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- 2026-04-03 23:16:37
- Company
- ‘HIV Is No Longer a Target of Discrimination'
- by Hwang, byoung woo Sep 11, 2025 06:09am
- While advances in antiretroviral drugs have made human immunodeficiency virus (HIV) a manageable chronic disease, experts point out that social awareness remains stagnant. Amid the reality that the suicide risk among infected individuals in Korea is nearly twice as high as among non-infected individuals, academia, patient groups, and industry have joined forces to end the discrimination. Medical professionals, HIV organizations, industry, and academia have united to end discrimination against people living with HIV, launching the ‘RED Period Consultative Body’ and holding a roundtable discussion on the 10th. Professor Beom-sik Chiin of the Infectious Disease Division at the National Medical Center The event featured speakers and panelists from various sectors who highlighted the persistent stigma and prejudice faced by people with HIV despite advances in treatment technology, emphasizing the need for improved awareness and policy support. The RED Period Campaign derives its name from the red ribbon symbolizing AIDS, embodying the meaning of putting an end to prejudice. Professor Beom-sik Chiin of the Infectious Disease Division at the National Medical Center, who presented at the event, emphasized the need for a fundamental shift in perception of the disease under the theme ‘Proposals for Ending Social Prejudice/Stigma in Line with Scientific Advances in the HIV Treatment Environment’. According to Professor Chin, advances in antiretroviral therapy (ART) mean that with early diagnosis and treatment, people living with HIV now have an average life expectancy similar to that of non-infected individuals. When medication suppresses viral activity to the point where HIV is undetectable in blood tests, the risk of transmission to others is also eliminated. This signifies that HIV is now a manageable and preventable chronic disease. However, social perceptions still lag behind scientific progress, hindering the quality of life for people living with HIV. An analysis of five-year mortality rates among individuals diagnosed with HIV in Korea in 2017 revealed that people living with HIV had a 1.84 times higher risk of death by suicide compared to those without HIV. Professor Chin stated, “Letting aside situations like being refused surgery in medical settings, people living with HIV still experience frustration due to HIV. I hope we can put an end to this by educating and promoting that safe medical care is possible if access to post-exposure prophylaxis is strengthened and implemented and promote the availability of financial support measures. He further noted, “Overcoming the deep-rooted stigma associated with the term ‘AIDS’ won't be easy. A starting point could be changing legal terminology, such as replacing ‘AIDS Prevention Act’ with alternative terms in public domains. This could minimize prejudice and stigma within institutional frameworks.” The findings of the ‘2025 National Survey on HIV Awareness,’ conducted by the LGBTQ+ rights organization Sinnaneun Center and Korea Research, were also released at the meeting. This survey, targeting 3,000 people nationwide, consisted of questions regarding ▲ awareness and understanding of HIV disease ▲ quantitative data on social misunderstandings and prejudice ▲ public perception of institutional support programs for HIV. The survey results showed that while 8 out of 10 people had heard of HIV, only 25% demonstrated sufficient awareness to distinguish between HIV and AIDS. Furthermore, only 13% of all respondents believed Korean society holds an open and inclusive attitude toward HIV, while 80% of respondents stated that improving HIV awareness in Korean society is necessary. Notably, 81% agreed on the need for active government policy support to reduce HIV infections. Professor Chin stated, “The most notable aspect of this survey is that members of our society themselves keenly recognize the lack of an open and inclusive attitude toward HIV.” He added, “I am confident that the survey results will serve as a crucial driving force for promoting activities to end prejudice and stigma surrounding HIV, alongside solid support for government policy support.” Following Professor Chin, Professor Jong-hyuk Lee of Kwangwoon University’s Department of Media & Communication introduced the campaign’s purpose and significance, emphasizing the need to build a healthier society by eradicating prejudice. The Red Period Campaign is not a one-off event but a long-term awareness project aimed at eliminating stigma around HIV. The council plans to lead continuous online and offline activities to engage broad sectors of society in collaboration. Finally, Dr. Tae-hyung Kim, Planning Director of the Korean Society for AIDS, said, “The Red Period campaign is a promise to end discrimination and stigma against people with HIV, and to build a society where everyone has equal access to treatment and prevention. HIV is no longer a target of stigma—it is a manageable chronic disease. We hope this message will reach both the public and the medical community, and that our efforts will contribute to Korea’s national goal of reducing new HIV infections by 50% by 2030.”
