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- 2026-04-21 12:21:04
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- Amvuttra for multiple neuropathy now prescribed at hospitals
- by Eo, Yun-Ho Mar 04, 2026 05:41pm
- A RNAi-based drug, 'Amvuttra,' currently seeking reimbursement listing, has entered the prescription area of general hospitals.According to industry sources, the new drug Amvuttra, a treatment for hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN), introduced to the Korean market by Medison Pharma Korea, has passed the drug committees (DC) of tertiary general hospitals, including Seoul Samsung Medical Center and Sinchon Severance Hospital.Medison Pharma is currently negotiating with the National Health Insurance Service (NHIS) for the drug price. Accordingly, once this drug is listed, it is expected to proceed quickly to prescription. Amvutra previously passed the Health Insurance Review and Assessment Service's (HIRA) Drug Reimbursement Evaluation Committee in December last year.Furthermore, Medison Pharma is currently operating Amvuttra's Expanded Access Program (EAP) for patients.Amvutra was designated as an orphan drug by the Ministry of Food and Drug Safety (MFDS) in November 2023 and received final approval in November last year.Amvutra is administered by subcutaneous injection once every 3 months. This drug targets and silences specific messenger RNA (mRNA), thereby blocking the production of both wild-type and mutant transthyretin (TTR) protein.The efficacy of Amvutra was demonstrated through the HELIOS-A Phase 3 study. The Phase 3 trial enrolled 164 patients with hATTR-PN and polyneuropathy across 22 countries. These patients were randomly assigned to either the Amvutra group (122 patients), receiving 25mg via subcutaneous injection every three months, or the 'Onpattro (patisiran)' group (42 patients), receiving 0.3mg/kg via intravenous injection every three weeks.Amvutra's efficacy was assessed by comparing its data with placebo data from the APOLLO study, which evaluated the efficacy and safety of Onpattro in a patient population similar to that in HELIOS-A.As a result, during the 9-month treatment period, the Amvutra group experienced less severe neurological impairment and showed improved quality of life compared to the placebo group. In the 10-meter walk test, which assesses a patient's walking speed and motor ability, the time taken by the vutrisiran group showed almost no change. NT-proBNP, a biomarker used to evaluate cardiac function, also showed improvement.Meanwhile, hATTR-PN, which affects approximately 1 in 100,000 people, is a disease caused by mutations in the transthyretin gene. It is characterized by systemic multiple autonomic neuropathies, including cardiac, gastrointestinal, and ophthalmic. Vyndaqel stabilizes the transthyretin protein.Generally, symptoms such as pain, paresthesia, and paralysis begin in the lower extremity nerves, where abnormal proteins tend to accumulate, eventually spreading to the upper body and affecting other organs, such as the heart, kidneys, and eyes. Life expectancy is 7 to 12 years on average from the onset of symptoms.
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- Will Vyloy secure reimb this year?...Passes CDDC review
- by Eo, Yun-Ho Feb 27, 2026 08:36am
- Attention is turning to whether the gastric cancer targeted therapy Vyloy will succeed in its renewed bid and secure reimbursement after clearing the Cancer Disease Deliberation Committee review.Vyloy (zolbetuximab), developed by Astellas Korea for Claudin 18.2–positive gastric cancer, passed the Health Insurance Review and Assessment Service (HIRA) Cancer Disease Deliberation Committee in October last year and is currently undergoing procedures for submission to the Drug Reimbursement Evaluation Committee.Approved in Korea in September 2024, Vyloy failed to clear the CDDC review with its initial application in February last year but promptly submitted a reapplication, ultimately securing approval.Vyloy is the world’s first approved Claudin 18.2–targeted therapy. It is an immunoglobulin monoclonal antibody that binds to Claudin 18.2, a protein expressed and exposed in gastric cells.According to the Phase III SPOTLIGHT study, which formed the basis for Vyloy's approval, the median progression-free survival (mPFS) for Vyloy combined with mFOLFOX6 (oxaliplatin, leucovorin, fluorouracil) was 10.61 months, exceeding the placebo group’s 8.67 months. Median overall survival (mOS) was also longer at 18.23 months versus 15.54 months.In the GLOW study, the Vyloy plus CAPOX (capecitabine and oxaliplatin) combination group achieved a median progression-free survival of 8.21 months, reducing the risk of disease progression or death by approximately 31%.Professor Sun Young Rha of Yonsei Cancer Center stated, “About 90% of patients with metastatic gastric cancer are HER2-negative, underscoring the urgent need for therapies targeting new biomarkers. Given that about 40% of HER2-negative patients are reported to be Claudin 18.2-positive, the emergence of Vyloy, which selectively binds to Claudin 18.2, presents a new therapeutic option for these patients.”Meanwhile, the Korean Gastric Cancer Association revised its treatment guidelines on January 6, 2025, in the Journal of Gastric Cancer (JGC), granting Vyloy the ‘highest-level’ recommendation as first-line therapy for patients who are HER2-negative and Claudin 18.2-positive.Vyloy has also been listed as a standard treatment option in Japan’s gastric cancer guidelines and the European Society for Medical Oncology (ESMO) clinical practice guidelines. It is included as a preferred regimen in the U.S. NCCN guidelines, rapidly establishing itself as a global standard of care for gastric cancer.
