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- 2026-06-06 11:22:09
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- Varying performance levels of medical imaging AI companies
- by Hwang, byoung woo May 26, 2026 03:21pm
- AI-generated imageDomestic medical imaging artificial intelligence (AI) companies reported varying performance in their first-quarter results, even as they posted losses.While attention was previously focused on whether these companies could generate any sales during the initial stages of commercialization, the market is now asking "How do these companies make money?"Consequently, the attention is on the Q1 2026 performance is not top-line sales rankings, but rather the specific channels through which sales is generated. Performance divergence among medical imaging AI companies is accelerating, depending on factors such as overseas commercialization channels, integration into domestic institutional healthcare frameworks, and volume-based recurring revenue streams.Positive indicators in overseas·recurring revenue…Lunit·Coreline Soft differentiating factorsLunit recorded revenue of KRW 24.0 billion for the first quarter of 2026, a 25% increase compared to the KRW 19.2 billion recorded in the same period last year. Concurrently, its operating loss narrowed from KRW 20.8 billion to KRW 13.6 billion, demonstrating increased revenue alongside a reduction in losses.The most critical indicator in Lunit’s performance is its overseas revenue. According to the company's Q1 financial data, international sales reached KRW 23.2 billion, a 29% increase from KRW 17.9 billion in the prior-year period, accounting for a 97% of total revenue.Domestic medical AI markets are highly susceptible to institutional and regulatory factors, such as New Medical Technology Assessments, non-reimbursement status, and reimbursement rates. Conversely, Lunit has successfully established a structure in which the vast majority of its quarterly revenue is secured through global distribution channels.By business segment, cancer screening remains the primary growth driver. Software revenue from Lunit's cancer screening segment totaled KRW 21.3 billion in Q1, accounting for approximately 89% of total revenue.Although its cancer treatment decision-support segment, which includes Lunit SCOPE, is emerging as a new growth vector, the core revenue generator as of Q1 2026 remains the cancer screening business, which includes diagnostic imaging assistance and breast cancer screening software.However, challenges persist on the bottom line. While its operating loss narrowed, the company still posted a KRW 13.6 billion deficit in the first quarter. Although an improving trend in profitability has been confirmed, further revenue expansion and disciplined cost management are required to achieve a turnaround to operating profitability.Comparison of 2025-2026 first quarter revenue of major medical imaging artificial intelligence (AI) companies (unit: KRW 100 million/source: quarterly reports). Lunit, Vuno, Deepnoid, Coreline Soft, and JLK.Coreline Soft, while not yet achieving Lunit's massive exterior performance, showed other positive indicators in its revenue structure.Coreline Soft recorded consolidated revenue of KRW 1.3 billion in the first quarter of this year, representing an approximate 44% increase year-over-year.Out of this total, overseas revenue amounted to approximately KRW 800 million, representing 62.4% of its overall business. This was the first time the company's international revenue share has exceeded 50%.The expansion of its recurring revenue stream is also noteworthy. The company announced that the share of recurring revenue derived from volume-based utilization, term licenses, and software maintenance agreements reached 49.1% in Q1, climbing roughly 10 percentage points from 38.9% in the prior-year period.Specifically, volume-based pay-per-use revenue surged by 319.7% year-over-year. This indicates that the business model of medical AI companies is successfully pivoting from one-off, on-premise deployments and perpetual license sales toward a framework dynamically tied to actual utilization rates and diagnostic screening traffic.This structural shift is closely aligned with international national screening initiatives. According to Coreline Soft's documents, the company secured 11 new hospital contracts in Germany during Q1 alone, surpassing its entire annual total of 10 new contracts in Germany for the previous year within a single quarter.Coinciding with Germany’s statutory health insurance reimbursement coverage for low-dose CT (LDCT) lung cancer screening, demand for AI-driven diagnostic reading, quality control, and longitudinal tracking systems is poised for further expansion.Ultimately, Lunit leveraged international revenue to establish a quarterly baseline of over KRW 20 billion, while Coreline Soft signaled a clear structural pivot toward recurring revenue streams despite its smaller absolute volume. The former differentiated itself through scale, and the latter through its business model structure.Vuno shows high reliance on DeepCARS…performance staggers due to regulatory variablesIn the case of Vuno, the company had previously achieved record-high consolidated annual revenue of KRW 34.8 billion last year, growing 35% year-over-year, and successfully narrowed its operating loss by 60% down to KRW 4.9 billion through aggressive cost-optimization initiatives.Performance was led by its flagship product, DeepCARS, an AI-driven cardiac arrest prediction medical device, which generated KRW 25.7 billion in revenue, representing an approximate 18% year-over-year increase.However, its momentum slowed in the first quarter of 2026, with revenue dipping 16% quarter over quarter to KRW 6.0 billion.The company explained that this temporary revenue fluctuation occurred as DeepCARS navigated the New Medical Technology Assessment