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- 2025-12-18 12:22:05
- Opinion
- [Reporter’s View] K-obesity drugs need to innovate
- by Choi, Da-eun Nov 07, 2025 06:16am
- The global obesity treatment market is expected to continue its rapid growth. Novartis ‘Wegovy’ and Eli Lilly's ‘Mounjaro’ are both now entering their third year as industry game-changers. Both drugs are glucagon-like peptide-1 (GLP-1) receptor agonist injections that suppress appetite and reduce weight, popularizing the recognition that obesity is not merely a cosmetic issue but a ‘disease’. In Korea, momentum is building, heralding the introduction of homegrown obesity drugs. Major pharmaceutical companies like Hanmi Pharmaceutical, Daewoong Pharmaceutical, and HK Inno.N have successively unveiled new candidates and initiated clinical trials. Their ambition is to reduce dependence on original drugs and secure market leadership through technological self-reliance. Yet, challenges remain formidable. The global leaders Wegovy and Mounjaro have already secured large-scale, long-term data after receiving FDA and EMA approvals through trials involving thousands of patients. Furthermore, the market's focus is shifting from injectables to oral tablets. Novo Nordisk's high-dose oral semaglutide and Eli Lilly's oral low-molecular-weight GLP-1 agonist ‘Orforglipron’ have both achieved positive results in Phase III clinical trials. Novo Nordisk has submitted its new drug application to the U.S. Food and Drug Administration (FDA), which is expected to make a decision on approval within the fourth quarter. If approved, commercialization is expected within the next year. Eli Lilly's Orforglipron has been designated for FDA Fast Track review and is currently under review. The company plans to apply for approval as an obesity treatment within this year and as a type 2 diabetes treatment next year. With the dawn of this ‘oral obesity drug’ era, the market landscape is expected to shift, driven by the convenience of administration and high treatment adherence rates offered by the oral formulations. In contrast, domestic pharmaceutical companies are still just in the entry stage. Major firms like Hanmi Pharma, Dong-A ST, Daewoong Pharmaceutical, and HK Inno.N have revealed their candidates and entered clinical trials, but most are still in the injectable formulation phase. Compared to global companies already advancing oral formulations to commercialization, the development speed gap is clear. Disparities exist not only in technological capability but also in clinical experience, data scale, and regulatory strategies. Safety and misuse are also growing concerns. While GLP-1 drugs deliver dramatic appetite suppression, they’ve also been linked to gastrointestinal disorders, muscle loss, and psychiatric side effects. Misuse of “weight-loss injections” has already become a social issue in both Western and Korean markets. If domestic pharmaceutical companies aim to enter the market with drugs using similar mechanisms, differentiating their safety profile is as essential as efficacy. Economics present another hurdle. Without reimbursement, the monthly cost of Wegovy or Mounjaro ranges from KRW 200,000 to KRW 500,000, depending on dosage. For a homegrown drug to succeed, it must compete with big pharma treatments through low production costs and reasonable pricing to build market dominance. Still, there are signs of promise. Hanmi Pharmaceutical is advancing multiple novel candidates, including the triple-action obesity treatment ‘HM15275’ that minimizes muscle loss, the muscle-building obesity treatment ‘HM17321’, and the oral GLP-1 receptor agonist obesity treatment ‘HM101460.’ Companies like Dong-A ST, Progen, and D&D Pharmatech are developing next-generation GLP-1 drugs that apply dual-action mechanisms. For domestically developed drugs to truly establish themselves as ‘K-Obesity drugs,’ four elements must align: technological capability, data, ethical standards, and speed. ‘Homegrown’ alone will not persuade patients or markets. However, if the focus is on ‘innovation’ rather than mere replication, there is ample potential for K-Obesity drugs’ success in the global market.
