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- 2026-03-10 00:45:09
- InterView
- [Reporter's View] CES 2026, Physical AI and utility task
- by Hwang, byoung woo Jan 08, 2026 07:31am
- One of the keywords from CES 2026, which opened in Las Vegas on January 6 (local time), was 'Physical AI.'As the world's largest tech exhibition, CES serves as a global stage for emerging trends in AI, digital healthcare, mobility, and smart homes.This year at CES, the primary themes in the medical sector were Medical AI with high clinical usability, automation-based diagnostic technologies, and innovations in women's health.While CES is intended to be a forum for the future of technology, this focus was even more pronounced this year.In this year's keynote, Nvidia put Physical AI at the forefront, emphasizing a flow of "Executable AI" spanning robotics, autonomous driving, and manufacturing. Even within the medical and healthcare sectors, Nvidia explained its utility cases in terms of products and partnerships rather than mere theoretical models.This shift is most visible in the digital health sector. CES designated digital health as a major pillar of its official programming.According to KOTRA analysis, the digital health sector saw a 7.4% year-over-year increase in participating companies, the highest growth rate among all industry groups at CES 2026.The term 'expansion' was also officially highlighted, with CES organizers noting that 2026 digital health programming would broaden to include women's health, AI, and wearables.However, the discussions surrounding Physical AI presents a new set of challenges for the domestic medical device industry, which has centered itself around digital health. The center of gravity is shifting from technological performance to the practical role played on-site.The industry is no longer satisfied with AI that proves its validity in research papers. It now demands evidence of how much it reduces bottlenecks in hospital workflows, cuts operating costs, and saves labor and time, ultimately translating these results into contracts.Digital health has long grown by "borrowing time from the market" under the guise of innovation. However, in the era of Physical AI, the market is asking whether that innovation can fundamentally alter cost structures and redesign daily clinical workflows.In this context, it is consistent with Lunit's position as an industry leader that has expanded its reach through global market share gains and strategic M&A that it continues to receive questions regarding its break-even point (BEP).This is not a task for any single company. The entire 'K-Medical Device' sector is expected to face a reality where medical software must integrate with hardware to prove tangible economic utility. For technology to become a reality, it must ultimately reach patients and medical professionals. The collaboration model recently demonstrated by Seers Technology and Daewoong Pharmaceutical is highly suggestive in this regard. A venture company with technical capacity, leveraging the robust sales network and trust of a traditional pharmaceutical firm to overcome the conservative barriers in the medical field, will be linked to future revenue demands.The question posed by CES 2026 is clear. Digital healthcare must now prove it is a tangible industry capable of generating revenue, overcoming its status as a mere 'future growth engine.'
- Company
- Multiple sclerosis drug Ocrevus lands in Big 5 Hospitals
- by Eo, Yun-Ho Jan 08, 2026 07:31am
- The new multiple sclerosis (MS) drug Ocrevus (ocrelizumab) may now be prescribed at top tertiary hospitals in Korea.According to industry sources, Roche Korea’s relapsing multiple sclerosis (MS) drug Ocrevus (ocrelizumab) has passed drug committee (DC) reviews at major medical institutions nationwide, including Korea’s “Big 5” general hospitals: Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, Seoul St. Mary's Hospital, and Severance Hospital.Since its reimbursement listing in March 2025, Ocrevus has rapidly expanded its prescribing base. With the recent domestic approval of a subcutaneous (SC) formulation, its influence in the MS treatment landscape is expected to continue to grow further.Ocrevus targets CD20-expressing B cells that affect the demyelinating process that causes neurological disorders in MS patients.MS is a chronic disease in which myelin is damaged by an autoimmune inflammatory response. Damage to the myelin sheath causes symptoms such as muscle weakness, fatigue, and vision impairment, and can lead to non-traumatic disability. As of 2022, an estimated 2,674 patients in Korea are known to be suffering from MS, with those in the 20s to 40s age group accounting for more than 62% of the total patient population.Antibody therapies such as Tysabri (natalizumab), Gilenya (fingolimod), and Mabthera (rituximab) have been used for the disease, but there has been a persistent call for additional high-efficacy drugs.Various new drugs have been developed overseas, including Novartis' Kesimpta (ofatumumab) and TG Therapeutics' Briumvi (ublituximab), but Roche's Ocrevus is the only one introduced in Korea.Ocrevus also offers an advantage in dosing convenience. Ocrevus can be administered once every 6 months, which is more convenient than Kesimpta (administered once every month).The approval was based on the Phase III OPERA-I and II studies. The studies evaluated the efficacy and safety of Ocrevus versus Biogen's interferon therapy Plegridy (interferon beta-1a) in patients with relapsing MS.In the trial, Ocrevus reduced the annualized relapse rate (ARR) by nearly half compared to Plegridy. Specifically, in the OPERA I study, the ARR was 0.156 for 96 weeks of Ocrevus versus 0.292 for the control arm, and in OPERA II, the ARR was 0.155 for 96 weeks of Ocrevus versus 0.290 for the control arm.Ocrevus also showed efficacy in the Phase III ORATORIO study in patients with primary progressive MS. In this study, Ocrevus reduced the risk of confirmed disability progression (CDP) by 24% over 12 weeks compared to the control group.Ho Jin Kim, professor of Neurology at the National Cancer Center, said, “In MS, even small differences in the early stages can have huge cumulative consequences. This is why the benefits of early access to highly effective therapies are significant. Such treatments will not only improve patients' quality of life but also help reduce the social and economic burden costs. Ocrevus is highly versatile because it has secured sufficient data not only on efficacy but also on long-term treatment administration.”
