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- 2026-09-08 04:26:45
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- COVID-19 vaccine developers drop out…GC Pharma remains
- by Choi Da Eun Jul 30, 2026 09:09am
- The competitive landscape for COVID-19 vaccine development in South Korea currently centers on GC Pharma. While numerous biopharmaceutical firms began vaccine R&D during the pandemic, the transition to endemic status led to program terminations and corporate downsizings, leaving GC Pharma as the only remaining participant in the Phase 2 clinical stage of the government’s "mRNA Vaccine Development Project for Pandemic Preparedness."GC Pharma recently submitted an amendment request for the Phase 2 clinical trial Investigational New Drug (IND) application for its COVID-19 mRNA vaccine candidate, 'GC4006A,' to the Ministry of Food and Drug Safety (MFDS). GC Pharma was previously designated as the sole company for the Phase 2 clinical research task under the government project jointly led by the Korea Disease Control and Prevention Agency (KDCA) and the Korea Health Industry Development Institute (KHIDI).According to the KDCA, approximately KRW 20 billion (around $14.5 million) in government R&D funding will be allocated to GC Pharma’s Phase 2 trial from August 2026 through December 2027. GC Pharma aims to initiate the Phase 2 trial within the year, submit the Phase 3 IND next year, and secure final marketing authorization by 2028.This study will evaluate the optimal dosage and immunogenicity of GC4006A in healthy adults and elderly individuals aged 19 to 85, comparing results against a control group. GC4006A is the first clinical-stage pipeline candidate developed using GC Pharma's proprietary mRNA-LNP platform.GC Pharma Major R&D Pipelines: GC Pharma is pursuing marketing authorization for its Hunter syndrome therapy 'GC1123B'. It is also advancing global clinical trials for its Sanfilippo syndrome type A candidate ('GC1130A') and Fabry disease therapy ('GC1134A'). In vaccines, in addition to GC4006A, GC Pharma is developing a Tdap vaccine candidate ('GC3111B') and a two-dose varicella vaccine ('MG1111D'). MG1111D is undergoing Phase 3 clinical trials in Thailand and Vietnam, entering Phase 3 trial IND in South Korea.From four non-clinical participating companies to a single Phase 2 candidateParticipating companies dwindled rapidly as government-funded projects advanced to higher clinical stages.During the pandemic, domestic firms pursued diverse platforms, including DNA, recombinant protein, and viral vector vaccines. However, as commercial viability dwindled amid the shift to endemic conditions, most developers suspended or slowed their programs.Consequently, the government-funded program downsized from four non-clinical contenders to a single Phase 2 candidate, leaving GC Pharma as the sole developer standing. If GC4006A achieves commercial approval, it will become South Korea’s second domestic COVID-19 vaccine and its first domestically developed mRNA vaccine.Previously, SK bioscience secured authorization for South Korea’s first domestic COVID-19 vaccine, 'SKYCovione' (a recombinant protein vaccine), in June 2022. No additional domestic COVID-19 vaccines have been approved since.Under this program, government regulatory support will continue throughout the authorization process. The KDCA plans to operate a regular consultative body with the MFDS to address regulatory issues during clinical development. However, this consultative effort is intended to facilitate administrative review and does not automatically guarantee expedited approval.While some industry observers question the commercial rationale for developing a COVID-19 vaccine in the endemic era, both health authorities and industry experts prioritize securing the underlying mRNA platform rather than the COVID-19 candidate itself.mRNA represents a next-generation platform technology that allows rapid candidate design following the identification of pathogen gene sequences during future outbreaks of emerging infectious diseases. The platform holds immense strategic value, as it can be deployed against future variants, avian influenza (AI), and novel respiratory pathogens.A "Two-Track" strategy for new orphan drugs and vaccines...mRNA development expands vaccine competitivenessFor GC Pharma, the project means more than developing a COVID-19 product. The company is expanding its R&D under a two-track growth strategy encompassing both rare-disease therapeutics and preventive vaccines.In rare diseases, GC Pharma is pursuing marketing authorization for its Hunter syndrome therapy 'GC1123B'. It is also advancing global clinical trials for its Sanfilippo syndrome type A candidate ('GC1130A') and Fabry disease therapy ('GC1134A'). In vaccines, in addition to GC4006A, GC Pharma is developing a Tdap vaccine candidate ('GC3111B') and a two-dose varicella vaccine ('MG1111D'). MG1111D is undergoing Phase 3 clinical trials in Thailand and Vietnam, with preparations underway to enter Phase 3 trials in South Korea.If GC4006A successfully processes through commercial approval, GC Pharma will add a next-generation mRNA platform to its existing preventive vaccine portfolio. This addition is expected to advance its vaccine pipeline while significantly enhancing its competitiveness for future pandemic response.An industry source said, "While the commercial market for COVID-19 vaccines has downsized significantly since the pandemic, the strategic value of the mRNA platform has only intensified," and added, "As one of the few domestic companies capable of developing both therapeutics and vaccines in-house, securing an mRNA vaccine platform will strengthen GC Pharma's dual-track R&D strategy."
