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- 2026-06-14 00:52:56
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- Prescription of severe asthma drug 'Tezspire' at general hospital imminent
- by Eo, Yun-Ho Jun 11, 2026 09:25am
- Product photo of TezspireNovel drug 'Tezspire (tezepelumab)' for severe asthma is becoming available for prescription in general hospitals.According to industry sources, AstraZeneca Korea’s severe asthma treatment Tezspire (tezepelumab), an anti-human thymic stromal lymphopoietin (TSLP) monoclonal antibody, has passed the drug committee (DC) reviews at Seoul National University Hospital, Gyeongsang National University Hospital, Kyungpook National University Hospital, Kyungpook National University Chilgok Hospital, Hallym University Sacred Heart Hospital, and Soonchunhyang University Hospital Seoul.Tezspire, approved in Korea in 2023, works by blocking TSLP, an upstream cytokine central to the asthma inflammatory cascade, thereby demonstrating efficacy in controlling symptoms and improving lung function across a broad spectrum of severe asthma patients, irrespective of their specific asthma phenotypes.The clinical efficacy of Tezspire was proven through two clinical studies, PATHWAY and NAVIGATOR. The primary endpoint for both clinical trials was the annualized rate of clinically significant asthma exacerbations measured over 52 weeks.In the PATHWAY study, which followed 550 severe asthma patients aged 18 and older for 52 weeks, the Tezspire group demonstrated an asthma exacerbation rate of 0.20, showing a significant difference compared with 0.72 in the placebo group.In the NAVIGATOR study, which evaluated 1,061 patients aged 12 and older with uncontrolled severe asthma over 52 weeks, Tezspire recorded an exacerbation rate of 0.93, significantly lower than the 2.10 of the placebo group.Regarding the secondary endpoint in both trials, the Tezspire group had a greater improvement from baseline in forced expiratory volume in one second (FEV₁) than placebo.Meanwhile, Tezspire recently secured a new indication for chronic rhinosinusitis with nasal polyps (CRSwNP). The efficacy of this indication was established via the WAYPOINT study.The WAYPOINT trial was a multi-center, randomized, double-blind, placebo-controlled Phase III clinical study conducted across 10 countries, involving 408 adult patients aged 18 and older presenting with severe, uncontrolled chronic rhinosinusitis with nasal polyps.The study results revealed that at week 52, the Tezspire group showed statistically significant improvement, demonstrating a reduction of -2.07 in the Nasal Polyp Score (NPS), which evaluates the size and extent of polyps, and a reduction of -1.03 in the Nasal Congestion Score (NCS), which measures the severity of nasal blockage, compared to the placebo cohort. Furthermore, these therapeutic improvements were maintained as early as week 4 and week 2 of treatment, respectively, and were sustained throughout the full 52-week duration.
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- ‘Statin side effects overstated…benefits of treatment outweigh risks’
- by Son, Hyung Min Jun 11, 2026 09:24am
- The growing perception online that statins cause muscle damage or diabetes has led to a new issue - delayed treatment for patients with dyslipidemiaExperts emphasized that while the risks of statin side effects are often exaggerated, the drug's efficacy in preventing myocardial infarction and stroke has been confirmed through large-scale clinical trials, underscoring the need for evidence-based treatment decisions.On June 10, Viatris Korea held a media session in Seongsu-dong, Seoul under the theme "Statin Myths and Facts," highlighting changes in the health information landscape and the importance of managing dyslipidemia.Dyslipidemia is a major chronic disease affecting approximately half of the adult population in Korea. Although it is a major risk factor for cardiovascular and cerebrovascular diseases such as myocardial infarction and stroke, many patients fail to recognize the need for treatment because the condition is often asymptomatic. Recently, the spread of unverified health information through social media platforms such as YouTube has led some patients to defer or discontinue treatment.Viatris media sessionSpread of "Don't take statins" messages raises concerns about treatment delaysDr. Min-wook Jang of the Jang Min-wook Brain Navigation Neurology Clinic noted that distorted information about statins is being repeatedly shared online.Common claims include denying the need to manage LDL cholesterol or suggesting that statins cause muscle damage and diabetes, making them more harmful than beneficial.Dr. Jang said, "An increasing number of younger patients have been deferring treatment because of unverified information. Postponing statin therapy can ultimately lead to irreversible outcomes such as heart attacks or strokes. Treatment decisions should be based on accumulated clinical evidence."He shared cases from his practice in which patients discontinued statin therapy after receiving misleading information and later suffered strokes, stressing the importance of relying on verified medical evidence rather than sensational online content.According to experts, the key goal of statin therapy is LDL cholesterol management.Multiple large-scale clinical studies and meta-analyses have shown that every 1 mmol/L (approximately 38.8 mg/dL) reduction in LDL cholesterol lowers the risk of major cardiovascular events, including heart attack and stroke, by about 22%.Among high-risk populations, which includes patients with diabetes, higher LDL cholesterol levels are associated with increased cardiovascular risk. Statin therapy has been shown to significantly reduce the risk of major cardiovascular events in these patients.The timing of treatment is also important. Delaying therapy after diagnosis prolongs exposure to elevated LDL cholesterol, thereby increasing cardiovascular risk. In contrast, initiating treatment relatively early can provide long-term preventive benefits.Experts also noted that concerns regarding statin side effects differ from what is observed in actual clinical data.From left: Prof. Nan-do Kim (Emeritus Professor, Consumer Science, Seoul National University), and Dr. Min-wook Jang (Director, Jang Min-wook Brain Navigation Neurology Clinic).Muscle-related adverse events have not shown significant differences compared with placebo groups in randomized controlled trials, while the risk of severe muscle damage such as rhabdomyolysis remains extremely low. The possibility of a nocebo effect—where patients experience or perceive symptoms more strongly because they expect side effects—has also been raised.In studies involving patients who considered discontinuing statin therapy because of muscle symptoms, no significant difference in muscle-related adverse events was observed between statin and placebo groups. Presenters suggested that some reported symptoms may be influenced more by patient perception than by the medication itself.Although some studies have reported a potential increase in diabetes risk, current clinical guidelines conclude that the overall benefits outweigh the risks when considering its effect in reducing heart attacks, strokes, and cardiovascular mortality.Dr. Jang explained that the annual risk of new-onset diabetes mellitus (NODM) associated with long-term statin use is approximately 0.1%, which is relatively low. In contrast, the benefits of LDL cholesterol reduction, stabilization of coronary plaque, and prevention of major atherosclerotic cardiovascular disease (ASCVD) events have been clearly demonstrated.Another meta-analysis found that treating 255 patients with statins for 4 years resulted in one additional case of new-onset diabetes. Dr. Jang noted that while the risk exists, the absolute risk remains relatively low.Dr.Jang said, "Patients at higher cardiovascular risk derive substantially greater clinical benefits from statin therapy. Rather than delaying treatment because of vague concerns about side effects, patients should assess their individual risk and begin treatment at an appropriate time."'Health intelligence' becomes more important amid the flood of health informationThe event also featured discussions on changes in health information consumption.Prof. Nando Kim, Emeritus Professor of Consumer Science at Seoul National University, argued that in an era overflowing with health information, the ability to search for, evaluate, and utilize health information has become increasingly important.Dr. Kim said, "We have moved beyond the era of IQ and EQ into the era of Health Quotient (HQ), the ability to understand one's health status, seek and evaluate health information, and choose appropriate medical interventions. As more people acquire medical knowledge through artificial intelligence, the ability to critically interpret information and make careful decisions becomes even more important."He added, "For conditions such as dyslipidemia, patients need to obtain science-driven information and take a proactive approach to management amid widespread misconceptions and misinformation."
