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- 2026-07-22 03:12:19
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- New patent registrations surge 41% this year
- by Kim, Jin-Gu Jun 26, 2026 09:45am
- A total of 142 products were newly registered in the Ministry of Food and Drug Safety’s (MFDS) Green List during the first half of this year, representing a 41% increase from the same period last year.The trend differed sharply between Korean subsidiaries of multinational pharmaceutical companies and Korean companies. The number of newly listed products from the Korean subsidiaries of multinational pharmaceutical companies surged 53%, from 72 to 110, while domestic pharmaceutical companies posted only a modest 10% increase, from 29 to 32.Among multinational companies, Eli Lilly Korea stood out with patent listings related to its obesity treatment Mounjaro (tirzepatide), while Chong Kun Dang drew attention among domestic companies with patent listings for diabetes combination therapies.New patent listings reach 142 in 1H… multinationals account for 77% of registrationsAccording to the MFDS on June 24, a total of 88 new patents were added to Korea’s Green List during the first half of this year, protecting 142 pharmaceutical products.In 1H last year, 101 products (66 patents) were newly listed. Measured by the number of listed products, this represents a 41% year-over-year increase.Patent registrations by Korean subsidiaries of multinational pharmaceutical companies were particularly prominent. Of the 142 newly listed products, 77%, so 120 products, belonged to multinational companies.The number of companies registering at least one patent increased from 18 to 24. The number of products listed by these companies rose from 72 to 110, a 53% increase, while the number of patents increased from 47 to 74, up 57%.In contrast, domestic pharmaceutical companies showed slower activity. The number of domestic companies registering at least one patent fell from 14 in 1H last year to 8 this year. The number of listed products increased only slightly, from 29 to 32 (10%), while the number of patents declined 26%, from 19 to 14.Lilly focuses on Mounjaro patents…Total reaches 48 since 2023Among multinational companies, Eli Lilly Korea was the most active patent filer, adding 22 products to the Green List during 1H this year alone.Most were related to the obesity therapy Mounjaro. These included 6 Mounjaro QuickPen Inj products (1 patent) and 12 Mounjaro vial products (2 patents).Lilly has continued to register Mounjaro-related patents since 2023.The company registered 12 products in 2023, 6 in 2024, 12 in 2025, and 18 in 1H this year, bringing the cumulative number of patent-protected Mounjaro products to 48.In addition, Daiichi Sankyo Korea newly listed 10 products related to ‘Datroway Inj’ and ‘Vanflyta Tab (6 patents).’ Astellas Pharma Korea listed 9 products related to ’Vyloy Inj’, while AstraZeneca Korea listed 8 products for ‘Lokelma Suspension Powder .’ Sanofi-Aventis Korea followed with 7 products, while AbbVie Korea, Medison Pharma Korea, Roche Korea and Takeda Korea each registered 6.Chong Kun Dang registers 14 diabetes combination products…followed by Celltrion, then SamohAmong domestic pharmaceutical companies, Chong Kun Dang and Celltrion’s listings stood out.Chong Kun Dang registered 14 new products on the Green List, which is the highest among Korean companies. The company filed 6 patents on ‘Duviempol XR Tab (lobeglitazone/empagliflozin/metformin),’ 4 patents on ‘Empamax M XR Tab (empagliflozin/metformin),’ 2 patents on ‘Empamax Tab (empagliflozin),’ and 2 patents on ‘Duviempa Tab (lobeglitazone/empagliflozin).’ All are diabetes combination therapies.Among them, Duviempol XR Tab and Duviempa Tabtab are combination therapies based on Chong Kun Dang’s in-house developed drug ‘Duvie ,’ which contains the active ingredient lobeglitazone.Empamax and Empamax M XR are improved versions of Boehringer Ingelheim’s Jardiance, whose substance patent expired in October last year. Chong Kun Dang applied co-crystal technology to empagliflozin to prevent discoloration seen with existing products and used a coating technology to address the compound’s susceptibility to moisture.Celltrion registered 1 patent each for its Remicade(infliximab) biosimilar ‘Remsima Pen’ and ‘Remsima Prefilled Syringe,’ as well as 4 patents related to the antihypertensive combination ‘Edardipine Tab (azilsartan/amlodipine).’Samo Pharmaceutical newly listed 3 dosage strengths of ‘Voxzogo (vosoritide),’ a treatment for pediatric achondroplasia. The patent holder is U.S.-based BioMarin, while Samo Pharmaceutical is listed as the Korean patent registrant. Samo introduced Voxzogo to the Korean market through its specialty medicines business unit and obtained domestic approval in December 2024.In addition, Hanmi Pharmaceutical filed 1 patent each for ‘Mirabek SR Tab’ and ‘Soranib.’ Sam-a Sam-A Pharm filed patents for 2 dosage strengths of ‘CITUS Chewable Tab,’ and Korea Pharma filed 2 patents related to ‘Accrufer Cap.’ Hyundai Pharm filed 1 patent for ‘Winlevi Cream.’
