LOGIN
ID
PW
MemberShip
2026-03-10 00:57:05
All News
Policy
Company
Product
Opinion
InterView
검색
Dailypharm Live Search
Close
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.
Opinion
[Reporter’s View] The gap between innovation and access
by
Son, Hyung Min
Sep 26, 2025 06:12am
Advances in medicine have created pivotal turning points in the course of human survival. Diseases once deemed incurable are gradually being reclassified as chronic conditions. From anticancer drugs to treatments for rare diseases and immunotherapies, innovative new drugs have not only prolonged patients’ lives but also increased the burden of responsibility borne by nations and societies. The problem lies in the fact that the ‘pace of innovation’ and the ‘pace of patient access’ are not on the same track. Korean patients are always left to wait. Even when news arrives that a new drug has been approved in the US or Europe, a gap of 1 to 3 years often exists before patients can actually receive a prescription domestically. This delay is not merely a procedural issue; it represents a lost opportunity for treatment. For a terminal cancer patient, 1 year can be their entire life. This is why it's not uncommon for patients to seek treatment abroad. At the center of this irony lies a uniquely Korean formula: price over innovation. The value of a new drug is first calculated by its burden on the national health insurance budget rather than by its clinical significance and impact on patient survival. While managing insurance finances is clearly a crucial task in national governance, the balance has tilted excessively toward fiscal restraint, depriving patients of the opportunity to timely benefit from innovations. This is also why pharmaceutical companies often push Korea down the priority list in their global launch strategies. The so-called ‘Korea passing’ concern is not an abstract warning but a real risk that delays actual patients' treatment opportunities. The global environment is not favorable either. President Trump’s MFN (Most Favored Nation) drug pricing policy has posed a threat to pricing systems worldwide. Under the pretense of protecting American patients, it targeted countries like Korea that maintain low drug price systems as risk factors. From the perspective of multinational pharmaceutical companies, the incentive to launch drugs in Korea has diminished because protecting prices in the US market has become more critical. In other words, Korea’s low drug prices translate directly into being deprioritized in global market strategies. This leads us to a fundamental question: what is a new drug to the patient? To the government, it may be a budget variable; to companies, a profit variable. But to patients, a new drug is a survival variable. Unless the perspective shifts from “how cheaply can we bring it in” to “how quickly and fairly can it reach patients,” the meaning of innovation becomes powerless in front of patients. Of course, the constraints of the national health insurance budget are an undeniable reality. Within limited resources, it's difficult to unconditionally recognize the value of new drugs and raise their prices. The government isn't sitting idle either. New attempts are being discussed, such as the approval-evaluation linkage pilot project, expansion of risk-sharing schemes, and recently, indication-based pricing. But the fundamental limitations remain. Within the current system, patient access to new drugs inevitably remains low. A radical policy shift is now needed. So what constitutes as ‘radical’? Suggestions include introducing value-based assessment that prioritizes clinical innovation and patient survival outcomes; implementing multi-layered risk-sharing schemes where government, pharmaceutical companies, and society share burdens; and establishing a national strategy vision that enhances international negotiation power and improves patient access. Furthermore, a paradigm shift is needed—one that recognizes healthcare not merely as a fiscal issue, but as a core national competitiveness factor. Medical innovation will not cease. The problem is that the speed at which this innovation reaches Korean patients remains sluggish. How long can we tolerate the paradox of patients lagging behind in this era of innovation? Now is the time for government, industry, and society to find answers together. A decisive policy action to align the speed of innovation with patients’ needs is urgently required—so that patients no longer have to waste their time waiting.
