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- 2026-06-06 11:22:09
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- Boryung loses first trial in Lenvima + Keytruda combo patent dispute
- by Kim, Jin-Gu Apr 30, 2026 08:24am
- Boryung has lost the first trial in a patent dispute over the combination therapy of the liver cancer treatment Lenvima (lenvatinib) and Keytruda (pembrolizumab). Although Boryung had already launched a generic after overcoming listed patents, the latest ruling has left the company facing marketing risks for key indications. To mitigate this risk, the company must now seek a reversal of the ruling by appealing to the Intellectual Property Court.According to industry sources on the 29th, the Intellectual Property Trial and Appeal Board recently issued a ruling of partial dismissal and partial rejection in a passive scope confirmation trial filed by Boryung against Eisai Korea and Merck regarding an unlisted patent (No. 10-2662228) related to the Lenvima + Keytruda combination therapy. The IPTAB also dismissed the invalidation trial request for the same patent.This patent covers the ‘combination of a PD-1 antagonist and a VEGFR/FGFR/RET tyrosine kinase inhibitor for treating cancer.’ Merck and Eisai registered this patent in April 2024. The patent covers the combination therapy of Lenvima and Keytruda for the first-line treatment of advanced endometrial cancer and advanced renal cell carcinoma.Among Lenvima’s indications - ▲ locally recurrent or metastatic progressive differentiated thyroid cancer, ▲first-line treatment for unresectable hepatocellular carcinoma, ▲combination therapy with pembrolizumab for the treatment of patients with advanced endometrial cancer, ▲combination therapy with pembrolizumab as first-line treatment for advanced renal cell carcinoma - this case is related to the 3rd and 4th indications.Industry analysis suggests that Boryung has effectively suffered a decisive defeat in the first-instance trial over the Lenvima + Keytruda combination patent. However, the ruling does not block the sale of Boryung’s Lenvima generic, Lenvanib. Previously, Boryung had bypassed or invalidated all four listed patents for Lenvima except the substance patent, and received marketing approval for Lenvanib in February last year. It then secured reimbursement listing in July and launched the product. Currently, Boryung’s Lenvanib is the only Lenvima generic on the market.However, due to this ruling, Lenvanib can no longer be used to treat advanced endometrial cancer and advanced renal cell carcinoma. This is because if Lenvanib is used for these indications, Boryung could face patent infringement lawsuits from Eisai and Merck.Eisai has already demonstrated a proactive stance in protecting its patent rights, as evidenced by its filing of an active scope confirmation trial regarding the scope of rights during a dispute over another use patent (10-1470653) against Boryung. Although that case concluded with Eisai voluntarily withdrawing its claim following Boryung’s victory in the invalidation trial, had the invalidation trial yielded the opposite result, it could have served as grounds for a patent infringement lawsuit.At present, Lenvima’s core market remains thyroid cancer and hepatocellular carcinoma (indications 1 and 2). However, Boryung’s concerns have grown as Lenvima’s focus in the global market is rapidly shifting toward combination therapy with Keytruda for endometrial cancer and renal cell carcinoma.To resolve this patent risk, Boryung must now decide whether to appeal. Industry observers expect that, given the growing importance of combination therapy in Lenvima’s global revenue mix, Boryung is unlikely to accept the first-instance defeat without a challenge.
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- Generic companies win ‘Jardiance Duo’ unlisted patent 1st instance trial
- by Kim, Jin-Gu Apr 30, 2026 08:24am
- Product photo of Jardiance TabFourteen pharmaceutical companies, including Chong Kun Dang, have won a favorable ruling in a patent dispute regarding unlisted patents for Jardiance Duo (empagliflozin + metformin).Analysis suggests that following their victory in the unlisted patent dispute for the Jardiance monotherapy late last year, this subsequent win for the metformin combination therapy significantly mitigates patent risks for generic products.According to pharmaceutical industry sources on the 29th, the Intellectual Property Trial and Appeal Board (IPTAB) issued a decision on the 28th in favor of the invalidation trial filed by Chong Kun Dang and others against Boehringer Ingelheim regarding the use patent for Jardiance Duo. In addition to Chong Kun Dang, generic companies participating in this trial include Genupharma, Pharmgen Science, Dongkoo Bio & Pharma, Daehan Nupharm, Dongwha Pharm, Young poong Pharmaceutical, Withus