- LOGIN
- MemberShip
- 2026-10-11 08:27:34
- Opinion
- [Reporter’s View] Rebate investigation expertise must survive system overhaul
- by Kim, Jin-Gu Oct 08, 2026 09:00am
- Korea’s criminal justice system has undergone a major overhaul with the abolition of the Prosecutors’ Office and the launch of the Public Prosecution Service and Serious Crimes Investigation Agency. Investigations in the healthcare sector have also been reorganized under the new framework.The Food and Drug Crime Investigation Division of the Seoul Western District Prosecutors’ Office, which had handled pharmaceutical and medical device rebate investigations, no longer exists. The joint investigation team that had focused on illegally operated hospitals and license-lending pharmacies has also been disbanded. Ongoing cases have been transferred to the police and other agencies.As the investigative system changed, the agency in charge of cases also changed. The key question is whether the investigative expertise accumulated over many years can be carried over into the new system.Healthcare crime investigations have undergone years of specialization. In 2011, the government established a joint investigative unit dedicated to pharmaceutical rebates. In 2013, the Seoul Western District Prosecutors’ Office was designated as a prosecution office specializing in food and drug safety. Its work later continued through the Food and Drug Investigation Division and the Food and Drug Crime Investigation Division, which handled rebate cases and a range of other healthcare crimes.In May this year, a joint investigation team targeting illegal medical and pharmaceutical practices was also established, led by prosecutors and police with participation from the Ministry of Health and Welfare, National Health Insurance Service, Health Insurance Review & Assessment Service, National Tax Service and Financial Supervisory Service. The team was designed to connect criminal investigations, administrative sanctions, recovery of health insurance funds and the tracing of criminal proceeds within a single coordinated framework.There was a clear reason for strengthening dedicated and joint investigations: criminal schemes are becoming increasingly complex.Recent cases have involved establishing paper companies, giving hospital officials equity stakes, and then paying rebates in the form of dividends. Other cases have involved payments disguised as research funding under the pretext of post-marketing surveillance. Rather than handing over cash or gift certificates directly, rebate schemes have evolved to resemble legitimate commercial transactions or research payments.Illegally operated hospitals and pharmacies have likewise moved beyond simple name-lending arrangements. Some schemes use multiple layers of corporate entities and contractual relationships to conceal the actual operator, while others transfer assets into third-party names to evade recovery. Identifying the true operator and tracing the flow of funds are becoming increasingly difficult.Such cases cannot be uncovered simply by examining the relevant laws. Investigators need to understand pharmaceutical sales practices and drug distribution structures, as well as how legitimate clinical trials are conducted and research funds are normally disbursed. They must also be able to trace National Health Insurance claims data, corporate relationships, and financial flows. Knowing which agency holds which information, and how those pieces of information can be connected, is equally important.Investigative expertise is built through layers of repeated cases being accumulated through trial and error. Judgment about which transactions warrant suspicion, how to distinguish legitimate contracts from sham transactions, and which records should be examined first becomes more refined with each case. The experience accumulated in this process is itself one of the most valuable investigative assets.Under the new system, these functions are divided among multiple agencies. Rebate cases are investigated by the police and, depending on the nature of the case, may fall to the Serious Crimes Investigation Agency. The Major Crimes Prosecution Division within the Prosecution Office is responsible for prosecuting healthcare cases and maintaining prosecutions. Cases previously handled by the joint investigation team are being distributed among police units.More important than the new division of responsibilities is preserving the expertise built up over the years. The investigative judgment gained through years of casework, along with established channels of cooperation among relevant agencies, must be carried forward into future investigations.Expertise does not come simply from an establishment of an organization. It gains strength through people, cases and time. It is sharpened by digging through countless cases, revisiting missed clues and keeping pace with new criminal methods. Healthcare crime continually changes shape as offenders exploit gaps in the system. The investigative framework can change. But the chain of expertise built over many years must not be broken.
- Opinion
- [Reporter’s View] Add a ‘super-innovative’ pharma track
- by Lee, Jeong-Hwan Oct 06, 2026 08:48am
- The Ministry of Health and Welfare has begun a full-fledged overhaul of its certification program for innovative pharmaceutical companies. The reform comes over a decade after the program was launched alongside the enactment of the Special Act on Fostering and Support of Pharmaceutical Industry.The pharmaceutical industry has welcomed the government’s move to replace the existing single-tier certification system with separate ‘leading’ and ‘growth’ tracks, institutionalize tailored incentives for each, and create a new certification track for overseas multinational drugmakers alongside Korean companies. The changes are also expected to help the ministry address longstanding criticism of operating an ‘impractical innovative pharmaceutical company certification program’ that has offered little in the way of meaningful benefits.However, Korea’s top-tier pharmaceutical companies seeking to take homegrown new drugs to global markets are calling for the ministry to go a step further. They propose creating a new, tentatively named “super-innovative pharmaceutical company” track above the existing innovative-company designation, with permanent preferential drug pricing and exemptions from post-listing price cuts rather than temporary pricing incentives.The call for another upgrade may appear premature when the government has only just begun selecting companies under the reformed certification system. Yet there are also legitimate concerns that the current framework could dampen leading drugmakers' appetite for new drug development if, even after investing enormous sums in R&D, they remain subject to an extensive array of post-listing price controls, including price-volume linkage and actual transaction price surveys.The ministry should therefore begin by positively considering a legislative amendment that would strengthen the preferential pricing provision under the current Special Act on Fostering and Support of the Pharmaceutical Industry, changing it from a discretionary provision stating that preferential treatment “may” be granted to a mandatory provision stating that it “shall” be granted. From there, it should begin a broader process of considering industry proposals, including the creation of a super-innovative pharmaceutical company track.In particular, the creation of a dedicated certification track for multinational drugmakers has undercut the ministry’s previous argument that further reform could trigger trade disputes, including concerns over compliance with the Korea-US Free Trade Agreement. With a framework now in place to address concerns over discriminatory treatment between domestic and foreign companies, that argument has lost much of its force.With a framework now in place to offer more aggressive incentives to companies that meet objective standards for R&D contribution and innovation, the government should accelerate efforts to identify preferential measures capable of driving faster growth in Korea’s pharmaceutical and biotech industry.If Korea wants to foster the innovative pharmaceutical companies of the future, the government must also put forward a next-generation policy framework that matches their level of innovation. It is time to give serious consideration to the industry’s proposals for a “super-innovative” track and mandatory preferential treatment, and build a virtuous drug-pricing ecosystem that ensures pharmaceutical and biotech companies investing boldly in innovation are duly rewarded in the market.