process, coinciding with the expiration of its assessment deferral window.Vuno’s challenge lies in the high concentration of its core revenue stream in domestic DeepCARS sales.Although Vuno has designated the US commercial launch of DeepCARS as its top strategic priority, a fully realized revenue stream backed by US regulatory clearance and insurance reimbursement has not yet materialized. Consequently, Vuno's Q1 financial performance remained dependent on domestic DeepCARS sales and the progress of the domestic New Medical Technology Assessment procedures.While market expansion is anticipated once the regulatory assessment process is finalized, establishing and diversifying commercial pipelines in global markets remains an urgent, ultimate objective.AI-generated imageDeepnoid·JLK, In a transitional phase prior to scaling revenue volumeDeepnoid generated only KRW 7.5 billion in annual revenue, falling significantly short of its previously guided revenue forecasts.Deepnoid attributed this discrepancy to slower-than-expected expansion in medical AI adoption, delays in securing health insurance reimbursement pricing and international regulatory clearances, and intensifying competition from incumbent PACS (Picture Archiving and Communication System) vendors.Furthermore, Deepnoid disclosed that it halted the standalone commercialization of DEEP:PHI, citing diminished differentiation for platform-type business models following the advent of generative AI.Its revenue for the first quarter of 2026 amounted to approximately KRW 400 million. Even within this figure, the company relied heavily on its industrial AI division (roughly KRW 300 million) rather than its core medical AI segment (which brought in just KRW 57.75 million).As operating deficits widened due to increased fixed costs associated with R&D scaling and expert talent acquisition, the company’s top priority has shifted to proving the self-sustainability of its medical division. This hinges on successfully anchoring its cerebral aneurysm solution, "DEEP:NEURO," within the domestic non-reimbursement market.JLK is actively driving market entry into the non-reimbursement sector for its pipeline expansion, including its large vessel occlusion (LVO) detection solution, "JLK-LVO", starting with the current non-reimbursement prescriptions of its ischemic stroke solution, "JLK-DWI."However, to overcome the limitations of a constrained domestic market, the company is committing substantial capital to establishing international commercial networks via its wholly owned subsidiaries in the United States (JLK USA INC.) and Japan (JLK Japan, Inc.).Both JLK USA and JLK Japan reported zero revenue in the first quarter, posting net losses of approximately KRW 100 million each. Because these international subsidiaries have yet to generate meaningful top-line contributions, the company is currently in a wait-and-see window to determine whether these infrastructure investments will successfully translate into global financial performance.A medical device industry employee stated, "With digital health companies that have secured insurance reimbursement pricing recently reporting robust financial metrics, pressure to perform is intensifying for medical imaging AI firms as well. We have entered a stage where regulatory clearance or initial hospital adoption alone no longer satisfies market evaluation. The core mandate now is establishing a commercial architecture that translates into sustainable, predictable revenue."
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- Will reimbursement of CDK4/6 inhibitors finally be expanded?
- by Eo, Yun-Ho May 26, 2026 03:21pm
- The decisive moment for expanding reimbursement coverage of CDK4/6 inhibitors in early breast cancer is approaching.According to industry sources, Eli Lilly Korea’s Verzenio (abemaciclib) and Novartis Korea’s Kisqali (ribociclib) are expected to be submitted this week to the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee.The specific indication under consideration for reimbursement expansion is “adjuvant therapy for patients with HR-positive (hormone receptor-positive)/HER2-negative stage II and III early breast cancer at high risk of recurrence.”Although the two drugs share the same mechanism of action, their situations differ somewhat. Verzenio is making its fourth attempt before the reimbursement committee, while Kisqali is being reviewed for the first time. The reimbursement expansion application for Kisqali was filed by the pharmaceutical company itself, whereas the application for Verzenio was submitted by the Breast Cancer Subcommittee of the Korean Society of Medical Oncology.Verzenio faced difficulties in being reviewed by CDDC from its first attempt for early breast cancer. After a long wait of 6 months after submitting the reimbursement application, it was finally reviewed by CDDC in May 2023, but the result was “reimbursement criteria not set.” Five months later, in October, Lilly resubmitted the reimbursement application to HIRA, and in March and July last year, it was submitted to CDDC for review, resulting in the same outcomes.The overall survival (OS) data was cited as the primary reason for Verzenio’s failure to secure expanded coverage. However, with Verzenio now securing OS data, expectations are rising for this CDDC review.In contrast, Kisqali, which is making its first attempt, has not yet secured OS data. While an improvement in OS is foreseeable, there is no direct supporting data available yet.Invasive disease-free survival (iDFS) is regarded as a clinically meaningful surrogate endpoint strongly correlated with OS in early breast cancer due to the disease characteristics, and Kisqali demonstrated encouraging results in the NATALEE study.Although the two drugs share the same mechanism, their differing circumstances make it noteworthy to see what outcomes the two drugs will yield at the CDDC review.