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- Twice-yearly HIV treatment 'Sunlenca' nearing KOR mkt entry
- by Eo, Yun-Ho Feb 27, 2026 08:35am
- The domestic market entry of twice-yearly injectable 'lenacapavir', a new drug for HIV prevention, is imminent.The Ministry of Food and Drug Safety (MFDS) is currently conducting a final review for the approval of Gilead Sciences' Sunlenca (lenacapavir), an HIV treatment. It is expected to be approved as early as the first half of this year.The drug's detailed indication is 'to be used in combination with other antiretrovirals to treat patients with multidrug-resistant HIV-1 infection for whom antiretrovirals cannot be used.'This drug is the first-in-class long-acting HIV-1 capsid inhibitor that is subcutaneously administered every six months. It was approved in the United States and Europe in 2022 and is available for prescription.The current HIV treatment regimen requires daily oral administration of antiretrovirals. As long-acting agents are being developed, the treatment frequency has been extended to every 2 or 6 months.Although this indication has not been submitted for approval in Korea, lenacapavir is gaining interest because it can be used for prophylaxis, beyond HIV treatment.This drug obtained approval in the United States in June last year and in Europe in August of the same year as a 'pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at increased risk of HIV-1 infection.' The product name for lenacapavir used for prophylaxis is 'Yeytuo.'The efficacy of lenacapavir for PrEP was demonstrated through the Phase 3 PURPOSE 1 and PURPOSE 2 trials.The PURPOSE 2 study result has shown that lenacapavir reduced HIV infection by 96% compared to baseline HIV prevalence (HIV).In a group of 2,180 participants, only two cases occurred, showing that 99.9% of the participants in the lenacapavir treatment group did not become infected with HIV.In 2024, Gilead Sciences concluded the double-blind trial conducted in Sub-Saharan Africa early after meeting the key endpoints. This PURPOSE1 clinical trial evaluated lenacapavir as a PrEP among cisgender women.Meanwhile, lenacapavir was selected as 'Breakthrough of the Year' in Science, the academic journal and outlet for scientific news, based on these study results.