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- ‘Yescarta demonstrates potential for long-term survival’
- by Son, Hyung Min Jun 25, 2026 09:04am
- The role of CAR-T therapy is expanding in the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).With long-term survival data for Yescarta being secured in patients who relapse or become refractory within 12 months of first-line treatment, treatment strategies in the second-line setting are also beginning to evolve.On June 24, Gilead Sciences Korea held a press conference in Seoul to mark the domestic launch of its CAR-T therapy ‘Yescarta (axicabtagene ciloleucel),’ highlighting the current treatment landscape and the therapy's clinical value in relapsed/refractory DLBCL.Professor Dok Hyun Yoon of the Division of Oncology at Asan Medical Center emphasized that substantial unmet needs remain for patients with relapsed or refractory DLBCL.Professor Dok Hyun Yoon of the Division of Oncology at Asan Medical CenterProfessor Yoon said, “DLBCL is the most common subtype of non-Hodgkin lymphoma, and some patients experience relapse or become refractory even after first-line treatment. In particular, patients who relapse within one year have a very poor prognosis, making the choice of treatment in the second-line setting significantly important for long-term outcomes.”DLBCL is one of the most aggressive forms of lymphoma. First-line treatment typically consists of R-CHOP-based chemoimmunotherapy (rituximab, cyclophosphamide, vincristine, and prednisone). While many patients can achieve complete remission with this regimen, approximately 30–40% eventually experience relapse or refractory disease.The challenge arises after relapse. In Korea, salvage chemotherapy followed by autologous stem cell transplantation remains the primary treatment strategy. However, treatment outcomes remain limited in real-world practice.“Response rates to salvage chemotherapy are generally low in relapsed or refractory patients, and only a limited number of patients proceed to autologous stem cell transplantation. Given the limitations of conventional therapies, it is important to implement advanced treatment options at the appropriate time to improve long-term survival.”Value of second-line CAR-T therapy confirmed in clinical trialsProfessor Seok Jin Kim, Division of Hematology-Oncology at Samsung Medical CenterProfessor Seok Jin Kim, Division of Hematology-Oncology at Samsung Medical Center, reviewed results from the pivotal ZUMA-7 study and emphasized the importance of the timing of CAR-T therapy.Yescarta is a CAR-T therapy manufactured using a patient’s own T cells, which are genetically engineered to recognize CD19 expressed on the surface of cancer cells.In Korea, Yescarta is approved for second-line treatment of adult patients with DLBCL that relapses within 12 months after first-line chemoimmunotherapy or is refractory to treatment, and for the treatment of relapsed or refractory DLBCL and primary mediastinal B-cell lymphoma (PMBCL) after at least two prior lines of systemic therapy.Notably, it is currently the only CAR-T therapy approved in Korea as a second-line treatment.The Phase III ZUMA-7 study compared Yescarta with standard-of-care treatment, including salvage chemotherapy and stem cell transplantation, in patients with large B-cell lymphoma who relapsed within 12 months of first-line therapy or were refractory to treatment.Results showed that Yescarta significantly improved event-free survival (EFS) compared with standard treatment and reduced the risk of relapse or death by 60%. In a four-year follow-up analysis, Yescarta reduced the risk of death by 27%, while the median overall survival (OS) had not yet been reached.“Even though a substantial number of patients in the standard-care arm later received CAR-T therapy or bispecific antibody treatments, the survival benefit of Yescarta was maintained. This demonstrates the importance of using CAR-T therapy at the appropriate stage rather than repeatedly administering multiple lines of therapy after relapse.”He added, “Patients who relapse within one year or are refractory from the outset face an extremely high risk of death from the disease. That is why CAR-T should be considered from the second-line setting.”Kim further noted, “More than half of these patients survived beyond four years, even though long-term survival would have been difficult to expect in the past in this population. The treatment goal in relapsed/refractory DLBCL is evolving from simple disease control to achieving long-term survival.”Gap remains between global standards and Korean clinical practiceExperts also highlighted the shift toward earlier use of CAR-T therapy.The current National Comprehensive Cancer Network (NCCN) guidelines recommend CAR-T therapy as a major second-line treatment option for patients with DLBCL who relapse within 12 months of first-line therapy or are refractory to treatment.In the past, patients with relapsed disease were first treated with salvage chemotherapy and autologous stem cell transplantation, with CAR-T therapy considered only later in the treatment sequence. However, treatment paradigms are increasingly shifting toward earlier use of CAR-T therapy in high-risk patients.Professor Kim said, “CAR-T therapy has already become a standard second-line treatment option in many countries. Korea also needs to establish an environment that allows patients to receive this therapy at the appropriate time.”Yescarta is currently reimbursed in 30 countries worldwide, and the cumulative number of treated patients has surpassed 28,700. Gilead Sciences Korea stated that it plans to continue discussions to broaden treatment access for patients in Korea.
- Company
- Insomnia drug Dayvigo approved in Korea
- by Son, Hyung Min Jun 25, 2026 09:04am
- Eisai Korea announced on the 24th that its insomnia treatment Dayvigo (lemborexant) received approval from the Ministry of Food and Drug Safety (MFDS) on June 23 for the treatment of adult patients aged 18 years and older who have difficulty initiating or maintaining sleep.Dayvigo is a dual orexin receptor antagonist (DORA) class drug that works by reversibly binding to orexin receptors OX1R and OX2R, thereby suppressing excessive wakefulness signals mediated by orexin, a neurotransmitter involved in maintaining wakefulness.Unlike conventional benzodiazepine or non-benzodiazepine (GABA class) sleep medications, which broadly suppress neural activity throughout the brain, Dayvigo promotes sleep by regulating wakefulness, allowing for a more natural sleep process.The recommended dose is 5 mg taken once daily immediately before bedtime. Depending on patient response and tolerability, the dose may be increased to a maximum of 10 mg.The approval was based on the global Phase III SUNRISE 1 and SUNRISE 2 studies.SUNRISE 1 enrolled 1,006 insomnia patients aged 55 years and older and compared Dayvigo with extended-release zolpidem and placebo.After one month of treatment, latency to persistent sleep (LPS) decreased by 19.5 minutes and 21.5 minutes in the Dayvigo 5 mg and 10 mg groups, respectively, compared with reductions of 7.9 minutes in the placebo group and 7.5 minutes in the extended-release zolpidem group.Sleep efficiency (SE) increased by 12.9% and 14.1%, respectively, while wake after sleep onset (WASO) decreased by 43.9 minutes and 46.4 minutes.In particular, wake after sleep onset during the second half of the night (WASO2H) decreased by 27.2 minutes and 28.8 minutes in the Dayvigo 5 mg and 10 mg groups, respectively, compared with a reduction of 21.4 minutes in the extended-release zolpidem group.Improvements were also confirmed in the SUNRISE 2 study, which evaluated Dayvigo’s long-term efficacy.In the study, which enrolled 949 adult insomnia patients aged 18 years and older, subjective sleep onset latency (sSOL) at 6 months decreased by 21.8 minutes and 28.2 minutes in the Dayvigo 5 mg and 10 mg groups, respectively, compared with an 11.4-minute reduction in the placebo group.Subjective sleep efficiency (sSE) increased by 14.2% and 14.3%, while subjective wake after sleep onset (sWASO) decreased by 46.8 minutes and 42.0 minutes, respectively. Response rates for both sleep initiation and sleep maintenance were higher than those observed with placebo, and the benefits were observed and maintained from the first week of treatment through 6 months.In terms of safety, somnolence was the most frequently reported adverse event in both studies. However, the incidence of serious adverse events was low. No rebound insomnia or withdrawal symptoms were observed, and no new safety concerns emerged during 6 months of long-term treatment.Hong-byung Koh, CEO of Eisai Korea, said, “Despite the significant impact insomnia has on patients’ daily lives and quality of life, unmet needs remain in treatment. We hope that the approval of Dayvigo will expand patient access to a new treatment option capable of addressing not only sleep onset insomnia but also sleep maintenance insomnia.”
