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- 2026-03-10 00:45:03
- InterView
- [Reporter’s View] Patients must feel the benefits
- by Son, Hyung Min Dec 08, 2025 08:58am
- South Korea has long been one of the world's most challenging markets for new drug entry. Global pharmaceutical companies, and even domestic firms, have historically been slow to step into Korea. The excessive delay in the time from approval to reimbursement compared to major countries was also a significant problem. Naturally, the term “Korea Passing” became an almost permanent fixture in the industry’s vocabulary.However, starting next year, this long-standing structure will begin to change. The Ministry of Health and Welfare has decided to overhaul the drug pricing system, which had remained as is for years, introducing measures like dual pricing, indication-specific pricing, and non-disclosure agreements.The backdrop to the government opening the door to drug price reform after over a decade of inaction lies the change triggered by the United States. When the Trump administration announced a policy to lower U.S. drug prices to most-favored-nation levels, global pharmaceutical companies' procurement strategies were shaken. Korea’s unusually low price levels emerged as a risk factor in global pricing strategies.Recent direct meetings between U.S. pharmaceutical association officials and the Korean government, where they conveyed concerns that “if this continues, Korean patients will be unable to use innovative new drugs,” are an extension of this trend.Korea’s low prices and long reimbursement timelines have already led to delayed launches or withdrawal of several therapies.Patient access to new medicines in Korea remains severely limited. According to the Korea Research-Based Pharma Industry Association (KRPIA), only 5% of global new drugs enter Korea within a year of their first global launch—just one-quarter of the OECD average. Korea’s new-drug approval rate (30%) is also far below the OECD average (49%) and the G20 average (46%).Some companies have completely withdrawn from the Korean market due to low drug pricing after patent expiration. AstraZeneca's decision to withdraw domestic sales of ‘Forxiga (dapagliflozin)’ after its patent expired is a notable example.The government’s new reform package seeks to directly address these challenges. From Dual pricing—separating list prices from actual transaction prices—to indication-based pricing, higher generic prices for R&D-intensive companies, these moves are closer to flexible drug pricing policies aligned with international standards.In other words, Korea is belatedly adopting approaches already established in the US and Europe. The direction of significantly lowering generic drug prices while protecting exit-prevention drugs and essential medicines, and providing incentives to innovative pharmaceutical companies, is seen as a flare signaling the restructuring of the pharmaceutical industry.The government has reset the playing field for the first time in a decade, and it’s the companies' turn to respond. We cannot allow a repeat of the situation where global anticancer drugs, approved for dozens of indications, fail to enter the Korean market due to pricing burdens, leaving some indications unaddressed or neglected. Nor can the strategy of deprioritizing Korea or exiting the market entirely before patent expiry continue.With the government’s system reform, structural barriers that global pharma long cited have now been meaningfully reduced.It’s time for companies to follow through and demonstrate concrete actions to broaden Korean patients' access to new drugs — such as expanding indications, reapplying for reimbursement, and reconsidering delayed launches —measures they have previously postponed.For the term ‘Korea passing’ to cease appearing in headlines, policy reform alone is not enough.Both the government and companies must demonstrate clear actions, viewing Korean patients through the lens of international standards and prioritizing treatment accessibility.
- InterView
- [Reporter’s View] Is the pricing reform realistic?
- by Hwang, byoung woo Dec 04, 2025 09:13am
- As the government unveils its drug-pricing reform plan, the pharmaceutical industry immediately began preparing its response. Yet many industry voices point out a widening gap between the policy’s stated direction and the realities companies face on the ground.Despite the government’s rationale of “industry restructuring,” concerns are growing over potential repercussions, including reduced R&D investment, weakened manufacturing capacity, and diminished momentum for new drug development. It remains unclear how carefully these impacts were factored into the new framework.This reform plan is reportedly designed based on the principles of streamlining the supply structure, establishing rational drug pricing, and strengthening the government’s fiscal soundness.Specifically, alleviating the burden on insurance finances and eliminating market duplication and inefficiencies are presented as core priorities, with the government emphasizing its intent to increase proactive efforts and support new drug development.But the response from the field tells a different story.A large portion of domestic pharmaceutical companies are already struggling with rising baseline costs—raw materials, labor, and clinical trial expenses. In this context, implementing drug price adjustments simultaneously constrains not only immediate profitability but also future investment capacity.This raises questions about the appropriateness of the policy's pace and intensity.Of course, there is a certain level of consensus on the broader direction of ensuring the sustainability of insurance finances and refining drug price management.However, given that domestic firms lack the robust R&D foundations owned by multinational companies, the reform is widely seen as a disproportionate burden on the local industry.Over the past several years, the Korean government has repeatedly positioned pharmaceuticals and biotech as a key future growth engine and implemented various support policies.Yet the latest pricing overhaul may likely conflict with companies’ mid- to long-term investment plans. Critics argue that prioritizing short-term fiscal stability may ultimately weaken Korea’s long-term industrial competitiveness.The pharmaceutical and biotech industries operate based on uncertainties, such as long-term R&D, potential failures, and technological advancements, rather than short-term profits.Therefore, drug pricing policy inherently carries significance beyond simple price adjustments —it can reshape the industry’s underlying dynamism.The intent behind the reform is understandable in some respects. But if the pace and magnitude of implementation are not calibrated properly, companies may be forced to reduce future R&D investment as their first line of survival.Consequently, a cautious approach is needed, as this could erode the industry's growth capacity and disrupt efforts to secure technological competitiveness. How to strike a delicate balance between government systems and the national strategy of fostering the industry as a future growth engine will be the key challenge moving forward.
