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- 2025-12-22 05:00:04
- Company
- Reimb extension of anticancer drug combos imminent
- by Moon, sung-ho May 02, 2025 05:56am
- With the government announcing a major overhaul of its reimbursement policy for the use of anticancer drug combination therapies, there are various predictions on what specific methodology would be adopted. Curiosity is also growing about the scope of reimbursement that will be granted among the numerous combination therapies available, as well as when it will be applied. #In particular, as the MOHW has only announced the overhaul without providing any specific details, pharmaceutical companies, healthcare professionals, and patients are paying close attention and offering various predictions. According to industry sources on the 28th, the Ministry of Health and Welfare recently announced a partial amendment to the “Detailed Standards for the Application of Medical Care Benefits” with the main focus on improving the reimbursement policy for combination therapies. If confirmed as is, the amendment will be applied starting next month. The key point of the amendment is to completely change the reimbursement method for combination therapies, which has recently emerged as a major option in cancer treatment. Over the past five years, a total of 54 combination therapies using anticancer drugs have been approved in Korea. Among these, 28 involved adding new drugs to existing ones, while 26 involved combining two new drugs. However, if a new drug that is not covered by insurance is added to a drug that is already covered, it is considered a new therapy, and the existing drug is also no longer covered, placing a significant burden on patients. Furthermore, as combination therapy has become a trend in new drug development not only in Korea but also in the global market, controversy has repeatedly arisen whenever a new combination is approved in Korea. Amidst this controversy, the MOHW decided to add the following content to the revised notice: “In cases where anticancer therapy already granted reimbursement is used in combination with other anticancer drugs, the existing coinsurance rate shall apply to the existing anticancer therapy.” The MOHW added, ”In accordance with the HIRA announcement that the drug administration standards for anticancer therapy will be changed, the cost burden regulations will also be revised accordingly.” For reference, the MOHW also provided HIRA's contact information instead of its own in the administrative notice. Following the administrative notice, patient groups and related organizations such as the KRPIA unanimously welcomed the MOHW's policy. However, as no further details have been provided, questions surrounding the specific methodology are growing. Based on the announcement alone, it is unclear whether all anticancer drugs that are currently reimbursed regardless of indication will immediately be granted the same coverage when used in combination with other anticancer drugs starting in May. Even if individual treatments are currently covered by reimbursement, if they are approved for new indications when used in combination and are not covered by reimbursement, there is uncertainty as to which of the treatments will be covered by reimbursement after the administrative notice is finalized. This naturally leads to the question of whether the more expensive or less expensive one of the two drugs will be reimbursed. In addition, there are questions about whether combination therapies that have been approved by the MFDS based only on progression-free survival (PFS) data without overall survival (OS) data will be reimbursed under the MOHW's new policy. Accordingly, the industry, especially the multinational pharmaceutical companies, is paying close attention to the HIRA Cancer Disease Deliberation Committee meeting scheduled for the 30th. If the MOHW administrative notice is finalized at the end of this month, the industry expects the additional details to be announced at the CDDC meeting held at the end of April. At a CDDC meeting in October last year, HIRA established deliberation principles for discussing whether to approve reimbursement for major combination therapies and has been gathering opinions from relevant academic societies. A CDDC member, who is a university hospital professor, said, “In previous discussions, HIRA did not allow the use of drug A with reimbursement and drug B with 100% coinsurance just because their combined use was approved by the MFDS. Instead, we decided to discuss it if a request was made through the collection of opinions from academic societies.” He added, ”Even if it is approved by the MFDS if reimbursement is granted as is, it will cause problems with insurance finances, so this would require the Cancer Drug Review Committee’s control.” He added, “We were originally scheduled to discuss the opinions on combination therapy reimbursement proposed by each academic society at the end of this month. We will focus on the recommendations made in the guidelines for anticancer drugs, but it is questionable whether it is possible to switch all the recommended therapies to reimbursement at once given the current situation.” This is why there are concerns in the frontline about what will happen if the MOHW's announcement is implemented in May. Some are fearing possible reimbursement cuts. With the MOHW's policy on combination therapy announced, a series of inquiries have already been pouring in from patients during outpatient visits. A professor of hematology and oncology at a tertiary hospital, who requested anonymity, said, “HIRA has gathered opinions on the reimbursement of combination therapy through academic societies, but it is still questionable whether everything can be applied in May. I am concerned that there will be cuts when we file the claims.” He added, ”In the case of multiple myeloma, combination therapy is always used for each stage of treatment. Moreover, the number of high-priced treatments has been increasing recently,” he said, expressing his concern, ”If reimbursement cuts are made, hospitals will suffer considerable damage. We must prepare for all possibilities.” As a result, if the MOHW's policy is applied as is to clinical practice, the sequencing itself, including the number of treatment sequences, will differ for each type of cancer. A pharmaceutical industry official explained, “Although this policy is being promoted specifically for anticancer drugs, issues of equity with other diseases are bound to arise in the future. If this policy is limited to anticancer drugs, the entire sequencing in clinical practice will change. If some drugs are used in the first line because they are reimbursed, there may be cancer types for which there are no treatment options that can be used with reimbursement in the second line.” The insider concluded, “Considering all these factors if the May notice is finalized, it could cause significant confusion in practice and the pharmaceutical industry. While patients may welcome this development, it is an issue that requires more systematic discussion.”
