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- 2026-04-20 23:21:47
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- Amgen’s BiTE platform to become a pillar of solid tumor strategy
- by Son, Hyung Min Apr 20, 2026 04:58pm
- Bispecific antibody-based immuno-oncology platforms are expanding beyond hematologic malignancies into solid tumors, emerging as a new axis of treatment strategy transformation.Amgen is rapidly expanding its position as a next-generation immuno-oncology strategy by broadening the application scope of its ‘BiTE (Bispecific T-cell Engager)’ technology based on a research and development system that combines genetics and artificial intelligence (AI).Meejin Cho, Hematology-Oncology TA Lead, Medical Affairs, Amgen KoreaOn the 17th, Amgen Korea held a media session at its Seoul headquarters under the theme “AMGEN INNOVATION TALK BiTE – Innovation Driving Changes in Patient Treatment,” and unveiled its R&D strategy and direction for BiTE platform expansion.Under its mission of “To Serve Patients,” Amgen has been developing treatment options in areas of serious diseases such as cancer, cardiovascular disease, inflammation, and rare diseases. Recently, the company has been focusing on simultaneously enhancing the precision and speed of new drug development by integrating AI technology based on its understanding of human genetics and disease biology.The R&D strategy is structured around three pillars: ▲identifying the root causes of diseases and discovering new targets, ▲developing diverse treatment modalities, and ▲innovating clinical trial design.These strategies are being implemented in actual research processes. Amgen uses large-scale genetic data accumulated through its subsidiary deCODE Genetics to analyze disease causes and treatment responses with high precision. In addition, it applies the AI platform ‘Freyja,’ developed in collaboration with NVIDIA, to predict the probability of success of candidate substances in advance, thereby improving development efficiency.The use of AI is also expanding in the clinical stage. By analyzing real-world patient data through its proprietary machine learning model ‘ATOMIC’ and identifying institutions with a high likelihood of participating in clinical trials, the company claims to have increased patient recruitment speed by approximately threefold compared to previous methods. This directly contributes to shortening the drug development timeline and improving patient access.On this foundation, Amgen’s core platform is BiTE. BiTE is a bispecific antibody-based immuno-oncology platform that enables a patient’s immune T cells to directly recognize and attack cancer cells.Cancer cells evade immune surveillance through various mechanisms. While existing immune checkpoint inhibitors restore T-cell activity by blocking the PD-1/PD-L1 binding, BiTE represents a more advanced approach.In some cancers, cells evade T-cell recognition by reducing MHC class I expression, but BiTE bypasses this limitation. Its structure allows it to bind simultaneously to the T-cell’s CD3 and the target antigen on the cancer cell, thereby inducing immune cells to directly attack cancer cells without relying on the TCR-MHC class I recognition process.In other words, unlike previous approaches that only activated immune responses, BiTE physically connects T cells and cancer cells, inducing immediate cell death.Based on these mechanistic strengths, BiTE is expanding its application across various cancer types and has already proven its clinical value in hematologic malignancies.‘Blincyto (blinatumomab),’ a treatment for acute lymphoblastic leukemia (ALL), induces anti-cancer effects by linking CD19-positive B cells and T cells and has demonstrated improved survival compared to existing treatments. Based on this evidence, it is recommended as first-line consolidation therapy in the NCCN guidelines.Building on this success, Amgen is expanding the application of BiTE technology to solid tumors. A prime example is “Imdelltra (tarlatamab),” a treatment for extensive-stage small cell lung cancer.Small-cell lung cancer is a disease with rapid progression and high recurrence rates, representing an area of significant unmet medical need. Imdelltra is a BiTE-based therapy that targets DLL3 to induce T cells to directly attack cancer cells.Clinical results have also demonstrated meaningful outcomes. In patients whose disease progressed after receiving at least two prior treatments, including platinum-based chemotherapy, Imdelltra achieved an objective response rate of approximately 40% and a median overall survival (mOS) of 14.3 months. In the Asian patient population, this was extended to 19 months.Based on these data, Imdelltra was approved in the United States in 2024 and recommended as a subsequent therapy (Category 1) in NCCN guidelines. In Korea, it has been designated as a Global Innovative product on Fast Track (GIFT) and approved, with reimbursement procedures currently underway.The emergence of Imdelltra is evaluated as a turning point in small cell lung cancer treatment, which has seen little change over the past 30 years.Meejin Cho, Hematology-Oncology TA Lead at Amgen Korea, explained, “BiTE is particularly effective in diseases with clear target antigens and rapid progression. Expanding from ALL to small cell lung cancer, which has a clear target, DLL3, is an extension of this strategy.”She added, “Among our current pipeline, we view prostate cancer as the area closest to commercialization. We will continue to expand our scope of application, focusing on cancer types with high unmet medical needs.”