Pharmaceutical, JW Pharmaceutical, Medica Korea, Boryung, Aprogen Biologics, Korea Pharma, Hanmi Pharm, and Aju Pharm.This patent is concerning the use patent for the combination therapy of empagliflozin and metformin, which is set to expire in November 2027. Notably, it was not listed in the Ministry of Food and Drug Safety’s (MFDS) patent Green List.Boehringer Ingelheim has registered two listed patents and seven unlisted patents related to Jardiance with the Korean Intellectual Property Office. Generic manufacturers successfully bypassed one of the listed patents in 2019. Based on that ruling, companies challenging the patent obtained generic product licenses and launched their generics in October last year, around the time of the expiration of the substance patent.However, the seven unlisted patents have been analyzed as potential obstacles to the sale of Jardiance generics. While they do not affect product authorization, selling products without overcoming unlisted patents carries the risk of patent infringement litigation.Boehringer Ingelheim’s unlisted patents related to Jardiance include ▲three use patents for empagliflozin single-agent ▲one use patent and one formulation patent for empagliflozin + metformin ▲one use patent for empagliflozin + linagliptin ▲one use patent for the triple combination therapy of empagliflozin + linagliptin + metformin.Korea's fourteen pharmaceutical companies, including Chong Kun Dang, Genupharma, Pharmgen Science, Dongkoo Bio & Pharma, Daehan Nupharm, Dongwha Pharm, Young poong Pharmaceutical, Withus Pharmaceutical, JW Pharmaceutical, Medica Korea, Boryung, Aprogen Biologics, Korea Pharma, Hanmi Pharm, and Aju Pharm have won a favorable ruling in a patent invalidation trial concerning unlisted patents for Jardiance Duo (empagliflozin + metformin).Among these, generic companis, including Genuone Sciences, Chong Kun Dang, Korea Prime Pharm, Boryung, and Huons, successfully invalidated one of the use patents for the Jardiance monotherapy formulation in November last year. Boehringer Ingelheim has appealed to the Patent Court following this first-instance defeat.With the sequential invalidation of the use patents for both the Jardiance monotherapy and the metformin combination product, industry analysts believe generic companies have resolved a substantial portion of the patent risks associated with product sales.However, generic manufacturers have failed to overcome the unlisted use patent for Esglito (empagliflozin + linagliptin). Companies including Genuone Sciences, Boryung, Dongkook Pharm, Medica Korea, Aprogen Biologics, Korea Prime Pharm, Daehwa Pharm, GC Biopharma, and Aju Holdings filed invalidation and passive negative scope confirmation trials against the Esglito patent. These companies received dismissal rulings in February and March of this year, respectively.Additionally, decisions regarding two cases of use patents for Jardiance and one case of formulation patent for Jardiance Duo is pending.
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- Darzalex SC Inj, expansion of three indications approved
- by Eo, Yun-Ho Apr 30, 2026 08:23am
- Product photo of Darzalex SC The application for the subcutaneous (SC) formulation of ‘Darzalex’ is expanding.According to industry sources, Janssen Korea obtained additional approvals from the Ministry of Food and Drug Safety (MFDS) on the 24th for three indications of Darzalex SC (daratumumab) Inj.This drug’s specific indications are ▲combination therapy with bortezomib + lenalidomide + dexamethasone (DVRd) for patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant ▲combination therapy with bortezomib + lenalidomide + dexamethasone (DVRd) for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant ▲combination therapy with pomalidomide + dexamethasone for patients with multiple myeloma who have received at least one prior therapy, including a proteasome inhibitor and lenalidomide.With these indications, Darzalex SC can now be utilized in a variety of ways in combination with ‘Revlimid (lenalidomide).’The newly added indications demonstrated efficacy in various Phase 3 clinical studies, including PERSEUS, CEPHEUS, and APOLLO.In these studies, Darzalex SC met primary endpoints, including progression-free survival (PFS).Meanwhile, Darzalex is the first human monoclonal antibody authorized for multiple myeloma. This drug’s active pharmaceutical ingredient, daratumumab, is designed to recognize and directly bind to CD38, a surface glycoprotein overexpressed on multiple myeloma cells.In January, the light chain (AL) amyloidosis indication for Darzalex SC Inj passed the Health Insurance Review and Assessment Service's (HIRA) Pharmaceutical Reimbursement Evaluation Committee. Currently, this drug is undergoing drug price negotiations with the National Health Insurance Service (NHIS).