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- Wegovy and Mounjaro reshape Korea’s obesity drug market
- by Chon, Seung-Hyun Feb 26, 2026 07:48am
- Following the market impact of the obesity treatment Wegovy, Mounjaro has now begun its full-scale expansion in the domestic market. Wegovy exceeded KRW 100 billion in sales for three consecutive quarters, with annual sales nearing KRW 500 billion. Mounjaro nearly reached KRW 200 billion in sales within just 3 months, significantly disrupting the obesity drug landscape. Previously dominant treatments such as Saxenda and Qsymia have seen their market influence sharply decline.According to market research institution IQVIA, Novo Nordisk’s Wegovy recorded annual sales of KRW 467 billion last year.Wegovy, which was approved by the Ministry of Food and Drug Safety in April 2023, is a glucagon-like peptide-1 (GLP-1) receptor agonist containing semaglutide. Novo Nordisk developed Wegovy after identifying weight loss effects during clinical trials of GLP-1 diabetes candidates, ultimately advancing semaglutide into a once-weekly treatment for obesity.Wegovy gained explosive popularity immediately after its domestic launch in October 2024. It rapidly ascended to the top of the obesity drug market, generating KRW 60.3 billion in sales in Q4 2024.Wegovy surpassed KRW 100 billion in quarterly sales just 9 months after launch, reaching KRW 133.8 billion in Q2 last year. It recorded KRW 137 billion and KRW 116.7 billion in Q3 and Q4, respectively, achieving quarterly sales exceeding KRW 100 billion for 3 consecutive quarters. Novo Nordisk strengthened its commercial presence by signing a co-promotion agreement with Chong Kun Dang for Wegovy in September last year.Even before its domestic launch, Wegovy gained global notoriety through word of mouth as the weight-loss secret of overseas celebrities, such as Tesla CEO Elon Musk, leading to worldwide shortages. Despite its high price, Wegovy garnered explosive interest immediately after its domestic release, causing initial shortages.Wegovy's sales in the Q4 last year decreased by 14.9% compared to the previous quarter, analyzed to be due to the impact of price reductions and the emergence of the new product Mounjaro. Following Mounjaro’s launch in August, Novo Nordisk reduced Wegovy’s supply price by approximately 40%.Eli Lilly’s Mounjaro, which was launched domestically in August, generated KRW 215.5 billion in sales during the second half of the year alone.Mounjaro acts on both the glucagon-like peptide-1 (GLP-1) receptor and the glucagon-like peptide-1 (GLP-1) receptor, enhancing insulin secretion, improving insulin resistance, and reducing glucagon secretion. This induces reductions in both pre- and post-meal blood glucose levels. In Korea, Mounjaro was initially approved as a diabetes treatment in June 2023 and later secured an additional obesity indication in August 2024.Mounjaro generated its first sales of KRW 28.4 billion in Q3 last year and significantly outpaced Wegovy with KRW 187.1 billion in Q4. In Q4 last year, Wegovy and Mounjaro combined reached KRW 303.8 billion in sales, marking a historic milestone in Korea’s obesity treatment market.Mounjaro also surpassed Wegovy in the global market. Last year, Mounjaro sales reached USD 23.065 billion (approximately KRW 33 trillion), substantially exceeding Wegovy’s sales of DKK 79.1 billion (approximately KRW 18 trillion).Saxenda and Qsymia, which previously led the obesity drug market before Wegovy's arrival, have seen their market positions significantly eroded.Novo Nordisk's Saxenda saw its sales shrink by 84.4% in just one year, plummeting from KRW 65.6 billion in 2024 to KRW 10.2 billion last year. Saxenda had dominated the obesity treatment market since its launch in 2019, achieving sales of KRW 42.6 billion that year and maintaining its leading position for 5 consecutive years until 2023. Saxenda's sales reached KRW 66.8 billion in 2023, but dropped significantly after Wegovy's launch.Launched domestically in 2018, Saxenda was the world’s first GLP-1 analogue approved for obesity treatment. It shares the same active ingredient (liraglutide) as Victoza, differing only in dosing regimen. The arrival of Wegovy, another GLP-1 agonist like Saxenda, has further eroded Saxenda's market share.Alvogen Korea’s Qsymia recorded annual sales of KRW 35.6 billion, reflecting an 8.8% year-on-year decline. Qsymia, a combination of phentermine and topiramate, entered the Korean market in late 2019. While Qsymia experienced a smaller sales decline compared with Saxenda, its revenue remained below 10% of Wegovy’s, indicating a substantial contraction in market presence.