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- SK Bioscience and CDC to develop an injectable rotavirus vaccine
- by Choi Da Eun Jun 10, 2026 08:41am
- SK Bioscience is partnering with the US Centers for Disease Control and Prevention (CDC) to develop an injectable rotavirus vaccine. Through collaboration with a global public health institution, the company aims to secure next-generation vaccine technologies and respond to growing vaccine demand, particularly in low- and middle-income countries.On the 9th, SK Bioscience announced that it had signed a licensing agreement with the CDC for the development of an injectable rotavirus vaccine.SK Bioscience headquarters in SongdoUnder the agreement, SK Bioscience will acquire technology for the CDC’s injectable inactivated rotavirus vaccine candidate and carry out process development aimed at improving manufacturing productivity. Once process development is completed, the company plans to proceed with subsequent clinical trials, regulatory approval, and eventual commercialization.The CDC has already developed the injectable inactivated rotavirus vaccine technology and completed a Phase I clinical trial. Building on this technology, SK Bioscience intends to accelerate development by establishing manufacturing processes that improve vaccine efficacy while reducing production costs.Research and development expenses will be jointly funded with a global health foundation. In June of last year, SK Bioscience signed an agreement with the RIGHT Foundation to receive support for process-development R&D costs related to the vaccine.The RIGHT Foundation is a public-private nonprofit organization established through joint funding from the Bill & Melinda Gates Foundation, the Korean government, and domestic life sciences companies. The foundation supports R&D projects aimed at reducing the burden of infectious diseases in low- and middle-income countries.Rotavirus is one of the leading infectious diseases causing severe diarrhea and dehydration in children under the age of five. According to research from Johns Hopkins University, approximately 24.4% of child deaths worldwide are associated with diarrhea resulting from rotavirus infection.Although currently available oral rotavirus vaccines demonstrate preventive efficacy over 85% in developed countries, their effectiveness reportedly falls below 50% in low- and middle-income countries with poor nutritional status and sanitation conditions. As a result, there has been a growing demand within the global health community for injectable vaccines capable of overcoming the limitations of oral formulations.The market is also experiencing strong growth. According to global market research institution Business Research Insights, the worldwide rotavirus vaccine market is expected to expand from approximately USD 8.1 billion in 2024 to USD 13.9 billion by 2033, representing an annual growth rate (CAGR) of about 6.2%.Annual procurement rose from approximately 900,000 doses in 2011 to 57 million doses in 2023, while demand from countries supported by Gavi, the Vaccine Alliance, is expected to reach approximately 64 million doses by 2028.UNICEF's procurement of rotavirus vaccines has been steadily increasing. The procurement volume, which stood at approximately 900,000 courses in 2011, grew to 57 million courses in 2023. Furthermore, the demand from countries supported by Gavi, the Vaccine Alliance, is projected to reach approximately 64 million courses by 2028.Jaeyong Ahn, President&CEO of SK Bioscience, stated, “We are honored to be able to contribute to solving global public health challenges based on innovative technology developed by the CDC. Working together with the RIGHT Foundation, we will continue developing innovative vaccines that improve the health of children in low- and middle-income countries and fulfill our role and contribute to advancing the global public health paradigm.”
