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- 2026-06-06 09:06:00
- InterView
- "Diagnostics offer an opportunity…'Tevimbra' for gastric cancer"
- by Son, Hyung Min Jun 01, 2026 09:03am
- The treatment landscape for metastatic gastric cancer is rapidly shifting toward a biomarker-driven precision medicine era. While treatment previously centered on cytotoxic chemotherapy, the recent advancements in which therapeutic strategies diverge based on diverse biomarkers, such as HER2, PD-L1, Claudin 18.2, and FGFR, has highlighted the importance of patient-tailored, personalized medicine.With the introduction of immuno-oncology (IO) agents and targeted therapies, the diagnostic process (identifying 'which type of patient' it is, as much as 'which drug to use') has entered a stage where it dictates the success or failure of treatment. As treatment options vary depending on HER2 positivity, PD-L1 expression levels, and Claudin 18.2 expression status, diagnostic accuracy and turnaround time are directly linked to therapeutic opportunities.DailyPharm met with Professor Min-hee Ryu and Professor Jaewon Hyung of the Department of Oncology and Professor Young Soo Park of the Department of Pathology from the Stomach Cancer Multidisciplinary Team at Asan Medical Center to discuss shifting therapeutic strategies driven by the expansion of precision diagnostics in gastric cancer, the clinical implications of Tumor Area Positivity (TAP)-based evaluation, and the evolving immuno-oncology landscape, including 'Tevimbra (tislelizumab)'.The Stomach Cancer Center's Multidisciplinary Team at Asan Medical Center. From left, Professor Min-hee Ryu of the Department of Oncology, Professor Young Soo Park of the Department of Pathology, and Professor Jaewon Hyung of the Department of Oncology As biomarkers expand, the testing and interpretation processes are becoming increasingly complex. In particular, since gastric cancer is recognized as a relatively fast-progressing malignancy, concerns are being raised that a prolonged diagnostic process may delay the optimal initiation timing for first-line therapy.Consequently, the importance of a multidisciplinary approach, in which multiple companion diagnostics (CDx) are performed concurrently at initial staging and the departments of pathology, medical oncology, surgery, and radiology collectively deliberate on the treatment direction, is growing. Asan Medical Center also operates a Stomach Cancer Center Multidisciplinary Team involving multiple clinical specialties, primarily focusing on patients with advanced gastric cancer to formulate optimal therapeutic strategies.In the cancer immunotherapy landscape, PD-L1 evaluation methodology has also become a new point of discussion. While the current domestic reimbursement environment is centered on Combined Positive Score (CPS)-based evaluation, certain recently introduced therapies use a Tumor Area Positivity (TAP)-based approach, raising the possibility that both assessment modalities will coexist in clinical practice for a period. In particular, the TAP-based SP263 assay is attracting attention for its real-world clinical utility and interpretive efficiency, as it is performed on automated platforms that enable a relatively rapid turnaround time.Tevimbra is also a therapeutic agent that uses TAP-based evaluation, and discussions suggest it could serve as a novel alternative for diagnostic efficiency while maintaining continuity with existing CPS-based checkpoint inhibitors. Furthermore, it demonstrated survival benefits in the first-line treatment of HER2-negative metastatic gastric cancer through the RATIONALE 305 study and is included in the US NCCN Guidelines as a recommended first-line treatment option (Category 2A) for patients with HER2-negative, PD-L1-expressing gastric and gastroesophageal junction (GEJ) cancers.In certain patient subgroups with high PD-L1 expression levels (CPS ≥ 5), Tevimbra is recommended as a preferred regimen (Category 1), and its potential is demonstrated in subgroup analyses of patients with peritoneal metastasis, which is also highlighted as a key point of interest.Experts assess that gastric cancer management is moving beyond simply adding new agents and is undergoing a rapid restructuring of the entire diagnosis-to-treatment process. They explain that the expansion of biomarker testing has heightened the clinical significance of pathological interpretation and that multidisciplinary collaboration has become a virtual necessity to avoid missing the critical window for treatment initiation. Q. Why is multidisciplinary care essential in gastric cancer?Professor Min-hee Ryu Professor Ryu: While some gastric cancer patients undergo only surgery or receive only systemic chemotherapy, the majority undergo surgery and chemotherapy either sequentially or concurrently. In the multidisciplinary team, we discuss the sequencing of modalities or, when a diagnosis is challenging, synthesize the opinions of pathology and radiology specialists to establish the diagnostic and therapeutic pathway.Furthermore, there are instances where the presence or absence of metastasis is ambiguous, making it difficult for a single clinical specialty to determine a treatment plan independently. In cases where multiple modalities must be introduced sequentially, discussions are necessary to clarify the treatment order or resolve any diagnostic ambiguity.Professor Park: The significant advantage of multidisciplinary care is that it provides a one-stop solution, rather than forcing patients to navigate multiple departments to gather separate opinions as they did in the past.As the life expectancy of cancer patients extends, we are seeing more patients presenting with multiple malignancies. For example, when a gastric tumor is detected in a patient who had lung cancer five years ago, multiple specialties convene to deliberate on whether to treat it as a primary gastric cancer or evaluate it as a metastasis from the previous malignancy. Consequently, it takes less time to establish a therapeutic strategy compared to the past, and the selected strategies are far more precise.Professor Hyung: Cancer treatment methods are diverse, including chemotherapy, radiation therapy, and surgical resection. In the case of metastatic cancer, systemic chemotherapy is not the sole mandate; instead, various departments collaborate to consider clinical intervention methods, and there are cases where the treatment prognosis improves when an intervention is introduced at the optimal timing. These aspects represent the advantages of the Asan Medical Center's Stomach Cancer Center Multidisciplinary Team.Q. With various therapeutic agents, such as immuno-oncology products and ADCs, recently introduced for gastric cancer, how have treatment goals or patient management approaches shifted following their introduction?Professor Ryu: Recently, as the efficacy of targeted therapies and immunotherapies has been validated in gastric cancer alongside cytotoxic agents, the importance of companion diagnostics to determine patient eligibility has grown substantially. While therapies were previously deployed uniformly without patient stratification, the paradigm has shifted toward screening and selecting patients who are highly likely to derive clinical benefit based on diagnostic readouts, driving improvements in therapeutic outcomes.Professor Hyung: For a long period following the ToGA trial, novel treatment options for gastric cancer remained limited, but the recent introduction of checkpoint inhibitors has dramatically altered the therapeutic landscape. In particular, the implementation of companion diagnostic concepts linked to PD-L1 expression has enabled personalized care, and the efficacy of immuno-oncology combination regimens is being validated. Furthermore, whereas we previously relied on a limited number of assays focused on HER2, we now consider a diverse array of biomarkers concurrently, such as Claudin 18.2, enabling tailored therapy to be far more sophisticated. Durable long-term responses are also being observed in some patients, which I view as a clinically profound shift.Professor Park: It is not that gastric cancer lacks biomarkers; various indicators such as EBV and MMR already existed