- Opinion
- Entresto patent upheld in US, invalidated in Korea…Approval the next hurdle
- by Kim, Jin-Gu Sep 30, 2026 08:52am
- The patent dispute surrounding Novartis’ heart failure treatment Entresto (sacubitril/valsartan) is drawing renewed attention in the US after a federal court ruled that Novartis lawfully listed an early combination patent for the drug in the Orange Book.This contrasts with the outcome in Korea. A Korean patent stemming from the same original invention as the US patent whose Orange Book listing was upheld was invalidated in a decision finalized in 2024. Generic drugmakers also secured a final victory this year in litigation over subsequent patents related to the complex used in Entresto.While the major patent barriers have effectively been cleared in Korea, no generic has yet reached the market. The key barrier to generic entry now has shifted from patents to formulation technology and regulatory approval.US court upholds Orange Book listing of Entresto combination patentThe US District Court for the Southern District of New York recently granted Novartis’ motion to dismiss a lawsuit filed by the Iron Workers Local 580 Insurance Fund.The issue was whether Novartis lawfully listed U.S. Patent No. 8101659 in the Orange Book for Entresto. The patent covers a pharmaceutical composition containing valsartan and sacubitril in an approximately 1:1 ratio. It was set to expire on Jan. 15, 2025, but pediatric exclusivity extended the protection through July 15 of that year.The insurance fund argued that because Entresto contains the two active ingredients in a combined complex, it was improper to list a patent that did not directly claim the complex itself in the Orange Book. The lawsuit alleged that without the patent, generics could have launched on Jan. 16, 2025, but pediatric exclusivity delayed their entry until July, forcing the fund to continue paying the higher cost of branded original Entresto in the interim.The court rejected the argument. It found that because the patent covers the combination of valsartan and sacubitril, the core active ingredients of Entresto, the fact that the two ingredients exist as a complex in the marketed product alone does not make the patent unrelated to Entresto.The US Court of Appeals for the Federal Circuit had previously upheld the validity of the patent in 2025. The court made clear at the time that the patent protects the “combination” of sacubitril and valsartan, rather than the sacubitril-valsartan “complex” itself.Related patent invalidated in Korea...Initial patent barrier removedIn Korea, however, the corresponding patent based on the same original invention was ultimately found invalid. Novartis had obtained a Korean patent for a “pharmaceutical composition comprising valsartan and an NEP inhibitor.” Although its claims are not identical to those of the US ’659 patent, it similarly covers the combination of valsartan and a sacubitril-class NEP inhibitor.Hanmi Pharmaceutical and other Korean generic drugmakers challenged the validity of the patent. In November 2023, the Patent Court ruled in favor of the generic companies, finding that the patent specification did not contain sufficient experimental data or specific descriptions demonstrating the therapeutic effects of using the two ingredients together for conditions including heart failure.The Supreme Court declined to hear Novartis’ appeal in April 2024, finalizing the invalidation of the patent. While the corresponding early combination patent in the US was recognized as valid protection for Entresto, the patent itself was invalidated in Korea.Entresto is not simply a mixture of sacubitril and valsartan. The two active ingredients, along with sodium and water molecules, form a supramolecular complex with a defined structure. While the initial patent broadly protected the combined use of sacubitril and valsartan, subsequent patents specifically protected the complex and crystalline forms used in the marketed product.Korean generic drugmakers also challenged these complex-related patents. One dispute centered on whether the 2.5-hydrate supramolecular complex used in Entresto and a different hydrate form developed by a generic company fell within the scope of the same patent.In January this year, the Supreme Court ultimately ruled that the generic company’s product did not fall within the scope of Novartis’ patent. The original complex contains valsartan, sacubitril, sodium, and water molecules at a ratio of 1:1:3:2.5, while the generic product has a ratio of 1:1:3:3, which the court found resulted in different crystal structures and properties.Generic drugmakers also prevailed in an invalidation action involving another complex patent. The Supreme Court found that the patent did not sufficiently describe manufacturing methods to enable the various complexes claimed in the patent to actually be produced, and dismissed Novartis’ appeal in January this year.Patent battles won, but no generics yet on marketDespite these victories, no Entresto generic has yet reached the Korean market. This is because invalidating or designing around a patent is a separate matter from developing a product equivalent to Entresto and obtaining regulatory approval.In Entresto, its two active ingredients form a specific structure. Even if a generic drugmaker develops a different crystalline form or formulation to avoid the patents, it must still achieve drug absorption and dissolution characteristics comparable to those of the originator and demonstrate bioequivalence.In other words, winning the patent disputes does not translate directly into a market launch.The situation also differs from that in the US. In the US, MSN launched its Entresto generic on July 22, 2025, shortly after pediatric exclusivity for the ’659 patent expired. Ten more generics entered the market two days later. According to the court ruling, 18 companies had sought approval for Entresto generics, 13 of which ultimately received final approval.In Korea, by contrast, generic companies have cleared the major patent barriers, but no product has yet received approval. Therefore, the focus of Korea’s Entresto generic race has shifted from whether companies can “overcome the patents” to whether they can “design around them while actually developing an equivalent product capable of securing regulatory approval.”
