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- 2026-07-22 03:12:17
- Policy
- Exports of K-bios reach record $4.5 billion in 1H 2026
- by Lee, Tak-Sun Jul 09, 2026 08:55am
- South Korea's biopharmaceutical industry posted its highest-ever export performance for the first half of the year, once again demonstrating its growing presence in the global market. The expansion was driven primarily by increasing market share in Europe, supported by strong manufacturing competitiveness and growing contract development and manufacturing organization (CDMO) orders.According to the Ministry of Food and Drug Safety (MFDS, Minister: Yu-Kyoung Oh), Korea's biopharmaceutical exports totaled USD 4.5 billion during the first half of 2026, representing a 15.3% increase from the same period last year. This is the highest first-half export figure on record.Over the past three years, Korea's biopharmaceutical exports have grown by more than 20% annually on average, nearly doubling in size. During the first half of this year, biopharmaceuticals accounted for 86.5% of Korea's total pharmaceutical exports (USD 5.2 billion), reaffirming their role as the primary driver of Korea’s pharmaceutical exports.Growth was also evident on a quarterly basis. Exports reached USD 2.0 billion in the first quarter and USD 2.5 billion in the second quarter, representing year-over-year increases of 11.1% and 15.3%, respectively. Monthly exports also set new records throughout the period. In June alone, exports reached USD 1.02 billion, marking the first time monthly biopharmaceutical exports exceeded the USD 1 billion threshold.Switzerland is the top export destination…Netherlands and France record rapid growthDuring the first half of the year, Korean biopharmaceuticals were exported to 163 countries worldwide. By export value, Switzerland ranked first with USD 770 million (17.1%), followed by the United States with USD 610 million (13.6%) and Hungary with USD 600 million (13.3%).Exports to Switzerland increased 67.4% (US$310 million) compared with the same period last year, allowing the country to maintain the top position for both the first quarter and the first half of the year. The increase was attributed mainly to higher CDMO orders secured by Korean companies from global pharmaceutical firms based in Switzerland, along with growing demand for biosimilars.Other European markets also posted strong growth. Exports to the Netherlands rose 80% to USD 450 million, making it Korea's fourth-largest export destination, while exports to France reached USD 160 million, allowing the country to enter Korea's top ten export markets for the first time, ranking ninth.Recombinant biologics account for 88% of exports…toxins and antitoxins also show strong performanceBy product category, recombinant biologics led exports with USD 3.97 billion, accounting for 88% of total biopharmaceutical exports. This is an 18.4% year-over-year increase. Exports of recombinant DNA products grew particularly rapidly in major European markets, especially in France (+630%), Belgium(+184%), and Italy(+147%).Exports of toxins and antitoxins reached USD 280 million, up 47.4% from a year earlier. The United States (USD 70 million) and China (USD 60 million) were the largest export markets, while exports to Southeast Asian countries such as Thailand (+119%) and Vietnam (+112%) more than doubled year on year. In contrast, vaccine exports declined 27.4% year over year to USD 120 million, with shipments primarily exported to Southeast Asia and Africa, including Thailand and Bangladesh.MFDS to implement ‘CDMO Special Act’ in December…will support the act through regulatory reformTo sustain the current momentum through the second half of the year, the MFDS plans to provide additional regulatory support. ‘The Special Act on Regulatory Support for Biopharmaceutical Contract Development and Manufacturing Organizations (CDMO Special Act),’ enacted last December, will officially take effect this coming December.Once implemented, the legislation will introduce an ‘Export Manufacturing Registration System,’ allowing CDMO companies manufacturing products exclusively for export to enter global markets without first obtaining a separate pharmaceutical manufacturing license. The MFDS also plans to introduce certification programs aimed at enhancing the credibility of domestically produced biopharmaceutical APIs.Young-jin Ahn, Director of the Biopharmaceuticals and Herbal Medicines Bureau at the MFDS, said, "We will innovate the review and approval process for new drugs and biosimilars while providing regulatory support throughout the entire product lifecycle so that safe therapies can reach patients around the world as quickly as possible. We will also provide tailored information to support Korean companies' overseas expansion and actively strengthen regulatory cooperation with our major export markets."