- Company
- Companies banned from displaying product names on souvenirs
- by Chon, Seung-Hyun Jan 08, 2026 07:31am
- Pharmaceutical companies are now prohibited from displaying product names on promotional material such as pens and notebooks provided to healthcare professionals at product briefing sessions; only the company name may be displayed.According to industry sources on the 7th, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) received Fair Trade Commission approval for the 5th revision of its ‘Fair Competition Code for Pharmaceutical Transactions’ and ‘Detailed Operational Standards for the Fair Competition Code.Among the newly added provisions, the scope of promotional items provided to healthcare professionals has been more clearly restricted.Previously, during product briefings conducted during visits to individual medical institutions, pharmaceutical companies were permitted to provide healthcare professionals with food and beverages, as well as low-value promotional items bearing either the company name or product name.Under the revised rules, companies are now allowed to provide pens and notebooks bearing only the company name strictly for the purpose of delivering medical and pharmaceutical information at on-site briefings. Product names are explicitly prohibited from being printed on these items. Additionally, commemorative gifts may not be provided, and the combined value of the pens and notebooks must fall within the scope of ‘commemorative gifts valued at KRW 50,000 or less’ as specified in the scope of economic benefits permitted under the Enforcement Rules of the Pharmaceutical Affairs Act.The revised code also introduces a new requirement mandating that pharmaceutical companies prepare and disclose an expenditure report detailing economic benefits provided to pharmacists, Korean medicine pharmacists, medical professionals, founders of medical institutions, or employees of medical institutions within 3 months after the end of each fiscal year. Companies must retain the expenditure report, related accounting records, and supporting documentation for 5 years.The definition of pharmaceutical sales promoters has also been expanded. In addition to pharmaceutical suppliers as defined under the Pharmaceutical Affairs Act (i.e., marketing authorization holders, importers, and wholesalers), the scope now explicitly includes “entities entrusted with pharmaceutical sales promotion and those re-entrusted by them.” This clarification means that CSOs (Contract Sales Organizations) acting on behalf of pharmaceutical companies or wholesalers are also subject to the Fair Competition Code's regulations on promotional activities.The revised code also newly stipulates that when pharmaceutical companies support domestic academic conferences or international academic conferences held in Korea, they must not provide any additional financial or in-kind benefits related to the same conference, such as donations, food and beverage offerings, booth rentals, or advertising.New sanctions have also been introduced for companies found to have illegally supported academic conferences.Under the revised provisions, if it is confirmed through a court ruling, administrative action, or investigation by KPBMA that a pharmaceutical company supported the hosting or operation of an academic conference for improper purposes, the Association is prohibited from approving that company’s support for any academic conference hosting or operation for a period of two years from the date the fact of supporting the hosting or operation for improper purposes is confirmed.