- Company
- Hanmi surpassed KRW 100B in technology fee revenue
- by Chon, Seung-Hyun Jul 30, 2026 09:09am
- Hanmi Pharmaceutical’s quarterly licensing revenue has surpassed KRW 100 billion for the first time in 11 years since 2015. The influx of a substantial upfront technology fee resulted from an out-licensing transaction with the global pharmaceutical giant Eli Lilly. Hanmi’s licensing revenues, which had fluctuated after exceeding KRW 500 billion in 2015, surged abruptly, resulting in an upward trend in the company’s financial performance.Hanmi Pharmaceutical According to Hanmi Pharmaceutical on the 29th, the company recorded KRW 112.8 billion in licensing revenue for the second quarter. This is a more than 50-fold jump from the KRW 2.2 billion posted in Q2 of last year. In contrast, the company’s licensing revenue in the first quarter of this year was just KRW 100 million.Hanmi secured an upfront payment from a licensing agreement with Eli Lilly. Last month, Hanmi entered into an exclusive out-licensing agreement with Eli Lilly for the development, manufacturing, and commercialization of its novel biopharmaceutical candidate, 'sonefpeglutide'. Hanmi secured a guaranteed upfront payment of $75 million (approximately 110 billion KRW) from Lilly. The company can receive up to an additional $1.185 billion (approximately KRW 1.8 trillion) upon achieving specified clinical development, regulatory approval, and commercialization milestones. Under the agreement, Hanmi will receive royalties following commercial launch. Sonefpeglutide is a novel drug candidate developed using LAPSCOVERY, Hanmi's proprietary long-acting platform technology. Focusing on the biological functions of glucagon-like peptide-2 (GLP-2), including promoting intestinal growth, reducing inflammation, and protecting and regenerating the intestinal mucosa, Hanmi conducted extensive non-clinical evaluations. The candidate is currently undergoing global Phase 2 clinical trials for the treatment of short bowel syndrome (SBS).Hanmi’s Q2 licensing revenue is the largest quarterly technology income in 11 years since Q4 2015, when it posted KRW 394.4 billion. After generating KRW 512.5 billion in total licensing revenue in 2015, Hanmi’s annual technology fee income had not surpassed KRW 100 billion until now. 2017's KRW 57.7 billion was the second highest.Following a series of mega-out-licensing deals in 2015, licensing revenue alone is a major cash cow for Hanmi.In 2015, upfront payments received from partners including Lilly, Boehringer Ingelheim, Sanofi, and Janssen generated a total of KRW 512.5 billion in licensing revenue. In 2016, KRW 27.7 billion in licensing revenue was recognized through tiered upfront payments from the Sanofi deal.Hanmi subsequently posted licensing revenues of KRW 57.7 billion in 2017, KRW 44.6 billion in 2018, and KRW 20.4 billion in 2019. During this period, upfront payments from Genentech were separately received. Hanmi signed a licensing agreement with Genentech in September 2016 for its RAF-targeted oncology candidate 'HM95573' ($80 million upfront, up to $830 million in milestones), recognizing the upfront payment on its books over 30 months. AI-generated image. Hanmi’s technology fee income by year (unit: KRW 100 million, source: Hanmi)In 2020, licensing revenue reached over KRW 10 billion, reflecting a $10 million upfront payment secured from MSD for epinopegdutide. Epinopegdutide is a dual GLP-1/glucagon receptor agonist that simultaneously stimulates insulin secretion and appetite suppression while increasing energy expenditure. In 2021, Hanmi generated KRW 22.7 billion in licensing revenue across two separate out-licensing transactions. In November 2021, the company licensed out 'HM43239', an FLT3 inhibitor in development for acute myeloid leukemia (AML), to US-based Aptose Biosciences. Under this deal, Hanmi received a fixed $12.5 million upfront payment (approx. KRW 15 billion), split into $5 million in cash and $7.5 million in Aptose stock. In late December 2021, Hanmi transferred exclusive Chinese rights to develop, manufacture, and commercialize the ophthalmic drug 'Luminate' to AffaMed Therapeutics, securing $6 million upfront. In 2023, Hanmi generated KRW 25.5 billion in licensing revenue. This included clinical milestones from MSD as epinopegdutide entered Phase 2b development, alongside sales royalties from its neutropenia treatment 'Rolvedon' following its US commercial launch. Rolvedon is a biopharmaceutical out-licensed by Hanmi to US-based Spectrum Pharmaceuticals in 2012.Last year, Hanmi entered into a global licensing agreement with Gilead Sciences and Health Hope Pharma, granting exclusive global rights for the development and commercialization of 'Encequidar', receiving an upfront payment of $2.5 million. Coupled with ongoing Rolvedon royalties, Hanmi posted KRW 16.6 billion in licensing revenue for the year.With the licensing revenue stream, Hanmi’s second-quarter operating profit expanded 116.9% year-over-year to KRW 131.1 billion, while total quarterly revenue surged 29.3% to KRW 467.2 billion. Both quarterly revenue and operating profit reached their highest levels since Q4 2015.
- Company
- Multinational pharmas transfer steady-selling brands to DKSH
- by Son, Hyung Min Jul 30, 2026 09:09am
- Major multinational pharmaceutical companies are increasingly outsourcing the sales and marketing of their long-established steady sellers that continue to maintain stable prescription demand even after patent expiry.In addition to signing simple transfers of product sales rights, the companies are also restructuring the organizations and personnel associated with those brands. The companies are increasingly concentrating their in-house capabilities on next-generation growth areas such as oncology, rare diseases and cell and gene therapies, while entrusting mature brands to specialized external partners.According to industry sources on the 30th, Novartis Korea is carrying out an organizational restructuring as it transfers the domestic commercial rights to the hypertension treatments Diovan (valsartan) and Exforge (valsartan/amlodipine) to DKSH Korea.Hypertension treatments Exforge, DiovanSome employees responsible for the products have reportedly been included in an early retirement program (ERP), and discussions are underway for others to transfer to DKSH Korea.The transaction is therefore leading not only to a change in the operator of the established brands but also to the redeployment of related organizations and personnel.Since exiting the respiratory business in 2022, Novartis Korea has been continuing the adjustment of its domestic portfolio, transferring its ophthalmology division to Santen Pharmaceutical last year. The latest organizational changes are seen as an extension of its effort to reshape the business around its growth areas.In 2024, AstraZeneca Korea transferred the hypertension treatments Atacand (candesartan) and Atacand Plus to DKSH.In the same year, Kyowa Kirin Korea transferred its prescription drug business, including the sales, academic support, distribution and marketing authorization for Romiplate (romiplostim), Nesp (darbepoetin alfa), Neulasta (pegfilgrastim), Regpara (cinacalcet) and Orkedia (evocalcet).With several flagship brands of multinational drugmakers transferred to DKSH over the past 2 years, the industry views the trend as a broader change in commercial strategy rather than a series of straightforward distribution agreements.Focuses on new drugs after ERP… outsources mature brandsProducts recently transferred to DKSH are all steady sellers that have all been on the market for a considerable period or that have lost patent protection.Atacand, Diovan and Exforge are established original brands in Korea’s hypertension market, while Nesp, Neulasta and Regpara also continue to generate steady prescriptions in their respective therapeutic areas. According to market research institution UBIST, combined sales of Diovan and Exforge reached KRW 110 billion last year, while Atacand and Atacand Plus generated KRW 34 billion.While it is difficult to expect rapid growth with these products, they are regarded as items that can secure stable sales. On the other hand, multinational pharmaceutical companies are reorganizing their organizations to focus their commercial capabilities on high-growth innovative drugs in areas such as oncology, rare diseases, cell and gene therapy, and obesity.Kyowa Kirin Korea transferred its prescription drug business in certain Asia-Pacific markets, including Korea, to DKSH in 2024 as part of a regional restructuring accompanied by an ERP.AstraZeneca Korea also implemented an ERP while divesting certain chronic disease products, and Novartis Korea is now adjusting its related organization alongside the transfer of Diovan and Exforge.Industry observers say voluntary retirement programs at multinational pharmaceutical companies should be seen not merely as workforce reductions, but as part of a process to reset the priorities of commercial organizations. Companies are retaining in-house responsibility for high-growth new drugs while using specialist partners to manage brands that have entered the mature stage of their life cycle.DKSH accelerates expansion of prescription drug businessThe shift reflects not only the strategies of multinational pharmaceutical companies but also DKSH’s efforts to expand its own business.Founded in Switzerland in 1865, DKSH currently operates in 35 markets. Its consolidated group revenue reached CHF 11.07 billion last year, with its Healthcare business unit contributing CHF 5.82 billion, or approximately 52.6% of the total.DKSH historically focused heavily on pharmaceutical distribution and supply chain management, but has recently been rapidly expanding its prescription drug commercialization business through its in-house sales and academic support organizations.For multinational pharmaceutical companies, using a specialist partner capable of handling sales, academic support, and distribution may be more efficient in terms of both cost and organizational management than maintaining a dedicated organization for each product.Some industry observers have suggested that DKSH may also have offered competitive contract terms as part of its business expansion, although specific details of the agreements have not been disclosed.Role expands beyond sales and distribution to reimbursementSevere aplastic anemia drug RomiplateDKSH’s role is also expanding beyond sales and distribution to encompass academic support, market access and post-approval commercialization.Romiplate is a representative example. After taking over Kyowa Kirin Korea’s prescription drug business, DKSH also worked on expanding reimbursement for the product.Reimbursement for Romiplate was recently expanded to cover its use in combination with immunosuppressive therapy as first-line treatment for patients with severe aplastic anemia who had not previously received treatment.The case shows that DKSH’s responsibilities after a business transfer extend beyond maintaining sales of existing products to broader commercialization activities. However, rather than interpreting the reimbursement expansion as the achievement of any one company, the significance lies in the widening scope of responsibilities being entrusted to external partners.DKSH’s global headquarters is also expanding its role as an Asia commercialization partner for biotechnology companies that may find it difficult to establish their own local commercial organizations.The company entered into a strategic partnership with US-based BridgeBio Pharma to support the approval and commercialization of Attruby (acoramidis), a treatment for transthyretin amyloid cardiomyopathy, in Korea, Australia, Singapore and Taiwan. In Korea, DKSH will be responsible for marketing authorization, market access and launch support.DKSH has also signed an exclusive distribution agreement with Xcell Therapeutics for India, where it will handle local sales of chemically defined media for cell and gene therapy.