- Company
- 10th year of Boksan-Suzuken partnership…"Establishing a platform for mutual growth"
- by Kim, Jin-Gu May 22, 2026 10:25am
- Commemorating the 10th anniversary of their strategic partnership, Boksan Nice and Japan's Suzuken presented the 'redefinition of roles between pharmaceutical companies-wholesalers' and the 'transition to digital distribution platforms' as key strategies to overcome the crisis facing the pharmaceutical industry, which is currently pressured by drug price cuts and market restructuring.On the 21st, Boksan Nice and Suzuken hosted the 'Boksan Nice-Suzuken Partnership 10th Anniversary Seminar' at the Orchid Room of the Westin Josun Seoul. The event brought together executives from both companies and around 80 stakeholders from the pharmaceutical distribution industry.The event was organized to reflect on the decade-long partnership between the two companies and to outline specific future collaboration pathways for pharmaceutical companies and the wholesale sector to achieve mutual growth amid ongoing large-scale drug price reductions and structural inefficiencies in distribution in South Korea. The two companies established their relationship in 2016 when Suzuken made a KRW 52 billion investment in Boksan Nice.In his opening remarks, Boksan Nice Chairman Eom Tae-ung emphasized, "This seminar goes beyond a simple 10th-anniversary celebration; it is a venue to collectively address the rapid changes and future direction facing the pharmaceutical industry and distribution sector today." and added, "As the global weight of marketing and distribution continues to grow, Boksan Nice’s clear direction in this era of selection and concentration is to become a healthy and competitive partner for domestic pharmaceutical companies."Suzuken Chairman Hiromi Miyata introduced the background behind the long-standing trust between the two companies over the past decade. Chairman Miyata stated, "When we entered the Korean market 10 years ago, we conducted interviews and surveys targeting pharmaceutical companies, healthcare institutions, and pharmacies, and Boksan Nice's reputation and credibility were overwhelmingly high," and added, "This deep trust became the decisive factor for our collaboration. Over the last 10 years, we have built a foundation for growth through continuous joint projects and close talent exchange. We will continue to support the growth of Boksan Nice."Boksan Nice Chairman Eom Tae-ung (left) and Suzuken Chairman Hiromi Miyata.Boksan Nice and Suzuken jointly assessed that the pharma-biotech markets and pharmaceutical distribution environments in both Korea and Japan are undergoing profound shifts. In Korea's case, a heightened sense of crisis is escalating due to large-scale drug pricing restructuring.In response to this crisis, Japan's Suzuken proposed a "digital platform" strategy as an alternative solution. Shigeru Asano, Director and Chairman of Suzuken, shared collaboration case studies from the Japanese market, noting, "Amid changing market environments, wholesalers as well as pharmaceutical companies must move beyond simple logistics fulfillment to deliver new value-added functionalities."Chairman Asano identified "Visualization, Connection, and Change" as the core strategies of the Suzuken Group, explaining, "We are currently building a digital-based 'healthcare data platform' that organically links data from medical institutions, healthcare professionals, and the supply chain," and added, "Through this, we will perform an advanced role by supporting the digital marketing efforts of pharmaceutical companies while, in turn, providing a stable infrastructure for pharmaceutical supply."Chairman Eom Seung-wook of Boksan Nice identified fundamental inefficiencies in the domestic pharmaceutical distribution structure and proposed streamlining distribution channels as a solution.Eom diagnosed, "Currently, there are around 4,000 wholesalers in Korea, and the collective market share of the top 10 companies does not exceed 40%," and added, "Consequently, Korean wholesalers have remained in the role of simple delivery vendors until now, and under the pressure of large-scale drug price cuts, the legacy approach is unsustainable for both pharmaceutical companies and wholesalers."Eom proposed a structural division of business as a concrete model for collaboration. He emphasized, "Simplifying distribution channels is no longer an option but an absolute necessity. Roles must be redefined so that pharmaceutical companies can focus entirely on their core operations, such as R&D and manufacturing. At the same time, wholesalers solely handle distribution and operational efficiency," and concluded, "Boksan Nice will become a core partner that substantially contributes to improving the profitability of pharmaceutical companies hit by drug price cuts by eliminating unnecessary costs, expanding market accessibility, and simplifying workflows."