alongside HER2 and PD-L1, and with the recent addition of novel targets like Claudin 18.2, biomarkers are becoming increasingly segmented. However, in the case of PD-L1, because different antibody clones, such as 22C3, 28-8, and SP263, are paired with distinct therapeutic agents, there is a logistical burden of performing multiple assays concurrently. In this regard, gastric cancer remains a malignancy where immunohistochemistry (IHC)-based testing plays a pivotal role.Q. What are TAP and CPS, and how do these PD-L1 evaluation methodologies differ?Professor Young Soo ParkProfessor Park: TAP is a methodology that determines positivity or negativity based on an area concept rather than a numerical count. Conversely, CPS is a numbers-based evaluation. While both serve as criteria to evaluate PD-L1, their analytical approaches differ.TAP measures the surface area of positively stained cells within the total tumor area, whereas CPS is a calculated ratio based on the raw count of positive cells. To date, the TAP method is generally known to demonstrate slightly higher concordance and reproducibility compared to CPS.In large tertiary hospitals with high daily case volumes, the difference in interpretation time between CPS and TAP may not be substantial, given extensive experience with CPS scoring. However, for pathologists who are initially adopting the workflow or in institutions with lower sample volumes, I believe TAP offers distinct advantages.In particular, because TAP is an area-based measurement, it possesses high potential for integration with AI-driven interpretation or deep learning-based analytics in the current environment, where slide scanning and digital pathology workflows are expanding.Professor Ryu: Because immune-checkpoint inhibitors are linked to companion diagnostics, regulatory approvals and reimbursements are structured around the specific assay methodologies and scoring criteria used for each agent. Currently, Opdivo and Keytruda are reimbursed based on the CPS criteria used in their registrational trials. At the same time, Tevimbra was developed using TAP, requiring ongoing discussions about how its reimbursement criteria will be established. In South Korea, HIRA tends to enforce criteria identical to those used in regulatory approval trials; therefore, it is highly likely that clinicians will continue to use the exact testing methodology aligned with each therapeutic agent. It appears that the two evaluation systems will co-exist for a certain period, aligned to their corresponding drugs.Professor Hyung: While there is a global trend toward a more flexible application by acknowledging a degree of interchangeability between diverse assays, South Korea maintains relatively stringent companion diagnostic standards, meaning that the diversity of testing modalities will likely be directly reflected in clinical practice. Ultimately, in real-world settings, an approach that synthesizes the patient's performance status and biomarker profiles to select the therapeutic option that best matches each metric will become critical.Q. What shifts do you anticipate new evaluation methodologies like TAP will bring to therapeutic strategies, clinical decision-making, and the future trajectory of PD-L1 assessment?Professor Park: Rather than an entirely unprecedented concept, TAP extends existing PD-L1 evaluation methodologies, such as CPS. However, its area-based approach makes it more intuitive and accessible. Due to the structure in South Korea, in which the exact assays and scoring criteria from pivotal trials are strictly applied, selective CPS and TAP utilization depending on the therapeutic agent will persist.Another critical aspect is the operational difference between the assays. The SP263 clone used for TAP is deployed on fully automated instrumentation enabling same-day staining. In contrast, the 22C3 or 28-8 pharmDx assays utilized for CPS rely on semi-automated platforms that can be more time-consuming or necessitate send-out testing to external reference labs. Taking these factors into account, the adoption of TAP should be viewed not as a matter of absolute superiority, but as a choice reflecting real-world clinical utility and accessibility.Professor Ryu: In clinical oncology, therapeutic decisions are based on pathology reports, making interpretive consistency and reproducibility paramount. Data to date suggest that TAP and CPS exhibit a substantial correlation. I believe both modalities are viable. However, when considering workflow convenience, staining intensity, crispness, and adaptability for digital pathology or AI-driven scoring, TAP may offer a slight competitive edge. In particular, SP263-based TAP is known to yield relatively distinct staining, which holds promise for practical clinical implementation.Professor Hyung: Because manual single-cell counting is highly labor-intensive, rapid and consistent interpretation will become increasingly critical moving forward. In that respect, the TAP method offers distinct advantages. Furthermore, given the growing trend toward digital pathology and AI-driven analytics, the area-based approach is technically easier to integrate, underscoring its strong future utility.Q. Multiple immune-checkpoint inhibitors have recently been introduced into the metastatic gastric cancer treatment landscape. In what ways do you think Tevimbra, as a later entrant to the market, distinguished from existing therapeutic options?Professor Jaewon Hyung Professor Hyung: Although Tevimbra has entered real-world clinical use, our institutional experience remains early, and without head-to-head comparative data, any definitive conclusions must be drawn cautiously. However, since a statistically significant improvement in overall survival (OS) was reported in its clinical trials and major guidelines like the NCCN recommend it on par with other checkpoint inhibitors, it is highly likely to deliver a comparable level of therapeutic efficacy.Notably, in gastric cancer, numerous observational data indicate that the efficacy of checkpoint inhibitors is relatively diminished in patients presenting with concurrent peritoneal metastasis and malignant ascites. There is anticipation that Tevimbra could serve as a valuable therapeutic agent, demonstrating added potential to address this specific area of high unmet medical need.Professor Ryu: Another frequently discussed aspect regarding Tevimbra is the peritoneal metastasis cohort. Historical data for conventional immune checkpoint inhibitors have indicated relatively limited efficacy in patients with peritoneal disease; conversely, subset analyses of Tevimbra have suggested signal activity and efficacy even in this cohort. Granted, variations in sample size exist, and whether these subgroup data can be directly generalized remains a separate issue. Nevertheless, demonstrating a potential therapeutic signal in peritoneal metastasis, setting it apart from legacy checkpoint inhibitors, is clinically noteworthy.Q. What are your perspectives on the current reimbursement criteria for immune-checkpoint inhibitors and the necessity of securing reimbursement for Tevimbra moving forward?Professor Ryu: From a clinician's perspective, expanding the therapeutic arsenal is inherently beneficial for patients. Furthermore, I believe institutional equity is crucial in this domain. While immune-checkpoint inhibitors generally share a similar mechanism of action, Tevimbra is characterized by its demonstrated potential for efficacy even in patients with peritoneal metastasis, as previously discussed. Therefore, Tevimbra must be integrated into the system as a therapeutic option on par with Opdivo or Keytruda. If one agent is reimbursed while another remains non-reimbursed, real-world clinical prescribing will inevitably lean heavily toward the insurance-covered medication.Professor Hyung: Diversifying therapeutic options yields clear advantages for both patients and treating physicians. Particularly in gastric cancer, the prevalence of peritoneal metastasis is substantial, and patients with metastasis have a poor prognosis. Consequently, if a treatment offers even a slight therapeutic advantage in this patient group, it would be highly beneficial in real-world clinical practice.