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- Topical JAK inhibitor 'Anzupgo cream' set for general hospital prescription
- by Eo, Yun-Ho Jun 10, 2026 08:41am
- The topical JAK inhibitor 'Anzupgo cream' is closer to being prescribed in general hospitals.According to industry sources, LEO Pharma Korea's Anzupgo (delgocitinib), a new drug for Chronic Hand Eczema (CHE), has passed drug committees (DC) of medical institutes, including Seoul National University Hospital, National Medical Center, and Hanyang University Seoul Hospital.As Anzupgo is being processed for insurance reimbursement listing, more hospitals will be able to prescribe this drug.Anzupgo is the only non-steroidal topical cream formulation approved for the treatment of moderate-to-severe CHE in adult patients who have not responded to, or for whom topical corticosteroids are not advisable.Anzupgo does not contain parabens or steroids. It works by suppressing the JAK-STAT signaling pathway, which is involved in various inflammatory reactions, by inhibiting the activity of JAK1, JAK2, JAK3, and TYK2, thereby helping to alleviate skin inflammation and pruritus.Previously, treatment options for CHE have been limited, with strong topical corticosteroids primarily being used. However, prolonged use of these agents can carry various risks, including skin barrier damage, skin atrophy, and dilated blood vessels.For cases where treatment effects did not appear in a short period, Korean treatment guidelines also recommended combining them with topical calcineurin inhibitors or systemic steroids.GSK's 'Alitoc (alitretinoin)', currently the only approved oral treatment for severe CHE, is used in patients who have not responded to at least 4 weeks of potent topical corticosteroid therapy. It improves symptoms through its skin-regulatory, anti-inflammatory, and immunomodulatory actions. It is known to be effective for the long-term management of chronic, severe hand eczema with a high risk of relapse.However, its continued use has been limited by concerns over various side effects, including hepatotoxicity, hypothyroidism, dyslipidemia, and fetal malformation.Anzupgo's efficacy was proven through the DELTA FORCE and DELTA 2 clinical studies, which included a direct comparison with GSK's Alitoc (alitretinoin).Anzupgo's efficacy was proven through the DELTA FORCE and DELTA 2 clinical studies, which included a direct comparison with GSK's Alitoc (alitretinoin).The DELTA 2 study enrolled 473 patients with moderate-to-severe CHE. Participants were randomized to either the delgocitinib cream or placebo cream application group, receiving treatment twice daily for 16 weeks.The primary endpoint was an Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) score of 0/1 measured at Week 16. Key secondary endpoints included the IGA-CHE score and the Hand Eczema Symptom Diary (HESD) score, both evaluated at Weeks 4 and 8.The results showed that the delgocitinib group significantly improved chronic hand eczema at Week 16 compared to the placebo group, meeting the primary and key secondary endpoints.
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- Dupixent indication expanded to bullous pemphigoid and CSU
- by Son, Hyung Min Jun 09, 2026 10:01am
- Dupixent pre-filled penSanofi announced that its Type 2 inflammation-targeting therapy ‘Dupixent (dupilumab)’ has been approved for two new indications -- bullous pemphigoid (BP) and chronic spontaneous urticaria (CSU).With this approval, Dupixent has become the first and only targeted therapy approved in Korea for the treatment of BP. It also provides an additional treatment option for patients with CSU whose symptoms are not adequately controlled with H1-antihistamine therapy.With the approval, Dupixent pre-filled syringe and pre-filled pen 300 mg may be used for the treatment of bullous pemphigoid in adults aged 18 years and older, and Dupixent pre-filled syringe and pre-filled pen 200 mg and 300 mg formulations may be used for the treatment of CSU in adults aged 18 years and older and adolescents aged 12–17 years whose symptoms are inadequately controlled with H1-antihistamines.Dupixent demonstrated clinical efficacy in adults with moderate-to-severe bullous pemphigoid in the ADEPT Phase II/III clinical trial, which served as the basis for the approval.Patients received Dupixent 300 mg in combination with standard systemic corticosteroid therapy, followed by gradual tapering according to disease status. At Week 36, the proportion of patients who achieved sustained disease control without oral corticosteroids (OCS) was higher in the Dupixent group than in the placebo group.The recently published 2025 Canadian Dermatology Association (CDA) Guidelines included Dupixent as a first-line treatment option for extensive bullous pemphigoid. In addition, the 2022 S2K International Expert Consensus Guidelines issued by the European Academy of Dermatology and Venereology (EADV) recommend Dupixent as a biologic treatment option for treatment-resistant bullous pemphigoid.Dupixent’s indication expansion to chronic spontaneous urticaria was based on results from the Phase III CUPID trial, which enrolled biologic-naïve patients aged 6 years and older whose symptoms persisted despite H1-antihistamine therapy.The primary endpoint was the change from baseline in the Weekly Itch Severity Score (ISS7) at Week 24. Key secondary endpoints included changes in the Urticaria Activity Score over 7 Days (UAS7), achievement of symptom control (UAS7 ≤ 6), and complete remission (UAS7 = 0). In the study, patients treated with Dupixent experienced a statistically significant reduction in itch severity (ISS7) compared with placebo, and the reduction in UAS7 from baseline was 66% in the Dupixent group and 48% in the placebo group, respectively.Previously, first-line treatment for chronic spontaneous urticaria consisted of second-generation H1-antihistamines, which could be increased to as much as four times the standard dose. However, a substantial unmet need persists because nearly half of patients fail to achieve adequate symptom control with H1-antihistamines alone. To address this, the 2026 international guideline update formally included Dupixent alongside omalizumab as a targeted second-line therapy for H1-antihistamine-refractory chronic spontaneous urticaria.Kyung-eun Bae, General Manager of Sanofi Korea, said, “Through these two indication expansions, we hope that patients suffering from poor quality of life associated with bullous pemphigoid and chronic spontaneous urticaria will receive the best possible treatments, improve their quality of life, and receive a higher standard of care. We will continue our efforts to improve the treatment environment for these patients.”
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- Is this the end of the era of animal testing?