- Policy
- MFDS warns against misuse of GLP-1 obesity drugs
- by Lee, Tak-Sun Jul 09, 2026 08:55am
- The Ministry of Food and Drug Safety (MFDS) has warned against the misuse and abuse of GLP-1-based obesity treatments, urging consumers not to use products purchased through overseas direct purchases. The agency also announced plans to intensify inspections of misleading advertisements by pharmacies and medical institutions.On July 8, the MFDS announced so following media reports on the growing misuse of GLP-1 obesity medications. The agency emphasized that these products should be used only in patients who meet the approved indications for obesity treatment and strictly in accordance with the approved prescribing information under the supervision of a healthcare professional.GLP-1 class obesity drugs contain glucagon-like peptide-1 (GLP-1), which increases glucose-dependent insulin secretion, suppresses glucagon release, delays gastric emptying, and promotes weight loss.These medicines are indicated for: ‘adults with obesity and an initial body mass index (BMI) of 30 kg/m² or higher,’ or ‘overweight adults with a BMI between 27 kg/m² and less than 30 kg/m² who have at least one weight-related comorbidity, such as hypertension.When GLP-1 obesity medications approved for adolescents are prescribed, special caution is also required because adolescents are still growing. Healthcare providers should closely monitor for insufficient nutritional intake and excessive weight loss that could affect growth, as well as gastrointestinal adverse events leading to dehydration and acute pancreatitis.The MFDS also noted that these products are often mistakenly perceived as simple "diet pills," leading to inappropriate use. The agency stressed that obesity treatments are prescription-only medicines and must be used only after being prescribed by a physician and accompanied by proper medication counseling from a pharmacist.In particular, products obtained through overseas direct purchases have not been approved in Korea, meaning their safety and efficacy have not been adequately verified. Also, because their manufacturing and distribution history cannot be confirmed, such products may be counterfeit or substandard medicines, posing significant health risks. Furthermore, consumers who experience harm after using these products may have difficulty obtaining legal protection, including product recalls or compensation.To promote the safe use of obesity medications and improve public understanding, the MFDS plans to produce card news materials and short-form videos for distribution through social media. The agency will also work with the Ministry of Education and the Ministry of Gender Equality and Family to provide information on the safe use of obesity medications through websites frequently visited by adolescents and parents.In addition, in cooperation with local governments, the MFDS plans to conduct intensive inspections and follow-up actions on medical institutions and pharmacies regarding off-label promotion and false or misleading advertising of obesity treatments.An MFDS official said, "We will continue making every effort to improve users' understanding of obesity treatments and actively provide information on their safe use within the approved indications, fostering an environment that supports the safe use of medicines."
