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- 2026-04-03 12:20:14
- 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.
- Policy
- Ofev will be reimbursed next month
- by Lee, Tak-Sun Apr 29, 2025 05:57am
- Product photo of Ofev Ofev Soft Cap (nintedanib esylate, Boehringer Ingelheim Korea) , which was approved in South Korea in 2016, will be listed for reimbursement next month, creating an opportunity for follow-on drugs. It took a long time to secure reimbursement, and with its compound patent already expired, generic manufacturers have obtained marketing authorization and are now awaiting reimbursement. Generic manufacturers plan to apply for reimbursement immediately upon Ofev’s listing to receive the same reimbursement price and commence market sales soon. Some generic companies are even securing distribution channels by launching non-reimbursed versions before the reimbursement takes effect. According to industry sources on the 28th, Ofev soft cap will be reimbursed from next month at KRW 26,220 for the 150 mg and KRW 20,960 for 100 mg. After Ofev was approved in South Korea in October 2016, the drug applied for reimbursement in October 2020 but was deemed non-reimbursable, and the company re-applied for reimbursement in March of last year. Ofev has secured three indications. At the time of its domestic approval in October 2016, it was indicated for idiopathic pulmonary fibrosis (IPF), in February 2020, for systemic sclerosis-associated ILD, and in June 2020, for chronic fibrosing ILD with a progressive phenotype (PPF). The current reimbursement criteria cover only ILD with a PPF. The Health Insurance Review & Assessment Service (HIRA) determined that reimbursement for IPF was not appropriate, as the company did not submit separate cost-effectiveness evidence. In the case of IPF, Ildong Pharmaceutical's Pirespa Tab (pirfenidone) established a dominant position when they were reimbursed under a risk-sharing agreement (RSA) starting in October 2015. Subsequently, generic pirfenidone formulations entered the market, and Pirespa Tab's RSA ended in October 2017. Currently, pirfenidone formulations from Ildong Pharmaceutical, Yungjin Pharmaceutical, Kolon Pharma, and Korea United Pharm are listed for reimbursement. When Pirespa entered the RSA, it was difficult for follow-on products in the same indication to be included in the scheme, making reimbursement listing for Ofev challenging. After securing Ofev's three indications in 2020, the company was reportedly focused on obtaining reimbursement for PPF, a segment with no market competition. The Drug Reimbursement Evaluation Committee (DREC) recognized clinical utility, citing the significant improvement in the annual decline rate of forced vital capacity (FVC) compared with placebo and judging that the cost-effectiveness ratio fell within an acceptable range, deeming reimbursement appropriate. Reimbursement also includes patients with systemic sclerosis-associated interstitial lung disease who exhibited delayed lung function decline. It is estimated that approximately 329 patients will be eligible for Ofev reimbursement in Korea. With reimbursement, annual out-of-pocket drug costs are expected to amount to KRW 5.74 million, significantly reducing the financial burden. Under non-reimbursed status, costs amounted to approximately KRW 19.14 million. However, the imminent entry of generic versions poses a threat to Ofev. Ofev's compound patent expired on January 25 of this year. As a result, generic manufacturers have either already launched their products or are preparing to do so following approval. The currently approved generics are Daewoong Pharmaceutical's Opevia Tab, Yungjin Pharm's Nintebro Tab, and Ildong's Cuinnta Tab. With Ofev being listed as an innovator drug, these generics are now more likely to receive reimbursement within three months of their listing applications. If they apply for reimbursement in May, they could be covered as early as August. The fact that the compound patent has expired and that nintedanib is designated as an orphan drug allows it to receive the same top reimbursement price as the original, creating opportunities for the generics. In particular, companies that have already established a foothold in the pulmonary fibrosis market with pirfenidone formulations can expect synergies by maintaining their existing customer base while expanding their product line. Pirfenidone and nintedanib have different reimbursed indications. Last year, pirfenidone formulations posted sales of KRW 34 billion for Ildong's Pirespa (according to UBIST) and KRW 4.9 billion for Yungjin's Fybro. Yungjin began marketing immediately after the patent expired, while Ildong recently started non-reimbursed marketing. Ildong held a symposium on the launch of Cuinnta Tab on the 26th–27th at the Gravity Chosun Seoul Pangyo Hotel, attended by approximately 80 respiratory medicine specialists from across the country.