- Company
- HPV prevention expanded to male adolescents
- by Son, Hyung Min May 22, 2026 10:25am
- With the National Immunization Program (NIP) expanding to include male adolescents, Korea’s HPV (human papillomavirus) prevention strategy is shifting from a male-centered approach to a system that prevents HPV in both male and female individuals.Analysts emphasize the significance of this move, noting that while major countries abroad have been implementing simultaneous vaccination for both genders for several years as part of their strategies to reduce HPV-related cancers, Korea has finally established a foundation for vaccinating male adolescents, albeit belatedly.On the 20th, MSD Korea held a media session at Seongam Art Hall in Seoul under the theme “A New Standard for HPV National Immunization: Vaccination for Both Genders.”Starting this month, the Korea Disease Control and Prevention Agency (KDCA) has included 12-year-old male adolescents (born in 2014) in the National HPV Immunization Program. Previously, the program only covered female adolescents aged 12 to 17 and low-income women.This expansion is considered significant because it extends free HPV vaccination, which had been limited to females for the past decade, to include male adolescents. According to the presented materials, the first-dose HPV vaccination rate among male adolescents in Korea stood at just 0.2%. In contrast, rates were 77.7% in Australia, 71.2% in the UK, and 59.0% in the US.HPV is known to be a virus that can infect both men and women. According to the International Papillomavirus Society (IPVS), approximately 5% of all cancer cases worldwide are reported to be related to HPV. While most infections clear up naturally, persistent infection can lead to cervical cancer, vaginal cancer, anal cancer, vulvar cancer, and genital warts.Dong-hyun Kim, Professor of Pediatrics at Inha University HospitalDong-hyun Kim, a professor of pediatrics at Inha University Hospital, stated, “HPV is not just a cervical cancer issue. It is a virus that can also cause anal cancer and genital warts in men. Since it is an infectious disease that affects and spreads among both men and women, it is difficult to approach it with prevention strategies targeting only a specific gender.”According to data from the Korea Disease Control and Prevention Agency, reported HPV cases in Korea increased from 10,945 in 2020 to 14,534 in 2024. In particular, reported cases among men rose 82.9% during the same period, from 117 to 214 cases. A domestic study of men found that approximately 59% tested positive for HPV DNA.Professor Kim cited high reinfection risk and low natural clearance rates as characteristics of HPV infection in men.“HPV is a virus that can infect both men and women, and it is not an issue limited to a specific gender. We need to approach prevention strategies from the perspective of infectious disease, rather than gender.”He continued, “Men often carry the virus asymptomatically, and the rate of natural clearance is known to be slower than in women. This means transmission may continue repeatedly without the person even being aware of it.“Experts recommend 11–12 years of age as the optimal age for HPV vaccination. This is because vaccination before sexual debut ensures high immunogenicity, and the 9–14 age group can expect a sufficient immune response with fewer doses than adults.Professor Kim emphasized that HPV vaccination is not a gender-specific issue, but an infectious disease prevention strategy for both men and women.The quadrivalent HPV vaccine available through the HPV national immunization program is administered in two doses for those aged 9 to 13 (6–12 months apart)In particular, study results showed that two doses administered at ages 9 to 13, when immune responses are active, demonstrated non-inferior immunogenicity (geometric mean antibody titers, GMT) against HPV types 16 and 18 compared with three doses in women aged 16 to 26. This highlights the need to secure preventive effects through early vaccination.Professor Kim said, “When vaccinated before age 15, two doses alone show high immunogenicity compared with three doses in older age groups. It is also meaningful in terms of vaccination convenience because it can be administered at the same time with other vaccines included in the national immunization schedule, such as Tdap and Japanese encephalitis vaccines.”He continued, “Overseas, countries have already set the eradication of cervical cancer as a national goal based on simultaneous vaccination of both men and women. Korea also needs to begin serious discussions on shifting its HPV prevention strategy, starting with this expansion of the NIP to male adolescents.”
- Company
- Reimbursement listing discussions for Vyloy in slow progress
- by Eo, Yun-Ho May 22, 2026 10:25am
- Reimbursement discussions for the gastric cancer-targeted anticancer therapy Vyloy remain sluggish. Therefore, attention is now on whether progress can be made within the first half of the year.According to Dailypharm coverage, Astellas Pharma Korea’s Claudin 18.2-positive gastric cancer targeted therapy Vyloy (zolbetuximab) is expected to be presented to the Pharmacoeconomic Evaluation Subcommittee of the Health Insurance Review and Assessment Service today, on the 21st.Vyloy passed the Cancer Drug Review Committee last October. This means more than 6 months have passed before its submission to the Pharmacoeconomic Evaluation Subcommittee.Vyloy, which was approved in Korea in September 2024, failed to pass the Cancer Drug Review Committee on its first attempt in February last year. However, the company immediately resubmitted the application and succeeded in obtaining a positive result. However, as subsequent procedures are proceeding slowly, it is expected to take even longer to reach a final listing decision.Vyloy is the world’s first approved Claudin 18.2–targeted therapy. It is a monoclonal immunoglobulin antibody that binds to Claudin 18.2, a protein expressed and exposed on gastric cells.According to the Phase III SPOTLIGHT study, which formed the basis for Vyloy's approval, the median progression-free survival (mPFS) for Vyloy combined with mFOLFOX6 (oxaliplatin, leucovorin, fluorouracil) was 10.61 months, exceeding the placebo group’s 8.67 months. Median overall survival (mOS) was also longer at 18.23 months versus 15.54 months.In the GLOW study, the Vyloy plus CAPOX (capecitabine and oxaliplatin) combination group achieved a median progression-free survival of 8.21 months, reducing the risk of disease progression or death by approximately 31%.Professor Sun Young Rha of Yonsei Cancer Center stated, “About 90% of patients with metastatic gastric cancer are HER2-negative, underscoring the urgent need for therapies targeting new biomarkers. Given that about 40% of HER2-negative patients are reported to be Claudin 18.2-positive, the emergence of Vyloy, which selectively binds to Claudin 18.2, presents a new therapeutic option for these patients.”Meanwhile, the Korean Gastric Cancer Association revised its treatment guidelines on January 6, 2025, in the Journal of Gastric Cancer (JGC), granting Vyloy the ‘highest-level’ recommendation as first-line therapy for patients who are HER2-negative and Claudin 18.2-positive.Vyloy has also been listed as a standard treatment option in Japan’s gastric cancer guidelines and the European Society for Medical Oncology (ESMO) clinical practice guidelines. It is included as a preferred regimen in the U.S. NCCN guidelines, rapidly establishing itself as a global standard of care for gastric cancer.