- InterView
- Anzupgo to address the unmet needs in chronic hand eczema
- by Eo, Yun-Ho Nov 18, 2025 06:13am
- Professor Sonja Molin, Division of Dermatology, Department of Medicine at Queen Since their emergence, JAK inhibitors have rapidly expanded their therapeutic footprint. Initially introduced as the first oral option in rheumatoid arthritis, a field previously reliant solely on injections, JAK inhibitors have since taken a pivotal role across the spectrum of autoimmune diseases, including ankylosing spondylitis, psoriatic arthritis, atopic dermatitis, and Crohn’s disease. In this context, JAK inhibitors are now breaking yet another barrier in disease management by shedding even the notion of being an ‘oral formulation’ and entering the market as topical ointment formulations, ushering in a new paradigm shift. In September, the Ministry of Food and Drug Safety granted marketing authorization for Anzupgo (delgocitinib), a treatment for chronic hand eczema (CHE). Specifically, Anzupgo is indicated for the topical treatment of“moderate-to-severe chronic hand eczema in adults who have an inadequate response to, or for whom treatment with topical corticosteroids is not advisable.” As a non-steroidal, topical, pan-JAK inhibitor, Anzupgo inhibits the activation of the JAK-STAT cellular signaling pathway, known to play a key role in the manifestation of hand eczema. Until now, treatment options for chronic hand eczema have been limited, with strong topical corticosteroids commonly used as first-line therapy. However, its long-term use carries risks of various side effects, including skin barrier damage, skin atrophy, and telangiectasia. Dailypharm met with Dr. Sonja Molin, Professor of Dermatology at Queen's University, to discuss the clinical value and therapeutic potential of Anzupgo, the first topical JAK inhibitor for CHE. Anzupgo cream-What is chronic hand eczema, and what is its prevalence? CHE is one of the most common skin conditions affecting the hands, and a large proportion of cases progress to chronic disease. CHE is known to affect approximately 1 in 10 adults worldwide. This disease causes significant functional, occupational, and psychological burdens, significantly reducing patients' quality of life. Approximately 70% of patients with severe CHE experience difficulties performing daily activities, which directly impacts their employment and income. As a result, early diagnosis and appropriate treatment are paramount to effectively reduce the disease burden for these patients. Therefore, raising awareness about CHE and expanding active treatment approaches are urgently needed. Many patients only visit general practitioners rather than dermatologists, meaning a significant number of cases are not fully reflected in official statistics. Consequently, the true prevalence of hand eczema is likely much higher than current estimates. -Chronic hand eczema is known to be morphologically diverse. Which subtypes primarily occur? CHE is a heterogeneous disorder influenced by multiple factors and manifests in various forms. According to the 2022 European guidelines, CHE is categorized into etiological subtypes and clinical subtypes. In practice, overlapping subtypes are quite common, with irritant contact dermatitis and allergic contact dermatitis being common causes. Clinical subtypes like bullous or hyperkeratotic hand eczema also require careful treatment. -Does Anzupgo show efficacy across all CHE subtypes? Anzupgo is approved for moderate to severe chronic hand eczema in adults who do not respond to or are not suitable for topical steroid therapy. Results from the Phase III clinical trial supporting its approval demonstrated that delgocitinib cream showed broad therapeutic responsiveness across all CHE subtypes. Mechanistically, Anzupgo not only provides anti-inflammatory effects but also helps restore the damaged skin barrier, making it suitable for treating irritant, allergic, vesicular, and hyperkeratotic subtypes. Clinically, patients with thick, severe hyperkeratotic lesions may exhibit slower treatment response. However, CHE is a chronic condition requiring long-term management, so continued treatment should be considered with expectations for gradual improvement. -What limitations exist with previous CHE treatments, and how does Anzupgo differ? As a dermatologist, I have long felt that existing treatment options for CHE are inadequate. For example, topical corticosteroids are internationally recommended as first-line therapy, but repeated long-term use often leads to diminished efficacy and local adverse effects, which are clear limitations. Alitretinoin is the only oral medication approved specifically for CHE and is effective for symptom control. However, concerns regarding teratogenicity restrict its use in women of childbearing potential, and routine lab monitoring is required, limiting its broader use. This unmet need means the disease burden associated with patients' symptoms remains a challenge that needs to be addressed. Therefore, the arrival of Anzupgo, a topical therapy with a novel mechanism and clinically proven efficacy and safety, is extremely welcome. - You have real-world experience prescribing Anzupgo. How do clinical outcomes compare with trial data? Having participated in the DELTA study, the pivotal clinical trial for Anzupgo, I was therefore already familiar with its efficacy and safety profile. As a dermatologist treating patients with CHE, my primary concern was whether the efficacy and safety profile demonstrated in clinical trials would translate identically to real-world patient outcomes. In conclusion, Anzupgo met these expectations and, in some cases, demonstrated even superior efficacy in real-world practice. Notably, it showed excellent responsiveness in the bullous subtype of CHE, where response to existing medications was often poor. Furthermore, the results of the DELTA FORCE study, which directly compared Anzupgo with the oral agent alitretinoin, are also impressive. It was surprising that delgocitinib cream demonstrated statistically significant clinical results compared to alitretinoin in the primary endpoint (change in HECSI score at Week 12 from baseline) and all other efficacy parameters. -When should patients previously treated with topical steroids consider switching to Anzupgo? If the response to topical corticosteroids is inadequate or relapses are frequent, the physician should consider other treatment options as early as possible. Since its approval in Germany last September, the use of Anzupgo has steadily increased. Awareness of delgocitinib cream is gradually growing among both healthcare professionals and patients, and overall treatment satisfaction is high.