- Opinion
- [Reporter’s View] ‘Selection & Focus’ to foster K-Bios
- by Hwang, byoung woo Nov 04, 2025 06:10am
- The keyword “selection and focus” resurfaced in this year’s National Assembly audit as a core strategy for fostering Korea’s pharmaceutical and bio industry. During the NA audit last month, lawmakers again raised the need for bold investment and full-cycle support for innovative drugs to strengthen Korea’s global competitiveness in the pharmaceutical and biotech industry. In response, Korea Health Industry Development Institute (KHIDI) President Soon-do Cha outlined the direction, stating, “We will strategically foster medical artificial intelligence (AI) and bio-data.” This signifies the government's emphasis on streamlining R&D efficiency centered on the two pillars of medical AI and bio-data. However, the perspective from the field is slightly different. While policy speaks of concentration, execution remains fragmented. AI, big data, advanced biotechnology, CDMO, vaccine self-sufficiency—all are repeatedly touted as core industries in discussions of the pharmaceutical and biotech sector, with similar slogans endlessly repeated. Consequently, budgets remain scattered across multiple ministries, and the pace of implementation varies widely. This means that while choices are plentiful, there are question marks about whether true focus is actually happening. The problem of lacking a proper control tower has also been a recurring topic for years. The medical AI and bio-data industries mentioned this time may seem like different fields at first glance, but they are closely connected. To harness AI, data infrastructure is essential. The government is pursuing a biobank of one million individuals, and hospitals are building their own data banks. The problem lies in utilization. Differences in linkage standards make analysis difficult even when data is combined, and there are also criticisms that companies spend months navigating access procedures. AI imaging solutions are increasing, but adoption in hospitals remains low. The government opened the regulatory door, but support measures to boost utilization are relatively inadequate. Data and technology are piling up, but the pipelines for their actual use are narrow. The government advocates selection and focus, but criticism follows that actual support is broad but shallow. The government often refers to its data-collection strategy as a “data dam.” Just as building a dam secures a water source, the data dam aims to prepare data resources for use in the AI era. But building the dam is only half the job — we also need pipelines that allow data to flow and be used. Even considering that government-level policies set the broad framework, the current situation demands clearer prioritization and guaranteed execution. If data fails to flow into industries and medical settings, policy choices lose their meaning. Having established the broad direction at the government level, clear priorities and execution must now follow. If data fails to flow into industries and medical settings, policy choices lose their meaning. During the NA audit, it was noted that as of 2023, the combined R&D investment of the top 10 domestic listed pharmaceutical companies amounted to only approximately KRW 1.3 trillion. This represents a significant gap compared to the KRW 20 trillion invested by global pharmaceutical giant Johnson & Johnson (J&J). Considering this, the government's approach of ‘select and focus’ is clearly the right direction. However, for the two pillars of medical AI and bio-data—presented by the state as future industries—to translate into industrial achievements, structural change is needed, not just slogans. Ultimately, the key lies in execution. Policy priorities must be clearly defined, and overlapping projects streamlined. If ‘selection and focus’ remains just a slogan, the industry will lose its direction once again. What is needed now is not a new strategy, but proof of focus demonstrated through action.