Opinion
[Reporter’s View] Legislation needed for telemedicine drugs
by
Lee, Jeong-Hwan
Sep 19, 2025 06:12am
Discussions on institutionalizing telemedicine have progressed swiftly after the Ministry of Health and Welfare submitted its proposal at the National Assembly last month, The Lee Jae-myung administration confirmed telemedicine as a national agenda, and the Democratic Party of Korea pledged to pass a Medical Service Act amendment during this NA session. In this process, several bills for the legalization of telemedicine have been additionally introduced in the National Assembly. Notably, these bills include new regulatory provisions for non-reimbursed drugs that the government has banned from tele-prescription due to their high risk of side effects and the lack of health insurance prescription data. Narcotics, psychotropic medicines, hair loss treatments, acne drugs, and obesity medications that are prohibited from tele-prescription have long been pointed out as areas of concern in the institutionalization of telemedicine, since excessive prescribing could lead to widespread adverse drug events and misuse. Particularly, if non-reimbursed prescription drugs are not properly regulated, telemedicine could result in patients concentrating at certain medical institutions or pharmacies in order to obtain such prescriptions, raising concerns among doctors and pharmacists. Fortunately, a bill (proposed by Representative Sun-min Kim of the Rebuilding Korea Party) has been introduced that makes it mandatory to use and check the Drug Utilization Review (DUR) system during telemedicine, thereby blocking patients from receiving prescriptions via telemedicine for drugs that the government has banned. This enables the National Assembly to deliberate on legislating regulatory provisions for prohibited tele-prescription drugs during bill reviews. Currently, even if the Ministry of Health and Welfare designates certain drugs as prohibited for tele-prescription based on feedback from the medical community, there is no enforcement mechanism if doctors ignore this and prescribe them via telemedicine. However, according to Representative Kim Sun-min, once the DUR requirement is legislated, prescriptions for such banned drugs will be automatically blocked. At present, more than 800 items fall under the category of drugs prohibited for tele-prescription, including narcotics, drugs with misuse potential, obesity drugs, and emergency contraceptives. Since these drugs can trigger a range of adverse outcomes when prescribed via telemedicine—such as misuse, concentration at specific medical institutions or pharmacies, and overprescribing—the mandatory use of DUR provision must be incorporated into institutional discussions to ensure a safe telemedicine environment. Representative Kim’s bill also specifies prohibited actions for telemedicine intermediaries, such as platform companies. This is another necessary provision for the safe legalization of telemedicine. Among these, the clauses that prohibit platforms from receiving monetary or other rebates in return for directing patient prescriptions to specific medical institutions or pharmacies, and that require platforms to submit statistical data quarterly to the Minister of Health and Welfare for telemedicine monitoring, along with stipulations for administrative actions such as corrective orders, license revocation, and business suspension in case of violations, are expected to effectively curb platform misconduct or illegal practices from the outset. As of the 17th, a total of 6 bills on the institutionalization of telemedicine are pending in the National Assembly, with additional bills being prepared. Beyond regulatory measures that prohibit tele-prescription drugs and platform supervision, many hurdles remain to achieve a comprehensive telemedicine system. With the possibility of institutionalizing the amendment of the Medical Service Act for telemedicine likely within the year, it is this reporter’s hope that the National Assembly fully demonstrate its legislative efforts and capabilities in unifying the diverse positions and opinions of relevant stakeholders—including the MOHW, doctors, pharmacists, and platforms—with the public at its core.
Opinion
[Reporter’s View] Real test begins for K-CDMOs
by
Son, Hyung Min
Sep 15, 2025 06:01am
In the midst of global supply chain restructuring, Korea’s CMO (Contract Manufacturing Organization) and CDMO (Contract Development and Manufacturing Organization) industries are emerging as new growth drivers for the biopharmaceutical sector. The shift away from China is acting as an opportunity factor, while independent achievements based on Korean firms’ technology and quality are also increasing. However, challenges such as potential overcompetition and global political and security risks still loom large. Samsung Biologics has been securing large-scale contracts since the beginning of this year. The company signed agreements worth more than USD 1 billion each with pharmaceutical firms in the U.S. and Europe. Its cumulative orders for the year have reached KRW 5.2435 trillion, nearly matching last year’s total of KRW 5.4035 trillion in just 8 months. Since its founding, the company’s cumulative orders have exceeded USD 20 billion. ST Pharm, though smaller in size, is also attracting attention with solid contracts. It secured a KRW 20.3 billion deal with a European pharmaceutical company for small-molecule APIs, and a KRW 18.3 billion supply contract with a U.S. biotech firm for oligonucleotide APIs. Its order backlog surged 76% from KRW 232 billion at the end of last year to KRW 407.9 billion as of date. Once considered a latecomer in RNA therapeutics manufacturing, ST Pharm has quickly increased its presence by signing consecutive deals with