- Company
- Prescription drug approvals·BE testing slowing down
- by Chon, Seung-Hyun Jan 08, 2026 07:31am
- The entries of pharmaceutical companies into the prescription drug market continued to slow last year. Approval numbers for new products have dropped by more than 80% compared to six years ago, when generic approvals were at their peak. Creating new revenue streams has become increasingly difficult due to tightened regulatory hurdles, such as restrictions on joint development and the implementation of a tiered drug pricing system. The number of bioequivalence trial approvals related to generic development continues to decline. Concerns are arising that upcoming pricing reforms next year, which will lower generic prices further, may completely extinguish the drive for pharmaceutical companies to enter new markets.Number of prescription drug approvals dropped 82% compared to 6 years ago...generic launch slowed down due to strengthened regulations of approvals and drug pricingAccording to data released by the Ministry of Food and Drug Safety (MFDS) on January 6, 747 prescription drugs were approved last year. There is a 29% increase from the 579 approvals in 2024, but this is an 18% decrease compared to the 915 approvals in 2023.The number of prescription approvals dropped by 33% over the past three years, from 1,118 approvals recorded in 2022.The downward trend has continued since approvals fell 38% from 4,195 in 2019 to 2,616 in 2020. Comparing last year's figures to 2019, the volume of prescription drug approvals has diminished by 82% in just six years.Number of prescription drug approvals by month (unit: number, source: MFDS)Industry analysts believe this slowdown in new generic entries has become solidified due to shifts in pricing and approval systems.Since July 2020, a tiered pricing system has been in implemented, where the ceiling price decreases the later a product is listed for reimbursement. If more than 20 generics of a specific ingredient are already listed, new entries can only receive a ceiling price as low as 85% of the existing lowest price. Furthermore, unless a pharmaceutical company develops the generic internally and conducts its own bioequivalence trials, the price drops significantly. This structure has led to a sharp decrease in approvals for generics that rely on contracted manufacturing.Higher regulatory approval barriers have contributed to diminished drive to market entries. Following the implementation of reform to the Pharmaceutical Affairs Act in July 2021, the number of incrementally modified drugs and generics that can be approved based on a single clinical trial has been limited. The new regulation, the so-called '1+3' rule, limits the number of incrementally modified drugs and generics that can be approved based on a single clinical trial. Specifically, a company that conducts its own trial can only share its data with three other products. Previously, multiple companies could receive approval for 'consigned generics' using the same data set. This regulation effectively made it impossible for 'unlimited generic replication.'The number of prescription drug approvals has shown robust growth since 2018, followed by a steady decline after 2020.In 2018, 1,562 prescription drugs were approved, averaging 130 per month. This figure surged more than twofold in 2019 to 4,195 approvals, or an average of 350 per month. In May 2019 alone, the number of approvals reached 584.From October 2018 to July 2020, over 100 prescription drugs were released every month. However, in August 2020, for the first time in 23 months, monthly approvals fell below 100. Following the approval of 216 items in January 2023, the monthly figure has remained below 100 for nearly three years, with the sole exception of July last year, when 118 approvals were recorded.The surge in 2019 and 2020 was attributed by the government’s movement toward stricter regulations. In 2018, 175 hypertension treatments containing the active ingredient valsartan were banned due to excessive impurities. In response, the MOHW and the MFDS formed a 'consultative body to improve the generic drug system' and limit the oversaturation of generics.As the government showed plans for these regulatory tightening measures, pharmaceutical companies moved ahead to secure generic product approvals, leading to a temporary spike. Since the actual implementation of these institutional reforms, the momentum for new market entries has slowed significantly.Bioequivalence trial approvals down 61% from 4 years ago…diminished new entries of generics·underlying effects of drug pricing re-evaluationRecent attempts to conduct bioequivalence trials for generic market entry have also stagnant.Last year, the number of bioequivalence trial plan approvals stood at 199, unchanged from 197 in 2023. This is a sharp decline from the 505 approvals recorded in 2021. Compared to four years ago, attempts at bioequivalence trials have decreased by 61%.On the surface, new generic entry attempts by pharmaceutical companies have significantly decreased. Industry experts diagnose this as a result of a lack of major generic market openings and the loss of momentum for latecomers following the implementation of the tiered drug pricing system.Number of bioequivalence testing plan approvals by year (unit: number, source: MFDS)The recent decline also reflects an underlying effect from the conclusion of the government's generic price re-evaluation.In June 2020, the Ministry of Health and Welfare (MOHW) announced a plan to re-evaluate pharmaceutical ceiling prices, maintaining existing prices only for generics that submitted proof of internal 'bioequivalence testing' and the use of 'registered drug master files (DMF)' by early 2023.The generic drug price re-evaluation is a policy that applies the new pricing system, which took effect in July 2020, to previously listed generic products. Under the reformed system, a generic product can receive the maximum price only if it meets both criteria, outlining that the manufacturer must conduct its own bioequivalence trial and use registered drug master files (DMFs).To avoid price cuts, pharmaceutical companies launched bioequivalence trials for generics that had already received approval. This strategy involved reformulating existing generics, conducting trials to prove equivalence, and obtaining modified approvals to maintain their current pricing. A common tactic was to switch from outsourced manufacturing to in-house production, thereby satisfying the 'conducted bioequivalence trial' requirement to evade price reductions.Consequently, approvals for bioequivalence trial plans, which recorded at 259 in 2019, rose by 24.7% to 323 in 2020 following the announcement of the re-evaluation. By 2021, this number doubled to 505 cases in just two years. Analysts suggest that with the conclusion of the price re-evaluation, the unusual phenomenon of conducting trials for already-approved generics has vanished, causing trial approval numbers to return to a downward trend.Pharmaceutical companies have already experienced significant losses due to these re-evaluations. In September 2023, the first round of generic price re-evaluations resulted in price cuts of up to 28.6% for 7,355 items. In March 2024, a second round saw prices for 948 items drop by as much as 27.9%. Additional cuts were also imposed on newly categorized products that require equivalence testing, such as sterile preparations like injectables.Pharmaceutical companies anticipate that another reform of the pricing system this year will further dampen market entry.In the reform scheduled for this July, the calculation base for generic prices is expected to drop from 53.55% of the pre-patent-expiration price of the original drug to the 40% range, with 40%-45% as the most likely target. Mathematically, if the maximum generic price falls from 53.55% to 40%, it represents a 25% deterioration in profitability.Entry barriers to late-stage generics are expected to rise as the government increases penalties for failing to meet maximum price requirements.Under the July 2020 reform, a generic price is reduced by 15% for each criterion not met. If both are not met, the price is cut by 27.75%. Currently, failing one criterion drops the 53.55% base to 45.52%, and failing both drops it to 38.69%.Under the upcoming reform, the reduction rate for failing a criterion will increase from 15% to 20%. If the new base is set at 45%, a generic failing one requirement will drop to 36%, and one failing both will fall to 28.8%. If the base is set at 40%, these figures drop further to 32.0% and 25.9%, respectively. In this scenario, a generic failing one requirement would see its price reduced by 20.9% compared to current levels. A generic failing two requirements would see its price reduced by 25.6%.If the criteria are set to 40% , a generic that relies on contracted manufacturing without conducting its own bioequivalence trial would be capped at 32.0% of the original drug's pre-patent price. This is a 29.7% decrease from the current 45.52%. Compared to the era before the 2020 ceiling price requirements were introduced, generic prices would be cut by more than 40% (from 53.55% to 32.00%). For those failing both requirements, the cap would be 25.6%, a 33.8% drop from the current 38.69%.The drive for latecomers to enter the market is expected to shrink further as the tiered pricing system is strengthened. The MOHW has proposed a plan to apply five percentage-point reductions, starting with the 11th generic entry of the same formulation, a significant tightening from the current 21st-entry regulation. Under the reformed system, this additional price cut measure will trigger much earlier, effectively lowering price standards across the entire generic sector.
- Policy
- Plan to waive Phase 3 for comb therapies for HTN and DYS
- by Lee, Tak-Sun Jan 08, 2026 07:31am