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- Capvaxive may be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Apr 29, 2026 03:48pm
- The pneumococcal vaccine ‘Capvaxive’ may be prescribed at general hospitals in Korea.According to industry sources, MSD Korea’s adult-only 21-valent pneumococcal conjugate vaccine Capvaxive has passed the Drug Committees (DC) of medical institutions, including Big 5 tertiary general hospitals such as Seoul National University Hospital and Sinchon Severance Hospital, as well as Kangnam Sacred Heart Hospital, Dongguk University Ilsan Hospital, Sun Medical Center, Seoul National University Bundang Hospital, Bundang Jesaeng Hospital, Andong Hospital, Chonnam National University Hospital, Pohang Semyeong Christianity Hospital, Hallym University Sacred Heart Hospital, and Chonnam National University Hwasun Hospital.Since its official launch in March, it appears to be rapidly establishing a vaccination environment.Capvaxive is an adult-specific 21-valent pneumococcal conjugate vaccine (PCV). In August 2025, it obtained approval from the Ministry of Food and Drug Safety for the prevention of invasive disease and pneumonia caused by serotypes (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) in adults aged 18 and older.The 21 serotypes account for up to 85% of the serotypes causing adult invasive pneumococcal disease (IPD) in the U.S. and about 74% in Korea.In particular, the vaccine newly includes 8 unique serotypes that were not included in any existing vaccine - 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. These serotypes reportedly account for about 30% of IPD in adults aged 65 and older in the U.S.After PCVs were introduced into Korea’s pediatric immunization program, the incidence of IPD in children declined significantly, and a decrease in the incidence of IPD caused by serotypes included in the vaccine has also been observed in adults due to the indirect protective effect of herd immunity among children.However, the incidence of IPD in adults is currently higher than in children, and due to serotype replacement, non-vaccine serotypes account for a significant portion of pneumococcal disease in adults.In particular, despite the very high fatality rate among the elderly aged 65 and older and those with underlying conditions when they contract IPD or pneumonia, there has been no vaccine option specialized for adults. As a result, there has been an unmet need for a tailored vaccine centered on the key serotypes associated with disease burden in adults.In fact, pneumonia ranked as the third leading cause of death in Korea as of 2024 and the leading cause of death among respiratory diseases. As of 2025, 76.9% of pneumococcal infections in Korea were reported to occur in adults aged 50 and older.Meanwhile, in STRIDE-3, Capvaxive’s pivotal clinical study, immunogenicity was assessed 30 days after vaccination in adults aged 18 and older with no previous vaccination experience. Capvaxive met non-inferiority criteria for all 10 serotypes commonly included in PCV20, the comparator. Among the 11 serotypes included only in Capvaxive, 10 met the criteria for immunogenic superiority compared with the comparator.
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- HER2-targeted bispecific Ab 'Ziihera' shows potential in gastric cancers
- by Son, Hyung Min Apr 29, 2026 03:48pm
- 'Ziihera,' approved as a biliary tract cancer, is now confirmed to have clinical potential in upper gastrointestinal cancers, including gastric cancer, accelerating the progress for expanded indications.Based on its dual targeting of HER2, this drug demonstrated a significant improvement in survival compared to existing treatments centered on trastuzumab. Its potential to reorganize the standard first-line treatment has been suggested.HER2-targeted bispecific antibody 'Ziihera' According to industry sources on the 29th, the U.S. Food and Drug Administration (FDA) recently accepted a supplemental Biologics License Application (sBLA) for the expanded indications for Ziihera (zanidatamab) and granted it Priority Review designation. Under the Prescription Drug User Fee Act (PDUFA), the FDA is scheduled to decide on the approval by August 25 of this year.The specific indication is for the first-line treatment of patients with HER2-positive locally advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, and gastroesophageal adenocarcinoma (GEA).Ziihera received accelerated approval in the U.S. in 2024 for the treatment of HER2-positive biliary tract cancer and was subsequently approved in South Korea last March.Ziihera is a new drug developed by the Canadian biopharmaceutical company Zymeworks. Following development, U.S.-based Jazz Pharmaceuticals licensed the development and commercialization rights for the substance from Zymeworks. Under the agreement, BeiGene holds the commercialization rights for Asian regions, including South Korea and China, excluding Japan.Ziihera is a bispecific antibody that binds two distinct sites on the HER2 receptor. It was developed with a mechanism that simultaneously enhances signal blockade and immune response induction compared to existing monoclonal antibodies.Notably, this development strategy highlights the potential for combination with BeiGene’s immunotherapy, Tevimbra (tislelizumab). The approach aims to maximize therapeutic effects by proposing a triplet therapy combining HER2-targeted therapy and immunotherapy.The Phase 3 HERIZON-GEA-01 study, which served as the basis for the Priority Review, enrolled 914 patients with gastric cancer.The clinical trial was designed to compare the efficacy of existing trastuzumab-based treatments with Ziihera-containing combination therapies and to verify the added effect of an immunotherapy combination strategy.Patients were divided into a trastuzumab + chemotherapy group and a Ziihera-containing combination group. Within the Ziihera group, subgroups were formed based on whether Tevimbra was co-administered.The results showed that