- by Cha, Ji-Hyun Jun 09, 2026 10:01am
- After the US government unveiled its roadmap to systematically decrease reliance on animal testing in drug development, Europe has officially announced measures to reduce animal use in pharmaceutical safety assessments. This shift aims to address the ethical controversies surrounding animal experimentation while significantly enhancing the predictive accuracy of human physiological responses. As global regulatory transitions begin, South Korean domestic companies possessing non-animal testing technologies, such as organoids, are gaining attention.EU joins systemic elimination of animal testing…accelerating safety assessment transformationsAccording to sources in the pharmaceutical biotech industry, the European Commission (EC) selected a roadmap on June 1st to systematically eliminate animal use in safety assessments for chemicals, including pharmaceuticals. This roadmap includes 15 distinct regulatory domains, including industrial and consumer chemicals, biocides and pesticides, human medicinal products, food and feed additives, and biocompatibility assessments for medical devices.The EC stated, "This roadmap proposes clear and concrete steps for transitioning toward innovative, non-animal approaches. We plan to maintain the absolute reliability of safety assessments to ensure a high level of protection for human and animal health, as well as the environment."The strategic framework presented by the EU rests on three primary pillars. ▲Accelerating the development and validation of non-animal testing methodologies ▲Expanding the utilization of research alongside artificial intelligence (AI) and data-driven analytics ▲Strengthening collaboration between EU member states and the international community.To support the development of alternative methods, the EC intends to grant developers access to the European Reference laboratories (EURLs) at the Joint Research Center (JRC) and to introduce a structured framework to map non-animal testing methods required in real-world regulatory settings. The EC will also incentivize the development of both EU and international standards to ensure these non-animal approaches can be effectively integrated into routine safety evaluations.Within the pharmaceutical sector, the roadmap outlines strategies to reduce the need for repeat-dose toxicity (RDT) studies for advanced cancers and severe or life-threatening conditions. The blueprint envisions substituting animal models with in vitro assays and computational simulations, and using virtual control groups to minimize the number of control animals deployed in RDT research.The EC plans to immediately implement this roadmap along with member states, EU agencies, and relevant stakeholders. It will convene a high-level meeting in 2029 to evaluate operational progress and audit the implementation status of non-animal approaches across applicable legislative frameworks, including the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation.FDA animal testing policy timeline for new drug development (source: KOREABIO) The EU's latest initiative aligns seamlessly with the ongoing policy directives driven by the United States government to reduce animal experimentation. Through the enactment of the FDA Modernization Act 2.0 in December 2022, the US Congress removed the statutory mandate requiring animal testing in the new drug approval pipeline, establishing a robust legal foundation for the use of non-animal methods such as cell-based assays, organoids, organ-on-a-chip technologies, and computational modeling.Accordingly, in April last year, the US Food and Drug Administration (FDA) announced a systemic transition plan to reduce, refine, and replace animal testing, beginning with monoclonal antibodies and certain medicinal products. The FDA aims to reduce, refine, and replace animal testing using New Approach Methodologies (NAMs), such as organoid toxicity testing, organs-on-chips, and AI-based computational models, and to leverage relevant datasets in Investigational New Drug (IND) applications or Biologics License Applications (BLAs) for biosimilars.In the same month, the US National Institutes of Health (NIH) also unveiled plans to establish a new organization to expand the use of human-based research technologies. The NIH intends to support the development, validation, and expanded use of non-animal approaches, including organoids, tissue chips, computational models, and real-world data—centered around the Office of Research Innovation, Validation, and Application (ORIVA).On March 18th of this year, the FDA released a draft guidance document allowing the submission of NAMs data for novel drug approval reviews. This guidance states that testing methods not previously approved as animal testing alternatives may be submitted. That validation or qualification evaluations need not be completed in advance for non-clinical toxicity and safety assessments. Furthermore, the NIH plans to invest more than $150 million to support the development and validation of NAMs.4.59 million laboratory animals in South Korea…Ethical lontroversies and limitations in replicating human responsesThe background behind the United States and Europe starting on reducing animal testing stem from ethical concerns and the limitations of replicating human physiological responses.First, demands to resolve the ethical problems associated with animal testing have been continuously raised, primarily by animal protection organizations, civil society, and academia. According to the EU, the number of animals used in regulatory testing from 2015 to 2023 exceeded 15 million. Among these, approximately 40% were deployed in chemical safety assessments.The scale of laboratory animal use is also substantial in South Korea. According to the 2024 Institutional Animal Care and Use Committee (IACUC) Operational Performance Survey by the Animal and Plant Quarantine Agency, the number of laboratory animals used domestically last year totaled 4.59 million. Relevant organizations and experts argue that, since numerous animals are used in experiments worldwide each year, unnecessary animal sacrifice must be reduced and the use of alternative testing methods expanded.Number of animals used in EU toxicity and other safety tests (Source: KOREABIO)The limitations in connecting animal test results to actual human responses during the new drug development process are another factor accelerating the regulatory transition. Conventional non-clinical trials have served as an essential gateway to assess the toxicity and efficacy of candidate substances. However, criticisms persist that accurately predicting human drug responses solely from animal results has clear limitations. In particular, with the emergence of novel types of medicines, such as antibodies and cell/gene therapies, the problem that animal models alone cannot fully replicate human immune responses and disease characteristics has been highlighted.Announcing its plan to expand the utilization of human-based research technologies in April last year, the NIH said, "Some research institutions have failed to draw sufficient conclusions when applying