- Opinion
- [Desk View] Unsettling relief from pharma tariff agreement
- by Chon, Seung-Hyun Nov 03, 2025 06:09am
- Analysis suggests that the burden of tariffs on the pharmaceutical sector has been significantly alleviated following the settlement of the US-Korea tariff negotiations, which had dragged on for about five months. According to the agreement, the Most Favored Nation (MFN) designation will be granted to synthetic new drugs and biological new drugs (biosimilars/biobetters) in the pharmaceutical sector. Generic drugs and natural resources not produced in the United States will be subject to zero tariffs. The pharmaceutical and biotech industries express clear relief. Concerns over pharmaceutical tariffs emerged after President Donald Trump stated on his social media platform, Truth Social, in September that "100% tariff would be imposed on all branded drugs and patented drugs from companies not building manufacturing plants in the U.S. starting the following month." The Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) welcomed the agreement, stating, "We greatly welcome the settlement of the Korea-U.S. tariff negotiations." They added, "Securing MFN designation along with maintaining zero tariffs for generic drugs ensures trade conditions that are not unfavorable compared to other major countries. We expect this to positively impact the strengthening of our pharmaceutical and bio-industry's global competitiveness." The KoreaBio Association also welcomed the agreement, stating, "With the tariff negotiation settlement, South Korea is not disadvantaged compared to competitors like Europe and Japan when exporting pharmaceuticals to the U.S., and we expect a significant reduction in trade uncertainties with the U.S." In fact, the expectation was that imposing tariffs would not have a significant impact on the overall domestic pharmaceutical industry, as the scale of Korean pharmaceutical and biotech companies' exports to the U.S. is small. Only a few companies, such as Celltrion, Samsung Biologics, Samsung Bioepis, SK Biopharmaceuticals, Daewoong Pharmaceutical, and Green Cross Corp, are actively pursuing entry into the U.S. market. The majority of domestic pharmaceutical and biotech companies have no experience entering the U.S. market. The fact is that the industry as a whole did not show strong interest because the pharmaceutical tariff risk was seen as 'someone else's problem' for most pharmaceutical and biotech companies. According to the Ministry of Food and Drug Safety (MFDS), the U.S. export value of domestically produced pharmaceuticals in Korea last year was $1.49117 billion (approximately KRW 2 trillion), accounting for only about 1% of the total U.S. export value of $127.8 billion. This is less than 5% of the $36.6 billion in automobile exports. Pharmaceutical exports to the U.S. are also dominated by Samsung Biologics and Celltrion. Samsung Biologics recorded U.S. export sales of KRW 1.1741 trillion last year through Contract Development and Manufacturing Organization (CDMO) services for biopharmaceuticals. Celltrion's biopharmaceutical sales in the North American market last year amounted to KRW 1.0453 trillion. Domestic pharmaceutical and biotech companies have released a total of 40 new drugs since SK Chemicals' Sunpla in 1999, up to Medytox's Nuviju in September this year. However, products that have entered the U.S. market are limited to LG Chem's Factive, Dong-A ST's Sivextro, Hanmi Pharmaceutical's Rolontis, and Yuhan Corporation's Leclaza. Most domestically developed new drugs that enter the U.S. do not have large export sales. Leclaza is gradually increasing sales after recent U.S. approval, but this does not count toward Korea's export performance, as the product is manufactured locally by its partner, Janssen, for sale in the U.S. This is the background why the pharmaceutical industry welcomed the US-Korea tariff negotiation, but did not achieve consensus across the entire industry. It is why they seem to be in vain. The settled negotiation is welcome, but it offers little immediate tangible benefit. In contrast to the vigorous success of domestic manufacturing, such as K-Beauty and K-Food, in the U.S. market, the performance report for K-Bio in the U.S. is still at a nascent stage. The majority of domestic pharmaceutical companies are still largely dependent on the domestic market. However, the recent increase in U.S. exports is encouraging. In 2014, the U.S. export value of domestic pharmaceuticals was $120.57 million, accounting for only 5.0% of the total export value of $2.40349 billion. Last year, the U.S. share of total pharmaceutical exports was 16.1%, an increase of more than threefold from 10 years ago. While the total pharmaceutical export volume last year increased by 3.9 times compared to 10 years ago, the U.S. export value increased by 12.4 times during the same period. The increase in U.S. exports of finished pharmaceutical products is a positive development. In 2014, API exports to the U.S. were $88.53 million, more than double the finished pharmaceutical product exports of $32.04 million. Last year, finished pharmaceutical products accounted for $1.29899 billion of U.S. pharmaceutical exports, exceeding API exports of $192.19 million by more than five times. In 2014, the U.S. ranked 6th among destination countries for pharmaceutical exports, but it jumped to 1st place last year. The U.S. export value of finished pharmaceutical products last year expanded by 40.5 times compared to 10 years ago, which is in contrast to the 2.2-fold increase in API U.S. export value over the past 10 years. This shows that finished pharmaceutical products incorporating domestic companies' R&D technology are gradually accelerating their penetration into the U.S. market, thus slowly but incrementally expanding their presence. Recently, not only biosimilars but also domestically developed botulinum toxin products and blood products are actively pursuing entry into the U.S. market. The success of new drug out-licensing among biotech companies is spreading, and there are increasingly noticeable cases of global pharmaceutical companies launching new drugs using K-Bio technology. We hope for a time when the R&D achievements of domestic pharmaceutical and biotech companies are used as wild cards on the global stage, leveraged in negotiations, and when successful tariff negotiations translate into tangible benefits.
