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- 2026-07-22 03:12:20
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- KCSOA makes a 3rd attempt to secure incorporation
- by Kim, Jin-Gu Jul 07, 2026 08:57am
- Korea Contract Sales Organization Association (KCSOA)The Korea Contract Sales Organization Association (KCSOA) is attempting a third time to secure official incorporation from regulatory authorities. Industry insiders indicate that the primary hurdle to obtaining approval will depend on the association's ability to recruit "solo-operator CSOs", individual entrepreneurs, and freelancers who currently represent more than 70% of all registered Contract Sales Organizations (CSOs) in South Korea.According to biopharmaceutical industry sources on the 6th, KCSOA is actively preparing to apply for official corporate body status. The association is reportedly refining its articles of incorporation and strategic business plans, which the Ministry of Health and Welfare (MOHW) cited as deficiencies in two prior rejections. KCSOA aims to finalize its organizational restructuring, including the appointment of a new executive board, within this month before resubmitting its formal application for incorporation to the MOHW in the second half of this year.This round of attempt is largely attributed to a shifting regulatory stance within the MOHW. The ministry recently acknowledged the need to establish an official communication channel with the CSO sector, expressing alignment with the fundamental need for a formalized association. However, the regulatory body also maintained a strict stance on statutory compliance, clarifying that it will evaluate any resubmission in strict accordance with relevant administrative regulations once the previously insufficient documentation is completely rectified.Industry analysts note that securing corporate body status is a foundational step toward expanding KCSOA’s official mandate. Once recognized as a legal entity by the MOHW, the association can serve as an accredited counterparty for government consultations. This would enable the organization to systematically drive industry-wide continuing education, regulatory policy initiatives, and self-regulatory compliance programs on behalf of the sector. Both the ministry and the industry share a consensus on the urgency of an official representative body as administrative demands rise, driven by mandatory compliance workflows such as annual 8-hour continuing education requirements, spend transparency reporting, and the oversight of multi-tier consignment and re-consignment contracts. 'Industry representativeness' is a critical benchmark for achieving official incorporation. During the administrative review process for non-profit organizations, a pivotal evaluation factor is whether the applicant represents the broader sector comprehensively, rather than disproportionately favoring a specific sub-segment or a select group of corporate entities.In particular, bringing solo-operator CSOs is considered the decisive variable in establishing true industry-wide representation. Since the implementation of the mandatory CSO Registration System in October 2024, approximately 15,000 entities have secured registration certificates from local municipal governments. Both state regulators and market insiders estimate that roughly 70% of these registrations (equivalent to nearly 10,000 operators) comprise individual business owners or freelancers acting as solo CSOs.However, significant practical barriers remain, as the association's current membership architecture is heavily weighted toward larger corporate CSOs. In standard pharmaceutical promotion models, a drug manufacturer enters into a primary consignment contract with a corporate CSO, which subsequently subcontracts operational volume to independent solo CSOs through reconsignment agreements. Because solo operators rely directly on corporate CSOs for their project pipelines, market analysts suggest that these independent freelancers see little tangible commercial incentive to join the association. The perception that membership yields minimal practical advantages while increasing administrative burdens also impedes the recruitment of individual members. A biopharmaceutical industry source noted that individual freelancers often display aversion to formalizing their status or exposing their identities through association registries. The source added that concerns over membership fees, coupled with apprehensions that individual voices might be marginalized within a corporate-dominated governance structure, further exacerbate this resistance.Despite these hurdles, voices within the CSO sector consistently maintain that establishing an official, recognized association is essential to the industry’s long-term evolution. The CEO of another prominent CSO noted, "The MOHW's shifting stance on the necessity of a formalized association is a highly welcome development. An official incorporation will empower the organization to fulfill its intended institutional mandates," and added, "There is strong consensus within the CSO community to cultivate a clean, compliant distribution ecosystem."The CEO further stated, "The outcome depends on how successfully the association can integrate solo CSOs into the institutional framework," and added, "A failure to encourage individual membership will inherently restrict both the legal representativeness and the association's self-regulatory capabilities."The CEO added, "To my knowledge, previous rejections were primarily affected by quantitative shortfalls such as total membership headcount and asset thresholds," and concluded, "MOHW should evaluate the association's qualitative operational capabilities and its institutional commitment to compliance alongside headcount and membership fee size."
