average survival period of 15.8 months, which was significantly longer than the placebo group. The analysis suggested that the Hetronifly group's mortality rate was 38% lower than the control group. Furthermore, a subgroup of Hetronifly-administered study participants who are Asians had 4.8 months extension in average survival period. Meanwhile, Henlius Biotech was initially launched as China's top company specializing in biosimilar antibodies. The company has developed biosimilar antibodies to several antibody drugs, including breast cancer medicine 'Herceptin (trastuzumab)' and AbbVie's rheumatoid arthritis medicine 'Humira (adalimumab),' and launched across countries.
- Company
- AbbVie Korea sales up twofold in two years
- by Son, Hyung Min Apr 07, 2025 05:51am
- With its new drugs for immune diseases, AbbVie Korea's sales have reportedly increased twofold in two years. AbbVie Korea is successfully transitioning generational changes for Humira follow-up of new drugs, including Skyrizi and Rinvoq. According to the Financial Supervisory Service on April 4, AbbVie recorded KRW 308.9 billion last year, up 32% from KRW 234.7 billion in 2023. Its operational profits for the same period increased from KRW 11.5 billion to KRW 14.7 billion, up 27%. AbbVie Korea AbbVie Korea's sales have been led by Humira. Developed by the global pharmaceutical company AbbVie, Humira is a treatment for autoimmune diseases, and it was approved in the United States in 2003. Humira is indicated for 15 autoimmune disease areas, including rheumatoid arthritis, Crohn's disease, ulcerative colitis, and psoriasis. However, after the Humira patent expired, the introduction of biosimilars, follow-up biological drugs with the same indications, and Janus Kinase (JAK) inhibitors led to declining sales. According to market research firm IQVIA, Humira sales once recorded KRW 104.0 billion in 2020 and decreased to KRW 80 billion in 2022. Consequently, there haven't been significant changes to AbbVie Korea's sales. AbbVie Korea recorded KRW 146.7 billion in 2020, KRW 140.4 billion in 2021, and KRW 154.6 billion in 2022, maintaining the KRW 100 billion sales range. However, in 2023, the domestic market saw significant traction for Rinvoq and Skyrizi, contributing to a substantial increase in AbbVie Korea's sales. AbbVie Korea recorded sales of KRW 234.7 billion in 2023, a 52% year-over-year increase. For the first time last year, its sales exceeded KRW 300 billion, with last year's total of KRW 308.9 billion representing a 100% increase compared to two years ago. Rinvoq, a JAK inhibitor that selectively targets JAK1, was approved in Korea in 2020 for the treatment of rheumatoid arthritis. It subsequently gained approval in 2021 for atopic dermatitis, and in 2022 and 2023, it expanded its indications to include ulcerative colitis and Crohn's disease, respectively. Sales for Rinvoq have increased with its expanded indications. According to market research firm UBIST, Rinvoq's sales in Korea increased by 450% from KRW 1.4 billion in 2021 to KRW 7.7 billion in 2022. After surpassing KRW 10 billion in early 2023, sales reached KRW 26.1 billion last year, setting a new record. AbbVie Korea is also optimistic about the growth prospects for 'Skyrizi,' a biologic targeting interleukin (IL)-23. Approved in 2019 for plaque psoriasis, Skyrizi was approved later in 2022 for psoriatic arthritis, and last year for palmoplantar pustulosis. According to IQVIA, Skyrizi's sales climbed steeply from KRW 8.4 billion in 2021 to KRW 16.5 billion in 2022, and then to KRW 27.6 billion in 2023. As of 2023, the combined sales of Rinvoq and Skyrizi have exceeded KRW 50 billion, signaling a successful generational transition from Humira in the autoimmune disease area. A CGRP peptide new drug, AbbVie Korea also optimistic for its next-generation drugs. Last year, the company received domestic approval for 'Aquipta,' a CGRP peptide new drug related to calcitonin genes. In this area, competitors such as Eli Lilly's Emgality and Teva's Ajovy have already made tractions, but Aqipta's advantage lies in its oral formulation. Furthermore, AbbVie Korea secured domestic approval last year for its bispecific antibody new drug, 'Epkinly,' which targets CD20 and CD3 expressed in blood cancers. Epkinly is indicated for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). In a global Phase 1/2 EPCORE NHL-1 study, Epkinly achieved an overall response rate (ORR) of 62%, with a complete response (CR) rate of 39%.