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- Three Korean companies rename Vemlidy generic products
- by Kim, Jin-Gu Jun 24, 2026 09:19am
- Daewoong Pharmaceutical, Dong-A ST, and Samil Pharmaceutical have consecutively changed the brand names of their generic versions of the hepatitis B treatment ‘Vemlidy (tenofovir alafenamide).’ The move is interpreted as the result of their final defeat in a trademark dispute with the originator company that reached the Supreme Court.According to industry sources on June 23, Dong-A ST changed the name of its product from ‘Vemlia Tab’ to ‘Tafria Tab’ effective June 22. On the same day, Samil Pharmaceutical changed ‘Vemlino Tab’ to ‘Teno-S Tab.’ Earlier, on June 16, Daewoong Pharmaceutical changed ‘Vemliver Tab’ to ‘Tafvir Tab.’As a result, three Vemlidy generics have undergone brand name changes one after another. The changes stem from the companies’ final defeat in a trademark dispute with the original manufacturer.Photos of Dong-A ST’s Vemlia, Samil Pharmaceutical’s Vemlino, and Daewoong Pharmaceutical’s Vemliver. The products have been renamed Tafria, Teno-S, and Tafvir, respectively.In July 2023, originator company Gilead Sciences filed trademark invalidation actions against the three companies, approximately four months after the generics received marketing approval. Gilead argued that the three-syllable element “Vemli” that appears in both the originator product Vemlidy and the three generic product names could cause trademark confusion.In April last year, the Intellectual Property Trial and Appeal Board ruled in favor of the generic manufacturers. The board concluded that, given the nature of prescription drugs prescribed and dispensed by healthcare professionals such as physicians and pharmacists, the likelihood of confusion or misunderstanding is low, and that the trademark should be perceived as a distinct coined term.Gilead appealed the decision to the Patent Court. In February this year, the Patent Court overturned the earlier ruling, finding that the generic product names were similar to the originator brand name and could create confusion.Following their loss in the second instance court, the generic manufacturers appealed to the Supreme Court. On the 11th, the Supreme Court dismissed the appeals without substantive review. This court’s dismissal without merit refers to a process where the Supreme Court upholds the lower court’s judgment without reviewing the case on its merits.Following their final defeat, the generic manufacturers had little choice but to change their product names, as continuing to market the products under the disputed names could be interpreted as trademark infringement. This ultimately led to the successive rebranding of all three products.The three companies now face the challenge of rebuilding brand recognition from scratch. They had spent nearly three years marketing the products under their previous names and establishing awareness among prescribers. In addition, the companies must undergo a series of administrative procedures, including changing product names in MFDS-approved labels, revising names on HIRA’s reimbursement listings, and replacing packaging materials and package inserts already in circulation.The pharmaceutical industry's attention is now focused on whether the other generic products, which did not adopt the 'Vemli-' prefix from the beginning, will benefit from this outcome. These include Chong Kun Dang’s Tenofobell-A, Hutecs Korea’s ‘Ganelid,’ Dongkook Pharmaceutical’s ‘Alfoterin,’ Samjin Pharmaceutical’s ‘Taflead,’ and Jeil Pharmaceutical’s ‘ Tecavir-D Tab.’ Gilead has not filed for the invalidation of the trademark rights for these products.Coincidentally, the three companies that lost the trademark dispute had held the top three prescription rankings among Vemlidy generics. According to pharmaceutical market research firm UBIST, the 2025 prescription sales of Samil Pharmaceutical’s Vemlino (rebranded as Teno-S) increased by 59% YoY to KRW 3.8 billion, Dong-A ST’s Vemlia (rebranded as Tafria) by 66% to KRW 2.9 billion, and Daewoong Pharmaceutical’s Vemliver (rebranded as Tafvir) by 93% to KRW 1.3 billion. In contrast, all remaining competing products recorded annual prescription sales of less than KRW 500 million.Vemlidy is a novel hepatitis B treatment developed by Gilead as the successor to Viread. Although Viread demonstrated strong antiviral efficacy against the hepatitis B virus, concerns remained regarding side effects such as renal impairment and reductions in bone mineral density. Vemlidy was developed to address these shortcomings. Clinical studies showed no significant occurrence of renal dysfunction or bone mineral density loss. The defining strength of this treatment lies in its proven long-term safety, given the chronic nature of hepatitis B and the need for prolonged treatment.Among major originator hepatitis B therapies, Vemlidy remains the only product that continues to grow. Prescription sales reached KRW 76.9 billion last year, an 8% increase YoY. In the first quarter of this year, sales rose 12% YoY to KRW 19.8 billion.
