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- 2026-07-22 00:21:10
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- Pharma biotech 'corporate name change' moves…12 companies this year
- by Cha, Ji-Hyun Jul 21, 2026 08:26am
- Pharmaceutical, biotech, and healthcare companies in South Korea are changing their corporate names one after another. This year alone, 12 companies have rebranded. While these changes aim to enhance brand value and clearly signal shifts in business structures and growth strategies, critics point out that without financial performance and business outcomes, they could end up as a mere “company signboard swap."According to the Financial Supervisory Service on July 20, DA Information, an IT subsidiary of Dong-A Socio Group, announced on July 16 that it will change its corporate name to 'DAI' (pronounced D-A-I). With this rebranding, the company aims to transition from its traditional focus on IT system operation and maintenance to become an AX (AI Transformation) partner that revolutionizes corporate decision-making and workflows. DAI plans to nurture AI-driven drug discovery platforms, AI-based healthcare platforms, pharmaceutical-specific GMP solutions, and AI agents as its new growth engines.Aptamer Sciences held an extraordinary general meeting of shareholders on July 8 and changed its corporate name to 'Choolip & Sciences'. Its English name was also changed from 'Aptamer Sciences Inc.' to 'CHOOLIP & SCIENCES Inc.' Regarding the reason for the change, the company explained, "The corporate name was changed in accordance with changes in management objectives and business diversification strategies."On the same day, Woojung Bio also changed its name to 'Kolmar Biotech' at an extraordinary shareholders' meeting. This is a follow-up measure following Kolmar Holdings' push to acquire management control. Previously, in March, Woojung Bio pursued a transfer of management rights by issuing KRW 35 billion in convertible bonds to Kolmar Holdings and delegating the voting rights of the then-largest shareholder. Accordingly, the blueprint is to reflect the Kolmar Group's identity in the new corporate name and enhance its brand value.2026 List of Corporate Name Changes for Pharma, Biotech, and Health Companies: SCM Lifescience changed its name to 'Poongjeon Pharmaceutical'. UBcare also changed its name to 'GC Medieye'. Neofect changed its corporate name to 'Dynamic Solution' on March 25. Seers Technology shortened its name to 'Seers' on March 27. U2Bio changed its name to 'Jigu Holdings' on March 30. Kukjeon Pharmaceutical changed its name to 'Kukjeon' on March 31. 'Orion Atomics' to AdBiotech. 'BNC Korea Co, Ltd' to 'BNC KOREA, Inc.' CHA Vaccine Research Institute changed its name to 'AriBio LAB' on April 30. Solux changed its name to 'AriBio Holdings' on June 29. Aptamer Sciences changed its corporate name to 'Choolip & Sciences'. Woojung Bio also changed its name to 'Kolmar Biotech'These are not the only companies changing their names. It is estimated that more than 13 pharmaceutical, biotech, and healthcare companies have changed their corporate names so far this year.Solux changed its name to 'AriBio Holdings' on June 29. This is part of an effort to restructure its governance and business framework around bio ahead of its upcoming merger with AriBio. Solux incorporated AriBio as a subsidiary after AriBio CEO Choung Jai-jun acquired management control of the company in 2023. It is currently pursuing an absorption merger with AriBio to pivot its LED-lighting-centered business model toward degenerative brain disease drug development and healthcare. Ahead of the merger, the company plans to align the group's governance and identity through the name change, ultimately building a holding company system that encompasses drug R&D·commercialization, and biotech investment functions.CHA Vaccine Research Institute changed its name to 'AriBio LAB' on April 30. This is also an extension of the plan to reorganize the biotech affiliate system around AriBio. In the process of pursuing the merger with AriBio, Solux also decided to acquire management control of Cha Vaccine Research Institute. This followed a contract signed in March, in which Solux and three other parties acquired a 33.3% stake in CHA Vaccine Research Institute, held by CHA Biotech, for KRW 23.8 billion. With this move, the goal is to reposition CHA Vaccine Research Institute as an R&D-specialized affiliate within the group and further solidify its biotech business foundation.Rebranding by traditional pharmaceutical firms is also noteworthy. Kukjeon Pharmaceutical changed its name to 'Kukjeon' on March 31, dropping the word 'Pharmaceutical'. The decision was made to expand its business scope beyond its existing image, which was limited to medicines, and to build a new corporate image. Based on its active pharmaceutical ingredient (API) business, Kukjeon aims to leap forward into an advanced materials company beyond pharma by nurturing electronic materials for semiconductors and displays as a new growth axis.There are also cases where companies reverted to their previous names during the process of realigning their business identity. AdBiotech, an animal health company, changed its name to 'Orion Atomics' last September, only to revert to its original name this March, about six months later. Along with the reinstatement of its old name, the company removed numerous business objectives unrelated to its core business, such as nuclear power, energy, batteries, and virtual assets. It reorganized its business structure around its traditional livestock and bio sectors, re-clarifying its corporate identity.In the case of BNC Korea, it retained its Korean corporate name and standardized only its English business name. It changed 'BNC Korea Co, Ltd' to 'BNC KOREA, Inc.' This measure was taken to unify the English trade names that had been used interchangeably in practice. There