- Company
- GE HealthCare rebounded with 300B won sales last year
- by Hwang, byoung woo Apr 20, 2026 04:58pm
- GE HealthCare, which is pushing for an "Integrated Precision Healthcare" that combines hardware with digital solutions, successfully led a sales rebound last year.Following the medical-government conflict that hit the industry in 2024, the expansion of communication with hospitals and clinics in South Korea via digital platforms is cited as a key factor in improving performance.After the 2024 medical-government crisis…V-shaped rebound in one year According to recently released audit reports, GE HealthCare Korea's sales in 2025 reached KRW 317.1 billion, a 14.9% increase from KRW 275.8 billion the previous year.After sales dropped 6.8% in 2024 to KRW 295.9 billion from 2023, the company quickly surpassed the KRW 300 billion the following year, signaling a significant recovery.Operating profit also increased by 13.4%, from KRW 16.86 billion in 2024 to KRW 19.13 billion in 2025. During the same period, net income rose from KRW 14.57 billion to KRW 17.09 billion. However, the operating profit margin remained stable at around 6.0% (6.1% in 2023, 6.1% in 2024, and 6.0% in 2025), indicating steady maintenance rather than a drastic improvement in profitability.GE HealthCare Korea's 4-Year Sales & Operating Profits: GE HealthCare Korea's sales in 2025 reached KRW 317.1 billion. Source: FSS DART, unit: KRW 100 million (Audit report re-graphed by Daily Pharm)As the medical-government conflict issues gradually resolve, the company's efforts to strengthen capabilities and improve its internal structure have been proven through these figures, suggesting a structural rebound rather than a simple recovery.In 2024, the decline in sales was largely due to a decrease in product sale, which dropped from KRW 193.8 billion to KRW 170.8 billion.In contrast, service sales increased from KRW 102.1 billion to KRW 104.9 billion during the same period, acting as a buffer while equipment sales were shaken.In 2025, both products and services rebounded simultaneously. Product sales reached KRW 203.9 billion, and service sales rose to KRW 113.2 billion.GE HealthCare Korea's Product Sales & Service Sales Ratio: GREEN-product sales, BLUE-service sales. Source: FSS DART, Unit: KRW 100 million. (Audit report re-graphed by Daily Pharm)GE HealthCare strengthens platform strategy…Expanding hospital collaborationsGE HealthCare is shifting its weight from a structure centered on equipment sales to a platform-based strategy.The core of this is the 'D3 Strategy,' which encompasses Device, Disease, and Digital. It aims to use AI to improve quality, support customized treatment, and ultimately integrate data into a cloud-based platform.Globally, GE HealthCare has obtained FDA clearance for 100 AI-enabled medical devices, setting a record for the most listings in four consecutive years.A representative technology, 'AIR Recon DL,' which offers both reduced MRI scan times and improved image quality, has been introduced to more than 20 medical institutions in Korea.SPI index displayed on the CARESCAPE CanvasAdditionally, in February, the Surgical Pleth Index (SPI), a monitoring indicator that quantifies pain responses during surgery, was listed as a "New Medical Technology." This expanded the company's presence beyond imaging into the operating room and patient monitoring sectors.The technology portfolio is shifting from simple imaging equipment to clinical decision-support tools.Consequently, partnerships with major hospitals are expanding beyond simple supply contracts into a system of "Reference Sites" and cooperative hospital networks.For example, Dongtan City Hospital was designated as an Asian regional reference site in January. Its AI Radiology Center serves as a hub where customers from Korea, ASEAN, Australia, and New Zealand can refer to operational cases.Gumi Gangdong Hospital signed an MOU for clinical cooperation and equipment operational efficiency. Daegu Miracle Women's Clinic is partnering to advance infertility treatment based on high-end ultrasound technology.These structures integrates everything from equipment supply to operational training, protocol sharing, and the expansion of clinical utilization into a single package.Yong-duck Kim, President & CEO of GE HealthCare Korea, stated, "The designation of Dongtan City Hospital as an Asian regional reference site signifies that the equipment operation and clinical environment of medical institutions in South Korea have been recognized as excellent global reference cases," and added, "GE HealthCare will continue to actively support Dongtan City Hospital in maintaining efficient and stable equipment operation and building a sustainable medical environment."