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- Reimbursement expansion for ‘Tevimbra’ gains momentum
- by Eo, Yun-Ho Jun 23, 2026 09:52am
- The cost-effective immuno-oncology therapy ‘Tevimbra’ is moving closer to a major expansion of National Health Insurance reimbursement in Korea.BeOne Medicines’ PD-1 inhibitor immunotherapy Tevimbra (tislelizumab) passed review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee on June 4 and is currently awaiting a pricing negotiation order from the Ministry of Health and Welfare.The reimbursement expansion application includes 5 indications: ▲first-line combination therapy for unresectable, locally advanced, or metastatic esophageal cancer, ▲first-line combination therapy for unresectable or metastatic HER2-negative gastric cancer or gastroesophageal junction adenocarcinoma, ▲two first-line combination therapy indications in non-small cell lung cancer (NSCLC) and second-line monotherapy.Accordingly, whether BeOne Medicines, which has announced plans to offer a reasonable price, can reshape the immuno-oncology treatment landscape is gaining attention.Tevimbra’s successful reimbursement review represents more than the entry of another new drug. As reimbursement coverage for immunotherapies has recently expanded across multiple indications, growing pressure on National Health Insurance finances has emerged as a key challenge. In this environment, Tevimbra is considered a candidate capable of achieving cost savings through substitution within the same class.Claims spending on immunotherapies led by Keytruda (pembrolizumab) is currently estimated to be approaching KRW 1 trillion annually, with lung and gastric cancers accounting for more than half of that amount. If Tevimbra demonstrates a certain level of substitution effect in these indications, it is expected that the fiscal savings, starting at tens of billions of won, will further increase with its use.Although immunotherapies are among the most expensive drug categories, intensified competition within the same class could ultimately drive down pricing structures across the market.Tevimbra’s reimbursement strategy appears to follow a phased expansion approach. After first securing approval and reimbursement in the second-line esophageal cancer setting, an area with significant unmet need due to the lack of reimbursed immunotherapy options, the company is now seeking to expand into major indications such as lung and gastric cancers.Its clinical value is also well established. Tevimbra’s therapeutic position has already been validated through global treatment guidelines. Major guidelines, including those from the NCCN and ESMO, recommend Tevimbra as a treatment option on par with previously launched immunotherapies.In addition, its structural design, which inhibits Fcγ receptor binding and thereby minimizes T-cell depletion, provides a mechanistic differentiation that supports its potential as an ‘enhanced PD-1 inhibitor’ beyond merely being a substitute therapy.Also, Tevimbra obtained additional indications late last year in treatment settings where the use of existing immunotherapies remains limited, including perioperative treatment for NSCLC and nasopharyngeal carcinoma, and is expected to continue expanding its therapeutic indication.An industry source commented, “With fiscal discipline in health insurance becoming a priority, immunotherapies with strong cost-effectiveness are naturally more attractive from a policy standpoint. Tevimbra’s price competitiveness is expected to emerge as a meaningful factor in this landscape.”
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- Finasteride 59%·dutasteride 61%...generics in the hair loss mkt
- by Chon, Seung-Hyun Jun 23, 2026 09:52am
- Generics are demonstrating dominance in the oral prescription hair loss treatment market. In the finasteride market, the market share of generics has surpassed the original brand, while in the dutasteride market, the generic share has surpassed 60%. Because of their low-price competitiveness, finasteride generics captured nearly 90% of the market share on a volume basis. Industry analysis anticipate that if the health authorities approve National Health Insurance (NHI) reimbursement to hair loss treatments, domestic pharmaceutical companies will benefit.According to data released by pharmaceutical market research firm IQVIA on June 23, sales of finasteride-based hair loss treatments reached KRW 21.4 billion in the first quarter of this year, a 3.0% year-over-year (YoY) increase. Organon Korea’s Propecia is the original 1mg finasteride formulation approved for the treatment of male alopecia in adult males aged 18 to 41. Proscar, which contains 5mg of finasteride, is indicated for benign prostatic hyperplasia (BPH).The finasteride hair loss treatment market has shown steady expansion, growing by 8.8% over the past three years from KRW 20.7 billion in Q1 2023. Quarterly sales trajectory of Propecia and generics (unit: KRW 100 million, source: IQVIA). BLUE: PROPESIA, GRAY: PROPESIA GENERICS, ORANGE LINE: Market share of generic products. AI-generated imageWithin the finasteride sector, generic products showed significantly higher growth rates compared to the original brand. In Q1, sales of the original Propecia amounted to KRW 8.7 billion, an 8.3% increase compared to the same period last year. However, this represents an 11.8% decline over a three-year period when compared to the KRW 9.9 billion recorded in Q1 2023. Propecia has been on a downward trajectory since peaking at KRW 10.2 billion in Q2 2023. Its Q1 revenue dropped by 14.6% relative to that Q2 2023.Meanwhile, Q1 revenue for Propecia generics amounted to KRW 12.6 billion, down 0.3% YoY. Although the quarterly growth rate of generics lagged behind the original brand this quarter, generic sales expanded by 17.5% over the past three years, from KRW 10.8 billion in Q1 2023. The revenue-based market share of generics in the finasteride hair loss market rose from 52.4% in Q1 2022 to 59.4% in Q1 of this year, climbing 7.0 percentage points over a four-year period.Quarterly market share of Propecia generic sales (unit: %, source: IQVIA). AI-generated imageBased on prescription volume, the dominance of generics becomes even more pronounced. In Q1, generics accounted for 88.2% of the total volume of finasteride hair loss treatments supplied. Due to their competitive pricing relative to the brand-name original, the volume-based market share significantly outpaced the revenue-based market share. The surge of generics was even more significant in the dutasteride market. GlaxoSmithKline's (GSK) Avodart is the original product in this market, indicated for the improvement of symptoms in benign prostatic hyperplasia (BPH) as well as the treatment of male pattern hair loss in adult males aged 18 to 50.In Q1, total sales in the dutasteride market reached KRW 27.4 billion, rising 12.9% YoY. Compared to the KRW 21.9 billion recorded in Q1 2023, the segment expanded by 24.9% over a three-year period, outpacing the growth rate of the finasteride market. In contrast to the overall market growth, the original Avodart generated KRW 10.4 billion in Q1, slipping 1.7% YoY. Avodart's growth has effectively stagnated, registering a 3.0% decline over three years from