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- 2026-04-21 07:56:04
- Policy
- Criticism over MFDS’s delayed crackdown on oral albumin
- by Lee, Tak-Sun Mar 26, 2026 09:29am
- Although the Ministry of Food and Drug Safety announced a planned inspection targeting false and exaggerated advertising of ‘oral albumin’ products, the market is criticizing the move as a ‘belated response’ that came only after consumer harm had already occurred.At the time the issue was first raised earlier this year by media outlets and civic groups, sales had already peaked, and illegal advertising intensified further during the Lunar New Year holiday season. Critics argue that the MFDS should have officially announced the inspection earlier through media channels to curb illegal market practices.AI-generated imageMFDS’s “Emergency Response Team for Unfair Food Practices,” which officially launched on the 24th, announced a focused inspection of unfair advertising for albumin-containing foods as its first initiative. Although albumin derived from eggs or milk is broken down into amino acids upon consumption and does not directly increase blood albumin levels, false advertisements have been rampant on home shopping channels and social media, claiming it has the same effects as the pharmaceutical ‘serum albumin.’In particular, as of December last year, albumin products ranked first in the number of home shopping health product broadcasts, and some products sold out more than 10 times, showing explosive sales. Despite being a high-priced product costing around KRW 100,000 per month, it successfully targeted consumers eager to recover from fatigue and boost their immunity.In January, Dailypharm had already published an in-depth report on the harms of oral albumin supplements, followed by similar media coverage.As the MFDS response remained insufficient despite media reports, civic groups and the medical community called for stronger action. On the 20th, the consumer advocacy group Consumers Together issued a statement calling it “a nationwide fraud that packages ordinary food without proven medical efficacy as if it had therapeutic effects. We ask the MFDS to conduct a full investigation into false advertising and impose strict penalties under a zero-tolerance principle.”Earlier, the Korean Medical Association also raised concerns, stating that “there is no clinical evidence supporting oral albumin.” It further indicated that it is considering referring so-called ‘show doctors’ who appeared in misleading advertisements by exploiting their professional authority, to the Ethics Committee and recommending disciplinary action.“Only acting after the peak?”… industry criticism growsIt was only after the KMA and consumer groups issued strong demands that the MFDS officially announced its first planned inspection of oral albumin products through its Emergency Response Team for Unfair Food Practices. However, the pharmaceutical sector and related industries are questioning the practicality of this planned inspection, as large-scale sales had already taken place during peak seasons such as the Lunar New Year.According to the distribution industry, many companies have already generated substantial profits and entered a discount phase to clear remaining inventory following the crackdown announcement. A pharmacist who requested anonymity criticized, “By the time the MFDS declared enforcement, companies had already sold most of their stock,” calling it “a textbook case of a belated response.” An industry official also pointed out that “At the very least, targeted inspections should have been conducted before the Lunar New Year, when sales peak.”In response to criticism of delayed action, the MFDS stated, “We have continuously conducted crackdowns on misleading advertisements for oral albumin products. The launch of this emergency response team is aimed at tackling overall unfair food practices, and is not a targeted inspection specifically for oral albumin.”However, criticism has emerged that there have been no officially planned inspections regarding false advertising of edible albumin products to date, and that existing crackdowns have relied primarily on online post-hoc monitoring. This suggests that there are limitations in responding to real-time advertisements on home shopping channels or social media.While the MFDS aims to overcome these limitations through the new emergency response team, it is expected to face growing accountability issues over consumer damage that has already occurred.