- Ministry of Food and Drug Safety (MFDS)The Ministry of Food and Drug Safety (MFDS) has announced an exemption for Phase 3 clinical trials of combination therapies targeting hypertension and dyslipidemia, provided the components do not mutually interfere with efficacy or safety. This exemption is also expected to extend to triple-combination therapies that include diuretics.However, the MFDS explained that Phase 3 data will be waived only if meta-analysis data confirm that treatments for hypertension and dyslipidemia do not affect each other’s therapeutic effects or safety profiles.The MFDS has prepared a revision to the 'Guidelines for Clinical Trials of Combination Drugs' and is collecting industry feedback through January 13.The new addition outlines a plan to rationalize data submission requirements for developing combination drugs intended for comorbid conditions, organized in a Q&A format within the guidelines.According to the guidelines, the MFDS stated, "Regarding combination drugs for the treatment of comorbid hypertension and dyslipidemia, we have determined that therapeutic confirmatory clinical trials (Phase 3) can be exempted for specific drug classes based on the results of meta-analysis performed on accumulated domestic clinical trial data."The MFDS added, "To date, hypertension + dyslipidemia combinations developed in Korea have primarily consisted of ARBs (Angiotensin II Receptor Blockers) or CCBs (Calcium Channel Blockers) for hypertension, and Statins or Ezetimibe for dyslipidemia," and explained," Meta-analysis of previously submitted clinical results indicate that these hypertension and dyslipidemia treatments do not mutually affect therapeutic efficacy or safety."Based on these findings, the MFDS has finalized a policy to exempt therapeutic confirmatory clinical trial data for companies developing combination drugs composed of ARB or CCB and Statin or Ezetimibe. Nevertheless, the MFDS noted that even within these classes, toxicological patterns or pharmacokinetic profiles may vary by specific active pharmaceutical ingredient (API).The MFDS explained that a therapeutic confirmatory clinical trial may be requested in some cases because the toxicity profile and pharmacokinetics may vary depending on APIs. The MFDS stated, "Developers must present a review of the impact on safety and efficacy based on trial data regarding absorption, distribution, metabolism, and excretion (ADME), as well as pharmacokinetic drug-drug interaction studies," the MFDS added. "If significant drug-drug interactions are observed in pharmacokinetic studies and are judged to potentially affect safety or efficacy, a therapeutic confirmatory clinical trial may be requested."Regarding triple-combination drugs that include a diuretic in addition to these two components, the MFDS explained that while Phase 3 data submission is the general rule, exemptions are possible under specific conditions.The MFDS stated, "For hypertension-dyslipidemia combinations containing drugs in addition to the mentioned classes (e.g., diuretics), therapeutic confirmatory clinical trials must be submitted as before. However, if meta-analysis data for the specific drug class being developed confirms that the hypertension and dyslipidemia treatments do not influence each other's efficacy and safety, the requirement for Phase 3 data may be waived."In cases where the combination includes a new drug ingredient or involves changes to dosage and administration, additional safety and efficacy data will be required. The MFDS advised, "If a new drug is included in the proposed combination or if it deviates from the approved labeling (dosage, administration, etc.) of the individual treatments, additional safety and efficacy evaluations may be necessary," and added, "We encourage companies to consult with the Ministry in advance."
- Company
- ‘No intention to manufacture APIs despite incentives’
- by Kim, Jin-Gu Jan 08, 2026 07:31am
- The pharmaceutical industry has assessed that the “supply-stability incentive” system, which is included in the government’s drug pricing reform plan, lacks sufficient appeal to drive actual production expansion.Seven out of ten CEOs of pharmaceutical and biotech companies responded that even if the premium is applied, they have no intention of engaging in active pharmaceutical ingredient (API) production or the manufacture of nationally essential medicines. Industry leaders pointed out that the incentive level is insufficient to offset rising costs and risks, becoming a temporary measure rather than a structural solution.7 in 10 CEOs: “Supply-stability incentive ineffective; no intention to expand production”On the 7th, the ‘Emergency Countermeasure Committee for Pharmaceutical Price System Reform to Promote the Development of the Pharmaceutical and Bio Industry’ (Emergency Committee) released the results of an urgent survey conducted among CEOs of pharmaceutical and biotech companies. Fifty-nine pharmaceutical and biotech companies participated in this survey.When asked if they were willing to produce APIs themselves to receive the ‘supply stability incentive,’ 69.5% (41 companies) responded ‘”no.”Similarly, a majority of respondents expressed reluctance to manufacture national essential medicines using domestically produced APIs, with 59.3% (35 companies) answering “no,” while only 35.6% (21 companies) said “yes.”Negative views also dominated assessments of the eligibility criteria and incentive rates associated with the supply-stability surcharge. 52.5% (31 companies) said the current framework was “not reasonable.”Key reasons cited included: ▲Surcharge levels insufficient to cover costs ▲Need for structural stability measures like permanent price cap increases rather than temporary surcharges ▲ Need to consider expanding incentives even for non-essential medicines when using domestic APIs.The Emergency Committee views that if the supply stability surcharge fails to function as a production incentive, it may also limit the policy goal of securing supply stability. The pharmaceutical industry consistently points out that the uncertainty is too high to justify additional investment solely to meet the incentive eligibility requirements.