- Opinion
- [Reporter’s View] The dark side of flashy health campaigns
- by Son, Hyung Min Oct 31, 2025 06:12am
- A breast cancer awareness campaign recently hosted by a certain magazine has sparked controversy. While claiming to promote disease awareness, the atmosphere on site told a different story. Amidst the dazzling lights, music, and flowing drinks, the term “breast cancer” was nowhere to be found. This leaves one wondering what meaning the event truly held for patients. Of course, cancer patients don’t have to be solemn at all times. Those fighting illness have every right to laugh and enjoy themselves. Cancer no longer equates solely to a brush with death. Thanks to early diagnosis and advances in new drugs, many patients return to their normal daily lives after treatment. In that sense, bright and uplifting messages are certainly needed. Moving beyond perceptions that emphasize only despair, the very attempt to speak of hope and recovery holds value. However, the problem arises when excessive brightness erases the disease's true nature. While survival rates for major solid cancers, including breast cancer, have significantly improved over the past decade due to the introduction of various new drugs, cancer remains a disease that fundamentally overturns a person's entire life. Patients endure complex treatment regimens involving chemotherapy, targeted therapies, and hormone therapy, suffering various side effects like vomiting, nausea, sleep disturbances, and gastrointestinal issues. In severe cases, serious adverse reactions such as interstitial lung disease or skin-peeling rashes can occur. Yet a casual belief is spreading that “cancer is easily cured these days.” Survival statistics may have improved, but patients’ quality of life and psychological suffering remain heavy burdens. Even after treatment ends, fear of recurrence, anxiety over physical changes, and the challenges of returning to society persist. Some awareness campaigns mirror the rosy social trend. They focus on imagery and commercial appeal rather than patients' realities, treating the disease as an event to be consumed. True awareness isn't about sugar-coating someone’s suffering. It must start with society genuinely seeing the suffering as it is and collectively understanding the fears and anxieties patients endure. What matters is the daily life of the patient who suffers from the illness and the hearts of the family members by their side. Without stepping into those shoes, genuine awareness cannot exist. The term “raising awareness” only gains meaning when patients remain at its core. What is needed more than a glamorous party is listening to the patient's voice. The reason positivity is needed is not to cover despair, but to face reality while holding onto hope. Ignorance about disease begins with indifference. True awareness begins with empathy. And empathy is only possible when it stems from a genuine desire to stand by the patient's side.
- Opinion
- [Reporter’s View] China’s rise poses new challenges
- by Hwang, byoung woo Oct 28, 2025 06:11am
- One of the most striking features at the European Society for Medical Oncology (ESMO 2025) Congress in Berlin, Germany, was the clear rise of China. Chinese researchers’ names appeared repeatedly across major sessions, and the word “China” was visible throughout the poster halls. Compared to previous years, more Chinese companies submitted abstracts, with some securing spots not only in ‘Late-breaking Abstract (LBA)’ presentations but also in the prestigious Presidential sessions, ESMO's highest-level presentations. This was a scene rarely seen at global conferences just a few years ago. Particularly noteworthy is that despite most corresponding authors and key speakers of major abstracts being Chinese researchers, they were included in core sessions, underscoring the growing recognition and expectation for Chinese innovation in oncology. Consequently, the ESMO 2025 press room saw a greater-than-usual number of Chinese journalists visiting for coverage. A representative case was the Phase III study on sacituzumab tirumotecan (Sac-TMT), an antibody-drug conjugate (ADC) jointly developed by Kelun-Biotech and Merck. In particular, China is leading a large number of next-generation modality studies, including antibody-drug conjugates (ADCs), bispecific antibodies, and immune-oncology combination therapies. Industry experts at the scene said that China has evolved from being a ‘fast follower’ to becoming a ‘fast mover.’ This transformation is underpinned by government support, substantial capital, and a rapid clinical system. China's regulatory, clinical, and investment ecosystems are organically integrated, with global development taken into account from the earliest candidate stage. The short turnaround between clinical registration and publication has become a competitive advantage. Of course, the sheer scale of China’s domestic market cannot be ignored. However, considering the recent wave of Chinese new drug data being presented at major academic conferences, the prevailing view is that it is no longer feasible to dismiss this as merely ‘for local use’. It's not that Korean companies haven't produced meaningful data. Some garnered attention with novel mechanisms and technologies, but the issues lie in speed and scale. The gap with China was evident in the number of publications, the depth of clinical stages, and global expansion capabilities. A researcher at the conference stated, “Even with promising candidates, the journey to clinical trials and approval