- Company
- GPP drug Spevigo can be prescribed in general hospitals
- by Eo, Yun-Ho Apr 07, 2025 05:51am
- 'Spevigo', a treatment for Generalized Pustular Psoriasis (GPP), may now be prescribed in general hospitals in Korea. According to industry sources, the new drug for generalized pustular psoriasis (GPP) from Boehringer Ingelheim Korea, Spevigo (spesolimab), has recently passed the Drug Committee (DC) of the Seoul National University Hospital. Spevigo is a humanized antagonistic monoclonal antibody that binds to the IL-36R. It prevents the subsequent activation of IL-36R and downstream activation of pro-inflammatory and pro-fibrotic pathways, providing a new treatment opportunity for GPP patients. Generalized Pustular Psoriasis (GPP) is characterized by systemic inflammation affecting the skin and internal organs. Its symptoms include diffuse erythema, fever, neutropenia, and skin pain. Spevigo is the first drug approved for GPP in Korea, and the drug is approved as a treatment for adult GPP patients who experience rapid worsening of their conditions. However, Spevigo is still not reimbursed in Korea. Spevigo was approved in Korea in August 2023, but there has been no progress in discussions on its reimbursement to date. As “generalized pustular psoriasis (KDC code L40.1)” has been included in the list of rare diseases eligible for special calculation since January 1 last year, there is also interest in whether the only treatment option, 'Spevigo', will be listed for reimbursement in Korea. Meanwhile, the company is accumulating data on the efficacy and safety of Spevigo in GPP patients through the Phase II Effisayil-1/2 trial and the Effisayil-ON, a five-year open-label extension study (OLE), and the Effisayil-REP study for patients with recurrent exacerbations. The results of the Phase II Effisayil 1 study, a 12-week clinical trial of 53 GPP patients who experienced flare-ups, showed that the percentage of patients who did not have visible pustules at the first week of treatment was 54% in the Spevigo group, compared to 6% in the placebo group, confirming the drug’s rapid elimination of pustules. The percentage of patients with completely or almost clear skin (GPPGA score of 0 or 1) was also 43% in the Spevigo group and 11% in the placebo group, confirming the significant skin symptom improvement effect of Spevigo. These effects of pustule removal and symptom improvement were consistent across all subgroups, regardless of gender, disease severity, race, or BMI. In addition, the time to GPP flare was determined in the first and largest Phase IIb clinical trial, the Effisayil 2 study, which evaluated the efficacy and safety of GPP flare prevention in 123 patients with GPP aged 12-75. The results showed that the high-dose Spevigo group’s flare improved by 84% compared to the placebo group.
- Policy
- Bylvay to be redeliberated for reimbursement in Korea
- by Lee, Tak-Sun Apr 07, 2025 05:51am
- Ipsen Korea’s Bylvay Cap, which has been undergoing an accelerated listing process as the first drug included in the pilot project for the parallel operation of the approval-benefit evaluation-drug price negotiation system, has failed to receive recognition as being eligible for reimbursement by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA). However, DREC’s result - 'redeliberation - has allowed the company to reattempt review at the next DREC meeting. HIRA announced on the 3rd that it will hold the 4th 2025 DREC meeting and redeliberate the reimbursement of Bylvay Cap. Ipsen Korea’s Bylvay Cap is a drug used to treat pruritus in patients with progressive familial intrahepatic cholestasis (PFIC), and it has attracted attention as the first drug selected for the pilot project for the parallel operation of the ‘approval-assessment-negotiation linkage’ system. The pilot project for the parallel operation of the ‘approval-assessment-negotiation linkage’ system was introduced to shorten the period from drug approval to reimbursement, and as the name suggests, the approval, evaluation, and negotiation process for a single drug is carried out all at once to shorten the period of listing. However, the evaluation stage has slowed down the process. The reimbursement of another drug included in the pilot project, Qarziba Inj, was also once delayed at the DREC review stage. Qarziba has been reimbursed by health insurance since December last year, but Bylvay has yet to pass the DREC review process. Last month, HIRA said that it was conducting an in-depth review of the clinical usefulness and cost-effectiveness of Bylvay after gathering the opinions of relevant experts and academic societies, saying that an assessment of the adequacy of reimbursement was underway. Some academics have expressed concern that not only is the speed of listing Bylvay Cap problematic but that the indications under reimbursement review are also narrow. On this day, the results of the deliberation on the Leqvio pre-filled syringe (inclisiran, Novartis Korea), which was on the agenda with the Bylvay Cap, showed that the reimbursement was appropriate if the company accepted an amount lower than the assessed amount. Accordingly, if Novartis accepts the assessed amount, the matter will move on to the negotiation stage with the National Health Insurance Service.