Ziihera-based treatment reduced the risk of disease progression or death by approximately 35% compared to the existing trastuzumab combination group, raising the median progression-free survival (PFS) to 12.4 months.In particular, the triplet therapy combining Ziihera and Tevimbra lowered the risk of death by 28%, recording a median overall survival (OS) of 26.4 months. However, this OS result did not meet the prespecified statistical significance threshold in the initial interim analysis, and additional analyses are pending.First-line treatment of gastric cancer reeorganized around immunotherapyHER2-targeted therapy in domestic gastric cancer treatment had remained largely unchanged for a long period. Since Herceptin (trastuzumab) was established as a first-line treatment option in 2010, there has been no new treatments to replace it.While successive efforts were made to develop follow-up options in the field of HER2-targeted therapy, most failed to yield meaningful outcomes in clinical trials. Lapatinib-based combination therapies (with paclitaxel or chemotherapy) and multiple HER2 blockade strategies involving 'Kadcyla (trastuzumab emtansine)' and 'Perjeta (pertuzumab)' suffered successive failures in clinical trials for gastric cancer patients.Immunotherapy 'Keytruda'This trend continued for about a decade until it reached a turning point in 2022. With the introduction of Enhertu (trastuzumab deruxtecan) for third-line HER2-positive gastric cancer, a follow-up HER2-targeted treatment option appeared for the first time. However, as the treatment line was limited to the third-line setting, there were limitations in changing the first-line treatment structure.Meanwhile, the treatment paradigm shifted to be reorganized around immunotherapies. Opdivo was introduced as a first-line treatment option soon after obtaining reimbursement for HER2-negative gastric cancer, and immunotherapy combination strategies became standard.Furthermore, Keytruda's scope expanded after obtaining approval as a first-line treatment for metastatic HER2-positive gastric cancer, followed by a recent indication expansion to HER2-negative gastric cancer. In particular, Keytruda was the first immunotherapy to obtain approval for HER2-positive gastric cancer, leading to the establishment of the strategy of combining existing HER2-targeted therapy with immunotherapy.Regarding this, Ziihera is entering the market as a new HER2-targeted option to replace trastuzumab alongside existing immunotherapy combination treatments. This strategy is evaluated as a differentiated approach to existing treatment flows, as Ziihera's strategy aims to replace the HER2-targeted agent in a setting where immunotherapy combinations are the standard.
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- Breast cancer drug 'Itovebi' prescriptions available at gen hospitals
- by Eo, Yun-Ho Apr 28, 2026 09:46am
- The new breast cancer drug 'Itovebi' is now available on the prescription lists of major general hospitals.According to industry sources, Roche Korea’s Itovebi (inavolisib), a treatment for PIK3CA mutation-positive, hormone receptor-positive (HR+), and human epidermal growth factor receptor 2-negative (HER2-) breast cancer, has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, and Asan Medical Center.Approved in South Korea in July last year, the specific indication for Itovebi is 'combination therapy with palbociclib and fulvestrant for adult patients with HR+, HER2-, and PIK3CA mutation-confirmed locally advanced or metastatic breast cancer who recurred during or within 12 months of completing adjuvant endocrine therapy.'However, if a patient has prior experience with CDK4/6 inhibitor treatment as an adjuvant therapy, more than 12 months must have elapsed since the completion of that treatment. For premenopausal women and male patients, an LHRH agonist is used in combination.Hormone receptor-positive breast cancer is the most common type, accounting for approximately 60% of all breast cancers, and it is estimated that about 40% of these cases carry the PIK3CA gene mutation. The activation of the PIK3CA mutation dysregulates the PI3K signaling pathway, often resulting in a poor prognosis, where existing treatments alone struggle to achieve sufficient efficacy.Itovebi demonstrated efficacy in the Phase 3 INAVO120 study. In a trial involving 161 patients with HR+, HER2-, and PIK3CA-mutated locally advanced or metastatic breast cancer, whose disease progressed during or within 12 months of adjuvant endocrine therapy and who had not received prior systemic therapy, the combination therapy of Itovebi with 'Ibrance (palbociclib)' and 'Faslodex (fulvestrant)' demonstrated a significant overall survival (OS) benefit compared to the control group (placebo + palbociclib + fulvestrant).At the median follow-up of 34.2 months, the median overall survival in the Itovebi group was 34 months, reducing the risk of death by 33%. The median progression-free survival (PFS) for the Itovebi group was 17.2 months, more than twice the 7.3 months observed in the control group, and the risk of disease progression or death was reduced by 58%. The objective response rate (ORR) was also more than two-fold higher in the Itovebi treatment group (62.7%) compared with the control group (28%).At the time of the final overall survival analysis, no new safety adverse events were observed, and the low rate of treatment discontinuation due to adverse events supported the drug's excellent tolerability.Professor Seock-Ah Im of the Department of Hemato-Oncology at Seoul National University Hospital stated, "PIK3CA mutation is an area with a significant unmet need for new treatments because it tumor growth and causes rapid disease progression, leading to a poor prognosis."Im added, "Through the INAVO120 study, Itovebi demonstrated a more than twofold extension in PFS compared to the existing standard of care for patients with the PIK3CA mutation, and it is the only PI3K inhibitor to confirm an OS extension."