- Company
- Could Spravato resolve treatment-resistant depression?
- by Hwang, byoung woo Sep 11, 2025 06:09am
- As Korea ranks first in suicide rates among OECD countries, the need for treatment support for ‘treatment-resistant depression’ is being emphasized. Experts stress the need for alternatives in treating treatment-resistant depression, a condition known to have a sevenfold higher risk of suicide attempts compared to general depression. On September 9, to mark World Suicide Prevention Day, Janssen Korea held a Masterclass to share the current state of TRD and the latest treatment insights. Professor Sung-jun Cho of Kangbuk Samsung Hospital’s Department of Psychiatry According to Statistics Korea's ‘2023 Cause of Death Statistics’, 13,978 people died by suicide in 2023. The suicide rate per 100,000 people in 2023 was 27.3, an 8.5% increase compared to 2022. This ranks Korea first among OECD countries in suicide rates, exceeding the OECD average by more than double. Depression is cited as one of the major factors for suicide. Psychological autopsy results from 1,099 suicide deaths over nine years from 2015 to 2023 (MOHW/Korea Foundation for Suicide Prevention, 2023 Psychological Autopsy Interview Results Report) estimated that 86.3% had suffered from mental illness prior to death, with 74.5% identified as having depressive disorder. Among those suspected of having a mental illness, 60.5% had received treatment or counseling for mental health issues before their death. Professor Sung-jun Cho of Kangbuk Samsung Hospital’s Department of Psychiatry noted, “In Korea, we can see that the prevalence of depression has surpassed the one million mark, which is significantly higher than in other countries. Because it is difficult to clearly define the presence or absence of depression, treatment is often challenging.” Major depressive disorder refers to a condition where persistent depressive mood and loss of interest lasting at least two weeks are accompanied by multiple physical symptoms and significant impairment of daily functioning. Among these patients, about 1 in 3 may have TRD, showing no response to various antidepressant treatments. TRD is generally defined as the ‘absence of a clinical response despite administration of at least two oral antidepressants at adequate doses for a sufficient duration.’ Professor Cho stated, “TRD patients incur over 40% more healthcare costs than patients with major depressive disorder. Not only is treatment difficult, but relapse rates are also higher compared to patients with major depressive disorder. Severe patients who struggle to maintain employment may experience a vicious cycle where their economic burden increases.” However, there is currently no universally standardized treatment for TRD. Treatment options for TRD include pharmacotherapy such as antidepressant optimization, switching or combination therapy, and augmentation therapy, as well as procedures like repetitive transcranial magnetic stimulation (rTMS) and electroconvulsive therapy (ECT). However, conventional pharmacotherapy takes time to achieve remission, making it difficult to expect an immediate response to suicidal impulses. Conventional depression treatments take approximately 37 to 51 days to achieve remission, making it easy to miss the golden window for treatment. Furthermore, the remission rate decreases sharply with each treatment failure. Amidst the growing need for rapid and effective treatments for TRD, attention is turning to the role Spravato (esketamine hydrochloride) could play in the field. It is the only drug approved in Korea for treatment-resistant depression. Unlike existing antidepressants targeting serotonin and norepinephrine, Spravato is a novel antidepressant acting on the NMDA receptor. Clinical studies have shown that Spravato produced clinically significant symptom improvement within 24 hours in TRD patients, achieving a 52.5% remission rate after 28 days of treatment. Furthermore, patients who maintained remission after 16 weeks of Spravato treatment saw a 51% reduction in relapse risk when treatment was continued. Professor Cho stated, “After about a month of Spravato treatment—once the induction phase was complete—more than half of the patients not only responded but reached remission. The rapid onset of effect, sometimes as early as the day after administration, is particularly notable.” However, Spravato is known to cost approximately KRW 400,000 per administration as it is not covered by reimbursement. Typically, two doses are administered per treatment session, costing about KRW 800,000 per visit. In the early stages, treatment is usually given twice per week, resulting in a weekly cost of about KRW 1.6 million. This high cost inevitably creates barriers to patient access. Current domestic suicide prevention policies for high-risk groups are limited to supporting treatment costs for injuries resulting from suicide attempts, counseling, and case management for attempters and bereaved families. Professor Cho argues that providing integrated healthcare services extending to practical treatments that can lead to long-term suicide prevention is necessary. Professor Cho stated, “In the clinical setting, there is talk that Spravato could realistically contribute to lowering suicide rates. However, there inevitably exists a cost barrier preventing its actual prescription.” He added, “We are beginning to see changes, such as the Jeonbuk Mental Health Welfare Center’s support program covering Spravato treatment costs for major depressive disorder patients. We need more initiatives like this to ensure continuous, active treatment.