- Policy
- Reimb for ovarian cancer treatment lacks full coverage
- by Whang, byung-woo May 02, 2025 05:56am
- Despite expanded reimbursement for homologous recombinant deficiency (HRD)-positive ovarian cancer, HRD-related tests remain non-reimbursed. The Korean medical community has taken the initiative to resolve this issue. Sources reported that the Korean Society of Gynecologic Oncology is collecting evidence to propose reimbursing the HRD tests to the Ministry of Health and Welfare (MOHW). HRD is the loss of homologous recombination repair, which is one of the DNA repair processes. When a patient tests positive for HRD, cancer cells are unable to repair DNA damage effectively. In particular, mutations in BRCA1/2 genes, commonly occurring in breast cancer and ovarian cancer, cause HRD. The HRD prevalence in ovarian cancer is clinically reported to be about 50%. The Korean Society of Gynecologic Oncology focuses on the HRD tests because of expanded reimbursement for the ovarian cancer treatment Zejula. The National Health Insurance reimbursement criteria for Zejula expanded since October last year to the treatment of HRD-positive ovarian cancer. Previously, reimbursement of Zejula was approved for patients with BRCA mutations-associated ovarian cancer who responded to platinum-based therapy in first-line treatment. Due to expanded reimbursement, Zejula is now the only PARP (Poly ADP-ribose Polymerase) inhibitor with insurance coverage for first-line maintenance therapy in HRD-positive ovarian cancer patients. Product photo of ZejulaAbout seven months after the reimbursement expansion, prescriptions for Zejula have continued to increase. Ovarian cancer patients take two 100 mg tablets once daily, and among conventional ovarian cancer treatments, Zejula is the only one with a once-daily dosing regimen. In particular, since long-term PFS extension benefits have been confirmed in the PRIMA trial and follow-up observational studies, increased prescriptions following reimbursement expansion were expected. The issue lies in the HRD-positive status that is central to the reimbursement expansion. Since the reimbursement criteria are for HRD-positive ovarian cancer treatment, confirming HRD positivity is essential. However, unlike Zejula being reimbursed, the HRD tests remain non-reimbursed. The HRD test requires a next-generation sequencing (NGS)-based gene panel assay, for which the patient must bear approximately KRW 2.5 million in costs. In contrast, BRCA1/2 mutation testing has relatively greater accessibility through national programs and partial health insurance coverage, creating a gap between the two tests. In other words, patients seeking a reimbursed prescription for Zejula must pay out-of-pocket for an expensive and non-reimbursed test. The Korean Society of Gynecologic Oncology has also recognized this issue and plans to propose a policy measure to address it. A society official stated, "From a patient's perspective, it is difficult to understand that a non-reimbursed test is required in order to prescribe a reimbursed drug," and added, "We are planning to review Korea's testing infrastructure and foreign precedents and convey related opinions to the MOHW." The society's proposal on HRD testing is scheduled to be submitted to the MOHW and the Health Insurance Review & Assessment Service (HIRA) as early as the first half of the year. However, whether they will lead to substantive discussions on formal reimbursement remains to be seen. Considering that the prevalence of HRD in ovarian cancer reaches about 50% and that most patients require testing before treatment, the real-world issue of financial burden persists. A Korean Society of Gynecologic Oncology representative added, "To improve treatment outcomes for ovarian cancer patients, the introduction and utilization of HRD testing are necessary. Therefore, institutional support will be necessary."
- Company
- Will Ebglyss benefit from the reimb changes in Korea
- by Eo, Yun-Ho May 02, 2025 05:56am
- With the tide turning in favor of allowing switching between atopic dermatitis treatments in Korea, all eyes are on whether Ebglyss will be able to emerge as a new player in the market. According to industry sources, Eli Lilly Korea accepted a price less than the evaluated amount(lower than the weighted average price of substitute drugs) set for Ebglyss (lebrikizumab) presented by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service in February and is currently negotiating drug prices with the National Health Insurance Service. If Ebglyss is listed, there will be 6 treatment options available for atopic dermatitis in Korea. The options include the biological agents (injectables) “Dupixent (dupilumab)” and “Adtralza (tralokinumab),” and JAK inhibitors (oral) “Rinvoq (upadacitinib),” “Civinqo (abrocitinib),” and “Olumiant (baricitinib).” The health authorities have recently been considering whether to allow JAK inhibitors to be used in cases where patients do not respond adequately to existing treatments (biological agents) or have poor tolerability, which is expected to further intensify market competition. If approved, Ebglyss will immediately benefit from the regulatory changes. It was approved by the Ministry of Food and Drug Safety in August 2024 for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years of age and older (weighing at least 40 kilograms) who are inadequately controlled by topical treatments or for whom such treatments are not recommended. Ebglyss demonstrated its clinical efficacy and safety profile in a pivotal Phase III clinical trial. Patients who achieve a clinical response after 16 weeks of treatment can thereafter receive a maintenance dose (250 mg) every 4 weeks, making it a useful first-line treatment option for patients with atopic dermatitis in Korea. The clinical studies on which the license was based are the Phase III ADvocate-1, ADvocate-2, and ADhere trials. The trials evaluated the clinical efficacy and safety of Ebglyss in 1062 adults and adolescents with moderate-to-severe atopic dermatitis. In ADvocate-1 and ADvocate-2, which evaluated Ebglyss as a monotherapy, Ebglyss improved outcomes, with 58.8% and 52.1% (16.2% and 18.1%, respectively in the placebo arm) achieving Eczema Area and Severity Index (EASI) 75; and 38.3% and 30.7% (9% and 9.5%, respectively in the placebo arm) achieving EASI 90 during the induction period (weeks 0-16) compared to placebo. Also, after one year of maintenance therapy (Week 52), 81.7% of the Ebglyss arm achieved EASI 75 (vs. 66.4% in the placebo arm) and 66.4% achieved EASI 90 (vs. 41.9% in the placebo arm), demonstrating significant symptom improvement in the long term.