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- Tariff risk again…pharma closely watches exports to the US
- by Kim, Jin-Gu Feb 25, 2026 05:46pm
- The US Supreme Court's ruling that reciprocal tariffs are unconstitutional, and President Trump's new 15% reciprocal tariff, come into effect at 2 PM on the 24th. The pharmaceutical and biotech industries are closely monitoring the situation as the risk of US tariffs may reignite.Currently, many view the impact of the new 15% tariff as limited. Major pharmaceutical and biotech companies that export have already prepared countermeasures by securing sufficient local inventory and expanding local production through manufacturing facilities in the United States. Some observers also predict that export performance, which surged significantly last year during the process of securing local inventory, may decrease to typical levels this year due to a base effect.New '15%' tariff takes effect…Prospects↑ for "Limited impact on Korean drug exports to the US"According to pharmaceutical industry sources on the 24th, the new 15% tariff imposed by US President Donald Trump on imports from all countries worldwide takes effect today (the 24th).Immediately following the US Supreme Court's ruling on the unconstitutionality of reciprocal tariffs on the 20th, President Trump announced that he had signed an executive order imposing a new 10% tariff. The following day, President Trump adjusted the tariff upward to 15%. According to the White House, the new tariff takes effect at 12:00 AM on the 24th, Eastern Time, which corresponds to 2 PM on the 24th, Korean Time.The new 15% tariff is based on 'Section 122 of the Trade Act.' This clause focuses on responding to serious international balance of payment deficits or a decline in the value of the dollar. It allows for the imposition of emergency tariffs of up to 15% for 150 days, which can be extended with congressional approval.Regarding the Supreme Court's ruling and President Trump's 15% tariff, the pharmaceutical industry is keeping a close watch, keeping in mind the possibility that US export risks could reignite.However, many view that the impact will be limited even if a 10% (or 15%) tariff is imposed. Indeed, during an emergency meeting immediately after President Trump's announcement, the Ministry of Trade, Industry and Energy explained, "While export uncertainty to the US has risen slightly, the export conditions for the US secured through the Korea-US tariff agreement will largely be maintained."An official from the domestic pharmaceutical and biotech industry also stated, "As a result, a new 15% tariff replaces the 15% reciprocal tariff. The key is whether the Most Favored Nation (MFN) status for medicines will be maintained following the conclusion of Korea-US tariff negotiations; however, regardless of MFN status, we have prepared measures, such as securing inventory in the US and acquiring local production facilities. Even if new tariffs are applied, we expect the impact to be minimal."Securing local stock + acquiring US manufacturing plants…Major pharmaceutical and biotech firms complete countermeasuresThe domestic pharmaceutical and biotech industry secured sufficient local inventory last year as a short-term measure ahead of the Trump administration's tariff imposition. Using Celltrion as an example, the company has preemptively secured two years' worth of inventory for products exported to the US as of early this year.In the mid- to long-term, measures have been put in place to minimize risk by acquiring local production facilities.Celltrion will engage in local production through Eli Lilly’s biologic manufacturing plant in Branchburg, New Jersey, which it acquired last year. In September last year, Celltrion acquired the Branchburg plant, with a production capacity of 66,000 liters, for KRW 460 billion (approximately USD 330 million). The acquisition process was finalized last month, and the facility reportedly began full-scale operations this month.Samsung Biologics plans to commence local production after finalizing the acquisition of a biologic manufacturing plant in Maryland, purchased in December last year, by next month. This plant has a production capacity of 60,000 liters, and the company is considering expanding to 40,000 liters.Preemptive export↑ last year for inventory accumulation…Export sales may decrease this year due to base effectSome in the pharmaceutical industry suggest that the export performance of Korean medicines to the US this year may appear to decrease on the surface compared to last year.This prospect suggests that while major companies preemptively increased export volumes last year to secure local inventory, leading to a significant spike in export performance, this year will see a decrease due to the resulting base effect.Sales performance of Korea's domestic medicines exported to the US (unit: USD 1 million; source: Korea Customs Service)According to the Korea Customs Service, the value of Korean medicines exported to the US reached USD 1.76 billion last year, the highest on record. Exports to the US have increased significantly over the past four years. Drug exports to the US, which were USD 843.94 million in 2022, grew by 7% to USD 903.3 million in 2023, and increased by approximately 50% to USD 1.358 billion in 2024. Building on this, high growth of nearly 30% continued last year, driving record-breaking performance for Korean medicines.However, this year is slightly different. In January of this year, the export value of Korean medicines to the US was USD 76.42 million, which is less than half of the USD 176.3 million recorded in January last year. This figure is also more than 25% lower than the USD 103.07 million recorded in January 2024.
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- Will Retevmo finally be reimbursed 5yrs post-approval?