- InterView
- ADCs rise to become SOC in key solid tumors
- by Son, Hyung Min Nov 06, 2025 06:32am
- Major antibody-drug conjugates (ADCs) are rapidly becoming standard-of-care (SOC) therapies across solid tumors, reshaping treatment paradigms. Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) has displaced Kadcyla (trastuzumab emtansine) as the new SOC in HER2-positive breast cancer. Enhertu is also validating potential as a first-line therapy in combination with the targeted therapy Perjeta (pertuzumab). In urothelial carcinoma, Astellas’ Padcev (enfortumab vedotin) is rising rapidly. Padcev monotherapy has already become SOC in second-line settings, and in first-line disease, Padcev + Keytruda (pembrolizumab) is now a preferred regimen in the NCCN guidelines, overtaking Bavencio (avelumab) + chemotherapy as the dominant option. Merck's existing immuno-oncology drug ‘Bavencio (avelumab)’ + chemotherapy, has been used as the SOC for urothelial carcinoma, but the introduction of Padcev significantly increased the likelihood of this position changing. Enhertu aims to become SOC across HER2-mutated solid cancers Enhertu is a next-generation ADC composed of a monoclonal antibody that has the same structure as trastuzumab, which binds to receptors overexpressed on cancer cells and a highly potent Topo I inhibitor payload, linked via a tumor-selective cleavable linker. ADCs are anticancer drugs manufactured by linking an antibody that binds to a specific target antigen on the surface of cancer cells with a drug that has cell-killing (cytotoxic) properties (payload). ADCs act selectively on cancer cells by using the selectivity of antibodies to their targets and the killing activity of drugs to increase therapeutic efficacy while minimizing side effects. In a head-to-head study, Enhertu nearly doubled progression-free survival (PFS) compared to Kadcyla. Enhertu and Kadcyla use the same trastuzumab backbone but with a different microtubule inhibitor payload. Unlike Kadcyla, which uses a microtubule inhibitor monomethyl auristatin E (MMAE) as its payload, Enhertu utilizes a topoisomerase I inhibitor. This difference led to a starkly contrasting efficacy. As a result, companies in Korea and abroad are actively pursuing ADC development using topoisomerase I inhibitor payloads. Among later-stage drugs, ‘Datroway (datopotamab)’ and ‘Trodelvy (sacituzumab govitecan)’ have adopted topoisomerase I inhibitor payloads. However, Enhertu's ambition extends beyond second-line HER2-positive breast cancer. It has shown potential not only as the second-line SOC for HER2-positive breast cancer but also as a first-line therapy, demonstrating efficacy across various solid tumors. Enhertu has established its efficacy in combination with Roche's Perjeta. Perjeta is one of the drugs used in the so-called ‘THP regimen (taxane + Herceptin + Perjeta)’, which serves as the standard first-line treatment for HER2-positive breast cancer. The Phase III DESTINY-Breast09 trial compared the efficacy and safety of Enhertu plus Perjeta versus THP therapy in 1,157 patients with previously untreated HER2-positive breast cancer. Patients were randomized in a 1:1:1 ratio to the Enhertu + placebo group (387 patients), the Enhertu + Perjeta group (383 patients), or the THP therapy group (387 patients). The primary endpoint was progression-free survival (PFS) assessed by blinded independent central review (BICR). Secondary endpoints included overall survival (OS), objective response rate (ORR), duration of response (DOR), and safety. During a median follow-up of 29 months (interim data cutoff February 26, 2025), the PFS in the Enhertu+Perjeta group was 40.7 months, longer than the 26.9 months in the THP therapy group. The ORR was 85.1% in the Enhertu+Perjeta group and 78.6% in the THP therapy group. DOR was 39.2 months in the Enhertu+Perjeta group and 26.4 months in the THP therapy group, showing a difference. The OS data were immature at the time of cutoff. In addition to breast cancer, Enhertu has been approved for gastric cancer and non-small cell lung cancer. In April last year, it also received accelerated approval from the U.S. Food and Drug Administration (FDA) for all HER2-positive solid tumors that lack alternative treatment options. Its potential is now being explored in cancers with limited treatment options, such as colorectal cancer and biliary tract cancer. Padcev seeks to become first-line SOC in urothelial carcinoma in combination with an immune-oncology drug Astellas’ Padcev is pushing toward first-line SOC in combination with Keytruda. That position had long been held by Bavencio plus chemotherapy. Bavencio is a relatively mild agent and has advantages for use in elderly patients and long-term administration. But Padcev’s clinical results are being regarded as groundbreaking. In the Phase III EV-302/KEYNOTE-A39 study, Padcev + Keytruda achieved a median overall survival (OS) of 31.5 months in previously untreated urothelial carcinoma patients. This represented a significant difference compared to the 16.1 months observed in the control group(chemotherapy). Although differences existed in the control group and clinical design, the median OS for the Bavencio maintenance therapy arm was 29.7 months. This represents an extension of over 9 months compared to the 20.5 months observed in the control group receiving maintenance therapy alone. However, patients were randomized after receiving approximately 4 months or more of prior treatment (4-6 cycles) with gemcitabine plus cisplatin or carboplatin combination therapy. Accordingly, the NCCN guidelines recommend Padcev + Keytruda as a Category 1 first-line therapy in locally advanced or metastatic urothelial carcinoma. For second-line or later settings, Padcev monotherapy is the preferred therapy, and for third-line or later, it is recommended as a Category 1 preferred therapy. Padcev also demonstrated efficacy in muscle-invasive bladder cancer, where radical cystectomy is the SOC, presenting new possibilities. The combination therapy of Padcev plus Keytruda demonstrated statistically significant improvements in event-free survival (EFS), overall survival (OS), and pathological complete response rate (pCR) compared to radical cystectomy+pelvic lymph node dissection (RC+PLND) alone. This study is the first randomized Phase III trial demonstrating a clear survival benefit from pre- and post-operative combination therapy in patients with cisplatin-ineligible, muscle-invasive bladder cancer who are eligible for surgery. Padcev is an ADC targeting Nectin-4, composed of a Nectin-4-specific fully human monoclonal antibody and MMAE. Padcev chose MMAE as the payload due to its synergistic effect with PD-1. Nectin-4 is overexpressed in urothelial carcinoma cells compared to normal tissue, providing high selectivity for cancer cells. After binding, it enters the cell and releases MMAE to induce cell death. When combined with PD-1 inhibitors like Keytruda, the cytotoxicity of MMAE synergizes with the immune activation from PD-1 inhibition, maximizing antitumor activity. Despite its aggressive nature, metastatic urothelial carcinoma has had no first-line treatment options beyond chemotherapy for 30 years, creating a significant unmet need. Before Padcev monthearpy, the response rate to immune-oncology drugs was only 13-28% regardless of PD-L1 status, and a significant number of patients experienced disease progression within 3 months of treatment. Therefore, whether Padcev + Keytruda becomes the new standard of care (SOC) in the first-line treatment space is now a matter of intense interest. Recently, this combination therapy cleared the first hurdle for reimbursement in Korea by passing the Cancer Disease Deliberation Committee, taking a significant step closer to commercialization in Korea.