is too slow. China is already opening institutional pathways at the national level.” The challenge for Korea’s pharma industry is clear: while scientific foundations are strong, the sector must overcome constraints in capital and manpower that are required to scale this into clinical development.. The direction for Korea to take is already being demonstrated by some companies. There has been an increase in cases where overseas clinical trials and regulatory approval processes are designed together from the initial stages, and platform-focused research, such as ADCs and bispecific antibodies, is also expanding. However, it is difficult to say that this strategy has spread across the entire industry. Clinical trials prioritizing domestic approval and single-candidate-focused development still dominate. Global design in new drug development is no longer a foreign concept in Korea. Many companies are designing overseas clinical trials and regulatory approval processes from the initial stages, keeping global expansion in mind. However, it is difficult to say that this strategy has become established across the entire industry. Clinical trials primarily targeting domestic approval and development centered on single candidates still constitute a significant portion. To compete globally, Korea must strengthen platform-based scalability, clinical design capabilities, and the talent ecosystem that supports both. The government, too, must move beyond short-term project funding and establish a strategic system that integrates global clinical development with regulatory reform. The pace of China’s progress, as this reporter felt in Berlin, is not merely in the sheer volume of research. It stemmed from a fundamental difference in the structure of the entire industry. Drug development is no longer a contest of ideas but of systems. If Korea’s government continues to highlight biopharma as a national growth engine yet fails to keep pace with this shift, the country risks being relegated to the role of a spectator in the global pharmaceutical arena.
- Opinion
- [Reporter's View] Transparent info, the key to vaccine trust
- by Son, Hyung Min Oct 17, 2025 06:11am
- Starting on the 15th of this month, simultaneous administration of COVID-19 and influenza perioperative vaccines has begun for older adults aged 65 and older and high-risk groups. The Korea Disease Control and Prevention Agency (KDCA) has informed that the rate of adverse events from simultaneous vaccination does not exceed that seen with each vaccine administered individually. Since this measure targets highly vulnerable groups, including the elderly and those with chronic diseases, minimizing vaccination anxiety and ensuring safety are crucial. Nevertheless, some recent research findings and statistics are being misinterpreted, leading to instances in which vaccines are interpreted as directly or indirectly linked to the occurrence of specific diseases. Trust in vaccines remains a challenge overseas as well. In the United States, controversy has arisen due to recent actions by the public health authorities of the Donald Trump administration, who attempted to link the COVID-19 vaccine to the deaths of 25 children. Some sources argue that the U.S. government is systematically spreading false information about vaccines. Although anxiety is spreading due to some shared reports that the incidence of specific diseases has increased after vaccination, medical data must always be analyzed by considering key variables. Even if a numerical difference appears, it does not necessarily imply causation. Various factors, including sample composition, observation period, lifestyle, and underlying conditions, can influence the results. The COVID-19 vaccine, developed using new technology and available for less than 6 years, also contributes to concerns about its long-term safety. In this situation, the government and medical professionals have a responsibility to inform the public using objective information thoroughly and to uphold the credibility of the National Immunization Program (NIP). Concerns about simultaneous vaccination must also be addressed transparently, based on scientific evidence. Concealing or minimizing adverse event reports may temporarily quell anxiety, but it ultimately damages overall public health confidence. Medical professionals and researchers must accumulate objective data through rigorous research processes and explain the results to the public as they are. Transparent communication, founded on ethics and responsibility, is the starting point for building sustainable public health trust. The NIP can only function properly when the public receiving the vaccine, the researchers conducting the studies, and the government guiding the policy all understand this process and fulfill their roles. It is crucial to remember that the very inclusion and implementation of the COVID-19 vaccine in the NIP already guarantees objectivity and trustworthiness. The vaccination program's design, review process, clinical trial data analysis, and adverse event monitoring are the outcomes of scientific verification. Even if there are concerns, the overall confidence cannot be shaken by a single piece of data or political claim. The anxiety and fatigue remaining after the pandemic still cause people to react sensitively to biased information. It must be recognized that an approach centered on scientific evidence and transparent communication is the only way to maintain vaccine confidence and protect the sustainable safety net of public healthcare.