are no other corporate name changes for this company within the past two years.In addition, U2Bio, Seers Technology, Neofect, SCM Lifescience, and UBcare have also successively changed their names this year. U2Bio changed its name to 'Jigu Holdings' on March 30. It reflected its identity as a holding company in its name in line with its physical split-off plan to transition into a venture holding company. Seers Technology shortened its name to 'Seers' on March 27 to clarify its strategic direction toward becoming a patient-centered, next-generation healthcare platform company, on the basis of its technology commercialization capabilities.Neofect changed its corporate name to 'Dynamic Solution' on March 25, citing an enhanced corporate image and strengthened competitiveness. SCM Lifescience changed its name to 'Poongjeon Pharmaceutical' on March 24, a move aimed at strengthening brand competitiveness and laying the groundwork for sustainable growth.UBcare also changed its name to 'GC Medieye' on March 24. This comes six years after the company was incorporated into the Green Cross (GC) Group when GC Green Cross Healthcare (currently GC Care) acquired management control for 208.8 billion KRW in 2020. This name change is interpreted as a move to bring the GC Group's identity to the forefront and emphasize its direction to transcend its existing electronic medical record (EMR) business and leap forward as an AI-based digital healthcare company.Changing a corporate name is an effective tool for companies to communicate their altered business structures and mid- to long-term strategies to the market while enhancing brand value. In particular, when an existing corporate name is tied to a specific technology or traditional manufacturing sector, changing it to a more scalable name can signal a strategic pivot toward becoming a comprehensive bio-healthcare enterprise externally.However, changing a corporate name does not alter a company's own competitiveness. Experts point out that even if a company changes its name as part of business diversification and entry into new markets, the move could be a mere "signboard change" that only inflates expectations if revenue expansion, profitability improvements, and R&D achievements do not follow. Given that there are already numerous cases where performance improvements or new business outcomes failed to materialize despite a name change, some argue that strengthening the competitiveness of the core business must take priority over a new name.
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- Kolon TissueGene’s osteoarthritis drug fails Phase 3 trial
- by Cha, Ji-Hyun Jul 21, 2026 08:25am
- Kolon TissueGene, Kolon Group’s biotechnology subsidiary, has failed to demonstrate improvements in pain and function in a US Phase III trial of its investigational drug for knee osteoarthritis.According to a regulatory filing disclosed to Korea's Financial Supervisory Service on July 20, the company announced topline results from the U.S. Phase III TG-G 15302 trial evaluating its knee osteoarthritis drug candidate ‘TG-C.’ At 12 months, TG-C failed to achieve statistical significance versus placebo on both co-primary endpoints: the Visual Analog Scale (VAS) pain score and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score.The VAS pain score decreased by an average of 38.7 points from baseline in the TG-C group and 39.2 points in the placebo group. The between-group difference was 0.5 points (p=0.8322). The WOMAC total score declined by 27.61 points in the TG-C group and 26.54 points in the placebo group. The between-group difference was -1.07 points (p=0.5701).The trial enrolled 531 patients with Kellgren-Lawrence Grade 2 or 3 knee osteoarthritis at 27 U.S. sites. Participants were randomized in a 2:1 ratio to receive a single intra-articular injection of TG-C or placebo and were followed for 24 months to evaluate efficacy and safety.No new or unexpected safety signals were identified. Treatment-emergent adverse events were reported in 83.9% of patients in the TG-C group and 78.1% in the placebo group, with most events classified as Grade 1 or 2. The overall rate of total knee replacement was 0.6% in the TG-C group compared with 5.3% in the placebo group.Kolon TissueGene plans to discuss the findings with the US Food and Drug Administration (FDA) after integrating the efficacy and safety results from this study with those from another ongoing U.S. Phase III trial.
- Company
- MSD develops first oral PCSK9 inhibitor
- by Son, Hyung Min Jul 20, 2026 08:51am
- MSD's launch of the world's first oral PCSK9 inhibitor is expected to reshape the dyslipidemia treatment market.The arrival of an oral therapy is likely to intensify competition over treatment convenience in a market that has until now evolved primarily by extending dosing intervals of injectable therapies.Oral PCSK9 inhibitor LipfendraAccording to industry sources, the U.S. Food and Drug Administration (FDA) approved Lipfendra (enlicitide) on July 16 for reducing low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia and heterozygous familial hypercholesterolemia (HeFH).Lipfendra is an oral PCSK9 inhibitor taken once daily at a 20mg dose as an adjunct to diet and exercise.PCSK9 inhibitors are indicated for patients whose LDL-C levels remain inadequately controlled despite lipid-lowering therapy, including high-intensity statins and ezetimibe, or for those requiring additional LDL-C reduction because of a high risk of atherosclerotic cardiovascular disease (ASCVD).All currently marketed PCSK9 inhibitors are injectables. Amgen's ‘Repatha (evolocumab)’ and Sanofi/Regeneron's ‘Praluent (alirocumab)’ are monoclonal antibodies administered every two weeks.Novartis' ‘Leqvio (inclisiran)’ is an siRNA therapy that suppresses PCSK9 production in the liver. After the initial administration, the second dose is administered after three months, and then every