- InterView
- [Reporter's View] Disparity btwn approval·reimb criteria for cancer drugs
- by Son, Hyung Min May 29, 2026 09:14am
- Recently, there has been a discrepancy between the scope of approval and health insurance reimbursement criteria in cancer treatment. Consequently, there are growing cases in which patients who are technically eligible for treatment under the approved indication are unable to achieve therapeutic benefits.Critics point out that the widening gap among global clinical guidelines, real-world clinical practice, and domestic regulatory approval and reimbursement criteria is becoming yet another barrier to patient care.The aims of regulatory approval and reimbursement are inherently different. Approval is a process of evaluating therapeutic viability based on safety and efficacy, whereas reimbursement evaluates both cost-effectiveness and clinical necessity within a constrained healthcare budget. Consequently, the criteria of these categories are different. However, instances where the approved label, global guideline recommendations, and actual reimbursement scope diverge are increasingly common, aggravating confusion in clinical settings.One of these examples is the treatment of advanced renal cell carcinoma (RCC).Global clinical guidelines offer a broader range of therapeutic choices following first-line immuno-oncology therapy for RCC.Major international guidelines, including the National Comprehensive Cancer Network (NCCN), European Society for Medical Oncology (ESMO), and European Association of Urology (EAU), recommend various targeted therapies as key subsequent lines of therapy after immuno-oncology combination therapies. In particular, certain agents are highlighted as preferred choices after first-line therapy, suggested as a flexible, sequential treatment strategy depending on patient status and therapeutic response.However, real-world clinical practices in South Korea are quite different. The approved scope for several subsequent treatment options is limited to prior exposure to VEGF-targeted therapy. Consequently, for patient cohorts who received first-line immuno-oncology combination therapy, utilization is restricted, and reimbursement is entirely unavailable. While global guidelines are expanding therapeutic choices, a restrictive structure remains, where approval and reimbursement criteria narrow down the eligible patient population.This gap is also evident in the treatment of metastatic gastric cancer. Based on evidence of survival benefits, immune-oncology combination therapy has recently become a key pillar of treatment, with some agents securing regulatory approval for an all-comer patient population. At the reimbursement stage, however, the target patient population is redefined by reflecting the biomarker thresholds based on PD-L1 expression levels, such as Combined Positive Score (CPS) or Tumor Area Positivity (TAP).As a result, certain eligible patients are excluded from reimbursement coverage. In real-world clinical practice, even when a physician determines a clear clinical necessity for treatment, considering patients whose biomarker scores are near the cut-off threshold or who have an overall poor performance status, therapeutic choices are limited by rigid reimbursement rules. This indicates that the discrepancy between regulatory approval and reimbursement guidelines directly lead to disparities in patient access to treatments.Of course, it is challenging to extend reimbursement coverage to every therapy based on its approved scope. Balancing fiscal sustainability and cost-effectiveness in the national health insurance budget is necessary.Selecting specific patient populations and establishing prioritization within limited financial resources are necessary steps. The critical issue, however, is the degree of the gap between these criteria and actual clinical practice. If global guidelines and regulatory frameworks are designed to expand access to treatment while reimbursement criteria remain anchored in outdated patient-selection frameworks, the lag between shifting therapeutic paradigms and institutional policies will inevitably widen.If regulatory approval is the process of unlocking therapeutic potential, reimbursement is the process that translates that potential into clinical reality. A certain degree of variance between the two criteria can exist. However, when the gap widens to the point of gauging patient access to life-saving treatments, it is time to re-evaluate what the system is missing.
- InterView
- [Reporter’s View] Beyond Korea's drug pricing reform
- by Lee, Jeong-Hwan May 22, 2026 10:25am
- The government has finalized implementation of a drug pricing system reform plan centered on applying a 45% pricing rate for generics and granting pricing incentives to innovative pharmaceutical companies, quasi-innovative pharmaceutical companies, and companies contributing to the stable supply of essential medicines. However, the tasks needed to maximize the effects of the reform and minimize side effects remain unfinished.Fortunately, the ruling party and the government appear to have immediately begun work on preparing the “next-level” administrative and legislative specifics needed to create synergy with the drug pricing reform.The direction is clear: Korea must break away from and reform the abnormal multi-product generic structure in which hundreds of products are approved for a single ingredient, leading the market to be mired in distorted promotional competition—specifically, illegal rebate competition—rather than competition based on product quality.The specific policy goal of the ruling party and the government is to broadly gather opinions from the pharmaceutical industry, professional organizations, and academia to reduce or abolish the currently permitted 1+3 contract-based joint bioequivalence system for generics, while also overhauling the pharmaceutical industry structure that abuses contract sales organizations (CSOs) to distribute illegal rebates.This is a necessary policy shift for Korea’s pharmaceutical industry to move beyond domestic generic drug sales competition and evolve into a nation capable of developing blockbuster new drugs that dominate the global market.Jae-hyun Lee, head of the Korea Regulatory Affairs Professional Society and an expert in drug approval regulations and health policy, criticized the 1+3 joint bioequivalence system as “a deformed system that cannot be found anywhere else in the world and the main culprit behind the proliferation of generics in Korea,” calling on the government to seriously reflect and change course.Lee said, “The domestic regulatory system itself, which grants product approval through joint bioequivalence, makes no sense. Even a 1+1 system, which would allow one contract manufacturer to grant approval rights to only one consignment company, is unreasonable. Korea needs to shift to a single-generic per product policy by abolishing consignment bioequivalence testing and eliminating identical generics.”Won-jun Cho, Senior Policy Advisor for Health and Medical Policy for the Democratic Party of Korea and the Director of the Party’s Policy Committee, also assessed that the Ministry of Health and Welfare’s planned drug pricing reform can land smoothly without distortion only if if the government actively considers abolishing consignment bioequivalence testing and simultaneously imposes strict regulations on CSOs, which are used as a means for illegal rebates.Cho said, “To maximize the effects of the drug pricing reform for real pharmaceutical companies leading innovation, quasi-innovation, and stable supply, we must eliminate ‘free-riding’ pharmaceutical companies and paper companies that contribute little to the pharmaceutical industry or national development and are solely focused on rebate-driven promotion and sales from generics approved via consignment bioequivalence studies. Together with the government, we will also pursue regulations against pharmaceutical companies and problematic CSOs that damage the sound distribution order of medicines by colluding with certain medical institutions to provide indirect rebates through CSOs, as well as substandard CSOs.”In other words, academia, the government, and the ruling party share the view that unresolved issues long left unattended must now be actively addressed following the implementation of the drug pricing reform.Accordingly, the government (Ministry of Health and Welfare and the Ministry of Food and Drug Safety), academia, and the National Assembly led by the ruling party are expected to take immediate legislative and administrative measures regarding the drug approval system and CSO regulations in the near future.The reason Korea needs to review the reduction or abolition of the 1+3 joint bioequivalence system from multiple angles is that it directly conflicts with the philosophy of the newly revised drug pricing system. It is difficult to establish a logical basis for guaranteeing the same drug price to consignment generic companies that have no production infrastructure or research personnel and simply resell drugs made by others under a different brand name, using only sales networks. After multiple rounds of gathering opinions from the pharmaceutical industry, the government needs to assess the utility and limitations of the consignment bioequivalence system and make a reasonable administrative decision.Furthermore, the success of the drug pricing reform plan also requires eliminating the illegal CSO rebate structure, which serves as a distorted business practice for some generic drug companies. In a situation where the products themselves have virtually no competitive edge, some generic drug companies currently rely on distributing rebates to doctors to induce prescriptions, and this must be stopped. Regulatory standards must be tightened to ensure that CSOs are no longer used as scapegoats.It is time to consider introducing a dual-penalty system that clearly links illegal rebate liability between pharmaceutical companies and CSOs, while also strengthening penalties for doctors who receive rebates to a level sufficient to restore market order. This is because drug price cuts alone cannot completely block the flow of illicit funds into illegal business practices.The Ministry of Health and Welfare’s drug pricing reform is the first step toward innovation in the pharmaceutical industry. Unless the National Assembly enacts legislation to eliminate unreasonable systems and health authorities follow up with aggressive measures, there is a risk that this reform plan will remain just another unfinished policy. To ensure that the principles of “removing free riders” and “rewarding innovation” become firmly rooted in the market, the 22nd National Assembly and the government must act without delay.
- InterView
- [Desk's View] The 16-year shackle around K-toxin must be broken
- by Lee, Seok-Jun May 19, 2026 11:08am
- The declassification of botulinum toxin as a National Core Technology is under discussion. This time, the atmosphere is noticeably different. It has been reported that the Biotechnology Expert Committee under the Ministry of Trade, Industry and Energy (MOTIE) has reached internal consensus in favor of declassification. All that remains now is a conclusion.According to MOTIE and industry sources, the Biotechnology Committee, operating under the Industrial Technology Protection Committee, is currently reviewing whether to remove botulinum toxin product manufacturing technology and its strains from the National Core Technologies designation list. MOTIE states that this is part of a routine, periodic review process to reassess 79 national core technologies across sectors such as semiconductors, displays, and biotechnology.However, the market does not view this as a mere routine review. This is because a regulatory controversy that has persisted for 16 years is shifting direction for the first time.In fact, sources inside and outside the industry observe that the Biotechnology Committee has reached consensus primarily on the declassification view. Assessments also indicate that the atmosphere shifted noticeably after MOTIE recently replaced several long-tenured, consecutively reappointed committee members.This change is significant. Previously, the controversy surrounding the national core technology designation for botulinum toxin focused on the issue of specific committee members serving long, consecutive terms. During last year's National Assembly audit, critics pointed out the expert committee's closed nature and its structural reliance on specific individuals. MOTIE's personnel overhaul aligns directly with this trend, implying that the newly appointed expert committee members for this year have converged on the opinion of lifting the designation. The core issue is simple. The current discussion is not about whether to unlock a single technology. It is about whether the outdated regulatory framework can be normalized.Meanwhile, the domestic botulinum toxin industry has long argued that the National Core Technology designation constitutes excessive, duplicate regulation. Their view is that because management systems are already functioning under the Pharmaceutical Affairs Act, the Infectious Disease Control and Prevention Act, and the Foreign Trade Act, layering National Core Technology regulations on top has only inflated administrative burdens.Critics have pointed out that South Korea is the only country to designate botulinum toxin as a National Core Technology, even though it is recognized globally as a generic manufacturing technology. Furthermore, the strains are publicly available on global genetic information networks, and a significant number of domestic companies utilize overseas strains. Despite this, additional reviews were repeatedly required in South Korea for every export, technical cooperation, and licensing process. Ultimately, it was a structure where administration outpaced industrial development.The problem lies in the outcome. The global botulinum toxin market has reorganized around American and European companies. Even though domestic companies possess manufacturing competitiveness, they have found themselves tied down by various administrative procedures. Uncertainty has also repeatedly plagued overseas market expansion and technology transfer negotiations.The National Core Technology system itself cannot be discredited. However, regulations must keep pace with reality. If the restrictive effects on industry outweigh the actual benefits of protection, the policy must be amended.Above all, these discussions must not end in another round of dragging time. In the past, whenever the possibility of declassification was raised, postponing a conclusion was a recurring pattern. In the meantime, market uncertainty only intensified.Now, the situation is different. A shift in the committee's internal current has been detected, and MOTIE has signaled a personnel overhaul. Now, only the final judgment remains.If the shackles that have bound K-toxin for 16 years cannot be broken this time either, the market will inevitably ask once again. For whose benefit is the South Korean biotech industry being regulated?The ball is now in the Industrial Technology Protection Committee's court. Conclusion awaits.