- Company
- Vadanem gains clinical evidence in renal anemia
- by Son, Hyung Min Jul 07, 2026 08:57am
- Treatment strategies for renal anemia in patients with chronic kidney disease (CKD) are expanding beyond conventional erythropoiesis-stimulating agents (ESAs) toward more individualized approaches based on patient characteristics.In particular, growing attention is being paid to the role of hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) in patients with ESA hyporesponsiveness or disordered iron metabolism, prompting active discussion on how these agents can be incorporated into clinical practice based on accumulating real-world clinical evidence.At the 46th Annual Meeting of the Korean society of Nephrology (KSN 2026) held by the Korean society of Nephrology in Seoul, a symposium highlighted the practical potential of Vadanem (vadadustat) based on the latest clinical evidence and real-world experience in the treatment of renal anemia.Speakers from Japan, Korea, Canada, and Taiwan shared the latest evidence on HIF-PHIs, evolving treatment paradigms, and country-specific clinical experience. The presentations focused on the clinical value of Vadanem and its use in practice.Renal anemia develops as CKD progresses, leading to a decrease in the production of endogenous erythropoietin (EPO) and is frequently accompanied by functional iron deficiency associated with inflammation. Consequently, some patients exhibit hyporesponsiveness, showing insufficient response to existing ESA therapy, which raises the need for new treatment strategies.Professor Masaomi Nangaku, The University of TokyoProfessor Masaomi Nangaku of The University of Tokyo presented results from a post hoc win statistics analysis of the INNO2VATE study, which enrolled patients receiving maintenance hemodialysis.The professor introduced results of the win statistics analysis comparing Vadanem with darbepoetin alfa. It used a hierarchical approach that prioritized clinically meaningful outcomes such as death and hospitalization. Results showed that Vadanem reduced the risk of death or hospitalization compared with darbepoetin alfa in analyses covering both the overall study period and the treatment period.Professor Nangaku said, “Vadanem demonstrated consistent non-inferiority to conventional ESA therapy with respect to major adverse cardiovascular events (MACE) regardless of patients' age, sex or geographic region.”He also suggested that the therapy may be particularly useful in patients with ESA hyporesponsiveness, elevated C-reactive protein (CRP) levels indicating inflammation, or reduced glomerular filtration rate (GFR).Prof. Sungjin Chung, Yeouido St. Mary's Hospital, who presented as a Korean expert, added that many dialysis patients in routine clinical practice still fail to achieve target hemoglobin (Hb) levels despite adequate ESA therapy or require repeated dose escalation in Korea."In these patients, treatment strategies should consider ESA hyporesponsiveness or resistance, creating a greater role and need for new therapeutic options.”Professor Chung added, “A meta-analysis of 10 randomized controlled trials (RCTs) demonstrated that Vadanem achieved comparable hemoglobin correction and maintenance to darbepoetin alfa, while maintaining a similar safety profile.Furthermore, based on its mechanism of regulating iron absorption, transport, and utilization through the HIF pathway, it is expected to improve iron utilization by reducing hepcidin. Also, its ability to induce physiological erythropoietic responses was presented as a clinical advantage.During the panel discussion, experts also discussed the long-term safety of HIF-PHIs and their potential role in future treatment strategies.The panel noted that concerns regarding malignancy and thromboembolic events reported with certain HIF-PHIs should not be generalized to the entire class. Instead, treatment decisions should consider the characteristics of individual agents and appropriate patient management.The experts further observed that although the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines currently recommend ESA therapy as the preferred initial treatment, continued accumulation of clinical evidence and long-term safety data could establish HIF-PHIs as an important therapeutic option in the future.They also suggested that HIF-PHIs are likely to expand treatment options by diversifying treatment strategies according to patient characteristics, rather than simply replacing ESA.Tanabe Pharma Korea said, "KSN 2026 is an important venue where the latest findings and innovative treatment methods in the field of nephrology from around the world are shared. Based on a solid partnership with the Korean Society of Nephrology, we will spare no effort for medical advancement and the promotion of human health.”