- Company
- Pfizer Korea’s dividend returns to ₩12.48 million
- by Chon, Seung-Hyun Apr 20, 2026 04:58pm
- Pfizer Korea paid a dividend of KRW 12.48 million to its parent company last year. While the company paid KRW 160 billion in dividends in 2023 and 2024 as earnings surged due to pandemic-related benefits, it returned to its “20% of preferred stock capital” dividend policy after 3 years, resulting in a dividend payout ratio of just 0.06%.According to the Financial Supervisory Service on the 18th, Pfizer Korea’s dividends paid to its parent company last year totaled KRW 12.48 million. The dividend payout ratio was 0.06%. This means that only 0.06% of last year’s net profit of KRW 19.8 billion was distributed to the parent company.Pfizer Korea’s dividend for last year was reduced by 99.98% compared to the previous year’s KRW 60.01 billion. In 2023, Pfizer Korea paid out KRW 100.012 billion in dividends. This is the first time in 3 years, since 2022, that Pfizer Korea has set its dividend at KRW 12.48 million.Pfizer Korea’s annual revenue (left) and operating profit (right) (Unit: KRW 100 million, Source: Financial Supervisory Service)Pfizer Korea’s largest shareholder is Pfizer’s Dutch subsidiary, ‘PF OFG South Korea 1 B.V.’, which holds a 99.99% stake.Pfizer Korea has maintained a unique dividend policy of keeping the annual dividend at KRW 12.48 million. From 2018 to 2022, it paid the same dividend of KRW 12.48 million for 5 consecutive years.Pfizer Korea calculated the dividend by applying a 20% dividend payout ratio to the preferred stock capital. Pfizer Korea’s total capital stock is KRW 922.92 million. Of this, common stock (172,104 shares) accounts for KRW 860.52 million, and preferred stock (12,480 shares) accounts for KRW 62.40 million. A dividend of KRW 12.48 million , 20% of the KRW 62.40 million in preferred stock capital, was set.The high dividends in 2023 and 2024 are analyzed as a result of significantly improved performance during the COVID-19 pandemic.Pfizer Korea recorded revenue of KRW 391.9 billion in 2020, which increased more than fourfold to KRW 1.694 trillion in 2021, and surged to KRW 3.2254 trillion in 2022, marking more than an eightfold increase over two years. Revenue in 2023 decreased to KRW 1.6018 trillion, about half of the previous year, but this figure is still more than four times higher than in 2020.Pfizer Korea recorded an operating loss of KRW 7.2 billion and a net loss of KRW 21.2 billion in 2020, but in 2022, operating profit and net profit reached KRW 120.1 billion and KRW 119.5 billion, respectively. In 2023, operating profit was KRW 59.2 billion and net profit was KRW 84.9 billion.Pfizer partnered with Germany’s BioNTech in March 2020, when COVID-19 began spreading globally, to develop an mRNA vaccine. The combination of BioNTech’s mRNA technology and Pfizer’s extensive global clinical experience created synergy.Pfizer successfully developed the Comirnaty vaccine with 95% efficacy in less than a year after the outbreak. It received emergency use authorization from the U.S. FDA in December 2020 and was approved in Korea in March of the following year, leading to full-scale supply through its Korean subsidiary. Pfizer also successfully developed the COVID-19 treatment Paxlovid, which the Korean government procured and used.In 2023 and 2024, annual dividends were maintained at KRW 12.48 million, but interim dividends of KRW 100 billion and KRW 60 billion were additionally paid, respectively. Dividend payout ratios reached 117.76% and 168.17% for 2023 and 2024.As performance declined after the COVID-19 pandemic phase, the company appears to have returned to its previous dividend policy. Pfizer Korea’s revenue in 2024 was KRW 783.7 billion, down 75.7% from two years prior, and operating profit decreased by 77.4% from KRW 120.1 billion to KRW 27.2 billion. Last year’s revenue and operating profit were KRW 586.1 billion and KRW 6 billion, respectively, decreasing by 25.2% and 77.9% year-on-year. Compared to 2022, revenue dropped by 81.9% and operating profit by 95.0%Over the past 20 years since 2005, Pfizer Korea has paid dividends of KRW 12.48 million based on the “20% preferred stock” rule in all but four years.In 2017, the dividend was set at KRW 79.794 billion, exceeding net profit. At the time, both common and preferred shares had a dividend rate of 660% of par value, increasing the total payout. In 2008, a dividend of KRW 190 billion was set. Despite recording a loss of KRW 600 million that year, the company set a dividend payout ratio of 3,045% relative to par value.