- Opinion
- [Reporter’s View] Loud on the launch, quiet on the exit
- by Hwang, byoung woo Sep 30, 2026 08:52am
- New business plans announced by companies remain on record as news. Even if the direction of a business changes over time, the original press releases and news articles remain searchable. That is why communicating a change in plans deserves as much attention as the announcement of a new venture.The recent case of Dong-A ST’s Versius surgical robot illustrates a broader contrast in how companies communicate the launch and the end of a business initiative. In May 2024, Dong-A ST signed an exclusive distribution agreement in Korea with CMR Surgical and issued a press release. It highlighted the product’s technology and ease of use and outlined plans to pursue regulatory approval in Korea and offer a new option in the laparoscopic surgical robot market.The initiative, which subsequently progressed to a regulatory filing in Korea, was terminated by mutual agreement between the two companies in the first half of this year. During Dailypharm’s report, the company confirmed the termination but said it was difficult to disclose the specific reasons due to circumstances involving both parties. The distribution plan was ultimately scrapped before the product could even be introduced in Korea.The rationale behind a business decision at its outset cannot always remain valid. Changes in market conditions or a partner’s strategy may require a company to change course. Reassessing where to focus resources is an important part of management, and the decision to end a business initiative alone should not automatically cast the original attempt as a failure.The scope of what can be disclosed may also be limited when a business involves a partner. Contractual terms and the internal considerations of both parties may make it difficult for one side to disclose all the details. A company’s response should not be viewed negatively simply because it does not reveal the specific reasons for ending a partnership.However still, the soundness of a business decision and how that decision is communicated externally requires collective consideration. If a company has used a press release to announce its market entry plans and expected benefits, it should also devise ways to inform those who received that information when the plans later change. It needs to provide a way to understand how the current situation differs from what was initially announced.This is not an issue limited to any one company. Any company announcing the introduction of new technology, a joint development project, or entry into a new business may face the same challenge.When presenting a new opportunity, companies tend to actively communicate the significance of the business and their plans for the future. When schedules are delayed, or partnerships end, however, they must consider their relationship with the other party, the scope of what can be disclosed, and how the market may interpret the change. Explaining what happened after plans change can therefore be more difficult.And not every change in business plans requires a separate press release. Depending on the importance and stage of the project, a company could update information previously posted on its website or communicate the change as part of its regular business updates. What matters is communication that connects what was announced in the past with where the business stands today.No company can succeed in every venture. Revising plans and winding down partnerships are also part of doing business. But explaining those changes in a timely manner can help build trust in the company’s future endeavors.The communication used to highlight the promise of a new business should continue even after the plans change. Corporate trust is built not only through the vision presented at the outset, but also through how a company explains what follows.
- Opinion
- "Wegovy, health benefits outweigh concerns about muscle loss"
- by Son, Hyung Min Sep 22, 2026 08:56am
- A professional opinion suggests that there is no need to be concerned about muscle loss related to the obesity treatment 'Wegovy'.Professor William Timothy Garvey of the Department of Nutrition Sciences at the University of Alabama at Birmingham (UAB) recently met with Daily Pharm and said, "There is no need to be concerned about muscle loss from GLP-1 agents," adding, "The health benefits gained from weight loss can be much greater, and healthier weight loss is possible if accompanied by protein intake, resistance training, and lifestyle improvements."Professor William Timothy Garvey of the Department of Nutrition Sciences at the University of Alabama at Birmingham (UAB)In addition, Professor Garvey said it is difficult to interpret the decrease in lean body mass that occurs during weight loss as identical to actual muscle loss. He argues that researchers must evaluate not only body composition changes but also treatment benefits, such as improvements in cardiovascular and metabolic diseases.Professor Garvey, who recently visited South Korea to attend the International Congress on Obesity and Metabolic Syndrome (ICOMES 2026) hosted by the Korean Society for the Study of Obesity, is an expert who has long researched obesity, insulin resistance, and cardiometabolic diseases.Professor Garvey also directly participated in major clinical trials of Wegovy (semaglutide). He served as the senior author on STEP 3 study, which evaluated the combined effects of an intensive lifestyle modification program and Wegovy, and as the lead author on STEP 5 study, which examined the long-term weight-loss effects of Wegovy over two years. Professor Garvey also served as senior author on the recently announced high-dose study, the STEP UP study.Professor Garvey's point in these studies is not simply how much weight was lost. His perspective is that one must closely observe which tissues decrease during weight loss, whether physical functions are maintained, and how cardiometabolic risk factors such as blood sugar, blood pressure, and lipids, as well as obesity-related complications, change.Professor Garvey also noted that much of the existing data on muscle loss relies on measurement methods that make it difficult to distinguish lean body mass from actual muscle. In recent MRI-based analyses, the extent of actual muscle reduction was smaller than previous estimates. In the STEP UP study, about 84% of the weight loss came from adipose tissue.Professor Garvey believes Wegovy should not be limited to weight loss alone. He explained that evidence of improvements in cardiovascular and metabolic risk factors is accumulating alongside weight loss, and that obesity must also be approached as a chronic disease requiring long-term treatment and management, much like diabetes or hypertension.Decrease in lean body mass is different from actual muscle loss… fat-centered weight loss confirmed in MRIProfessor Garvey pointed out that when interpreting the controversy over muscle loss with GLP-1 class obesity treatments, one must first examine how body composition is measured.To date, dual-energy X-ray absorptiometry (DXA) has been used primarily in related studies. While this method is highly accurate in measuring bone mass and fat mass, it has limitations in measuring lean body mass. Lean body mass includes not only muscle but also body fluids, bones, and organ tissues altogether.Professor Garvey explained, "The proportion of actual muscle among the lean body mass measured by DXA may only be a maximum of 50%," adding, "Just because there is a result showing that one-third of the weight loss is lean body mass, the entirety of that cannot be viewed as muscle loss."Recently, studies using MRI to evaluate changes in actual muscle and surrounding tissues more closely have increased.According to Professor Garvey, some studies have shown that the proportion of actual muscle reduction during weight loss is around 10%, rather than the previously discussed 30% range. The remaining significant portion was attributed to decreases in intramuscular glycogen or adipose tissue surrounding the muscles.Professor Garvey added, "This is a result showing the possibility that actual muscle loss is not as large as the DXA-based estimates," and, "Additional data is needed to further investigate."The STEP UP study also conducted a body composition sub-analysis using MRI to evaluate the effects of high-dose (7.2mg) Wegovy.The analysis results showed that approximately 84% of the weight lost after Wegovy administration originated from adipose tissue. Adipose tissue and visceral abdominal fat decreased by more than 30%, and lean body mass decreased by about 10%.Despite the changes in body composition, no deterioration in muscle function was observed. In the 30-second sit-to-stand test, muscle function in the Wegovy-administered group was maintained or slightly improved, with no significant worsening even compared with the placebo group.Professor Garvey pointed out, "Regardless of the method used to lose weight, fat generally decreases first and in greater amounts, and some reduction in muscle mass may also occur," adding, "The important thing is whether the reduced muscle mass is at a level that causes practical harm to the patient."Professor Garvey continued, "While visiting South Korea, I felt that concerns about muscle loss are emerging among many patients and the media," adding, "Considering both expected benefits and potential side effects together before starting treatment is a sound and critical attitude."Professor Garvey remarked, "There is no need to be overly concerned about muscle loss," adding, "The health benefits gained from weight loss can be much greater, and healthier weight loss is possible if reduced food intake is supplemented mainly with protein while accompanied by resistance training and lifestyle improvements."However, Professor Garvey noted that older adults and postmenopausal women require more careful management.Professor Garvey recommended, "Postmenopausal women are already experiencing changes in body composition, such as an increase in body fat and a decrease in lean body mass," adding, "It is necessary to increase the dosage slowly and adequately maintain protein, iron, and calcium intake while simultaneously engaging in resistance training."Managing cardiometabolic risks beyond weight loss… focus on complication-centered treatmentProfessor Garvey urged that the significance of second-generation obesity treatments, including Wegovy, should not be found solely in the simple extent of weight reduction.If the average weight loss from obesity treatments used before 2014 was generally less than 10%, second-generation treatments such as Wegovy show an average weight loss of around 15%, allowing more patients to reach clinically meaningful weight-loss goals.Such a change was also evident in studies accompanied by lifestyle modifications. In STEP 3, adding Wegovy 2.4mg to intensive dietary, exercise, and behavioral counseling resulted in an average weight loss of 16.0% at 68 weeks. The placebo group averaged 5.7%, and about one-third of the Wegovy group lost more than 20% of their body weight.Professor Garvey presented this result as evidence that additional weight-loss effects can be expected when lifestyle modifications and drug therapy are combined.He also cited improvements in obesity-related complications.Professor Garvey said, "The reason for classifying Wegovy as a second-generation treatment is not solely because of the average 15% level of weight loss," adding, "It is important that one can simultaneously expect health benefits that lower the risk of various complications associated with obesity and improve metabolic health."In the STEP clinical trials, along with weight loss, researchers confirmed improvements in fasting blood sugar, fasting insulin, insulin sensitivity, triglycerides, blood pressure, and CRP, an inflammatory marker.In the SELECT study, which evaluated the cardiovascular benefits of Wegovy, approximately 17,600 non-diabetic overweight and obese patients with a history of cardiovascular disease were tracked for about four years. As a result, the risk of major adverse cardiovascular events was about 20% lower compared to the placebo group.Professor Garvey interpreted this as evidence demonstrating that the evaluation criteria for obesity treatment are shifting from weight loss to complication management.Professor Garvey stated, "The purpose of obesity treatment lies in elevating the patient's quality of life and lowering mortality and hospitalization rates by preventing and improving related complications," adding, "Recently, clinical trials are also changing toward setting complication improvement as a primary endpoint, moving beyond simply how much weight was lost."In addition to obesity and cardiovascular diseases, Wegovy's active ingredient, semaglutide, is accumulating clinical evidence in cardiometabolic areas such as metabolic dysfunction-associated steatohepatitis (MASH) and diabetic kidney disease.Professor Garvey evaluated, "If obesity and insulin resistance persist, they can lead to cardiovascular diseases, diabetes, and chronic kidney disease by passing through prediabetes, metabolic syndrome, hypertension, dyslipidemia, and fatty liver," adding, "Semaglutide has shown the possibility of managing multiple cardiometabolic risk factors within a single treatment strategy.""Yo-yo effect, not a matter of willpower"… obesity, requires long-term managementProfessor Garvey believes that, even with Wegovy, maintaining the effects matters more than short-term weight loss.When weight decreases, the human body responds physiologically to return to its previous weight. As satiety signals weaken and appetite signals strengthen, the likelihood of weight regain increases if treatment is discontinued.Professor Garvey stressed that such weight regain should not be viewed as a lack of willpower on the patient's part.Professor Garvey emphasized, "Gaining weight again is not the patient's fault, but a phenomenon related to the pathophysiology of the disease called obesity," adding, "Just as one does not arbitrarily discontinue diabetes or hypertension medications just because their condition has improved, obesity must also be