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- 2026-09-08 00:27:24
- 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.
- Opinion
- [Reporter’s View] Aging society redefines new drug value
- by Son, Hyung Min Aug 04, 2026 10:50am
- Korea has entered a super-aged society. With life expectancy on the rise, the challenges healthcare must address are evolving as well. The focus is no longer simply on helping people live longer, but on enabling them to maintain healthy, independent lives for as long as possible. This shift is already reshaping not only clinical practice but also the development of innovative new drugs and clinical trial designs.Traditionally, the value of a new medicine has largely been measured by how much it delays disease progression compared with existing therapies. In oncology, overall survival (OS) and progression-free survival (PFS) have been the benchmark endpoints. For cardiovascular therapies, reductions in cardiovascular events have been key, while delaying the need for dialysis has been a major outcome for chronic kidney disease treatments. These endpoints remain the gold standard for demonstrating clinical efficacy.However, recent global clinical trials reveal a noticeable shift. Studies are increasingly incorporating patient-reported outcomes (PROs), health-related quality of life (QoL), time to symptom deterioration, reductions in hospitalizations and readmissions, and preservation of physical function as primary or key secondary endpoints—measures that reflect outcomes patients directly experience during treatment.Quality of life, once regarded as a supplementary outcome, has now become one of the principal measures used to demonstrate the clinical value of innovative therapies.This evolution reflects more than a change in clinical trial design. It signals a broader transformation in what healthcare seeks to achieve in a super-aged society. For older patients, treatment success cannot simply be defined by extending survival by a few additional months. Whether patients can maintain their daily routines, avoid repeated hospitalizations, and continue living independently while receiving treatment is becoming increasingly important.The same trend is evident in the field of disease prevention. Modern vaccines and preventive therapies are no longer evaluated solely on their ability to prevent infection. They are increasingly assessed on their capacity to reduce progression to severe disease, prevent hospitalization, and help individuals maintain healthy daily lives. The growing emphasis on prevention strategies as a means of extending healthy life expectancy while reducing the burden on healthcare systems reflects this broader shift.Ultimately, prevention and treatment are converging toward the same objective. Prevention seeks to preserve good health for as long as possible, while treatment aims to manage disease in a way that allows patients to maintain their quality of life. Preventing disease, detecting it early, providing appropriate treatment, and helping patients continue their daily lives afterward are becoming the defining principles of modern healthcare across the entire continuum of care.As a result, the competitiveness of innovative medicines can no longer be judged solely by their therapeutic efficacy. While extending survival remains critically important, equal attention is now being paid to how significantly a treatment improves patients' lives.Indeed, global pharmaceutical companies are increasingly presenting quality-of-life data and patient-reported outcomes in clinical trials to demonstrate the value of their therapies. In many respects, this represents one of the earliest indicators of the direction healthcare must take in a super-aged society.Korea’s transition into a super-aged society is demanding a new role for innovative medicines. As contemporary clinical trials increasingly recognize quality of life, preservation of function and reductions in hospitalization as key measures of treatment success, regulatory approval, reimbursement and healthcare policy must also evolve to reflect these changes. Assessing not only how long patients live, but how profoundly a therapy improves their lives is the new challenge a super-aged society presents to healthcare.
- Opinion
- [Desk’s View] AI era, will MRs disappear or be empowered?