- InterView
- "GI Innovation challenges melanoma"
- by Hwang, byoung woo Oct 21, 2025 06:18am
- GI Innovation is accelerating its entry into the global market. The company unveiled clinical data for its new immunotherapy drug candidate, 'GI-102,' at the ESMO Congress 2025 (European Society for Medical Oncology). GI-102 is drawing attention for its potential to overcome resistance, as it showed clinical improvement, including tumor shrinkage of more than half, even in melanoma patients who did not respond to PD-1 antibody monotherapy. Based on the latest results, the company has strategized to expand collaboration with global pharmaceutical companies for joint clinical trials and aims for first-line treatment for melanoma. DailyPharm met with Myoung Ho Jang, CEO of GI Innovation, and Nari Yun, Director, at the ESMO Congress 2025 to hear about the significance of the GI-102 poster presentation and the company's future strategy. (from left) Na Ri Yun, Executive Vice President (Clinical Dev & Strategy) and Myoung Ho Jang, CEO of GI Innovation "Demonstrated activity in patients refractory or resistant to immunotherapies…potential to overcome Keytruda resistance" The new drug candidate GI-102 is a fusion protein developed using the company's proprietary "Immune-cytokine" platform. It is structured to maintain the anti-cancer immune activation function of IL-2 (Interleukin-2) while reducing toxicity by combining it with the immunomodulatory protein CD80. It works by a differentiated mechanism that directly activates immune cells and suppresses regulatory T-cells (immunosuppressive cells), thus being assessed as an innovative candidate that can compensate for the limitations of existing PD-1 antibodies. According to the GI-102 poster presentation at ESMO Congress 2025, the drug showed significant anti-cancer activity in a combination trial targeting patients refractory or resistant to PD-1 antibodies. In the initial combination trial, 10 melanoma patients who were refractory to PD-1 antibodies, the combination of GI-102 and Keytruda (pembrolizumab) recorded an objective response rate (ORR) of 40% and a disease control rate (DCR) of 70%. Notably, a case was presented where a patient whose disease had progressed just two months after initial Keytruda treatment achieved a partial response (PR), with the tumor shrinking by approximately 59%, after the GI-102 combination therapy. In this case, the tumor reduction (cPR, -59%) and progression-free survival (PFS) of 3.9 months were observed when GI-102 was combined with the same drug backbone. Na Ri Yun, Executive Vice President of GI Innovation (Clinical Dev & Strategy), explained, "The fact that the tumor shrank by more than half in a patient who did not respond to PD-1 antibody monotherapy signifies the potential to overcome refractoriness," and added, "The key finding is that GI-102 dramatically increases the number of immune cells (lymphocytes) that determine the response rate of immunotherapies." The GI-102 combination group also showed an increasing trend in anti-cancer immune cells, such as CD8⁺ and CD4⁺ T-cells, as treatment progressed. Yun mentioned, "We confirmed a clear increase in anti-cancer immune cells, such as CD8⁺ and CD4⁺ T-cells, following the GI-102 combination," and added, "When the number of immune cells increases, there are more targets for the PD-1 antibody to bind to, which ultimately strengthens the anti-cancer effect." Notably, no dose-limiting toxicities (DLT) were observed in this combination trial. Most adverse events, such as fever and chills, were mild (Grade 1-2). Although elevated liver enzymes occurred transiently in some patients during the first treatment cycle, they recovered to the normal range. The company explained that "global pharmaceutical companies also assessed these to be manageable through meetings." Yun said, "The frequency of side effects was significantly low compared to conventional IL-2 class drugs, and patients tolerated the treatment well." She added, "We have obtained very positive data in terms of safety." Myoung Ho Jang, CEO of GI Innovation, said, "This data confirmed that GI-102 monotherapy shows activity comparable to global blockbuster immunotherapies," and assed that "The combination therapy was confirmed to induce a response even in patient populations that existing PD-1 antibodies could not reach." Jang added, "GI-102 is garnering high interest from global pharmaceutical companies because it is an IL-2-based immunocytokine that suppresses regulatory T-cells." Active discussions with global pharma..."A head-to-head challenge in first-line melanoma treatments" GI Innovation engaged in discussions with global pharmaceutical companies at the conference regarding collaborative clinical trials for first-line melanoma treatment. Currently, PD-1 antibodies like Keytruda and Opdivo (nivolumab) are approved as first-line monotherapies for melanoma. Jang said, "We are having positive discussions with global pharmaceutical companies here at ESMO 2025," and added, "We are reviewing a randomized clinical design to 'head-to-head' compare the efficacy of the GI-102 combination effect against PD-1 monotherapy." Yun added, "Melanoma is the only cancer type where PD-1 monotherapy is the standard of care. Proving the superiority of GI-102 here will increase its potential for expansion into other solid tumors." The fact that the company is considering a direct comparison clinical trial against a first-line monotherapy is evidence of its confidence in the results. Notably, GI Innovation stated that it is considering developing GI-102 not merely as a technology transfer (L/O) but as a co-clinical/co-commercialization model with global pharmaceutical companies. Jang stressed, "While we are in discussions for the technology transfer of GI-101A, we prefer a model where the company retains certain rights and co-develops GI-102 with a global pharmaceutical company," and stressed, "Our goal is to increase long-term value through a direct commercialization structure, creating direct revenue rather than just royalty income." Yun added, "We favor a partnership structure where the company proactively secures rights so as not to be swayed even if a global pharmaceutical company's internal priorities change." In conclusion, the analysis suggests that the discussions held at ESMO Congress 2025 confirmed GI-102's competitiveness in the global market. Finally, Jang said, "Although we are starting with melanoma, we expect a rapid expansion into other solid tumors through off-label use as clinical evidence accumulates," and added, "The conference provided us with confidence that GI-102 possesses genuine competitiveness in the global market."