- Opinion
- [Op-Ed] Patients, no time left for 'new drug comb therapies'
- by Eo, Yun-Ho Oct 15, 2025 06:11am
- Eunyoung Lee, Board of Director of the Korea Alliance of Patients Organization"My father (in his 60s), who has been diagnosed with urothelial carcinoma, is paying 10 million won every three weeks for combination cancer therapy that is non-reimbursed. The disaster medical expense program provided the cost. However, we feel helpless upon the news that the fund is being delayed." This is part of a public complaint filed at the Korea Alliance of Patients Organization. This case reflects the current situation in which access to new drug treatments depends on individuals' financial ability. In April, the government amended part of the National Health Insurance criteria for combinations of anticancer therapy. It was intended to correct an unjust system in which previously reimbursed pharmaceuticals are no longer covered when used in combination with a new, non-reimbursed drug. The Patients Organization and related academics have long demanded this, and it was a significant change that improved access to treatment. The combination therapy containing urothelial treatments 'Padcev (enfortumab)' and 'Keytruda (pembrolizumab)' is the key example. The Padcev + Keytruda combination therapy received approval from the Ministry of Food and Drug Safety in July 2024 as a first-line treatment indication. The clinical trial results demonstrated that the Padcev + Keytruda combination therapy reduced the mortality risk by 53% compared to the existing chemotherapy and extended overall survival by over 2-fold. The results were presented at ASCO GU 2024. In particular, the Padcev combination therapy is already reimbursed in six of the A8 countries whose drug prices Korea references: the United States, the United Kingdom, France, Germany, Japan, and Canada. The United Kingdom is operating the 'Combination Therapy Framework' to enhance patient accessibility. Furthermore, it reportedly allows swift discussion of reimbursement for new drugs developed by different pharmaceutical companies when there is sufficient clinical evidence. However, in Korea, the combination therapy was considered by the Cancer Disease Review Committee (CDRC), but it failed to set reimbursement criteria. It is reportedly anticipated to be reconsidered for CDRC in October. It means that no discussion has yet begun. During this time, patients paid high-priced, non-reimbursed treatment out of pocket. Several patients have given up on receiving treatment. The Padcev + Keytruda combination therapy for one month costs from approximately million won to 10 million won. Urothelial carcinoma is highly likely to relapse and metastasize, and it has only a few treatment options. Despite the clinical efficacy of a combination therapy, the evaluation and negotiation process is complicated for new combination drugs developed by different pharmaceutical companies. Therefore, the reimbursement discussion is being delayed. Whereas the government took the first step toward 'combination with existing reimbursed pharmaceutical and new drug' with the amendment in April, an institutional basis must now be established so that 'combination of new drug-new drug' is reasonably evaluated and discussed. There must be a procedure for reviewing the clinical value of combination therapies and for guiding collaborative models between companies. As the discussion on new drug-new drug combination therapy is being delayed, there are fewer treatment opportunities for patients, and treatment options become more limited. Patients sincerely wish for opportunities to access the currently available treatment, not the launch of new drugs. We wish that clinically proven combination therapies were swiftly and reasonably evaluated. The current situation in which systemic procedures and structural limitations triumph over patients' willingness to continue treatment, and the treatment effectiveness must be improved.