- by Lee, Seok-Jun Aug 03, 2026 05:18pm
- It’s not true that AI is threatening every occupation. It simply replaces tasks that can be aided first. Conversely, those who turn AI into their own tool will have more advantage than before. This applies across every industry. Marketing representatives (MRs) in the pharmaceutical sector are now confronting this challenge.AI retrieves product information faster than individuals. It can outline research articles and clinical guidelines, analyze sales and customer data, and more. It also prioritizes which medical professionals to visit. Much of the work that previously relied on MR’s knowledge and experience can now be done by AI.Then, what remains for the MR?Ultimately, it comes down to ‘face-to-face meetings.’In pharmaceutical sales, the fundamental role of MR lies in direct engagement with medical professionals. No matter how effectively AI seeks information, it cannot meet doctors. Reading subtle reactions, discerning the underlying intent of questions, and pivoting the conversation in real time remain uniquely human capabilities.In the past, visit frequency served as a key competitive edge for MRs. By maximizing touchpoints and building relationships, MRs delivered product information and provided data necessary for prescribing decisions.That is no longer the case. Physicians now utilize AI to source the information they need independently. They no longer rely on MRs to review drug details or clinical studies. Consequently, the rationale for in-person meetings based solely on basic information delivery is diminishing.Paradoxically, this makes 'face-to-face interaction' even more critical.The priority has shifted from how often MRs visit to what value they deliver during those interactions. Clear, impactful communication matters more than merely possessing vast knowledge. MRs must understand clinicians' inquiries and provide evidence-based responses, interpreting and tailoring the same dataset to fit each physician's specific practice setting.AI can make these interactions substantially more refined.MRS analyze data to identify key target customers. Before field visits, MRs can practice handling anticipated questions and objections with AI models. Gaps identified during actual interactions can be analyzed and addressed in follow-up calls. Internal sales training can similarly pivot from memorizing product specs to simulating real-world physician scenarios.Ultimately, the evolution of pharmaceutical sales in the AI era is straightforward.Delegating to AI what AI does best and allowing humans to focus on what humans are good at. This means reallocating time previously spent on information retrieval and data analysis toward high-value dialogue and trust-building with medical professionals.What matters is not the extent of AI implementation, but how effectively AI is leveraged to maximize the value of every single interaction with a physician.Pharmaceutical companies face the same dilemma. Simply adopting an AI platform does not automatically grant a commercial edge. What matters far more is how companies fill the capacity freed up by AI and which strategic roles they direct their MRs to concentrate on.This is where the future trajectories of MRs will diverge.MRs who remain confined to routine information delivery and repetitive call cycles will inevitably see their roles diminish. Conversely, the value of MRs who offload analytical tasks to AI and concentrate on meaningful physician engagement will continue to appreciate.In the end, the answer returns to the human element. As AI automates routine tasks, human professionals must excel even further at what only humans can do.MRs who AI will replace versus MRs who will be empowered. Pharmaceutical sales in South Korea now stand at this crossroads.
- Opinion
- “Drug pricing intervention contributes to the crisis in essential healthcare and shortage of drugs”
- by Lee, Jeong-Hwan Jul 28, 2026 08:57am
- Representative Jooyoung Lee of the Reform Party has proposed “separating the mandatory national health insurance designation system” and “expanding physician clinical autonomy” as core solutions to strengthen regional, essential, and public healthcare, a primary national policy agenda of the Lee Jae Myung administration.To resolve chronic supply shortages of essential medicines, including pediatric formulations, and to prevent the global pharmaceutical giants from the so-called “Korea passing” phenomenon with ultra-high-cost innovative therapies, Rep. Lee emphasized the need to build a social consensus where the government, patients, and pharmaceutical companies share appropriate cost burdens. Rep. Lee stressed that the ultimate goal must be to establish a regulatory environment that aligns drug reimbursement prices with global standards.According to Lee’s assessment, the fundamental cause behind both the supply disruptions of low-margin essential pediatric drugs and the “Korea passing” phenomenon by multinational pharmaceutical firms lies in the government’s excessively restrictive drug pricing policies.Addressing the conflicts between medical doctors and traditional Korean medicine practitioners, Lee presented a bold policy proposal: applying strict, conservative, evidence-based licensing principles and removing evidence-lacking traditional Korean medicine interventions from National Health Insurance coverage, following a broader social consensus.This proposal draws attention because of Lee’s firsthand experience as a pediatric emergency care specialist and her active legislative service on the Health and Welfare Committee during the first half of the 22nd National Assembly.Representative Jooyoung Lee of the Reform PartyIn an interview at the National Assembly Members’ Office Building in Yeouido on the 26th, Rep. Lee reflected on her achievements in the first half of the Assembly, outlined her goals for the second half, and detailed the path forward for modernizing South Korea’s public health policies.