six months.While the PCSK9 inhibitor market has focused on reducing injection frequency and extending dosing intervals, Lipfendra has differentiated itself with oral administration.Lipfendra is a macrocyclic peptide-based oral PCSK9 inhibitor. It inhibits PCSK9 to increase hepatic clearance of LDL cholesterol and targets the same pathway as injectable PCSK9 inhibitors as an oral formulation.However, there are certain restrictions during its intake. Lipfendra may be taken with water, coffee, or tea, but patients must avoid eating for at least 30 minutes afterward to ensure adequate drug absorption.Approval supported by two global Phase III trialsLipfendra's approval was based on results from the CORALreef Lipids and CORALreef HeFH studies, part of MSD's global Phase III CORALreef program.CORALreef Lipids was a multicenter, randomized, double-blind, placebo-controlled Phase III trial involving 2,904 patients with hypercholesterolemia.Participants were those receiving stable lipid-lowering therapy, including moderate- or high-intensity statins that still required additional LDL-C reduction.In the trial, Lipfendra reduced LDL-C by 56% versus placebo at Week 24. LDL-C fell 57% from baseline in the Lipfendra group, while it increased by 3% in the placebo group.In the CORALreef HeFH study, which involved 303 patients with heterozygous familial hypercholesterolemia, Lipfendra reduced LDL-C by 59% versus placebo at Week 24. LDL-C declined 58% from baseline in the Lipfendra group but increased by 3% in the placebo group.Beyond LDL-C reduction, Lipfendra also lowered non-high-density lipoprotein cholesterol (non-HDL-C) and apolipoprotein B (ApoB), both associated with ASCVD risk.Among patients with hypercholesterolemia, Lipfendra reduced non-HDL-C by an average of 54% and ApoB by 50%. In patients with HeFH, the corresponding reductions were 52% and 48%, respectively.Overall safety was comparable to placebo. In the hypercholesterolemia study, adverse event rates were similar between the two groups. In the HeFH study, however, diarrhea and dizziness occurred more frequently with Lipfendra.Diarrhea was reported in 7% of patients receiving Lipfendra versus 2% with placebo, while dizziness occurred in 9% and 4%, respectively. Treatment discontinuation due to adverse events was similar between groups.Although Lipfendra has demonstrated robust LDL-C lowering, it has yet to demonstrate reduction in major cardiovascular events such as myocardial infarction, stroke, or cardiovascular death.MSD is currently evaluating its effects on cardiovascular events and mortality in the CORALreef Outcomes trial involving more than 14,500 participants. Patient enrollment has been completed.The overall CORALreef clinical program includes more than 19,000 patients with hypercholesterolemia. In addition to the cardiovascular outcomes trial, MSD is conducting long-term extension studies as well as trials in pediatric patients and combination therapy with Lipfendra.Lipfendra is also expected to play an important role in MSD's long-term growth strategy. Its oral formulation and relatively lower price may act in favor when seeking to expand into the injectable-dominated PCSK9 inhibitor market.Lipfendra is priced at USD 315 per month in the United States. This is lower than some of the currently marketed PCSK9 therapies.The market expects Lipfendra to become one of MSD's key growth drivers following the loss of patent exclusivity for Keytruda (pembrolizumab), with peak annual global sales projected at up to USD 5 billion.
- Company
- Trajenta generics capture just 20% market share after 2 years
- by Kim, Jin-Gu Jul 16, 2026 08:52am
- Although more than 2 years have passed after generic versions of the DPP-4 inhibitor ‘Trajenta (linagliptin)’ entered the Korean market, the generics continue to account for only about 20% of prescriptions.The sluggish uptake contrasts with the intense interest shown around the time of the original drug’s patent expiry, when 68 companies obtained approval for 293 generic products. 2 years after launch, the average quarterly prescription value per company remains around KRW 100 million, while 87 products from more than 30 companies have been voluntarily withdrawn due to poor commercial performance.Trajenta and Trajenta Duo post KRW 19 billion in Q2 prescriptions…down 9% year over yearAccording to market research institution UBIST on the 16th, the combined outpatient prescription market for Trajenta and its generics totaled KRW 23.7 billion in Q2 2026, down 3% from a year earlier.The decline was driven primarily by lower sales of the original products. Prescriptions for Trajenta monotherapy fell 19%, from KRW 9.1 billion in Q2 2025 to KRW 7.4 billion in Q2 this year. Prescriptions for Trajenta Duo, the metformin combination, fell from KRW 11.7 billion to KRW 11.6 billion.The decline reflects both generic competition and reimbursement price reductions following the expiration of pricing premiums. The reimbursement price for Trajenta monotherapy was cut by 30% (from KRW 750 to KRW 525) when generics were launched in July 2024. Following the expiration of the one-year pricing premium in June 2025, the reimbursement price was further reduced to KRW 402. Prices for the fixed-dose combination Trajenta Duo were also reduced, depending on strength, from KRW 387 to KRW 338–344, then to KRW 259.Trajenta generics account for only 20% of market 2 years into launch….slowest penetration among DDP-4 inhibitorsSince the expiry of Trajenta's composition patent in June 2024, generic manufacturers have gradually increased prescription volumes. Combined prescriptions for Trajenta and Trajenta Duo generics reached KRW 4.8 billion in Q2, up 28% year-on-year.However, the prevailing industry assessment is that the penetration rate of Tradjenta generics has fallen short of expectations. The gap becomes even more pronounced when compared to the progress of other DPP-4 inhibitor