- Policy
- Preferential framework ahead of certification?...drug pricing reform
- by Jung, Heung-Jun Jul 09, 2026 08:55am
- The Ministry of Health and Welfare (MOHW) is implementing preferential pricing benefits in August. Yet, the criteria for certifying Innovative and Semi-Innovative companies are incomplete. (AI-generated image)The South Korean government is being called for failing to account for newly certified Innovative·Semi-Innovative Pharmaceutical Companies as it pushes ahead with a reform of drug pricing calculations and price reductions for prior-listed drugs. Critics point out that the policy reform is not being processed in an appropriate sequence, given that the preferential pricing benefits are scheduled to take effect as early as next month, even though official applications for this year's Innovative and Semi-Innovative certifications have not yet opened. Furthermore, price reductions for baseline-listed drugs are set to begin in November, based on the September drug formulary registry, triggering widespread confusion about how the exemptions for Innovative and Semi-Innovative companies will be applied in practice. For the current year, the plan is to cut prices from 53.55% to 51% exclusively for medications listed before 2012, creating an administrative bottleneck in which products eligible for special exemptions must be reclassified retrospectively. According to industry sources on the 7th, generic drug pricing calculation and premium mechanisms, including the newly established "Semi-Innovative" company list, are set for an extensive restructuring next month. However, the certification process for Semi-Innovative companies has not even commenced. Similarly, new designations for Innovative Pharmaceutical Companies are not scheduled until December, meaning that structural revisions to the pricing and premium systems will precede the actual certifications. Consequently, pharmaceutical companies seeking Semi-Innovative status or aiming for new Innovative designations are effectively forced to delay their health insurance reimbursement listings to secure preferential pricing benefits. Because the Semi-Innovative and Innovative tiers receive a 50% and 60% pricing premium, respectively, missing out on these certifications results in a 5% to 15% financial penalty compared to the baseline calculation rate of 45%. An official from domestic pharmaceutical company said, "The government seems to force the timeline forward, but they simply need to let go of the rigid notion that it must be launched this year," and added, "From a regulatory coherence standpoint, postponing the implementation by just a few months would resolve everything. We intend to submit our formal feedback during the administrative notice period." The Ministry of Health and Welfare (MOHW) is currently collecting public and industry feedback on the partial amendment draft of the 'Criteria for Determination and Adjustment of Drugs' through an administrative notice period ending on the 13th. The pharmaceutical industry strongly maintains that the implementation timeline must be recalibrated to minimize operational confusion on the ground. The same structural misalignment applies to price cuts for prior-listed drugs, in which Innovative and Semi-Innovative enterprises are legally entitled to a 3-4 year grace period or a special exemption. The government is reportedly planning to categorize products according to the September Drug Reimbursement List and enforce price reductions in November. However, because no company has been certified as Semi-Innovative yet, it is impossible to identify which drugs qualify for exemptions under the prior-listed price cuts. Ultimately, eligibility for these exemptions can only be determined through a retrospective reclassification after the certification applications and evaluations are finalized.An official from another pharmaceutical company expressed frustration, stating, "This policy reform was originally intended to incentivize R&D innovation through pricing premiums. The logical sequence should be to finalize company certifications before altering the system. It appears the government is simply sticking to its original schedule regardless of the logical workflow."
- Policy
- Salt-modified Forxiga IMDs secure reimbursement in Korea
- by Jung, Heung-Jun Jul 08, 2026 08:54am
- Forxiga generics continue to enter the reimbursement market following the original product’s market withdrawal in 2024With generic versions of the original Forxiga (dapagliflozin) showing a continued rise in sales, companies continue to enter the Forxiga market.Among them, one product has secured pricing advantages by switching from contract manufacturing to in-house production, further intensifying competition.According to industry sources on the 6th, Withus Pharmaceutical's Posijin Tab (dapagliflozin citrate) 5 mg and 10 mg were added to the National Health Insurance reimbursement list this month. Having satisfied all pricing criteria, the products were listed at KRW 262 and KRW 393, respectively.Posijin carries the same brand name as a dapagliflozin product that Withus originally obtained marketing approval for in 2020. At that time, the product was manufactured under contract by Sam Chun Dangg Pharm, but its approval was voluntarily withdrawn in October 2024.The newly listed ‘Posijin Tab,’ despite sharing the same brand name, differs from its predecessor in that it uses a modified salt form. In addition, it was developed through the company's own bioequivalence study rather than contract manufacturing, allowing it to satisfy all pricing requirements. It obtained regulatory approval in April this year and secured reimbursement just four months later.Although it retains the same product name as the previously withdrawn version, the new Posijin differs in that it now fulfills all requirements for pricing advantages. It also expands the reimbursed product lineup by offering an additional 5 mg strength, which was not available in the previous version.A Withus Pharmaceutical official said, "We pursued this strategy because in-house manufacturing offers pricing advantages. There was no other special reason," expressing expectations that the product will contribute to sales growth following the company’s full-scale marketing activities.Sales of Forxiga generics have continued to increase following AstraZeneca Korea's voluntary withdrawal of the original product from the domestic market in 2024, with generic manufacturers benefiting from the resulting market opportunity.Among generic manufacturers, HK inno.N, Boryung, Daewoong Bio, and Hanmi Pharmaceutical have emerged as the leading competitors in sales.According to pharmaceutical market research firm UBIST, HK inno.N's Dapa N recorded sales of KRW 10.5 billion, representing 341% growth from KRW 2.4 billion the previous year. Boryung's Truedapa posted KRW 5.6 billion, up 19% year over year. Sales of Daewoong Bio's Forxidapa increased from KRW 2.3 billion to KRW 6.0 billion, a 157% increase, while Hanmi Pharmaceutical's product grew from KRW 4.0 billion to KRW 5.8 billion, representing 45% growth.However, competition among SGLT-2 inhibitor monotherapy generics has become even more complex after a large number of Jardiance (empagliflozin) generics entered the market following patent expiration in the fourth quarter of last year.