- Company
- Prescription drug approvals hit 3-year high in 1H 2026
- by Chon, Seung-Hyun Jul 07, 2026 08:57am
- The number of prescription drug approvals in Korea reached a three-year high in the first half of 2026, reflecting pharmaceutical companies' active efforts to expand their product portfolios and enter new markets. There are also some analyses that many companies accelerated regulatory filings to secure reimbursement at higher prices before generic pricing reforms take effect in August. Although approvals rebounded during the first half of this year, the total remains more than 70% lower than 6 years ago following tighter pricing and regulatory policies introduced since 2020.According to the Ministry of Food and Drug Safety (MFDS), 499 prescription drugs were approved during the first half of 2026, representing a 58.4% increase from the same period last year. After reaching 585 approvals in the first half of 2023, the figure declined to 324 in 2024 and 315 in 2025 before rebounding this year to its highest level in 3 years.The increase suggests pharmaceutical companies have recently stepped up efforts to expand their product portfolios. June alone accounted for 118 approvals, while 106 products were approved in April, marking the second month this year in which monthly approvals exceeded 100.By comparison, only July recorded more than 100 prescription drug approvals last year. Also, no month exceeded that level in 2024. In 2023, only January surpassed the 100-approval mark.Average monthly approvals reached 83 products during the first half, the highest level since the 93 recorded in 2022. Although the annual monthly average had declined from 93 in 2023 to 76 in 2024 and 48 in 2025, approvals have rebounded to an upward curve this year.Among the products approved in June, 48 orally disintegrating tablet (ODT) fixed-dose combinations of ezetimibe and rosuvastatin received marketing authorization. Companies obtaining approvals included Theragen Etex, Il-Yang Pharm, Ilhwa, Celltrion Pharm, KS Pharm, Dongkook Pharmaceutical, Mother’s Pharmaceutical, Jin Yang Pharmaceutical, HanAll Biopharma, Daehan Nupharm, Unimed Pharm, Withus Pharmaceutical, GC Biopharma, CMG Pharmaceuticals, Samjin Pharmaceutical, and GL Pharma.Competition also intensified in the market for potassium-competitive acid blockers (P-CABs) containing vonoprazan. Vonoprazan, the active ingredient of Takeda's product Vocinti that has not yet been launched in Korea, attracted significant interest, with Korean pharmaceutical companies obtaining 58 approvals for generic vonoprazan products during the first half alone. Companies preparing to enter the vonoprazan market include CMG Pharmaceutical, Unimed Pharmaceutical, Korea PMG Pharm, Medica Korea, DongKoo Bio & Pharma, Samjin Pharmaceutical, Eden Pharma, Celltrion Pharm, Alvogen Korea, BC World Pharmaceutical, KS Pharm, Yuhan Corporation, Dongkook Pharmaceutical, Genu Pharma, YooYoung Pharmaceutical, KyongDong Pharml, Vivozon Pharmaceutical, Hana Pharm, Korea Prime Pharm, GenuOne Sciences, Kolon Pharma, Korea Arlico Pharm, Ahn-Gook Pharm, Saehan Pharm, GC Biopharma, White Life Science, Samik Pharm, Mother’s Pharmaceutical, and Kyongbo Pharmaceutical.Industry observers believe another factor behind the increase is companies' efforts to secure as many reimbursements before the pricing reform takes effect in August.Under proposed revisions to the ‘Standards for the Determination and Adjustment of Drug Prices’ recently released by the Ministry of Health and Welfare (MOHW), the maximum reimbursement price for both off-patent originators and generic drugs will fall from 53.55% to 45% of the original branded drug price beginning in August, equivalent to a 16% reduction in generic reimbursement prices.Price reductions could become even steeper for products that fail to satisfy the requirements for receiving the highest reimbursement level, including conducting their own bioequivalence studies and using domestically registered active pharmaceutical ingredients (APIs).Under the revised system, the penalty for failing to satisfy the maximum-price requirements will increase from 15% to 20%. Since July 2020, generic manufacturers have been required to both conduct their own BE studies and use registered APIs to qualify for the maximum reimbursement price of 53.55%. Previously, the reimbursement ceiling fell by 15% for each unmet requirement, resulting in a total reduction of 27.75% if neither criterion was met. Under that system, reimbursement fell from 53.55% to 45.52% when one requirement was unmet and to 38.69% when neither requirement was satisfied.Under the revised framework, the new maximum reimbursement ratio of 45% will fall to 36% if one requirement is not met (20% cut) and to 28.8% if neither requirement is satisfied. Compared with the current system, these changes represent additional reimbursement reductions of 20.9% and 25.6%, respectively.From the industry's perspective, obtaining reimbursement before implementation of the new pricing rules allows products to receive relatively higher reimbursement prices, providing a strong incentive to accelerate approvals.Despite this year's rebound, prescription drug approvals remain well below historical levels. During the first half of 2019 and 2020, the MFDS approved 2,209 and 2,015 prescription drugs, respectively. The total fell to 1,073 in the first half of 2021 before declining further from 2022 onward. Compared with 2020, approvals in the first half of 2026 were 75.2% lower.Industry analysts attribute the sustained decline in generic market entry to changes in both the drug pricing and regulatory systems.Beginning in July 2020, Korea introduced a tiered reimbursement pricing system, under which reimbursement ceilings decline the longer the listing is delayed. Once 20 or more generic products are listed for a given ingredient, newly listed products are reimbursed at only 85% of the lowest existing reimbursement price. Because companies that do not independently develop generics or conduct their own bioequivalence studies receive substantially lower reimbursement, approvals for fully consigned generics have declined sharply.Regulatory barriers have also become more stringent. Since July 2021, amendments to the Pharmaceutical Affairs Act introduced the so-called "1+3 rule," limiting the number of generic and incrementally modified drugs that can rely on a single bioequivalence study.Under the regulation, if a generic is manufactured at the same facility using the same formulation and manufacturing process as the product for which the bioequivalence study was conducted, the bioequivalence data may be referenced by only three additional products. In other words, one bioequivalence study can support approval of only four generic products. Likewise, clinical data may be shared only with the original contract research organization’s product and up to three additional products.Previously, once one manufacturer obtained approval based on a bioequivalence study, dozens of other companies frequently obtained approvals for outsourced generics using the same data. The introduction of restrictions on joint development effectively ended the practice of unlimited generic replication.The surge in approvals during 2019 and 2020 was itself driven by anticipation of tighter government regulation. In 2018, sales of 175 valsartan-containing antihypertensive products were suspended after excessive levels of impurities were detected. In response, the MOHW and MFDS established a consultative body to develop measures aimed at curbing the excessive proliferation of generic drugs.As the government signaled stricter regulation, pharmaceutical companies rushed to secure generic approvals before the new rules took effect. Since implementation of the reforms, however, new market entry has slowed considerably.