- Company
- Organon commences exclusive sales of Atozet and Vytorin
- by Kim, Jin-Gu Jul 29, 2026 08:50am
- Product photo of ‘Atozet’ and ‘Vytorin’Organon Korea and Chong Kun Dang Pharmaceutical are terminating their co-promotion agreement for the dyslipidemia therapies 'Atozet' and 'Vytorin'. According to pharmaceutical industry sources on the 28th, Organon Korea recently announced on its internal notice board that, following strategic business discussions with Chong Kun Dang, the two companies agreed to terminate their co-promotion agreement for Atozet and Vytorin, effective July 31. Consequently, starting August 1, Organon Korea will be responsible for all distribution, sales, and marketing operations for both products.Atozet and Vytorin are ezetimibe-based lipid-lowering combination drugs. Atozet is a combination therapy containing ezetimibe with atorvastatin, while Vytorin combines ezetimibe with simvastatin. Both therapies work by a dual-inhibition mechanism that simultaneously suppresses cholesterol absorption in the intestines and cholesterol synthesis in the liver. The partnership between the two companies commenced in January 2016 through a co-promotion agreement between MSD Korea and Chong Kun Dang. Following Organon's spinoff from MSD in 2021, the partnership was maintained, continuing their collaboration for a full decade.The collaboration between Chong Kun Dang’s strong primary care clinic sales network and MSD/Organon’s original branding yielded synergy, establishing Atozet as a blockbuster therapy generating over KRW 100 billion in annual prescription sales. The termination of the agreement is expected to have a different impact on the future sales strategies, marketing operations, and financial performance of both firms. Organon Korea, transitioning to a direct, sole-commercialization model, is expected to maximize product profit margins. The company aims to improve profitability after eliminating co-promotion commission payments previously disbursed to Chong Kun Dang.However, a key challenge for Organon Korea will be whether its internal sales department can effectively bridge the gap left by Chong Kun Dang’s extensive primary care clinic sales infrastructure. Given that the dyslipidemia market heavily relies on clinic-level prescriptions, defending market share during the initial transition to direct sales will be the primary goal.Quarterly prescription sales for ‘Atozet’ and ‘Vytorin’ (unit: KRW 100 million, source: UBIST). GREEN-Atozet, RED-VytroinConversely, Chong Kun Dang is expected to transition its commercial focus toward its proprietary generic version, 'Lipilouzet'. Chong Kun Dang secured regulatory approval for Lipilouzet in October 2020 and currently serves as a contract manufacturing organization (CMO), producing the same generic formulation for 19 other pharmaceutical companies. While co-promoting a major original blockbuster drug helps sustain overall sales scale, sharing margin cuts reduces profitability. In contrast, commercializing its own generic, Lipilouzet, alongside generating CMO revenues from third-party partners, offers significantly higher profit margins. Thus, while Atozet's departure will temporarily reduce Chong Kun Dang's sales volume, the company anticipates improved overall operating margins, driven by a higher proportion of high-margin products.According to the pharmaceutical market research firm UBIST, Atozet recorded KRW 66.9 billion in prescription sales during the first half of this year, marking a 7% year-over-year (YoY) increase from the KRW 62.5 billion sales in H1 of last year. Over the same period, Vytorin’s prescription sales dropped 16% from KRW 6.0 billion to KRW 5.0 billion, while Chong Kun Dang’s Lipilouzet showed a 35% YoY surge, an increase from KRW 1.5 billion to KRW 2.0 billion.
- Company
- "RSV prevention option for infants has been added"
- by Son, Hyung Min Jul 29, 2026 08:50am
- A new treatment option has entered South Korea's infant respiratory syncytial virus (RSV) prophylaxis market.Following domestic regulatory authorization of MSD Korea's long-acting antibody injection 'Enflonsia (clesrovimab)', competition in the infant RSV market is set to intensify alongside Sanofi and AstraZeneca's 'Beyfortus (nirsevimab)'.On the 29th, MSD Korea hosted a press conference at The Plaza Hotel in Jung-gu, Seoul, to celebrate the domestic approval of Enflonsia.Professor Ki Wook Yoon of the Department of Pediatrics at Seoul National University College of MedicineEnflonsia was approved in South Korea on the 1st of last month as a long-acting preventive monoclonal antibody indicated for the prevention of RSV-induced lower respiratory tract disease (LRTD) in newborns and infants. The antibody is distinguished by its fixed-dose administration design, which requires no weight-based dosage adjustments. Providing sustained protective efficacy for 5 to 6 months post-injection, a single dose delivers comprehensive coverage throughout an entire RSV epidemic season.In South Korea, RSV typically peaks between October and March. Enflonsia can be administered immediately at birth for newborns during the active season, or as a single dose before the start of the first RSV season for infants born during off-season months. RSV infections initially present with mild, cold-like symptoms. The infections frequently progress to severe lower respiratory tract complications, such as acute bronchiolitis and pneumonia, in infants under one year of age, often requiring emergency intervention and inpatient hospitalization.Professor Ki Wook Yoon of the Department of Pediatrics at Seoul National University College of Medicine (Public Relations Director of the Korean Society of Pediatric Infectious Diseases) stated, "Young infants are exceptionally vulnerable to severe RSV disease due to their immature immune systems and narrow airway anatomy," and added, "When infection progresses to severe lower respiratory disease requiring medical management, the clinical burden centers heavily on acute hospitalizations."Professor Yoon added, "Infant RSV prophylaxis strategies must expand beyond simply blocking initial transmission to substantially mitigating the burdens experienced by pediatric patients and their families, including acute hospital admissions and severe lower respiratory tract illness."According to a nationwide Korean study (2007–2019) published last year, which analyzed National Health Insurance (NHI) claims data, 44.7% of pediatric RSV cases in South Korea under age 5 required hospitalization.Infants aged 6 to 11 months were the most heavily impacted cohort, accounting for 48.2% of total RSV hospitalizations and 57.3% of intensive care unit (ICU) admissions among children under 5. Infants under 6 months of age demonstrated the longest average hospital stay at approximately 8.35 days.In the Phase 2b/3 CLEVER clinical trial, a single dose of Enflonsia reduced the incidence of RSV-associated medically attended lower respiratory tract infections by 60.5%. It decreased the risk of RSV-associated hospitalizations by 84.3%.Furthermore, in the Phase 3 SMART trial evaluating high-risk infants and young children, Enflonsia demonstrated a safety profile comparable to the existing standard-of-care RSV antibody, 'Synagis (palivizumab)', confirming consistent preventive efficacy.Professor Yoon noted, "Because the burden of RSV hospitalizations and severe lower respiratory tract disease concentrates heavily during an infant's first year of life, evaluation of preventive interventions must consider how effectively they reduce medically attended severe disease and hospital admissions alongside overall infection rates."Professor Yoon concluded by emphasizing, "Given that Enflonsia demonstrated efficacy in reducing RSV-related lower respiratory infections as well as hospitalizations, the evidence demonstrates the clinical value of this drug as an essential preventive option capable of alleviating the overall disease burden for infants entering their first RSV season."