- Company
- Will Balversa make progress toward reimb in Korea this year?
- by Eo, Yun-Ho Sep 10, 2025 06:14am
- Attention is focused on whether progress will be made in the insurance reimbursement listing process for ‘Balversa,’ the first targeted therapy for bladder cancer. According to industry sources, Janssen Korea’s FGFR inhibitor for urothelial carcinoma, Balversa (erdafitinib), passed review by the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service (HIRA) this past May. Discussions are now underway for its submission as an agenda to the Drug Reimbursement Evaluation Committee later this year. The specific indication under review for reimbursement is ‘treatment of adult patients with unresectable locally advanced or metastatic urothelial carcinoma with FGFR3 genetic alterations, whose disease has progressed during or after at least one prior systemic therapy including a PD-1 or PD-L1 inhibitor.’ At the time of its original domestic approval in 2022, Balversa’s indication was,“Treatment of adult patients with locally advanced or metastatic urothelial carcinoma harboring FGFR2 or FGFR3 alterations, whose disease has progressed during or after at least one platinum-based chemotherapy, or within 12 months of receiving neoadjuvant or adjuvant chemotherapy, including platinum-based chemotherapy.” However, immune checkpoint inhibitors targeting PD-1 and PD-L1 have been approved for use in the first- and second-line settings since then, creating a need to demonstrate Balversa’s efficacy in patients pretreated with these agents. This unmet need was addressed by the publication of results of the Phase III THOR trial, which compared Balversa to chemotherapy in patients with FGFR3/2-altered metastatic urothelial carcinoma who had progressed following 1–2 lines of therapy, including immunotherapy. The study demonstrated an overall survival (OS) benefit with Balversa. According to the THOR trial results, during a median follow-up period of 15.9 months, the median overall survival (mOS) in the Balversa treatment group was 12.1 months, representing a 36% reduction in the risk of death compared to 7.8 months in the chemotherapy group. Based on these results, the U.S. FDA approved the conversion of Valbessa's designation to full marketing approval in January, with the approval conditions set under more limited terms than the initial approval. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) also recently recommended expanding Valbessa's indications. Janssen Korea has additionally submitted the THOR study results to the Ministry of Food and Drug Safety (MFDS) in Korea. These developments culminated in the positive opinion from the Cancer Disease Deliberation Committee in May. Whether Balversa will secure reimbursement within the year and become an accessible treatment option for Korean patients remains to be seen. Meanwhile, bladder cancer has been one representative cancer that has had no targeted therapy options available. Balversa became the first targeted anticancer drug for bladder cancer through its novel mechanism that inhibits FGFR (Fibroblast Growth Factor Receptor). FGFR is one of the biological signals involved in cancer cell growth and is associated with multiple cancer types. FGFR alterations are particularly common in bladder cancer, observed in approximately 20-30% of patients.
- Company
- Samsung Biologics signs KRW 1.8T contract deal
- by Chon, Seung-Hyun Sep 10, 2025 06:13am
- Samsung Biologics announced on September 9 that it has signed a Contract Manufacturing Organization (CMO) agreement worth $1.294 billion (approximately KRW 1.800 trillion) with a U.S.-based pharmaceutical company Samsung BiologicsThis contract is the second-largest one in the company's history, following a deal worth approximately KRW 2 trillion with a European pharmaceutical company in January. The contract is set to run until December 31, 2029. The client and product name have not been disclosed due to confidentiality clauses. Samsung Biologics' cumulative contract value for this year has reached KRW 5.2435 trillion. In just eight months, the company has nearly matched its total contract value from last year (KRW 5.4035 trillion). Its total cumulative contract value since its founding has now exceeded $20 billion. Samsung Biologics said, "Even as business uncertainties for the entire bio-industry, such as a global economic slowdown and tariff impacts, continue to grow, our consecutive large-scale contracts once again prove our competitiveness and the market's trust in us." Samsung Biologics is expanding its production capacity to meet the increasing demand for biopharmaceuticals. Its fifth plant, a 180,000-liter production facility that integrates the best practices from plants 1-4, began full-scale operation in April. With this, Samsung Biologics has secured a total production capacity of 784,000 liters, making it the world's largest. Samsung Biologics has obtained a total of 382 manufacturing approvals from major global regulatory agencies in the U.S., Europe, and Japan. The company stated that the number of approvals continues to increase with its expanding production capacity, and its pass rate for regulatory audits remains among the highest in the industry. Samsung Biologics added, "We are continuously expanding our customer base by securing numerous new contracts across the globe this year, including in the U.S., Europe, and Asia, based on our core competitiveness of overwhelming production capacity, quality, and various track records."