- Company
- Pfizer set to join RSV vaccine competition with Abrysvo
- by Eo, Yun-Ho Jul 07, 2026 08:57am
- Pfizer is set to officially enter the Korean respiratory syncytial virus (RSV) vaccine market.According to industry sources, the Ministry of Food and Drug Safety (MFDS) has entered the final stage of its review for ‘Abrysvo,’ Pfizer Korea's RSV vaccine. With its approval imminent, commercial launch is expected in the third quarter this year.Abrysvo’s initial indications are expected to include routine immunisation for infants, as well as indications for ▲ Passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy, ▲ prevention of RSV-associated LRTD in adults aged 60 years and older.Abrysvo targets the fusion (F) protein, the major surface protein of RSV. It is specifically designed using the prefusion form of the F protein (pre-F), which the virus uses to enter host cells.The pre-F protein represents the structural form immediately before viral fusion with host cells and is recognized as the antigenic configuration that most effectively induces neutralizing antibodies. Abrysvo induces an immune response using a stabilized version of this prefusion protein.Abrysvo is a bivalent vaccine designed to provide protection against both major RSV subtypes, RSV-A and RSV-B. Its maternal immunization strategy relies on antibodies transferred across the placenta to protect infants during the first months of life.RSV is a prominent respiratory virus responsible for pneumonia and bronchiolitis. While it can infect people of all ages, the infection rate is particularly high among infants. It is known that approximately 90% of infants worldwide are infected with RSV before the age of two. In some cases, it can progress to serious lower respiratory tract diseases such as pneumonia or bronchiolitis, making RSV one of the leading causes of infant hospital admissions.Clinical evidence supporting Abrysvo comes from the Phase III MATISSE study. The trial demonstrated that vaccination in late pregnancy significantly reduced the risk of severe RSV-associated lower respiratory tract infection in infants in the first 6 months after birth through maternal antibody transfer.The anticipated approval and entry of Abrysvo is expected to further intensify competition in Korea's infant RSV prevention market, which is already occupied by Sanofi's ‘Beyfortus’ and MSD's ‘Enflonsia.’