- Company
- Pharma companies accelerate investment in future growth
- by Cha, Ji-Hyun Jul 29, 2026 08:49am
- Major Korean pharmaceutical and biotechnology companies are moving to expand production and research facilities. Their investments range from trillion-won biologics manufacturing plants to large-scale research complexes. The strategy is to use accumulated cash-generation capacity and financial headroom to expand production and prepare proactively for future demand.According to the Financial Supervisory Service on the 28th, GC Biopharma recently decided to invest KRW 140 billion in a new production line at its Ochang plant in North Chungcheong Province. The investment is equivalent to 10% of the company’s consolidated equity as of the end of last year and will run through the end of 2030.The project is intended to establish a production base for a subcutaneous formulation of the immunoglobulin therapy Alyglo. Alyglo is a plasma-derived product manufactured by isolating and purifying immunoglobulin from blood plasma and is used to treat primary immunodeficiency diseases, including congenital immunodeficiency. GC Biopharma is developing a subcutaneous version of Alyglo, which is currently administered intravenously, to improve convenience for patients. The company aims to submit a Phase III clinical trial application to the US Food and Drug Administration next year. The new line is intended to secure production capacity in advance of commercialization and anticipated growth of US demand.Ahn-Gook Pharm held a board meeting on the 14th and approved a KRW 48.5 billion investment to expand its Hyangnam plant in Hwaseong, Gyeonggi Province. The amount is equivalent to 29% of consolidated equity as of the end of last year.The investment will be made in the plant located in the pharmaceutical industrial complex in Hyangnam-eup, Hwaseong. Construction began that day and is scheduled for completion by the end of December next year. The company said the expansion is being made to increase production capacity.Chong Kun Dang will build a biopharmaceutical research complex in the Baegot district of Siheung, Gyeonggi Province. The facility investment totals KRW 392.5 billion, equivalent to 39% of consolidated equity as of the end of last year. The company will continue investment through the end of August 2028.The project covers a 79,790.8㎡ site near 302 Baegot-dong, Siheung. Chong Kun Dang previously acquired the site for KRW 94.9 billion in June last year. The company plans to create an integrated research complex comprising biopharmaceutical research facilities, a research support center and R&D validation facilities.The new complex will conduct research and development of next-generation therapies, including cell and gene therapies, antibody-drug conjugates, recombinant proteins and bispecific antibodies. Chong Kun Dang also plans to establish an AI-enabled drug discovery platform and develop the site into an R&D hub linking candidate discovery, research, development and validation in one location. Collaboration is also expected with the nearby Seoul National University Hospital in Siheung Baegot, as well as companies and research institutes.These are not the only companies undertaking large-scale facility investments. Pharmaceutical and biotechnology companies have announced a series of investments in production and research facilities this year.HK inno.N will invest KRW 97 billion to build a new solid oral dosage manufacturing facility with a total floor area of 12,561.98㎡ on the remaining land at its Osong plant in North Chungcheong Province. The investment will continue through the end of January 2028. The company plans to secure medium- and long-term growth engines and strengthen competitiveness by expanding production capacity.Celltrion will invest KRW 1.2265 trillion to build its fourth and fifth plants at its Songdo campus in Incheon. It plans to apply automation systems and smart factory technologies to the new facilities to improve production efficiency and process flexibility. The plants will be designed to accommodate production ranging from small-volume, multi-product manufacturing to large-scale commercial output. They will be used not only for established flagship products but also for follow-on biosimilars and new drug pipelines.Celltrion is also expanding both drug substance (DS) and drug product (DP) manufacturing capacity in the US and Korea. At its DS plant in Branchburg, New Jersey, the company has increased the scale of the planned expansion to add 75,000 liters of capacity. Once completed, capacity will rise from 66,000 liters to over 141,000 liters. When the fourth and fifth Songdo plants are also completed, Celltrion’s total DS production capacity will increase from 316,000 liters to 571,000 liters.In the DP segment, a new plant at the Songdo campus is scheduled for completion this year. The facility will be able to produce 6.5 million liquid vials annually. Combined with the existing production line at Plant 2, annual capacity in Songdo will rise to 10.5 million vials. Celltrion has also selected a site for a new DP plant in the Yesan Industrial Complex in South Chungcheong Province and plans to begin design work this year. The group expects to be able to manufacture approximately 90% of global DP demand in-house once Celltrion Pharm completes the expansion of its prefilled syringe production facilities.BTGEN, formerly STgen Bio and a subsidiary of Dong-A Socio Holdings, will also invest KRW 109 billion to expand its biologics manufacturing facilities. The investment includes the expansion of buildings and production equipment and will continue through the end of March 2028. BTGEN plans to increase its biologics manufacturing capacity through the project.Industry observers attribute this acceleration in future investment to the back of strong earnings made by Korean pharmaceutical and biotechnology companies.Celltrion posted consolidated revenue of KRW 1.3937 trillion and operating profit of KRW 451.8 billion in Q2, up 45% and 86%, respectively, year over year. In addition to solid sales of existing flagship products, increased revenue from higher-margin new biosimilars such as Remsima SC and Yuflyma drove the company’s earnings growth.Profitability also improved significantly as the rising contribution of new products coincided with the depletion of high-cost inventory and better production yields. 1H operating profit rose 97% year over year to KRW 773.7 billion, while the operating margin increased by 9 percentage points to 31% from 22% a year earlier.HK inno.N is also maintaining earnings growth on the back of strong prescription drug sales. Q1 revenue rose 5% year over year to KRW 258.7 billion, while operating profit increased 31% to KRW 33.2 billion. The improvement was driven by broad growth across its prescription drug business, including IV solutions, cardiovascular drugs and oncology products. Q1 IV solution sales rose 11% year over year to KRW 37.1 billion, while cardiovascular sales increased 10% to KRW 73 billion. Oncology sales climbed 34% to KRW 29.2 billion with the addition of the in-licensed drug Avastin.Ahn-Gook Pharm also expanded its investment capacity on the back of improved earnings. Consolidated Q1 revenue increased 31% year over year to KRW 98.9 billion, while operating profit surged 174% to KRW 16 billion. Its operating margin stood at 16.2%. The company’s earnings improvement was driven by simultaneous growth in its flagship prescription drug and health and beauty businesses.Chong Kun Dang’s consolidated Q1 revenue increased 12% year over