generics whose patents expired earlier.For example, generics of ‘Tenelia (teneligliptin)’ had already captured 60% of the market 2 years after launch, and overtook the original drug.Generics of ‘Galvus (vildagliptin),’ the first DPP-4 inhibitor to lose patent protection, achieved a 48% market share within 2 years. Meanwhile, generics of ‘Januvia (sitagliptin),’ whose patent expired in September 2023, had reached a 23% market share after 2 years, three percentage points higher than Trajenta generics at the same stage (20%).Although the first generic exclusivity period expired in March last year, allowing many additional manufacturers to enter the market, the influx failed to lead to a rebound in the overall generic market.Average quarterly prescriptions remain around KRW 100 million per company…87 products withdraw from the market after ‘no-questions-asked generic approvals’Commercial performance has also been disappointing at the company level. As of Q2, no manufacturer had generated more than KRW 1 billion in combined quarterly prescriptions for Trajenta and Trajenta Duo generics. Only KyungDong Pharm (KRW 970 million) and Kyongbo Pharmaceutical (KRW 810 million) exceeded KRW 500 million in quarterly prescriptions.Most companies have failed to reach KRW 100 million in quarterly prescriptions. Among the 32 companies currently marketing Trajenta generics, 22 (68%) generated less than KRW 100 million in combined quarterly prescriptions. On average, quarterly prescriptions amount to just over KRW 100 million per company.The situation stands in sharp contrast to the enthusiasm seen during the approval stage. Following successful patent challenges in 2018, generic manufacturers aggressively pursued marketing authorizations. A total of 68 companies obtained approval for 293 generic products of Trajenta monotherapy and Trajenta Duo.In reality, however, only about half of the approved products were eventually launched. Instead, more companies have chosen to exit the market by voluntarily withdrawing approvals or declining to renew marketing authorizations upon expiration. To date, 87 products from 31 companies have been removed from the approval list.Industry observers attribute the trend to indiscriminate approval filings timed around the patent expiry of a blockbuster diabetes drug, resulting in excessive competition. As promotional costs to secure prescriptions have risen while profit margins have fallen short of expectations, many small and mid-sized pharmaceutical companies have entered a phase of portfolio rationalization by abandoning unprofitable products.Another factor behind the slow uptake is that Trajenta was the last major DPP-4 inhibitor to lose patent protection. By the time Trajenta generics entered the market, generics of Galvus, Tenelia, and Januvia had already established themselves, leaving late-arriving Trajenta generics struggling to compete for market share.
- Company
- Dong-A ST presents preclinical data on 2 Alzheimer's candidates at AAIC
- by Choi Da Eun Jul 16, 2026 08:52am
- Dong-A ST announced on July 15 that it presented poster sessions at the Alzheimer's Association International Conference (AAIC), held in London, UK, from July 12–15, showcasing preclinical findings for its Alzheimer's disease drug candidates ‘DA-7505,’ a GPX4 activator, and ‘DA-7503,’ a tau aggregation inhibitor.On July 13, the company presented data on DA-7505. According to the findings, DA-7505 binds to GPX4 in neurons, enhances its catalytic activity, and suppresses protein degradation under ferroptotic conditions, effectively reducing lipid peroxidation and cell death.The candidate also demonstrated superior anti-inflammatory activity compared with conventional reactive oxygen species (ROS) targeting inhibitors. In an Alzheimer's disease mouse model, it improved cognitive function, supporting its potential as a disease-modifying therapy (DMT).Dong-A ST said the company expects to expand DA-7505’s indication to other neurodegenerative diseases beyond Alzheimer's disease through its dual mechanism of action that suppresses both neurodegeneration and neuroinflammation.Ferroptosis is an iron-dependent form of programmed cell death caused by lipid peroxidation and is known to play a role in the development of several neurodegenerative disorders, including Alzheimer's and Parkinson's diseases. DA-7505 is a first-in-class GPX4-targeting small molecule with high blood-brain barrier (BBB) permeability.On July 14, the company also presented preclinical results for DA-7503, its tau aggregation inhibitor.In a tauopathy mouse model, DA-7503 significantly improved both cognitive and motor function even at low doses, demonstrating therapeutic activity despite low systemic exposure. The therapeutic effect increased in a dose-dependent manner, while the compound effectively inhibited tau hyperphosphorylation, oligomer formation, tau aggregation, and accumulation in the cerebral cortex and hippocampus.In an Alzheimer's disease model, DA-7503, co-administered with the current standard-of-care anti-amyloid-beta antibody lecanemab, produced additional improvements in both tau and amyloid-beta pathology. The company said the findings support DA-7503's potential as a disease-modifying therapy and highlight the promise of a dual-target strategy that simultaneously targets both tau and amyloid-beta pathology.DA-7503 is a small-molecule compound that selectively targets pathological tau protein to inhibit oligomer formation and intracellular accumulation. It is currently undergoing a Phase 1 clinical trial.A Dong-A ST official said, "The AAIC presentations further demonstrated the therapeutic potential of DA-7503 and DA-7505 for neurodegenerative diseases. We will continue developing next-generation therapies targeting multiple pathological mechanisms of Alzheimer's disease and tauopathies to address the significant unmet medical needs in neurodegenerative disorders."