animal model results to human diseases, such as Alzheimer's disease and cancer. These limitations may stem from differences in anatomy, physiology, lifespan, and disease characteristics between humans and animals. Even if humans and animals share genes, there can be differences in the functions of organs and bodily systems, which can create constraints in applying animal model results to human diseases."Even if a candidate substance confirms efficacy and safety in animal testing, its development can be discontinued if the expected effects do not manifest or unexpected toxicities are identified in human clinical trials. In such cases, years of research and development expenses, and the manpower invested in candidate discovery, non-clinical trials, and production process development, cannot be recovered, leading to the burden of delaying subsequent pipeline schedules. This is why regulatory bodies in various countries are rushing to introduce alternative testing methods.South Korea also accelerates alternative testing implementation…Korean organoid companies riseAlong with the global regulatory shift, the institutionalization and serialization of alternative testing methods are gathering full momentum in South Korea. Following the establishment of a foundational research base, the government is refortifying the legal basis for applications within the pharmaceutical sector and taking steps to preempt international standards for advanced alternative testing methods, such as organoids.In South Korea, the Ministry of Food and Drug Safety (MFDS) established the foundation for the development and validation of alternative testing methods by establishing the Korean Center for the Validation of Alternative Methods (KoCVAM) in 2009. In 2011, the MFDS joined the International Cooperation on Alternative Test Methods (ICATM) and has since participated in the development of international testing guidelines alongside regulatory agencies of major countries, including the United States and Europe.The MFDS has also officially begun to establish international standards. Last year, the MFDS launched the Committee for the International Standardization of Organoid Testing Methods and partnered with the Organisation for Economic Co-operation and Development (OECD) to develop international guidelines for organoid-based toxicity testing. The government plans to leverage the 14th World Congress on Alternatives and Animal Use in the Life Sciences (WC14), which will be held in Seoul in 2027, as an opportunity to enhance the regulatory utility of domestic technologies on the international stage.Collaboration between industry and research institutes has also begun. Last August, the 'K-Organoid Consortium' was launched, involving 27 corporations, including Samsung Biologics, Daewoong Pharmaceutical, and JW Pharmaceutical, as well as 18 research institutions. The consortium promotes standardization of testing methods, the development of industrial support infrastructure, and international cooperation, thereby supporting the global regulatory acceptance and market entry of domestic organoid technologies.Korean Companies Developing Organoids: JW Pharmaceutical, Kangstem Biotech, Gradient Bioconvergence, Next&Bio, Daewoong Pharmaceutical, ROKIT Healthcare, Samsung Biologics, MBD, OrganoidSciences, Ipsell, and T&R Biofab.As the reduction of animal testing and the adoption of non-animal testing methodologies spread globally, Korean companies with relevant technologies are garnering significant attention. Anticipation is growing that if global regulatory bodies expand the scope of utilizing non-animal testing datasets, such as organoids, organs-on-chips, and AI-based predictive models, it will lead to increased opportunities for technical validation and collaboration with global pharmaceutical companies for domestic firms.OrganoidSciences is regarded as one of the most active companies in the organoid field. Through its organoid-based drug evaluation platform 'ODISEI', the company replicates actual human organ architecture and disease microenvironments to evaluate the efficacy and toxicity of candidate compounds. It is also developing an organoid-based regenerative medicine pipeline called 'ATORM'; its lead asset, ATORM-C, recently secured Phase I IND approval from the MFDS for patients with Crohn's disease, successfully entering the clinical phase.MBD is developing patient-tailored workflows for predicting anticancer drug response using 3D cell culture technology. The company has proprietary automation technologies to uniformly mass-produce tumoroids (cancer mimics) from minimal patient specimens, alongside 'OncoCensi', a tumoroid-based assay evaluating chemosensitivity to anticancer therapies. Following a successful technical evaluation in November 2024, MBD filed a preliminary KOSDAQ listing review application with the Korea Exchange this past April, officially initiating its initial public offering (IPO) process.Samsung Biologics launched 'Samsung Organoid', an anticancer drug-screening service based on cancer-patient-derived organoids, in June last year. JW Pharmaceutical utilized human skin organoids to evaluate the hair follicle-generating efficacy of its alopecia drug candidate 'JW0061', and the candidate molecule is currently advancing toward entry into Phase I clinical trials. Daewoong is developing mass-production bioprocess technologies for organoid-based regenerative therapeutics with support from the Ministry of Trade, Industry and Energy (MOTIE). Its objective is to establish manufacturing protocols for therapeutics designed to assist in the regeneration of damaged organs and tissues, such as the heart, liver, and kidneys, and to expand its scope into treatments for intractable diseases.Lastly, Gradient Bioconvergence is operating oncology target discovery and drug response prediction businesses that pair AI and gene-editing technologies with a repository of approximately 1,000 patient-derived organoids and genomic datasets. Kangstem Biotech is engineering skin disease models based on skin organoids. Next&Bio is developing platforms for efficacy evaluation powered by patient-derived cancer organoids and microphysiological systems. Ipsell is advancing the commercialization of 'POLAR', an alternative testing platform leveraging induced pluripotent stem cells (iPSCs) and organoids. Concurrently, T&R Biofab is developing 3D bioprinting and vascularized tissue technologies, while ROKIT Healthcare is developing a patient-centric, personalized regenerative medicine platform.
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- Rybrevant accelerates expansion into solid tumors
- by Son, Hyung Min Jun 08, 2026 08:52am