- Company
- 'Fruzaqla' passes the Cancer Disease Review Committee
- by Eo, Yun-Ho Apr 20, 2026 04:58pm
- Product photo of FruzaqlaInterest is drawn to the health insurance reimbursement listing process for 'Fruzaqla,' a new treatment for colorectal cancer.According to industry sources, Takeda Pharmaceuticals Korea's Fruzaqla (fruquintinib), a colorectal cancer treatment that selectively inhibits Vascular Endothelial Growth Factor Receptor (VEGFR) 1, 2, and 3, is currently under discussion at the subcommittee level. This drug passed the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA) last March.It is to be seen whether Fruzaqla will pass the Pharmaceutical Reimbursement Evaluation Committee, the final hurdle at the HIRA stage, this year to become a standard treatment option for colorectal cancer.Approved in South Korea in March of last year, Fruzaqla is an innovative anti-cancer drug previously designated as both an Orphan Drug and the item for the Global Innovative products on Fast Track (GIFT) program.The specific indication for this drug is: "The treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy."Currently, Fruzaqla remains a non-reimbursed drug. Takeda submitted an application for reimbursement to the health authorities last year and is currently proceeding through the listing steps. It remains to be seen if Fruzaqla will successfully secure reimbursement to allow for seamless prescribing to patients.The clinical utility of Fruzaqla was confirmed through the FRESCO and FRESCO-2 Phase 3 studies.Results from these trials demonstrated that Fruzaqla extended the median overall survival (mOS) to 9.3 months in previously treated metastatic colorectal cancer patients, a 2.7-month increase compared to the placebo group. Furthermore, it reduced the risk of death by 35%.In addition to its clinical efficacy, Fruzaqla is an oral medication taken once daily without complex dietary restrictions. This convenience is expected to have a positive impact on patients' quality of life alongside its therapeutic effects.Professor Dong-hoe Koo of the Department of Oncology at Kangbuk Samsung Hospital stated, "Fruzaqla has high drug specificity because it does not target unnecessary receptors. This allows for efficient VEGFR inhibition and continuous drug exposure. Its potential for combination therapy with existing agents is also worth evaluating in future clinical settings."Meanwhile, colorectal cancer refers to malignant tumors occurring in the colon and rectum, categorized into colon cancer or rectal cancer depending on the location. Metastatic colorectal cancer (mCRC) occurs when the tumor spreads beyond the primary site to invade other organs.As of 2022, the incidence rate of colorectal cancer in South Korea was 61.1 per 100,000 people, ranking second to thyroid cancer. Notably, the incidence rate among the younger population aged 40 and under stands at 12.9 per 100,000, the highest in the world. It poses a serious public health situation.
- Company
- Multinational pharma employees in Korea earn over ₩100M on average
- by Son, Hyung Min Apr 20, 2026 04:58pm
- Last year, the average annual salary of employees at Korean subsidiaries of major multinational pharmaceutical companies exceeded KRW 100 million. Boehringer Ingelheim Korea and Viatris Korea were found to have average salaries reaching KRW 150 million.According to an analysis of audit reports from 27 multinational pharmaceutical subsidiaries disclosed by the Financial Supervisory Service, the average employee salary was KRW 114.37 million. Of these, 21 companies paid average annual salaries of KRW 100 million or more, indicating that a high-salary structure has spread across the industry.This average salary was calculated based only on salary items listed in audit reports, excluding welfare benefits, bonuses, incentives, or retirement benefits. Additionally, there may be some discrepancy between this figure and the actual perceived annual salary due to differences in accounting treatment of labor costs across companies.Among the companies surveyed, Boehringer Ingelheim Korea recorded the highest average salary. The company paid a total of KRW 24.94 billion in salaries last year, an 8.8% increase year-over-year. The average salary per employee rose from KRW 139.8 million in 2024 to KRW 157.86 million last year, an increase of KRW 18.06 million.Viatris Korea ranked second with KRW 145.26 million per employee. This represents an increase of approximately KRW 10 million compared to the previous year’s average of KRW 135.87 million. The company’s total payroll for last year was KRW 13.28 billion, a 14.5% increase from 2023.Gilead Sciences Korea paid an average of KRW 139.94 million per employee, slightly down from KRW 141.32 million in 2024. Total salary payments decreased by 2.4% to KRW 12.97 billion.Pfizer Korea’s average salary was KRW 127.42 million, about KRW 1 million higher than in 2023.However, total salary expenses fell 6.3% to KRW 47.78 billion. This increase in the average annual salary per employee is attributed to a decline in the number of employees from 404 in 2024 to 375 last year.Pfizer has operated a voluntary retirement program since the end of the pandemic. Severance pay, which serves as a form of compensation, surged by 202.0% from KRW 5.33billion in 2024 to KRW 16.11 billion last year, reflecting changes in the labor cost structure.In addition, Sanofi-Aventis Korea, GSK, Ferring Korea, UCB Korea, Amgen Korea, Janssen Korea, Novo Nordisk, AbbVie Korea, Lundbeck Korea, Abbott Korea, Galderma Korea, AstraZeneca Korea, Handok Teva, and Servier Korea all paid employee salaries exceeding KRW 100 million.Merck Korea’s total salary rose to KRW 45.38 billion, an 8.2% increase from KRW 41.96 billion in 2024. However, the average annual salary per employee was KRW 80.96 million, a 7.2% decrease from the KRW 87.2 million in the previous year. This decrease in the average per-employee figure was due to the increase in the number of employees from 481 to 579.For BMS Korea, both total salary and retirement benefit expenses increased. The company’s total salary last year amounted to KRW 24.9 billion, an 8.4% increase from the previous year. During the same period, retirement benefit expenses rose by 169.4%, from KRW 3.3 billion to KRW 8.8 billion.BMS Korea implemented an ERP program for some employees last year. Consequently, the number of employees reported in the audit report decreased slightly from 209 to 190. The company’s average annual salary for executives and employees was KRW 130.58 million last year, ranking fifth among the surveyed companies.