- Policy
- Pharma companies may suffer KRW 600B annual loss shock
- by Lee, Jeong-Hwan Mar 25, 2026 07:21am
- The Ministry of Health and Welfare (MOHW)'s 'drug pricing system reform plan' to raise the low-price purchasing incentive rate for hospitals and pharmacies from 20% to 35%. Concerns about pharmaceutical industry shock.The government's 'drug pricing system reform plan' to raise the low-price purchasing incentive rate for hospitals and pharmacies from 20% to 35% is facing criticism. Critics pointed out that it is an administrative move that will increase pharmaceutical companies' losses.The pharmaceutical industry is already enduring approximately KRW 350 billion in annual revenue losses under the 20% incentive system. Concerns are rising that if the government transitions to a market-linked actual transaction price system by expanding the incentive rate to 35%, annual losses will exceed KRW 600 billion, inevitably causing market contraction.Given that the government already implements price cuts for existing generic drugs, analysis suggests that raising the low-price purchasing incentive rate will further worsen pharmaceutical companies' profitability, potentially threatening the production and stable supply of essential medicines.On the 24th, the Ministry of Health and Welfare (MOHW) announced a regulation raising the incentive rate paid to medical institutions and pharmacies for low-priced purchasing from 20% to 35% as part of the actual transaction price-based price reduction method. This reform aims to restructure the current system into a market-linked actual transaction price model.The low-price purchasing incentive is a system in which, if a medical institution or pharmacy purchases a drug from a pharmaceutical company at a price below the government-set insurance ceiling price, a portion of those savings is returned to the institution as an incentive.Under the current 20% rate, if a hospital purchases a drug at KRW 100 below the reference price (ceiling price), it receives a KRW 20 incentive.While systemically designed to improve purchasing efficiency and save the National Health Insurance budget, the system has been criticized for pressuring pharmaceutical companies to reduce prices.The pharmaceutical industry estimates that current losses amount to KRW 350 billion annually under the 20% rate. Based on this, pharmaceutical industry argues that a 35% incentive rate would result in annual drug revenue losses to KRW 600 billion or more.Furthermore, assessments suggest that if the price-reduction mechanism for actual transaction price investigations fails to operate properly despite the 35% rate, pharmaceutical companies could face actual losses exceeding these calculations.Concerns are rising that the overall profit base of the pharmaceutical industry could be destabilized if additional price pressures, such as the increased incentive rate, are added to the Ministry's general policy of cutting prices for listed drugs.The MOHW's proposal to raise the incentive rate (from 20% to 35%) is seen as a measure that strengthens the mechanism for transferring price-cutting pressure to manufacturers. Hospitals and pharmacies will have a greater incentive to purchase drugs at the lowest possible prices to secure larger rewards, which may put pressure on pharmaceutical companies to lower their supply prices.An official from a mid-sized Korean pharmaceutical company stated, "While the official insurance drug price may remain the same, the structure forces actual transaction prices to keep falling. If the incentive rate is raised, hospitals, which have more authority, will demand stronger price cuts. Pharmaceutical companies may face significant burdens."The official added, "The current actual transaction price reduction system and the 20% incentive rate must be maintained so that it can alleviate the excessive burden on the industry," and emphasized, "Raising the incentive rate exacerbates the issue of increased losses, especially when a pharmaceutical company sells more. This may ultimately force certain companies to abandon the stable supply of essential medicines."