- Policy
- Medical cannabis restricted under outdated narcotics regulations
- by Lee, Jeong-Hwan Jul 08, 2026 08:53am
- Product photo of EpidiolexBoth the ruling and the opposition parties in South Korea are introducing bills to permit the domestic commercialization and marketing authorization of medical cannabis that offers validated clinical efficacy without psychoactive or addictive risks, such as cannabidiol (CBD). This would increase the likelihood of bypassing long-standing regulatory bottlenecks for treatment access for patients, such as those with epilepsyIf enacted, the legislation will improve South Korea's outdated Narcotics Control Act, which previously failed to distinguish non-psychoactive CBD from psychoactive tetrahydrocannabinol (THC). This regulatory reclassification is anticipated to bring a regulatory shift within the conservative Ministry of Food and Drug Safety (MFDS).On the 6th, Rep. Hyungdong Kim of the People Power Party submitted a bill that reclassifies medically viable cannabis derivatives as psychotropic substances. By clarifying the definition of cannabis, the amendment enables pharmaceutical companies to apply for domestic manufacturing and marketing authorizations.Earlier in March, Rep. Mihwa Seo of the Democratic Party of Korea introduced a separate amendment to the Narcotics Control Act with a similar regulatory intent.Globally, regulatory bodies have increasingly removed CBD-based therapeutics from restricted narcotics schedules, facilitating commercial product development and expanding patient care. In contrast, the South Korean MFDS has restricted access solely to personal-use imports handled via the Korea Orphan & Essential Drug Center (KODC), under the rationale that full commercial legalization could precipitate widespread substance abuse. Consequently, patients with intractable epilepsy continue to face severe therapeutic limitations. At present, Epidiolex, an orphan therapeutic indicated for rare pediatric-onset epilepsies, remains the only medical cannabis-derived pharmaceutical authorized for use in South Korea.Although Epidiolex relies entirely on imports, its reimbursement status has significantly reduced out-of-pocket expenses for patients. However, the remaining premium cost is borne entirely by national health insurance fiscal reserves, impacting state healthcare expenditure.Ultimately, the current law must be amended before the patent expiration of Epidiolex. Aligning domestic CBD regulations with international standards would enable domestic generic drug manufacturers to initiate bioequivalent CBD generics, thereby conserving national health insurance resources. This strategic commercial and fiscal implication explains why the pharmaceutical sector is closely tracking the legislative proposals introduced by Representatives Kim and Seo. Rep. Kim’s proposed bill classifies medically viable cannabis derivatives as psychotropic medicines. It also expands the statutory definition of a cannabis cultivator to allow cultivation intended for supplying raw materials to licensed narcotics manufacturers for pharmaceutical production, moving beyond traditional fiber or seed harvesting constraints, subject to explicit authorization from the Minister of the MFDS.Rep. Kim’s proposed bill strictly prohibits the handling or distribution of cannabis-derived psychotropics that deviate from supply chain compliance standards mandated by Presidential Decree, establishing stringent penalties for non-compliance. Furthermore, cultivators producing cannabis for pharmaceutical manufacturing are required to report total acreage, operational status, and harvest yields to the MFDS Minister under Prime Ministerial Decrees, with a mandatory clause dictating that any crop volume exceeding predefined supply contracts must be destroyed and formally documented.Additionally, the bill mandates the creation of a specialized institute, the "Medical Narcotics Raw Material Management Center", to secure active pharmaceutical ingredients (APIs) and oversee safety compliance. This center will monitor designated cultivation zones and manage annual cultivation supply agreements