- Company
- Implementing biocide regulations…burden on GMP plants
- by Hwang, byoung woo Jul 16, 2026 08:52am
- Reference image (AI-generated image)Folllowing the implementation of the Biocidal Products Approval System has introduced a new variable to sterile environment management in pharmaceutical manufacturing plants.As regulations are applied to the disinfectants and sterilizing agents used to maintain sterility in pharmaceutical manufacturing processes, the burden of replacement and validation is emerging as a new challenge in the manufacutring sector.According to the pharmaceutical industry on July 14, concerns over potential on-site confusion have been raised as some disinfectants and sterilizing agents used in pharmaceutical manufacturing facilities intersect with the Ministry of Climate, Energy and Environment (MCEE) s Biocidal Products Approval System.Strengthened biocide management since the humidifier disinfectant incidentThe background of this issue is the Act on Safety Management of Household Chemical Products and Biocides (K-BPR). This framework was introduced to strengthen the safety management of chemical substances and biocidal products following the humidifier disinfectant disaster.The system addresses the pre-market regulation of biocidal substances and products used to eliminate or inhibit harmful organisms. Under this structure, even existing substances or products must undergo approval or registration processes after a designated grace period to remain in use.The government granted a transition period until December 31, 2025, for manufacturers and importers, and until June 30, 2026, for distributors. As of July, the grace period has effectively expired, and the regulations are now fully implemented.The issue lies in the nature of the disinfectants and sterilizing agents used in pharmaceutical manufacturing facilities. While products applied directly to the human body, such as hand sanitizers, fall under the jurisdiction of the Ministry of Food and Drug Safety (MFDS), disinfectants used to maintain sterile manufacturing environments in cleanrooms and controlled areas within pharmaceutical plants can be subject to the MCEE’s biocidal product regulations.Currently, pharmaceutical processes manage the manufacturing environment in accordance with Good Manufacturing Practice (GMP) standards. In particular, for sterile manufacturing processes such as vaccines and injectables, environmental control is directly linked to product quality; thus, the environment around workspaces and equipment must be maintained at a certain level to prevent microbial contamination during manufacturing.The disinfectants used in this process are treated not merely as cleaning supplies, but as an integral part of manufacturing environmental control. Their areas of use, application methods, dosage, rotation cycles, and quality documentation are all managed within the facility's quality management system.Disinfectant replacemet is not simply a procurement changeThe primary concern for the industry lies in the process of replacing disinfectants or sterilizing agents. If a situation arises where existing disinfectants can no longer be used or must be immediately replaced with approved products, pharmaceutical companies face challenges that go far beyond simply sourcing alternative products.Under the GMP framework, changing even a single disinfectant requires significant time and resources. Industry insiders point out that the impact of the new disinfectant on work areas and equipment must be thoroughly evaluated and reviewed.Furthermore, the industry explains that efficacy testing against microorganisms is mandatory. Validation must be performed to verify whether the new disinfectant delivers the same level of bactericidal effect as the previous product. This process inevitably entails revisions to cleaning and disinfection procedures, environmental monitoring standards, standard operating procedures (SOPs), and quality documentation.Concerns are also raised that currently approved biocidal products may not fully satisfy the stringent requirements demanded by pharmaceutical GMP. This implies that simply being an approved product does not mean it can be immediately introduced into a sterile manufacturing environment.A pharmaceutical industry official explained, "Since biocides are not directly introduced into the bulk vaccine substance but are used to sanitize the manufacturing environment to maintain sterility, they do not affect the ingredients or stability of the vaccine product itself. However, under GMP, changing even a single disinfectant inevitably requires several months or more of time and resources."Discussions on temporary relief measures underway…facilities must prepare responsesConsequently, there are worries that forcing an immediate switch to alternative disinfectants without government grace periods could create physical bottlenecks and operational risks for production and release schedules due to the time required for product review and mandatory validation.However, production disruptions have not materialized at this stage. The industry and relevant government ministries are continuing discussions on practical implementation methods at manufacturing sites, and temporary relief measures are reportedly being considered for disinfectants and sterilizing agents used in biopharmaceutical manufacturing.The pharmaceutical industry is also assessing risks with a primary focus on supply stability. Manufacturers are auditing the approval status of their currently used disinfectants, identifying potential alternatives, and assessing the need for change control, while actively consulting with relevant ministries and industry associations.Experts advise that in the long run, companies must prepare their own response strategies regardless of the discussions surrounding regulatory grace periods. Some companies are reportedly not fully aware of the approval requirements for products used on-site or directly imported, making on-site guidance and raising regulatory awareness key tasks ahead.An industry representative commented, "Pharmaceutical manufacturing sites strictly manage sterile conditions in accordance with GMP standards. We are not dismissing the intent of the law. Rather, we need the application standards to be clarified to prevent confusion on-site, taking into account the unique characteristics of the pharmaceutical manufacturing environment."He added, "For products with critical supply schedules, such as vaccines that must be supplied during specific seasons, even a minor change can case a significant burden on the shop floor. It is crucial for government agencies and the industry to cooperate and coordinate so that the system can be successfully implemented without causing supply disruptions."