- InterView
- 'Insomnia can become chronic if left untreated'
- by Son, Hyung Min Apr 28, 2026 09:46am
- The importance of timely treatment of insomnia is being emphasized, as insomnia, once considered merely a lack of sleep, can develop into a chronic condition if it persists.While the number of patients diagnosed and treated in Korea remains at around 700,000, it is estimated that 20–30% of adults actually experience insomnia symptoms. As the gap between symptom experience and treatment persists, the need for early intervention is increasing.Professor Wonju Kim of the Department of Neurology at Gangnam Severance Hospital explained in a recent interview with Daily Pharm, “Insomnia does not simply mean having difficulty falling asleep. It is a disorder that also includes repeatedly waking up during sleep or waking up earlier than planned. We consider treatment necessary when these sleep problems persist and lead to impaired daily functioning, such as fatigue, decreased concentration, and daytime sleepiness.”He continued, “If appropriate intervention is not made, especially in the early stages, symptoms can become prolonged and progress into chronic insomnia. It is crucial not to miss the optimal timing for treatment.”Lack of sleep increases the risk of systemic diseases… the importance of insomnia management highlightedProfessor Wonju Kim, Department of Neurology, Gangnam Severance HospitalInsomnia manifests in various forms, including ▲ difficulty falling asleep, ▲ difficulty staying asleep, and ▲ waking up too early in the morning. It is classified as a medical condition, not merely a lack of sleep, but when it is accompanied by a decline in daily functioning.In particular, acute insomnia caused temporarily by external stress can progress to chronic insomnia lasting more than three months if left untreated.Professor Kim said, “The longer insomnia persists, the more difficult it becomes to treat, and the longer treatment may take. Active treatment in the early stage is important.”According to the HIRA Open Data Portal, the number of patients with insomnia in Korea increased from about 650,000 in 2020 to about 760,000 in 2024.Insomnia affects not only sleep but also overall health. Persistent sleep deprivation is known to be associated with reduced concentration, emotional dysregulation, as well as increased risks of cardiovascular disease, diabetes, and depression.Currently, insomnia treatment is divided into cognitive behavioral therapy and pharmacotherapy. Although cognitive behavioral therapy is recommended as the standard treatment, its use is limited in Korea, resulting in a treatment structure that relies heavily on medication in actual clinical practice.Professor Kim explained, “Cognitive behavioral therapy involves identifying a patient’s sleep habits, analyzing them, and continuously correcting inappropriate sleep behaviors. It also includes correcting the misconception that insomnia is an extremely severe disease. However, in Korea, such treatment is not widely implemented due to high manpower requirements and constraints such as insurance reimbursement.”New alternatives amid limitations of pharmacotherapy…DORA proposes an approach based on regulating the arousal systemPharmacotherapy typically includes benzodiazepines and non-benzodiazepine agents, as well as other drugs acting on the same receptors, melatonin, antihistamines, and antidepressants.Professor Kim said, “Existing drugs have proven efficacy, but there is a burden associated with long-term use due to tolerance and dependence issues. Both patients and healthcare providers often face difficulties in maintaining treatment.”He continued, “There is also the issue where efficacy gradually decreases with long-term use, leading to the need to increase the dosage. In elderly patients, there have been reports of the drug’s effects persisting into the next day or abnormal behaviors such as nightmares and sleepwalking. Such side effects are particularly prominent with zolpidem-class drugs.”Amid these limitations, a new treatment approach that regulates the arousal system, DORA (dual orexin receptor antagonist) class drugs, is gaining attention.DORA works by binding to and inhibiting orexin receptors (OX1R, OX2R), which are neurotransmitters responsible for maintaining wakefulness, thereby lowering arousal levels and inducing sleep. This is a fundamentally different approach from conventional methods that directly suppress the central nervous system to induce drowsiness.Professor Kim stated, “Unlike melatonin, which induces sleep, orexin is a neurotransmitter that maintains wakefulness. Sleep and wakefulness exist in a balanced relationship. When wakefulness increases, sleep decreases, and conversely, when sleep increases, wakefulness decreases.”Orexin is produced and secreted by neurons and plays an important role in maintaining wakefulness. A deficiency of this substance is associated with narcolepsy, a condition characterized by an inability to maintain wakefulness and sudden episodes of falling asleep, which is known to be associated with reduced orexin secretion.DORA utilizes this mechanism in reverse. It works by blocking orexin receptors to reduce excessive wakefulness, thereby inducing more natural sleep.This approach differs from existing benzodiazepine-class drugs in that it does not simply induce drowsiness but regulates the sleep-wake balance itself. In particular, while GABA-class sleep aids such as zolpidem affect sleep architecture, including slow-wave sleep and REM sleep, DORA is gaining attention for its ability to induce more physiological sleep without significantly disrupting sleep structure.Professor Kim stated, “DORA-class drugs lower arousal levels to induce more natural sleep. Another characteristic is that they do not significantly alter sleep structure. They hold the potential to alleviate the concerns of tolerance and dependence that have been problematic in existing treatments, and are meaningful in expanding the range of insomnia treatment strategies.”However, the most important factors in treating insomnia remain lifestyle adjustments and environmental modifications.Professor Kim added, “Insomnia often arises from a combination of lifestyle habits and psychological factors. Approaches that correct sleep habits must be combined with drug therapy. Above all, it is crucial for patients to recognize insomnia as a medical condition and begin treatment early. Not missing the treatment window determines long-term prognosis.”
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- [Reporter's View] What's fair for addressing unmet needs
- by Son, Hyung Min Apr 26, 2026 01:44pm
- Now, cancer therapy has entered a stage where a single option cannot explain it all. Previously, when cytotoxic chemotherapy was the center of treatment, the type of cancer was the core criterion for determining a treatment strategy.However, the situation is different now. Even within the same cancer type, entirely different agents are selected based on biomarkers, and even the sequence of treatment and combination strategies varies. The structure has changed to the point where a single disease is effectively split into several different diseases.This change is not a phenomenon limited to specific areas. Non-small cell lung cancer (NSCLC) treatment has been subdivided based on various genetic mutations, and the approach to colorectal cancer also varies depending on biomarker characteristics such as BRAF. Targeted-based therapy is also expanding in rare cancers like biliary tract cancer.Even in diseases where options were limited in the past, the treatment strategy must be redesigned.The problem is that this variation does not stop at simply increasing options but leads to an expansion of the treatment scope.Treatments previously applied primarily to metastatic patients are gradually expanding to include patients with stages 1 to 3, the early-stage patient group. As neoadjuvant, adjuvant, maintenance, and combination therapies are discussed simultaneously, treatment is shifting toward a structure that starts earlier and lasts longer.Of course, from the patient's perspective, the ideal scenario is to receive reimbursement for all possible treatments. If newly emerging agents can be used for more patients at an earlier stage, the opportunity for treatment expands. However, the fact that these changes are occurring simultaneously across multiple cancer types rather than in a specific disease presents another dilemma.Each treatment expansion may be a valid choice. However, the story changes if the same trend is repeated across various cancer types. This is because it is realistically difficult to raise all areas at the same pace with limited resources. Ultimately, it becomes necessary to decide which area to invest more resources in first.In this process, there is one point to be cautious of. The needs of other cancer types must not be ignored simply because discussions are active and voices are loud in a specific cancer type.Unmet needs are not a concept confined to specific diseases. Unmet needs are presented in different forms across various cancer types. There is a possibility that while the necessity of one area is emphasized, the gaps in other areas may be relatively overshadowed.Ultimately, the question is clear: "To what extent and by what criteria will we apply the increased treatment options?" Applying all treatments to all patients may be ideal, but it is not a realistically possible option. Therefore, a discussion is needed on what criteria will be used to set priorities.More opportunities for patients are available due to advances in cancer treatment. However, consideration must also be given to how to distribute those opportunities and to striking a balance to prevent bias toward specific areas during that process. This is why we must reconsider the concept of unmet needs from a broader perspective.