with licensed growers for downstream pharmaceutical formulation.The legislative objective is to establish a highly regulated, government-controlled supply chain tracking everything from raw crop cultivation through extraction, purification, active ingredient manufacturing, and raw material volume allocation.An official from the National Assembly's Health and Welfare Committee note, "The swift passage of the Narcotics Control Act amendment, along with supportive government initiatives to localize CBD oil production, would effectively prevent fiscal loss from national health insurance resources while significantly expanding therapeutic options for patients with intractable conditions like epilepsy," and added, "The bill encompasses both the clinical optimization and national health security."Meanwhile, following the introduction of this bill, Rep. Kim plans to host a policy forum on the 7th at the National Assembly Representatives Office Building to continue discussions under the theme "Strategies for Introducing Cannabis-Derived Pharmaceuticals to Expand Therapeutic Options for Rare·Intractable Disease Patients and Secure Essential Medicine Supply Chains".
- Policy
- Generic reimb listings jump 24% in 1H ahead of pricing ratio cut
- by Jung, Heung-Jun Jul 06, 2026 10:48am
- The number of generic drugs added to Korea's National Health Insurance reimbursement list increased 24% YoY in the first half of 2026. Industry experts view this rise as the pharmaceutical companies’ rush to secure reimbursement listings ahead of the scheduled reduction in the generic pricing ratio to 45% in August.According to health authorities and industry sources on July 3, a total of 373 generic products were added to the reimbursement list between January and June this year.AI-generated imageBy comparison, 300 generic products were listed during the same period last year, meaning 73 more products entered the reimbursement list in the first half of 2026.However, the increase cannot be attributed solely to the upcoming pricing reform and the rate reduction that is set to follow. Reimbursement applications also tend to surge when patents or post-marketing surveillance (PMS) exclusivity for major products expire.For example, following the expiration of the compound patent for Jardiance in October last year, 235 follow-on generics from 37 pharmaceutical companies were simultaneously added to the reimbursement list.Given that no major products lost patent or PMS protection during the first half of this year, the industry believes the government's pharmaceutical pricing reform played a significant role in the increase.The pricing reform announced in November last year included a substantial reduction in the generic reimbursement pricing ratio from the original 53.55%. For companies that are not designated as innovative or quasi-innovative pharmaceutical manufacturers, the lower pricing ratio is expected to significantly reduce reimbursement prices and directly affect product sales.In addition, the penalty for failing to satisfy all reimbursement eligibility criteria will increase from 15% to 20%, further encouraging companies to obtain reimbursement listings before the revised pricing rules take effect.Including the 69 generic products added to the reimbursement list this month, a total of 442 generic products have newly gained reimbursement coverage this year. These products effectively represent the final group to secure reimbursement before the pricing rate is lowered next month.In May, the Ministry of Health and Welfare (MOHW) released proposed revisions to the ‘Standards for the Determination and Adjustment of Drug Prices’ for public comment, with the consultation period remaining open until July 13.The revised notification is scheduled to take effect on August 1. From that date, the generic pricing ratio will be reduced from 53.55% to 45%.Under the revised framework, generic products meeting all reimbursement eligibility criteria will receive a pricing ratio of 45%, those satisfying one criterion will receive 36%, and products meeting none of the criteria will be priced at 29% of the reference level.