- Company
- "Global AI drug discovery accelerates…KOR faces talent·data shortage"
- by Jung, Heung-Jun Jul 06, 2026 10:48am
- The global drug discovery ecosystem is restructuring centered on artificial intelligence (AI). Partnerships between big tech and big pharma companies are driving rapid advancements across the entire drug development lifecycle. However, the Korean biopharmaceutical industry continues to face significant hurdles, including a shortage of skilled talent and limited access to data.Dr. Pyo Junhee, Director of the AI Institute for Drug DevelopmentOn the afternoon of the 2nd, Director Pyo outlined the accelerating AI drug discovery ecosystem during a workshop titled "Future trends of AI technology in the biopharmaceutical industry," which was jointly hosted by the Pharmaceutical Society of Korea (PSK), the Korean Society of Pharmaceutical Sciences and Technology (KSPST), and the Korean Academy of FDC Regulatory Science.During her presentation, Pyo emphasized that among the pipelines currently under development by global big pharma companies, it has become difficult to find a novel drug candidate that does not integrate AI.Big pharma companies are staking its future on strengthening internal capabilities, aggressively recruiting AI engineers and data scientists for 100 to 200 positions.The growth trajectory is further accelerated by the interest and capital injection from big tech companies that view AI-driven drug discovery as a primary growth engine. Consequently, there has been a massive influx of "bio-sequence Large Language Models (LLMs)" capable of decoding and understanding biological sequences such as DNA and RNA. "Nvidia announced a partnership with Eli Lilly to build an AI drug discovery factory, while Google DeepMind developed AlphaFold3 and recently unveiled enhanced iterations of the model," Pyo explained. She noted that when Nvidia initially launched its 'BioNeMo' platform, several Big Pharma companies reportedly paused physical laboratory experiments to run toxicity predictions through BioNeMo, subsequently recalibrating their pipeline priorities. Furthermore, Anthropic recently introduced 'Claude for Science,' which offers comprehensive end-to-end workflows tailored for drug discovery. Using a multi-agent AI framework, a coordinator agent categorizes a research task, after which specialized sub-agents, focusing on genomics or structural biology, independently validate and integrate their findings.Pyo emphasized that the industry has shifted beyond merely accelerating isolated research steps. Realizing an era where hypothesis generation, experimental design, and data analysis are fully automated has already become a reality.Accordingly, Pyo stressed that the industry is no longer competing on the speed of localized workflows, but has officially entered an era of intense competition over de novo structural design.However, the Korean pharmaceutical industry continues to face bottlenecks, most notably a severe shortage of skilled personnel, as well as data scarcity and data quality issues."We conducted a survey to identify the specific pain points of domestic pharmaceutical companies and AI drug discovery firms," Pyo stated. "The most prevalent response was a shortage of proficient talent and recruitment difficulties, followed closely by data availability and quality concerns."Because proprietary drug discovery data represents a highly valuable corporate asset for individual companies, it is rarely generalized and remains highly fragmented or siloed across the industry.To address this, Pyo suggested that "data partnerships structured around commercial transactions or mutual research needs may be selectively feasible when financial incentives align. Additionally, we are seeing the emergence of specialized consortia aimed at solving common clinical goals, such as sharing control-arm data from clinical trials."The South Korean government is also actively investing in AI-driven pharmaceutical advancement through initiatives such as the K-AI Drug Discovery Preclinical and Clinical Model Development Project. In late 2025, the Ministry of Health and Welfare (MOHW) allocated approximately KRW 37.1 billion to the 'K-AI Drug Discovery Preclinical and Clinical Model Development Project', appointing lead operating organizations to foster a AI-driven development ecosystem. The Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), which houses the AIDD, was designated as a primary lead institution. "Currently, three major hospitals, pharmaceutical corporations, and research institutions are collaborating to build integrated datasets that bridge the preclinical and clinical phases," Pyo said. "Using these datasets, we are developing foundation models and a diverse array of downstream AI applications." Pyo concluded by stating, "For clinical complexities that AI alone cannot fully resolve, we are integrating various predictive simulation models to develop a platform capable of optimizing clinical trial designs."
- Company
- 'Perjeta' adjuvant therapy resubmitted to the CDRC
- by Eo, Yun-Ho Jul 06, 2026 10:48am
- Product photo of PerjetaAttention is focused on whether the post-operative adjuvant therapy indication for breast cancer treatment, 'Perjeta,' can be revived in the market.According to industry sources, an application for the expanded reimbursement criteria for the post-operative adjuvant therapy of Roche Korea's HER2-positive breast cancer treatment Perjeta (pertuzumab) is scheduled to be considered at the upcoming meeting of the Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) on the 8th.Earlier this year, the Breast Cancer Division of the Korean Society of Medical Oncology (KSMO) submitted its application to expand the reimbursement criteria for Perjeta. While a prior expansion request by Roche was expected to be reviewed by the CDRC in October last year, the discussion fell through due to a regulatory realignment of the selective reimbursement criteria for pharmaceuticals.Currently, Perjeta is reimbursed for HER2-positive metastatic or unresectable locally recurrent breast cancer. For early-stage breast cancer, it is reimbursed under selective reimbursement as a neoadjuvant/pre-operative therapy, with a patient co-payment rate of 30%.However, its use as a post-operative adjuvant therapy, a critical therapeutic stage for preventing disease recurrence, has remained non-reimbursed (100% out-of-pocket patient cost) since regulatory approval in South Korea in 2018, thereby limiting patient access.Unlike the neoadjuvant chemotherapy, which is reimbursed under the 30% selective reimbursement, the adjuvant indication lacked high-level recommendation grades in global clinical guidelines or long-term follow-up data at the time of its initial review in 2019.However, the 10-year follow-up results from the global Phase 3 APHINITY trial, published last year, are anticipated to fill this clinical evidence gap.According to the study, the adjuvant combination therapy of Perjeta + 'Herceptin (trastuzumab)' demonstrated a clear clinical benefit, significantly reducing the risk of death by 21% compared to monotherapy in the lymph node-positive patient cohort, who face a high risk of disease recurrence.Meanwhile, the Perjeta-Herceptin combination therapy is currently recommended as a Category 1 treatment under the U.S. NCCN Guidelines for post-operative adjuvant therapy in lymph node-positive, HER2-positive early breast cancer. It is being recommended a Category 1 recommendation for post-operative adjuvant therapy in high-risk, lymph node-positive patients who have achieved a pathological complete response (pCR) following neoadjuvant chemotherapy.