- Company
- Nucala Autoinjector soon to be reimbursed
- by Eo, Yun-Ho Apr 17, 2026 09:03am
- The self-injectable formulation of the antibody therapy Nucala is expected to be included in the insurance reimbursement system in Korea.According to Dailypharm coverage, GSK Korea has recently reached a final agreement on price negotiations with the National Health Insurance Service for the Nucala autoinjector (mepolizumab).This drug accepted the condition of “accepting a price below the evaluation amount” proposed by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in January and entered price negotiations in March.Since the Nucala Autoinjector has additional indications compared to the existing Nucala, its reimbursement listing process was conducted in a manner equivalent to that for a new drug. rather than a formulation addition.Nucala Autoinjector, which received domestic approval in March of last year, was launched as a non-reimbursed product in November of the same year after securing distribution channels and supply volume.It remains to be seen whether Nucala, which has established a foothold in the eosinophilic asthma market, will be able to expand its influence with the launch of this new formulation and successful reimbursement.The new autoinjector formulation has expanded its indications beyond the existing treatment of severe eosinophilic asthma in adults and adolescents (aged 12 and older) to include ▲ eosinophilic granulomatosis with polyangiitis (EGPA) in adults and ▲ hypereosinophilic syndrome (HES) in adults.This drug is a self-administered injectable used for the treatment of eosinophilic diseases. It is used as an add-on maintenance therapy for severe eosinophilic asthma (SEA) in adolescents and adults aged 12 years and older, as well as for eosinophilic granulomatosis with polyangiitis (EGPA) in adults and hypereosinophilic syndrome (HES) in adults (excluding FIP1L1-PDGFRα-positive patients).The autoinjector formulation allows patients to conveniently administer the drug themselves at home, featuring a self-administration success rate of over 96%, high patient preference, and ease of use.Meanwhile, Nucala is poised to enhance its competitiveness by securing an indication for chronic obstructive pulmonary disease (COPD). In May, the drug received additional approval from the U.S. FDA for ‘add-on maintenance therapy for adult patients with COPD with an eosinophilic phenotype.’This approval was based on the results of the Phase III MATINEE and METREX studies. In these studies, among a broad spectrum of COPD patients with an eosinophilic phenotype, the Nucala treatment group showed a significantly lower annual rate of moderate-to-severe exacerbations compared to the placebo group.
- Company
- Novartis Korea wins nod for oral urticaria drug 'Rhapsido'
- by Son, Hyung Min Apr 16, 2026 02:26pm
- Rhapsido (remibrutinib)Novartis Korea (CEO Yoo Byung-jae) announced on the 14th that 'Rhapsido (remibrutinib),' the first oral BTK inhibitor for the treatment of chronic urticaria, has received domestic approval in South Korea for the treatment of adult patients with Chronic Spontaneous Urticaria (CSU) whose symptoms are inadequately controlled by second-generation antihistamines.Rhapsido is an oral inhibitor that targets Bruton's Tyrosine Kinase (BTK).In the mast cell-activating process of CSU, BTK in mast cells triggers the release of inflammatory mediators, such as histamine, leading to symptoms including hives, angioedema, and itching.By highly selectively inhibiting BTK, Rhapsido blocks the secretion of these inflammatory mediators at an early stage.While conventional antihistamines treat the condition after histamine and other substances have already been released from mast cells, Rhapsido's strategy is to prevent their secretion from the start.The approval was based on results from the global Phase 3 clinical trials, 'REMIX-1' and 'REMIX-2.' Both studies were multicenter, randomized, double-blind, placebo-controlled studies evaluating the efficacy and safety of Rhapsido in patients aged 18 and older with CSU inadequately controlled by H1-antihistamines.Based on the study results, Rhapsido significantly improved the primary endpoint, which was the weekly Urticaria Activity Score (UAS7) at week 12 compared to the baseline. This result remained consistent through week 24.By week 12, symptom improvement (UAS7 ≥ 10.5 reduction) was confirmed, with approximately 47–50% of patients achieving well-controlled status (UAS7 ≤ 6) and 28–31% experiencing complete symptom resolution (UAS7 = 0).A 52-week long-term analysis showed that approximately 62% of patients maintained symptom control (UAS7 ≤ 6), while 45% maintained complete symptom resolution (UAS7 = 0).The incidence of adverse events was similar between the Rhapsido group (64.9%) and the placebo group (64.7%), with most reactions being mild to moderate. This safety profile remained consistent throughout the 52-week treatment period.Based on this clinical evidence, Rhapsido is recommended as an oral targeted therapy in the 2026 International Guideline for Urticaria for patients who are not adequately controlled despite increasing the dosage of second-generation antihistamines to 4 times the standard dose.While antihistamines are widely used as first-line therapy, it is reported that symptoms persist in more than half of patients even with increased doses. Rhapsido addresses this significant unmet need as the first approved oral targeted therapy, offering rapid and significant symptom improvement along with the convenience of oral administration.Professor Young-min Ye of the Department of Allergy and Clinical Immunology at Ajou University Hospital stated, "The introduction of a new mechanism of action targeting BTK is clinically significant because it offers hope for efficacy across a broader range of patients, regardless of the immunological variations in the pathogenesis of urticaria," and added, "It is particularly noteworthy that the treatment effect appears within one week and is sustained for up to 52 weeks." Furthermore, Ye added, "It is important to consider proactive treatment aimed at 'rapid and complete symptom management' by consulting with experts."Park Joo-young, Executive Director of the Immunology Business Unit at Novartis Korea, stated, "CSU is a disease where symptoms recur unpredictably, placing a heavy burden on patients, especially those in socially and economically active age groups. The approval of Rhapsido marks a major turning point by providing a new treatment option for those who could not achieve sufficient symptom control with existing therapies." In conclusion, Park added, "Based on our expertise in the field of immunological diseases, Novartis Korea will continue to play a role in ensuring that CSU patients can plan their lives without the frustration of treatment failure."