- by Eo, Yun-Ho Feb 25, 2026 05:45pm
- Attention is once again turning to whether the RET-targeted anticancer therapy Retevmo can finally conclude its reimbursement listing process.Despite domestic regulatory approval, reimbursement coverage has yet to be granted nearly 5 years later, extending the wait for eligible patients.According to industry sources, Eli Lilly Korea resubmitted its reimbursement application for Retevmo (selpercatinib), indicated for RET-mutated non-small cell lung cancer (NSCLC), in April of last year. The therapy subsequently passed the Health Insurance Review and Assessment Service (HIRA) Cancer Disease Review Committee again in September. Follow-up procedures, including pharmacoeconomic evaluation, are reportedly in progress.The company has already submitted the required documentation, including the pharmacoeconomic evaluation data. However, specific timelines for review or details regarding price negotiations remain difficult to ascertain at this stage.Retevmo endured a truly arduous journey through the listing process. The drug received approval from the Ministry of Food and Drug Safety in March 2022. Subsequently, reimbursement criteria were established by the Health Insurance Review and Assessment Service in November 2022, and it passed the Drug Reimbursement Evaluation Committee in May 2023, gaining recognition for its cost-effectiveness.However, its listing fell through in August 2023 when price negotiations with the National Health Insurance Service broke down. Then, in October 2023, Phase III clinical trial data showing improved overall survival (OS) were announced, prompting the company to reapply based on this evidence.RET mutations represent rare genetic alterations identified in approximately 1–2% of NSCLC patients.Currently, Retevmo remains the only RET-targeted therapy approved in Korea. Conventional chemotherapy and immunotherapy have historically shown limitations in response rates and durability within this patient population.Meanwhile, the US National Comprehensive Cancer Network (NCCN) Guidelines recommend Retevmo as a Preferred Category 1 option for first-line treatment of RET-mutated metastatic NSCLC. This is the highest level of evidence and expert consensus. While it is considered a treatment option immediately upon diagnosis in global standards, it remains non-reimbursed in Korea.Of course, many anticancer drugs designated as global standard treatments remain non-covered in Korea. However, Retevmo differs in that, despite having already been recognized for cost-effectiveness once and securing additional clinical evidence after negotiations stalled, discussions for its coverage have been prolonged.Among the A7 reference pricing countries, Retevmo is reimbursed and actively used in clinical practice across six nations (the United States, Germany, Italy, the United Kingdom, Switzerland, and Japan), with France being the sole exception.
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- Imfinzi reimbursed for gastrointestinal cancer in Korea
- by Son, Hyung Min Feb 25, 2026 05:45pm
- AstraZeneca’s immuno-oncology drug Imfinzi is poised for expanded reimbursement in first-line hepatocellular carcinoma and biliary tract cancer, signaling potential shifts in gastrointestinal cancer treatment strategies.In hepatocellular carcinoma, the Imfinzi + Imjudo combination is expected to compete with the Tecentriq+Avastin regimen. In biliary tract cancer, an Imfinzi-based triplet combination will face off against Keytruda-based combination therapy. Given the characteristics of immunotherapy combinations, which carry a relatively lower bleeding risk, and the fact that reimbursement for Imfinzi is being applied first, there is an atmosphere of anticipation for a first-mover advantage in the market.AstraZeneca's immuno-oncology drug ImjudoAccording to industry sources on the 25th, the reimbursement expansion for AstraZeneca's immuno-oncology drug Imfinzi (durvalumab) is scheduled for next month.For hepatocellular carcinoma, the reimbursed regimen includes the PD-L1 inhibitor Imfinzi combined with the CTLA-4 inhibitor Imjudo (tremelimumab). Both drugs are immunotherapies, designed to enhance antitumor responses by simultaneously promoting initial T-cell activation and sustaining immune activity while blocking immune evasion mechanisms.Clinical efficacy of the Imfinzi+Imjudo combination was demonstrated in the Phase III HIMALAYA study. The trial evaluated 1,171 treatment-naïve patients aged 18 years or older with unresectable hepatocellular carcinoma, comparing Imfinzi + Imjudo