- Company
- New dementia drug Leqembi expands prescriptions in KOR
- by Eo, Yun-Ho May 02, 2025 05:55am
- Despite being a non-reimbursed drug, the Alzheimer's treatment Leqembi is being actively prescribed in Korea. According to industry sources, Eisai Korea's Leqembi (lecanemab) is now available for prescription at major tertiary hospitals including Samsung Medica Center, Seoul National University Hospital, Asan Medical Center, and Sinchon Severance Hospital, as well as other medical institutions such as Gachon University Gil Hospital, Korea University Guro Hospital, Busan Paik Hospital, and Ilsan Gospel Hospital. Since its official launch late last year, the drug has been rapidly expanding its prescription scope in Korea. Leqembi has been proven to reduce the rate of disease progression and slow cognitive decline by selectively binding to amyloid beta (Aβ) aggregates, which are a known cause of Alzheimer's disease. Due to the lack of treatments for the disease, the desperation of the patients and their families had been indescribable. In addition to public petitions, the MFDS's Korea Orphan & Essential Drug Center has been inundated with inquiries on the date of Leqembi’s approval and supply in Korea. However, the problem is the price of the drug. In the U.S., Leqembi costs about KRW 35 million per year; in Japan, it costs KRW 27 million. Due to its high price, it will take a while for the drug to be approved in Korea and be listed for reimbursement as it requires a tug-of-war between pharmaceutical companies and the government. In the Clarity AD study, Leqembi achieved statistically significant results in both its primary and secondary endpoints. Specifically, Leqembi delayed clinical decline in brain function by 27% at 18 months compared to placebo. While the market for amyloid-targeted therapies such as Leqembi is gaining recognition for its effect in delaying the onset of dementia, the use of the drug has been hampered by its characteristic side effects. The amyloid-related imaging abnormalities (ARIA) that are often mentioned as an issue, are abnormal signals observed on MRI scans, such as brain edema or microhemorrhage that are detected with the drug’s use. Depending on how the adverse event occurs, ARIA is classified as ARIA-E and ARIA-H. ARIA-E can be observed on MRI as brain edema or sulcal effusions, and ARIA-H as microhemorrhage and superficial siderosis. Meanwhile, Leqembi has recently received approval from the European Commission (EC). As a result, Leqembi has become the first new Alzheimer's disease drug with a novel mechanism of action to be approved in Europe.
- Opinion
- [Reporter's View] USIM data leakage incident is a warning
- by Kim, Jin-Gu May 02, 2025 05:55am
- The SKT USIM data leakage incident has spread anxiety throughout society. Previously, there have been countless personal data security breaches, but the latest incident is considered differently. The scale of the expected damage is so large that it’s hard to estimate. Long lines have formed in front of SKT stores as people wait to replace their USIM cards. This incident not only exposes gaps in telecom security but also serves as a reminder of the importance of personal data protection across all sectors. The pharmaceutical and biotech industry is no exception. The information handled by biopharmaceutical companies goes far beyond simple customer data. Health information of clinical trial participants, disease and genetic data, and records of drug responses are high-risk data that, if hacked, could cause irreparable damage. Moreover, such information is routinely shared through collaborations with external partners, including hospitals, research institutes, and CROs. Even a single vulnerability in the security framework could jeopardize the entire ecosystem. The biopharmaceutical industry has had personal data breaches before. In 2024, one firm was indicted for illegally collecting the names, diagnoses, and prescribed medications of 39,000 patients from four general hospitals. In 2023, another company suffered a hack that exposed sensitive data, such as physicians' and pharmacists' names, affiliated institutions, specialties, email addresses, and mobile phone numbers. Within companies, information security departments are often undervalued. They don't directly contribute to productivity, and the nature of their work means 'doing a good job' is frequently taken for granted. Yet data security is not solely the IT department's responsibility. Every organization member, from the CEO to the researchers, must be aware of 'data risks.' Especially now, as AI-driven drug development, digital health, and telemedicine expand data-driven business models, information protection becomes not just an obligation but a 'competitive advantage.' The SKT incident is a warning. The pharmaceutical industry should learn from it, audit its security frameworks, and strengthen its crisis-response capabilities. A single moment of neglect could make the biopharmaceutical industry the next victim. It can take years to build trust, but only a single day to lose it.