- Company
- New drugs for ovarian cancer obtain reimbursement
- by Son, Hyung Min Jul 16, 2026 08:52am
- The treatment landscape for ovarian cancer is rapidly changing, including early maintenance therapy to the post-recurrence, platinum-resistant stage.Given that expanded reimbursement for PARP inhibitors is possible, antibody-drug conjugates (ADCs) and immunotherapies have demonstrated survival benefit in platinum-resistant ovarian cancer, further shaping patient-specific, biomarker-driven treatment strategies.PARP inhibitor 'Lynparza'According to industry sources on July 16, the Pharmaceutical Reimbursement Evaluation Committee (PREC) of the Health Insurance Review and Assessment Service (HIRA) recently recognized the reimbursement appropriateness of 'Lynparza (olaparib)' as a first-line maintenance therapy for homologous recombination deficiency (HRD)-positive advanced ovarian cancer.Specifically, Lynparza passed the PREC review as a maintenance therapy in combination with bevacizumab for adult patients with HRD-positive, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have responded to first-line platinum-based chemotherapy combined with bevacizumab.This decision opens the possibility of expanding Lynparza's reimbursement, previously centered on BRCA-mutated patients, to include HRD-positive patients. Furthermore, in platinum-resistant ovarian cancer, the folate receptor alpha (FRα)-targeted ADC 'Elahere (mirvetuximab soravtansine)' is undergoing the reimbursement process. At the same time, the immunotherapy 'Keytruda (pembrolizumab)' recently added a new indication, expanding treatment options across the entire spectrum of ovarian cancer.A significant majority of ovarian cancer cases are diagnosed at an advanced stage. Even if patients respond to surgery and platinum-based chemotherapy, approximately 70% to 80% experience recurrence. A key characteristic of the disease is that as recurrences repeat, resistance to platinum-based chemotherapies develops, making treatment increasingly difficult.This PREC decision is significant in that it opens the possibility of broadening the patient population eligible for early maintenance therapy in ovarian cancer.Recently, the importance of early maintenance therapy, considering not only progression-free survival (PFS) to delay recurrence but also overall survival (OS), has been increasing in ovarian cancer treatment.Lynparza demonstrated long-term survival in BRCA-mutant patients in the SOLO-1 study and in HRD-positive patients in the PAOLA-1 study. Notably, the long-term follow-up results of PAOLA-1 supported the clinical value of early maintenance therapy, showing that the combination of Lynparza and bevacizumab reduced the risk of death by 38% in HRD-positive patients.Another PARP inhibitor, 'Zejula (niraparib)', is also reimbursed under national health insurance for first-line ovarian cancer maintenance therapy. The industry expects therapeutic strategies for selecting maintenance therapies to be further strengthened by comprehensively considering BRCA mutations, HRD status, and prior therapies.Platinum-resistant ovarian cancer, The era of ADC therapyADC anticancer drug 'Elahere'The treatment landscape for platinum-resistant ovarian cancer is also changing.Previously, non-platinum chemotherapies such as pegylated liposomal doxorubicin, topotecan, and paclitaxel were primarily used.However, their treatment response rates and survival benefits were limited, making this a therapeutic area with highly unmet medical needs, with some studies reporting objective response rates (ORRs) in the single digits.In this situation, Elahere, which secured domestic approval last December, presented a new treatment option as the first folate receptor alpha (FRα)-targeted ADC for ovarian cancer. Its national health insurance reimbursement process also began in earnest after passing the Cancer Disease Review Committee (CDRC) this past May.Elahere operates by selectively binding to FRα on the surface of cancer cells and then releasing a cytotoxic payload inside the cell. Approximately 35% to 40% of ovarian cancer patients are known to be FRα-positive, meeting the treatment criteria, and its expression is reported to remain relatively consistent from the time of diagnosis through the recurrence stage.In the MIRASOL study, Elahere extended the median OS to 16.46 months compared with conventional chemotherapy, approximately 4 months longer than the control group (12.75 months).It also achieved an ORR of 42.3%, demonstrating a rare, statistically significant improvement in OS in the platinum-resistant ovarian cancer setting.Keytruda joins the race…expanding the role of immunotherapyImmunotherapy 'Keytruda'Immunotherapy has also entered the treatment arena for platinum-resistant ovarian cancer.Keytruda recently added a therapeutic indication for patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer whose tumors express PD-L1 (CPS 1 or higher) and who have received 1 to 2 prior lines of systemic therapy.In the KEYNOTE-B96 study that served as the basis for approval, the Keytruda combination therapy reduced the risk of disease progression or death by 28% and the risk of death by 24%, confirming statistically significant improvements in both PFS and OS. The median OS for the Keytruda group was 18.2 months.While conventional immunotherapies previously failed to demonstrate meaningful survival improvements in ovarian cancer, KEYNOTE-B96 study is considered highly significant because it demonstrated clinical efficacy by specifically selecting PD-L1-positive patients.Previously, ovarian cancer treatment was primarily limited to surgery and platinum-based chemotherapy, and targeted therapy was limited to choosing a PARP inhibitor based on BRCA mutation status.Recently, the paradigm is rapidly transitioning toward biomarker-driven therapeutic strategies, such as expanding maintenance therapy eligibility based on HRD status and selecting ADCs or immunotherapies based on FRα or PD-L1 expression post-recurrence.Opinions are also emerging that the importance of companion diagnostics (CDx) will grow alongside therapeutics. The prevailing outlook is that identifying key biomarkers, such as BRCA, HRD, FRα, and PD-L1, at the initial stage of diagnosis to inform the design of patient-specific treatment sequences will become the new standard of care.