- Company
- MSD-Boryung signs copromotion agreement for Enflonsia
- by Kim, Jin-Gu Jul 03, 2026 09:03am
- MSD Korea has partnered with Boryung Biopharma to commercialize Enflonsia (clesrovimab), its monoclonal antibody for the prevention of respiratory syncytial virus (RSV) in neonates and infants.According to industry sources, on July 1 the two companies signed a strategic partnership agreement covering domestic distribution and co-promotion of Enflonsia in Korea. Under the agreement, Boryung Biopharma will begin handling domestic distribution and joint promotional activities targeting healthcare professionals starting July 1.Enflonsia is a long-acting monoclonal antibody that provides at least 5-6 months of protection following a single dose in neonates and infants. In the large-scale global Phase III CLEVER trial, the therapy demonstrated clinical efficacy, reducing RSV-related hospitalizations by 84.2%.Expectations are rising on site on the convenience of administration of Enflonsia. Compared with Beyfortus, which has already established a presence in the market, Enflonsia offers a simpler dosing regimen. Beyfortus requires different dosage strengths depending on an infant's body weight (5 kg) as the dosing threshold. In contrast, Enflonsia is administered as a single fixed dose regardless of body weight.The infant RSV prevention market in Korea is currently led by Sanofi and SK Bioscience. To strengthen its market position, MSD Korea selected Boryung Biopharma as its commercialization partner, citing the company's extensive distribution network and long-standing expertise in vaccine and pharmaceutical sales, particularly in primary care clinics.The upcoming RSV season in the second half of the year is expected to be the first major commercial opportunity for Enflonsia. In Korea, the RSV season typically runs from October through March. Infants born during the RSV season are expected to receive a single dose shortly after birth, while those born outside the season are scheduled to receive one dose before the start of their first RSV season. The two companies plan to rapidly expand the product's market presence in line with this schedule.Although RSV infection typically begins with symptoms resembling those of the common cold, it can progress to lower respiratory tract infections, including bronchiolitis and pneumonia, in infants younger than one year of age, often requiring hospitalization.According to a nationwide study based on National Health Insurance claims data covering 2007 to 2019, published last year, 44.7% of Korean children younger than five years diagnosed with RSV required hospitalization. In particular, infants aged 6 to 11 months accounted for approximately 48.2% of RSV-related hospitalizations and 57.3% of intensive care unit (ICU) admissions among children under five, representing the highest hospitalization burden. Infants younger than six months had the longest average hospital stay, at 8.35 days.Enflonsia received marketing authorization in Korea on July 1. The approval was supported by results from the global Phase IIb/III CLEVER trial and the Phase III SMART study.The CLEVER study evaluated approximately 3,600 healthy newborns and infants born at 29 weeks' gestation or later across 22 countries and demonstrated a 60.4% reduction versus placebo in the primary endpoint of medically attended lower respiratory tract infection (MALRI) associated with RSV.In the safety analysis, more than 96% of adverse events reported with Enflonsia were mild or moderate in severity. The Phase III SMART study, which enrolled premature infants and infants at high risk for severe RSV disease, including those with chronic lung disease (CLD) or congenital heart disease (CHD), also demonstrated an overall safety profile comparable to that of the control treatment (palivizumab).