- Company
- Entry of oral GLP-1 obesity drug imminent...Novo vs Lilly
- by Son, Hyung Min Apr 30, 2025 06:11am
- The launch of an oral GLP-1 class obesity drug is imminent. Novo Nordisk recently completed a Phase III clinical trial for its oral obesity drug candidate and submitted a marketing authorization application to the U.S. Food and Drug Administration (FDA). Eli Lilly, a competitor of Novo Nordisk, is also developing an oral GLP-1 class drug candidate, orforglipron, as a successor to Zepbound. Lilly has confirmed significant weight loss effects of its candidate in a Phase III clinical trial. In addition, domestic and international pharmaceutical companies such as Viking Therapeutics, Ildong Pharmaceutical, and D&D Pharmatech are also actively developing oral GLP-1 drugs. Novo and Lilly complete Phase III trials side by side According to industry sources on the 28th, Novo Nordisk has completed a Phase III clinical trial for its oral semaglutide-based obesity drug candidate and recently submitted a marketing authorization application to the FDA. The pharmaceutical industry has been racing to develop new formulations since GLP-1 class obesity treatments such as Saxenda, Wegovy, and Zepbound emerged as global blockbuster drugs. The existing drug Saxenda requires once-daily administration, while Wegovy and Zepbound require weekly injections. Oral formulations are expected to gain a competitive edge in terms of convenience of administration. Novo Nordisk, which developed the oral diabetes drug Rybelsus containing semaglutide, has also begun developing an oral obesity drug. In the OASIS1 clinical trial, which confirmed the weight-loss effect of oral semaglutide, a 50mg dose of the compound demonstrated a 15% reduction in body weight compared to placebo over 68 weeks. This result was statistically significant compared to the placebo group, and adverse reactions were comparable to those observed in previous injectable clinical trials. Novo Nordisk is also developing a combination oral formulation of GLP-1 and amylin analog to stay ahead of the competition. According to clinical results disclosed to date, the average weight loss effect of this new drug candidate at week 12 was 12%. Eli Lilly has also recently disclosed the results of a Phase III clinical trial for its oral GLP-1 agent. Lilly's investigational drug, orforglipron, demonstrated simultaneous effects on HbA1c and weight loss. In the Phase III clinical trial named ACHIEVE-1, orforglipron 36 mg (once daily) reduced HbA1c by an average of 1.5% over 40 weeks. During the same period, the placebo group saw a reduction of only 0.1%. Additionally, the orforglipron group showed an average weight loss rate of 7.9%, compared to 1.6% in the placebo group, demonstrating a significant difference. In terms of safety, no significant adverse reactions were observed beyond the gastrointestinal side effects that are characteristic of GLP-1 class drug. The rate of treatment discontinuation due to adverse effects was 8% in the orforglipron 36 mg group, higher than the 1% in the placebo group, but most were mild-to-moderate in severity. No serious adverse reactions, such as liver toxicity, were reported. Lilly is preparing to submit a marketing authorization application for the obesity indication of orforglipron by the end of this year, with the diabetes indication targeted for submission in 2026. Lilly aims to shift the paradigm of the GLP-1 market, which has been dominated by injectable formulations, by leveraging orforglipron. Lilly expects a strong response from the medical field, as orforglipron is an oral small molecule drug with manufacturing ease and supply flexibility. In fact, Lilly has already invested billions of dollars in expanding its production infrastructure in the U.S. since last year to prepare for the global launch of orforglipron. Novo Nordisk and Lilly lead the oral obesity drug pathway, with Viking and Ildong among other domestic and international pharmaceutical companies in pursuit Semaglutide-based obesity drugsIn addition to Novo Nordisk and Lilly, Viking Therapeutics, Ildong Pharmaceutical, and D&D Pharmatech are also actively developing oral GLP-1 drugs. Viking Therapeutics recently announced the results of a Phase I clinical trial of VK2735, an oral candidate drug targeting GLP-1/ glucose-dependent insulinotropic polypeptide (GIP). This study evaluated the safety and tolerability of VK2735 in healthy adults with a body mass index (BMI) of 30 kg/m² or higher, who received a single daily dose of VK2735 for 28 days. The clinical results demonstrated encouraging safety and tolerability of VK2735 at a maximum daily dose of 40 mg. In detail, VK2735 at 40 mg showed a maximum weight loss effect of 5.3% compared to baseline. In terms of safety, all treatment-related adverse events reported in participants who received VK2735 were mild-or-moderate. The majority (76%) were mild, and vomiting, one of the representative side effects of obesity drugs, was not reported. Viking Therapeutics plans to confirm the potential of VK2735 through a Phase II clinical trial Yunovia, a new drug research and development subsidiary of the Ildong Pharmaceutical, is conducting a Phase I clinical trial on ID110521156, a new drug candidate in the GLP-1 receptor agonist class targeting metabolic diseases such as diabetes and obesity. ID110521156 is a small molecule drug, and the company aims to develop it as an oral synthetic new drug for diabetes and obesity with distinct advantages over existing representative treatments, such as peptide injections, including superior productivity and excellent ease of use. Previously, Yunovia confirmed the efficacy of its candidate’s insulin secretion and blood sugar control through preclinical efficacy and toxicity evaluations. Its candidate also demonstrated superior safety compared to competing drugs in the same class and confirmed promising drug characteristics in the recently completed Phase I single-ascending dose (SAD) trial. D&D Pharmatech is collaborating with U.S.-based Metsera on the development of an oral obesity drug. Previously, Metsera entered into a technology transfer agreement with D&D Pharmatech in April 2023 to acquire the rights to 'DD02S,' an oral GLP-1-based peptide obesity treatment candidate, and 'DD03,' an oral GLP-1, GIP, and glucagon receptor triple agonist obesity treatment candiate. The first patient dosing for a Phase I/II clinical trial on DD02S was completed in North America last November. D&D Pharmatech confirmed that DD02S demonstrated more than 12.5 times higher absorption rate than the currently marketed oral GLP-1-based obesity treatment ‘Rybelsus (semaglutide)’ in preclinical studies.