“A policy objective that is not aimed at implementing…must separate the mandatory designation scheme and expand clinical autonomy”Rep Lee criticized the establishment of the “Division of Regional, Essential, and Public Healthcare” within the Ministry of Health and Welfare (MOHW), led by Minister Jung Eun Kyeong, calling it “misnamed”.Rep. Lee analyzed that regional, essential, and public healthcare represent distinct domains with differing mandates. However, the government consolidated them into a single senior executive office without clear conceptual definitions or targeted policy objectives.Lee stated, “Simply consolidating these disparate sectors into a single administrative block prevents the implementation of effective, domain-specific policies.”Rep. Lee further analyzed that the current crisis in essential medical care stems from the Health Insurance Review and Assessment Service's (HIRA) overall cuts to claims and a regulatory administration that is heavily focused on control.In a system where physicians face arbitrary claims reductions even after delivering optimal care to intractable patients, while bearing total civil and criminal liability for clinical outcomes, few medical graduates will choose essential specialties.Consequently, Lee stressed that policies should actively respect and compensate “medical autonomy.” On a broader scale, she urged social consensus around separating the mandatory health insurance designation system for healthcare providers. This would grant physicians active pricing autonomy for their specialized procedures, creating an environment in which they can deliver uncompromised, optimal patient care without resorting to defensive medicine. Rep. Lee further criticized the recent implementation of “monitored reimbursement” schemes, such as those targeting manual therapy, describing them as excessive constraints on both physician autonomy and patient rights to treatment. Lee stated, “Promoting essential healthcare requires giving physicians clinical and economic autonomy rather than pricing procedures individually. Medical students choose aesthetics over vital care because aesthetic medicine allows physicians to reap proportional rewards for excellence, set competitive prices based on skill, and operate in a market-driven environment,” and explained that “This market freedom is precisely why South Korea’s aesthetic and dermatological care became globally competitive and cost-effective.”Medical students and residents currently choosing essential specialties cannot help but feel that their clinical autonomy and future income depend entirely on political shifts,” Rep. Lee stated. “This dynamic implies essential care physicians as ‘civil servants whose fees and procedures are dictated entirely by the government, yet who alone bear all legal liability.’ Calling for the revitalization of essential care while devaluing vital medicine is a fundamental irony.”She noted, “Who would choose essential specialties if, after years of rigorous medical education, every clinical decision and prescription is audited by the Health Insurance Review and Assessment Service (HIRA), while physicians bear sole and disproportionate liability for patient outcomes?”, and added, “Crucially, withholding autonomy from essential care specialists causes clinical techniques to vanish. Today, pediatric surgical procedures have contracted to one-tenth of past levels, and specialists capable of conducting pediatric dialysis have effectively disappeared.”Rep. Lee urged that “If the government intends to expand managed coverage, it must shrink the scope of mandatory benefits. She emphasized that HIRA’s operational structure—which currently incentivizes claims reductions—must shift to excuse cuts upon reasonable clinical justification,” and added, “If government intervention continues to intensify, unconventional and erratic medical practices will inevitably proliferate. It is time to guarantee medical autonomy and seriously consider decoupling from the mandatory health insurance designation system.”“Essential medicines shortage is due to the government’s excessive control on drug pricing…new drugs must be fairly priced”Rep. Lee pointed to excessive government price suppression as the root cause of chronic supply shortages of essential pediatric medications—such as Ativan—as well as the “Korea passing” phenomenon, in which global pharmaceutical firms bypass South Korea with clinically validated, ultra-high-cost novel therapeutics.She warned that unless South Korea reimburses breakthrough therapies at prices aligned with global standards, the country will be thoroughly isolated from the influx of advanced novel drugs.To address ultra-high-cost therapies without overwhelming limited National Health Insurance (NHI) reserves, Lee suggested that the government cover a reasonable portion of the cost while diversifying patient co-payments. This would allow overall pricing to meet global benchmarks without delaying domestic commercial launches.“The supply instability surrounding pediatric and essential medicines, as well as the ‘Korea passing’ of ultra-high-cost, single-dose therapies, stems fundamentally from a failure to recognize fair drug value,” Lee stated. “While it may sound like a call for higher government spending, the price mechanism is the underlying driver. Resolving this requires aligned efforts between the government and the public to reach a broader social consensus.”Rep. Lee noted, “Attempting to cover full drug costs exclusively through National Health Insurance severely strains public finances. Ultimately, South Korea must pay prices aligned with global averages. The government should reimburse what it can afford, while exploring mechanisms to diversify patient cost-sharing.”Lee urged, “The government must recognize the urgency of failures in essential drug supply and delays in novel drug launches. It is time for decisive policy measures to guarantee appropriate pricing for low-margin essential drugs and breakthrough innovations alike. Providing adequate reimbursement and establishing a rational pricing environment will swiftly stabilize local supply chains and enhance patient access.”