- Policy
- 13 items including Jakavi receive price cuts in May
- by Lee, Tak-Sun Apr 29, 2025 05:56am
- Starting May 1, the insurance price ceiling of 13 items on the drug reimbursement list will be reduced. Among them, five items are voluntary reductions requested by the manufacturers. According to industry sources on the 28th, the insurance ceiling prices of 13 items will be reduced in May, including the price of Jakavi Tab, which will be lowered based on the Price-Volume Agreement. Jakavi Tab (ruxolitinib phosphate, Novartis), a treatment for myelofibrosis, will have its price reduced under Type B Price-Volume Agreement negotiations. Type B negotiations are conducted if the maximum price was previously adjusted under Type A negotiations, or if the claims amount for the same product group has increased by more than 60% compared to the previous year's claims amount without Type A negotiations, or the increase is 10% or more and the increase amount exceeds KRW 50 billion. In such cases, the price is adjusted through price negotiations with the National Health Insurance Service. Accordingly, the price of Jakavi 5mg tablets will be reduced from KRW 25,962 to KRW 25,339, Jakavi 10mg tablets from KRW 38,943 to KRW 38,398, Jakavi 15mg tablets from KRW 52,199 to KRW 59,460, and Jakavi 20 mg tablets will be reduced from KRW 52,213 to KRW 50,960. Lorviqua, reimbursement for which has been expanded to cover the reimbursement of first-line treatment for anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer, underwent a procedure to adjust the maximum price in accordance with the expansion of the scope of use of risk-sharing agreement drugs. As a result, the price of Lorviqua Tab 25mg will be reduced from KRW 52,819 to KRW 51,234, and the price of Lorviqua Tab 100mg will be reduced from KRW 158,457 to KRW 153,703. Two migraine treatment drugs that contain naratriptan, will have their prices reduced due to the expiration of the pricing premium. This is because there are now four or more Naratan ODT 2.5mg products available. The health authorities terminate the premium pricing immediately when the number of companies with the same formulation registered after the expiration of the premium pricing period (one year) reaches four or more. As a result, the price of CMG Pharm’s Narafil ODF 2. 2.5mg will be reduced from KRW 2,437 to KRW 2,193, and Yuyu Pharmaceutical's Nagran ODT 2.5mg will be reduced from KRW 2,867 to KRW 2,193. These products were previously granted first-generic exclusivity last month, but the premium was terminated within a month due to the introduction of same-ingredient products. A total of 5 products will have their price ceiling reduced following voluntary price reduction requests from manufacturers. These include 3 products from Daewoong Bio (Serotapin Tab), one from Bukwang Pharm (Ariplus Tab), and one from Hyundai Pharm (DM Duo Tab). The price of Serotapin Tab 25mg will be reduced from KRW 274 to KRW 230, Serotapin Tab 100mg from KRW 688 to KRW 544, and Serotapin Tab 200mg from KRW 1,012 to KRW 927. The price of Ariplus Tab will be adjusted from KRW 3,879 to KRW 2,990, and DM Duo Tab will be adjusted from KRW 3,879 to KRW 3,658. Ariplus and DM Duo are donepezil + memantine combination drugs that were listed for reimbursement in March. Bukwang and Hyundai voluntarily lowered their drug prices just two months after their release.
- Company
- ‘Oral drug Fabhalta changes PNH treatment paradigm'
- by Son, Hyung Min Apr 29, 2025 05:56am
- Youngil Koh, Professor of Hematology/Medical Oncology, Seoul National University Hospital “While significant progress has been made in the treatment of paroxysmal nocturnal hemoglobinuria (PNH), unmet needs remain. Given the relatively young age of patients, there is an increasing emphasis on the need for treatment strategies that not only ensure survival but also improve anemia and enable patients to return to their daily lives. Therefore, I believe that Fabhalta, which improves ease of administration and has been shown to be effective in improving anemia, will become more widely used." Youngil Koh, Professor of Hematology/Medical Oncology, at Seoul National University Hospital, emphasized so in a recent interview with Dailypharm regarding the paradigm shift being made in the PNH treatment landscape. PNH is a rare condition caused by acquired genetic mutations. While the term “acquired mutation” often brings to mind cancer, PNH is classified as a type of “clonal hematopoiesis,” not a blood cancer. While multiple mutations in hematopoietic stem cells can lead to blood cancer, PNH occurs when a single mutation occurs in the PIGA gene, which is located on the X chromosome. PNH is currently known to have no fundamental cure. However, with advancements in science, treatment approaches have been evolving with therapies developed to inhibit the activity of the complement system. The complement system is a core component of the innate immune system, serving as a powerful defense mechanism that directly attacks and destroys pathogens. This system consists of multiple pathways, including C3 and C5, and ultimately forms the “membrane attack complex (MAC),” which destroys red blood cells. Until now, treatments that inhibit C5, located at the terminal pathway of the complement system, have been primarily