- Policy
- Stelara biosimilar ‘Epyztek Pen’ listed for reimb next month
- by Jung, Heung-Jun Mar 25, 2026 07:21am
- The pen formulation of Samsung Bioepis’s autoimmune disease treatment Epyztek (ustekinumab) is scheduled to become the first reimbursed product of its ingredient class next month.Samsung Bioepis appears to be pursuing a differentiation strategy with a pen formulation that even the original product, Janssen Korea’s ‘Stelara,’ has neither received approval nor reimbursement for.According to industry sources on the 24th, Samsung Bioepis will expand its reimbursement lineup next month with a prefilled pen formulation of its Stelara biosimilar Epyztek.Like Stelara, Epyztek is an autoimmune treatment indicated for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. In South Korea, it competes in the market alongside Celltrion’s biosimilar ‘Steqeyma’ and others.The pen formulation, scheduled for listing next month, allows patients to administer the medication conveniently and accurately, giving it a competitive edge in self-administration settings.Stelara is currently approved only in intravenous, subcutaneous, and prefilled syringe formulations, making the prefilled pen the first of its kind among products with the same active ingredient. Samsung Bioepis secured its place on the reimbursement list just 3 months after receiving approval from the MFDS last January.This preemptive addition of a new formulation is expected to continue its offensive not only against biosimilar competitors but also in the battle for market share against the original product.Samsung Bioepis is targeting the market with a price lower than the original. The newly listed Epyztek Prefilled Pen 90 mg/1 mL is expected to receive an insurance ceiling price in the KRW 1.27 million range.The original Stelara Prefilled Syringe 45 mg/0.5 mL is priced at KRW 1,745,600, while Epyztek Prefilled Syringe at the same dose is about 30% cheaper at KRW 1,233,376. The pen formulation offers double the dosage but is priced about 27% lower.Leveraging its lower price and the addition of new formulations, the company is expected to begin a full-scale push to expand its market share starting in the second quarter of this year.Samsung Bioepis sells Epyztek (known as Pyzchiva in the U.S. and Europe) not only in Korea but also in Europe and the U.S. through its partner, Sandoz.
- Policy
- Anticancer drugs account for record high share of pharma expenditures
- by Jung, Heung-Jun Mar 24, 2026 08:16am
- Claims for anticancer drugs are rising steeply within Korea’s national health insurance pharmaceutical expenditures. It exceeded KRW 3 trillion the year before last, surpassing anti-atherosclerosis drugs for the first time.While total drug expenditures rose by 5.6%, claims for anticancer drugs climbed by 15%, the largest increase by far among the 5 five therapeutic classes in terms of spending.Anticancer drug claims exceed KRW 3 trillionAccording to the 2024 Status of Expenditures on Reimbursed Drugs Report released by the National Health Insurance Service on the 23rd, health insurance drug expenditures totaled KRW 27.6625 trillion, a 5.6% increase from the previous year’s KRW 26.1966 trillion.Drug costs accounted for 23.8% of total healthcare expenditure of KRW 116.2375 trillion. As of 2023, the proportion of drug expenditures in Korea’s current health expenditure was 19.4%, which is 5 percentage points higher than the OECD average of 14.4%.Among major overseas countries (A8) that Korea uses for drug price references, Korea’s spending ratio was also higher than Japan (17.6%), Germany (13.7%), and the UK (9.7%).◆ Anticancer drug claims reach KRW 3.1432 trillion... share hits record high of 11.4%Claims and spending share for anticancer agents reached all-time highs. Claims totaled KRW 3.1432 trillion in the year before last, up 15% from KRW 2.7336 trillion the previous year.The top 5 therapeutic classes accounted for 40.4% of total drug expenditure, with anticancer drugs holding the largest share at 11.4%. Until now, anti-atherosclerotic drugs had previously held the highest claim amount and market share, but anticancer drugs rose to the top spot for the first time.Drug costs for cancer patients totaled KRW 4.2958 trillion, an 11.9% increase from the previous year. This marks the largest growth rate in the past 5 years.◆ By ingredient, “ezetimibe + rosuvastatin” ranked highest…up 16% to exceed KRW 700 billionBy ingredient, spending on ezetimibe + rosuvastatin rose 16.3% year on year, reaching KRW 704.6 billion.Choline alfoscerate came in second at KRW 557.6 billion, down 1% from the previous year. Atorvastatin also declined slightly, with claims of KRW 554.3 billion, down 0.8%. The antiplatelet agent clopidogrel reached KRW 441.8 billion, up 5.7%.◆ Decline in original drug claims...generic share rises to 44.4%Original drug claims showed a declining trend, while generic claims increased. In the year before last, spending on original drugs amounted to KRW 15.3434 trillion, accounting for 55.6% of total pharmaceutical expenditure, down from 59.1% the year before.In contrast, generic drug claims totaled KRW 12.2591 trillion. This accounted for 44.4% of total drug expenditure, an increase from 40.9% the previous year.Since 2021, the spending share of original drugs has continued to decline while that of generics has risen, narrowing the gap in reimbursement claims between the two categories.An NHIS official said, “In line with government policy direction, we will further refine implementation measures and actively support the execution of tasks for the benefit of the public and the development of the pharmaceutical industry, while making every effort to ease patients’ drug cost burdens and ensure the financial sustainability of the National Health Insurance system.”