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- [Reporter’s View] Rapid support for essential medicines put to the test
- by Jung, Heung-Jun Apr 22, 2026 08:54am
- As the supply of essential medicines, such as basic IV solutions, is being affected by the aftermath of the Middle East war, attention is focusing on the government’s flexible drug price support measures.Since the outbreak of the Middle East situation, the government has been pouring out multifaceted measures such as priority supply of naphtha, strengthened monitoring of pharmaceutical supply and demand, and prohibition of hoarding.While the immediate focus is on supply management, follow-up support measures are also needed. This is because the burden on pharmaceutical companies producing essential drugs is gradually increasing and could potentially lead to supply instability.In particular, intravenous solutions, where raw materials account for a large portion of production costs, are bearing the brunt of the impact. According to industry sources, the prices of raw materials, which make up about 30–40% of costs, are rising sharply due to naphtha supply instability.Because it is impossible to know when the Middle East situation will stabilize, pharmaceutical companies producing IV solutions are concerned about mounting losses.While this varies by product type, basic IV solutions already have low drug prices. This means that the losses pharmaceutical companies must absorb due to rising costs could become an even greater burden.The government is not sitting idly by. The Ministry of Health and Welfare is strengthening supply and demand monitoring in collaboration with the Health Insurance Review and Assessment Service (HIRA) and the National Health Insurance Service (NHIS). Based on this, it appears they will also review the necessity of raising drug prices.However, the Ministry appears to be exercising caution regarding how much of the situation is truly attributable to the Middle East war. This is because it is necessary to distinguish between cost increases caused by force majeure supply chain shocks and routine price increases caused by other factors.While it is positive that the government is considering supporting production through drug price hikes, the issues lie in implementation speed and flexibility.If the process proceeds via the existing drug price adjustment mechanism, there could be a delay of up to several months between review and actual implementation. This has the limitation of being too slow to defend against cost shocks occurring in real time.Because the government is monitoring price and supply fluctuations of petrochemical raw materials such as naphtha, it could also use this as a basis for drug price support.For example, if price increases and supply instability are expected for the next three months, a flexible support mechanism could be implemented that applies price increases only during that specific period. The rate of increase could be determined according to the degree to which subsidiary raw material prices have affected costs.On the 14th, the Ministry of Economy and Finance and the Ministry of Trade, Industry, and Energy Free Trade Zones announced the “Regulation on Prohibition of Hoarding and Emergency Supply-Demand Adjustment of Petrochemical Raw Materials,” which allows the government to issue supply adjustment orders and provides for compensation for losses incurred in such cases. This reflects the judgment that active government intervention is necessary depending on the severity of the situation.The Ministry of Health and Welfare recently finalized a reform plan containing measures for “operating a supply-friendly drug pricing system for essential medicines.” The main thrust of the plan is to strengthen proactive support to ensure a stable supply.The current situation in the Middle East serves as a test bed for applying such a government policy direction. Along with strengthening supply and demand monitoring, there is a need to consider flexible drug pricing support measures to ensure the stable production of essential medicines.
- InterView
- [Reporter's View] Cut drug prices, expand R&D…SMEs 'exit pressure'
- by Choi Da Eun Apr 02, 2026 08:46am
- The government's recently announced "Drug Pricing System Improvement Plan" appears adequate in terms of its direction. The intent is to improve the market structure, which is currently centered on generics, to provide incentives for pharmaceutical companies to invest in R&D, and to promote self-sufficiency in raw materials. Furthermore, shifting the industrial constitution away from the simple, repetitive manufacturing of off-patent drugs is agreeable.However, the general opinion from the clinical settings is different. There is significant concern that the policy's incentives may actually act as a double burden for many pharmaceutical companies.The core value of this reform is a structure that guarantees relatively higher drug prices for companies with a high R&D investment ratio, in exchange for lower generic drug prices. The higher the ratio of R&D relative to sales, the more a company's generic prices are recognized, which directly correlates to corporate profitability.The problem is that this structure does not operate identically for all companies. While it may serve as a reward for top-tier pharmaceutical companies that have already secured a certain level of R&D capability and capital, it is highly likely to act as a barrier to entry for small and medium-sized enterprises (SMEs).This is because revenue is shrinking as the generic price calculation rate is lowered from 53.55% to 45%, and the timing of "tiered price reductions" for follow-on products applies to the 13th entry. If these tiered price cuts are applied to existing listed products as well, it will be difficult for many SMEs to avoid an immediate drop in cash flow.Of course, the government explains that it will provide incentives through 'Innovative' and 'New Innovative' pharmaceutical company designations. The plan is to guarantee drug prices at a maximum level of 60% for companies with high R&D ratios and apply preferential additions even to companies with a certain level of investment.However, pre-investment is required to meet these standards. A structure where one must increase R&D investment to receive benefits while revenues are decreasing is likely to become a selective incentive that is difficult for companies lacking financial flexibility to access.While the prices of generics, the immediate main source of revenue, are being cut, companies must conversely raise their R&D proportions, which requires pouring tens or hundreds of billions of won, to preserve their lowered profitability. It is a structure where companies are forced into natural extinction in the market if they fail to win the title of a 'New Innovative pharmaceutical company.'A bigger issue is that such a structure could deepen industrial polarization. While top-tier pharmaceutical companies with capital power maximize benefits by expanding R&D investment, SMEs may be pushed out of the market due to limited investment capacity.The government has stated that it will save approximately KRW 2.4 trillion in health insurance costs over the next 11 years through this move, but the price could be the collapse of the ecosystem for smaller pharmaceutical companies that have not yet built up R&D capacity. Some critics argue that this drug pricing reform is essentially a forced restructuring of the domestic pharmaceutical industry.One industry official stated, "While we agree with the direction, the current structure only allows companies with existing capacity to grow further," adding, "Unless realistic support measures that allow SMEs to participate in R&D are implemented as well, the policy effects will inevitably be limited."Pharmaceutical R&D is a long-distance race. It is difficult to evaluate based on short-term results, and the fruits only appear after investing enormous time and effort. In that sense, this drug pricing reform is like placing companies with different levels of physical fitness on the same track from the starting line and demanding they run faster.Furthermore, R&D investment carries the possibility of failure. It is not easy for a company with a weakened profit base to continue bold investments in an area where performance relative to investment is not guaranteed. Consequently, some companies may be driven to focus on securing short-term profits rather than on R&D, or even to downsize their businesses altogether for survival.There is no disagreement with the direction of reducing the overabundance of generics and advancing the industrial structure. However, speed and method are the problem. An approach that induces structural shift solely through uniform price cuts and selective incentives may result in side effects.Unless an environment is established where SMEs can gradually build R&D capabilities while maintaining a minimum investment capacity, this reform is likely to result in industrial contraction rather than promoting innovation. Ultimately, additional incentives must be planned so that policies aimed at lowering drug prices and increasing R&D do not contradict.