- Company
- Nature highlights Hanmi, SK Biopharm’s innovation
- by Cha, Ji-Hyun Jul 03, 2026 09:03am
- The global pharmaceutical and biotechnology industry is increasingly recognizing the growing presence of K-Bios. A leading international journal in drug discovery has identified Hanmi Pharmaceutical and SK Biopharmaceuticals as companies leading the development of innovative medicines among biopharmaceutical firms in Asia and other emerging markets, highlighting Korea's transition from a generic-focused industry to one driven by research and development (R&D)-based innovation-driven new drug porfolio.According to the Korea Biotechnology Industry Organization's Bioeconomy Research Center on July 2, ‘Nature Reviews Drug Discovery’ recently published an analysis examining changes in R&D productivity among biopharmaceutical companies across Asia and emerging markets. Nature Reviews Drug Discovery is one of the most prestigious publications in drug discovery and development. It had a 2024 Journal Impact Factor (JIF) of 101.8, placing it among the world's highest-impact scientific journals.The researchers evaluated 45 biopharmaceutical companies with annual sales exceeding USD 500 million over the 2010–2025 period. The analysis assessed R&D investment, clinical pipeline composition, and revenue trends to determine the extent to which each company had transitioned from a generic-based business model to an innovation-driven new drug portfolio. Companies were subsequently classified as innovation leaders, emerging innovators, or generic-focused companies based on their R&D intensity and proportion of innovative assets.Among Korean companies, Hanmi Pharmaceutical and SK Biopharmaceuticals were classified as innovation leaders, the highest category in the study. They joined 9 Chinese companies in the same group, including BeOne, CSPC Pharmaceutical Group, Jiangsu Hengrui Pharmaceuticals, Henlius, Innovent Biologics, Junshi Biosciences, and Sino Biopharmaceutical. The findings place the two Korean companies alongside some of China's leading global pharmaceutical firms.Hanmi Pharmaceutical was recognized for maintaining a consistently high level of R&D investment. According to the study, the company invested approximately 17% of its revenue in R&D over the past decade, up from roughly 10% during the 2010–2015 period. The journal also highlighted Hanmi's strategy of focusing on innovative drug development in metabolic and rare diseases.Hanmi is currently expanding its pipeline, particularly in obesity and metabolic disorders. Its long-acting GLP-1 (glucagon-like peptide-1) obesity candidate efpeglenatide, developed using the company's proprietary ‘LAPSCOVERY’ platform, has advanced into the regulatory submission stage based on positive domestic Phase III results. The company is also broadening its metabolic disease portfolio by developing a GLP-1/GIP/glucagon triple agonist and next-generation obesity therapies designed to preserve and increase muscle mass. In addition, Hanmi continues to develop novel therapies for rare diseases and oncology using its proprietary technology platforms.Analysis of R&D Intensity and Portfolio Innovation Index Across 45 Biopharmaceutical Companies in Asia and Emerging Markets (2010–2025), Published in the International Journal Nature Reviews Drug Discovery (Source: Bioeconomy Research Center, KoreaBIO)The published analysis also recognized SK Biopharmaceuticals as an innovation leader, reflecting its successful development and global commercialization of proprietary medicines. The company has established a fully integrated business model spanning drug discovery through commercialization, with a focus on central nervous system (CNS) disorders.SK Biopharmaceuticals is expanding into next-generation therapeutic modalities, building on the global development and commercialization experience gained through its proprietary epilepsy drug ‘cenobamate.’ In addition to its CNS franchise, the company has identified radiopharmaceutical therapy (RPT) and targeted protein degradation (TPD) as future growth engines. It is currently developing multiple radiopharmaceutical candidates based on actinium-225 and lutetium-177, while also advancing oncology programs utilizing TPD technology.유한양행, 대웅제약, 삼성바이오로직스, GC는 신흥 혁신기업에 이름을 올렸다. 연구진은 이들 기업을 혁신 선도기업 단계로 분류하지는 않았으나 제네릭 중심 기업과 달리 R&D 투자와 혁신 포트폴리오 전환을 이어가는 기업군으로 평가했다.Yuhan Corporation, Daewoong Pharmaceutical, Samsung Biologics, and GC were classified as emerging innovators. Although they were not placed in the innovation leader category, the researchers recognized these companies as actively increasing R&D investment and shifting toward innovation-based portfolios rather than relying primarily on generic medicines.In particular, Yuhan Corporation’s R&D spending rose from less than 5% of revenue during 2010–2015 to approximately 12% during 2020–2025. Its growing investment in oncology research and its strategic transition from a traditional generic-based business to an innovation-focused pharmaceutical company were cited as key factors behind its classification.The findings carry significance as it signifies that the structural transformation of Korea's pharmaceutical and biotechnology industry is now gaining recognition on the global stage. Korean companies have steadily demonstrated their innovative capabilities through technology licensing, global clinical development, and overseas approvals of proprietary medicines. The findings published this time are noteworthy because it attributes these achievements not to isolated successes by individual companies, but to sustained increases in R&D investment and a long-term shift toward innovation-driven portfolios.The researchers concluded, "Several leading biopharmaceutical innovators in Asia, particularly those in China and South Korea, have chosen the path of innovation and are well positioned to challenge established global competitors in Europe and the United States over the coming years."