“Market-linked actual transaction pricing system may intensify non-voluntary price competition”Concerns were also raised regarding the market-linked actual transaction price system.When asked about the potential impact on corporate competition and distribution strategies if the market-linked actual transaction price system is introduced and the incentive payment rate is expanded from the current 20% to 50% (multiple responses allowed), 91.5% of respondents (54 companies) answered that “profitability will deteriorate due to intensified involuntary price competition.”Additionally, many responded that changes in sales and distribution strategies would be inevitable, such as ▲the strengthening of healthcare institutions' unilateral bargaining power due to the expanded incentive payments and ▲the increased use of CSOs.Regarding “Innovation incentives”… “Innovation incentives will decrease in practice” concerns ariseRegarding whether the innovation incentive would provide a meaningful preferential benefit, the most common response was ‘preferential treatment will actually decline’ at 49.2% (29 companies).Companies giving this response cited reasons including: ▲ Not qualifying for innovation criteria, ▲ Benefits dropping to the 40% range after the incentive period ends, resulting in minimal benefit, ▲ Narrowing of eligibility from the previous 68% incentive group to only the top 30% of companies by R&D spending ratio, ▲ Incentives being temporary, with benefits immediately reduced if R&D investment levels change.Regarding the validity of the ‘classification criteria and validity of the innovation preferential rate,’ 72.9% (43 companies) answered “not valid.’Reasons cited included: ▲unreasonable differential application of incentives ▲need to judge innovation criteria based not only on R&D spending ratio but also on the quality of overall research outcomes (e.g., new drug pipelines).As for improvements needed in the current Innovative Pharmaceutical Company designation criteria, respondents suggested including facility investment, venture investment, number of clinical trials, technology transfers, and patent registrations in the calculation of R&D expenditures.Additionally, regarding the appropriate bonus period, 32.2% (19 companies) responded ‘3+3 years’.Policy improvements: flexibility in innovation criteria, funds, and tax supportIn response to an open-ended question on additional government support measures needed beyond the current drug pricing reform to promote R&D investment and innovation across the pharmaceutical and biotech ecosystem, the most frequently cited proposal was greater flexibility in the criteria for designating innovative pharmaceutical companies (25 companies).Additionally, many companies highlighted the need for: ▲Expanding funds and R&D tax credits ▲Supporting investments in manufacturing facilities and quality control ▲Providing preferential treatment for suppliers of essential medicines and exit-prevention drugs, along with support for companies addressing supply instability.Finally, 50 companies opposed the inclusion of generic drugs in the price-volume agreement negotiations.Reasons cited included: ▲Generics already have sufficiently low prices, making further reductions double regulation ▲Expanding generic use already contributes to health insurance cost savings ▲Inconsistency with systems in major overseas countries that only apply such measures to new drugs.
- Company
- Pharmaceutical exports to Venezuela account for 0.02%
- by Kim, Jin-Gu Jan 07, 2026 08:46am
- Korea’s pharmaceutical exports to Venezuela totaled USD 1.53 million (approximately KRW 2.2 billion) last year, leading to projections that the impact of the recent U.S. military operation in Venezuela on Korean drug exports will be limited.According to the Korea Customs Service, on January 6, Korean pharmaceutical exports to Venezuela through November last year amounted to USD 1.526 million. This represents just 0.02% of Korea’s total pharmaceutical exports (USD 7.92788 billion) over the same period.Domestic pharmaceutical exports to Venezuela have fluctuated significantly over the past decade. Export volumes stood at USD 3.25 million in 2016, plummeted to USD 130,000 in 2017, rebounded sharply to USD 5.13 million in 2023, and then fell again to USD 650,000 the following year.Despite these fluctuations, Venezuela’s share of Korea’s total pharmaceutical exports has consistently remained below 0.1%. This is why the impact of the U.S. military operation in Venezuela is expected to be minimal on Korea’s pharmaceutical exports.The assessment is that the geopolitical variables affecting neighboring Latin American countries are also unlikely to have significant ripple effects. Domestic pharmaceutical companies primarily sign bundled regional contracts to supply medicines, covering multiple nearby markets like Colombia, Ecuador, and Peru, rather than exporting to Venezuela on a standalone basis. Under this structure, shortfalls in one country can often be offset by volumes in others, mitigating overall contract risk.However, given that Venezuela was mentioned as a competitive export region for domestic P-CAB class gastroesophageal reflux disease (GERD) treatments alongside