- Opinion
- [Reporter’s View] Consideration in legislating telemedicine
- by Lee, Jeong-Hwan Apr 30, 2025 06:07am
- Following the presidential election on June 3, which will determine the next president and new administration, one of the most urgent healthcare policies that would need to be addressed is ‘non-face-to-face treatment,’ or telemedicine. Currently, two bills to formalize telemedicine, which is currently under pilot programs, are pending in the National Assembly. Both bills were proposed by members of the People Power Party (Rep Bo-yoon Choi and Jaejun Woo). The Democratic Party of Korea is also preparing to introduce a bill to formalize telemedicine. Amid this situation, platforms that mediate telemedicine services have urged the National Assembly and the government to legalize telemedicine by fully permitting its use for all patients and to establish a system for delivering prescription medications to patients. They argued that implementing the Yoon Suk Yeol administration's unrestricted pilot program, which was launched with the goal of activating and fostering the telemedicine industry, as is, would minimize patient inconvenience and allow platforms currently operating as intermediaries to maintain and expand their revenue models. From the perspective of platforms that generate revenue by mediating telemedicine and prescription between medical institutions, patients, and pharmacies, calling for the institutionalization of telemedicine under a “negative approach” that maximizes the scope of its application is understandable. However, this conflicts with the fundamental principle of South Korea's healthcare system, which prioritizes in-person diagnosis and prescription, which is why the agenda requires careful consideration. Since telemedicine was permitted in Korea in February 2020 due to the COVID-19 pandemic, the platform industry has developed rapidly over the past 5 years. It is also a true that these platforms contributed to the stable implementation of telemedicine and preventing national and social panic caused by the spread of new infectious diseases. Nevertheless, the full legalization of telemedicine without clarifying distinctions between initial and follow-up visits or specifying the scope of application raises sufficient concerns that it could undermine or distort the domestic system built on the principles of in-person diagnosis and prescription. Furthermore, it is necessary for the executive and legislative authorities to carefully consider whether it is truly a top priority to dismantle regulations and legalize telemedicine so that all patients can receive telemedicine without any barriers, even in metropolitan areas such as Seoul and Gyeonggi Province, where medical institutions are abundant. In simpler terms, it is essential to closely examine the potential side effects that may arise if an environment is created where patients with minor illnesses can easily obtain prescription medications through telemedicine simply because they find it inconvenient to visit a hospital. The Ministry of Health and Welfare has already confirmed that non-face-to-face medical consultations have affected the overprescription of obesity drugs such as Saxenda during the pilot project, and has implemented supplementary administrative measures such as revising the list of prohibited drugs. Currently, the medical community and pharmacists are raising questions about the necessity of allowing telemedicine for conditions like hair loss or acne, which are relatively non-urgent and have low severity, as well as the need for medication prescriptions in such cases. Without properly understanding this reality, simply transferring the current unrestricted telemedicine system into legislation based on the fact that South Korea has implemented telemedicine for over 5 years could accelerate distortions in the medical delivery system or increase the risk of abnormal diagnostic and prescription practices. While radical reforms may sometimes be necessary to modernize outdated systems, such reforms inevitably come with corresponding side effects. Prior to the COVID-19 pandemic, South Korea's healthcare system had not faced significant issues, except for shortages in essential and regional medical care. Therefore, the legislative direction for the institutionalization of telemedicine to be discussed by the National Assembly after the 21st presidential election should focus on effectively resolving the collapse of essential and regional medical care, rather than promoting the telemedicine industry or developing platform business models. South Korea's healthcare system has been established and developed over the past 25 years since the separation of medical and pharmaceutical services in 2000, under the slogan “Diagnosis by doctors, dispensing by pharmacists.” If telemedicine policies are legalized solely based on the global and nationwide shock and damage caused by the novel infectious disease pandemic over the past few years, there is a risk that a system that disregards the domestic healthcare delivery system and pharmacy ecosystem may replace the current system that has been established since the separation of medical and pharmaceutical services. Given that the outcome of the June 3 presidential election will determine whether the current administration remains in power or changes, the specific direction of the telemedicine systemization will also be influenced by the results of the presidential election and subsequent legislative reviews in the National Assembly. The new president and government should prioritize making a social consensus on institutionalizing telemedicine in a manner that maintains and restores a safe and unbiased healthcare system, rather than focusing on telemedicine for the industry revitalization.