approached as a chronic disease requiring continuous treatment and management."Long-term follow-up studies also supported this perspective.In STEP 5, after 104 weeks of Wegovy treatment, patients maintained an average weight loss of approximately 15.2%. The proportion of patients who achieved a weight loss of 5% or more was tabulated at 77.1% in the Wegovy group and 34.4% in the placebo group.Experts said it is difficult to decide whether to continue treatment, adjust the dosage, or discontinue it based solely on weight changes. The intention is that metabolic indicators such as blood sugar, blood pressure, and lipids, as well as comorbidities and the patient's treatment goals, must be considered comprehensively.Professor Garvey predicted that, as obesity treatments develop, increasing treatment persistence will become important.Currently, the development of long-acting formulations with extended administration intervals, oral medications, and treatments combining multiple mechanisms such as amylin, glucagon, GIP, and PYY, in addition to GLP-1, is continuing.Professor Garvey suggested, "One of the biggest challenges in obesity treatment is patients prematurely discontinuing treatment," adding, "Technological advancements that extend administration intervals or expand oral medication options can help increase the treatment persistence rate."High doses and diverse formulations are introduced… treatments tailored to each patient are also specifiedAs the choices for obesity treatments increase, future treatment strategies are expected to become further segmented according to the patient's weight loss goals and comorbidities.Professor Garvey noted that even within the same Wegovy treatment, dosage selection can vary depending on individual patient responses and the required level of weight loss. This means that high-dose treatment can become another option for patients who do not achieve sufficient effects with the existing 2.4mg or who require additional weight loss.The study that examined this possibility is STEP UP. It compared the effects of Wegovy 2.4mg with a once-weekly high dose of 7.2mg.In the study, the average weight loss in the Wegovy 7.2mg group was approximately 21%, based on an analysis assuming continued treatment. The 2.4mg group was 17.5%, and the placebo group was 2.4%. The proportion who lost 25% or more of their body weight also differed: 33.2% in the 7.2mg group, 16.7% in the 2.4mg group, and 0% in the placebo group.Professor Garvey said, "As there are individual differences in drug responses for each patient, it is meaningful in that a new option has emerged for patients who require a higher dose."Professor Garvey suggested that, even when selecting medications, clinicians should use an approach based on individual patient characteristics rather than uniformly applying the treatment that showed the greatest weight-loss effect.This means that patients who have a high BMI and mobility difficulties, thus requiring a large amount of weight loss, and patients with specific comorbidities such as cardiovascular disease or diabetes, may have different necessary treatment strategies.Professor Garvey concluded with the anticipation that "If a patient has a history of cardiovascular diseases such as myocardial infarction or stroke, or has accompanying diabetes, there is sufficient basis to consider a medication like semaglutide that has proven efficacy in related clinical trials," adding, "A personalized approach of selecting a treatment that fits the patient's condition and treatment goals among various treatment options will become important."
- Opinion
- [Desk’s View] An 'Exeption’ for drug price cuts must be approved
- by Lee, Tak-Sun Sep 08, 2026 09:01am
- It is difficult to understand the operation of the government's drug price reduction system. This is because countless variables and conditions are intertwined, including eligibility criteria for targeted drugs, implementation timelines, price reduction rates, and the number of products containing identical active pharmaceutical ingredients.The Ministry of Health and Welfare's (MOHW) decision to schedule the drug price cut for currently listed drugs for April next year likely reflects the friction and difficulty of applying complex calculation formulas across tens of thousands of items en masse.The real issue is that even if the government and pharmaceutical companies fine-tune the granular details, unfairly affected products will inevitably fall through the cracks of the current system. Without a reasonable exception and relief mechanism, the industry will have no choice but to be dragged into litigation once again, followed by greater administrative voids and market disruption.The recent appellate court ruling in favor of Mother's Pharmaceutical, overturning the first-instance decision in its lawsuit seeking cancellation of the drug price-reduction administrative disposition filed against the Ministry of Health and Welfare (MOHW), is highly suggestive. The Seoul High Court ruled that the 15% price cut disposition imposed on three of Mother's Pharmaceutical's herbal medicine formulations, including 'Sto M Tab.', was unjust.The prices of the items in question were slashed during the 2021 criteria-based drug price re-evaluation due to "failure to demonstrate in-house bioequivalence". However, their failure to provide proof stemmed from a structural flaw rather than negligence by the pharmaceutical manufacturer. Even the competent regulatory authority, the Ministry of Food and Drug Safety (MFDS), failed to establish protocols for demonstrating equivalence in herbal medicinal preparations, publicly announcing the equivalence re-evaluation only after the price-reduction disposition had already been issued. In essence, prices were reduced for failing to provide proof when no criteria for proof existed. The court's finding that the disposition lacked rationality and validity is an entirely commonsense judgment.If the Supreme Court finalizes this ruling, it will lead to the conclusion that the existing price-reduction dispositions imposed on herbal drug formulations subject to MFDS equivalence re-evaluations were fundamentally unlawful. However, pharmaceutical companies that could not endure the price reductions and have already withdrawn from the market have no recourse for compensation anywhere.There is no guarantee that the same catastrophe will not recur in this large-scale re-evaluation of currently listed drugs, conducted for the first time in five years. If one judges all pharmaceutical products under the same standard, blind spots like the Mother's Pharmaceutical case will inevitably emerge at some point.If the administration cannot flexibly accommodate exceptional circumstances, resolving disputes will ultimately fall to the judiciary. Unnecessary litigation expenses and wasted administrative resources translate directly into societal costs. Before applying a conventional review to this round of drug price re-evaluations for currently listed drugs, a mechanism must be implemented to screen and review, in advance, exceptional items that suffer from systemic contradictions.