year to KRW 447.8 billion, while operating profit rose 13% to KRW 14.1 billion. GC Biopharma’s consolidated Q1 revenue increased 14% to KRW 435.5 billion, while operating profit rose 47% to KRW 11.7 billion.BTGEN is also among the companies that have posted rapid earnings growth. Its revenue increased 76% year over year to KRW 103.7 billion last year, while operating profit surged 318% to KRW 7.1 billion. Basically, the company’s revenue nearly doubled and operating profit more than quadrupled in one year. Increased global commercial production of the Stelara biosimilar Imuldosa and higher exports of an anemia treatment biosimilar drove the company’s growth. However, in Q2 this year, revenue fell 45% year over year to KRW 13.7 billion and operating profit declined 90% to KRW 400 million, with orders from major customers concentrated in 2H.The sector is regarded as establishing a virtuous cycle in which funds generated through stronger earnings are being reinvested in production and research facilities. The companies aim to use expanded capacity to meet future demand for biologics and prescription drugs and convert that demand into further revenue and profit growth. Expectations are growing that their large-scale expansion projects will help them capture future demand and further strengthen their medium- and long-term growth foundations.
- Company
- RSV market competition intensifies in Korea
- by Son, Hyung Min Jul 29, 2026 08:49am
- The respiratory syncytial virus (RSV) prevention market is rapidly expanding across both adult and infant populations. In adults, GSK and Moderna are competing with vaccines, while in infants, Sanofi and MSD are competing with long-acting preventive antibody injections, with Pfizer’s maternal immunization vaccine also expected to enter the market.With RSV prevention options becoming more diverse, calls are growing for financial support through inclusion in the National Immunization Program (NIP) or National Health Insurance reimbursement to enable broader market uptake. In particular, because preventive antibody injections for infants are medicines rather than vaccines, policymakers still need to determine whether their access should be expanded through the NIP or health insurance reimbursement.According to industry sources on the 29th, competition is rapidly taking shape in Korea’s RSV prevention market, especially around adult vaccines and preventive antibody injections for infants.In the adult market, GSK’s Arexvy is competing with Moderna’s mRESVIA. In the infant market, MSD Korea’s Enflonsia (clesrovimab) has received domestic authorization following Sanofi’s Beyfortus (nirsevimab). Pfizer’s RSV vaccine for pregnant women, Abrysvo, is also reportedly nearing approval in Korea.RSV generally causes mild cold-like symptoms, but in infants, older adults, and patients with chronic diseases, it can progress to lower respiratory tract diseases such as bronchiolitis or pneumonia. Infants entering their first RSV season are particularly vulnerable because their immune systems are not fully developed and their airways are narrow, increasing the risk of severe disease and hospitalization.A study analyzing Korean National Health Insurance claims data found that as many as 18,434 RSV cases occurred annually among children under five from 2007 to 2019, and 44.7% of all patients were hospitalized.Infants aged 6 to 11 months accounted for 48.2% of RSV hospitalizations and 57.3% of intensive care unit admissions. Patients under 6 months had the longest average hospitalized days at 8.35 days, indicating a burden not only on infant health but also on caregiver responsibilities and healthcare resources.Indication for GSK’s Arexvy expands to high-risk adults…builds long-term protection evidenceGSK’s Arexvy, Moderna’s mRESVIAIn the adult RSV vaccine market, the expansion of Arexvy’s indication is expected to reshape the competitive landscape.GSK recently expanded the indication for Arexvy to high-risk adults aged 18 to 49. In addition to adults aged 60 and older and high-risk adults aged 50 to 59, the vaccine now covers adults aged 18 and older at increased risk of severe RSV due to chronic respiratory disease, cardiovascular disease, diabetes, chronic kidney disease, or immunocompromising conditions.The expanded indication was based on a global Phase IIIb trial in high-risk adults aged 18 to 49. The study compared immune responses in this population with those in adults aged 60 and older and demonstrated non-inferiority. The safety profile was also comparable to that observed in previously vaccinated groups.Arexvy has also generated evidence of efficacy and long-term protection in older adults. In the Phase III AReSVi-006 trial, its efficacy against RSV-associated lower respiratory tract disease during the first RSV season was 82.6% among adults aged 60 and older. The prevention effect was 94.6% among adults with at least one underlying condition.Long-term follow-up showed cumulative efficacy of 62.9% over three RSV seasons after a single dose, while efficacy against severe RSV-associated lower respiratory tract disease was 67.4%. Although efficacy declined over time, the vaccine demonstrated protection across 3 seasons without a booster dose.Moderna entered the competition with mRESVIA, which uses an mRNA platform. The vaccine is designed to produce the RSV F protein and is differentiated by extending the mRNA platform technology accumulated through COVID-19 vaccines to RSV prevention.In Korea, mRESVIA is approved for preventing RSV-associated lower respiratory tract disease in adults aged 60 and older. Whether the indication will be expanded beyond older adults to younger high-risk groups, such as chronic disease and immunocompromised patients, is expected to be a key variable in the adult market.Sanofi and MSD compete with preventive antibody injections…highlights reductions in hospitalization and severe diseaseIn the infant market, long-acting monoclonal antibodies formed the competitive landscape rather than vaccines.Sanofi’s Beyfortus is a preventive antibody injection that directly administers antibodies to newborns and infants entering their first RSV season, providing protection immediately after infection. A single dose is designed to maintain protection for approximately 5 months.RSV preventive antibody injections Beyfortus, EnflonsiaBeyfortus can be used not only in infants during their first RSV season but also in children under 24 months who remain at high risk of severe disease during their second season. The dose during the first season varies according to body weight, while a separate dose is used for high-risk children during the second season.MSD Korea entered the infant RSV preventive antibody market after receiving domestic approval for Enflonsia in June.Enflonsia is approved to prevent RSV-associated lower respiratory tract disease in newborns and infants entering their first RSV season or born during the season. It can be administered once at a fixed dose of 105 mg regardless of body weight, with protection lasting for at least 5-6 months.The global Phase IIb/III CLEVER trial supporting approval enrolled approximately 3,600 healthy preterm and full-term infants born at 29 weeks of gestation or later across 22 countries, including Korea.The study showed that Enflonsia reduced the risk of medically attended RSV-associated lower respiratory tract infection by 60.4% versus placebo through 150 days after administration. During the same period, it reduced the risk of RSV-related hospitalization by 84.2%. Through 180 days, it lowered the risk of medically