- ASCO venue (Source: ASCO).Johnson & Johnson’s EGFR-MET bispecific antibody Rybrevant (amivantamab) is expanding its development program beyond lung cancer into new solid tumor indications, including colorectal cancer and head and neck cancer.Major clinical data for Rybrevant in solid tumors were presented at the 2026 American Society of Clinical Oncology (ASCO 2026) Annual Meeting, which was held recently in Chicago.While Rybrevant has steadily expanded its presence in the treatment of EGFR-mutated non-small cell lung cancer (NSCLC), the company is now broadening its research focus to a variety of solid tumors in which EGFR and MET signaling pathways play important roles.In particular, attention is rising over the possibility of future label expansion, as meaningful clinical outcomes have been observed in patient populations with limited treatment options or in those who have not achieved sufficient benefit with existing EGFR inhibitors.High response rates in head and neck cancer… shows potential as a later-line treatment alternativeThe most notable findings came from a study involving recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).Although treatment outcomes for recurrent or metastatic HNSCC have improved following the introduction of immuno-oncology drugs and platinum-based chemotherapy, treatment options remain limited after disease progression. In particular, patients with HPV-unrelated disease tend to have poor prognoses, creating an ongoing need for new treatment alternatives.The Phase Ib/II OrigAMI-4 study evaluated subcutaneous (SC) Rybrevant monotherapy in 102 patients with HPV-unrelated recurrent or metastatic HNSCC whose disease had progressed after treatment with PD-(L)1-based immunotherapy and platinum-based chemotherapy.The analysis showed an objective response rate (ORR) of 47%. Four patients achieved a complete response (CR), while 44 achieved a partial response (PR). Tumor reduction in target lesions was observed in 79% of patients.Responses were also rapid. The median time to first response was 6.6 weeks, while the median duration of response (DOR) was 7.2 months. Median progression-free survival (PFS) was 6.8 months.Industry experts believe these results compare favorably with those of Merck’s EGFR-targeted therapy ‘Erbitux (cetuximab),’ which is currently used in this setting. According to previously published data cited by the investigators, Erbitux demonstrated an ORR of 24% and a median PFS of 3.8 months in a comparable patient population.The high rate of tumor shrinkage was also noteworthy. In the study, 79% of all patients experienced reductions in target lesions.The safety profile was consistent with that found in Rybrevant studies. The most common adverse events included hypoalbuminemia, rash, acneiform dermatitis, paronychia, stomatitis, and fatigue. Treatment-related reactions occurred in 13% of patients, but were all Grade 1 or 2. The treatment discontinuation rate due to treatment-related adverse events (TRAEs) was 6%.Company seeks to gain first-line indication for head and neck cancer … Phase III development underwayJohnson & Johnson is also conducting a global Phase III trial on Rybrevant’s use in the first-line treatment setting for recurrent or metastatic HNSCC.The OrigAMI-5 study is a Phase III trial evaluating Rybrevant in combination with Keytruda (pembrolizumab) and carboplatin in approximately 500 patients with HPV-unrelated recurrent or metastatic HNSCC. The regimen is being directly compared with the current standard-of-care combination of Keytruda, platinum-based chemotherapy, and 5-FU.Although Keytruda-based regimens are currently considered the standard first-line treatment for recurrent or metastatic HNSCC, response rates and long-term survival outcomes remain limited. Investigators are looking into whether adding Rybrevant could improve outcomes, given the high levels of EGFR and MET expression observed in head and neck cancer.The study will be conducted at approximately 205 sites across 22 countries worldwide. Co-primary endpoints are ORR and overall survival (OS). Additional endpoints include PFS, DOR, and patient-reported outcomes (PROs).Given that Rybrevant monotherapy achieved a 47% ORR in patients whose disease had progressed after immunotherapy and platinum-based chemotherapy in the OrigAMI-4 study, attention is now turning to whether the Phase III results could potentially alter future treatment strategies for head and neck cancer.Demonstrates activity in CMS4 colorectal cancer… Highlighting the potential of MET-targeted therapyJohnson & Johnson's ‘Rybrevant’In colorectal cancer, new data suggest that Rybrevant may help overcome some of the limitations associated with existing EGFR inhibitors.The OrigAMI-1 study evaluated Rybrevant monotherapy in patients with metastatic colorectal cancer lacking KRAS, NRAS, BRAF, and EGFR extracellular domain mutations, as well as HER2 amplification. All participants had previously received second- or third-line treatment in the metastatic setting.This analysis focused on Consensus Molecular Subtypes (CMS), one of the major molecular classification systems for colorectal cancer.CMS2 is a classic subtype characterized by high EGFR dependency and is known to respond well to EGFR inhibitors. In contrast, CMS4 exhibits mesenchymal characteristics associated with MET signaling activation and is known for its poor prognosis and generally limited responsiveness to EGFR inhibitors.Previous studies reported that disease control rates (DCR) with Erbitux monotherapy were 68% in CMS2 patients but only 29% in CMS4 patients.However, Rybrevant demonstrated relatively consistent efficacy across both subtypes.Median PFS was 4.2 months in CMS2 patients and 5.3 months in CMS4 patients. Median OS was 11.3 months and 13.5 months, respectively, showing no major differences between the groups.ORR was 26% in CMS2 patients and 16% in CMS4 patients, while DCR reached 83% and 74%, respectively. According to the investigators, treatment outcomes were also generally consistent regardless of tumor location.The researchers concluded that Rybrevant maintained antitumor activity even in CMS4 subtypes, which are less dependent on EGFR signaling, based on the drug’s dual-target inhibition effect that targets both EGFR and MET pathways.Because CMS4 is widely recognized as a subtype associated with resistance to conventional EGFR inhibitors, the findings are being viewed as evidence supporting the clinical value of a strategy that targets MET alongside EGFR.
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- Domestic surgical robot development speeds up
- by Hwang, byoung woo Jun 08, 2026 08:52am