- InterView
- [Reporter's View] Let's focus on building 'solid pharmas'
- by Lee, Jeong-Hwan Apr 01, 2026 08:15am
- Why does the conflict between the Ministry of Health and Welfare (MOHW) and the pharmaceutical industry over drug pricing reforms repeat the same patterns? The MOHW finalized a reform plan at the Health Insurance Policy Review Committee, held in March, focusing on reducing generic drug prices while providing incentives for innovative pharmaceutical companies and those contributing to the supply of unstable essential medicines. However, the differences in position between the two parties do not seem to be clearly resolved.The MOHW promised to exchange information and gather opinions to design a reform plan that could also be favorable to the pharmaceutical industry, addressing the National Assembly, the media, and the industry. However, the prevailing assessment is that these efforts remained insufficient and incomplete.Of course, it is impossible to devise an administration or policy that satisfies everyone 100%. The MOHW's stance during deliberations on this drug-pricing reform was unsatisfactory.The MOHW's challenge is understandable. Lee Hyung-hoon, the 2nd Vice Minister of Health and Welfare and Chairman of the Health Insurance Policy Review Committee, expressed the hardship during the process of establishing the reform plan. Lee noted that it is not easy to achieve both the conflicting tasks of ensuring health insurance efficiency and fostering the pharmaceutical industry. Lee's sincere statement received positive responses from reporters, offering a chance to experience and empathize with the difficulties of operating executive branch policy.Despite this, the MOHW must seek better ways to engage the pharmaceutical industry when devising future drug pricing reforms. This is to minimize the aftereffects of exhaustive clashes between the government and industry, while improving the likelihood of a soft policy landing.Health economists point out that the MOHW has not made sufficient effort to design a drug-pricing system that balances equity between the domestic and multinational, foreign-capital pharmaceutical industries.Furthermore, they note that it is difficult to discern the MOHW's philosophy and specific direction for managing National Health Insurance finances. They stated that the administrative goals are so blunt and ambiguous that it is difficult to predict them. The criticism is that if the MOHW were to reveal its inner thoughts transparently, proper consultation would be possible.The MOHW emphasized the "structural improvement toward innovative new drugs" as the justification for this drug pricing reform and as a mechanism to appeal that it is inevitable to cut the prices of already-listed generics.While the direction might not be wrong, the slope was too steep. South Korea's pharmaceutical industry is still centered on generics. The quality and self-sufficiency rate of generics are high. In reality, hundreds of items are licensed, prescribed, and distributed for a single active ingredient.On the other hand, only 41 domestically developed new drugs have obtained marketing authorization. The first domestically developed new drug was Sunpla (SK Pharma), authorized in July 1999, and the most recent domestic new drug is Xcopri (Dong-A ST), which received its license in November 2025, making it the 41st. Among these, no new drug has achieved blockbuster-level sales.To demand that the domestic pharmaceutical industry, which has birthed 41 new drugs over 25 years and is still evaluated as being at a "high school level" or a "twenty-year-old" who has just removed the label of a minor, instantly stop manufacturing and selling generics to produce blockbuster results is an excessively harsh demand.The reform plan should have reflected more of the industry's concerns about how much new drug Research and Development (R&D) will be revitalized by this drug pricing reform, how negative it will be for the supply of price-stabilized medicines, and the potential causal link to employment stability.In MOHW data on the direction of drug pricing reform, one word stood out: "solid pharmaceutical companies."The MOHW expressed its ambition to use this reform as a turning point to cultivate and support robust pharmaceutical companies that are sincere about new drug development and the stable supply of essential medicines, rather than being buried only in generic sales competition.To achieve this ambition, the MOHW must set transparent, clear standards for what constitutes a "solid pharmaceutical company" and develop evaluation indicators. A process involving a public-private consultative body is necessary. This means that active administration and two-way communication are absolutely required to align the "zero point" regarding "robustness" with pharmaceutical companies.During the process of establishing drug pricing reform plan, many "solid" pharmaceutical companies that have secured R&D ratios criticized the government, saying, "It is doubtful whether the MOHW or the MFDS has the standards to distinguish innovative pharmaceutical companies that are sincere about industrial development and public health, or if they even have the evaluation data."The point was that government administration capable of distinguishing "paper companies" that rely on consigned generic production as their core revenue source from "real" pharmaceutical companies has not been properly carried out until now.In a situation where there is zero trust in whether the government has the criteria to distinguish the wheat from the chaff or the administrative power to do so, the MOHW suddenly pushed a reform plan to cut generic prices by up to 40% while favoring companies that have proven innovation. The industry voiced that they were told to just "sign it," which led to frustration and even fear.When promoting the reform plan, the MOHW must conduct follow-up oversight to develop a comprehensive report card that clearly distinguishes robust pharmaceutical companies and provides tailored support.The MOHW now faces the difficult task of communicating closely with the pharmaceutical industry to find and resolve the blind spots in government administration regarding the resolution of the multi-item generic structure, while recognizing that high-quality generics are the heart of K-Pharmaceuticals and the "two legs" that will support the future of industry and employment.We anticipate MOHW administration that identifies field-level clues to fundamentally shift the policy paradigm away from simply cutting generic prices. This would be catching two birds with one stone: health insurance cost savings and new drug development.