used. Notably, the introduction of Soliris, an injectable medication administered every 2 weeks, followed by Ultomiris, which can be administered every 8 weeks, has improved the treatment landscape. Many patients still manage their condition using these treatments. However, among the PNH patients receiving treatment, unmet needs still remain in those suffering from persistent fatigue, insufficient symptom improvement, and blood transfusion dependence. In particular, even when C5 is inhibited, the activation of the upstream C3 pathway continues, leading to the premature removal of red blood cells in the liver and spleen and the repeated need for blood transfusions. Professor Koh said, “Statistically, only about 20% of all PNH patients are reported to have their symptoms sufficiently controlled by C5 inhibitors alone to enable them to live normal lives. The remaining 80% of patients cannot completely control their symptoms, and about half of them clearly need other treatment options.” He added, “The complement system is composed of multiple pathways, with C3 located at the upper stage and C5 at the lower stage. While existing C5 inhibitors have acted by blocking the lower stage, it has been confirmed in actual clinical settings that inhibiting C5 alone may still pose issues due to the activation of C3 at the upper stage.” Introduction of Fabhalta, the first oral option Fabhalta was developed to address these issues and works by inhibiting complement factor B, which plays an important role in C3 activation. By regulating the overactivation of C3, it enables a new therapeutic approach to areas that were not addressed by existing C5 treatments. Based on this mechanism of action, Fabhalta is attracting attention as a new treatment option that can meet unmet needs that could not be addressed with existing C5 inhibitors alone. In particular, this treatment has the advantage of being effective against anemia and extravascular hemolysis. Fabhalta demonstrated efficacy in the APPLY-PNH Phase III clinical trial, which enrolled 97 adult PNH patients aged 18 years and older with residual anemia (mean hemoglobin level less than 10 g/dL) despite receiving C5 inhibitors for at least 6 months. Through random assignment, 35 of the 97 patients continued C5 inhibitor treatment, while the remaining 62 switched to Fabhalta, and the effects of the treatments were evaluated for 24 weeks. The clinical results showed that patients who switched to Fabhalta had normalized hemoglobin levels from week 4, and this effect continued through week 24. Hemoglobin normalization was confirmed in approximately two out of three patients. In addition, four out of five patients showed clinically significant increases in hemoglobin levels, and 95% of patients overcame their blood transfusion dependence. No adverse reactions requiring discontinuation of treatment occurred with Fabhalta. The incidence of acute hemolysis was significantly lower than that of C5 inhibitors, and although headaches, diarrhea, and nausea occurred, they were generally mild and resolved within one week. Professor Koh said, “The main purpose of this clinical trial was to confirm the effectiveness of Fabhalta in improving anemia, and the results showed that the hemoglobin level improved in more than 80% of the Fabhalta group and that blood transfusions were avoided in about 90% of the cases. On the other hand, no such improvement was observed in the group of patients who received only conventional C5 inhibitors.” He added, “These results are considered to have served as clinical proof that Fabhalta is a treatment option that can improve anemia that could not be resolved with existing treatments and significantly reduce dependence on blood transfusions.” The strength of Fabhalta lies in its formulation. As an oral medication, Fabhalta is easier to administer than existing intravenous formulations such as Soliris and Ultomiris. Many patients in clinical practice have expressed their desire to switch to Fabhalta if it becomes reimbursed by insurance, and Koh explained that patient satisfaction with treatment is likely to increase not only because of improved hemoglobin levels but also because of the switch to an oral formulation. Professor Koh stated, “PNH has an average onset age in the early 40s, making it more common in relatively younger age groups. In actual practice, many patients continue working while undergoing treatment. Among existing treatments, Ultomiris is an injectable medication administered every 2 months, which reduces the burden of hospital visits compared to Soliris, significantly improving patient satisfaction. Based on this experience, Fabhalta is the first oral medication that can be taken without visiting a hospital, which is a big change for patients in terms of the method of administration alone." Unmet demand remains…Treatment environment needs improvement Professor Koh expressed a very positive outlook on the ongoing development of therapies with various complement inhibition mechanisms because these can potentially address the unmet needs that could not be resolved with existing C5 inhibitors. For example, Fabhalta inhibits factor B, Empaveli (pegcetacoplan) inhibits factor C3, and Voydeya (danicopan) inhibits factor D, with each drug having a different treatment profile because they act