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- 2026-07-19 18:14:26
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- 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value per company remains around KRW 100 million, while 87 products from more than 30 companies have been voluntarily withdrawn due to poor commercial performance.Trajenta and Trajenta Duo post KRW 19 billion in Q2 prescriptions…down 9% year over yearAccording to market research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."
- Policy
- President Lee calls for review of Mifegyne approval
- by Kang, Shin-Kook Jul 16, 2026 08:52am
- President Lee Jae-myung speaks during a Cabinet meeting on July 14President Jae-myung Lee has instructed relevant ministries to prepare a balanced approach to the approval of the abortion medication Mifegyne (mifepristone).During a cabinet meeting on July 14, President Lee mentioned Mifegyne, stating, “The current ban has led women who need the drug to purchase it through overseas direct purchases, exposing them to safety risks. It does not seem right to neglect the situation as is.”President Lee asked the Ministry of Food and Drug Safety (MFDS), the Ministry of Gender Equality and Family, and the Ministry of Government Legislation for detailed information on actual use patterns and developments following the Constitutional Court's ruling. Lee said, "The appropriate standard may vary depending on a woman's health condition. It doesn’t seem that setting a strict legal cutoff by gestational week needs to be a definitive standard. Entrusting the decision to physicians' conscience and professional judgment could also be one option,” calling on the ministries to explore a pragmatic compromise.Prime Minister Seong-sook Han responded that the matter is highly sensitive and said the government would prepare an agenda in consultation with the relevant ministries before revisiting the issue.President Lee's remarks immediately drew opposition from medical groups.The Korean Association of Obstetricians & Gynecologists (KAOG) issued a statement on July 14 criticizing the President's directive to seek practical solutions for introducing Mifegyne into Korea. In the statement, KAOG stated, “Introducing the drug without supporting legislation and adequate medical safety verification would threaten women's health. If the policy is pushed forward, the association will launch a strong campaign, including a nationwide refusal movement.”KAOG added, “If the drug is distributed without sufficient preparation, women could face severe bleeding, infections, and incomplete abortions requiring emergency surgery. Permitting early access before establishing safety guidelines and a proper distribution system would effectively turn the public into subjects of a dangerous medical experiment.”In contrast, public health advocacy groups welcomed the President's comments. The Korean Pharmacists for Democratic Society (President: Kyung-Lim Jeon) said, “President Lee has repeatedly expressed support for the need to introduce medical abortion drugs and included the issue among his 123 national policy initiatives, yet the Ministry of Health and Welfare and the MFDS have made little progress toward approval. As a result, women requiring abortion care have been left in a regulatory gray area.”“Simply approving abortion medication would not be sufficient to enable the practical approach emphasized by the President. We welcome the President's position, and the discussion should move beyond punishment and focus instead on protecting sexual and reproductive health and rights.Mifegyne is an oral medical abortion drug developed by the French pharmaceutical company Exelgyn. It received an essential medicine designation from the World Health Organization (WHO) and is currently approved in more than 80 countries. In Korea, however, it has yet to receive marketing approval.Hyundai Pharm previously secured Korean commercialization rights for the combination product ‘Mifegymiso Tab’ from the UK's LinePharma and has pursued marketing approval with the MFDS. However, the application process has repeatedly stalled for years because of unclear regulatory requirements and requests for additional data, resulting in multiple voluntary withdrawals and resubmissions.
- 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."
- Policy
- Korean CSO organization aims to officialize this year
- by Lee, Jeong-Hwan Jul 15, 2026 08:49am
- South Korea’s pharmaceutical contract sales organizations (CSOs) are drawing industry attention after outlining a structured action plan to secure official incorporation as legal entities under the Ministry of Health and Welfare (MOHW) this year.The Korea Contract Sales Organization Association (KCSOA), which currently operates as a temporary body, plans to recruit founding members, secure an initial milestone of 1,000 member companies, conduct nationwide briefing sessions, and ultimately secure 2,000 member companies before submitting its formal application for regulatory approval.The KSCSOA aims to emerge from the shadows of grey-market operations and establish itself as a legitimate, self-reliant partner dedicated to advancing the domestic pharmaceutical distribution system.On the 14th, a KCSOA official stated, "Given that the MOHW has explicitly highlighted the necessity of a formalized CSO association to establish robust regulatory and administrative frameworks for a fair drug distribution structure, we plan to gather industry opinions and pursue official incorporation within this year."Roadmap for KCSOA's incorporation in 2026. KCSOA aims to secure the MOHW's official authorization between November and December.Industry experts emphasize that the success of KCSOA's incorporation will hinge entirely on representativeness. Whether the association can legitimately represent the collective interests of over 10,000 registered CSOs nationwide, and whether it possesses the practical operational capabilities to drive domestic pharmaceutical development, including promoting compliant drug distribution, will directly linked to the MOHW’s final administrative decision.Consequently, KCSOA intends to recruit founding members, reach the 1,000-member milestone, and secure dedicated physical office space. The association will host nationwide meetings through August to explain the incorporation process, followed by an aggressive, highly focused membership campaign.Securing 2,000 member companies is the objective the association aims to achieve before filing its official application.Upon achieving the initial milestone of 1,000 members and subsequently scaling up to 2,000 through its regional briefing sessions, the association will immediately file for official corporate body status. Marking its third attempt, KCSOA expects to submit the application before October of this year.Under its projected timeline, KCSOA aims to secure the MOHW's official authorization between November and December, followed by its formal corporate launch and the unveiling of its strategic business roadmap for 2027.This drive within the CSO sector serves as clear evidence of its desire to bring transparency to an industry historically relegated to the fringes of pharmaceutical marketing, and to reposition itself as an equal partner in the growth of the broader healthcare ecosystem.Amid the government’s intensifying crackdowns on illegal CSO rebates and a rapidly evolving regulatory environment, securing credible, legally incorporated status is essential for the association to project a unified, authoritative voice to the MOHW and the National Assembly.If the association successfully clears this third regulatory hurdle as planned, it will officially be incorporated in November or December, commencing as a formalized entity with an actionable 2027 business plan.As KCSOA accelerates its timeline toward incorporation with a concrete target of 2,000 member companies, the wider biopharmaceutical industry is closely watching whether these efforts will culminate in final ministerial approval.A CSO industry official remarked, "The KCSOA is currently aiming for its incorporation bid through internal restructuring, including the election of a new chairperson this summer, alongside expanding membership," and added, "Because the MOHW is demanding robust evidence of industry representation and concrete, detailed operational plans, the KCSOA will gather the collective opinion of regional CSOs through its nationwide meetings before submitting its third application."
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