- Policy
- Will Mifegyne gain momentum for Korean entry?
- by Lee, Jeong-Hwan Mar 24, 2026 08:16am
- The domestic introduction of Mifegyne, the abortion drug whose marketing approval by the Ministry of Food and Drug Safety has been delayed for a long time, is expected to gain momentum.This follows recent remarks by Yong-jin Park, vice chair of the Regulatory Reform Committee, who identified the delay in Mifegyne’s approval as a prime example of irrational administrative regulation and announced his intention to work toward a solution.Vice Chair Park is reportedly determined to ensure domestic approval through administrative action even before legislation is enacted, given that the introduction of Mifegyne is regarded as a matter of national policy.Vice Chair Yong-jin ParkVice Chair Park views the issue of Mifegyne’s introduction from a global standards perspective. He argues that the situation where only Korea is blocking a drug already permitted in over 100 countries worldwide, including OECD nations, solely due to administrative procedures, represents an irrational regulation unique to Korea.Vice Chair Park believes that the reality where women are forced to purchase the drug through underground channels despite its globally proven safety due to administrative barriers threatens women’s health rights and must not be ignored.The MFDS has maintained a cautious stance on approving Mifegyne on the grounds that follow-up legislation has not yet been made since the Constitutional Court’s 2019 decision declaring the abortion law unconstitutional.Vice Chair Park believes that if the MFDS takes a more forward-looking approach to the regulatory barriers it has tied itself to, a solution can be found.This effectively suggests the need to expedite the timing of domestic approval and introduction through proactive government action, even before the legislature completes the relevant process.Attention is now focused on whether the drug could be approved before the National Assembly passes a proposed revision to the Mother and Child Health Act, introduced by Democratic Party of Korea lawmaker In-soon Nam and others, that would allow medication-induced abortion.If the MFDS adopts administrative regulations or establishes a separate approval process, the official introduction of Mifegyne in Korea will gain momentum.An industry official stated, “If Vice Chairman Park’s plan to ease administrative regulations is effectively implemented, the MFDS will be able to exercise proactive administration even amid a legislative vacuum. It would become a representative example of the government putting forward a preemptive alternative at the administrative level.”
- Policy
- Afilivu’s price cut and lists PFS formulation to chase Eylea
- by Jung, Heung-Jun Mar 24, 2026 08:16am
- Samsung Bioepis is stepping up its pursuit of Eylea by lowering the price of its macular degeneration treatment Afilivu and expanding into the prefilled syringe (PFS) segment.Next month, Afilivu Prefilled Syringe 6.6 mg/0.165 mL (aflibercept) will be listed for reimbursement, and the price of the existing Afilivu injection will be voluntarily cut to KRW 198,000, matching the market’s lowest price.According to industry sources on the 23rd, Samsung Bioepis is simultaneously pursuing both a price reduction and the addition of a new formulation to strengthen Afilivu’s competitiveness.Samsung Biologics expands Aflilivu's competitivity by introducing a PFS version with reimbursement. AI-generated imageThe ceiling price of Afilivu 40 mg, previously KRW 298,000, will be voluntarily reduced by KRW 100,000 to KRW 198,000.This matches the lowest price set by Sam Chun Dang Pharm’s Eylea biosimilar ‘Vgenfli Inj.’The Afilivu PFS formulation entering reimbursement this time has also been listed at the same price of KRW 198,000. Not only Eylea, but also Celltrion’s Eydenzelt and Sam Chun Dang Pharm’s Vgenfli already have PFS formulations in their reimbursement lineups.Celltrion also expanded its prescription lineup by listing the PFS formulation last November. Although the Afilivu PFS formulation is a later entrant compared to these, it appears the company will launch a full-scale market offensive by lowering its price.Sales of Afilivu in Korea were suspended early last year due to a preliminary injunction filed by the original developer, Regeneron, seeking to halt sales. However, after the injunction was overturned in December of the same year, domestic distribution and sales resumed. Samil Pharmaceutical holds the exclusive domestic sales rights.It is said to have shown a rapid recovery in sales since resuming distribution. Samil is expected to continue expanding prescriptions through sales activities that now include the PFS formulation.The domestic Eylea market is estimated at about KRW 100 billion. Samsung Bioepis, Celltrion, and Sam Chun Dang Pharm are all closely chasing Eylea and competing to expand market share.In particular, fierce competition is expected between Samsung Bioepis and Sam Chun Dang Pharm, as they are clashing with a lowest-price strategy.