“If South Korea is perceived globally as a market that aggressively slashes drug prices, domestic pharmaceutical companies will lack the capital required for novel drug R&D. At the same time, multinational firms will increasingly delay launches or exit the domestic market altogether,” Rep. Lee furthered stated, “For high-cost, life-saving drugs, an environment must be cultivated where patients also share an appropriate portion of the financial burden beyond the state-funded coverage limit.”“These issues would not arise if health insurance reserves were sufficient,” Lee added. “For ultra-high-cost gene and cell therapies, calculating parameters like disease prevalence, life expectancy impact, and avoided downstream healthcare costs can inform the creation of a dedicated fund outside the main NHI budget. Establishing a separate funding pool supported by tax incentives would lighten the financial burden on the government, drugmakers, and patients alike, ensuring life-saving treatments reach pediatric patients without delay.”Regarding professional conflicts and the integration of medical fields, Rep. Lee proposed using global scientific standards as the definitive benchmark. She argued that for traditional Korean medicine to achieve formal medical recognition and insurance reimbursement, it must independently demonstrate compliance with international evidence-based standards.Noting that much of traditional medicine currently lacks rigorous scientific validation that meets global standards, Lee raised fundamental questions about universal health insurance coverage for traditional medicine, suggesting that discussions should begin to separate traditional medicine from the core National Health Insurance framework.“First-half achievements in novel drug access…sustained health policy focus in second half”Having served on the Health and Welfare Committee during the first half of the 22nd National Assembly, Rep. Lee will transition to the Education Committee for the second half. Despite leaving the committee, she affirmed that as Chief Policy Officer of the Reform Party and a practicing medical professional, she will continue to address critical healthcare issues rigorously.Specifically, she expressed her intention to leverage her practical expertise on the Education Committee to scrutinize the impending fallout from the government’s expansion of medical school enrollment quotas.according Reflecting on her legislative record, Lee noted, “The most memorable moments were those when my efforts delivered tangible help to patients in need.”Rep. Lee’s key achievements include resolving regulatory deadlocks to expand patient access to combination oncology therapies, maintenance regimens for hematologic malignancies, and adult epilepsy medications. By convening policy forums and persistently pressing health authorities, her office opened new pathways to care for patients fighting critical illnesses.“Receiving letters from patients stating that access to these therapies brought them closer to full recovery was deeply gratifying,” Lee recalled. “Patient advocacy groups that initially approached us with skepticism returned in subsequent years expressing confidence that working with our office yields real change. We also worked to reform perceptions surrounding excessive criminal prosecution in emergency and essential care, planting seeds for systemic change.”Addressing concerns that moving to the Education Committee might distance her from healthcare issues, Lee drew a firm line.“I will continue to speak out on essential health legislation, media discourses, and policy forums. Leaving the Health and Welfare Committee does not mean I will step back from health and welfare issues,” she noted. “My office will continue to champion healthcare and pediatric policies at the party policy committee level.”Rep. Lee emphasized that her new assignment to the Education Committee remains directly intertwined with the healthcare crisis, as the operational and educational disruptions stemming from the medical school quota expansion will first manifest within academic institutions. “I am uniquely positioned to bring sharp, practical scrutiny to these challenges,” she concluded.Although Rep. Lee's committee assignment in the National Assembly is set to shift in the second half of the term, Representative Lee’s focus remains steadfastly anchored on the “clinical frontlines and patients” and “future education.” This is why her upcoming legislative endeavors on the Education Committee is drawing attention.
- Opinion
- ‘GSK will continue bringing innovative drugs to Korea’
- by Son, Hyung Min Jul 27, 2026 08:43am
- This year marks the 40th anniversary of GSK Korea. Since its establishment in 1986 with a focus on infectious disease prevention and basic public health, the company has steadily reshaped its portfolio, expanding from respiratory diseases and immunology to infectious diseases and, more recently, oncology.Korea is one of the key countries where GSK concentrates its R&D capabilities. Last year, GSK Korea conducted a total of 60 research projects, including global clinical trials, post-marketing surveillance studies, non-interventional studies, and investigator-initiated trials. Approximately 5,838 Korean patients participated in these studies, while the company's R&D investment reached KRW 31.7 billion during the same period.Approaching both the first anniversary of his appointment and the company's 40th anniversary, Gunnar Riediger, who assumed leadership of GSK Korea in August last year, outlined a vision that positions Korea as more than