attended severe RSV-associated lower respiratory tract infection by 91.7%.In the safety analysis, more than 96% of reported adverse events were mild or moderate.In the Phase III SMART trial involving preterm infants and infants with chronic lung disease or congenital heart disease who were at high risk of severe RSV, Enflonsia showed a generally similar safety profile to the established preventive antibody injection Synagis (palivizumab).Enflonsia’s fixed-dose regimen is expected to simplify administration in clinical practice as there is no need to calculate the dose based on body weight or prepare different product presentations; it may improve convenience at healthcare institutions treating infants of varying birth dates, lunar ages and weights.MSD Korea is also seeking to expand Enflonsia’s indication beyond the first RSV season to include children at high risk of severe disease during their second season.The company has obtained follow-up data from the Phase III SMART trial in children under 2 years of age who remained at high risk across two RSV seasons. Among children given Enflonsia during their second season, blood drug concentrations were similar to those observed in healthy infants during their first season, while the safety profile remained consistent with earlier results.If the indication is expanded to high-risk infants in their second season, the scope of competition with Beyfortus, which already holds that indication, is also expected to widen.Pfizer’s Abrysvo nears approval… adding maternal immunization strategyRSV vaccine AbrysvoPfizer is preparing to enter the infant RSV prevention market with a maternal immunization strategy that differs from those of preventive antibody injections.Abrysvo is administered to pregnant women so that antibodies generated by vaccination are transferred to the fetus through the placenta. Unlike preventive antibody injections administered directly to infants after birth, the vaccine is designed to provide passive immunity against RSV from birth through vaccination during pregnancy.In the US, Abrysvo was approved in 2023 for administration to pregnant women at 32 to 36 weeks of gestation to prevent RSV-associated lower respiratory tract disease and severe lower respiratory tract disease in infants through six months of age. It was the first vaccine approved to prevent RSV in infants through maternal immunization.In the Phase III MATISSE trial supporting approval, vaccination during pregnancy reduced the risk of severe RSV-associated lower respiratory tract disease in infants by 81.8% through 90 days after birth. Efficacy through 180 days was 69.4%.Abrysvo is also expected to receive approval in Korea soon. Once approved, infant RSV prevention will be divided between direct administration of a long-acting antibody after birth and transfer of antibodies before birth through maternal vaccination.Because the 2 strategies differ in their target populations and timing of administration, they are likely to be selected based on maternal vaccination status, the infant’s birth timing, underlying conditions and risk of severe disease rather than serving as complete substitutes.Prevention options become available… NIP and insurance coverage remain market variablesAs RSV prevention products become available across adult and infant populations, attention is shifting to their funding mechanisms.Given Korea’s transition to a super-aged society and the burden of hospitalization and mortality among older adults, the possible inclusion of RSV vaccines for older adults in the NIP may eventually be discussed. However, additional policy evidence is needed regarding the domestic disease burden, cost-effectiveness, and priority vaccination groups.The framework for preventive antibody injections in infants is more complex. Beyfortus and Enflonsia are used to prevent infection but are monoclonal antibodies rather than vaccines. Policymakers must therefore determine whether they should be included in the NIP for government purchase and supply or covered through health insurance and prescribed by healthcare institutions.The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommends long-acting preventive antibody injections for infants under 8 months who are entering or are already in their first RSV season. Overseas, preventive antibodies are increasingly being incorporated into public health prevention strategies.At a press conference held on the 28th to mark Enflonsia’s approval, MSD Korea also emphasized the need to secure access through either NIP inclusion or health insurance coverage.Discussions on institutional access in Korea’s RSV prevention market may therefore initially progress more rapidly in the infant segment. The government has historically prioritized the pediatric NIP over vaccination programs for older adults.With the hospitalization and severe disease burden of RSV in infants already established and multiple products demonstrating preventive efficacy, calls for financial support are increasing. Sanofi and MSD are exploring potential NIP inclusion or health insurance coverage for their preventive antibodies. Once Prizer receives approval for Abrysvo in Korea, policy discussions on infant RSV prevention are expected to broaden to include maternal immunization.
- Company
- Daiichi Sankyo's major cardiovascular drugs hit by supply shortages
- by Son, Hyung Min Jul 28, 2026 12:01pm
- Supply shortages of Daiichi Sankyo Korea’s major cardiovascular drugs are placing increasing pressure on medical sites.Production and shipment schedules have been delayed due to maintenance work at the company’s overseas manufacturing facility, resulting in simultaneous supply disruptions for the anticoagulant ‘Lixiana (edoxaban),’ the triple-combination antihypertensive ‘Sevikar HCT (olmesartan/amlodipine/hydrochlorothiazide),’ and the antiplatelet agent Efient (prasugrel).Although severity varies by product and strength, supplies of some products have deteriorated to the point that inventories are scarce across distribution channels. Hospitals, clinics, and pharmacies have reportedly been checking remaining stock or considering alternative therapies in an effort to maintain existing prescriptions.According to industry sources on July 28, supply shortages of Lixiana, Sevikar HCT, and Efient have persisted since last month.(Clockwise from the left) Lixiana, Sevikar HCT, and EfientDaiichi Sankyo Korea attributed the disruption to maintenance work at its manufacturing facility in Germany, which delayed production and shipments. The manufacturing issue is understood to be affecting product supplies not only in Korea but also across global markets.A Daiichi Sankyo Korea official said, "The products are not completely out of stock, but we have been unable to distribute enough inventory to meet market demand. However, we assess that the supply issues are gradually easing."Lixiana is currently experiencing the most severe supply shortage. Inventories of Lixiana 15mg and 30mg have virtually been depleted, and it is understood that even 60mg, which had relatively remaining stock, is left with almost no supply capacity.Some healthcare institutions are receiving limited quantities that can only meet individual patient prescriptions. Even major wholesalers and the distribution network of Daewoong Pharmaceutical, which co-promotes the product, have been unable to secure sufficient inventories, making it difficult to fulfill orders from medical institutions.Lixiana is a direct oral anticoagulant (DOAC) indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and to treat deep vein