- Company
- Truqap targets the treatment gap in second-line breast cancer
- by Son, Hyung Min Apr 16, 2026 02:26pm
- As the treatment gap after CDK4/6 inhibitors persists in HR+/HER2- metastatic breast cancer, precision treatment strategies targeting genetic mutations are emerging as a new alternative.In particular, the AKT inhibitor Truqap (capivasertib) continues to gain global guideline recommendations and expanded reimbursement based on its clinical efficacy, leading to calls for its improved treatment access in Korea as well.On the 14th, AstraZeneca Korea held the “Breast Cancer Precision Treatment Strategy Academy” in Seoul to mark the second anniversary of Truqap’s approval, and shared current treatment strategies and unmet needs in HR+/HER2- metastatic breast cancer.Joohyuk Sohn, Professor of Medical Oncology at Yonsei Cancer CenterCurrently, CDK4/6 inhibitors in combination with endocrine therapy have become the standard of care for first-line treatment of HR+/HER2- metastatic breast cancer. However, a significant number of patients experience disease progression due to resistance. The problem is that in the subsequent second-line setting, the actual available options are limited depending on patient characteristics and genetic mutations.In particular, around half of these patients harbor mutations in PIK3CA, AKT1, or PTEN, which are regarded as major factors affecting disease progression and treatment response. As patients with these mutations have been reported to have a poorer prognosis compared to those without mutations, the need for targeted treatment strategies has been raised constantly.The domestic environment also acts as a variable. Given the relatively high proportion of premenopausal patients in Korea, endocrine-based treatment options that can be used without ovarian suppression are limited, and there is strong demand for treatment strategies that allow patients to continue therapy while preserving quality of life.In fact, after CDK4/6 inhibitor treatment, median progression-free survival (PFS) with endocrine monotherapy is only about two months, indicating limitations in treatment durability.In this setting, Truqap is drawing attention as a treatment option that can target specific gene mutations. According to the Phase III CAPItello-291 study, Truqap plus fulvestrant improved median PFS to 7.3 months, about 2.5 times longer than fulvestrant alone, and reduced the risk of disease progression or death by 50% in patients with PIK3CA/AKT1/PTEN mutations.This study is significant because it included a large number of patients with prior CDK4/6 inhibitor treatment experience, reflecting real-world clinical settings. Additionally, it demonstrated consistent treatment efficacy trends regardless of menopausal status and is therefore considered highly applicable to Korean patient populations as well.In terms of safety, the regimen was shown to be manageable. In an analysis including patients with hemoglobin A1c (HbA1c) below 8%, the rate of grade 3 or higher hyperglycemia was 2.3%. Its clinical value stands out in that it enables a treatment strategy that considers quality of life while maintaining endocrine therapy-based treatment.Currently, Truqap is recommended as a Category 1 option for second-line treatment in mutation-positive patients in the U.S. NCCN guidelines, and has also secured a high level of recommendation from the European Society for Medical Oncology (ESMO). It has already been reimbursed in eight countries, including the United States, the United Kingdom, Canada, and Australia.By contrast, reimbursement has still not been granted despite nearly two years having passed since approval, and limitations in patient access remain. Although it was designated as a candidate for the Global Innovative products on Fast Track (GIFT) program, in acknowledgement of its therapeutic need and innovation, its actual use in clinical practice remains constrained.Professor Joohyuk Sohn of the Department of Medical Oncology at Yonsei Cancer Center said, “There remains a gap in second-line treatment for HR+/HER2- metastatic breast cancer with gene mutations. We need to establish an institutional framework to ensure that treatments with proven clinical utility can actually be used in patient care.”