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- J&J medical device business grows in tandem
- by Hwang, byoung woo Apr 27, 2026 09:03am
- The two companies leading Johnson & Johnson Korea’s medical device business solidified their foothold in the domestic market last year by driving revenue growth.While Johnson & Johnson Medical Korea (J&J Medical) rebounded from negative growth in 2024, Johnson & Johnson Vision Korea (J&J Vision) reaffirmed its robust sales growth trend.‘Medical’ achieves v-shaped rebound… ‘Vision’ shows steady upward trendFirst, looking at J&J Medical’s revenue, sales have fluctuated over the past four years.Revenue, which stood at KRW 280.1 billion in 2022, rose to KRW 301.1 billion in 2023, surpassing the KRW 300 billion mark. However, in 2024, amid changes in the market environment and a temporary adjustment period, revenue fell to KRW 269.8 billion, down about 10.3% year on year.But last year, the Medical division successfully achieved a V-shaped rebound, recording revenue of KRW 301.6 billion, up about 11.7% from the previous year.Operating profit, which had fallen to KRW 13.4 billion in 2024, also showed a clear recovery in 2025, reaching KRW 17.1 billion, indicating improved profitability.By contrast, J&J Vision, established following the spin-off from Johnson & Johnson Korea, continued its upward sales trend and expanded its scale.After posting revenue of about KRW 26.5 billion in 2022, its first year following the business split, which reflected only three months of operations, J&J Vision recorded about KRW 156.5 billion in revenue in the full fiscal year of 2023. It then posted KRW 168.2 billion in 2024 and KRW 176.3 billion in 2025, maintaining stable growth each year.However, for J&J, the increasing burden of cost of goods sold has remained a drawback, as it reduced the quality of profitability despite top-line expansion.Cost of sales, which stood at KRW 81.9 billion in 2024, increased to KRW 110.6 billion in 2025, expanding the cost burden. This appears to have weighed on profitability despite revenue growth.J&J Vision’s SG&A expenses in 2025 were KRW 56.9 billion, down KRW 21 billion from KRW 77.9 billion the previous year. The largest decreases came from advertising and promotion expenses. Advertising expenses fell by KRW 2.2 billion, from KRW 7.9 billion in 2024 to KRW 5.7 billion in 2025, while promotion expenses fell by KRW 28.6 billion, from KRW 45.1 billion in 2024 to KRW 26.5 billion in 2025.Medical expands high-value treatment equipment…targets hospital marketJ&J Medical’s return to sales in the KRW 300 billion range is interpreted as the result of new product launches combined with infrastructure investment.Indeed, J&J MedTech Korea, which handles J&J Medical products, has been expanding its influence by introducing new technologies every year.In April 2024, the orthopedic surgical robot VELYS received domestic approval for total knee arthroplasty. In April and November last year, the company introduced the pulsed field ablation platform VARIPULSE and the ultra-small artificial heart pump Impella CP, respectively.Notably, along with new product approvals, the company opened a training center at its Seoul headquarters at the end of 2024, where Korean healthcare professionals can receive procedural education and training on the company’s latest therapeutic devices, aiming to create synergy.In addition, last year the company also opened the ‘Busan MedTech Lab,’ a procedural training center in Busan, expanding its procedural education infrastructure to regional areas.Changes in sales and revenue share by J&J medical device business entityThrough these two training centers, the company is focusing on increasing touchpoints for Johnson & Johnson MedTech’s flagship surgical medical devices, and these efforts are being analyzed to contribute to revenue growth.At the time, Jin-yong Oh, North Asia Area Managing Director of Johnson & Johnson MedTech, said, “With the opening of the training center, we hope to actively operate procedural education and training based on Johnson & Johnson MedTech Korea’s advanced medical devices and treatment solutions, thereby contributing to improving Korean healthcare professionals’ procedural capabilities. We will continue working to rapidly introduce innovative products to Korea that can help patients live healthier lives.”Ultimately, considering how J&J Medical’s major product groups are in knee replacement and atrial fibrillation, areas where patient numbers continue to rise along with population aging, the influence of high-value, hospital-based equipment is expected to grow further.Premium ophthalmology and lens strategy…profitability put to the testJ&J Vision’s growth trajectory is interpreted as the result of a strategy that maximized expertise in the ophthalmology specialty area, Surgical Vision, and the contact lens business.In particular, premium product lines played a key role by targeting both the increase in cataract patients amid the transition into a super-aged society and demand for vision correction among younger consumers.In fact, with the number of cataract patients in Korea reaching approximately 1.5 million as of 2024, J&J Vision has launched new products as the market shifts toward next-generation multifocal intraocular lenses (IOLs).In September last year, the company introduced TECNIS Odyssey, a next-generation multifocal intraocular lens for cataract surgery, and is actively targeting the market through the product.However, given that contact lenses, another major revenue pillar, are classified as a consumer medical device, the need to address rising cost pressures is expected to grow.Since the company already secured profitability last year by reducing SG&A expenses, its response measures this year are expected to become a key issue.Ultimately, the fact that both Medical and Vision share the challenge of rising cost burdens is likely to act as a variable affecting future performance.This is because Medical faces cost pressures due to its structure centered on high-priced equipment, while Vision is relatively more susceptible to cost fluctuations due to the nature of its contact lens-focused consumer goods business.Ultimately, future performance is expected to hinge not on the sheer scale of sales, but on the company’s ability to expand the share of premium products and manage its cost structure.