- InterView
- [Desk View] Generic bias influencing drug pricing policy
- by Chon, Seung-Hyun Mar 30, 2026 09:12am
- The government decided to lower the price calculation standard for generic drugs from the current 53.55% of the price of the original drug before the patent expiration to 45%. Despite strong opposition from the pharmaceutical industry, the final decision is reportedly similar to the initial draft proposed last year.In November 2023, the Ministry of Health and Welfare (MOHW) reported to the Health Insurance Policy Review Committee a plan to reduce generic pricing to approximately 40%. At that time, the MOHW suggested a plan to adjust drug prices to current levels, ranging from 45-50% to 40%. As products with prices above 45% are classified as targets of adjustment, the government intended that the prices of generic drugs should not exceed that threshold. The original plan was reflected in the final decision.The pharmaceutical industry proposed 48.20% (a 10% reduction from 53.55%) as the figure that they can endure. However, at a Health Insurance Policy Review Committee meeting on the 11th, the MOHW presented a calculation rate in the low-to-mid 40%. Ultimately, while the MOHW secured an alibi of communication over the past five months, the outcome remains largely unchanged from the draft presented nearly half a year ago.While this means that a 45% generic price standard would be reduced by 16.0%, the actual reduction rate grows exponentially when the government's complex price-cutting measures are applied.Under the drug-pricing reform system, the price-cut rate for failing to meet the "highest price requirement" will expand from 15% to 20%. Since July 2020, generic products must meet two conditions to receive the highest price: conducting bioequivalence (BE) studies and using Registered Drug Substances (DMF). For each unmet requirement, the ceiling price drops by a set percentage. Failing both requirements currently results in a 27.75% reduction from the maximum.When applying the new 45% base and the 20% penalty for unmet requirements, generics failing one requirement drop to 36% (a 20.9% drop), and generics failing both requirements drop to 28.8% (a 25.6% drop). By applying a reinforced tiered-pricing system to the drug pricing reform system, entry for late-mover generics would be completely blocked.According to the guidelines following the drug pricing reform in 2020, even if a product meets both standard requirements, if there are already 20 or more identical formulations listed, the 21st product is listed at 85% of the lowest price of the existing formulations or 38.69%, whichever is lower). Currently, the 21st generic drug is set at 32.86%. Compared to the 53.55% maximum, this represents a 38.6% drop for the first product subject to tiered pricing. Prices for the 22nd and 23rd generics drop even further.Under the new reform plan, the 13th generic drug (failing both requirements) would drop to 24.48%. Comparing the same 13th-entry generic, the ratio drops from 53.55% under the old system to less than half under the new reform. By the 13th and 14th entries, prices could drop to as low as KRW 14.98 and KRW 9.20, respectively.Additional mechanisms have been added for price cuts even if a drug was listed at the highest price. To prevent market overheating upon the entry of the first generic, the MOHW intends to apply tiered price cuts to any generic that causes the number of identical formulations to exceed 13. Even if a company is among the first 12 and receives the 45% maximum, if subsequent entries push the total past 13, that product's price will be cut by 15% after one year. This means even the very first generic could see its price drop to 38.25% within 12 months, a 28.58% reduction from the current industry maximum.The pharmaceutical industry argues that the government has meticulously designed to drop drug price over 20% while inhibiting genetic entry of generics.The government's prejudice against generics surfaced amid the drug price reform process. It was based on the prejudice that the increase in generic use could be problematic. Health authorities repeatedly cite rising generic drug expenditures as a threat to the stability of the National Health Insurance (NHI). In 2024, generic drug spending reached KRW 12.44 trillion, a 36.8% increase from KRW 9.09 trillion in 2020. However, the government's argument is that the increased use of generics, which are cheaper than originals, actually saves the NHI budget.Data show that for 14 of 16 dosages among the five most frequently prescribed active ingredients (including atorvastatin, clopidogrel, and rosuvastatin), the weighted-average price is lower than the price of the original drug. This structure demonstrates that as clinical sites prescribe more affordable generics, the overall weighted-average price falls below that of the originals, thereby contributing to fiscal savings. Critics argue the government has focused on statistics on total spending to justify price cuts while ignoring the per-unit savings generics provide.The industry also points out that the government is ignoring existing approvals and regulations.Since July 2020, the number of consigned generics has plummeted because companies must perform their own bioequivalence studies to secure higher prices. Since July 2021, the number of generics that can be approved using a single clinical trial is limited (so called '1+3'). In the past, it was common for dozens of pharmaceutical companies to obtain approval for consigned generics using the same data once a specific company received approval through its own BE testing. However, with the implementation of joint development regulations, 'unlimited replication of generics' is no longer possible.In fact, these regulations have already stifled the entry generics. The number of prescription drug approvals dropped 38% from 4,195 in 2019 to 2,616 in 2020. Last year, only 747 prescription drugs were approved, an 82% drop in six years.The MOHW rationalized the reform by pointing to excessive competition and significant increased number of small-scale firms. The MOHW noted that companies with annual production under KRW 1 billion grew from 54 in 2012 (18.9%). Then, the figure more than doubled to 121 in 2024 (39.3%). However, data details shows that the number of these small-scale firms is declining. The number of firms with an annual finished drug production value of less than KRW 1 billion increased from 51 in 2014 to 124 within just one year. While the growth of these firms slowed starting in 2016, it spiked again to 137 in 2020. Since then, the numbers have declined: down to 133 in 2021 (a decrease of 4 from the previous year) and to 121 in 2024, which is a reduction of 16 companies compared to 4 years prior.The government ignored the impact of the recent regulatory change and overestimated the entry of generics by comparing it with a figure from 10 years prior. Throughout the reform process, the pharmaceutical industry appealed for a policy compromise, citing concerns over reduced R&D investment and job losses.While the government introduced the term "New Innovative Pharmaceutical Company" to offer price incentives for R&D-Intensive firms, the industry remains skeptical of its effectiveness. The industry views the government as having failed to communicate and as having made the system more complex. Ultimately, the industry's distrust of the government has grown.