- Company
- Yuhan sets record-breaking deals and exports
- by Chon, Seung-Hyun May 21, 2026 10:16am
- Yuhan Corp’s active pharmaceutical ingredient (API) export business is continuing its strong momentum. The company secured its largest-ever single contract worth over KRW 200 billion. Through supply agreements signed since last year, Yuhan has already secured API export sales approaching KRW 300 billion for this year. As multinational pharmaceutical companies increasingly recognize the quality of Yuhan’s APIs, the company has continued landing major contracts, more than doubling overseas sales compared to five years ago. Yuhan Chemical, which manufactures and supplies the APIs, is also accelerating factory expansion efforts after repeatedly posting record-breaking performances.According to the Financial Supervisory Service on the 20th, Yuhan signed a KRW 210.2 billion API supply agreement with Gilead Sciences. The contract amount corresponds to 9.91% of the company’s recent revenue.The contract period runs from May 19, 2026 through December 31, 2027. Yuhan purchases APIs manufactured by its subsidiary, Yuhan Chemical, and exports them to multinational pharmaceutical companies. Under the structure, Yuhan secures orders from global pharmaceutical firms, while Yuhan Chemical handles the actual production.Yuhan Corp’s main API supply agreements (Source: Financial Supervisory Service) *AI-generated imageThis marks the largest single API export contract in Yuhan’s history. The previous record was a KRW 140 billion antibiotic API supply agreement signed with Wyeth in 2007. Yuhan has now broken its own record for the largest single contract after 19 years.If the supply volume is exhausted within the contract period of one year and seven months, this implies average monthly sales of over KRW 10 billion. Since 2024, Yuhan Corp has secured a series of large-scale API supply agreements. Most of these contracts are with Gilead.In September 2024, Yuhan signed a KRW 107.7 billion HIV treatment API supply agreement with Gilead.Last year alone, Yuhan signed three separate API supply agreements with Gilead totaling KRW 258.1 billion. In May this year, the company also finalized a KRW 56 billion API supply agreement with BridgeBio Pharma. Industry analysts believe repeated large-scale contracts reflect multinational pharmaceutical companies’ confidence in Yuhan’s API quality and stable supply capabilities.All API supply agreements signed since last year are expected to generate revenue this year. A contract signed with Gilead in May last year scheduled KRW 88.8 billion in supplies from May 2025 through December 2026.Another KRW 84.3 billion contract signed in August last year covers supply from March 2026 through February 2027. In addition, a KRW 85 billion HCV treatment API supply agreement signed in August last year will generate sales over a two-year period beginning this May. Assuming supplies proceed as scheduled, Yuhan is expected to secure more than KRW 280 billion in overseas sales this year alone.Yuhan’s overseas business revenue has expanded significantly amid strong API export growth.The company’s overseas business revenue reached KRW 386.5 billion last year, up 26.1% year-on-year. After surpassing KRW 300 billion for the first time in 2024 and setting a new record for the first time in seven years since 2017, the company achieved a second consecutive annual record high. Compared to export sales of KRW 182 billion in 2022, Yuhan’s export revenue more than doubled within three years, reflecting a steep growth trajectory over the past three years.AI-generated imageYuhan recorded export sales in the KRW 200 billion range for four consecutive years from 2016 to 2019, but this dropped to KRW 144.9 billion in 2020. Exports rebounded to KRW 156.2 billion in 2021, up 7.9% year-on-year, and have continued rising for five consecutive years through last year. In the first quarter of this year, overseas business revenue reached KRW 106 billion, up 21.4% from the same period last year, maintaining the upward trend.While overseas operations accounted for only 8.9% of Yuhan’s total revenue in 2020, this share has risen for five consecutive years, reaching 17.7% last year.Yuhan Chemical, which supplies APIs to Yuhan, is also posting strong results.Yuhan Chemical recorded KRW 289.7 billion in sales last year, up 36.5% from KRW 212.3 billion the previous year, while operating profit rose 89.9% year-on-year to KRW 22.9 billion. Operating margin improved by 2.2 percentage points to 7.9%. Compared to sales of KRW 149.5 billion in 2022, last year’s revenue nearly doubled within three years. Operating profit during the same period more than tripled from KRW 6.6 billion.Yuhan Chemical is also accelerating its expansion plans to increase production capacity. In April last year, the company completed the expansion of the HB building at its Hwaseong plant, securing production capacity of 995,000 liters. The facility is equipped with continuous manufacturing systems and data-integrity-based infrastructure, earning recognition for achieving global-level quality competitiveness. This has enabled the company to establish a one-stop response system covering everything from small-scale clinical manufacturing to large-scale commercial production.Additional expansion is also underway. Yuhan Chemical is building an HC facility at the Hwaseong plant with a capacity of 292,000 liters. Construction is scheduled to begin this year, with operations targeted for the first half of 2028. Upon completion, Yuhan Chemical’s total production capacity is expected to expand to 11,287,000 liters. Through this, the company aims to secure manufacturing infrastructure capable of responding to growing global CDMO demand while strengthening its mid- to long-term growth momentum.