- Company
- Generic DOACs take over half of Xarelto mkt
- by Kim, Jin-Gu Apr 27, 2026 09:03am
- The KRW 260 billion direct oral anticoagulant (DOAC) market is seeing rapid generic penetration. Generic share has reached 49% for Xarelto (rivaroxaban) and 25% for Eliquis (apixaban).Industry attention is now focused on Lixiana (edoxaban), whose generics are expected to launch later this year. As the top-prescribed product, its generic entry is expected to reshape the entire DOAC market. Fifteen companies have already received approvals and are waiting to launch.DOAC market at KRW 60.8 billion in Q1…decline since Q3 2024According to market research firm UBIST, outpatient prescriptions in the domestic DOAC market totaled KRW 60.8 billion in Q1.Overall, the market has been declining since Q3 2024, due to patent expirations, generic launches, and the resulting price cuts.Xarelto’s patent expired in Q2 2021. Since then, 65 companies have launched Xarelto generics. These generics have rapidly increased their prescription volume since then. Since Q3 last year, they have maintained a market share of around 49% in the rivaroxaban market. This means that, just over four years after the launch of generics, their market share has expanded to a level comparable to that of the original product.Amid the rapid growth of generics, prescriptions for the original Xarelto have been steadily declining. Q1 prescriptions were KRW 7.2 billion, down 6% YoY, roughly half of the KRW 16.3 billion recorded in Q3 2021.Competition among generic products is also intensifying. As of Q1, Hanmi Pharm’s ‘Riroxban’ took the top spot among generics with prescription sales of KRW 2.2 billion, a 3% increase YoY. In contrast, the products ranked 2nd through 4th—Samjin Pharmaceutical’s ‘Rivoxaban,’ Chong Kun Dang’s ‘Riroxia’ and Daewoong Bio’s ‘Varelto’—all saw prescription sales decline by more than 10%.As competition intensifies, the number of companies withdrawing from the market is also increasing. Last year, 14 products from six companies left the market due to the expiration of their validity periods. This year, market exit appears to be accelerating, with the validity periods of 38 products from 14 companies set to expire.Eliquis generics reach 25% share just a year and a half after re-entryEliquis generics re-entered the market in Q4 2024. The generics were originally launched in June 2019. At the time, generic manufacturers released the products based on favorable rulings in the first and second instances of patent litigation. However, the situation reversed in April 2021 when the Supreme Court overturned the lower court rulings and ruled in favor of the originator, BMS. Generic manufacturers immediately withdrew from the market. This created a three-and-a-half-year gap in the market until the Eliquis composition patent expired last September.Since re-entering the market, Eliquis generics have been gradually increasing their market share. The combined prescription value for Eliquis generics in the first quarter was KRW 3.2 billion, representing a market share of approximately 25% in the apixaban-based DOAC market. This is higher than the market share just before withdrawal (24% in Q1 2021). As of Q1, Chong Kun Dang’s ‘Liquisia’ and Samjin Pharmaceutical’s ‘Elxaban’ recorded KRW 1.4 billion and KRW 1.2 billion, respectively, taking the top two spots among generics. Prescription sales for other products were less than KRW 300 million.In contrast, sales of the original Eliquis fell by 27% from KRW 13.5 billion to KRW 9.8 billion in just one year. Compared to the KRW 20.5 billion recorded in Q3 2024, just before the re-entry of generics, prescription sales have dropped to less than half in just a year and a half.Lixiana, the current market leader, faces patent expiration by the end of this year… DOAC market to be reshaped with the entry of genericsIndustry attention is now focused on the generics of Lixiana, the market leader. Lixiana’s composition patent expires this November. Generic companies have successfully circumvented the remaining patents.Currently, 15 pharmaceutical companies, including Nexpharm Korea, DongKwang Pharm, Dongkook Pharmaceutical, Samsung Pharm, Shinil Pharma, Shinpoong Pharm, Ahngook Pharmaceutical, HK Inno.N, Ildong Pharmaceutical, Genuone Science, Union Korea Pharm, Korea Prime Pharm, Handok, and Hanmi Pharmaceutical, are awaiting the patent expiration with 35 generic product approvals already secured. With a KRW 120 billion market at stake, expectations among generic drug manufacturers are reportedly high.Last year also saw a series of challenges to patents by generic companies. In 2023 alone, about 10 companies, including HLB Pharmaceutical, Daehwa Pharmaceuticals, Austin Pharma, CMG Pharmaceutical, Chong Kun Dang, Huons, Korea United Pharm, NBK Bio Korea Pharm, Myungmoon Pharm, and Boryung, filed patent invalidation suits and won