- Opinion
- ADC option for HR+ breast cancer...'Datroway' garners attention
- by Son, Hyung Min Sep 04, 2026 08:47am
- Which therapeutic options to choose from following CDK4/6 inhibitor treatment in the course of hormone receptor-positive (HR+)/HER2-negative (HR-) metastatic breast cancer treatment is becoming a major issue.The establishment of a combination therapy of endocrine therapy and a CDK4/6 inhibitor as the first-line standard therapy has significantly improved early-stage therapeutic outcomes and quality of life. However, therapeutic options that secure both therapeutic effects and tolerability are relatively limited when drug resistance occurs.Professor Kyung Hwa Park of the Division of Medical Oncology at Korea University Anam Hospital In South Korea, due to limited follow-up endocrine-based therapeutic options, patients whose disease has progressed often move on to chemotherapy. Industry experts view this process as increasing patient burden, such as hair loss, accumulated toxicity, and daily life struggles.'Datroway (datopotamab deruxtecan),' a TROP2-directed antibody-drug conjugate (ADC) recently approved in South Korea, is drawing attention as a novel treatment option distinct from conventional chemotherapy for patients with HR+/HER2- metastatic breast cancer.In a recent interview with Daily Pharm, Professor Kyung Hwa Park of the Division of Medical Oncology at Korea University Anam Hospital stated, "Patients treated with CDK4/6 inhibitors have high expectations for maintaining a high quality of life and sustaining daily routines for a prolonged period," and added, "However, patients feel frustrated because there are not enough subsequent treatment options to continue that."Professor Park continued, "In this situation, the approval of Datroway and availability of a new ADC treatment option is highly meaningful, as it allows patients to expect a relatively long progression-free survival (PFS) while maintaining their quality of life."Shortened survival following CDK4/6 inhibitor use… Subsequent treatment is not availableFor HR+/HER2- metastatic breast cancer, combination therapy of endocrine therapy and a CDK4/6 inhibitor is generally used as first-line treatment.The issue arises after resistance develops. Among patients whose disease progressed after CDK4/6 inhibitor use, the median PFS is less than 4 months;. In comparison, median PFS with chemotherapy is 6.4 months in the first-line setting, but drops to about 4.1 months in the third-line setting. In practice, only 31% of all patients proceeded to third-line therapy.Professor Park pointed out that this issue can be even more pronounced in Korea's domestic treatment landscape.Professor Park stated, "In Korea, subsequent endocrine therapies that can realistically be used are limited to fulvestrant monotherapy or the combination of everolimus plus exemestane," adding, "For patients with ESR1 gene mutations, there are no available drugs, leaving them at a stage where they must consider participating in clinical trials."Ultimately, a substantial number of patients transition to chemotherapy, but the reluctance felt by patients is considerable.Professor Park added, "Rather than financial reasons, many patients who have maintained their daily lives while undergoing treatment with CDK4/6 inhibitors do not want to switch to chemotherapy, which causes hair loss and makes daily living difficult."Datroway improves PFS… Safety is the benefitLast March, Datroway was approved in Korea for the treatment of patients with HR+/HER2- metastatic breast cancer who have received prior endocrine-based therapy and systemic chemotherapy in the advanced setting.In the TROPION-Breast01 study, the basis for approval, Datroway reduced the risk of disease progression or death by 37% compared with investigator's choice of chemotherapy.The median PFS was 6.9 months in the Datroway group and 4.9 months in the control group, with a hazard ratio (HR) of 0.63. The objective response rates (ORR) were 36.4% and 22.9%, respectively.The therapeutic effect demonstrated a consistent pattern regardless of prior lines of therapy, prior CDK4/6 inhibitor use, or HER2-low versus IHC 0 status.Professor Park viewed this as a case where, rather than focusing solely on the absolute PFS difference of two months, one must consider the limitations of existing therapies alongside patient characteristics.Professor Park noted, "While it is a difference of about two months, a PFS of approximately seven months is a considerably meaningful figure," adding, "Even when cytotoxic chemotherapies are effective, it can be difficult to maintain treatment for a long time due to cumulative toxicities such as peripheral neuropathy, hand-foot syndrome, and edema."Professor Park further added, "A major advantage of ADCs is that patients can sustain treatment with a relatively lower burden of cumulative toxicity."Considering both quality of life and Toxicity… "Maintaining daily life Is also a treatment outcome"In TROPION-Breast01, differences from conventional chemotherapy were also confirmed in terms of patient-reported outcomes (PROs) and safety.Analysis of time to confirmed deterioration showed a time to deterioration in quality of life of 9 months in the Datroway arm versus 4.8 months in the control group. Time to pain deterioration also differed, at 9 months versus 5.5 months, respectively.The incidence of Grade 3 or higher treatment-related adverse events was 20.8% in the Datroway group and 44.7% in the control group. Neutropenia was recorded in 1.1% and 30.8% of patients, respectively.Professor Park said, "Previsously, what mattered to metastatic cancer patients was how many more months they could live, but nowadays they ask whether they can travel abroad or go to a swimming pool during treatment," adding, "As more patients view cancer as a condition to live with while receiving treatment, maintaining quality of life and extending meaningful time have become essential."While adverse events such as stomatitis and ocular toxicities can occur with Datroway treatment, Professor Park's view is that many of them are preventable and manageable.Based on Professor Park's involvment in clinical trials, she explained, "There were low-grade cases of stomatitis that were managed using steroid mouthwashes, and patients with blurred vision were managed without major issues through appropriate ophthalmologic care and treatment," adding, "The incidence of high-grade adverse