neighboring Latin American countries, the possibility that it could act as a mid-to-long-term variable has been raised. Relevant companies are closely monitoring developments.HK Inno.N is aiming to expand its flagship GERD drug K-CAB into 18 Latin American countries, including Venezuela. In 2018, the company signed a finished-product export and distribution agreement with major Latin American pharmaceutical company Laboratorios Carnot, covering Mexico, Venezuela, Colombia, Peru, Chile, Ecuador, Uruguay, Paraguay, Bolivia, the Dominican Republic, Guatemala, Honduras, Nicaragua, Costa Rica, Panama, and El Salvador. Subsequently, in 2022, it added a technology transfer agreement with Eurofarma for Brazil.Onconic Therapeutics has also established a supply structure for its GERD drug Jaqbo, following a technology export agreement with Mexican pharmaceutical company Laboratorios Senosiain, covering 19 Latin American countries, including Venezuela.Daewoong Pharmaceutical is actively pursuing Latin American expansion for its P-CAB drug Fexuclue, aiming for global expansion into 100 countries. The product has already been launched in Mexico, Ecuador, and Chile, with regulatory applications submitted in Brazil and Peru. While no official entry into Venezuela has been announced, a regional strategy encompassing neighboring countries is being considered. Daewoong previously employed a bundled contract strategy with local partners for its botulinum toxin product ‘Nabota’ in Latin America. An industry official stated, “Exports of pharmaceuticals to Venezuela were already limited in scale, and the contract structure was mostly regional agreements. It seems unlikely that this situation will have a direct impact. However, considering the geopolitical risks surrounding the Latin American pharmaceutical market in the mid to long term, companies should review export routes and contract structures.”The United States launched military operations on Venezuela's capital, Caracas, and other locations in the early hours of the 3rd (local time). President Donald Trump announced via Truth Social that they had successfully captured Nicolas Maduro. Regarding the reason for the operation, President Trump stated, “Maduro committed narco-terrorism crimes against Americans, and he will face justice. The United States will govern Venezuela until the regime change, and Maduro will face U.S. judicial proceedings.”
- Policy
- ImmuneOncia, Merck, and Bayer receive orphan drug designation
- by Lee, Tak-Sun Jan 07, 2026 08:46am
- Three new drug candidates, including ImmuneOncia's lymphoma treatment candidate danverstotug, have been designated as orphan drugs in Korea.Designation as orphan drugs increases the likelihood of expedited approval through fast-track review, potentially accelerating the commercialization of these products.On January 2, the Ministry of Food and Drug Safety (MFDS) announced the designation of three new drug candidates, danverstotug, mirdametinib, sevabertinib, as orphan drugs.Danverstotug is a novel lymphoma drug candidate being commercialized by ImmuneOncia, Yuhan Corporation's immune-oncology subsidiary.As an immunotherapy targeting relapsed/refractory NK/T-cell lymphoma, it demonstrated efficacy in a domestic Phase II clinical trial, based on which the company applied for orphan drug designation to the MFDS last July.According to the company, the Phase II study in patients with relapsed or refractory NK/T-cell lymphoma who had failed first-line therapy showed an objective response rate (ORR) of 79% and a complete response (CR) rate of 63%.The median progression-free survival (PFS) was 29.4 months, while overall survival (OS) rates were 85% at one year and 78% at two years. Adverse reactions were mostly mild, and 40% of all patients completed the two years of long term treatment.The company has completed the commercial manufacturing technology transfer for this drug to Lonza, a global contract development and manufacturing organization (CDMO). ImmuneOncia aims to launch the drug before 2030.Mirdametinib is a drug used for neurofibromatosis with plexiform neurofibroma that received US FDA approval in February last year. The drug is expected to compete with Koselugo (selumetinib, AstraZeneca), an existing therapy for neurofibromatosis.Mirdametinib was developed by US-based biotech SpringWorks Therapeutics, which was acquired by Merck (Germany) in April last year for USD 3.9 billion.Bayer’s sevabertinib is an investigational therapy for HER2-positive non–small cell lung cancer, an area with limited treatment options. The drug is gaining attention as a potential alternative for patients who do not respond to existing therapies. The US FDA has granted the drug accelerated approval status and is conducting a priority review.When designated as an orphan drug, data submission required for approval is simplified, allowing exemptions from bridging studies, conditional approval, and fee reductions. It also enables a fast-track approval process through priority review. The Ministry of Food and Drug Safety (MFDS) recently relaxed the requirements for orphan drug designation, lowering regulatory barriers. Previously, data demonstrating improved efficacy over existing alternatives was required, but under the revised rules, such data are no longer mandatory for orphan drug designation.