- Company
- ERP wave hits major multinational pharmas in Korea
- by Son, Hyung Min Jul 15, 2026 08:49am
- AI-generated imageMajor multinational pharmaceutical companies in Korea are carrying out a series of organizational restructuring initiatives to realign their local operations.The voluntary early retirement programs (ERPs) launched by Bristol Myers Squibb (BMS), Takeda, and MSD reflect how strategic shifts in the innovative drug portfolios of their global headquarters are influencing the structure of their Korean affiliates.According to industry sources on July 15, BMS Korea recently launched an ERP targeting commercial employees with 10 years or more of tenure. Eligible employees include those in sales, marketing, wholesale management, business development (BD), and other commercial functions.The compensation package is reportedly based on "2N+8 (years of service x 2 + 8 months of salary)', with additional individual severance pay added.BMS Korea said the organizational changes are part of its broader global portfolio strategy.A BMS official said, "We have continuously evolved our portfolio through strategic prioritization and resource allocation to deliver innovative therapies to patients with serious diseases more quickly. This organizational change also reflects a comprehensive assessment of our Korean portfolio, patient needs, and market environment, and represents a strategic decision to establish a more agile and sustainable operating model."In recent years, BMS has expanded its pipeline in neuroscience, radiopharmaceuticals (RPTs), and oncology through acquisitions of Karuna Therapeutics, RayzeBio, Mirati Therapeutics, and SystImmune. At the same time, the company has been pursuing cost-efficiency measures to prepare for patent expirations of its major products such as ‘Eliquis (apixaban)’ and ‘Revlimid (lenalidomide).’Although the company has launched several innovative products in Korea, including Zeposia (ozanimod), Sotyktu (deucravacitinib), and Camzyos (mavacamten), none has yet matched the commercial impact of its flagship immuno-oncology therapy ‘Opdivo (nivolumab).’ As a result, the company's commercial organization is also being restructured to reflect its evolving product portfolio.Takeda Korea has likewise recently launched an ERP. The program targets employees designated by the company, with compensation reportedly following the same 2N+8 formula plus additional severance payments. For employees with 15 years of tenure, the total severance package is reportedly around KRW 150 million.The company has been streamlining its organization and improving cost efficiency under the direction of its Japanese headquarters. The company had also recently appointed a new head for its Korean affiliate. Industry observers believe the company's Korean operations are being adjusted in line with its global business restructuring strategy.MSD and Novartis also conduct ERP…reorganizes around future growth areasMSD Korea completed its ERP program for its Human Health division last week. The Human Health organization consists of prescription medicines, vaccines, commercial operations, and external affairs functions.The company emphasized that the ERP was not driven by the performance or patent expiration of individual products, but rather formed part of a broader organizational restructuring to support future product launches and business expansion.An MSD Korea representative said, “While continuing our growth in oncology, we are preparing to expand our portfolio into cardiovascular and metabolic diseases, infectious diseases, immunology, and ophthalmology. The ERP was implemented as part of our transition toward a more agile and innovative organization capable of supporting launches across these therapeutic areas."The representative added, "The ERP is designed to support employees who voluntarily choose to pursue new career opportunities. Ultimately, we seek to strengthen the organization's execution capabilities and operational efficiency to support future growth and long-term sustainability."“We will continue delivering new treatment and prevention options through science-driven innovation while keeping the health of Korean patients as our highest priority.”Meanwhile, Novartis Korea is also reportedly undergoing organizational restructuring. Industry sources believe the changes are somewhat related to the recent downsizing of its cardiovascular (CV) business unit.Novartis has steadily adjusted its domestic business portfolio in recent years, including discontinuing its respiratory business in 2022 and transferring its ophthalmology business to Santen Pharmaceutical last year. The latest organizational changes are likewise viewed as part of the company's broader strategy to focus resources on higher-growth therapeutic areas.Recent ERP programs among multinational pharmaceutical companies are increasingly aimed at reorganizing local operations to align with changes in their global innovative drug portfolios, rather than simply reducing costs. While streamlining off-patent product businesses, companies are reallocating resources toward growth areas such as oncology, immunology, cardiovascular and metabolic diseases, and radiopharmaceuticals (RPTs), with corresponding adjustments to their Korean organizations.For example, Pfizer previously undertook a similar global restructuring following declining sales of its COVID-19 vaccine and antiviral treatment. Such organizational restructuring among Korean affiliates is expected to continue as multinational pharmaceutical companies continue shifting toward innovation-driven portfolios.A multinational pharmaceutical company official said, "In the past, ERP programs were largely aimed at reducing costs or responding to weak business performance. Today, they are increasingly focused on reorganizing companies around their future business strategies and innovative drug portfolios. We're seeing more cases where strategic changes at global headquarters are directly reflected in the organizational structure of Korean affiliates."