events that lead patients to visit hospitals or emergency rooms due to neutropenia or interstitial lung disease was very low."Switching to an ADC considering tumor burden and comorbiditiesThen, which HR+/HER2- patients should clinicians consider first for Datroway?Professor Park identified patients whose disease progresses rapidly despite CDK4/6 inhibitors, or those unlikely to respond to subsequent endocrine therapy, as primary candidates.She said, "Some patients experience disease progression within six months of using first-line therapies. For such patients, switching promptly to an ADC can be considered as the next treatment," adding, "The same applies to patients whose disease was controlled for a relatively long period with CDK4/6 inhibitors, but who have a high tumor burden or lack suitable subsequent endocrine therapy."Switching to an ADC can also be considered when targeted therapies such as PI3K or AKT inhibitors are difficult to use because of the patient's physical condition or underlying comorbidities.Patients with HER2 IHC (immunohistochemistry) 0 are also a population for whom Datroway can be considered. This is because they can leverage TROP2 as an independent target, even when existing HER2-targeted ADCs are restricted.Professor Park suggested, "Datroway can be considered for patients with HER2 0 status, patients who have HER2-low disease but face difficulties using HER2 ADCs due to cardiac function or other comorbidities, and vulnerable patients for whom safety is paramount.""Diversity of treatment options is crucial for patients"However, the issue of insurance reimbursement remains to enhance real-world access to treatment in Korea.Aside from clinical need, Professor Park anticipated that securing reimbursement for Datroway will not be simple. This is because evaluation standards have been raised as other ADCs demonstrated high clinical achievements and even improvements in overall survival (OS).Nevertheless, Professor Park emphasized the need to secure treatment options with diverse mechanisms and modes of administration, as every patient differs in organ function, comorbidities, susceptibility to toxicity, and hospital accessibility.Professor Park stated, "From a clinician's perspective, because each patient's condition, comorbidities, and organ function status are entirely different, it is essential to secure diversity in treatment options in terms of toxicity and tolerability."In conclusion, Professor Park said, "Continuing treatment while maintaining quality of life is an extension of meaningful time that is hard to measure in monetary terms," emphasizing that "As patients with metastatic breast cancer can maintain their daily routines and sustain their roles in their families and society while undergoing treatment, such benefit must also be viewed as an important aspect of care."
- Opinion
- [Desk’s View] Rare disease pilot needs participation, not hesitation
- by Eo, Yun-Ho Aug 10, 2026 08:43am
- Fast-tracking the reimbursement listing process by reducing the review period for new drugs deemed necessary for patients. This is an objective few would oppose. That said, previous initiatives of this kind have consistently faced questions over their effectiveness.In many cases, difficulties in demonstrating cost-effectiveness or prolonged review timelines meant that products were rarely listed within the target timeframe. Against this backdrop, the government has introduced a far more ambitious proposal.The pilot program for the ‘expedited reimbursement of rare disease therapies’ aims to complete listing within 100 days. More significant than the timeline itself is the mechanism: both cost-effectiveness assessments and price negotiations will be waived, while eligible products will be listed upfront at 90% of the lowest adjusted A8 reference price without negotiations over projected budget impact.Eligible medicines must treat diseases covered under Korea's Critical Illness Special Calculation program, excluding rare cancers. Products should already be approved, under regulatory review, or preparing for submission, and must already be reimbursed in at least three of the eight A8 reference countries. Applications will be accepted through August, with the pilot scheduled to begin in October.By waiving pharmacoeconomic evaluation and adopting an upfront listing model similar to the waived products, the pilot effectively embraces the "list first, evaluate later" approach that the pharmaceutical industry has long advocated.Despite achieving this long-sought goal, the industry reaction is lukewarm. The industry's greatest concern is in generating evidence for the post-listing reassessment. The government plans to establish real-world registries to generate real-world evidence (RWE) and reassess products after 5 years. Depending on the results, reimbursement status could remain unchanged, the price could be reduced, or patients could be required to pay the full cost.With debate over the validity of RWE itself yet to be fully resolved, such reassessments could, in effect, cause a product to lose reimbursement status after 5 years. From the perspective of multinational pharmaceutical companies, this could mean that the Korean government officially labels one of their products as ‘ineffective.’Another new requirement is the mandatory submission of a ‘patient treatment continuity assurance plan,’ a document that has never before existed in Korea's reimbursement system. With no detailed guidance yet available, this unknown requirement is adding to companies' hesitation. Because the pilot targets rare disease therapies, whose patients generally have longer life expectancies than cancer patients, concerns also remain over expenditure caps.The industry needs to show courage. It was the one that had been persistently asking the government to "Open the door first and tighten the rules later." Bold reforms inevitably come with risks. A pilot program is, by definition, a testing ground that lays the ground for a permanent system. Pharmaceutical companies need to actively participate and voice their opinions to establish a stable framework for the final program. The government, too, is concerned that the Trump administration's most-favored-nation (MFN) pricing policy could affect access to innovative medicines. The rising awarness of the need for a change has triggered the pilot. Such a long-awaited project should not be left to wither away in calculated neglect."