- Company
- Will 'Tibsovo' be listed for reimbursement in H2?
- by Eo, Yun-Ho Sep 10, 2025 06:13am
- Product photo of Tibsovo As 'Tibsovo' seeks insurance reimbursement for cholangiocarcinoma, a disease with limited treatment options, attention is being paid to whether it will achieve results in the second half of this year. According to industry sources, Servier's Tibsovo (ivosidenib) is currently under discussion for the review schedule for the Drug Reimbursement Evaluation Committee (DREC). Tibsovo is a targeted cancer drug for cholangiocarcinoma and acute myeloid leukemia (AML), and it has passed the Health Insurance Review & Assessment Service (HIRA)'s Cancer Disease Review Committee. This is the second attempt for Tibsovo to be listed for cholangiocarcinoma indication. Tibsovo's AML indication passed the Cancer Disease Review Committee in October of last year. Tibsovo's indication is specified as follows: If a patient tests positive for IDH1 mutation, Tibsovo can be used as a ▲Monotherapy in patients with locally advanced or metastatic AML who have had prior therapy ▲Combination therapy with 'azacitidine' in adult patients over 75 years with accompanying disease that cannot be treated with chemotherapy. Cholangiocarcinoma is a cancer with a poor prognosis. The five-year relative survival rate is only 28.9%. 65% of the patients with cholangiocarcinoma of the liver are found be non-operable when diagnosed. Tibsovo is the only targeted drug recommended as a Category 1, the highest grade, by the National Comprehensive Cancer Network (NCCN) for a second-line treatment for cholangiocarcinoma. According to ClarlDHy Phase 3 clinical trial, Tibsovo reduced the disease progression by 63% compared to a placebo and had a median progression-free survival (PFS) of 2.7 months (placebo 1.4 months). Also, patients treated with Tibsovo had a median overall survival (OS) of 10.3 months, which was longer over twice than 5.1 months of those treated with a placebo. Meanwhile, in the AGILE Phase 3 trial involving patients with AML, Tibsovo was demonstrated to improve event-free survival (EFS) when combined with azacitidine, and the overall survival (OS) was significantly improved. The patients treated with Tibsovo had a median OS of 24.0 months (placebo 7.9 months). In a long-term follow-up study, the median OS of Tibsovo combination therapy was 29.3 months, over 3.7-fold longer than that of placebo combination therapy. Professor Kyu-Pyo Kim of Asan Medical Center's Department of Oncology said, "Tibsovo is indicated to treat IDH1 mutation-positive cholangiocarcinoma and AML. The efficacy and safety of this drug were confirmed in clinical trials. Notably, considering that both studies have been designed to allow switching regimen, a significant improvement in OS indicates a very meaningful outcome." Professor Kim added, "Since a new targeted drug that is effective for cholangiocarcinoma and AML, diseases with limited treatment options, has emerged, it is expected to contribute to improving treatment outcomes and quality of life in patients with cholangiocarcinoma and AML in Korea."