- InterView
- "New landscape in DLBCL trt…Columvi·Polivy's bigger role"
- by Hwang, byoung woo Oct 10, 2025 06:06am
- Diffuse large B-cell lymphoma (DLBCL) has been known to lack new treatment options besides rituximab (MabThera) for over 20 years. Approximately one-third of DLBCL patients who undergo existing treatments (primarily R-CHOP) experience relapse or become non-responsive, and the second-line treatment has been limited to intensive chemotherapy and autologous stem cell transplant. However, the treatment paradigm is changing as innovative treatments, including antibody-drug conjugate (ADC), bi-specific antibodies, and CAR-T cell therapies, have emerged recently. During the meeting with DailyPharm, Professor Gareth Gregory of Monash University in Australia emphasized the role of treatments with new mechanisms, such as Polivy and Columvi, for older adults or patients who failed previous therapies. DLBCL still lacks treatments for older adults or transplant-ineligible patients…second-line treatment alternatives are needed Professor Gareth Gregory of Monash University in AustraliaAccording to Professor Gregory, the highest unmet needs for DLBCL are the second-line treatment. Exiting treatment data show that approximately one-third of all patients with DLBCL experience disease progression despite undergoing first-line treatments. To date, treatment options have been limited to intensive chemotherapy and autologous stem cell transplant. Professor Gregory said, "A significant proportion of DLBCL patients globally are elderly, aged 68 or older, and often have comorbidities, thus most of them are ineligible for autologous stem cell transplant," and added, "Given the high relapse rate characteristic of lymphoma, the response rate for patients receiving CAR-T or autologous stem cell transplant treatment in the second line is only about 21%, highlighting a significant need for more effective and safer therapeutic options." For this reason, interest has grown in treatments with new mechanisms, like bispecific antibodies. The need for monotherapy or combination therapy options, particularly for elderly patients or those who have failed previous treatments, is persistently being raised. Among the therapies currently driving a paradigm shift in DLBCL treatment are Polivy (polatuzumab vedotin) and the combination therapy of the bispecific antibody Columvi (glofitamab) with Gemcitabine and Oxaliplatin (GemOx). Particularly in the first-line setting, Polivy in combination with R-CHP is emerging as the new standard of care, replacing the traditional R-CHOP. For relapsed/refractory patients, the combination of the bispecific antibody Columvi and GemOx is gaining attention as a powerful alternative that shows long-term efficacy. Regarding this, Professor Gregory emphasized that the core of DLBCL treatment is not the 'effectiveness of a single agent,' but the 'design of the entire treatment journey.' For example, this involves a strategy in which Polivy reduces the risk of relapse in the first line, and Columvi increases the complete response rate in the second-line treatment setting, thereby extending treatment continuity. Professor Gregory said, "Polivy reduces the risk of relapse and death in first-line treatment, and Columvi offers the potential for long-term survival for relapsed patients," and added, "Both treatments are evolving to improve the patient's entire treatment journey." Polivy drives changes to the first-line setting...increased expectation of expanded reimbursement Polivy is evaluated as a key therapy for reducing the risk of recurrence associated with the conventional R-CHOPregimen and for improving long-term patient survival. Fortunately, it recently passed the Cancer Disease Review Committee (CDRC) in Korea, raising expectations for expanded reimbursement for first-line treatment. The 5-year follow-up data from the POLARIX study showed that the Polivy + R-CHP combination therapy improved both progression-free survival (PFS) and overall survival (OS) compared with conventional R-CHOP, and the rate of transition to subsequent treatments was significantly lower. Professor Gregory said, "Polivy combination therapy has been included in the first-line recommendations in guidelines in multiple countries, including Australia," and added, "Tolerability was similar to or better than R-CHOP, and we confirmed a long-term trend of reduced risk of relapse and death." Furthermore, Professor Gregory also pointed out that, given the characteristic of DLBCL, where the risk of relapse increases sharply if complete response is not achieved in the first line, the Polivy combination therapy is significant for its role in reducing treatment burden and medical resource consumption. He said, "Polivy combination therapy is significant not only for its treatment results but also for the efficiency of medical resources," and added, "Reducing relapse shortens the complex treatment process that leads to high-intensity therapies, and can also reduce patient hospitalization time, medical costs, and the loss of social productivity." Columvi offers long-term survival potential for relapsed patients...reimbursement remains a hurdle Meanwhile, in the second-line setting, Columvi is showing new possibilities. Columvi, a bispecific antibody, targets T cells and B cells simultaneously, achieving a high response rate even in relapsed/refractory patients with reduced chemotherapy response. In the 2-year follow-up analysis of the STARGLO Phase 3 trial, the Columvi + GemOx combination group had a 4-fold increase in PFS (13.8 months vs. 3.6 months) and a more than 2-fold improvement in complete response rate (58%) compared with the rituximab + GemOx group. Notably, 82% of patients who achieved remission maintained their response for at least 1 year, demonstrating the potential for long-term survival despite the fixed duration of therapy. Columvi's step-up dosing strategy is highlighted as a clinical feature that secures safety by minimizing immune-related side effects. Professor Gregory said, "Bispecific antibodies carry the risk of Cytokine Release Syndrome (CRS) due to immune system activation, but Columvi can be managed safely through step-up dosing and pre-treatment," and emphasized, "Columvi has the biggest advantage in that it is an 'off-the-shelf' therapy, meaning it can be administered immediately after diagnosis." He assessed, "Some patients in the STARGLO trial have maintained a long-term response for over four years, and for patients ineligible for CAR-T or transplant, the Columvi combination therapy offers a possibility of cure." Despite these therapeutic effects, the issue of utilization in Korea remains a reimbursement barrier. Polivy was stuck in a non-reimbursed state for five years after its 2020 approval, and Columvi also failed to pass the CDRC in December last year. Although Polivy initiated its first step toward reimbursement this year with discussions for first-line coverage, Columvi is still waiting for reimbursement listing for its second-line indication. Professor Gregory mentioned, "Effective treatment is meaningless if it is not delivered to the patient," and added, "Drugs with better accessibility and tolerability should realistically be reimbursed, especially compared to high-cost therapies like CAR-T, which are restricted to limited facilities." According to Professor Gregory, Australia has already approved reimbursement for the combination therapy of Columvi + GemOx for autologous stem cell transplant-ineligible patients, using the same criteria as those used in the clinical trial patient population. Finally, he said, "The ultimate goal of lymphoma treatment is to create patient-centered outcomes. If a treatment has sufficient accumulated clinical data, it should be applied to the field quickly," and added, "Institutional support is needed so that patients can receive the best care more safely and rapidly."