their cases.Challenges to the Lixiana formulation patent were conducted on a large scale in 2018 and concluded with a victory for the generic drug companies. Analysts suggest that a significant number of companies that were unable to avoid the patent at that time subsequently filed patent challenges in order to launch Lixiana generics. The pharmaceutical industry forecasts that about 30 companies, including those that have already received approval, will join the competition.The original Lixiana further expanded its prescription volume ahead of the launch of generics. Lixiana’s prescription sales in Q1 reached KRW 31.8 billion, a 5% increase YoY. This marks the highest quarterly sales figure on record.Lixiana was the last of the DOAC class of drugs to be launched. In South Korea, Xarelto (rivaroxaban) was approved in 2009, followed by Pradaxa (dabigatran) and Eliquis (apixaban) in 2011, then Lixiana in 2015. In the early stages of its launch, Lixiana ranked third in the market, trailing behind Xarelto and Eliquis. However, after partnering with Daewoong Pharmaceutical as its domestic co-promotion partner, it rose to the top of the market in 2019 and has been steadily increasing its prescription volume ever since.
- Company
- Alcon rebounds after a 21% decline in sales
- by Hwang, byoung woo Apr 27, 2026 09:03am
- After a 21.4% decline in sales in 2023, Alcon Korea rebounded within two years, with simultaneous improvements in operating profit and net income.Beyond recovering its external scale, the company appears to have achieved both cost structure restructuring and a business portfolio realignment.2023 inventory optimization and 'selection and concentration'Alcon Korea's sales reached a peak of KRW 261.6 billion in 2022, up from KRW 238.3 billion in 2021, before decreasing by approximately 21.4% to KRW 205.4 billion in 2023.While no direct external factors for the sudden drop in sales are stated, some background can be inferred from changes in the asset structure, such as 'timing of revenue recognition' and 'changes in inventory assets,' as detailed in the indicators.In fact, 'revenue recognized at a point in time (primarily sales of products and goods),' which amounted to KRW 246.2 billion in 2022, dropped to KRW 189.9 billion in 2023.Additionally, purchases of goods decreased significantly from KRW 264.0 billion in 2022 to KRW 163.3 billion in 2023.Accounting treatments for inventory assets also affected gains and losses. In the 2023 audit report's adjustment items for operating cash flow, inventory valuation losses were indicated in parentheses, reflecting them as a reversal. Changes in the allowance for valuation losses on goods are also confirmed in the deferred tax notes.However, since the audit report does not explain this as the result of poor performance in specific items or inventory clearance, the 2023 sales decrease can be interpreted as a phase in which reduced product sales coincided with inventory and channel adjustments.After undergoing this process, sales is rebounding. After bottoming out at KRW 205.4 billion in 2023, sales rebounded to KRW 226.6 billion in 2024 and KRW 234.8 billion in 2025, recovering to 2021 figures.Alcon Korea's 5-Year Sales: After bottoming out at KRW 205.4 billion in 2023, sales rebounded to KRW 226.6 billion in 2024 and KRW 234.8 billion in 2025 (Source: FSS DART, Unit: KRW 100 million)Easing inventory burden while adjusting product salesNotably, profitability indicators improved significantly during the revenue rebound process.Generally, a decrease in revenue leads to lower profits due to fixed costs, but Alcon Korea has shown a trend of maintaining profitability.Looking at the trend in operating profit, the company posted KRW 7.2 billion in 2023, even as sales plummeted, compared to KRW 9.1 billion in 2022.In 2024, when the structural improvement was completed, the company recorded KRW 11.4 billion, a 57% surge from the previous year and the highest operating profit in the last five years, and continued its solid performance with KRW 10.6 billion in 2025.Net income also doubled from KRW 4.1 billion in 2023 to KRW 8.2 billion in 2024, then to KRW 9.1 billion in 2025, demonstrating a robust internal foundation.The factor that had the greatest impact on this profitability improvement was the control of selling, general, and administrative (SG&A) expenses. SG&A expenses, which reached KRW 83.6 billion in 2022, were significantly reduced to KRW 74.3 billion in 2023 and KRW 68.8 billion in 2024.Specifically, the efficiency of marketing expense targeting stands out. Advertising and promotion expenses decreased every year, from KRW 19.8 billion in 2022 to KRW 12.4 billion in 2023, KRW 8.3 billion in 2024, and KRW 7.5 billion in 2025.The fact that sales rebounded after 2024, despite cutting advertising costs by more than half, is considered a positive factor.Alcon Korea's 5-Year Operating