- AI-generated imageNumerous companies in the Korean domestic medical device industry are targeting the surgical robot market. Efforts to integrate robotic technology continue across diverse fields, including laparoscopic surgical robots, orthopedics, neurosurgery, endoscopy, and vascular intervention.However, analysis suggests that, independent of increased market entry, core technological competitiveness remains limited compared to that of major countries. This is because competition in surgical robotics is shifting beyond the simple development of robotic arms or surgical instruments toward precision control, sensing, autonomous control, and data-driven surgical support technologies.The success of surgical robotics is 'precision control'According to the "Patent Trends Related to Precision Control of Surgical Robots" report published by the Korea Health Industry Development Institute (KHIDI), the global surgical robot market is projected to grow from approximately $9.2 billion in 2025 to around $38.4 billion by 2034. The compound annual growth rate (CAGR) is 17.2%.Drivers behind this market expansion include rising demand for minimally invasive surgery (MIS), the need for enhanced surgical accuracy, and technological advancements in integrating imaging, sensor, and control systems.In particular, recent surgical robots are evolving away from purely control-hardware systems toward intelligent platforms that combine imaging, sensors, artificial intelligence, and control algorithms.The core competitiveness of surgical robots is shifting toward precision control technology.Precision control is a technology that translates a clinician's manipulations into stable surgical motions through position·velocity control, force control, tremor compensation, and motion scaling. Because it directly influences surgical accuracy and safety, it is classified as a foundational technology that dictates product competitiveness.Surgical robot precision control technologies are categorized into sensing-based feedback control, interaction-based control, and autonomous navigation control.Source: Korea Health Industry Development Institute (KHIDI) reportThe importance of precision control is also confirmed in patent trends. According to the report, 4,097 patents related to detailed surgical robot precision control technologies were compiled from 2016 to 2025. Among these, interaction-based control accounted for 2,420 patents, representing 59.1%. Sensing feedback control accounted for 1,129 patents (27.6%), while autonomous navigation accounted for 548 patents (13.4%).While interaction-based control still commands the largest share, technical trends are shifting. Analysis indicates that while the proportion of interaction-based control is declining, the shares of sensing-based feedback control and autonomous navigation are on the rise.This means that surgical robots are moving beyond hardware that only transmits a clinician's movements, evolving into platforms that recognize and compensate for the real-time surgical environment.South Korea's patent applications stands at 4.5%...lowest among major nationsIn terms of patent applications, a distinct competitive landscape emerged, centered heavily on the United States and China. From 2016 to 2025, a total of 3,481 surgical robot precision control patents were filed across the IP5 patent offices (South Korea, the United States, Japan, Europe, and China).By country, the United States Patent and Trademark Office (USPTO) commanded the highest share of applications at 39.9%. China accounted for 29.8%, Europe for 14.0%, and Japan for 11.8%. South Korea recorded 4.5%, the lowest among major countries.South Korea's position was also limited in terms of qualitative patent competitiveness. Among the 3,481 patents published over the past decade, a comparison of patent competitiveness among major nations, focusing on the 1,011 patents registered with the USPTO, revealed that US patents accounted for 745 patents (73.7%).During the same period, Europe recorded 163 patents (16.1%), followed by ▲Japan with 38 ▲China with 20 ▲South Korea with 6.South Korea was presented with a forward citation count of 143, a patent family country count of 20, a patent citation intensity of 23.8, a Patent Impact Index (PII) of 0.0, and a Patent Market Power Index (PMPI) of 0.8. Considering these metrics, the country's overall technological impact and global scalability are evaluated as limited.Year-over-year rate of change in surgical robot precision control patent applications by country (Source: Korea Health Industry Development Institute (KHIDI) report)Gaps across detailed technology segments were also substantial. In the patent competitiveness analysis for sensing feedback control, South Korea held 5 patents, accounting for 1.6% of the total. In interaction-based control, it held 1 patent (0.1%), and in navigation autonomous control, it remained at 2 patents (1.3%).The United States showed a share exceeding 70% across all three sub-segments. It accounted for 238 patents (74.1%) in sensing-based feedback control, 547 patents (74.2%) in interaction-based control, and 118 patents (75.2%) in autonomous navigation control.Patent concentration by specific corporate players was also high. The share of applications by the top 10 companies across each detailed technology exceeded 50%: 53.3% for sensing feedback control, 55.3% for interaction-based control, and 57.3% for navigation autonomous control. This indicates that the surgical robot market is unlikely to be reshaped by simply launching a product.Technology accumulation is more critical than product launchThe prospects for Korean domestic surgical robot enterprises lie in technology accumulation rather than in market entry itself. Surgical robotics is a convergent industry integrating robotics, artificial intelligence, sensors, image processing, and control software.Fabricating robotic arms or localizing surgical instrumentation alone is insufficient to close the gap with global market leaders. Precision control technology directly dictates intraoperative safety. Product competitiveness is determined by how accurately the system reflects minute movements at the surgical site, how reliably it compensates for clinician hand tremors, and how sophisticatedly it manages the forces generated during tissue contact.A comparison of patent competitiveness among major nations, focusing on the 1,011 patents registered with the USPTO, revealed that US patents accounted for 745 patents (73.7%). During the same period, Europe recorded 163 patents (16.1%), followed by Japan with 38, China with 20, and South Korea with 6. (source: Korea Health Industry Development Institute (KHIDI) report)Joint development with clinical sites is also vital. Precision control technology cannot secure commercial viability based purely on laboratory-level performance. Parameters such as operability, stability, and fatigue reduction that clinicians can actively sense must be validated within real-world surgical environments.A global patent strategy must also be designed from the initial phases. Surgical robotics is an area where targeting only the domestic market is unsustainable. From early development, strategies are required to secure enforceable patents in major markets such as the United States and Europe while simultaneously deploying patent-circumvention tactics against competitors.It is challenging for domestic firms to compete head-to-head with global leaders across all domains. A realistic approach involves a field-targeting strategy focusing on precision control technologies tailored to specific surgical specialties, particular techniques, or distinct hospital requirements.An industry insider said, "As surgical robotics is a convergent industry combining robotics, artificial intelligence, sensors, image processing, and control software, securing global competitiveness is difficult through simple product development alone," and added, "The aim for domestic firms will be concurrently establishing real-world clinical validation and global patent strategies centered heavily around core precision control technologies."