- InterView
- "Gilead-Kite will lead the trt landscape for DLBCL in KOR"
- by Hwang, byoung woo Sep 10, 2025 06:12am
- With the approval of the CAR-T cell therapy Yescarta (axicabtagene ciloleucel) in Korea, a shift in the treatment landscape for Diffuse Large B-cell Lymphoma (DLBCL) is anticipated. Analysis suggests that an innovative therapeutic option that has demonstrated higher cure rates and improved survival compared to existing second-line treatments is expected to provide a new option for patients in Korea. Gilead Sciences and Kite Pharma plan to use Yescarta's Korean approval to strengthen their cooperation with Korea's health authorities and medical institutions, focusing on addressing the unmet needs of DLBCL patients. DailyPharm met with Diego Santoro, Head of the International Region for Kite Pharma (a Gilead Sciences company), to hear about the company's specific plans. Diego Santoro is an expert who has led the commercialization and expansion of access for CAR-T cell therapies in key countries such as Japan, Korea, and Brazil, with over 25 years of leadership experience at global pharmaceutical companies. Yescarta's Milestone in DLBCL Treatment..."Became a Key Treatment Option" Diffuse Large B-cell Lymphoma (DLBCL) is a very rapidly progressing disease, with approximately 40% of patients who receive first-line treatment experiencing a relapse. Previously, the average survival period after second-line treatment was only about 6 months, but with the introduction of CAR-T therapies, survival rates have significantly improved. Diego Santoro, Head of the International Region for Kite PharmaThrough one of the world's largest clinical studies, Yescarta demonstrated that approximately 41% of patients survive for over 5 years. Yescarta is currently approved in over 40 countries, and its reimbursement has been secured in numerous countries based on its therapeutic efficacy and financial feasibility, expanding patient access. From this perspective, Yescarta is also expected to become an important therapeutic option that addresses unmet needs in Korea. Diego Santoro explained, "Korean medical professionals were well-informed about Yescarta's clinical data even before its approval, and the demand for its introduction was high." He added, "The biggest differentiation factor is that it allows patients to start treatment at an earlier stage, which improves prognosis and increases the possibility of a cure. The trend in clinical practice is already shifting, with patients who were previously considered for third-line therapy now being treated at the second-line stage." In other words, by administering CAR-T earlier at the second-line treatment stage, rather than waiting until the third-line as in the past, it is possible to suppress the cancer early and aim for a cure. For Yescarta, which has already proven its efficacy in the global market, to secure influence in Korea, three major challenges exist: access, supply, and competing treatments. Among these, entry into the national health insurance system will be the biggest hurdle for expanding access. Regarding this, Santoro said, "Yescarta's reimbursement application was submitted at the end of August, immediately following its domestic approval in Korea. We are currently expediting the submission of all relevant documents and are ready to enter into full-scale discussions with the government," and added, "Gilead and Kite Pharam will focus on improving patient access by collaborating closely with the government, as well as with Korean medical professionals and patient organizations." And added, "We are fully aware of the concerns regarding the drug's price and institutional challenges. During the negotiation process, we plan to present a compelling case about Yescarta's differentiated clinical value as a second-line therapy and how earlier treatment improves patient outcomes and the possibility of a full recovery." "Quickly applying for reimbursement...patient access is the main priority" Another task is the supply issue. Currently, both the reimbursed CAR-T therapy Kymriah and Yescarta require harvesting the patient's cells in Korea, sending them to the U.S. for manufacturing, and then bringing the finished product back to Korea. There is a concern that this process can delay treatment, which is critical for CAR-T patients, and potentially worsen their prognosis. Regarding this, Santoro said, "The speed of supply is the priority for treatment outcomes with CAR-T therapies, so we prioritize it above all else." He added, "Based on the experience accumulated from treating over 31,000 patients worldwide, Gilead and Kite Pharma have achieved a CAR-T therapy manufacturing success rate of over 96%, which is the highest in the industry, and a vein-to-vein (V2V) time that is among the fastest globally." V2V refers to the time from a patient's leukocyte collection to the infusion of the therapy. The company maintains a supply time of less than 30 days in Asia and plans to guarantee the same volume for Korea. He said, "We ensure that the collected cells are not frozen and arrive at the manufacturing site within 72 hours. In the actual supply process, we always secure more than two backup flights to prevent any disruption to patient treatment." He stated, "We know that a difference of even 1-3 days can have a significant impact on a patient's treatment outcome, so our goal is to provide the therapy as quickly as possible." Regarding competition with new options like recently emerged bispecific antibodies, Santoro emphasized, "In most countries, bispecific antibodies are approved as third-line therapies after CAR-T, and the guidelines from major academic societies and institutions also recommend the use of CAR-T therapies in early stages." Aim to Become a Hub for CAR-T Therapy in Asia Santoro views that Yescarta's approval in Korea represents not just a commercial entry but also a significant medical and scientific milestone. He said, "Korea is a competitive country with excellent medical infrastructure and highly skilled medical professionals. The swift approval of Yescarta is expected to bring a positive change to the patient treatment environment, alongside existing anti-cancer drugs." Kite Pharma has a strong history of collaboration with Korea's medical institutions and health authorities, as it highly values Korea's capabilities. Based on this foundation, Kite Pharma has presented a blueprint to develop Korea into a hub for CAR-T therapy in Asia by investing in training medical professionals and strengthening hospital capabilities. Finally, Santoro stated, "The approval of Yescarta as a second-line therapy in Korea is an important starting point that will significantly change the patient treatment environment." He added, "Based on our global experience, we will provide trustworthy and innovative treatment options to Korean patients."
- InterView
- Dong-A ST launches Sterlara biosimilar Imuldosa in the US
- by Cha, Jihyun Aug 20, 2025 06:22am
- Dong-A ST (CEO: Jae-Hoon Jeong) announced on the 19th that the company has launched IMULDOSA (project name DMB-3115, active ingredient ustekinumab), a biosimilar version of Stelara, in the US through its partners, multinational pharmaceutical companies Intas Pharmaceuticals and Accord Biopharma. IMULDOSA is biosimilar version of Janssen’s Stelara that is indicated for the treatment of inflammatory conditions such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Stelara has generated global sales of approximately USD 21.552 billion (IQVIA 2024 cumulative revenue). IMULDOSA has been launched in 14 countries, including Germany, the United Kingdom, and Spain, and has obtained marketing authorization in the MENA region, including Saudi Arabia, Qatar, and the United Arab Emirates. A representative from Dong-A ST stated, “With the launch of IMULDOSA in the United States following its introduction in Europe, our global market expansion is gaining momentum. We will strive to ensure that IMULDOSA becomes an effective treatment option for patients worldwide.” IMULDOSA was jointly developed by Dong-A Socio Holdings and Meiji Seika Pharma since 2013. In July 2020, the rights for development and commercialization were transferred to Dong-A ST to facilitate efficient global project execution, and the two companies have since continued joint development. In July 2021, a global license-out agreement for IMULDOSA was signed with the multinational pharmaceutical company Intas Pharmaceuticals. Intas is commercializing IMULDOSA through its global subsidiaries, including Accord BioPharma in the U.S. and Accord Healthcare in Europe, the UK, and Canada.