- Company
- K-pharma unveils results on TPD to ADC at AACR
- by Son, Hyung Min Apr 30, 2025 06:07am
- The Korean pharmaceutical and biotech industry has shown achievements in developing anticancer drugs equipped with novel mechanisms. They demonstrated potential in areas that have rapidly risen as R&D trends, such as targeted protein degraders, antibody-drug conjugates (ADCs), and bispecific antibodies. According to industry sources on the 29th, the American Association for Cancer Research Annual Meeting (AACR 2025) began on the 25th and will run for five days in Chicago, USA. The AACR is classified as one of the world’s top three oncology conferences, along with the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO). The annual meeting primarily features early‐stage clinical results for anticancer drug candidates, such as preclinical and phase 1 data. Dong-A ST·Therapex demonstrated achievements in preclinical trials involving TPD Companies such as Dong-A ST, Therapex, Pin Therapeutics, and Nibec unveiled their development results for targeted protein degraders (TPDs) at this meeting. While conventional small‐molecule therapies inhibit protein function, TPD drugs are designed to fundamentally degrade and remove disease-causing proteins, offering superior therapeutic efficacy and eliminating resistance issues. TPD drugs's advantage lies in their ability to target over 80 % of disease-causing proteins that cannot be modulated by conventional small‐molecule compounds. Dong-A ST unveiled preclinical results for its EGFR-targeted protein degrader 'SC2073' at this meeting. Currently available EGFR-positive lung cancer treatments include first-generation Iressa (gefitinib, AstraZeneca) and Tarceva (erlotinib, Roche), second-generation Giotrif (afatinib, Boehringer Ingelheim) and Vizimpro (dacomitinib, Pfizer), and third-generation Leclaza (lazertinib, Yuhan) and Tagrisso (osimertinib, AstraZeneca). However, resistance often develops even with highly effective targeted therapies. The C797S mutation is a key resistance mechanism in EGFR-positive treatment. Moreover, treatment options remain limited after resistance to targeted therapies emerges. For patients with resistance to targeted therapies, options such as platinum-based chemotherapy, docetaxel, or immuno-oncology agents are available, but response rates show no significant improvement. SC2073 acts on an allosteric binding site of EGFR and selectively degrades only the mutant EGFR forms that are resistant to existing non-small cell lung cancer (NSCLC) therapies. It does not affect normal EGFR, thereby minimizing associated side effects. Therapex unveiled data on its degrader antibody–drug conjugate (DAC) 'TRX-214-1002,' which links a GSPT1 molecular glue to a CD33 antibody, at AACR 2025. DACs are expected to offer higher safety than ADCs because they employ TPDs, small molecules that degrade proteins. ADCs are novel anticancer drugs that connect an antibody, which binds to specific antigens on the surface of cancer cells, with a cytotoxic drug linked by a linker. ADCs use antibodies' selectivity for their targets and the drug's cytotoxic activity to selectively target cancer cells, thereby increasing therapeutic efficacy while minimizing side effects. While Roche's Kadcyla, the first-generation ADC, is only approved for breast cancer, second-generation ADCs are approved for various indications. Enhertu and Trodelvy have been shown to be effective in various solid cancer areas, such as breast cancer, non-small cell lung cancer (NSCLC), and colorectal cancer. Despite its high intracellular target specificity and ability to induce decreased protein expression, TPD has low in vivo utilization. Developers are conducting clinical trials to use TPD and ADC for precise target identification. AACR 2025 Therapex is developing TRX-214-1002 as a treatment for acute myeloid leukemia (AML) that is refractory to existing therapies or has low drug responsiveness. In July of last year, it received support from the Korea Drug Development Fund (KDDF) to advance its development. TRX-214-1002 attaches a GSPT1 payload to the same antibody used in the ADC therapeutic 'Mylotarg.' Preclinical results showed that TRX-214-1002 demonstrated improved outcomes in AML treatment compared with conventional ADC therapies. Pin Therapeutics has unveiled the preclinical research results for 'PIN-5018' for the first time. PIN-5018 is a molecular glue degrader targeting CK1α (Casein Kinase 1 alpha), operating via a mechanism that blocks cancer cell survival pathways. Pin Therapeutics has unveiled the preclinical research results for 'PIN-5018' for the first time. PIN-5018 is a molecular glue degrader targeting CK1α (Casein Kinase 1 alpha), operating via a mechanism that blocks cancer cell survival pathways. CK1α is a serine/threonine kinase that plays essential roles in cell cycle regulation, DNA repair, immune responses, and other vital functions. PIN-5018 works by suppressing cancer cell growth and survival through induction of the degradation of this protein. PIN-5018 is being developed specifically for MSS (Microsatellite Stable) colorectal cancer, which has a low response rate to immuno-oncology drugs. MSS-type colorectal cancer accounts for approximately 80–85% of all colorectal cancers. Still, it is classified as an area of high unmet need because current response rates to immuno-oncology drugs or targeted therapies are low, and the duration of response is short. Pin Therapeutics reported that PIN-5018 demonstrated superior antitumor efficacy compared to existing first-line therapies in preclinical studies and showed positive potential as a monotherapy and in combination regimens. Yuhan·Celltrion·Aptamer Sciences presented preclinical results for ADCs and bispecific antibodies Yuhan and ABL Bio presented preclinical data on 'YH32364' (ABL104) in a poster session at this AACR meeting. YH32364 is designed as a bispecific antibody that simultaneously targets EGFR and 4-1BB. EGFR is a well-known biomarker expressed in major solid tumors, including non–small cell lung cancer (NSCLC) and colorectal cancer. By simultaneously targeting EGFR and T-cell activating 4-1BB, Yuhan aims to maximize the antitumor effect of this immuno-oncology candidate. Yuhan reported that in a preclinical efficacy trial, YH32364 showed stronger superior effects in EGFR-expressing tumors compared to cetuximab. It was demonstrated that the candidate drug retained long-term anti-tumor effects through immunological memory. Furthermore, it was confirmed that YH32364 activated 4-1BB signaling in EGFR-expressing tumors, leading to the recruitment of tumor-infiltrating immune cells and altering the tumor microenvironment. Cetuximab is an anticancer agent that targets the EGFR receptor and is used to treat