simply a commercial market for its pharmaceuticals. Riediger said the company aims to expand opportunities for Korean healthcare professionals and patients to participate in global new drug development while strengthening its role in bringing innovative medicines to Korean clinical practice more quickly.At a recent meeting with reporters, General Manager Riediger said Korea is among the key countries executing GSK's global strategy, expressing his stance to expand clinical development and the introduction of innovative medicines continuously. In addition, he presented plans to continue investment in the Korean market, focusing on respiratory and immunological disorders, oncology, HIV, and vaccines."Korea has world-class healthcare capabilities"...Recognized as a key clinical development hubGunnar Riediger, General Manager of GSK KoreaRiediger said the most impressive aspect of Korea during his first year has been its world-class healthcare infrastructure and research capabilities.He believes these strengths are further enhancing Korea's role in the global new drug development process."Reflecting on my experience over the past year, Korea's healthcare infrastructure has been impressive. The country possesses world-class human resources including medical experts, healthcare professionals, and clinical trial researchers. Together, these strengths create an outstanding environment for carrying out global clinical development projects.”GSK is currently conducting around 70 clinical development programs in Korea, primarily in oncology and immunology. The portfolio spans both early- and late-stage development, and Korea is regarded as one of the company's top 10 countries in its global clinical development strategy.Riediger said. "Korea is an important strategic market for GSK from a clinical research perspective, Its capability to conduct research across the full spectrum of development, from early-stage to late-stage clinical trials, means it will continue to play a significant role in our global R&D efforts."He also emphasized that innovative medicines must ultimately reach patients, and that fostering the environment is as important as R&D.Riediger said, "Innovation should not end at R&D. What matters is ensuring that patients can actually benefit from it. Going forward, GSK Korea will continue working with the government, the medical community, and other stakeholders to improve patient access to innovative medicines and contribute to the advancement of Korea's healthcare."Expanding portfolio around core therapeutic areas..."We will continue introducing innovative medicines"Riediger said GSK Korea will continue introducing new medicines and expanding indications in line with GSK's global R&D strategy, focusing on the company's core therapeutic areas.GSK's key R&D focus areas include respiratory, immunology and inflammation, oncology, HIV, and infectious diseases and vaccines. According to Riediger, GSK Korea is likewise expanding its research activities and product portfolio in line with the company’s global strategy.Over the past year, the company has made notable progress in hematologic malignancies. Omjjara (momelotinib), a treatment for myelofibrosis, secured National Health Insurance reimbursement listing following its launch in Korea, while Blenrep (belantamab mafodotin), an antibody-drug conjugate (ADC) for multiple myeloma, was also introduced to the Korean market.Riediger said, "What we have achieved for Korean patients over the past 12 to 18 months demonstrates that GSK's strategy of focusing on core therapeutic areas is translating into tangible outcomes. While continuing lifecycle management through indication expansions for existing products, we are also preparing to introduce new treatment options in solid tumors and hepatitis B."He added, " As the approximately 70 clinical development projects currently underway begin to bear fruit, Korean patients will continue to gain access to new treatment options over the coming months and years."Going forward, GSK Korea is also expected to play an expanded role in disease prevention. The company has long established a strong presence in Korea's pediatric vaccine market through participation in the National Immunization Program (NIP). However, as Korea enters a super-aged society, the importance of vaccination for adults and older populations is increasing, while government support remains largely focused on children.These demographic changes present both new opportunities and new challenges for GSK Korea. The company has built an adult vaccination portfolio that includes the RSV vaccine ‘Arexvy’ and the shingles vaccine ‘Shingrix.’ Alongside maintaining its competitiveness in pediatric vaccines, expanding awareness of the clinical value and societal importance of adult immunization and fostering the market for vaccination among older adults will be key priorities under Riediger’s leadership.Riediger said the role of vaccination must evolve as Korea enters a super-aged society. He explained that the national vaccination policy should expand beyond children's immunization to address the emerging healthcare needs of an aging population."GSK has long contributed to Korea’s National Immunization Program. Based on the available data, we have continued to emphasize that policymakers need to pay greater attention to the evolving healthcare needs of an aging population. A prevention-focused approach must be reflected in national healthcare policies and strategies.""Vaccination is no longer limited to preventing infectious diseases. Its broader value, including reducing caregiver burden, lowering healthcare costs, decreasing hospitalizations, and improving quality of life, should also be taken into account. Particularly in a country like Korea, which has transitioned into a super-aged society, a prevention-focused approach can serve as an important foundation for the healthcare system."