- InterView
- V-olet challenges to become a blockbuster fat-destroying inj
- by Nho, Byung Chul Jul 08, 2025 06:36am
- Kim Seul-ki, PM of Daewoong Pharmaceutical Daewoong Pharmaceutical's V-olet Inj, a deoxycolic acid (DCA)-based fat-destroying injectable, is garnering attention as it implements an external expansion strategy to become a global blockbuster drug, following Nabota Inj. Launched in 2021, V-olet Inj is an injectable that demonstrates significant improvement in moderate-to-severe bulging or excessive submental fat in adults through its mechanism of irreversible fat cell destruction and collagen synthesis. It currently holds a 90% market share in the Korean market. Deoxycholic acid (DCA) is a secondary bile acid that emulsifies and breaks down fat in the body. The active ingredient used in V-olet Inj is 100% chemically synthesized DCA, not derived from human or animal sources. Kim Seul-ki, PM of Daewoong Pharmaceutical's Nabota Business Team, stated, "V-olet Inj demonstrated significant submental fat improvement and safety in Koreans through a domestic Phase 3 clinical study." Kim added, "It is currently regarded as the only original product among related products launched in Korea." Notably, 72.1% of V-olet Inj recipients showed significantly higher satisfaction (compared to 25.4% for placebo), and not a single serious adverse event (SAE) occurred. Currently, V-olet Inj's domestic sales are handled by DNC Aesthetics and approximately 500 Daewoong Pharmaceutical sales representatives, and it is highly likely to surpass KRW 10 billion in annual sales soon. Kim stated, "Marketing approval for V-olet Inj was granted in the Philippines, and the company plans to seek approvals and launches in other Asia-Pacific countries, including China, Indonesia, and Thailand. Nabota, a blockbuster drug, is currently marketed in over 80 countries globally, and we are pursuing a product expansion strategy like Nabota." Q&A with Kim Seul-ki, PM, Daewoong Pharmaceutical. -Please introduce yourself. =Hello. I am Kim Seul-ki, overseeing the marketing of Daewoong Pharmaceutical's medical aesthetics pipeline, Nabota, and V-olet Inj. I was solely responsible for the launch of V-olet Inj in 2021, so it has already been five years since its release. -Belkyra was withdrawn from the Korean market, and there was a period without DCA-component products.What was the motivation for Daewoong Pharmaceutical to launch V-olet Inj in 2021? =Daewoong Pharmaceutical strives to develop and market differentiated, high-quality products. I believe DCA fat reduction was one of them. DCA is the only ingredient approved for fat improvement, so its efficacy is not disputed. The problem was that Belkyra was too expensive, which led to its failure in the Korean market. 'PPC (phosphatidylcholine),' which is currently suspended from sale but was previously used, and 'combination contour injections,' which most aesthetic clinics still offer, remain very popular fat-dissolving procedures. We assessed that the obesity market and fat-dissolving market would continue to grow, just as GLP-1 drugs like Wegovy are gaining attention today. As everyone is aware, Daewoong Pharmaceutical has been manufacturing and selling Nabota for over ten years. We believed that Nabota, indicated for wrinkle and muscle hypertrophy improvement, and V-olet Inj, focused on fat improvement, could create good synergy, and that V-olet Inj could establish itself as the next-generation product following Nabota. -V-olet Inj's initial launch reaction was significant, and I understand it quickly revitalized the DCA market in a short period. What's the secret to its rapid market impact? =It's thanks to our efforts to build trust as the first domestically produced DCA injectable. Notably, its approval as the only specialized pharmaceutical for fat improvement, along with its differentiated mechanism of action for fat cell destruction, was well communicated to medical professionals through significant effort. I believe that actively sharing the experiences of medical professionals with extensive clinical experience in the DCA field, and continuously conducting research to build trust, so that medical professionals can use it confidently, has played a significant role. Initially, concerns arose about potential side effects due to the word 'destruction.' Still, by emphasizing and educating on 'proper injection techniques,' many medical professionals are now using it with peace of mind. Additionally, when V-olet Inj was launched, some individuals were using DCA products with cosmetic approval that were not intended for internal body injection. By emphasizing the importance of approved specialized pharmaceuticals even more, those products seem to have largely disappeared now. I believe we played a significant role in changing market perception as well. -With V-olet Inj's success, many competing products are being launched. There are products like Bellacholine, which was launched last year. What are V-olet Inj's unique advantages? =The biggest differentiator is that V-olet Inj has undergone Phase 1-3 clinical studies and post-marketing surveillance (PMS), which current competing products have not. This allowed us to confirm its efficacy and safety in real-world clinical settings. Since DCA is currently the only approved ingredient in the fat-dissolving market, it was important for us to have clinical data to support its more widespread use, similar to toxins or fillers, in Korea. We have results from clinical studies involving over 960 Koreans. Now, in 5th year since launch, we have accumulated tens of thousands of treatment cases, which is another advantage. -It seems there are many more products available now for obesity and body contouring. Considering the mechanistic characteristics of fat-destroying injectables, what differentiates them from other products?. =Body contouring has become much easier thanks to drugs like Wegovy and various EBD (Energy-Based Device) products available today. However, DCA, meaning V-olet Inj, is the only injectable that can precisely target and destroy fat. There are also fat-destroying devices, such as InMode, but it's challenging to predict which fat layer those devices will target. In contrast, V-olet Inj is injected directly into the middle layer of fat, so it can be said to destroy the core of the fat. Additionally, one might worry about skin sagging as fat disappears, but V-olet Inj promotes collagen synthesis, which also improves skin elasticity. Compared to appetite suppressants like GLP-1 drugs, if you've ever tried dieting, you know that even if you lose weight, areas like a double chin or arm fat don't easily go away. V-olet Inj's advantage lies in its ability to target such areas and smoothly sculpt the body precisely. -In addition to submental fat improvement, research on body procedures seems to be active both domestically and internationally. Do you have plans for indication expansion? =V-olet Inj's approved indication is for improving moderate-to-severe bulging or excessive submental fat in adults. However, based on DCA's mechanism of action in improving fat, we conducted case studies with clinical research on various body areas. The results of a study on arm fat (upper arm) improvement using DCA were published in March. We confirmed for the first time in Koreans the effect of improving fat thickness and circumference in the upper arms. Overseas, research using DCA injectables on various fat-containing areas (e.g., jowls, abdomen, flanks, thighs, accessory breasts [axillary fat], under the buttocks, above the knees, "buffalo hump" neck, under-eye fat, lipomas, etc.) is already actively reported. Internally, we are viewing the market demand and potential for indication expansion positively. Currently, we are starting with small-scale studies, such as case studies. Thanks to its fat-destroying mechanism, its expandability seems limitless. -Daewoong Pharmaceutical plays a pioneering role in the domestic DCA market; however, competition is likely to intensify further. As the leading company in the fat-destroying injectable market, what are Daewoong's future aspirations and plans? =As you mentioned, competition in the domestic DCA market will indeed become very fierce. As various competing products emerge, the DCA market itself is expected to grow, which I view as a positive development from a marketer's perspective. V-olet Inj demonstrated trustworthiness in Korea. To help the DCA market grow to the size of the KRW 100 billion toxin market in Korea, as a pioneer of DCA, we plan to continue research on usage methods to help medical professionals utilize V-olet Inj more effectively. Furthermore, through various activities to deliver correct awareness and knowledge about fat improvement procedures to the public, we aim to create a more valuable market.