- Opinion
- [Desk’s View] Lift botulinum toxin’s core tech designation
- by Lee, Seok-Jun Oct 14, 2025 06:40am
- Calls to lift the “national core technology” designation from botulinum toxin are rising once again — and this time, the long-standing issue must be resolved. The industry has been calling for this for a long time. The demand was made in 2023, and again the following year. Yet, it remains stuck in neutral. The decision must now be made with resolve. Over 75% of the field wants the designation lifted. According to a January survey by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), 12 out of 16 companies surveyed expressed support for lifting the designation. The government should listen — it’s time to face industrial reality. The reasoning is clear. Botulinum toxin technology is already a key part of the global market, yet in Korea, it remains shackled by its “core technology” label. Regulations meant to protect it are now hindering growth. It's not protection; it's a hindrance. Botulinum toxin extends far beyond cosmetic use — it’s a therapeutic tool for conditions like dystonia, migraines, and cerebral palsy. But researchers struggle even to conduct clinical trials, and in the meantime, patients lose access to potential treatments. The rhetoric of “safety” has come to block the right to health. The rest of the world has been taking a different approach — adjusting regulations to strengthen competitiveness. Only Korea stands still. This must change. Of course, deregulation does not mean neglect. Safety measures must become tighter. Strengthen the basics: quality control, crackdowns on illegal distribution, and side effect monitoring. The key is balance. Restriction does not guarantee safety, and deregulation does not create danger. Smart regulation is the answer. The government must judge with an industrial strategy perspective. Companies must maintain trust through quality. The medical community and civil society must also join in the oversight. The botulinum toxin debate is not a technological issue. It is about how our society treats technology. We must move forward with trust, not fear. This is the time for wise regulatory innovation. The answer is to ‘remove’ toxin from the National Core Technology list.
- Opinion
- [Reporter's View] 'National Core Tech' status for Botox
- by Hwang, byoung woo Sep 30, 2025 06:13am
- The discussion regarding delisting botulinum toxin as a National Core Technology continues to yield no results. Despite increasing demands from the industry, regulatory reform has not improved. The arguments for and against lifting the listing continue, and the discussion has not advanced. In a National Assembly forum on September 29, the industry and civil society groups advocating for delisting spoke unanimously. "Overlapping regulations cause delays in research and development and hindering investment attraction." Key concerns raised at the forum included the lack of transparency in the criteria for designation and delisting, as well as the unpredictable timeframes involved. Critics also pointed out that the process, which requires review by multiple government ministries, increases the burden on companies, leading to wasted time and cost. Ultimately, critics argued that classifying an already commercialized technology as a National Core Technology undermines global competitiveness. Indeed, a survey presented at the forum showed that 82% of responding companies favored delisting. This suggests that the call to lift the designation is more a consensus across the industry rather than a simple demand. This situation even led to the sharp term 'regulatory capture' being used during the discussion, reflecting a mistrust that the purpose of the regulation has morphed from industry protection into maintenance. However, the Ministry of Trade, Industry and Energy, which was present at the meeting, expressed caution, stating that while they agree on the need for improvement, they "must hear opposing opinions as well as those in favor." Questions remain about whether the government, which is the only neutral party that can maintain balance between conflicting opinions, is actively fostering the discussion. It appears the situation requires the government to go beyond merely "listening to opinions" and actively planning and coordinating the debate. Without an active control tower, the discussion is not advancing. The solution is clear: The designation and delisting procedures must be standardized and the time required for the process must be disclosed transparently. A permanent consultative body involving industry, academia, and government must establish rational criteria, and if necessary, consider a phased or differentiated management approach. In this process, the government must act as the accountable facilitator, balancing the views of both sides and connecting them to an actionable roadmap. The longer the discussion drags on, the greater the anxiety for the industry and the higher the risk of falling behind in global competition. To halt this cycle of stagnation, the government must take action. What's needed now is not a reconfirmation of the pros and cons of delisting, but the government's decision and leadership.