- Company
- "Cold chain requires quality infrastructure"…Temp Chain Company
- by Hwang, byoung woo Apr 16, 2026 02:26pm
- As the biopharmaceutical market expands, the importance of quality control during the drug transportation phase is growing rapidly.Temp Chain Company, a company specializing in passive cold chain technology, is accelerating its push into the global market, specifically targeting the large-scale biopharmaceutical transport sector.By focusing on large-scale shipping containers that maintain temperatures for extended periods without external power, the company is expanding collaborations with global pharmaceutical giants and logistics firms. The company is also pursuing a strategy to extend its reach from air-centric transport to ocean freight, aiming to establish itself as a core bio-logistics infrastructure provider.DailyPharm met with Hyun Chul Kim, CEO of Temp Chain Company, to discuss their technical competitiveness, market strategy, and global expansion plans.A paradigm shift to cold chain…highlights the quality infrastructure, moving beyond logisticsTemp Chain Company develops passive cold chain solutions that minimize temperature deviations during long-distance transport of biopharmaceuticals. Currently, they are targeting the global market with large-scale shipping containers that maintain constant temperatures for long durations without an external power source.Hyun Chul Kim, CEO of Temp Chain CompanyKim stated, "Biopharmaceuticals are extremely sensitive to temperature changes. It is crucial to maintain the quality achieved during production through the logistics stage," and that "Cold chain is no longer viewed as mere logistics equipment; it is now recognized as essential infrastructure that determines the quality of the medicine."Kim explained that as the proportion of biopharmaceuticals in the market grows, the role of cold chain is evolving. While the focus used to be simply on refrigeration, the industry now demands long-distance transport stability and data-driven quality management.In particular, Kim emphasized that as global supply chains expand and extreme weather events become more frequent, the transport environment is becoming increasingly complex, underscoring the need for technology that can reliably maintain temperatures over long periods."Bio-logistics must ensure temperature stability across the entire transport process, not just in specific segments," he noted. "Structural design that can maintain temperatures reliably even during long-distance transport is our core competitiveness."Temp Chain Company is gaining attention for delivering tangible results beyond mere solutions. The company has already secured contracts with major domestic pharmaceutical companies. It is expanding collaborations with global pharma giants like Pfizer and Johnson & Johnson, as well as leading logistics providers such as DHL and Expeditors.These achievements serve as proof that the company has moved beyond the technical validation stage and into commercial application, securing both temperature stability and cost-efficiency in high-volume transport environments.From materials to finished products…Differentiation through integrated technologyTemp Chain Company's collaborative success is based on its integrated technological competitiveness. The performance of a passive cold chain is determined by insulation performance and thermal storage technology. Temp Chain Company has secured both performance and stability by developing and producing Vacuum Insulation Panels (VIP) and Phase Change Materials (PCM) in-house, starting from the material stage."The core of cold chain equipment lies in the insulation structure and thermal storage design, yet most companies source these materials externally," Kim stated. "Temp Chain Company has established a system to handle everything internally, from material development and product design to manufacturing and performance verification."This structure also serves as a strength in terms of R&D speed and price competitiveness. It allows the company to optimize designs based on customer needs and quickly implement improvements. Furthermore, the structural design for ensuring temperature stability in long-distance transport environments is cited as a major competitive edge.Temp Chain Company is building a unique position in the global market through designs specifically specialized for large-scale biopharmaceutical transport. Even when competing against established global leaders, the company is gaining achievements."We focused our development on achieving both large-scale capacity and lightweight design while securing performance and price competitiveness," Kim emphasized. "Solutions that provide efficiency in high-volume transport environments are gaining significant interest in the market."A transportation device, developed with Temp Chain Company's in-house technology, for passive cold chain solutionExpanding global collaboration…Moving beyond air to oceanTemp Chain Company is intensifying its market entry by expanding partnerships with global pharmaceutical companies and logistics firms. As biopharmaceutical production and supply become increasingly globalized, demand for long-distance transport is rising sharply, accompanied by a growing need to reduce logistics costs."Pharmaceutical companies are looking for transport methods that can maintain quality while improving logistics efficiency," Kim said. "Interest is growing in passive cold chains that offer large capacity, lightweight features, and low management costs."A key part of their strategy is expanding from air-centric structures to ocean freight. While ocean transport is highly cost-competitive, it is a field with significant technical barriers due to the difficulty of maintaining temperatures for extended periods.To address this, the company is advancing its technology by accumulating transport data through R&D."By expanding into ocean freight, we can lower long-distance transport costs while ensuring stability," Kim explained. "Our goal is to build a cold chain solution that can be utilized in multimodal transport environments."Kim added, "With the expansion of global supply chains, hybrid logistics systems that link various modes of transport will become important," and that "If transport environments involving air, sea, rail, and truck expand, passive cold chain technology, which reduces dependence on electricity, will be ideally suited for such changes."Aiming to grow into a "Bio-Logistics Infrastructure Company"Temp Chain Company aims to grow beyond a simple equipment supplier to become a biopharmaceutical logistics infrastructure company.This goal is based on the judgment that logistics technology is becoming a factor that determines industrial competitiveness alongside the expansion of the biopharmaceutical market."Cold chain is becoming a mandatory infrastructure that must be considered during drug development and commercialization," Kim said. "It will evolve toward ensuring long-distance transport stability and data-based quality management."As the ocean freight-based business grows, the company has identified 2029 as a major business pivot point. At that stage, they plan to consider an IPO or a strategic investment, depending on corporate value and market conditions.In the long term, Kim predicts the role of the cold chain will expand amid changes in the global health environment."Technology is needed to supply biopharmaceuticals even in regions lacking reliable refrigeration infrastructure," Kim stated. "Passive cold chain technology can contribute to solving these issues."In conclusion, Kim added, "Our goal is to create an environment where biopharmaceuticals can be supplied more reliably by establishing global transport solutions that link air and sea. We will continue to expand our presence in the global market based on our technological competitiveness."