- Policy
- DREC members’ term extended due to delayed nominations
- by Lee, Tak-Sun Sep 10, 2025 06:13am
- The term of office for members of the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA), which is responsible for the final drug reimbursement adequacy evaluations, has been extended. Although their term was originally scheduled to end on the 7th, the extension was explained as due to delays in the candidate recommendation process for the next committee members. According to HIRA, the terms of both the 9th DREC and its subcommittee members have been extended. The 9th committee began its term on September 8, 2023, and was set to end on September 7, 2025. Each term lasts two years, and the current committee has 75 members in total. Accordingly, HIRA has been accepting nominations for candidates for the 10th-term DREC from various organizations since last month. DREC members are appointed based on recommendations from academic societies and organizations, with medical and pharmaceutical-related professional societies recommending around 70 members. The Korean Pharmaceutical Association can recommend one expert. However, due to delays in candidate recommendations, the composition of the 10th DREC could not be completed before the expiration of the 9th DREC's term. Consequently, the terms of the 9th DREC members have been extended. DREC’s operating regulations also stipulate that members whose terms have expired shall continue to perform their duties until their successors are appointed. HIRA explained that it plans to promptly finalize the recommendation process and complete the composition of the 10th committee. It maintains that there will be no changes to the DREC's schedule. The next DREC meeting is scheduled for October 2nd, which is likely to be attended by the existing 9th committee members. Once the 10th committee is formed, its subcommittees—including those for reimbursement standards, pharmacoeconomic evaluation, risk-sharing agreement, budget impact assessment, herbal medicines, and post-listing evaluation—will also be reconstituted. The DREC generally consists of around 105 members. The 31 medical societies eligible to recommend candidates include the Korean Society of Cardiology, Korean Society of Gastroenterology, Korean Academy of Tuberculosis and Respiratory Diseases, Korean Endocrine Society, Korean Pediatric Society, Korean Neurological Association, Korean Neuropsychiatric Association, Korean Surgical Society, Korean Cancer Association, Korean Academy of Family Medicine, Korean Dermatological Association, Korean Urological Association, Korean Ophthalmological Society, Korean Society of Otorhinolaryngology – Head and Neck Surgery, Korean Association for the Study of the Liver, Korean Diabetes Association, Korean Society of Nuclear Medicine, Korean Society of Infectious Diseases, Korean College of Rheumatology, Korean Society for Transplantation, Korean Society of Hematology, Korean Association for Lung Cancer, Korean Breast Cancer Society, Korean Gastric Cancer Association, Korean Society of Gynecologic Oncology, Korean Society of Pediatric Hematology-Oncology, Korean Urological Oncology Society, Korean Orthopedic Association, Korean Society of Coloproctology, Korean Society of Medical Oncology, and Korean Society of Surgical Oncology. At each monthly meeting, 20 committee members are randomly selected to participate. In July, HIRA revised its regulations, granting the HIRA President the authority to appoint the committee chairperson and to determine the composition of subcommittees and appoint subcommittee chairs. HIRA explained this as a measure to enhance the effectiveness of the DREC's composition and operation. However, some in the industry have expressed concerns that this could undermine the committee's fairness and neutrality.
- Company
- Early diagnosis and personalized therapy are key
- by Son, Hyung Min Sep 10, 2025 06:12am
- Hong-Ki Min, Division of Rheumatology, Konkuk University Medical Center “The treatment options for rheumatoid arthritis (RA) have become far more diverse than in the past. Contrary to the past when management focused primarily on alleviating symptoms, today, with early diagnosis and tailored treatment strategies, it is possible to maintain long-term remission. Patients can now continue their daily lives with fewer limitations, marking a major paradigm shift in their care.” This was the assessment shared by Professor Hong-Ki Min of Konkuk University Medical Center’s Division of Rheumatology in a recent interview with Dailypharm. Rheumatoid arthritis is a common autoimmune disease diagnosed in Korea, where the immune system attacks the joints, causing inflammation that often begins in small joints such as the wrists and fingers, and may progress to larger joints throughout the body, such as the knees and ankles. In its early stages, it is often mistaken for simple joint pain and neglected. However, missing the optimal treatment window can lead to joint deformity and loss of function, significantly restricting daily life. Furthermore, the risk of systemic complications like cardiovascular and pulmonary diseases increases, classifying it as a systemic disease beyond a simple joint disorder. The cornerstone of RA treatment is pharmacotherapy, including disease-modifying antirheumatic drugs (DMARDs) such as methotrexate (MTX). Professor Min explained, “During treatment, it is crucial to monitor not only inflammation suppression but also long-term side effects, infections, and the occurrence of cardiovascular disease. Depending on the patient’s needs, therapy may be switched to biologics or Janus kinase (JAK) inhibitors.” Currently, various