- Policy
- Menarini withdraws approval for angina drug Ranexa
- by Lee, Tak-Sun Mar 24, 2026 08:16am
- ‘Ranexa (ranolazine), a new angina treatment with a novel mechanism of action that had garnered high expectations as the first of its kind in over 20 years, has given up on entering the Korean market five years after its local approval.Used as a second-line treatment for angina, the drug had remained approved but never been listed for reimbursement. As a result, it appears that the company decided to withdraw the product once the re-examination period expired.According to the Ministry of Food and Drug Safety, Menarini Korea voluntarily withdrew marketing authorization for three strengths of Ranexa extended-release tablets—375 mg, 500 mg, and 750 mg, as of the 23rd. Having obtained domestic approval in March 2020, the drug never made it to market and has now disappeared from the regulatory records after five years.Unlike existing beta-blockers or calcium channel blockers (CCBs), Ranexa garnered attention for its unique mechanism of action, which selectively inhibits sodium channels within cardiac muscle cells. Because it does not significantly affect blood pressure or heart rate, it has been considered an alternative for patients whose symptoms are difficult to control with existing medications.However, it never made it onto the national health insurance reimbursement list after approval. To make matters worse, the re-examination period granted at the time of approval reportedly expired on the 15th.Although three months remained before the application period for re-examination closed, the company appears to have chosen to withdraw the approval rather than pursue re-examination. Since no actual sales took place after approval, it is assumed that conducting a re-examination would also have been difficult.The drug was approved by the US FDA in January 2006. At the time, it was the first new angina treatment to gain approval in the United States in more than 20 years, drawing considerable attention.While it was approved in the US. as a first-line treatment for chronic angina, it was approved as a second-line treatment when it received approval in Europe. On July 9, 2008, the European Medicines Agency (EMA) approved it as an add-on therapy for first-line stable angina treatment.When it received domestic approval on March 16, 2020, the indications were also determined based on the European approval. Menarini Korea conducted bridging studies and other procedures to obtain domestic approval for this drug, ultimately receiving approval one year and eight months after filing.Low market potential is cited as the reason for withdrawing from the domestic market. With existing angina treatments already priced low, it is believed that Ranexa, as a second-line therapy, also faced an environment in which it would be difficult to secure a sufficiently high reimbursement price.Currently, there are no generics containing the same active ingredient available. Consequently, medications containing ranolazine are no longer available in Korea.An industry official said, “When a new drug gives up entering the Korean market because of marketability issues, it ultimately only lowers treatment accessibility for patients. When a new drug is withdrawn, it is necessary to closely examine whether there are any generics with the same ingredient or alternative medicines available.”