- Company
- Inhaled therapy recommended, but oral drugs still dominate asthma mkt
- by Son, Hyung Min Apr 16, 2026 02:26pm
- A significant gap between guidelines and clinical practice has been revealed in the field of asthma. Despite inhalers being recommended as the first-line standard therapy for asthma treatment, prescribing continues to focus on oral medications.In particular, it has been pointed out that the failure to implement standard treatment in clinical practice has been exposed, with a lack of training on the use of inhalers and the absence of a corresponding reimbursement system identified as structural causes.On the 15th, AstraZeneca Korea held a media session at its headquarters in Samseong-dong under the theme “Latest Insights on Asthma and Chronic Obstructive Pulmonary Disease (COPD) Treatment,” and shared the current status and challenges of respiratory disease treatment in Korea.The company has a broad asthma and COPD treatment portfolio, including ‘Symbicort (budesonide/formoterol),’ ‘Fasenra (benralizumab),’ ‘Breztri (budesonide/glycopyrronium/formoterol),’ and ‘Tezspire (tezepelumab).’However, even though a range of inhaled treatment options are available, including inhaled corticosteroids (ICS), long-acting beta2-agonists (LABA), and long-acting muscarinic antagonists (LAMA), actual prescribing patterns are diverging from guideline recommendations.According to the Health Insurance Review and Assessment Service’s “2024 (11th) Asthma Care Quality Assessment,” the ICS prescribing rate, a key indicator in asthma treatment, was 51.9%, only 0.1 percentage point higher than the previous year’s 51.8%.Jin-Kook Lee, Professor of Respiratory Medicine at Seoul St. Mary’s HospitalThe problem is that this gap widens as one moves down to primary care settings. The ICS prescription rate at clinics was 38.1%, significantly lower than the overall average, while the rate of prescribing oral corticosteroids (OCS) without ICS was 26.5%, the highest among provider types.Although asthma treatment guidelines recommend inhaled medications as the first-line treatment for both disease-modifying and symptom-relieving agents, actual prescribing patterns do not adequately reflect this.Prescription patterns by route of administration also support this trend. As of 2024, among patients receiving a single mode of administration, oral drugs accounted for the largest share at 42.0%, while inhaled therapies accounted for only 12.4%. Patches accounted for a mere 0.5%.Among oral drugs, leukotriene receptor antagonists (LTRA) accounted for the highest share at 63.4%, while ICS remained the central component among inhaled therapies at 51.9%.A lack of education on proper use of inhalers is identified as a key factor behind this bias toward oral medications.Professor Jin-Kook Lee of the Department of Respiratory Medicine at Seoul St. Mary’s Hospital pointed out, “Although there are already enough treatments available for asthma and COPD, the reason they are not used effectively in practice is that inhaler-use education is not being delivered properly. With inhalers, proper technique determines treatment effectiveness, but there is not enough time or service fee incentives for institutions to provide education on this to patients.”“Inhaler education requires at least 30 minutes, but the current clinical environment cannot accommodate this. Unless fees or incentives for education are established, resolving this issue will not be easy.”Although treatment options in severe asthma are expanding around biologics, limitations in access still remain. In reality, more than 90% of patients still experience difficulty in daily life, and the burden of side effects from long-term oral steroid use remains high.The situation is not much different for COPD. While it is estimated that approximately 13% of the domestic population aged 40 and older has the condition, the actual diagnosis rate is only 2.8%, and the treatment rate is a mere 1.6%.To address these issues, the government introduced pulmonary function testing into the national health screening program starting this year. However, there are concerns that the effect may remain limited unless a management system is built to ensure that early diagnosis actually leads to treatment.Ultimately, structural improvements are needed across the entire “diagnosis-treatment-management” process for both asthma and COPD. In particular, establishing education and reimbursement systems to ensure the adoption of inhaler-based standard therapy in actual practice has emerged as a core task.Professor Lee emphasized, “Inhalers are the foundation and standard of treatment for asthma and COPD, but the current system makes it difficult to use them properly. Since oral medications cannot replace inhalers, we must establish both an educational system that extends to primary care facilities and a corresponding fee system that supports it.”