various cancers, including colorectal cancer, head and neck cancer, and lung cancer. It is particularly well known to be effective in colorectal cancer patients with KRAS gene mutations. Yuhan stated that YH32364 works by activating immune cells through EGFR-specific 4-1BB signaling in tumors. The company hopes YH32364 will be more effective in a wide variety of EGFR-expressing solid cancers than anti-EGFR mAb. AACR 2025 Celltrion presented preclinical results for its multi-specific antibody-based anticancer drug candidate, 'CT-P72.' CT-P72 is a multi-specific antibody immunotherapy co-developed by Celltrion and Abpro, a biotechnology company based in the United States. This therapy is designed as a T-cell engager (TCE), which connects cancer cells that express HER2 (Human Epidermal Growth Factor Receptor 2) with T cells, a type of immune cell, to help eliminate the cancer cells. T-cell engagers are a bispecific antibody-based modality that physically links cancer cells and immune cells to treat cancer. This mechanism can harness the human immune system to attack cancer, enabling more precise targeting of cancer cells and eliciting a potent immune response. CT-P72 is designed to simultaneously target HER2 and the immune cell surface protein CD3 to activate T cells and attack cancer cells while minimizing toxicity to normal cells. In particular, it demonstrated high tumor inhibition by selectively acting on cancer cells in HER2-overexpressing tumor models. Moreover, CT-P72 consistently maintained its antitumor efficacy in both in vitro and in vivo studies, and in primate toxicity tests, it exhibited 180-fold superior safety compared to a reference compound. Aptamer Sciences presented pre-clinical results of its new ADC candidate product, 'AST-203.' AST-203 targets the protein TROP2, which is predominantly expressed in breast, pancreatic, gastric, and lung cancers. This drug candidate binds selectively to TROP2-positive tumors, penetrates the cells, and releases the microtubule inhibitor MMAE to induce cancer cell death. AST-203 is made by conjugating TROP2-targeting antibody with 'MMAE,' a microtubule disruption agent, with linker 'VC-PAB.' TROP2 is an intracellular calcium signal transducer involved in cell proliferation and survival. Among TROP2-targeting drugs, the commercialized products are Gilead's ADC Trodelvy and Daiichi Sankyo/AstraZeneca's Datroway. Both products are approved for breast cancer indications only. Because TROP2 is mainly found in breast cancer, NSCLC, colorectal cancer, and pancreatic cancer, later entrants are conducting clinical trials targeting these major solid tumors. Aptamer Sciences is exploring ways to overcome the limitations of existing ADC therapies using its proprietary ADC platform technology, 'Aptamer.' Aptamers are one-tenth the size of antibodies, allowing deeper penetration into tumor tissue and rapid delivery to target cells for therapeutic effect. In preclinical studies, Aptamer Sciences confirmed the potential of AST-203 in tumor spheroid models (three-dimensional aggregates of cultured cells). According to the company, AST-203 demonstrated a 6.7-fold higher tumor penetration rate than Trodelvy.
- Company
- ‘Policy support required for hidradenitis suppurativa’
- by Whang, byung-woo Apr 30, 2025 06:06am
- “Hidradenitis suppurativa is difficult to cure and requires long-term treatment. As it is a rare disease, I think it is desirable to increase access to treatments with clear treatment benefits by providing both reimbursement and special calculation for this disease, which has a small number of patients.” Hidradenitis suppurativa is a disease whose exact cause or pathogenesis has not yet been fully identified, and it is a rare disease with a prevalence rate of less than 1% in South Korea. The number of patients with hidradenitis suppurativa in South Korea is estimated to be approximately 10,000 as of 2022, which only includes those who have been clearly diagnosed after experiencing recurrent lesions and formation of tracts beneath the skin. Although TNF-α inhibitors are a reimbursable treatment option, options are limited when considering treatment failure and side effects. Joo Yeon Ko, Department of Dermatology, Hanyang University Medical CenterAt an interview with Dailypharm, Joo Yeon Ko, Professor of Dermatology at Hanyang University Medical Center emphasized the need to improve access by expanding treatment options for hidradenitis suppurativa. Hidradenitis suppurativa causes abscesses to form in various areas around the sebaceous glands beneath the skin. Unlike typical abscesses, the lesions are connected to each other, forming channels known as “tracts.” It is broadly classified into ▲active, where inflammation persists, and ▲inactive, where no further inflammation occurs; however, it is difficult to clearly distinguish between the active and inactive states. Professor Ko explained, “Even in the same patient, the condition can be highly active at one time and stable at another, so the medication and treatment methods used may vary depending on the individual's condition. In the case of active disease, the patient experiences severe pain due to inflammation in areas such as the armpits, and the goal of treatment is to reduce the frequency of the inflammation.” He continued, “Mild-to-moderate patients rarely visit university hospitals, and mild patients with symptoms in one or two areas are mainly treated at private clinics. It is important to identify the potential for progression to severe disease in mild patients, as a higher recurrence rate is associated with a higher risk of progression.” Limited treatment options for suppurative hidradenitis, IL-17 emerges but faces hurdles for use The basic treatment for suppurative hidradenitis is I&D (incision and drainage), which involves incising the area where the patient feels pain to remove the internal inflammation. In addition, antibiotics are administered for about 3 months to reduce inflammation, and if there is a high risk of recurrence, sebum inhibitors used to treat acne are also used. However, in severe cases, these treatments are not sufficient to control the inflammation, and biological agents are used. Currently, Humira (adalimumab), a TNF-α inhibitor, is covered by insurance. In addition, although not yet covered by insurance, the interleukin-17 (IL-17) inhibitor Cosentyx (secukinumab) was approved in Korea in 2015, approximately 8 years after the approval of Humira. Professor Ko said, “TNF-α inhibitors covered by insurance have the advantage of broadly blocking inflammation, but they also have the limitation of blocking the inflammatory response that is necessary for our bodies. IL-17 inhibitors have a more targeted mechanism than TNF-α inhibitors and show similar therapeutic