at different sites. Professor Koh said, “All of these treatments can be effective in meeting unmet needs, but they have distinct advantages and disadvantages in terms of dosage method and whether they are used in combination. Empaveli requires twice-weekly subcutaneous injections, which can be burdensome, but it can be an effective option for patients who have little aversion to injections. On the other hand, Voydeya requires combination therapy with a C5 inhibitor, which increases the medication burden, but it also has the advantage of potentially improving adherence through the use of a combination injection.” He added, “However, under the current reimbursement standards in Korea, initial treatment must still begin with C5 inhibitors, so in practice, we discuss which drug patients may switch to when unmet needs arise, such as anemia.” Novartis Korea is currently negotiating Fabhalta’s drug prices with the National Health Insurance Service, the final gatekeeper for insurance reimbursement. Professor Koh said, “When discussing with patients, there are quite a few cases where they are waiting for reimbursement for Fabhalta. We have recommended Empalveli to some patients, but many of them feel burdened by the twice-weekly injections and have expressed their intention to switch to oral medication once it becomes covered by insurance. This tendency is particularly prominent among young patients who are socially active.” He added, “Fabhalta has shown potential as a first-line treatment option. In the future, newly developed drugs with new mechanisms of action must be adopted as first-line treatments so that PNH patients can be said to be receiving more practical and comprehensive care.”
- Company
- Launch of a nasal spray vaccine imminent
- by Whang, byung-woo Apr 29, 2025 05:56am
- AstraZeneca Korea's nasal spray, four-valent influenza vaccine 'FluMist' is set to launch domestically in the second half of the year, and new competition is expected. Product photo of FluMistAccording to industry sources, AstraZeneca Korea is preparing to introduce FluMist for the 2025–2026 influenza vaccination season. FluMist is a live‐attenuated, four-valent influenza vaccine administered via nasal spray. This drug was approved by the Ministry of Food and Drug Safety (MFDS) on May 22 last year and is indicated for the prevention of influenza in children and adolescents aged 24 months to 17 years, and in adults up to 49 years of age. FluMist was first approved by the U.S. Food and Drug Administration (FDA) in 2003 and its indication was expanded to four-valent vaccine in 2012. Notably, in September of last year, it became the first self‐administered influenza vaccine approved by the FDA. Globally, FluMist recorded sales of KRW 252.7 billion (USD 175 million) in 2023. In South Korea, GC launched FluMist in 2009 after acquiring it from MedImmune but discontinued sales in 2014 after underperforming. At that time, it was introduced as a three-valent formulation. Thus, a nasal spray-type influenza vaccine will be launched approximately ten years later as a four-valent formulation. Furthermore, it is also the first influenza vaccine to be launched in South Korea by AstraZeneca. The company has reportedly begun preparations for launch, including hiring dedicated staff. In a recent organizational restructuring, AstraZeneca Korea consolidated all its product lines, excluding oncology and rare diseases, into a single division where it will be responsible for the influenza vaccine business. Once FluMist is introduced domestically in the second half of the year, it will provide a new option in a market dominated by injectable vaccines. The Korean market for influenza vaccination includes domestic and foreign manufacturers designated in the National Immunization Program (NIP). Currently, available vaccines are all injectable formulations. The introduction of a nasal spray delivery method is expected to be particularly attractive for children and adolescents who fear needles. According to the Korea Disease Control and Prevention Agency (KDCA), the pediatric influenza vaccination rate in 2024 is approximately 60%, lower than the adult rate (over 80%), with needle phobia identified as a significant barrier. FluMist's nasal delivery could help overcome this. However, several constraints, notably price, remain before FluMist can gain significant market traction. In North America, FluMist is priced about 20–30% higher than injectable vaccines, suggesting it may also be positioned as a premium product in Korea. A further hurdle is that FluMist's primary target population, children and adolescents, is already covered by free NIP vaccinations. There may be little incentive to choose a paid nasal spray alternative. Additionally, the storage and administration requirements for a nasal spray differ from those for injectables, posing an adaptation challenge for healthcare institutions. As a result, some industry observers expect FluMist to be adopted initially by large tertiary hospitals. A vaccine industry employee said, "A nasal spray influenza vaccine can offer an alternative for those with needle phobia, but factors such as price, consumer perception, and competition remain variables. We expect AstraZeneca Korea to monitor the market closely before finalizing its marketing strategy."