versus Bayer’s Nexavar (sorafenib).Results showed that the Imfinzi+Imjudo combination therapy reduced the risk of death by 22% compared to Nexavar monotherapy. The overall survival (OS) for the Imfinzi + Ibrutinib combination therapy was 16.4 months versus 13.8 months for Nexavar monotherapy.The Imfinzi+Imjudo regimen will compete with Roche’s reimbursed Tecentriq (atezolizumab)+Avastin (bevacizumab) combination.A key advantage cited for the Imfinzi+Imjudo regimen is reduced bleeding risk. Tecentriq+Avastin is known to be associated with relatively higher bleeding incidence attributable to Avastin.Competition is expected to intensify further with the introduction of later entrants. Ono Pharmaceutical and Bristol Myers Squibb (BMS) are currently preparing reimbursement applications for the Opdivo(nivolumab)+Yervoy (ipilimumab) combination in hepatocellular carcinoma. This Opdivo(nivolumab)+Yervoy (ipilimumab) regimen is a combination of PD-1 and CTLA-4 class immuno-oncology drugs.Opdivo+Yervoy’s primary advantage lies in its OS outcomes. In the Phase III CheckMate-9DW study, median OS reached 23.6 months, exceeding the 20.6 months observed with Eisai’s Lenvima (lenvatinib) or Nexavar.Furthermore, recently released 4-year analysis results showed the overall survival rate was 31% in the Opdivo + Yervoy group, higher than the 18% in the control group.First-line coverage for biliary tract cancer...Competition with KeytrudaAstraZeneca's immuno-oncology drug ‘Imfinzi’For biliary tract cancer, coverage for the combination therapy Imfinzi+gemcitabine+cisplatin will be newly established. The specific indication is for the treatment of unresectable locally advanced or metastatic biliary tract cancer. Reimbursement is limited to adenocarcinoma and excludes ampullary carcinoma.Although biliary tract cancer affects relatively few patients, early diagnosis is difficult. Due to rapid metastasis to surrounding organs and high recurrence rates, the 5-year relative survival rate (2017-2021) is only 28.9%. Seven out of ten patients die from biliary tract cancer. It has also been a challenging field for drug development. The combination therapy of Imfinzi+gemcitabine+cisplatin demonstrated a 2-year overall survival rate of 24.9% in the TOPAZ-1 clinical trial led by Korean medical teams, confirming a survival rate more than double that of the existing standard treatment (10.4%).Furthermore, the TOURMALINE study showed that the combination of Imfinzi, gemcitabine, and cisplatin demonstrated similar efficacy compared to other gemcitabine-based chemotherapy combinations (such as oxaliplatin, paclitaxel, carboplatin, etc.). The objective response rate (ORR) for the primary combination therapy in that clinical trial was 27%.With this reimbursement, Imfinzi will directly compete with Keytruda plus gemcitabine plus cisplatin combination therapy in the first-line biliary tract cancer treatment space.Keytruda-based therapy received regulatory approval for expanded indications in April 2024. Supporting clinical data demonstrated a median OS of 12.7 months. However, the earlier reimbursement approval of the Imfinzi regimen is expected to confer market entry advantages.
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- Fintepla’s reimbursement listing process draws attention
- by Eo, Yun-Ho Feb 24, 2026 03:55pm
- Attention is focused on the insurance reimbursement process for ‘Fintepla’, a drug included in Korea’s approval-evaluation-negotiation parallel pilot program.The reimbursement application for UCB Pharma Korea’s Dravet syndrome drug Fintepla (penfluramine) has been submitted to the Health Insurance Review and Assessment Service's (HIRA) Pharmacoeconomic Evaluation Subcommittee and is currently undergoing subsequent procedures.Approved domestically last December, Fintepla was designated as an orphan drug and was selected as a candidate for the second phase of the government's ‘Approval-Evaluation-Negotiation Parallel Pilot Program’. Amid ongoing debates about the effectiveness of the pilot program, it remains to be seen whether Fintepla can smoothly complete the listing procedures, including review by the Drug Reimbursement Evaluation Committee.Dravet syndrome is an ultra-rare, pediatric, intractable disorder that typically manifests in infancy. According to experts, approximately 80% of cases are associated with SCN1A mutations.It typically manifests around 12 months of age, with up to 15% of patients dying during infancy or adolescence. Patients face elevated risks of both physical and neurodevelopmental comorbidities, including