effects and superior safety.” According to overseas and domestic guidelines, both TNF-α inhibitors and IL-17 inhibitors are currently recommended as first-line treatment options. If sufficient therapeutic effects are not achieved with oral medications, one of the two approved biological agents can be selected. Regarding this, Professor Ko explained, “Although TNF-α inhibitors have been covered by insurance in Korea for over 5 years, not many patients actually use them on-site. TNF-α inhibitors have a broad anti-inflammatory mechanism, which raises concerns about side effects, and when we explain this to patients, they are reluctant to use them.” In actual treatment, patients who received IL-17 inhibitors (Cosentyx) showed a significant improvement in quality of life after continuing treatment for one and a half years, said Professor Ko. Previously, patients had severe symptoms requiring surgery and were unable to move their arms properly, but after treatment, their symptoms improved significantly, and the use of antibiotics and other medications decreased to 25% of the previous level. Professor Ko stated, “In global clinical trials, approximately 60% of patients achieved HiSCR 50 with Cosentyx. This means that 60% of patients experienced a 50% or greater improvement in symptoms. While a 50% improvement may seem modest, it actually represents a significant improvement.” He added, “Hidradenitis suppurativa is a disease that develops at a young age and requires long-term management, so controlling it with medications that have few side effects is the best approach. In this regard, I believe Cosentyx is a good option at this point.” “Hidradenitis suppurativa, a rare and intractable disease pustular psoriasis…unrestricted special reimbursement calculation support is needed” However, there are restrictions on the use of the IL-17 inhibitor Cosentyx. Unlike Humira, which is covered by reimbursement, Cosentyx is not yet covered. In fact, Novartis Korea applied for reimbursement expansion for Cosentyx for hidradenitis suppurativa in November last year, but the discussions are at a standstill. Professor Ko said, “IL-17 inhibitors have already been used extensively in psoriasis, so there is a tendency to prefer Cosentyx, but it is difficult to use it actively because it is not covered by insurance. Currently, if TNF-α inhibitors are used and sufficient effects are not seen, the cost of using Cosentyx thereafter is extremely high.” Professor Ko emphasized that while it may be worth considering distinguishing treatment sequence within biological agents based on practical factors like drug prices, from a medical perspective, it is important to prioritize options that have fewer side effects. He said, “If TNF-α inhibitors are used in the first line and are not effective, using Cosentyx as a the next treatment option can be an alternative, but this cannot be considered the ideal approach from a medical standpoint. In the long term, it would be desirable to apply reimbursement so that both treatments can be used on an equal footing.” Additionally, Professor Ko stressed the need for policy support to apply special reimbursement calculation provisions for the rare and intractable disease suppurative hidradenitis. Currently, suppurative hidradenitis is classified according to severity, and only severe cases are eligible for special reimbursement and insurance coverage, but the total number of patients is only about 10,000, and among them, less than 1,000 are estimated to be severe cases. Therefore, even if reimbursement and special calculations are applied simultaneously, it is unlikely to place a significant financial burden on the government. Professor Ko said, “For diseases like hidradenitis suppurativa, which have a small number of patients and treatments offer clear benefits, it is necessary to increase access to treatment by providing both reimbursement and special calculations. Even if reimbursement and special calculations are applied simultaneously, only a few dozen patients will actually benefit and use Cosentyx each year.” Finally, he added, “Effective medications for treating hidradenitis suppurativa are continuing to emerge, and better ones will be developed in the future. I hope patients do not lose hope and actively consult with medical professionals and seek treatment.”
- Opinion
- [Reporter's View] Prescribing pre-reviewed new drugs
- by Eo, Yun-Ho Apr 30, 2025 06:06am
- New drugs that patients long-awaited are being reimbursed, but no hospitals are prescribing them. There have been various attempts at improving the system, but an issue related to new drug access remains unresolved in South Korea. Public petitions for reimbursement of a particular new drug are frequently listed, and more patient organizations are gathering petition signatures. Yet, new drugs that successfully overcome challenges to be listed often are not prescribed at hospitals even though there are no prescription requirements, often mandated for gene therapies, for these drugs. Although these are first-in-class drugs and quality for reimbursement, there are only a handful of drugs that become prescribed at medical institutes throughout the country half a year after inclusion to the reimbursement list. This often occurs because hospitals tend to be afraid of being responsible for high-cost drugs after administration of such drugs upon doctor's advice and having the risk of insurance deduction. Distributing companies often contribute to this matter. During the process of distribution, loss results in substantial financial loss. Many of these cases involve drugs that have undergone a pre-review system for reimbursement. The 'pre-review' system processes the appropriateness of reimbursement for high-cost orphan drugs before authorization. It has been established to consider strengthening patient drug access and protecting National Health Insurance finance. It conducts both pre-reviews of determining the appropriate patient pool and continuance of administration after approval through pre-review. In other words, especially for high-cost drugs, the system offers a pre-review to determine whether a drug is deemed reimbursable. Drugs that underwent pre-review can be prescribed during an emergency and under a doctor's advice. The problem is that the drug has been administered but is deemed not reimbursable afterward. It does not mean that hospitals and distributors must endure losses. However, these drugs have been added to the reimbursement list after substantial efforts and demands. Hospitals and distributors need to collaborate on the issue of 'risk-sharing.' These drugs entered the system after meeting the criteria for at least two types of risk-sharing agreement (RSAs). There is no time to hesitate, and we must find a solution.