the KRW 10.7 billion recorded in Q1 2022.Conversely, generics to Avodart posted Q1 revenues of KRW 17.0 billion, surging 24.2% YoY. This marks an increase of 75.3% over a four-year period from the KRW 9.7 billion recorded in Q1 2022, demonstrating a steep upward trajectory. Quarterly sales trajectory of Avodart and generic (unit: KRW 100 million, source; IQVIA). GREEN: AVODART, BLUE: AVODART GENERICS, ORANGE LINE: Market share of generics. AI-generated imageThe revenue share of generics in the dutasteride market stood at 45.9% in Q1 2022, crossed the 50% threshold in Q1 2023, and advanced further to 61.0% in Q1 of this year. The expanding footprint of generics is attributed to aggressive market penetration by approximately 70 domestic pharmaceutical manufacturersIn Q1, the volume-based market share of dutasteride generics reached 68.0%, exceeding its revenue-based counterpart by 7.0 percentage points. This gap is analyzed as a direct result of entering the market with low-cost pricing advantages, driving up volume distribution. Among domestic companies, Hanall Biopharma demonstrated the most outstanding performance across both the finasteride and dutasteride generic markets. In Q1, Hanall Biopharma generated a combined revenue of KRW 6.2 billion from its Avodart generic, Adamo (KRW 5.4 billion), and its Propecia generic, Hair Gro (KRW 700 million).Other domestic companies, including Dongkoo Bio & Pharma, The U Pharmaceuticals, Dong-A ST, and Genuone Sciences, each recorded quarterly revenues exceeding KRW 1 billion in their respective Avodart and Propecia generic portfolios. Industry insiders anticipate that if hair loss treatments are officially listed for national health insurance reimbursement, high-share generic manufacturers will see a benefit in sales alongside the original brands.According to data on the "Supply Status of Hair Loss Treatment-related Medicines" submitted by the Health Insurance Review and Assessment Service (HIRA) to Rep. Kim Sunmin’s office (Rebuilding Korea Party), the total supply value of prescription-only hair loss treatments reached KRW 256.8 billion last year. Based on last year's supply data, if the patient co-payment rate for reimbursed hair loss treatments is set at 30%, it is estimated that the National Health Insurance fund would be responsible for an annual fiscal burden of approximately KRW 180 billion.
- Company
- Domestic DMFs lose ground despite pricing incentives
- by Kim, Jin-Gu Jun 23, 2026 09:52am
- Despite the government's efforts to encourage the use of domestically produced active pharmaceutical ingredients (APIs) through pricing incentives, the pharmaceutical industry remains largely unconvinced.The number of domestic Drug Master File (DMF) registrations in the first half of this year remained at a level similar to last year and fell below the half-year average recorded over the past 5 years, prompting criticism that more practical and effective policies are needed to promote API localization.According to the Ministry of Food and Drug Safety (MFDS) on June 22, a total of 434 new DMFs had been registered as of June 19 this year. Of those, only 22 were registered by companies located in South Korea. The figure includes only fully domestic APIs, for which the entire manufacturing process, from starting materials and intermediates to the final API, was carried out within Korea.This is similar to the 22 registrations recorded in the first half of last year and the 21 registrations in the second half of last year. However, compared with the average of 28.3 registrations per half-year over the past 5 years since the first half of 2021, the number has actually declined by 6 cases. Compared with 41 registrations recorded in each half of 2021, when the COVID-19 pandemic fueled calls for greater self-reliance of APIs, the current level is nearly half.The downward trend remains evident even when the scope is broadened to include partially domestic DMFs, in which at least one stage, from material, intermediate, to final API, is manufactured in Korea. The number of partially domestic DMFs in the first half of this year was 29, down 5 cases from 34 during the same period last year and about 6 below the 5-year half-year average of 36.6.When considering how the Ministry of Health and Welfare announced a pricing premium ‘up to 10 years’ under its pharmaceutical pricing reform for drugs using domestic APIs, this decline has drawn criticism that the system has little practical effect.The government had pledged substantial pricing incentives for products considered strategically important for strengthening domestic API self-sufficiency. While generic drug pricing rates are set to fall from 53.55% to 45% of the original drug’s price, premiums equivalent to 68% will be granted to ▲ supply-stabilization medicines produced using self-manufactured APIs, ▲national essential medicines using domestic APIs, and ▲ self-manufactured injectable antibiotics and pediatric medicines.Previously, such incentives applied only to newly listed products, but the revised policy will also apply retroactively to already listed products. For both essential medicines produced using domestic raw materials and those that utilize locally sourced API, the basic 10-year preferential pricing period will continue if additional requirements are met and the supply remains limited to three or fewer companies.Despite the prospect of reimbursement incentives lasting more than a decade, industry response has been lukewarm. Industry observers note that the government's pricing premium is insufficient to offset the overwhelming manufacturing cost gap compared with when using Chinese and Indian APIs.In fact, registrations of Chinese and Indian APIs surged to the second-highest level on record during the first half of this year.Of the 434 DMFs registered during the period, 381 originated from China or India, accounting for approximately 88% of the total. This is the second highest over the past 5 years, following a 90% share in the first half of last year. Chinese and Indian DMFs accounted for roughly 60% of registrations until 2022, exceeded 70% in 2023, and surpassed 80% in the first half of last year.Meanwhile, API supply diversification has deteriorated significantly. The share of APIs sourced from regions outside Korea, China, and India, such as North America, Europe, and Japan, had exceeded 30% as recently as the first half of 2022. However, the figure has steadily declined and now stands at just 7% in the first half of this year.An industry official criticized, “Considering labor costs, raw material procurement expenses, and environmental compliance costs, the production cost of domestic APIs is uncompetitive compared to those from China and India. The modest premium proposed by the government is nowhere near enough to provide pharmaceutical companies with an economic incentive to shift away from their existing China- and India-based API supply chains.”The official added, “The pricing reform still lacks clear subordinate regulations or guidelines regarding how the origin of starting materials and intermediates will be recognized. As a result, there is considerable confusion in the industry over exactly how much localization is required in order to qualify for preferential pricing.”