- Policy
- Talks continue on price cuts for listed fixed-dose combos
- by Jung, Heung-Jun Jul 06, 2026 10:48am
- With follow-up working-level discussions on price reductions for already-listed fixed-dose combination (FDC) products set to continue, reimbursement prices for FDCs are at risk of being uniformly cut, with the extent depending on the final pricing formula.If the government applies the 45% cut rate to the current maximum reimbursement level for FDCs, set at 53.55%, FDC prices would be reduced by approximately 16%, mirroring the across-the-board reduction planned for single-ingredient products.As a result, the pharmaceutical industry is expected to propose an alternative approach under which FDC reimbursement prices would be calculated by summing the reimbursement prices of each ingredient after applying the 45% pricing ratio.According to industry sources on July 6, the Ministry of Health and Welfare (MOHW), the Health Insurance Review and Assessment Service (HIRA), the National Health Insurance Service (NHIS), and industry representatives will hold another working-level meeting on the drug pricing reform, with price reductions for listed FDC products set to be one of the key agenda items.With the revised ‘Standards for the Determination and Adjustment of Drug Prices’ scheduled to take effect next month and the implementation of price reductions for listed products to follow, the government is expected to finalize the methodology for reducing reimbursement prices of FDC products soon.During previous discussions, using the current maximum reimbursement level for FDCs (53.55%) as the baseline and recalculating prices using the new 45% pricing ratio was proposed.AI-generated imageThe pharmaceutical industry, however, has consistently pushed for FDC reimbursement prices being set by adding together the revised reimbursement prices of each individual ingredient after applying the 45% pricing ratio separately.For example, an ezetimibe 10 mg/rosuvastatin 10 mg fixed-dose combination currently has a maximum reimbursement price of KRW 1,251. If that price is deemed to be 53.55% and recalculated directly to 45%, the reimbursement price would fall by approximately 16% to KRW 1,051. In contrast, if the reimbursement prices of ezetimibe 10 mg and rosuvastatin 10 mg are each recalculated at 45% and then combined, the resulting reimbursement price would be KRW 1,141, representing a smaller reduction of approximately 8.8%.Because reimbursement price reductions are directly linked to declines in product revenue, the industry naturally favors the latter methodology, combining the reimbursement prices of the individual components.Industry stakeholders also argue that the current reimbursement system already affects FDC prices through changes in the reimbursement prices of their individual components and contend that the same linkage principle should also be applied when implementing price reductions for listed FDC products.If the individual 45% pricing approach is adopted, the extent of the price reduction would vary depending on the specific dosage combination. Some products could see only minimal price decreases, allowing manufacturers to partially offset the expected decline in sales.However, the government has maintained its position that FDC products should be subject to the same uniform 16% reduction as single-ingredient products. Consequently, it is considered unlikely that authorities will accept the industry's proposal to base reimbursement prices on the combined reimbursement levels of the individual components.
- Policy
- Novo Nordisk's hemophilia A treatment 'denecimig' wins ODD
- by Lee, Tak-Sun Jul 02, 2026 09:17am