- Company
- Breztri enters reimbursement price negotiations
- by Eo, Yun-Ho Jul 03, 2026 09:02am
- The triple-combination inhaler ‘Breztri’ has entered the final stage of the National Health Insurance reimbursement process in Korea.According to industry sources, the Ministry of Health and Welfare (MOHW) recently instructed the National Health Insurance Service (NHIS) to begin reimbursement price negotiations for Breztri Aerosphere (budesonide/glycopyrronium/formoterol), which is marketed by AstraZeneca Korea for the maintenance treatment of adults with moderate to severe COPD. The first round of negotiations is expected to begin next week.Breztri entered price negotiations after agreeing to receive a price below the price assessed as appropriate by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) in May.Breztri Aerosphere is a single-inhaler triple therapy (SITT) combining an inhaled corticosteroid (ICS), a long-acting β2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA) in one inhaler. It is indicated as maintenance therapy for adults with COPD to improve symptom control and reduce exacerbations, and is administered twice daily.The efficacy and safety of Breztri Aerosphere have been confirmed in the global Phase III ETHOS and KRONOS trials.The ETHOS (The Efficacy and Safety of Triple Therapy in Obstructive Lung Disease) study was a multicenter, randomized, double-blind Phase III trial involving 8,588 patients (aged 40 to 80 years) with moderate to very severe COPD who were treated over 52 weeks.Study results showed that Breztri Aerosphere reduced the annual rate of moderate or severe COPD exacerbations by approximately 24% compared with LAMA/LABA dual therapy, and by approximately 13% compared with ICS/LABA therapy, with both differences reaching statistical significance.In a post hoc analysis of the ETHOS study, treatment with Breztri Aerosphere was also associated with a significant reduction in all-cause mortality compared with LAMA/LABA therapy.Another pivotal Phase III trial, KRONOS, demonstrated improvements in lung function with Breztri Aerosphere.The KRONOS study enrolled 1,902 patients with moderate to very severe COPD and followed them for 24 weeks. At Week 24, Breztri Aerosphere improved lung function by 22 mL compared with LAMA/LABA therapy and by 74 mL compared with ICS/LABA (BFF MDI).COPD is a representative chronic respiratory disease caused by abnormalities of the airways and alveoli, including chronic bronchitis, bronchiolitis, and emphysema. It is characterized by chronic respiratory symptoms such as dyspnea and cough, together with persistent and progressive airflow obstruction.According to the 2026 Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, triple therapy with ICS, LAMA and LABA is recommended for patients receiving ICS/LABA who either continue to experience a high symptom burden despite no recent exacerbations or who experience exacerbations with a blood eosinophil count of at least 100 cells/μL.
- Company
- Eli Lilly Korea appoints Seiya Komatsu as new GM
- by Son, Hyung Min Jul 02, 2026 09:17am
- Seiya Komatsu, Eli Lilly's new General Manager.Eli Lilly Korea has officially announced the appointment of Seiya Komatsu as its new General Manager.Komatsu is a global business leader who began his career at Eli Lilly and Company’s global headquarters in talent acquisition. Over his tenure, he has accumulated extensive expertise including, sales, marketing, business innovation, and corporate operations across both Japan and the United States.Komatsu, who holds a Master of Business Administration (MBA) from Brigham Young University (BYU) in the United States, has diverse leadership roles at Eli Lilly, beginning his commercial career in sales at Eli Lilly Japan's Diabetes Business Unit, later serving as a U.S. District Sales Manager in Texas. Starting in 2020, Komatsu managed the brand marketing strategy for the company’s high-profile incretin portfolio at Eli Lilly Japan. He served as Vice President and Head of the Neuroscience Business Unit at Eli Lilly Japan immediately before his current appointment in Korea.In his inaugural address, Komatsu remarked, "It is a profound honor to lead Eli Lilly Korea during such a milestone year as Eli Lilly and Company celebrates its 150th anniversary," and added, "South Korea is a vital strategic market for Lilly, backed by world-class biotechnology infrastructure and highly skilled scientific talent. My primary focus will be accelerating the introduction of our innovative pipeline and significantly enhancing patient access to life-changing therapies in Korea."Komatsu further added, "We aim to serve as a bridge connecting Lilly’s expansive global network with South Korea's robust biopharmaceutical capabilities, ensuring that Lilly’s 150-year core values of patient-centered innovation and care continue in South Korea."Eli Lilly Korea remains a key contributor to the domestic healthcare ecosystem, advancing clinical research and commercializing innovative therapies across critical therapeutic areas, including cardiovascular and metabolic diseases, neurodegenerative disorders, oncology, and immunology. The company recently signed a $500 million investment agreement with the Ministry of Health and Welfare (MOHW). Eli Lilly Korea is currently establishing a domestic hub for Lilly Gateway Labs (LGL) in Songdo, Incheon, to deepen open innovation and partnerships within the Korean biotech ecosystem.