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- Envlo accumulates evidence in Asia through H2H SGLT-2 trial
- by Hwang, byoung woo Jun 05, 2026 09:36am
- Daewoong Pharmaceutical is accelerating efforts to accumulate real-world clinical evidence in Asian patients through a direct head-to-head clinical trial of its domestically developed diabetes drug Envlo (enavogliflozin) against other SGLT-2 inhibitors.The company announced on June 4 that it presented interim analysis results and the latest progress of the ENVELOP study at the 39th Korean Diabetes Association Spring Scientific Meeting, held from April 30 to May 2 at the Kimdaejin Convention Center in Gwangju.The ENVELOP study is a large-scale investigation led by Professor Sin Gon Kim of Korea University College of Medicine, with participation from a nationwide multicenter research network. The study was designed to evaluate whether Envlo, Korea's 36th domestically developed new drug, can generate clinical evidence supporting cardiovascular disease prevention and kidney function improvement in Asian patients with diabetes in real-world practice.In diabetes treatment, SGLT-2 inhibitors have expanded their role beyond glycemic control, based on their cardiovascular and renal protective benefits. As cardiovascular death and declining kidney function are major determinants of prognosis in patients with diabetes, integrated management of cardiovascular-kidney-metabolic (CKM) health has become increasingly important.Daewoong noted that while large global Cardiovascular Outcome Trials (CVOTs) have established the cardiovascular and renal benefits of the SGLT-2 inhibitor class, most were placebo-controlled studies. Consequently, evidence directly comparing agents within the class has remained limited, making treatment selection in actual clinical practice challenging.The ENVELOP was specifically designed to address this evidence gap. According to Daewoong, the trial directly compares Envlo with two SGLT-2 inhibitors—dapagliflozin and empagliflozin—with a primary objective of demonstrating non-inferiority.Importantly, the study employs a pragmatic clinical trial design, reflecting data generated in real-world clinical practice rather than a strictly controlled experimental environment. Conducted as a multicenter, prospective study involving endocrinologists from 55 institutions across Korea, it is expected to provide clinically meaningful evidence specific to Asian populations, including Korean patients, unlike existing global clinical data accumulated primarily around Western populations.The study is progressing smoothly. As of April 2026, approximately 88% of the target enrollment of 2,862 patients have been enrolled. The average age of the enrolled patients was 60.4 years, and the average body mass index (BMI) was 26.26 kg/m².Interim analysis showed no statistically significant differences versus comparator groups in key endpoints, including hemoglobin A1c (HbA1c), estimated glomerular filtration rate (eGFR), and urine albumin-creatinine ratio (UACR).Daewoong Pharmaceutical noted how this study was conducted based on an Asian patient population with an average BMI of approximately 26 kg/m². This is because it can reflect the characteristics of Korean and Asian patients, who have different profiles in terms of cardiovascular risk structures and renal disease prevalence compared to existing Western-centered global clinical trials. The company expects the findings to serve as important academic and clinical evidence for prescribing decisions throughout Asia.Professor Sin Gon Kim of Korea University College of Medicine said, "Although GLP-1 therapies have recently attracted significant attention, SGLT-2 inhibitors continue to demonstrate unique advantages in terms of proven cardiovascular and renal protection as well as cost-effectiveness. Through this study, we hope to generate long-term evidence for Asian patients and further elevate the global standing of Korean medicine."Hyung Chul Park, Head of ETC Marketing at Daewoong Pharmaceutical, stated, "The ENVELOP study holds particular significance as it generates differentiated clinical evidence for Envlo based on real-world clinical practice data. As the world's first direct comparison among SGLT-2 inhibitors, it has the potential to become an important academic asset that could influence treatment-selection criteria in Korea."He added, "We will continue strengthening data-driven marketing efforts in Korea and abroad while generating Korean-specific clinical evidence to provide optimal treatment options for patients with diabetes.”The study was unveiled at the 39th Spring Scientific Meeting of the Korean Diabetes Association, which was held under the theme ‘Challenges and Innovations for Overcoming Diabetes.’ During the event, a total of 63 sessions were held, featuring presentations by 213 domestic and international experts and 106 poster presentations
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- Gov’t shifts focus to flu prevention beyond managing vaccination rates
- by Son, Hyung Min Jun 05, 2026 09:35am
- As South Korea entered a super-aged society last year, with the population aged 65 and over surpassing 10 million, calls are growing for a shift in the direction of influenza vaccination policy for older adults.Recent calls from the Korean Senior Citizens Association (KSCA) and political parties for the adoption of high-immunogenicity influenza vaccines for older adults have sparked interest in whether the National Immunization Program (NIP) can evolve from a policy focused primarily on vaccination coverage to one centered on effective prevention.According to industry sources on the 4th, the KSCA mentioned the need to transition toward a tailored influenza vaccination strategy for older adults for a policy recommendation this year, in a proposal.The association noted that while free influenza vaccination is currently provided to older adults aged 65 and over through the National Immunization Program, the vaccine's effectiveness may be relatively low due to age-related decline in immune function. Accordingly, it suggested the need to consider the phased introduction of vaccines with higher preventive efficacy to ensure the practical prevention of diseases and secure the health rights of seniors.The issue has also gained attention in the political arena.Both the Democratic Party of Korea and the People Power Party recently referenced the introduction or gradual expansion of high-immunogenicity influenza vaccines for older adults in their policy platforms. Although their implementation approaches differ, both parties share the view that vaccination policy for older adults should move beyond vaccination rates and place greater emphasis on actual preventive effectiveness.Disease burden remains high despite strong vaccination coverageInfluenza vaccination coverage among Koreans aged 65 years and older remains above 80%. Nevertheless, influenza-related hospitalizations and deaths continue to be concentrated in this age group, and the disease burden has increased alongside larger seasonal outbreaks.Experts attribute this phenomenon to immunosenescence, the gradual deterioration of immune system function associated with aging. As immune responses generated after vaccination weaken with age, the real-world protective effect of vaccines may also decline.In a study conducted by eight university hospitals in Korea, the effectiveness of standard-dose influenza vaccines among adults aged 65 years and older was estimated to be around 14%.As a result, experts argue that vaccination coverage alone is insufficient to reduce disease burden in older adults and that vaccination strategies should also consider reductions in hospitalization and severe disease.Major countries expand strategies focused on the prevention effect.Many countries have already expanded vaccination strategies tailored to age and risk profiles.The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) has recommended high-immunogenicity vaccines—including high-dose and adjuvanted influenza vaccines—for adults aged 65 years and older since the 2022–2023 influenza season.Germany's Standing Committee on Vaccination (STIKO) recommends high-dose influenza vaccines for adults aged 60 years and older. Taiwan introduced high-immunogenicity vaccines this year for elderly residents of long-term care facilities, while Japan is expanding the use of such vaccines among adults aged 75 years and older.The policies of these countries focus not only on managing the simple vaccination rate but also on meaningful health outcomes such as reduced hospitalization rates, prevention of severe illness, and alleviation of healthcare burdens.However, further discussion will be needed before high-immunogenicity vaccines can be incorporated into Korea's National Immunization Program. Issues such as financial burden, cost-effectiveness assessments, and prioritization of target populations remain to be addressed.Whether the policy is ultimately adopted will depend on future discussions by the Korea Disease Control and Prevention Agency (KDCA) and the Korea Expert Committee on Immunization Practices (KECIP). Nevertheless, as Korea continues to age rapidly and the infectious disease burden among older adults increases, debate over shifting vaccination policy from a vaccination rate-focused approach to one centered on the preventive effect and progression to severe disease is expected to continue.