- AI-generated imageNovo Nordisk's hemophilia A treatment 'denecimig (injection)' and Novartis's 'ianalumab (injection)' for moderate-to-severe adult Sjögren's disease have been designated as orphan drugs.On the 1st, the Ministry of Food and Drug Safety (MFDS) officially announced these new designations. Through this revision, both ingredients have been officially listed on the orphan drug list under Item Ga (Table 1) and Item Na (Table 2) of Article 2, Subparagraph 18 of the Pharmaceutical Affairs Act, respectively, providing novel therapeutic alternatives in the rare disease market in South Korea.First, 'denecimig (injection)', added as the 8th ingredient under Item Ga (Table 1) of the Pharmaceutical Affairs Act, is a novel candidate being developed by Novo Nordisk to address hemophilia A, a prominent rare hemorrhagic disorder. Under current domestic regulations, 'Item Ga' classifications are reserved for therapies targeting rare conditions officially designated by the Ministry of Health and Welfare (MOHW) under the 'Rare Disease Management Act'. The regulatory inclusion of denecimig is expected to significantly broaden clinical choices for domestic hemophilia A patients who face a lifelong risk of spontaneous hemorrhage and subsequent articular complications.The inclusion of denecimig expands Item Ga (Table 1) orphan drug list of the MFDS comprising eight active ingredients. The current Item Ga list already includes 'nipocalimab (injection)' for generalized myasthenia gravis, which causes systemic muscle weakness; 'pegunigalsidase alfa (injection)' for Fabry disease, a disorder where intracellular glycolipid accumulation leads to renal and cardiac impairment; and 'onasemnogene abeparvovec (injection)' for infantile, pediatric, bulbar, and adult-onset spinal muscular atrophy (SMA), which induces muscle wasting via motor neuron degeneration.The list has been expanded to include eight items, including 'garadacimab (injection)' for C1-esterase inhibitor deficiency, which triggers acute subcutaneous and mucosal edema; 'miglustat (capsule)' and 'cipaglucosidase alfa (injection)' administered in combination for Pompe disease, which causes progressive muscle weakness; 'vamorolone (oral suspension)' for severe muscular dystrophy, a pediatric genetic disorder characterized by progressive muscle loss; and 'acoramidis hydrochloride (tablet)' for transthyretin amyloid cardiomyopathy (ATTR-CM), where abnormal amyloid fibril deposition leads to heart failure, alongside the newly added hemophilia A treatment denecimig (injection).Additionally, 'ianalumab (injection)', listed under No. 409 in Item Na (Table 2) of the Pharmaceutical Affairs Act, was developed by Novartis as a treatment for patients with moderate-to-severe adult Sjögren's disease. The "Item Na" designation is granted to medicinal products targeting diseases with a domestic prevalence of 20,000 or fewer individuals, where no appropriate alternative treatment is available or where the candidate demonstrates a significantly improved safety or efficacy profile compared to existing standards of care.Sjögren's disease is a systemic autoimmune disorder characterized by chronic exocrine gland inflammation accompanied by severe dry eyes, dry mouth, and arthralgia. Yet, there has been a significant unmet medical need due to the absence of targeted, disease-modifying therapies. As a monoclonal antibody injection, ianalumab targets and inhibits B cells driving the autoimmune response, anticipated to mark a significant turning point for patients who previously lacked viable therapeutic options.An MFDS official said, "This revision is a measure to provide safe and effective therapeutic options for patients with hemophilia A and Sjögren's disease, who have faced hardships due to limited local patient populations or a lack of alternative treatments. The official added that the ministry will continue to actively use the Item Ga and Na system to enhance patient access to treatments for rare and intractable conditions, while rapidly designating essential medicines to establish a stable domestic supply chain.Once an item is designated as an orphan drug, it becomes eligible for expedited review during the marketing authorization process. It receives various commercial and regulatory incentives, including a specified period of post-marketing exclusivity. Furthermore, the submission requirements for regulatory approval are streamlined, enabling pathways such as conditional approval and waivers for local bridging data, and an expedited evaluation process is implemented through priority review. Additionally, reductions or exemptions of regulatory application fees are provided.