motor impairment, language delay, autism spectrum disorders, intellectual disability, and ADHD.Caregivers also endure high caregiving stress and low quality of life, including the burden of 24-hour care, career disruptions, and loss of income.Frequent, long-term seizures in Dravet syndrome patients not only degrade the quality of life for both patients and caregivers but also carry a risk of sudden unexpected death in epilepsy (SUDEP). Therefore, seizure reduction or elimination is the central treatment objective for the condition.However, conventional antiepileptic drugs often show limited efficacy, and certain therapies may even exacerbate seizures, leaving considerable unmet medical need in the domestic treatment landscape. Fintepla is being evaluated as a treatment option that not only reduces seizure frequency but may also achieve near-complete seizure control in some patients.Fintepla’s clinical value has been demonstrated through 3 randomized Phase III trials (Study 1–3).An integrated analysis combining data from 119 patients enrolled in Study 1 and participants recruited in Study 3 showed that the Fintepla treatment group showed a reduction in monthly convulsive seizure frequency (MCSF) by 62.3% and 64.8%, respectively. Notably, near-complete seizure elimination was observed exclusively in the Fintepla treatment groups.Study 2, a 15-week trial consisting of a six-week baseline, three-week titration, and 12-week maintenance phase, randomized patients 1:1 to receive Fintepla or placebo alongside standard therapy with stiripentol (plus clobazam and/or valproate). Results showed that 54% of patients in the Fintepla combination group achieved at least a 50% reduction in MCSF from baseline, compared with only 5% in the placebo group.
- Company
- Two years after Forxiga exit… Jardiance 34%↑, Dapa.N↑
- by Kim, Jin-Gu Feb 23, 2026 09:16am
- Two years after the withdrawal of the SGLT-2 inhibitor ‘Forxiga (dapagliflozin)’ from the Korean market, ‘Jardiance (empagliflozin)’ is strengthening its dominant position in this market, expanding its prescription performance by over 30%.Among the flood of generics launched following Forxiga’s patent expiration, HK inno.N’s Dapa.N has shown particularly strong growth. Industry observers attribute this largely to the product’s successful succession of indications from the originator.Two years postexit… Jardiance prescriptions rise from KRW 58.1billion to 77.7billionAccording to the pharmaceutical market research firm UBIST on the 21st, outpatient prescriptions for SGLT-2 inhibitor monotherapies reached KRW 164.9B last year. This represents a 17.9% increase compared with KRW 139.8 billion in 2023, just before Forxiga’s market withdrawal.The market experienced substantial shifts surrounding Forxiga’s exit. AstraZeneca Korea decided to withdraw Forxiga from the Korean market at the end of 2023. The following year, it halted the domestic supply of new inventory, leaving only existing stock circulating in the market. In April 2024, the company voluntarily withdrew marketing authorization, followed by full reimbursement delisting in December, and completed its full withdrawal from the market.Forxiga recorded KRW 55.5 billion in prescriptions just before its market exit in Korea. At the time, fierce marketing and sales competition unfolded in the SGLT-2 monotherapy market among competing brands and generic manufacturers to capture the over KRW 50 billion annual gap left by Forxiga. Analysts note that this competitive dynamic contributed to nearly 18% market expansion over the two-year period.During this period, Jardiance’s prescription sales grew significantly. Jardiance's prescription sales, which were KRW 58.1 billion in 2023, increased to KRW 77.7 billion last year, marking a 33.8% growth. In this process, Jardiance strengthened its dominant market position. As of last year, Jardiance’s market share in the SGLT-2 monotherapy segment reached 47.2%, approaching half of total prescriptions.A potential variable is the entry of Jardiance generics. Following the expiration of Jardiance’s substance patent last October, 23 generic versions entered the market. The market penetration of Jardiance generics this year could potentially influence the original drug’s dominant position going forward.Another original product, Daewoong Pharmaceutical’s Envlo (enavogliflozin), also saw a significant increase in prescriptions around the time of Forxiga's withdrawal. Since its launch in May 2023, prescriptions increased from KRW 3.2 billion to KRW 10.6 billion in 2024, then to KRW 11.8 