- Company
- Rare cancer drug 'Welireg' faces another reimb hurdle
- by Eo, Yun-Ho Jan 07, 2026 08:46am
- The rare anti-cancer drug 'Welireg' has once again failed to be added to the insurance reimbursement list. This is the third round.MSD Korea submitted a reimbursement application for its Welireg (belzutifan), an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, in June of last year. However, the company received a decision of 'reimbursement criteria have not been set' from the final review of the Cancer Drug Review Committee (CDRC), held at the end of 2025.This is the third report of Welireg failing to pass the CDRC review following previous failures in August 2025 and March of last year. Since its domestic approval in May 2023, the drug has remained non-reimbursed for over 2.5 years. Attention is now focused on whether Welireg will be summitted again for listing in 2026.Welireg was designated as an orphan drug in Korea in 2023 for the rare disease indication of von Hippel-Lindau (VHL) disease and received final approval in May of the same year.The specific indications include the treatment of adult patients with VHL disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), where immediate surgery is not required.Welireg works by reducing the transcription and expression of HIF-2α target genes involved in cell proliferation, angiogenesis, and tumor growth.The efficacy of Welireg was demonstrated in the open-label Study 004, which enrolled 61 patients with VHL-associated RCC who had at least one measurable solid tumor localized to the kidney.Enrolled patients also had other VHL-associated tumors, including CNS hemangioblastomas and pancreatic neuroendocrine tumors.The primary efficacy endpoint of the clinical trial was the objective response rate (ORR), measured by radiological assessment using RECIST v1.1 evaluated by an independent review committee. Additional efficacy endpoints included duration of response (DoR) and time to response (TTR).The results showed that Welireg achieved an ORR of 49% in patients with VHL-associated RCC. All responses were partial responses. The median DoR has not yet been reached, and 56% of patients had response persistence for at least 12 months. The median TTR was 8 months.Furthermore, in 24 patients with VHL-associated CNS hemangioblastomas, the ORR was 63%. Within this group, the complete response (CR) rate was 4%, and the partial response (PR) rate was 58%.
- InterView
- [Reporter’s View] High-priced drugs: efficacy vs. efficiency
- by Son, Hyung Min Jan 07, 2026 08:46am
- The launch of high-priced anticancer drugs and treatments for rare diseases will continue. There is no question that the efficacy of new drugs is improving, with a growing number of therapies extending survival or even offering the possibility of a cure.The problem lies in how, for whom, and by what criteria these treatments should be used. This question is generating considerable debate in practice.According to the collective views of oncology specialists, the current reimbursement framework is producing paradoxical outcomes.This is because drugs for cancers with large patient populations are failing to secure reimbursement approval, even when they demonstrate strong clinical efficacy, simply because of concerns over financial sustainability. More problematic than the negative reimbursement decision itself is the lack of explanation regarding the rationale and criteria behind such decisions.In the past, in addition to the improvement in overall survival (OS), the contribution of domestic patients to clinical trials was a key evaluation factor during approval or reimbursement review for new drugs. If domestic patients contributed to the clinical results, this was also partially reflected in the approval and reimbursement decision-making process.Recently, however, a clear shift has emerged. Regardless of clinical benefit, drugs targeting cancers with large patient populations tend to be disadvantaged in reimbursement discussions, while coverage is increasingly concentrated on rare cancers with smaller patient populations. This perception is widely shared among clinicians.If reimbursement policies have been adjusted due to financial constraints, the criteria and reasoning behind those decisions must be explained more clearly. Otherwise, patients are left unable to understand why the treatment they need is denied reimbursement.Clinicians are well aware that healthcare resources are limited. However, there is growing concern over whether those limited resources are truly being allocated to where they are most needed.For example, during cancer follow-up care, CT, MRI, and PET scans are often repeated without clear clinical justification. Streamlining expenditures in these areas could free up a substantial amount of funding for essential treatments.The national health screening system also warrants reconsideration. Currently, cancer patients receive the same health screening notifications as the general population, leading to redundant examinations.Despite cancer patients undergoing regular follow-up and monitoring at hospitals, the central data system fails to administratively distinguish them. Simply excluding cancer patients from routine general health screenings could significantly reduce unnecessary expenditures.The government states that the ongoing drug price reforms and reimbursement system improvements are intended to safeguard the National Health Insurance finances and ultimately save patients with cancer and rare diseases. The direction itself, aimed at improving access to new drugs, cannot be denied. However, it is clear that before restricting treatment access, citing limited resources, we must first examine whether there are areas where public funds are being wasted inefficiently.In the era of high-priced innovative medicines, reimbursement decisions are not merely about reducing or expanding reimbursement. They are about choosing between efficacy and efficiency. If patient survival and access to treatment are truly the guiding principles, then the priority should be eliminating unnecessary spending and systemic inefficiencies.