- Policy
- Boehringer launches P2T for obesity drug candidate
- by Lee, Tak-Sun Jul 02, 2026 09:16am
- Boehringer Ingelheim has begun a Phase II clinical trial in Korea for its next-generation triple-acting obesity drug candidate, accelerating its efforts to compete in the global obesity treatment market.According to the pharmaceutical and biotechnology industry on July 1, the Ministry of Food and Drug Safety (MFDS) approved a Phase II clinical trial application on June 29 for ‘BI 3034701,’ an investigational therapy for obesity and overweight submitted by Boehringer Ingelheim Korea. The study is a 42-week dose-finding trial designed to evaluate the efficacy and safety of subcutaneous BI 3034701 compared with placebo in obese or overweight participants.The multinational Phase II study plans to enroll 22 participants in Korea. Five major university hospitals have been selected as domestic trial sites: Asan Medical Center, Korea University Anam Hospital, Seoul National University Bundang Hospital, Bucheon St. Mary's Hospital of The Catholic University of Korea, and Daejeon Eulji Medical Center. The trial is expected to continue for approximately two years, through July 2028.BI 3034701 was originally developed by Danish bioventure Gubra. In June 2023, Boehringer Ingelheim acquired global rights to the candidate under a licensing agreement. It is being developed as the first 'triple agonist' combining GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide) activity with NPY2R (neuropeptide Y receptor type 2) agonist, which suppresses appetite through an additional biological pathway. By blocking appetite through three distinct pathways, it is expected to demonstrate significantly more powerful weight-loss effect and improved safety compared to existing obesity treatments."Boehringer Ingelheim initiated its Phase I program in June 2024 and completed the study in August 2025. In topline results announced in December 2025, the company reported favorable safety and tolerability, along with encouraging early signals of weight loss. It subsequently outlined plans to advance into a Phase II trial in April this year and has now moved quickly to initiate the study in Korea following regulatory approval.Participants will be randomly assigned in a double-blind design to one of seven treatment groups and will receive once-weekly subcutaneous injections. The primary endpoint of the study is the percentage change in body weight at Week 42. Additional endpoints will include changes in waist circumference and blood pressure, as well as the proportions of participants achieving at least 5% and up to 20% or greater weight loss, to determine the optimal therapeutic dose.An industry official said, “While today's obesity treatment market is dominated by single- and dual-agonist therapies such as Wegovy and Zepbound, triple agonists are widely viewed as the next-generation game-changer. With Korea moving quickly to approve this Phase II study in line with the global development program, competition to secure a leading position in the next-generation obesity market is expected to intensify."
- Policy
- Jeil’s Beova enters pricing negotiations for reimbursement
- by Jung, Heung-Jun Jul 01, 2026 09:18am
- Jeil Pharmaceutical's overactive bladder (OAB) treatment Beova Tab (vibegron) has entered drug price negotiations with the National Health Insurance Service (NHIS), bringing the product one step closer to reimbursement listing in Korea.The product is expected to begin competing in earnest with mirabegron-based therapies, including Betmiga, in the second half of this year.According to industry sources on June 30, Jeil Pharmaceutical recently entered reimbursement price negotiations with the NHIS for Beova Tab, which passed reimbursement evaluation by the Drug Reimbursement Evaluation Committee (DREC) in April.At the time, DREC concluded that Beova was eligible for reimbursement for the treatment of ‘urinary urgency, increased urinary frequency, and urge urinary incontinence associated with overactive bladder,’ subject to the manufacturer accepting a price at or below the committee's assessed reimbursement price.As Jeil Pharmaceutical accepted the pricing condition, negotiations with the NHIS will focus on specifics, including the projected claims amount.Beova Tab, developed by Japan's Kyorin Pharmaceutical, was launched in Korea by Jeil Pharmaceutical in January 2023 and has remained a non-reimbursed product for the past 3 years. The company applied for reimbursement in December last year and has since been undergoing the reimbursement listing process.In August last year, Jeil also expanded its market strategy by launching a sister product, ‘Jeil Vibegron Tab,’ through its affiliate Jeil Health Science, positioning the company to increase its market share once reimbursement is granted.The company is expected to begin targeting the mirabegron market from Q3 this year. Its main competitors will include Astellas Pharma Korea’s Betmiga and Betmiga generics.According to pharmaceutical market research institution UBIST, Betmiga generated KRW 35 billion in sales last year, up 5% from the previous year. Among generic products, Mirabek from Hanmi Pharmaceutical recorded KRW 17.4 billion in sales, up 7%, while Betagron from Genuone Sciences rose 45% to KRW 6.7 billion, and Selebeta posted approximately 1% growth to KRW 7.6 billion.Supported by continued growth of both the original product and generic competitors, the Korean mirabegron market has remained robust.By comparison, Beova Tab recorded production output worth only KRW 860 million in 2024. However, as reimbursement is expected to take effect in the second half of this year, the product is expected to see a substantial increase in sales.Vibegron has been promoted as offering a mechanism of action similar to mirabegron while being associated with fewer adverse effects. Jeil Pharmaceutical is therefore expected to emphasize this advantage while expanding its presence in the overactive bladder market.