billion last year.Forxiga generics mark KRW 74.6 billion combined... ‘Dapa.N’ sales surge with inherited indicationsForxiga generics have also successfully filled the void left by the original. Notably, HK Inn.N’s Dapa.N, which inherited Forxiga’s indications, has recently shown a particularly pronounced upward trend in prescription sales.Forxiga generics were launched en masse in 2023 following the expiration of the original product's substance patent. A total of 86 companies obtained generic product approvals, with 65 of them launching products.Within the overall SGLT-2 inhibitor market, prescription sales for dapagliflozin-containing products increased slightly from KRW 73.4 billion in 2023 to KRW 74.6 billion last year. The 2023 structure, which consisted of KRW 55.5 billion for the original Forxiga + 17.2 billion won for generics, was replaced by KRW 74.6 billion entirely from generics last year.Among the generics, HK inno.N’s Dapa.N has demonstrated particularly strong prescription growth. In April 2024, AstraZeneca Korea withdrew Forxiga’s marketing authorization while simultaneously transferring clinical data to the company, enabling Dapa.N to inherit Forxiga’s indications.Immediately after the indication succession, Dapa.N’s prescription growth was limited. However, the upward trend accelerated from the fourth quarter of 2024. Prescriptions, which stood at KRW 2.4 billion in 2024, surged more than fourfold to KRW 10.5 billion last year. Analysts suggest that the declining domestic supply of Forxiga shifted prescription demand toward Dapa.N.Excluding Dapa.N, other Forxiga generics showed mixed performance. Last year, Daewoong Bio’s ‘Forxidapa’ recorded KRW 6.0 billion, Hanmi Pharmaceutical’s ‘Dapalon’ KRW 5.8 billion, and Boryung’s ‘Trudapa’ KRW 5.6 billion. Additionally, Aju Pharm’s ‘Daparil’, Dong-A ST’s ‘Dapapro’, Chong Kun Dang’s ‘Exiglu’, and Daewon Pharm’s ‘Dapawon’ exceeded KRW 3.0 billion in prescriptions.In contrast, most companies recorded prescriptions below KRW 1.0 billion. Of the 65 companies that launched products, 49 reported annual prescription performance under KRW 1.0 billion. This suggests that only about one in four generic companies entering this market achieved the expected commercial outcomes.
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- Fruzaqla may be prescribed in general hospitals in Korea
- by Eo, Yun-Ho Feb 23, 2026 09:15am
- The new colorectal cancer therapy Fruzaqla may be prescribed at general hospitals in Korea.According to industry sources, Takeda Pharmaceutical Korea's colorectal cancer treatment Fruzaqla (fruquintinib), which selectively inhibits vascular endothelial growth factor receptor (VEGFR)-1,2,3, has passed the Drug Committee (DC) reviews of major medical institutions nationwide, including Korea’s ‘Big 5’ teritary hospitals - Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary’s Hospital, Asan Medical Center, and Severance Hospital.Approved in Korea in March last year, Fruzaqla was previously designated as a drug for the Global Innovative Products on Fast Track (GIFT) program as an innovative oncology therapy.Specifically, the drug is indicated for 'patients with metastatic colorectal cancer (mCRC ) who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, and have been treated with, or are not candidates for, available therapies including anti-VEGF agents, anti-EGFR agents (for RAS wild-type disease), and trifluridine/tipiracil or regorafenib.However, Fruzaqla is yet to be reimbursed in Korea. Takeda submitted its reimbursement application to health authorities last year, and the listing process is currently ongoing. This is why whether Fruzaqla will secure coverage and enable broader patient access is gaining attention.Meanwhile, Fruzaqla’s clinical efficacy was demonstrated in the Phase III FRESCO and FRESCO-2 trials.Clinical findings showed that Fruzaqla extended median overall survival (mOS) by 2.7 months to 9.3 months in patients with previously treated metastatic colorectal cancer compared to placebo, while reducing the risk of death by 35%.In addition, as an oral medication taken once daily without complex dietary restrictions, Fruzaqla is expected to positively impact both treatment efficacy and patient quality of life.Dong-Hoe Koo, Professor of Oncology at Kangbuk Samsung Hospital, said, “Fruzaqla exhibits high drug specificity and avoids unnecessary targets. This enables efficient VEGFR inhibition and sustained drug exposure. The potential for combination strategies with existing therapies warrants further clinical investigation.”