- Opinion
- [Desk’s View] MFDS should clarify AAP safety message
- by Lee, Tak-Sun Sep 29, 2025 06:08am
- Unforeseen moves by U.S. President Donald Trump are having a considerable impact in Korea. After sudden tariff hikes rattled the Korean economy, an unexpected drug safety issue has now emerged. The domestic healthcare market, which is reliant on overseas drugs, is reeling from Trump-related risks. The controversy began on the 22nd when President Trump stated at a press conference that acetaminophen is not safe for pregnant women. He said, “Acetaminophen, widely known as Tylenol, may increase the risk of autism in children if taken during pregnancy. The U.S. Food and Drug Administration will notify doctors of this, and if necessary, recommend restricting Tylenol use during pregnancy.” Acetaminophen, widely known under the brand name Tylenol (Kenvue), is one of the most commonly used fever reducers and pain relievers in Korea. It is generally regarded as relatively safe for pregnant women and young children, which is why healthcare professionals frequently recommend it to such patients. Trump's remarks appear to be based on a recently published report by a research team at the Icahn School of Medicine at Mount Sinai in the United States. This report suggests a possible link between Tylenol use and autism. However, academic communities in Korea and abroad are pointing out that Trump's statement is premature, as scientific evidence linking acetaminophen to autism remains insufficient. The Korean Pharmaceutical Association stated, “Major global health authorities and academic organizations have made it clear that there is insufficient scientific evidence to support such claims at this time.” The Korean Medical Association also dismissed the claims, citing insufficient evidence. KMA spokesman Sung-keun Kim said in a regular briefing, “There is no scientifically established evidence to support the claim that taking Tylenol during pregnancy causes autism in the fetus.” The same sentiment is echoed overseas. WHO spokesman Tarik Jasarevic told reporters at a press briefing, “Evidence remains inconsistent.” The European Medicines Agency (EMA) also stated in a release, “Based on the evidence available to date, no association has been found between the use of paracetamol (the active ingredient name for acetaminophen in Europe) during pregnancy and autism.” However, confusion persists as the US Food and Drug Administration (FDA), the regulatory authority for Tylenol’s home country, has yet to issue an official statement. The stance of the Ministry of Food and Drug Safety (MFDS) is also ambiguous. While the MFDS stated it would receive relevant data from manufacturers and discuss the matter, it has not issued a clear message. It did note, however, that under current approval guidelines, if a pregnant woman experiences a persistent fever above 38°C in early pregnancy, it could affect fetal neural development. In such cases, acetaminophen-based fever reducers and pain relievers may be taken, but the dosage should not exceed 4,000 mg per day. It added that since individual medical situations may vary, pregnant women should consult a healthcare professional before taking any medication containing acetaminophen. This reflects a cautious stance regarding the link between acetaminophen use during pregnancy and autism. This is understood to be a comprehensive reflection of the lack of official statements from the U.S. President, a key ally, and the FDA. Nevertheless, compared to the WHO and EMA stating there is still no clear evidence, this stance appears overly passive. Furthermore, the title of the official press release, “Consult a healthcare professional and take as directed,” seems to shift the burden onto private experts rather than the government. Had the government clearly communicated that, at least for now, evidence is insufficient and that the drug should be taken according to current approved guidelines, it would have alleviated public anxiety. The Ministry of Food and Drug Safety (MFDS), despite being a regulatory body like the FDA or EMA, has faced significant criticism in the past for making decisions based on politics rather than scientific evidence. Of course, it is not entirely independent from government influence, and unlike the FDA or EMA, it lacks manpower and expertise; therefore, direct comparisons may not be fair. Nevertheless, if Korea is to be recognized as a member of the advanced nations and if MFDS truly seeks global recognition as a competent regulatory agency—as it often promotes—then in such controversies, it must deliver clearer, science-first messages. That would undoubtedly strengthen public trust in MFDS by showing that science is prioritized over politics.