- Company
- Samsung Bioepis enters Japanese market with Nipro
- by Hwang, byoung woo May 21, 2026 10:16am
- Samsung Bioepis product image_SB17 JapanSamsung Bioepis has officially entered the Japanese market with the launch of its first biosimilar product in the country.Samsung Bioepis announced on the 20th that it has launched the autoimmune disease treatment ‘SB17’ (active ingredient: ustekinumab) in Japan through its local marketing partner, Nipro Corporation.The product is approved in Japan as ‘Ustekinumab BS 45 mg Syringe for S.C. Injection「NIPRO」.’SB17 referencs Johnson & Johnson’s autoimmune disease treatment Stelara. The therapy works by inhibiting the activity of interleukin-12 and interleukin-23, signaling molecules involved in immune responses. In Japan, the product has been approved for the treatment of plaque psoriasis and psoriatic arthritis.Samsung Bioepis received marketing authorization for SB17 from Japan’s Ministry of Health, Labour and Welfare in December last year. The product was officially launched follosing its listing on Japan’s National Health Insurance reimbursement list on the 19th.The launch carries significance as it marks Samsung Bioepis’ first commercialized biosimilar product in Japan. Last June, the company signed a strategic partnership agreement with Nipro to commercialize multiple biosimilar products in Japan, including its Stelara biosimilar.Samsung Bioepis plans to expand the launch of subsequent biosimilar products in Japan, starting with this SB17 launch.Jin-han Chung, Vice President and Head of Commercial Strategy for International Markets, at Samsung Bioepis. said, “By providing high-quality biosimilar treatment options to patients with autoimmune diseases in Japan, we hope to improve treatment accessibility and will continue to strive to address unmet needs across various therapeutic areas.”Meanwhile, Samsung Bioepis is marketing its Stelara biosimilar under the brand name ‘Pyzchiva’ in Europe and the United States, and ‘Epyztek’ in Korea.
- Company
- BeOne Medicines strengthens clinical-centered role
- by Son, Hyung Min May 21, 2026 10:16am
- BeOne Medicines is accelerating its research through an early-stage clinical-focused anticancer development strategy. As the paradigm of anticancer drug development shifts toward biomarker-based precision medicine, integrated Phase 1/2 development and simultaneous verification of multiple treatment strategies are becoming increasingly common.In particular, the company is strengthening combination therapy strategies and patient-selection-based development from the early stages while also focusing on expanding its domestic clinical network. According to the company, rather than simply competing on development speed, the focus is on rapidly delivering effective therapies while maintaining patient safety and data integrity.On the 19th, BeOne Medicines held a media forum in Gwanghwamun, Seoul under the theme “Latest Trends in Oncology Clinical Research and the Current Status and Outlook of Domestic Clinical Trials.” The event was organized ahead of Clinical Trials Day on the 20th.Presentations highlighted recent changes in oncology clinical research trends, the strengths and challenges of Korea’s clinical trial environment, and the need to expand early-stage clinical research.Eui-kyung Lee, Regional Communication and Patient Engagement Lead at BeOne Medicines, said, “From the company’s founding stage, BeOne Medicines aimed to create a structure that more rapidly and comprehensively connects drug discovery, clinical development, regulatory approval, and commercialization. In fact, since our in-house clinical team directly manages most of our trials, the time required until database lock is approximately 30% faster than the industry averageShe added, “We invest more in clinical research than we generate in sales. Guided by the philosophy that only innovation that reaches patients is true innovation, we are conducting oncology research focused on improving patient accessibility.”According to BeOne Medicines, the company currently has more than 180 ongoing global clinical trials, with over 40 studies already in Phase III or regulatory review stage. Approximately 30,000 patients are participating in these global trials.“Boundary between Phase 1 and 2 Is blurring”…Combination and frontline treatment validation begins earlierHye-sun Kim, Associate Director, Scientific Site Engagement Lead, Clinical operations at BeOne Medicines KoreaHye-sun Kim, Associate Director of Clinical Operations at BeOne Medicines Korea, explained that oncology clinical trials are increasingly moving away from traditional phased development structures.Kim said, “In the past, the process was sequential: determining dose in Phase I, confirming efficacy in Phase II, and then proceeding to confirmatory Phase III trials. Recently, however, integrated Phase I/II designs that simultaneously evaluate multiple patient groups and combination strategies have become increasingly common.”She continued, “While it was previously common to first obtain approval for monotherapy in later-line treatments before moving it to earlier-line settings, the trend is now shifting toward evaluating c combinations involving chemotherapy, immuno-oncology agents, and targeted therapies from the early stages.”She also emphasized the growing importance of biomarkers.Kim stated, “Biomarkers are evolving beyond mere tools for identifying targets to serve as a language that explains outcomes. Today’s clinical trials must simultaneously consider patient selection, risk management, treatment timing, and combination strategies, making their design and operation far more complex than in the past.”She also noted that the rapid expansion of antibody-drug conjugates (ADCs), bispecific antibodies, and multi-target therapies is increasing the burden of clinical trial design.