- Policy
- CKD and Samjin win approval for 3mg donepezil 3 mg
- by Lee, Tak-Sun Mar 23, 2026 08:42am
- Leading generic manufacturers of the long-standing best-selling dementia treatment “Donepezil” are strengthening their product lineups by introducing a new 3mg low-dose formulation.Attention is focused on whether this will change a market structure that has so far centered on 5 mg and 10 mg products.According to the Ministry of Food and Drug Safety, following the approval of Chong Kun Dang’s “Neuropezil Tab 3mg” on the 18th, Samjin Pharmaceutical’s “Neutoin Tab 3mg” received marketing authorization two days later on the 20th.Neuropezil and Neutoin are leading donepezil generics that have recorded outpatient prescription sales of KRW 12.9 billion and KRW 5.2 billion, respectively, last year, based on Ubest data.The company that first opened the 3 mg donepezil market was Hyundai Pharm. On June 28, 2023, Hyundai became the first in Korea to win approval for ‘Hipezil 3 mg’, taking the lead in the low-dose market. Later, on February 27 last year, Myungin Pharmaceutical obtained the first generic approval with ‘Silvercept 3 mg.’ Silvercept also recorded KRW 5.3 billion in outpatient prescriptions last year, ranking relatively high among generics.At present, even Aricept, the original donepezil brand, does not have a 3 mg lineup in Korea. However, the fact that 3 mg products are already marketed and widely used in clinical practice in neighboring Japan became a key driver for Korean companies’ development efforts.The reason the pharmaceutical industry is focusing on the 3mg strength is safety. While donepezil is highly effective in alleviating dementia symptoms, a considerable number of patients report gastrointestinal side effects such as nausea, vomiting, and diarrhea during the initial stages of treatment.Korean companies, including Hyundai Pharm, developed 3 mg products so that the initial dose could be set at 3 mg for patients at high risk of gastrointestinal side effects or for elderly patients. During the approval process, two studies published in SCI-level academic journals were submitted as clinical evidence, and Japanese marketing authorization information was also used as reference material.An industry official stated, “Donepezil 3mg will serve as a useful alternative for high-risk patients who had to discontinue drug therapy due to side effects. With major pharmaceutical companies such as Chong Kun Dang and Samjin Pharmaceutical joining the field, the proportion of low-dose prescriptions in the dementia treatment market is expected to gradually increase in the future.”
- Policy
- Tightened rebate rules pressure innovative pharma certifications
- by Lee, Jeong-Hwan Mar 23, 2026 08:42am
- As the Ministry of Health and Welfare designs a reform of the innovative pharmaceutical company certification criteria, the pharmaceutical industry is raising concerns that the revised framework must include a system capable of reflecting companies’ self-regulatory efforts in compliance management, such as the prohibition of illegal rebates.The argument is that the reform plan must explicitly include provisions allowing the certification review process to consider a corporation’s efforts to prohibit rebates when illegal rebates are provided or detected due to individual misconduct by sales representatives, despite thorough management and supervision by the company itself.The logic behind this is that incorporating such provisions into the reform plan would prevent cases where certification is unfairly revoked due to rebates in which the corporation was not involved, while also creating incentives for pharmaceutical companies to operate internal compliance systems and lead self-policing efforts against rebates.According to the pharmaceutical industry and the ministry on the 20th, an amendment to the administrative notice improving the certification review criteria for Innovative Pharmaceutical Companies will soon be released for public comment.The MOHW plans to incorporate a revised statute of limitations for rebates, which would exclude illegal rebates occurring “more than five years prior” to the date of certification or recertification following the implementation of the reform plan.This is intended to encourage pharmaceutical companies’ commitment to developing innovative new drugs by not linking the revocation of Innovative Pharmaceutical Company certification to illegal rebates that occurred too long ago.However, the pharmaceutical industry argues that, in addition to this five-year rebate exclusion rule, the reform should also contain a mechanism to address the unintended consequence where pharmaceutical companies that have made sufficient efforts to prevent illegal rebates still face unconditional certification revocation, following the exemption for rebates older than five years.In other words, even where a company has established systems for monitoring and managing rebate prohibitions and has worked diligently