- Opinion
- "Eylea increases dosing-interval flexibility...long-term wAMD trt”
- by Son, Hyung Min Jul 22, 2026 08:49am
- "Treatment for macular degeneration is no longer simply about extending the administration interval. It is now about how flexibly a treatment strategy can be provided according to a patient's condition. The biggest shift is that with a single agent, the treatment interval can be extended up to 24 weeks while still allowing for 4-week dosing intervals if needed."Seung Young Yu, Professor of Ophthalmology at Kyung Hee University HospitalProfessor Seung Young Yu of the Department of Ophthalmology at Kyung Hee University Hospital recently met with DailyPharm and highlighted the dosing-interval flexibility and treatment durability as the primary strengths of Eylea (aflibercept) in the management of neovascular (wet) age-related macular degeneration (wAMD).Neovascular macular degeneration is a leading cause of senile blindness, characterized by abnormal neovascularization that leads to hemorrhaging and exudation. To preserve vision, long-term anti-vascular endothelial growth factor (anti-VEGF) therapy is required. However, repeated intravitreal injections and frequent hospital visits are a heavy burden to both patients and caregivers.A global survey reported that 6 out of 10 patients discontinued treatment within two years of initiation, thereby treatment adherence remains a major challenge to overcome.Recently, to alleviate the burden of repetitive injections and hospital visits, long-acting therapeutics capable of extending treatment intervals as much as possible while maintaining efficacy are continuously being developed. In real-world clinical practice, the importance of maintaining treatment while adjusting dosing intervals based on patient conditions is growing significantly.In this context, the label for the high-dose formulation of Eylea Inj (8mg) was updated in February to allow administration at intervals of up to 24 weeks during maintenance therapy.At the same time, the minimum dosing interval was shortened from 8 weeks to 4 weeks, enabling patients with stable lesions to reduce their injection frequency and hospital visit burden, while allowing patients with high disease activity to continue treatment at shorter intervals. Is is considered significant because it establishes a basis for widening or narrowing treatment intervals based on patient status with a single agent.This approval was based on 156-week (3-year) extension data from the Phase 3 global PULSAR study. In this trial, the Eylea 8mg group maintained consistent improvements in visual acuity and reductions in central retinal thickness (CRT) through 3 years, with no new safety signals identified.Sixty percent of study participants maintained a final dosing interval of 4 months or longer; among them, 40% achieved intervals of 5 months or longer, and 24% achieved 6 months or longer. This secured clinical evidence that treatment burden can be reduced while preserving efficacy and safety over long-term treatment.Professor Yu stated, "There was a strong need for therapeutics that could reduce hospital visits even by one fewer visit and extend injection intervals by even a single month. With the introduction of next-generation, high-dose treatments, we are seeing an increasing number of cases switching to these therapies in actual clinical settings, and I believe this shift is reflected in the market."Q. Dosing interval of Eylea 8mg is the longest among anti-VEGF therapies. What are the characteristics of this drug?Eylea has a 'trap'-like structure that completely encapsulates VEGF by embracing it with both arms to suppress neovascularization. In particular, Eylea 8mg is a high-dose formulation with four times the molar dose of the original 2mg version, designed to penetrate tissues faster and deeper, with a longer half-life. Because it completely encapsulates VEGF, I believe its neovascular suppression effect is somewhat superior. Furthermore, it simultaneously targets multiple angiogenic factors, including VEGF-A, VEGF-B, and PlGF, to inhibit neovascularization.Given its unique drug structure, Eylea 8mg strongly binds VEGF, while its high-dose design maintains effective concentrations over a long period, demonstrating excellent therapeutic efficacy.Q. In clinical practice, is there a distinct group of patients expected to benefit particularly from extended dosing intervals?Wet macular degeneration is a disease in which metabolic waste accumulates, damaging tissue, and new blood vessels form in an effort to repair the damage. In cases where such tissue damage has progressed further, where significant waste has accumulated in the interim, or where the blood vessels themselves have become fibrotic, Eylea 8mg tends to be particularly effective.In South Korea, patients with polypoidal choroidal vasculopathy (PCV), characterized by aneurysm-like lesions on the blood vessels, account for about 30% to 40% of cases. Eylea 8mg seems to lower neovascular activity even better in these PCV patients. Efficacy is superior, and because of this strong response, it offers the advantage of maintaining longer treatment intervals. Therefore, therapeutic response tends to be favorable in PCV patients with these polypoid lesions.Q. Could you explain the long-term clinical data for Eylea 