- InterView
- 'Viatris will lead market with innovation and leadership'
- by Whang, byung-woo Jun 10, 2025 06:04am
- “Viatris Korea is pursuing growth through two pillars: a core brand-focused business and new pipelines. Based on the pillars, we expect to secure growth momentum once again on a global scale.” Viatris Korea is working to strengthen its position in the domestic market by introducing a global innovative pipeline and driving continuous growth with its existing key product portfolio. While striving to maintain its leadership in the chronic disease treatment market with products such as Lipitor, the company is also planning a two-track strategy to add innovation for future growth. Dailypharm met with Bill Schuster, Representative Director & Country Manager of Viatris Korea, who is entering his third year in office, to hear about the company's growth strategy and mid- to long-term plans. Bill Schuster marks third year as CEO: "Organizational culture is key to growth” Since Bill Schuster took office, Viatris Korea has actively pursued changes to improve its organizational culture and strengthen its market response. Bill Schuster, Representative Director & Country Manager of Viatris Korea"In his first year as CEO in 2023, he focused on fostering a voluntary and participatory organizational culture led by employees, forming a task force centered on junior and mid-level managers, and working to redefine the company’s core values and principles of conduct." Schuster described his leadership style as “transformational leadership.” He explained, “I have not only strived to provide direction for our members but also to empower them with motivation and autonomy to achieve our shared vision." He added, "After experiencing the Great East Japan Earthquake, I came to realize the importance of work-life balance. Since then, I have led by example as a leader, fostering a culture that values and promotes work-life balance."’ A notable aspect of this transformation is the hospital-centric “Go-to-Market” strategy, which strengthens market response around Schuster's leadership. “At Viatris, we have delineated roles by focusing on the hospital channel ourselves while assigning our partners to the clinic channel, thereby eliminating redundant sales structures across the two.” He added, “By strengthening key field-oriented functions, we go beyond being just a sales organization and seek to forge strategic partnerships.” As part of such strategy, the company has strengthened collaborations with Jeil Pharmaceutical in the cardiovascular disease treatment sector and with SK Chemical in the pain management treatment sector. He stated, “We have significantly expanded our hospital channel workforce and established a Key Account Management (KAM) system to provide tailored management for major hospitals and distribution channels. Additionally, we are identifying new opportunities with small and medium-sized hospitals through our Sales Account Management (SAM) system.” These efforts align with Viatris Korea's portfolio. While its major therapeutic agents, such as Lipitor, which ranks first in the single-agent market for dyslipidemia, and Norvasc, which ranks first among CCB (calcium channel blocker) class hypertension treatments, hold high market shares, the company is also facing challenges due to the emergence of new treatment options. In response, Schuster emphasized the expansion of the “base business centered on core brands.” He stated, “South Korea has one of the fastest aging populations in the world, so the demand for chronic diseases such as cardiovascular and pain conditions is expected to continue to grow. In response, Viatris plans to carry out initiatives that raise disease awareness and improve treatment access.” This also includes strengthening market responsiveness through artificial intelligence (AI) and digital strategies. Schuster said, “We are preparing a system that leverages AI technology to precisely analyze marketing performance and optimize resource allocation.” He added, “A pilot project is currently underway, with full-scale implementation targeted for 2025.” He added, “We will leverage AI to analyze customer channel preferences and market trends and develop tailored communication strategies to deliver optimal information to both patients and healthcare professionals. In particular, we plan to actively adopt digital healthcare technologies to support more effective disease management for patients, especially in the areas of cardiovascular health and chronic pain.” Viatris Korea secures growth momentum with customized capabilities for new drug launches "In particular, Viatris Korea is laying the foundation for introducing global innovative drug pipelines into the domestic market, with the aim of establishing new growth engines for the future." Notably, the acute pain treatment 'Meloxicam (MR-107A-02)' and the low-dose contraceptive patch 'XULANE LO' have shown positive effects in global Phase III clinical trials, raising expectations. Specifically, Meloxicam is anticipated to arise as a non-opioid alternative and a new first-line treatment option for moderate to severe acute pain. XULANE LO, a low-dose estrogen patch requiring a once-weekly application, is also receiving positive evaluations for its market potential. The company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the second half of 2025. If Viatris Korea maintains its existing core business while introducing new drugs over the next few years, concerns about the sustainability of the company’s long-term growth will be resolved. Schuster emphasized, “While we already possess some of the necessary capabilities, we have determined that this is the time to enhance and expand our internal systems and personnel in preparation for future launches. Therefore, building the capabilities to execute new pipelines over the next few years will be a critical task.” Currently, Viatris Korea has all the core functions, including development, approval, and compliance, and is capable of handling processes such as bridging clinical trials and approval applications with its own capabilities. However, the company plans to nurture a dedicated organization internally to establish launch strategies, secure market recognition, and handle customer communication in preparation for the launch of new drugs. He added, “We aim to become a partner that goes beyond simply importing and selling drugs, and instead works to build a scientific and institutional foundation in Korea in the mid-to long- -term, we will not hesitate to make the necessary investments and collaborations to achieve this.” Finally, he added, “Viatris Korea is committed to sustainable growth in the domestic market and will actively introduce global innovations to contribute to the local healthcare environment. We will continue to fulfill our responsibility as a company that enables patients to lead healthier lives.”