- Company
- Changes to TAVI reimb criteria… TAVI mkt intensifies
- by Hwang, byoung woo Jun 23, 2026 09:52am
- Patient access to aortic stenosis therapies is set to expand following a reform of South Korea's National Health Insurance reimbursement criteria for Transcatheter Aortic Valve Implantation (TAVI).Attention is turning to whether this criteria change will accelerate market growth, as the policy transitions from restricting reimbursement to patients aged 80 and older or those deemed inoperable to a system allowing the medical consensus of multidisciplinary Heart Teams. Transitioning from "patients aged 80" and "inoperable" to "clinical necessity"The Ministry of Health and Welfare (MOHW) has issued a revised administrative notice on 'Detailed Criteria and Methods for Applying Reimbursement' and effective June 22, reimbursement criteria for TAVI will undergo reform. The core reform shifts the criteria from "inoperable" to "clinical necessity," as adjudicated by institutional multidisciplinary Heart Teams.TAVI is a minimally invasive structural heart procedure that treats aortic stenosis by deploying a bioprosthetic valve via a catheter, eliminating the need for open-heart surgery. While initially targeted at elderly patients with high surgical risk, accumulating global clinical evidence has expanded its therapeutic indications to broader patient populations, both domestically and internationally. Previously, national health insurance reimbursement for TAVI was approved only for patients in high-risk categories with a Society of Thoracic Surgeons (STS) score exceeding 8%, those aged 80 or older, or cases where all cardiovascular thoracic surgeons on the institutional Heart Team explicitly signed off on the patient's surgical inoperability. The reform preserves the reimbursement criteria for high-risk surgical patients and individuals aged 80 and older. Crucially, however, it expands eligibility to include any patient for whom the entire multidisciplinary Heart Team agrees that a TAVI procedure is clinically necessary. This updates the regulatory method from a rigid system reliant solely on age or operability thresholds to a nuanced approach centered on patient-specific clinical needs. Consequently, this reform is highly likely to improve access for patients in their 70s, a cohort that previously fell into a regulatory blind spot. Under the old rules, septuagenarian patients seeking TAVI had to either incur an extraordinary out-of-pocket financial burden or navigate the high procedural barrier of securing an inoperable consensus from at least 2 cardiovascular thoracic surgeons.The operational mandates for institutional Heart Teams have also been streamlined to fit clinical realities. Previously, the system required at least two cardiovascular thoracic surgeons with over 5 years of post-fellowship cardiovascular surgical experience. The amendment now allows hospitals to meet this staffing requirement with a single surgeon with more than 10 years of experience in cardiovascular surgery. Furthermore, the mandatory in-person attendance requirement for anesthesiologists and radiologists has been changed to an "as-needed" consultation basis, with virtual video conferencing explicitly permitted in unavoidable circumstances. Another notable shift introduces a formalized re-deliberation mechanism: if the Heart Team fails to reach unanimous consensus initially, the team must engage in subsequent discussions to finalize an aligned therapeutic pathway. Professor Sung-jin Hong of the Department of Cardiology at Severance Hospital (insurance committee member for the Korean Society of Cardiology·the Korean Society of Interventional Cardiology) said, "This revision clarifies the decision-making architecture of the multidisciplinary Heart Team while realigning staffing criteria and operational rules with real-world settings. It will alleviate some of the procedural and personnel burdens that previously hindered practical clinical deployment."Improved patient access, emerges as a variable of market expansionThis reform of reimbursement criteria is likely to directly influence the structural heart market alongside expanding patient access. Broadening the criteria for reimbursed procedures allows patients who previously deferred treatment due to intense cost pressures or restrictive institutional thresholds to enter the reimbursed clinical pool. The prevalence of aortic stenosis has been accelerating rapidly alongside demographic aging. According to National Health Insurance data, the number of documented aortic stenosis (ICD-10: I35.0) patients escalated by approximately 56% over a four-year window, growing from 16,537 in 2020 to 25,826 in 2024. Within the same timeframe, ultra-elderly patients aged 80 and older surged by roughly 90%, from 6,283 to 11,944 individuals.Patients in their late 70s are regarded as the key market variable. While patients aged 80 and older already enjoyed robust therapeutic access within the existing coverage framework, the 70s cohort faced severe regulatory constraints despite being optimal clinical candidates for TAVI. By enabling reimbursement whenever the Heart Team establishes clinical utility, this reform is expected to resolve deferred procedural demand. Shifts are also anticipated at the institutional level. Lowering the minimum surgeon requirements and permitting remote participation will substantially reduce the operational burden of running a Heart Team. However, because TAVI is a highly complex intervention requiring advanced capital equipment, specialized hybrid theater setups, and extensive operator experience, the regulatory relaxation alone will not translate into an immediate, decentralized explosion of procedures across all community hospitals. The rationalization of procedural tariffs remains unresolved. Industry stakeholders have consistently noted that the current fee schedule does not adequately capture the intrinsic complexity and the intense multidisciplinary coordination of TAVI. Even with wider reimbursement boundaries, the velocity of