to maintain compliance, it should be guaranteed the right to present a defense during the certification revocation review process if a rebate occurred due to the misconduct of an individual sales representative.On this, the industry said, “We are not asking for all rebates stemming from individual sales representatives’ misconduct to be automatically excluded from grounds for certification revocation. Rather, we are asking that an administrative track be established to allow for due consideration of the corporation’s efforts toward compliance-oriented management.”The reason for this is that if this provision is not reflected in the reform plan, pharmaceutical companies’ efforts toward compliance management to prohibit rebates will not be reflected at all during certification revocation reviews. This would increase the need to contest the unfairness of certification revocation in court, potentially leading to a significant rise in unnecessary administrative revocation lawsuits between pharmaceutical companies and the MOHW.In particular, pharmaceutical companies point out that the current regulations under review by the MOHW, which hold corporations jointly liable for the personal illegal acts of their internal sales representatives, while specifying that administrative sanctions for illegal rebates by Contract Sales Organizations (CSOs) should be imposed solely on the CSOs without linking them to the corporations, raise concerns that this could encourage pharmaceutical companies to abandon their own sales organizations and shift to CSO-based sales operations.In addition, as the ministry’s current drug pricing reform proposal moves in the direction of strengthening preferential measures based on whether a company is certified as an innovative company, there is concern that the management damage to companies whose certification is unfairly revoked will become far greater than before if no provision is included to reflect compliance management efforts.An industry official said, “If companies that have internal rebate-prevention systems and have made genuine efforts to control illegal conduct are judged under the same certification revocation standard as companies that do not implement compliance management, then the incentive for firms to eliminate illegal practices on their own disappears. There is also concern about the adverse effect that, as a disparity in administrative penalties arises between a pharmaceutical company’s internal sales staff and external CSO sales staff, if pharmaceutical companies decide to reduce the risk of administrative penalties by relying on CSO sales, the risk of circumventing regulations through backdoor rebate practices will increase.”Meanwhile, it appears unlikely that this reform proposal will include a provision to convert the revocation standard for innovative company certification in rebate-related cases into a demerit-point system.
- Policy
- Bispecific Ab 'Ziihera inj' for biliary tract cancer wins nod
- by Lee, Tak-Sun Mar 20, 2026 08:55am
- 'Ziihera inj'BeOne Medicines Korea's bispecific antibody for biliary tract cancer, 'Ziihera inj,' has obtained final approval. Analysis suggests that the expedited approval was made possible through the GIFT (Global Innovative product on Fast Track) review process. It is expected to provide new therapeutic opportunities for patients with biliary tract cancer.The Ministry of Food and Drug Safety (MFDS, Minister Oh Yu-Kyoung) announced that it has approved the imported orphan drug 'Ziihera inj 300mg (zanidatamab)' on the 19th.Ziihera is an orphan drug indicated for the treatment of adult patients with unresectable, locally advanced, or metastatic HER2-positive (IHC 3+) biliary tract cancer who have previously received at least one systemic therapy.HER2-positive (IHC 3+) refers to a state where HER2, a protein involved in regulating cell growth, is highly overexpressed as determined by an Immunohistochemistry (IHC) test.This drug is a bispecific antibody that simultaneously binds to two different extracellular domains (ECD4 and ECD2) of the HER2 protein. As an antineoplastic agent, its mechanism involves reducing HER2 expression to inhibit the growth of tumor cells. It is the first drug approved in South Korea for this specific indication. Consequently, expectations are high that it will offer a new treatment window for patients suffering from biliary tract cancer.Ziihera inj received expedited review after being designated as the 40th product under the 'Global Innovative product on Fast Track (GIFT)' system. GIFT is a support program designed to accelerate the commercialization of globally innovative medical products by assisting in the early stages of development (clinical trials).An official from the MFDS stated, "We will continue to ensure that new treatments for patients with rare and intractable diseases are supplied promptly, using our expertise in regulatory science, thereby expanding their opportunities for treatment."