thrombosis and pulmonary embolism. Because anticoagulants are often taken continuously over the long term, supply interruptions may force physicians to switch patients to alternative products within the same class.Sevikar HCT and Efient are also experiencing varying degrees of shortages depending on the strength, but overall, supplies remain insufficient to fully meet demand.Sevikar HCT is an olmesartan-based triple-combination antihypertensive, while Efient is an antiplatelet therapy used to prevent thrombotic cardiovascular events in patients with acute coronary syndrome.Because all three products are maintenance therapies for patients with cardiovascular disease, prolonged supply disruptions could further increase the burden on-site. Even when alternative products or therapies are available, treatment changes must be made carefully based on each patient's clinical condition and response to previous therapy.A distribution industry official said, "Lixiana 15 mg and 30 mg are virtually impossible to obtain, and inventories of the 60 mg strength are also running very low. Even when hospitals place orders, they are often supplied with only part of the requested quantity or with only the minimum amount needed for individual patients."The official added, "Neither wholesalers nor the co-promotion partner have sufficient inventories, suggesting that this is not a problem at a particular distribution stage but rather an overall product supply shortage. The disruption has continued for more than a month, and uncertainty over when supplies will normalize is increasing anxiety in the field."Some speculate the shift in business strategy had an effect… industry eyes timing of supply normalizationThe situation has also prompted speculation that, beyond temporary production issues, changes in Daiichi Sankyo's business priorities may have contributed to the shortage.As competition in the Lixiana market is set to intensify with generic versions of Lixiana expected to enter Korea's National Health Insurance reimbursement system in the second half of the year, Daiichi Sankyo has been focusing its investments on oncology, particularly antibody-drug conjugates (ADCs).The company has been expanding its global oncology business around ‘Enhertu (trastuzumab deruxtecan)’ and ‘Datroway (datopotamab deruxtecan)’ while also accelerating the development and commercialization of follow-on ADCs. As a result, some have questioned whether production and supply of cardiovascular products approaching patent expiry have become a lower priority than in the past.However, as this supply delay is known to have occurred simultaneously in the global market rather than being limited to South Korea, the prevailing view is that it is difficult to interpret it as being directly linked to patent expirations or domestic sales strategies. There is little evidence to suggest the company intentionally reduced supplies to the Korean market because of patent expiration or domestic commercial strategy.The key question now is when supplies will return to normal. If the disruption continues, it could increase the burden of switching prescriptions for hospitals and pharmacies while also causing inconvenience for patients who have been taking these therapies over the long term.Daiichi Sankyo Korea is reportedly coordinating the timing for resuming domestic supply based on the completion of maintenance work at the manufacturing facility and product-specific shipment schedules.
- Company
- Sales of 7 Celltrion products surpass ₩100 Billion in 1H
- by Chon, Seung-Hyun Jul 28, 2026 08:57am
- Celltrion's recently launched products have become a major growth engine. In the first half of this year, sales from newer products exceeded those of legacy products by more than 60%. 8 of the company's 9 newer products recorded year-on-year sales growth, more than compensating for the stagnation of older products and driving overall revenue growth. The strong performance of higher-margin products also significantly improved profitability.According to Celltrion on July 27, seven of its 12 marketed products generated more than KRW 100 billion in sales during the first half of the year.The products are: Remsima, Truxima, Remsima SC, Yuflyma, Omlyclo, Stoboclo/Osenvelt, and Vegzelma.Celltrion has obtained regulatory approvals in Europe and the US for Remsima, Herzuma, Truxima, Remsima SC, Zymfentra, Yuflyma, Vegzelma, Steqeyma, Stoboclo/Osenvelt, Omlyclo, Avtozma, and Eydenzelt.Remsima is a biosimilar referencing the autoimmune disease therapy Remicade. Herzuma and Truxima are biosimilars of the oncology drugs Herceptin and MabThera, respectively. Remsima SC is a subcutaneous (SC) formulation developed by Celltrion by converting the original intravenous (IV) formulation of Remsima. In the US, Remsima SC received new drug approval under the brand name Zymfentra.Yuflyma is a biosimilar version of the autoimmune therapy Humira. Vegzelma and Steqeyma reference the original drugs Avastin and Stelara, respectively. Stoboclo and Osenvelt are biosimilars of the bone disease therapies Prolia and Xgeva. Omlyclo is a biosimilar version of the allergy and asthma treatment Xolair, while Avtozma and Eydenzelt reference the original products Actemra and Eylea, respectively.AI-generated imageThe growth momentum of newer products significantly outpaced that of the legacy portfolio.Celltrion classifies Remsima, Herzuma, and Truxima, which were launched during the early stages of its biosimilar business, as legacy products. Biologics introduced since 2020—including Remsima SC, Yuflyma, Vegzelma, Steqeyma, Stoboclo/Osenvelt, Omlyclo, Avtozma, and Eydenzelt—are categorized as newer products.Sales from the newer portfolio rose 72.0% year over year to KRW 1.4061 trillion in the first half, up from KRW 817.3 billion a year earlier. In contrast, combined sales of the 3 legacy products edged down 0.4% to KRW 832.0 billion from KRW 835.3 billion. Sales of newer products exceeded those of legacy products by 69.0%, underscoring their role as the primary driver of the company's growth.Among the three legacy products, only Truxima posted sales growth during the first half. Truxima generated KRW 288.8 billion in sales, up 24.8% year over year. Meanwhile, sales of Remsima and Herzuma declined 6.4% and 27.3%, respectively.8 of the 9 newer products recorded higher sales in the first half of this year than last year.Remsima SC generated KRW 356.7 billion in first-half sales, up 20.3% year over year. Yuflyma’s sales increased 21.4% to KRW 309.5 billion from KRW 254.9 billion generated last year.Omlyclo and Stoboclo/Osenvelt reported eightfold and fifteenfold increases in sales, respectively, surpassing KRW 100 billion in half-year sales for the first time. Although Vegzelma's first-half sales declined 17.5% year over year to KRW 114.7 billion, it also exceeded the KRW 100 billion mark.Newer products accounted for 65% of Celltrion's sales in the second quarter of this year, up from 53% in the same period last year.The expanding contribution of newer products is directly enhancing the company’s profitability. Most of Celltrion's recently launched products are sold through the company's own direct sales infrastructure, a structure that delivers higher margins than sales conducted through overseas commercial partners.In the first half, Celltrion posted operating profit of KRW 773.7 billion, up 97.4% year over year, while revenue increased 40.8% to KRW 2.5387 trillion. Its operating margin improved to 30.5% in H1 from 21.7% a year earlier, representing an increase of 8.8 percentage points year over year.