real-world market expansion could remain constrained unless hospital fee margins and cost allocations are structurally improved.Despite this, the revision is widely evaluated as the critical regulatory inflection point for long-term category growth. Positioned at the intersection of a rising patient census, demographic aging, and a global trend toward expanded clinical indications, the relaxation of reimbursement rules is highly likely to enlarge the total addressable market. Edwards maintains market dominance as Medtronic chases afterWith anticipation over market expansion mounting, commercial competition among global medtech giants is garnering attention. According to industry sources, the domestic TAVI market is currently dominated by Edwards Lifesciences, which commands a majority share, pursued closely by Medtronic. Abbott and MicroPort also maintain active footholds as they attempt to scale their respective market shares. The reimbursement expansion is initially expected to play to the strengths of incumbent leader Edwards Lifesciences. Companies with deep clinical track records and established brand equity are historically best positioned to capture the immediate influx of newly unlocked demands.However, Medtronic is introducing aggressive competitive variables. This past March, Medtronic commercially launched its next-generation TAVI system, the Evolut FX+, in South Korea. The platform features an advanced design engineered to optimize future coronary access, facilitating subsequent percutaneous coronary interventions (PCI). This product strategy is interpreted as a strategy to target long-term survivors and younger patient demographics. As the TAVI target population changes from extreme-risk, elderly patients to a broader clinical demographic, competitive differentiators are evolving beyond immediate procedural success toward long-term post-procedural management and cross-departmental treatment access. Medtronic’s focus on a "lifetime management" framework for its new platform aligns directly with this shifting clinical trend. Professor Hong stated, "As we transition deeper into a super-aged society, the clinical need for TAVI will continue to intensify," and added, "Streamlining the multi-disciplinary decision-making process will provide clinical utility, ensuring patients receive optimal interventions without missing critical therapeutic windows." Professor Hong emphasized, "While this regulatory shift is a starting point, it must be followed by an established system to expand reimbursement scope, enabling patient access to appropriate care at the right time."
- Company
- ‘Bimzelx sets new goals in psoriasis treatment’
- by Son, Hyung Min Jun 21, 2026 02:49pm
- Advances in high-efficacy biologics are pushing the boundaries of psoriasis treatment. The therapeutic goals for psoriasis are being redefined by the emergence of high-efficacy biologic therapies.In the past, achieving PASI 75 (75% improvement in the Psoriasis Area and Severity Index) was considered the primary treatment goal. More recently, however, treatment expectations have evolved beyond PASI 90 to PASI 100, reflecting growing aspirations for complete skin clearance.On June 18, UCB Korea held a press conference at the Andaz Hotel in Seoul to commemorate the first anniversary of reimbursement coverage for its psoriasis treatment Bimzelx (bimekizumab).From the left: Lionel Houle (Marketing Lead, UCB), Tae-Gyun Kim (Dermatology, Severance Hospital), Mindy Kim (Dermatology and HS Medical Lead, UCB)Bimzelx is the first and only dual-inhibition biologic that simultaneously blocks interleukin (IL)-17A and IL-17F. The therapy received Korean approval in August 2024 for the treatment of moderate-to-severe plaque psoriasis and was launched with reimbursement in June last year.Psoriasis is a chronic inflammatory disease characterized by recurrent cycles of exacerbation and remission, necessitating long-term treatment and continuous management. Beyond being a skin disorder, it is associated with a variety of systemic conditions, including psoriatic arthritis, hypertension, diabetes, and dyslipidemia, rendering proactive disease management essential.As psoriasis patients are known to face a 1.5- to 2.5-fold higher risk of developing systemic diseases than the general population, treatment strategies increasingly emphasize not only improvement of skin symptoms but also long-term disease control and quality-of-life enhancement.Bimzelx demonstrated robust efficacy in the Phase III BE READY study.At Week 16, the PASI 90 response rate reached 90.8%, while the PASI 100 response rate, indicating complete clearance of skin lesions, was 68.2%. In addition, the Investigator's Global Assessment (IGA) 0/1 success rate was 92.6%, significantly higher than the placebo group's 1.2%.Bimzelx also demonstrated superior results in head-to-head studies against other biologics. Bimzelx demonstrated statistically significant superiority in PASI 100 response rates compared with Stelara (ustekinumab), Humira (adalimumab), and Cosentyx (secukinumab).Long-term sustained effect of Bimzelx was also confirmed. According to findings from the open-label extension study BE BRIGHT, Bimzelx's high PASI 100 response rates were maintained consistently over 3 years.Dosing convenience is another distinguishing feature. Among IL-17 biologics currently available in Korea, Bimzelx is the only therapy that allows maintenance dosing to be conducted every eight weeks.Dr.Tae-Gyun Kim, Professor of Dermatology at Severance Hospital, said, “In the past, PASI 75 was often considered an acceptable treatment goal, but today the goal has shifted to PASI 90 and even PASI 100. Bimzelx is a treatment option that allows for these higher therapeutic goals."He added, "Its dual mechanism of action targeting both IL-17A and IL-17F offers the mechanistic advantage of more broadly suppressing psoriasis-related inflammatory pathways. Based on its strong skin clearance efficacy and durable long-term response, Bimzelx is establishing a new benchmark in psoriasis treatment."