- Company
- Samjin joins Faslodex generic race
- by Hwang, byoung woo Jul 14, 2026 08:03am
- Samjin Pharmaceutical has entered the competition for generic versions of AstraZeneca's breast cancer therapy Faslodex (fulvestrant), raising attention on whether this may expand the overall market for fulvestrant products in Korea.(from the left) Faslodex, Fulvet, FulveserdAccording to the Health Insurance Review and Assessment Service (HIRA), Dongkook Pharmaceutical's Fulverant Prefilled Inj (0.5 g/pack) and Samjin Pharmaceutical's Fulveserd Inj (0.5 g/pack) have been listed for reimbursment, effective as of July 1.Fulvestrant is a selective estrogen receptor degrader (SERD) that works by degrading and eliminating estrogen receptors, allowing it to remain effective even in patients who have developed resistance to hormone therapy.The drug is indicated for patients with hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer, a population that accounts for approximately 70% of breast cancer cases in Korea.The Korean fulvestrant market first opened to generic competition in 2022, when Boryung's Fulvet became the first reimbursed generic following the original drug Faslodex. In February 2025, Korus Korea’s Elbracan was subsequently added to the reimbursement list.While Samjin officially entered the market following reimbursement approval, Dongkook Pharmaceutical has not announced a commercial launch schedule yet.However, market conditions remain challenging. Faslodex recorded approximately KRW 3.3 billion in import value in 2024. This is half the level seen after 2023. Boryung's Fulvet imports recorded only KRW 500 million during the same period.According to IQVIA, Faslodex generated KRW 6.1 billion in sales last year, while Fulvet recorded approximately KRW 800 million. Korus Korea’s Elbracan has yet to generate meaningful sales.Although the market has grown in 2025 compared with 2024, the entire fulvestrant segment still remains below KRW 10 billion.In such a context, later entrants are expected to focus not only on gaining market share from competitors but also on expanding the overall size of the market.Since receiving reimbursement in 2019, the original Faslodex has undergone a series of reimbursement price cuts following the entry of generic competitors and the expiration of applicable pricing premiums. After signing a Flexible Pricing Agreement with the National Health Insurance Service (NHIS) in June, Faslodex's current listed price stands at KRW 974,917.The reimbursement price for the earlier generics, Fulvet and Elbracan, is KRW 288,194. By comparison, Samjin's Fulveserd received a lower reimbursement price of KRW 244,965, while Dongkook chose the same reimbursement price as the existing generics.NHIS resultsAccordingly, Samjin is expected to compete by leveraging its relatively lower reimbursement price.Boryung, however, emphasized that Fulvet should be viewed in the context of sales synergies with the company’s broader oncology portfolio rather than as a standalone product.A Boryung representative said, "As a leading domestic oncology company, we developed and supply the first fulvestrant generic to provide patients with a broader range of treatment options. We also expect meaningful synergies with our existing breast cancer portfolio."As Samjin Pharmaceutical is also developing a generic version of Ibrance (palbociclib), it put forward the diversification of its breast cancer portfolio and the improvement of patient access as key strategic priorities.A Samjin representative said, “Like Petra (letrozole), which we already commercialized, we expect Fulveserd to also establish itself successfully in Korea’s market. We also plan to sequentially introduce additional breast cancer generics, including palbociclib, as well as innovative therapies in Korea."The representative added, "By maximizing our capability to manufacture active pharmaceutical ingredients in-house, Samjin aims to become a reliable partner capable of providing healthcare professionals and patients with a broad range of treatment options at more affordable prices through a stable supply chain."
- Company
- Novo Nordisk's Alhemo approved in Korea
- by Son, Hyung Min Jul 14, 2026 08:03am
- Novo Nordisk’s ‘Alhemo’Novo Nordisk Korea announced that the Ministry of Food and Drug Safety (MFDS) has approved Alhemo (concizumab) for routine prophylaxis to prevent bleeding episodes in patients aged 12 years and older with hemophilia.Alhemo can be used in patients with both hemophilia A and B, regardless of the presence of factor VIII (FVIII) or factor IX (FIX) inhibitors.Notably, it is the first once-daily subcutaneous prophylactic therapy available for patients with hemophilia B who have developed factor IX inhibitors, a population that previously had limited treatment options.Concizumab, the active ingredient in Alhemo, prevents bleeding by blocking tissue factor pathway inhibitor (TFPI), thereby increasing thrombin generation.Its Korean approval was based on results from the global Phase III explorer7 and explorer8 clinical trials.The explorer7 study evaluated prophylactic efficacy in patients with hemophilia A or B who had developed factor VIII or IX inhibitors. Results showed that patients receiving Alhemo prophylaxis had an annualized bleeding rate (ABR) of 1.7 for treated spontaneous and traumatic bleeding episodes, representing an approximately 86% reduction compared with 11.8 in the non-prophylaxis control group.In addition, 63.6% of patients receiving prophylaxis achieved zero bleeding, experiencing no bleeding episodes requiring treatment over a 24-week period. The median annualized treated bleeding rate was zero.Long-term follow-up demonstrated that plasma concizumab concentrations remained stable, and no new thromboembolic events were reported through 56 weeks after the clinical trials resumed. Alhemo is administered using Novo Nordisk's prefilled pen device, designed with patient convenience in mind. The device also allows individualized maintenance dose adjustments based on the patient's body weight and plasma concentration.Kasper Roseeuw Poulsen, General Manager of Novo Nordisk Korea, said, "Alhemo offers a new prophylactic treatment option for patients with hemophilia B and factor IX inhibitors, an area where treatment options have been limited. We expect its convenience in administration and bleeding prevention effect to improve the patients’ treatment experience.”