8mg?The PULSAR study was extended up to 3 years (156 weeks). Looking at the Year 1 and Year 2 results, after stabilizing the disease with 3 initial loading injections, a significant number of patients were able to extend their treatment intervals to 3, 4, and even 6 months. Previously, patients typically had to receive injections every 2 months, so treatment intervals have expanded substantially.Generally, therapeutic efficacy can decline somewhat after two years. However, through this extension study, Eylea 8mg proved that these results were maintained consistently through Year 3, and safety remained comparable despite the reduced injection frequency. In other words, this trial demonstrated the longest-term efficacy and safety among clinical studies of 2nd-generation anti-VEGF therapies available to date.Q. Could you share a case where Eylea 8mg was particularly effective?In South Korea, many patients present with polyp-like lesions at the ends of blood vessels. From an outcome standpoint, I believe the extent of regression in these polyps is crucial. While the original Eylea 2mg was already better at regressing polyps than other agents, my recent experience suggests that Eylea 8mg clears polyps even better. Once the polyps disappear, maintenance intervals can be extended further, and the required injection frequency decreases. In the past, about 70% to 80% of cases required combination laser therapy to close these polyps, but recently I am seeing many cases where polyps regress effectively with Eylea 8mg monotherapy.When laser therapy is combined with Eylea 8mg treatment, polyps appear to regress in about 80% to 90% of cases. While the PULSAR study reported around 50% to 60%, in my personal clinical experience, polyps seem to close at a somewhat higher rate. Since this presentation is particularly common among Korean patients, I believe Eylea 8mg is more effective in these individuals than Eylea 2mg or other agents.With Eylea 2mg, three initial injections were considered to yield a polyp closure rate of about 40%, but in my experience with Eylea 8mg, improvements reach about 70% to 80%. Clinical trial publications report around 60%.This patient type accounts for about 30% to 40% of cases in South Korea. In actual cases, polyps begin to shrink two weeks after a single injection, and by the time patients return for their third injection, the polyps have almost disappeared. The vascular network also shrinks significantly, and by week 12, the polyps are completely gone. Once this is achieved, injection intervals can be extended substantially thereafter. Ultimately, how well these polyps are closed is key, and Eylea 8mg may be more effective in that regard.Q. Various treatment options have entered this market. What are criteria for selecting a therapeutic agent?First, I look at the vascular architecture. There are roughly four major phenotypes of neovascularization, and drug response appears to vary slightly with morphology. Second, I select the drug with the highest efficacy. Third, I choose a drug that allows for even one fewer injection per year. I consider that to be more economical. While biosimilars may offer upfront financial advantages, when considering indirect costs like hospital visits associated with injection therapy, receiving even one fewer injection per year can ultimately prove more cost-effective. Above all, the most critical factor I evaluate is safety.Q. With many Eylea 2mg biosimilars entering the market, what do you see as the key differentiators for the originator 'Eylea'?Biosimilars are not identical copies of the originator. The major advantage of Eylea is its vast body of accumulated long-term data. Through clinical practice, we have gathered extensive experience in observing patient treatment responses and determining how to extend dosing intervals. Moreover, its safety profile is thoroughly validated, and it has a long track record of continuous use in a large patient population.Thus, its greatest strength lies in our rich, accumulated experience in titrating treatment intervals, as well as our deep understanding of the drug's safety and therapeutic response. While biosimilars have demonstrated bioequivalence to the originator, they do not yet possess the extensive, long-term data that Eylea holds.Q. What do you consider most critical in the long-term management of macular degeneration?With the introduction of 2nd-generation anti-VEGF agents like Eylea, the most dramatic shift has been in patient quality of life. I had a patient living in Jeolla-do who was unable to travel to the hospital alone. His son, residing in Seoul, had to personally bring him up, stay overnight, administer the injection the next day, and return home together. Because of this, even when treatment was needed every 2 months, I inevitably had to instruct them to visit once every 3 months. Therefore, I believe the difference between two months and three months is immense.Even a slight extension of the treatment interval improves patient quality of life and positively impacts clinical outcomes. Some people ask, "What difference does extending from 2 to 3 weeks make?" but I believe that difference is vital. In practice, extending treatment intervals has significantly alleviated the burden on both my patients and me, as I experience it in daily practices.