- Company
- Lotte Biologics Songdo Plant 1 near completion
- by Hwang, byoung woo Jun 21, 2026 02:49pm
- Lotte Biologics Songdo BiocampusLotte Biologics’ global CDMO business strategy is taking shape along with the near completion of the company’s Songdo Plant 1 at its Songdo Bio Campus.Lotte Biologics, which has continued order acquisition activities from its Syracuse Bio Campus in the US, plans to fully launch a “dual-site” operating system connecting North America and Asia upon completion of its Songdo Plant 1.Songdo Plant 1 in approval of use process… Production base becomes realityLotte Biologics is known to have recently completed construction of Plant 1 at its Songdo Bio Campus in Incheon and applied for use approval with the Incheon Free Economic Zone Authority. Plant 1, which is located in Block Ki20 of Songdo International City District 11, is a 120,000L antibody drug production facility.Once the use approval process is completed, Lotte Biologics will have a total production capacity of 160,000L, which includes its existing 40,000L biopharmaceutical production plant in Syracuse, U.S.The broader picture for the Songdo Bio Campus is also becoming more concrete. Lotte Biologics is pursuing plans to build two additional production facilities in Songdo of the same scale as Plant 1. If all three plants are built as planned, the company will secure a total production infrastructure of 400,000L, including the Syracuse plant’s capacity.However, completion of the plant does not immediately mean commercial production. After use approval, the company must go through production preparation steps, including trial runs, validation, and quality system checks, before responding to regulatory on-site inspections and client technical due diligence audits. The company had previously set the first half of 2027 as its target for commercial production, and with the recent acceleration of the completion schedule, it appears to be speeding up subsequent preparation procedures as well.Industry observers believe the visible progress toward completion of Songdo Plant 1 will become a meaningful turning point for Lotte Biologics’ business development activities. Previously, the Songdo plant had been introduced mainly as a mid- to long-term investment plan or through renderings, but the company has now entered a stage where it can hold discussions with customers based on the plant’s actual production facilities and process configurations.First real-world Songdo marketing activities held at BIO USALotte Biologics plans to highlight this momentum at the 2026 BIO International Convention (BIO USA) to be held in San Diego, US, this month. The company has participated in BIO USA for five consecutive years since 2022.This year’s independent exhibition booth will include private meeting rooms for discussions with global customers and networking spaces for visitors.Notably, the company plans to disclose actual photo and video content showcasing its Songdo Bio Campus Plant 1. It will introduce the production process, floor-by-floor structure, and key equipment, directly demonstrating its large-scale commercial production capabilities and manufacturing competitiveness for customer-specific solutions.Lotte Biologics BIO International 2026 booth overviewFor the company, this year’s BIO USA is expected to serve as an opportunity to leverage the Songdo plant as a tangible asset rather than a simple investment plan. While the Songdo plant had previously been described as a future production base to potential clients, the company can now provide prospective clients with a detailed look at the plant’s facility and equipment, facilitating more concrete production discussions.The dual-site strategy is also becoming clearer, in which Syracuse will serve as a one-stop CDMO hub centered on antibodies and ADCs, and Songdo as a large-scale production base. The ability to utilize both a North American manufacturing base and an Asian large-scale manufacturing base could serve as a differentiating point in global customer acquisition.Workforce expands in line with operational preparationsPreparations for plant operation are also understood to lead to workforce expansion. Lotte Biologics has proactively secured production, quality, and operations personnel during the construction period of Songdo Plant 1. This is because once the physical plant is complete, initial operating personnel must be in place for the company to immediately proceed with trial runs, equipment qualification, and quality system checks.According to industry sources, Lotte Biologics is expected to continue hiring through the end of the year. If preparations for Songdo Plant 1 operation are followed by construction of additional plants, demand for production, quality, and engineering personnel is expected to increase further.This year’s contract wins also support this trend. In January, Lotte Biologics signed a biopharmaceutical contract manufacturing agreement with Rakuten Medical for the global clinical and commercial production of a photoimmunotherapy-based head and neck cancer treatment. The contract includes the provision of bioconjugation services using the company’s ADC facility in Syracuse.Also, in April, the company signed a CDMO contract with a US-based oncology biotech company for antibody drug substance production and process development. Lotte Biologics agreed to support production of antibody materials needed for late-stage global clinical trials and large-scale process optimization at its Syracuse Bio Campus.In May, it also signed an additional antibody drug production contract with the UK biotech company Ottimo Pharma. The agreement expands the scope of cooperation following a contract signed in June last year and includes not only the production of drug substance for Ottimo Pharma’s new drug Jankistomig, but also process development.Lotte Biologics’ next task is how quickly it can convert Songdo Plant 1 into a production facility capable of responding to regulatory inspections and customer audits after use approval. Given the nature of the CDMO business, a new plant cannot secure order competitiveness through physical completion alone. Production equipment qualification, quality operating systems, experience responding to regulatory authorities, and the ability to handle customer technical audits must all be in place.Using the Songdo plant as a smart factory, the company aims to strengthen production efficiency and quality management systems. It also plans to secure process flexibility to respond to diverse production needs from potential global customers. Expansion of production and quality personnel is also being conducted in line with plant operation preparations.Lotte Biologics has previously stated its goal of reaching KRW 1.5 trillion in sales by 2030 and becoming one of the world’s Top 10 CDMO companies. With the visible completion of Songdo Plant 1 and its participation in BIO USA, the company appears to be expanding global customer touchpoints to support that goal.A Lotte Biologics official said, “With the completion of Songdo Bio Campus Plant 1 imminent, we are now able to introduce our competitive production capabilities to potential global customers. Based on our dual-site operating system connecting Syracuse and Songdo, we will further strengthen our global CDMO competitiveness.”