- Opinion
- [Reporter’s View] Tighter disclosure rules stall biotech innovation
- by Cha, Ji-Hyun Aug 09, 2026 04:04pm
- Korea's financial regulators have once again moved to tighten disclosure requirements for the pharmaceutical and biotech sector. The latest measures require companies to provide more detailed justification for valuations during initial public offerings (IPOs) and disclose more specific terms of technology licensing agreements. The stated goal is to reduce information asymmetry and strengthen investor protection.The government’s policy objective of improving disclosure transparency is well-founded. Confidence in capital markets begins with adequate disclosure. Given past cases in which clinical results or licensing deals were overstated, or public disclosures conflicted with media reports, specific standards and guidelines are a welcome development.The problem lies in the policy's overall direction. Recent regulatory reforms affecting the pharmaceutical and biotech industry have focused almost exclusively on investor protection and tighter oversight. Authorities have raised participation requirements for institutional investors involved in IPO pricing and expanded mandatory lock-up periods for allocated shares. They have now gone even further by strengthening disclosure obligations related to corporate valuations and research and development achievements.In contrast, little progress has been made in expanding exit opportunities for investors. For Korean biotech startups and their investors, an IPO remains virtually the only viable exit strategy. Because the mergers and acquisitions (M&A) market remains underdeveloped, opportunities to recover investments through corporate sales or stake disposals are limited. This is why a significant number of biotech ventures continue to rely almost exclusively on public listings, regardless of their stage of development or market conditions.Yet there has been little meaningful policy effort to address this structural issue. While IPO rules, disclosure requirements and listing regulations continue to become more stringent, few initiatives have been introduced to promote M&A activity or encourage corporate acquisitions through government incentives. In effect, policymakers are raising the bar for going public without preparing other exit routes for investors.When exits are blocked, venture capital cannot get back its investments from existing funds, making it difficult to raise new funds. As investment capital dries up, early-stage biotech startups are among the first to feel the impact. Even with technological capabilities, an increasing number of companies have no choice but to delay development schedules or halt pipelines because they fail to secure the funds necessary for entering clinical trials and conducting subsequent research and development.Meanwhile, companies that have lost their competitiveness often remain in the market instead of being consolidated through acquisitions or restructuring, surviving on government subsidies or repeated equity offerings and convertible bond issuances. As capital and talent remain tied up in underperforming companies, funding fails to reach more promising innovators. Ultimately, innovative companies lose growth opportunities, while so-called "zombie biotechs" remain in the market.Investor protection is a fundamental principle of any capital market. But a market that focuses solely on protection without providing viable exit opportunities cannot remain sustainable. It is time for policymakers to shift their focus beyond ‘how companies should be listed and regulated’ to ‘how investments can be exited and recycled into innovation.’ The government should introduce tax incentives and expand policy financing that reduce the burden of corporate acquisitions, and create diverse exit channels such as M&A and secondary share sales. Only then can recovered capital flow back into innovative companies, creating a sustainable virtuous cycle for Korea's biotech ecosystem.
- Opinion
- [Reporter's View] Surgical robotics, What is needed to export domestic tech?
- by Hwang, byoung woo Aug 09, 2026 04:04pm
- Surgical robotics companies in South Korea are seeking unexplored domains in the global market.Some companies are directly challenging the laparoscopic surgery market established by Da Vinci; others are focusing on specific surgical procedures, such as orthopedics, neurosurgery, and kidney stone removal. Rather than simply following the market built by the industry leader, this strategy aims first to secure domains where domestic companies can fully demonstrate their technological capabilities.What is noteworthy in these challenges extends beyond robotic technology. South Korea is a market equipped with highly skilled medical professionals and the capacity to integrate novel medical technologies into clinical practice rapidly. Intuitive, a global leader in surgical robotics, also highly values the proficiency and robotic surgery execution capabilities of Korean clinicians.Outcomes in robotic surgery are not determined solely by equipment performance. Clinical value is generated only when medical practitioners' surgical skills, hands-on experience with equipment, and hospital operating room management systems come together. For domestic companies, this means that surgical experience accumulated alongside Korean clinicians can itself serve as a core competitive advantage in overseas markets.Domestic references are also crucial. Not just merely tracking how many units were installed in which hospitals, real surgical volume, applicable surgical techniques, patient outcomes, and physician learning curves must be accumulated. If companies can package domestically validated equipment with surgical techniques and training programs, they can reduce the adoption barriers that foreign hospitals must overcome.Notably, many of the areas targeted by domestic companies do not directly compete with leading global platforms. If Korean physicians develop novel surgical techniques and companies reflect them into hardware and software improvements, there is potential to establish a Korean-style standard in specific surgical procedures. This creates an export model that goes beyond shipping a single device to bundling clinician training, surgical protocols, and clinical data together.Establishing such a virtuous cycle is difficult through corporate effort alone. For emerging medical device companies to secure sufficient domestic clinical experience, active hospital participation is required; conversely, for hospitals to adopt new systems, they must overcome burdens related to cost and safety. The time and financial investment needed to generate clinical evidence are also substantial.Policy support must also extend beyond simple R&D funding or capital equipment purchases. Public hospital demonstrations should be designed to lead to real-world surgeries and long-term data accumulation, with the resulting evidence used for international regulatory approvals and export documentation. The scope of support needs to be broadened to encompass clinician training, maintenance systems, and local partner identification.Institutional discussions to evaluate the clinical value of robotic surgery must progress concurrently. If comprehensive reimbursement is difficult, criteria should first be established to assess efficacy, safety, and patient benefits by specific surgical procedure. Products that fail to secure operational adoption in their home market face steep challenges in earning sufficient credibility overseas.The strength of South Korea's surgical robotics industry does not lie solely in robotic arms or software. Its core competitiveness is in the coexistence of highly-skilled medical professionals, real-world clinical settings, and companies capable of rapidly reflecting clinical feedback into product design.If the surgical skills of Korean medical professionals and real-world clinical data are integrated into the niche markets identified by domestic surgical robots, domestic references can become assets that drive overseas exports. What is needed now is not unconditional support for companies, but considerate policy design that connects these unique strengths into a sustainable industry ecosystem.