- Opinion
- Samoh Pharm’s expansion after Voxzogo reimb…orphan drug portfolio
- by Hwang, byoung woo Jul 20, 2026 08:50am
- The reimbursement of 'Voxzogo (vosoritide),' the first treatment for pediatric achondroplasia in South Korea, under the national health insurance has opened a new treatment option for patients. At the same time, it has provided a turning point for Samoh Pharm to expand its rare disease business, spanning over 20 years, to the next level.Chang-Deok Ji, Managing Director of the Orphan Drug Business Unit at Samoh Pharm, who spearheaded the domestic introduction and launch of Voxzogo, sought to establish a new commercialization model through this project, connecting global innovative therapeutics with the domestic healthcare environment.DailyPharm met with Ji from Samoh Pharm's Orphan Drug Business Unit to discuss the significance of the Voxzogo launch, the company's rare-disease business strategy, and its future vision."Voxzogo is a project that takes our accumulated experience to the next level"Chang-Deok Ji, Managing Director of the Orphan Drug Business Unit at Samoh PharmDirector Ji evaluated Voxzogo as a project with a distinctly different nature from previous rare-disease drug launches.Over the past 20 years, Samoh Pharm has accumulated specialized expertise by introducing and supplying a range of orphan drugs in South Korea, including treatments for Fabry disease, Gaucher disease, Pompe disease, mucopolysaccharidosis (MPS), and phenylketonuria (PKU).Ji explained that while Voxzogo is an extension of this trajectory, its significance lies in the fact that it served as an opportunity to upgrade the company's business operations and commercialization capabilities rather than simply adding a new product to the portfolio."Rather than just being a single new product, Voxzogo is part of a project that implements our accumulated experience and know-how in a new way, and it marks a turning point for our rare disease business to leap forward to the next level," Ji said.Voxzogo is the first pharmacological treatment option approved in South Korea for pediatric patients with achondroplasia aged 4 months and older whose growth plates are not yet closed. It is recognized as an innovative therapeutic that regulates the FGFR3 signaling pathway through a CNP analog mechanism."While being the country's first treatment option is important, the greater significance lies in offering patients and caregivers the possibility that 'treatment is now a choice,'" Ji said. "Since achondroplasia accompanies not only short stature but also recurrent surgeries and various complications, we can expect long-term health management and improved quality of life beyond just growth enhancement.""Rare disease business is about creating a treatment setting, not just selling a product"Ji has built a 25-year career in the pharmaceutical industry, dedicating more than 15 years to the rare disease sector. He has led organizational setup and new product launches at global rare-disease enterprises, executing a range of commercialization projects. The Voxzogo project is an example of how to optimize and apply this extensive experience in the domestic medical landscape."Our role is to connect globally accumulated innovation with the domestic healthcare environment so that it translates into patient treatment," he explained.The Voxzogo business was implemented through close collaboration with BioMarin Pharmaceutical. The structure leverages BioMarin's R&D capabilities and global experience, alongside Samoh Pharm's domestic execution capabilities, to successfully integrate the innovative therapeutic into local clinical practice.However, Ji emphasized that the core of the rare disease business lies in building a comprehensive therapeutic environment rather than the product itself."The rare disease sector is not an area where a market is formed simply by launching a single product. From patient identification and diagnosis to the initiation of treatment and long-term management, every stage must be organically linked for the therapy to reach the patient successfully," Ji noted.Based on this philosophy, Ji established an operational framework within the Orphan Drug Business Unit that seamlessly connects medical affairs, marketing, and patient support functions."What matters more than the size of the organization is expertise and execution," Ji said. "Our competitiveness lies in providing rapid and sophisticated support to healthcare providers and patients based on a lean yet powerful organization.""Voxzogo is not the end, but a greater beginning"Ji assessed that the impact of Voxzogo extends beyond the performance of a single product, serving as a blueprint for the future direction of the rare disease business."What we confirmed through Voxzogo was not merely the market potential of a single innovative therapeutic," he shared. "Rather, it proved that we could realize a patient-centric rare disease commercialization model by establishing a sophisticated Pricing and Reimbursement (P&R) process based on a Risk Sharing Agreement (RSA), creating a performance evaluation framework utilizing Real-World Data (RWD), and securing agile execution through a lean and robust organization."Based on this milestone, Samoh Pharm plans to expand its commercialization capabilities by leveraging its accumulated rare disease expertise across its broader ethical drug (ETC) portfolio and pipeline.Furthermore, the company envisions continuously developing an integrated collaboration model that connects medical professionals, patients, the government, academic societies, and global partners.Ji said, "In the rare disease business, the process of connecting patients with treatment opportunities holds far greater meaning than short-term financial performance," and added, “We will continue collaborating with global partners so that more patients can gain access to innovative treatments."Ji concluded by noting, ”The very moment a patient begins their treatment is when our role begins,” and added, “Voxzogo is not just a single project, but a starting point for our new therapeutic opportunities for an even broader population of rare disease patients."