- Policy
- Gov’t works to stop the shortage of essential drugs
- by Lee, Jeong-Hwan Apr 07, 2025 05:50am
- The government will come up with improvement measures within this year to eradicate and alleviate the instability in the supply of national essential drugs, which has been occurring frequently since the COVID-19 pandemic. The government plans to begin the groundwork for overhauling the entire system, including the method for designating national essential drugs, the operation of the council of relevant government ministries and agencies, and government policy support and preferential measures for stable supply. This is done by examining the current status of the essential drug systems in major countries overseas and seeking ways to improve the stability of supply based on an analysis of the current status of Korea’s operation of the essential medicine system. On the 6th, the Ministry of Food and Drug Safety announced that it would begin research on ways to collaborate on the classification and stable supply of essential medicines. This is a response to the growing risk of health security crises and the increasing frequency of shortages of essential drugs such as cold medicines that arose as countries around the world have adopted a national drug policy centered on their own countries since the COVID-19 pandemic. Since 2017, the government has designated and managed drugs that are essential for medical sites such as disease control and radiation disaster prevention, and therefore must be supplied stably as national essential medicines. The Minister of Health and Welfare and the Minister of Food and Drug Safety designate the essential medicines in consultation with the heads of relevant central administrative agencies. However, as front-line pharmacies are constantly experiencing difficulties in obtaining essential medicines, citizens are repeatedly unable to purchase essential drugs such as cold medicine and fever reducers when they need them. The Ministry of Food and Drug Safety examines the purpose of the essential medicine system in advanced pharmaceutical countries and investigates the classification method by type, such as the nature of the product and its intended use. The plan is to look into the current state of the system, including the selection criteria, procedures, and collection of advisory opinions, and analyze the current use of policy support and preferential measures for the stable supply of essential medicines, as well as the current state of operation of organizations such as selection and advisory councils and committees. Based on this, the research team will seek direction for the advancement of Korea's national essential drug policy. As the number of national essential medicines that were first designated around government stockpiles has gradually increased to include items that require a stable supply in the private medical field, the overall goal is to find improvement measures that reflect the characteristics of each national essential medicine. Afterward, the government will prepare a plan to improve the criteria for designating national essential medicines, review the classification plan by use, and come up with a plan to reorganize the list, as well as an operational plan to maintain its suitability in the field. The research will comprehensively review the necessity of each product in the product group when designating and re-evaluating national essential medicines. In addition, it will consider the need to distinguish the system from similar systems and review the scope of designation and exclusion of national essential medicines. Ultimately, it will establish a plan for reorganizing and operating the Stable Supply Council and Sub-Council to facilitate discussions on the designation of national essential medicines and stable supply. The MFDS explained, “We will identify the government policy tools and the collaboration needs with relevant ministries and agencies that can be used to enable the council to determine and implement policies for the stable supply of essential medicines. We will also identify the improvements needed to strengthen the capacity to support the stable supply of national essential medicines, and find ways to strengthen the human and material infrastructure for this.”