“In the past, therapies targeted a single mechanism, but now development involves simultaneously controlling two or more targets or utilizing immune cells. This is an era in which drug-drug interactions, toxicity management, and optimal dose adjustment all need to be considered.”She added, “Simply moving quickly does not in itself constitute innovation. The key is to rapidly deliver effective treatments to patients who truly need them while maintaining patient safety and data integrity.”Korea’s strength in early-stage clinical trials highlightedJihye Cha, Senior Manager and Scientific Site Engagement Lead at BeOne Medicines KoreaJihye Cha, Senior Manager and Scientific Site Engagement Lead at BeOne Medicines Korea, said Korea still maintains strong competitiveness in the global oncology clinical trial landscape.According to Cha, Korea ranked fourth globally in 2023 and sixth in 2024 in terms of company-sponsored clinical trial registration data, particularly maintaining strength in early-stage clinical trials.Cha said, “Korea’s strengths include rapid patient enrollment, high data reliability, and strong global communication capabilities among investigators. The university hospital-centered healthcare system also enables highly efficient clinical trial execution.”She added, “The direction of global clinical development is shifting beyond simple trial execution toward involvement from the strategic development stage itself. Investigators and institutions, therefore, need to expand their roles in early-stage clinical research.”BeOne Medicines is also accelerating the expansion of early-stage clinical trials in Korea, leveraging the domestic clinical environment.According to the company, it has conducted or is conducting 55 clinical trials domestically, including 20 Phase I, 15 Phase II, and 20 Phase III trials. Currently, 27 studies are ongoing, involving more than 1,300 registered patients in Korea. Solid tumors account for approximately 75% of the company’s domestic clinical portfolio.In particular, various target- and modality-based pipelines beginning with immuno-oncology therapies are entering Korean clinical trials, and key candidates targeting breast cancer, lung cancer, liver cancer, and gynecologic cancers are preparing to advance into subsequent clinical phases.Cha explained, “Over the past three years, we have been one of the companies conducting the largest number of Phase 1 clinical trials in Korea. We are expanding clinical opportunities so that as many investigators and institutions as possible can gain experience with promising novel therapies.”She added, “People sometimes ask why more anticancer drugs are needed when so many already exist, but from the patient perspective, that is absolutely not the case. Even within the same cancer type, biomarkers and treatment responses differ greatly between patients, so more treatment options are still needed.”BeOne Medicines also stated that it is expanding discussions with Korean biotech companies regarding combination therapies and collaborative research.A company representative said, “We have held approximately 30 meetings with Korean biotech companies. We are focusing on systematically expanding domestic R&D synergies primarily through licensing-in opportunities.”
- Company
- The 10th anniversary of 'Tagrisso' approval in Korea
- by Son, Hyung Min May 20, 2026 02:28pm
- As the therapeutic landscape for EGFR-mutated non-small cell lung cancer (NSCLC) shifts toward all-cycle management from early to metastatic stages, AstraZeneca’s 'Tagrisso (osimertinib)' is recognized as a key driver of treatment strategy changes, based on clinical evidence accumulated over the past decade.Industry analysis suggests that by securing clinical data demonstrating not only progression-free survival (PFS) but also overall survival (OS) improvements and reduced post-operative recurrence, the treatment paradigm for EGFR-mutated lung cancer is transitioning from a life-extension focus to expanding curability.Se Hoon Lee, Professor of Hematology-Oncology at Samsung Medical CenterOn May 19, AstraZeneca Korea hosted a press conference at the Plaza Hotel in Jung-gu, Seoul, to commemorate the 10th anniversary of Tagrisso’s approval in South Korea, sharing major global clinical trial outcomes and the future direction of its treatment strategies.Tagrisso was first approved in South Korea in May 2016 as a second-line therapy for patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. This drug received an expanded indication for first-line monotherapy in 2018. In 2021, Tagrisso became the only EGFR tyrosine kinase inhibitor (EGFR-TKI) to secure an indication for adjuvant therapy following complete surgical resection.Furthermore, its indication for combination use with platinum-based chemotherapy, broadening its therapeutic scope in 2024 byCurrently, Tagrisso is the only third-generation EGFR-TKI recommended as a "Preferred" Category 1 option by the National Comprehensive Cancer Network (NCCN) guidelines for both first-line monotherapy and combination chemotherapy regimens. Its application