Profit & New Income: GREEN-operating profit, BLUE- Net Income (Source: FSS DART, Unit: KRW 100 million)Expansion of the dual-axis portfolio…surgical and vision careAlcon is building an unrivaled eye care ecosystem through its 'Surgical Division,' which handles surgical equipment, and the 'Vision Care Business,' which handles lenses and other products.The biggest driver of the Surgical Division's momentum is 'PersonalEYES,' a comprehensive, personalized vision correction procedure launched in Korea in 2024.This system, which creates a unique 3D virtual eye model for each patient through Sightmap equipment, presented clinical results showing that all patients recovered 1.0 vision and 89% achieved 1.2 vision three months after surgery.Additionally, PanOptix, a trifocal intraocular lens launched in 2015, marks its 10th anniversary and become a major product, surpassing 3 million cumulative global implantations.Wojciech Michalik, Head of Alcon Korea Vision Care BusinessThe Vision Care Business is also steadily expanding its market influence through products such as the large-capacity daily-wear soft contact lens 'Precision1 for Astigmatism WSL & EasyFit,' launched in August last year.In fact, since 2022, the Alcon Korea Vision Care Business has been selected as the 'Alcon Affiliate of the Year' for three consecutive years, a first among Alcon's global branches.Accordingly, former CEO Bang Hyo-jeong, who led the explosive growth of the Korean market, was promoted to Cluster President for Europe, and Wojciech Michalik, a 15-year ophthalmology expert, took office as the new General Manager in 2025 to demonstrate new leadership.Roger Lopez, President of Alcon International Vision Care, stated, "As a global leader in eye care, Alcon strives to help internal talent grow into global leaders, and this personnel appointment reflects that strategic direction."Lopez added, "Based on the leadership and achievements demonstrated by both leaders in their respective regions, we expect them to promote sustainable business in new markets and contribute to further strengthening the capabilities of the International Vision Care Business"
- Company
- Leqembi may be prescribed at major hospitals in Korea
- by Eo, Yun-Ho Apr 27, 2026 09:03am
- The new Alzheimer's drug ‘Leqembi’ has secured prescription access at tertiary general hospitals in Korea.According to industry sources, Eisai Korea's Leqembi (lecanemab) has now been approved by the Drug Committees (DC) of major hospitals nationwide, including the Big 5 medical institutions—Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Severance Hospital in Sinchon—as well as Gachon University Gil Medical Center, Korea University Guro Hospital, Konkuk University Medical Center, Pusan National University Hospital, Busan Paik Hospital, Seoul National University Bundang Hospital, Chonnam National University Hospital, Jeonbuk National University Hospital, and Hallym University Sacred Heart Hospital.Since its domestic launch at the end of 2024, prescriptions have expanded rapidly.Leqembi selectively binds to beta-amyloid (β-amyloid, βA), known to be a causative substance of Alzheimer’s disease, and has been proven to slow disease progression and delay cognitive decline.However, Leqembi is not yet covered by insurance. The annual drug price is approximately KRW 35 million in the U.S. and about KRW 27 million in Japan. It is expected to take considerable time before being listed for reimbursement due to prolonged negotiations between the pharmaceutical company and the government.Leqembi demonstrated statistically significant results in both primary and secondary endpoints in the Clarity AD clinical trial. In particular, the Leqembi treatment group delayed clinical cognitive decline by 27% compared to the placebo group over an 18-month period.However, while the market for amyloid-targeted therapies like Leqembi generally acknowledges their effectiveness in delaying the onset of dementia, the characteristic side effects associated with their use are cited as a major obstacle.Amyloid-Related Imaging Abnormalities (ARIA), which is often cited as a problem, refers to abnormal signals such as brain edema or microhemorrhages detected via MRI following drug administration.Depending on the nature of the side effects, ARIA is classified into “ARIA-E,” characterized by cerebral vascular edema and extravascular extravasation, and “ARIA-H,” characterized by microhemorrhages and hemosiderosis findings.Meanwhile, last year, a special committee composed of 11 members from the Korean Dementia Association established and released domestic guidelines for Leqembi use.The guidelines include specific details on ▲ patient selection criteria ▲ necessary tests and preparations prior to administration ▲ administration methods ▲ monitoring, and management of drug-related adverse reactions ▲ counseling for patients and caregivers.