global companies. SK Pharmteco achieved a symbolic milestone in December last year with a KRW 2 trillion order for obesity drug APIs. At a time when global pharmaceutical firms are heavily investing in the development of GLP-1 class drugs, the fact that a Korean CDMO has actively joined this trend carries significance. At the same time, the company has also demonstrated diversification potential in cell and gene therapy (CGT), securing a contract with Switzerland’s Ferring Pharmaceuticals for a bladder cancer therapy. Smaller and mid-sized firms are also moving actively. ENcell signed a KRW 5.7 billion AAV gene therapy CDMO contract with the Korea Research Institute of Bioscience and Biotechnology in July, the largest single deal in the company’s history and equivalent to 80% of its annual revenue. Prestige Biologics landed a KRW 13.2 billion deal with an undisclosed pharma company, laying the groundwork for long-term CDMO operations. Medipost also entered the CDMO market in earnest with a KRW 2 billion deal for cell therapy manufacturing. However, viewing this trend solely as a ‘tailwind’ may raise issues. While it's true that global pharmaceutical companies are turning their attention to Korea, it also means the competitive arena has broadened and become more complex. Potential manufacturing bases like India and Eastern Europe are also rapidly expanding their scale. This is precisely why Korean CDMOs must differentiate themselves by emphasizing development capabilities and innovative technologies, moving beyond simple contract manufacturing. Moreover, the moment dependency increases, paradoxically, so does the risk. If revenue becomes concentrated on specific companies or products, the structure becomes entrenched, making it more vulnerable to external environmental changes. To avoid a ‘second China dependence’ incident, the contract portfolio needs to be diversified, and a mid-to-long-term investment roadmap supported. The surge in orders driven by the de-China effect is also sparking concerns of excessive competition among Korean companies. While the U.S. Biosecure Act may restrict Chinese firms, companies from Japan and Eastern Europe are also moving to capture opportunities in supply chain realignment. This makes it difficult to assume that Korea alone will enjoy a sustained boom. The recent contract wins are certainly encouraging signals. Yet, as the saying goes, true competitiveness lies not in winning contracts but in maintaining them. What is needed now is not celebration, but sober assessment.’ The boom Korean CDMOs are experiencing is only the beginning. The answer to whether they can lead the global market through ‘development’ and ‘innovation’ beyond mere ‘contract manufacturing’ will naturally emerge through the challenges ahead.
Opinion
[Reporter's View] Interest Rate Cuts and Investment Revival
by
Kim, Jin-Gu
Sep 09, 2025 06:13am
Will the long wait finally come to an end? With growing expectations that the U.S. Federal Reserve will lower its benchmark interest rate, optimism is rising that frozen investor sentiment could finally thaw. The Korean pharmaceutical and biotech sector, particularly bio-ventures with strained finances, has endured severe challenges. As external funding dried up in the wake of the COVID-19 endemic, many companies were forced to let go of researchers, sell off facilities and patents, and, in many cases, shut down entirely. Even as of September 2025, numerous firms remain on the brink of survival. Investment in actual biotech ventures peaked in 2021 and has sharply contracted since. According to the Korea Venture Capital Association, domestic venture investment in the bio-medical sector, which reached KRW 1.677 trillion in 2021, shrank to KRW 1.1058 trillion in 2022 and KRW 884.4 billion in 2023. Although it rebounded to KRW 1.0695 trillion last year, it remains at the 2019 level (KRW 1.1033 trillion). Analysts attribute this investment contraction to the prolonged period of high interest rates. The U.S. Federal Reserve's tightening stance has dampened the investment environment globally and across all industries, squeezing the lifeblood of biotech ventures with weak funding capabilities. However, the situation is shifting as strong signals for U.S. interest rate cuts emerge. Recent wobbles in U.S. economic indicators have bolstered financial market expectations that the Fed will lower its benchmark rate by 25-50 basis points this month. Major investment institutions, including Morgan Stanley, also strongly anticipate rate cuts within the year. Of course, a reduction in the U.S. Federal Reserve's benchmark rate does not immediately guarantee a flood of new investment capital into domestic pharmaceutical and biotech companies. A clear time lag is expected before the waves of the global macroeconomy reach Korea. Time is also needed for investor confidence to recover. Even if investment sentiment does recover, the likelihood of funds flowing into companies that have yet to prove their performance remains limited. Still, even a modest easing of funding pressures that have strangled biotech R&D would be highly meaningful. For ventures and mid-sized firms caught at the crossroads of survival, it may provide the breathing room needed to continue both research and operations. The darkest hour comes before the dawn. As signs of recovery emerge from an investment environment battered by high rates, an opportunity for renewed growth is approaching. The capabilities honed through enduring harsh times will fuel the upcoming leap. Pushing through just a little further now could turn past perseverance into tangible results. It is this reporter’s hope that the Korean pharmaceutical and biotech industry seizes this change as an opportunity to make a new leap forward.
<
1
2
3
4
5
6
7
8
9
10
>