- Company
- Calls for reform in NHI access for third-line mCRC treatment
- by Son, Hyung Min Jul 27, 2026 08:43am
- There is a growing demand in South Korea to improve access to third-line treatments under the National Health Insurance (NHI) for metastatic colorectal cancer (mCRC) to enhance patient survival.While health insurance coverage is relatively comprehensive for first- and second-line treatments in South Korea, global standard-of-care agents used in subsequent lines remain non-reimbursed. In response, health authorities have acknowledged the high unmet medical need in third-line treatment, stating that they are evaluating measures to improve patient access.On the 24th, a symposium titled "Policy Forum for Improving the Treatment Environment for Metastatic Colorectal Cancer Where Early Treatment Access Determines Survival" was held at the National Assembly, hosted by Representative Mihwa Seo of the Democratic Party of Korea.Rep. Seo stated, "In metastatic colorectal cancer, treatment timing and therapeutic access exert a direct impact on overall survival, yet reimbursed options in third-line are not available in South Korea," and added, "A rational reimbursement framework must be established to prevent patients from forfeiting treatment due to financial toxicity."A policy symposium on improving the treatment environment for metastatic colorectal cancer was held on July 24 at the National Assembly Members' Office Building.Third-line treatments are not reimbursed...Leading to drops in treatment ratesPresenting at the forum, Professor Myung Ah Lee of the Division of Oncology at Seoul St. Mary's Hospital diagnosed that as patients with metastatic colorectal cancer progress through sequential lines of therapy, acquired resistance and disease progression progressively deteriorate their systemic performance status. Dr. Lee explained that non-reimbursed drug costs starting at the third-line setting lead to a sharp decline in the proportion of patients maintaining ongoing treatment.Professor Lee pointed out, "Reimbursement is well-integrated through first- and second-line systemic chemotherapy, resulting in a manageable financial burden for patients. However, from the third-line setting onward, patients with good performance status are frequently unable to receive treatment simply because no reimbursed agents exist," and added, "An increasing number of patients are discontinuing treatment despite viable therapeutic opportunities due strictly to financial constraints."Currently, first-line therapy for metastatic colorectal cancer primarily utilizes oxaliplatin- or irinotecan-based cytotoxic chemotherapy in combination with targeted biologics. Second-line treatment involves switching to the alternative chemotherapy backbone not administered in the first-line setting.However, the treatment landscape shifts dramatically following failure of both lines. While a small subset of patients with specific biomarkers can access immune checkpoint inhibitors or targeted agents, the eligible patient population remains narrow.For the majority of patients, global standard-of-care regimens recommended in guidelines, such as the combination of 'Lonsurf (trifluridine/tipiracil)' plus 'Avastin (bevacizumab)', 'Stivarga (regorafenib)', and 'Fruzaqla (fruquintinib)', are all non-reimbursed in South Korea.Professor Lee emphasized, "In the U.S. and Europe, Stivarga, Lonsurf-Avastin combination, and Fruzaqla are recommended from the third-line setting, but none of these regimens are reimbursed in South Korea," and added, "We need a regulatory environment where therapeutics capable of preserving quality of life alongside overall survival can enter the national health insurance benefit umbrella more rapidly."Access to Next-Generation Sequencing (NGS) testing for precision oncology was also pointed out to be resolved, as the absence of genomic profiling data restricts patient eligibility for biomarker-driven novel drugs and clinical trial enrollment.Professor Lee stated, "While international practice is moving toward routine genomic profiling for patients with metastatic or recurrent solid tumors, domestic reimbursement in Korea remains restricted outside of specific cancer types," and expressed concerns that "Consequently, patients who wish to participate in clinical trials for novel therapies often cannot enroll due to a lack of genetic sequencing results."Experts urged that even in third-line and subsequent settings, clinicians must have the therapeutic flexibility to decide the sequence of care based on patient performance status, prior treatment history, and specific toxicity profiles.Professor Dong-Hoe Koo of the Division of Hematology-Oncology at Kangbuk Samsung Hospital explained, "Each therapeutic option possesses distinct efficacy as well as unique toxicity profiles, such as fatigue, thrombocytopenia, hand-foot syndrome, and hypertension,” and added, “Drug selection should be personalized according to prior treatment exposure and individual patient vulnerability to specific adverse events."Dr. Koo added, "Because third-line therapeutics established as global standards remain non-reimbursed in Korea, a patient's financial status directly dictates therapeutic choices," and added, "Reimbursement access must be improved so that patients with preserved performance status can gain survival opportunities through third-line and subsequent therapies."(From left) Min-Jung Kim, Administrative officer at the Ministry of Health and Welfare; So-Young Lee, Manager of the Pharmaceutical Benefit Management Division at HIRA; Professor Dong-Hoe Koo of Kangbuk Samsung Hospital; and Professor Myung Ah Lee of Seoul St. Mary's Hospital.Discussions continue on regulatory reforms to address unmet medical needDuring the panel discussion, structural limitations in the pharmacoeconomic evaluation process and directions for regulatory reform emerged as key agenda items.Reporter Yun-Ho Eo of DailyPharm pointed out that novel therapeutics approved via placebo-controlled clinical trials face structural disadvantages during pharmacoeconomic evaluations, as they are forced to compete against outdated comparator drugs.Eo stated, "Recently, we have observed significant delays between passing the Cancer Disease Review Committee (CDRC) and being tabled before the Pharmaceutical Reimbursement Evaluation Committee (PREC)," and added, "Special policy mechanisms need to be considered for diseases where a new treatment landscape has formed, but cost-effectiveness is inherently difficult to prove due to outdated comparator drugs."Eo added, "Even if a drug does not qualify for a full pharmacoeconomic evaluation waiver or an elevated Incremental Cost-Effectiveness Ratio (ICER) threshold, we need flexible regulatory pathways for drugs occupying an intermediate tier," and added, "Multinational pharmaceutical subsidiaries in Korea must also actively negotiate with their global headquarters rather than abandoning reimbursement due to challenging external environments."Government representatives acknowledged the severity of the coverage gap in third-line metastatic colorectal cancer. They explained that regulatory reforms are underway to incorporate high unmet medical needs into reimbursement decision-making.Lee stated, "We are aware of the reality that patients face due to a lack of options in third-line therapy, and we feel a deep sense of responsibility," and added, "Under the principle that unmet medical needs in life-threatening severe diseases should be evaluated through dedicated mechanisms, we are accelerating regulatory reforms."The government currently operates a "conditional early listing with post-evaluation" pathway for high-cost novel drugs that demonstrate substantial unmet medical need despite limited clinical evidence. Separately, health authorities are evaluating flexible ICER thresholds for therapies indicated for severe diseases where applying standard ICER benchmarks is unfeasible.Lee stated, "A research initiative evaluating the application of flexible ICER thresholds is scheduled for completion around November of this year, after which implementation will proceed," and added, "Even before the completion of this research, working-level staff is thoroughly reviewing data so that the evaluation committee can adequately consider disease characteristics and unmet needs."Lee noted, "In reviewing third-line treatments, including Fruzaqla, we are re-examining the reasons why previous agents failed to secure reimbursement, the criteria applied at the time, and our newly evolved administrative procedures," and added, "Even before the research findings are published, we will fully consider the third-line colorectal cancer reimbursement gap within the committee's existing criteria and authority."Min-Jung Kim, Manager of the Division of Health Insurance Benefits at the Ministry of Health and Welfare, noted, "Because National Health Insurance operates within a finite budget, we must strike a balance between patient access and fiscal sustainability," and added, "We are striving to establish rational reimbursement solutions by comprehensively reviewing the clinical value of therapeutics and their impact on patient quality of life."Kim added, "It is important for pharmaceutical companies to demonstrate proactive negotiation and a willingness to improve patient access," and concluded, "The government will continue driving regulatory improvements to ensure that essential therapeutics are supplied to patients more rapidly."