as a post-operative adjuvant therapy also holds a Category 1 recommendation.Se Hoon Lee, Professor of Hematology-Oncology at Samsung Medical Center, said, "The lung cancer targeted therapy paradigm has evolved most rapidly for the EGFR mutation," and added, "With a high prevalence of these mutations among Korean patients and subsequent improvements in survival rates driven by targeted therapies, the outpatient landscape for long-term patient management has fundamentally transformed."Professor Lee added, "The advancement of EGFR-TKIs, including those for Tagrisso, established the benchmark for developing subsequent mutation-targeted strategies in ALK, ROS1, and KRAS." Professor Lee said, "Progression beyond treating metastatic disease to a stage where we aim for a cure in Stage I and II patients is highly meaningful."Ji Yoon Lee, AstraZeneca Korea's Medical Affairs Unit DirectorIndeed, Tagrisso has built clinical evidence across various stages of the disease through major global clinical trials, including FLAURA, FLAURA2, ADAURA, LAURA, and AURA3.In the FLAURA study, Tagrisso became the standard of care by demonstrating both overall survival (OS) and progression-free survival (PFS) benefits in the first-line treatment of advanced NSCLC positive for EGFR Exon 19 deletions or Exon 21 (L858R) mutations.After that, in the FLAURA2 study, the final analysis of Tagrisso combined with platinum-based chemotherapy demonstrated a median OS of 47.5 months. Experts highlighted that the combination also showed a trend toward a reduced risk of death in patients with central nervous system (CNS) metastases compared to the control group.In the ADAURA study, which evaluated post-operative adjuvant therapy, the analysis of the overall patient population with Stages IB to IIIA disease demonstrated a 73% reduction in the risk of disease recurrence or death compared with the control group, highlighting its potential to expand into early-stage treatment.Additionally, the LAURA study reported a statistically significant prolongation of progression-free survival in patients with unresectable Stage III disease, extending the drug's targeted strategy into the locally advanced setting.Ji Yoon Lee, AstraZeneca Korea's Medical Affairs Unit Director, said, "Over the past 10 years, Tagrisso has continuously accumulated core clinical evidence within the global and domestic EGFR-mutated NSCLC treatment landscape," and added, "We will continue our research and development efforts to advance tailored treatment strategies optimized for specific patient characteristics and disease stages."Hyun Ju Lee, AstraZeneca Korea's Oncology Business Unit director, stated, "The 10th anniversary of Tagrisso’s approval in South Korea represents the shifting paradigm of EGFR-mutated lung cancer care. Based on our oncology R&D capabilities and leadership, we will continue to contribute to improving a patient-centric treatment environment."
- Company
- Blincyto enters pricing negotiations as consolidation therapy
- by Eo, Yun-Ho May 19, 2026 11:08am
- The blood cancer treatment ‘Blincyto’ has entered the final stage of the process to expand its health insurance coverage in Korea.According to industry sources, Amgen Korea recently began drug price negotiations with the National Health Insurance Service regarding reimbursement for Blincyto (blinatumomab) as consolidation therapy for precursor B-cell acute lymphoblastic leukemia (ALL).The indication, which received expanded approval in Korea in February 2025, previously passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in April.Patients with Philadelphia chromosome-negative (Ph-) precursor B-cell ALL frequently experience relapse even after achieving minimal residual disease (MRD)-negative status through conventional chemotherapy-based induction therapy, and continue to face challenges with long-term survival even after hematopoietic stem cell transplantation, indicating a significant unmet medical need.Blincyto’s consolidation therapy indication demonstrated efficacy through the E1910, AALL1731, AALL1331, and 20120215 studies.In the E1910 study, which compared chemotherapy alone versus alternating Blincyto and chemotherapy as post-induction consolidation therapy in adult precursor B-cell ALL patients, the 3-year overall survival (OS) rate among MRD-negative patients was 85% in the Blincyto-plus-chemotherapy alternating group, compared to 68% in the chemotherapy-alone group.Compared with chemotherapy alone, the Blincyto-plus-chemotherapy alternating group showed a 59% reduction in risk of death over a median follow-up period of 43 months.In addition, the 3-year recurrence-free survival (RFS) rate was 80% in the Blincyto-plus-chemotherapy alternating group versus 64% in the chemotherapy-alone group, representing a 47% reduction in the risk of recurrence or death over a median follow-up of 43 months.Furthermore, results from the AALL1731 study involving MRD-negative pediatric precursor B-cell ALL patients in the National Cancer Institute (NCI) standard-risk (SR) category at average or high risk of relapse showed that the estimated 3-year disease-free survival rate at a median follow-up of 2.5 years was 96.0% in the Blincyto-plus-chemotherapy alternating group, s a significant improvement compared to 87.9% in the chemotherapy-alone group.Meanwhile, the ‘2024 National Comprehensive Cancer Network (NCCN) Guidelines’ recommend a regimen that includes Blincyto as first-line consolidation therapy.