treatment options for rheumatoid arthritis have emerged, including not only immunosuppressants but also biologics and JAK inhibitors. Notably, JAK inhibitors like Eisai’s Jyseleca and AbbVie’s Rinvoq have gained attention because they are oral therapies, offering an alternative to injections and significantly improving convenience. Professor Min stated, “JAK inhibitors are evaluated as being equivalent to biologics in terms of efficacy. They represent an important alternative for patients with significant aversion to injections.” “Cross-switching between JAK inhibitors now permitted... expanding treatment options” Previously, patients who switched from biologics to a JAK inhibitor and failed to respond had no choice but to return to biologics, as switching between different JAK inhibitors was not permitted under Korea’s reimbursement regulations. However, following advocacy by physicians and the Korean College of Rheumatology and patient requests, the government approved reimbursement for switching between JAK inhibitors as of December 2023. This has reduced the burden associated with switching between biologics to JAK inhibitors. Professor Min explained that while the expansion of treatment options enables personalized therapy, institutional limitations still exist. Under Korea's health insurance system, switching to a specific drug requires at least six months of use. Even if the effect is insufficient, maintaining the drug for that period is necessary before switching to another option. Professor Min stated, “The rheumatoid arthritis treatment environment has significantly improved compared to the past. New drugs with diverse mechanisms have emerged, and treatment strategies have become more specialized, leading to an increase in patients maintaining remission for extended periods.” He added, “This can be particularly challenging for patients who show resistance to multiple drugs. Some patients cannot revert to their previous medication even if the effect diminishes after switching, leaving physicians in a difficult position.” With treatment options becoming diversified and personalized care made possible, early diagnosis has become more important than ever. Because RA directly attacks the joints, failure to diagnose and treat early can lead to irreversible joint deformities and functional impairment. The Korean College of Rheumatology is running a nationwide campaign under the theme “Early Diagnosis, Specialist Care.” This goes beyond a simple recommendation for medical care and is an academic-level message aimed at preventing long-term complications and preserving patients' quality of life. Professor Min concluded, “RA patients who are not treated in time risk joint damage, deformity, and disability, which significantly reduce quality of life. But today, with more therapeutic options available, patients should not lose hope. With regular specialist care, patients can fully maintain their daily social activities.”
- 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."
- Company
- Launch of K-new drugs in the Chinese market is accelerated
- by Chon, Seung-Hyun Sep 10, 2025 06:12am
- New drugs developed in Korea are successively entering the Chinese market. Based on their commercial success in the Korean market, new P-CAB (Potassium-Competitive Acid Blocker) drugs for gastroesophageal reflux disease are quickly entering the approximately KRW 3 trillion-worth Chinese market. Fexuclue has become the second P-CAB to enter the Chinese market after K-CAB. Zaqubo is also in the approval process. Improvement is expected in the massive pharmaceutical trade deficit with China, which has exceeded KRW 5 trillion over the past 10 years. Fexuclue Launches in the Chinese Market, following K-CAB...Zaqubo Also Enters Approval Process According to industry sources on September 8, Daewoong Pharmaceutical received product approval for Fexuclue 40mg from China's National Medical Products Administration (NMPA) on September 5. Fexuclue obtained approval in China for the treatment of gastroesophageal reflux disease. Daewoong Pharmaceutical applied for Fexuclue approval in China in June 2023, and obtained the product approval in two years. Fexuclue is a 'P-CAB' gastroesophageal reflux disease treatment developed by Daewoong Pharmaceutical. It was approved as the 34th domestically developed new drug in December 2021. Fexuclue is a new Korean drug that Daewoong Pharmaceutical successfully developed with proprietary technology over 13 years, starting in 2008. P-CAB anti-ulcer drugs work by competitively binding to the proton pump and potassium ions, which are located in the final stage of acid secretion in parietal cells, thereby inhibiting gastric acid secretion. P-CAB new drugs have proven their commercial value in Korea by proven advantages such as a faster onset of action and the ability to be taken regardless of meals, unlike conventional PPI (Proton Pump Inhibitor) class products. According to global market research firm IMS data, the size of China's anti-ulcer drug market is approximately KRW 3 trillion, making it the largest in the world. With its 1.4 billion population adopting more Westernized dietary habits, the number of gastroesophageal reflux disease patients is rapidly increasing, and treatment demand is expected to expand. Daewoong Pharmaceutical projected, "Fexuclue is expected to rapidly increase market share in the Chinese anti-ulcer drug market by improving upon the drawbacks of existing PPIs, such as slow onset of action, short half-life, and the need for pre-meal administration." Fexuclue is highly regarded for its long half-life, which enables sustained acid suppression and provides excellent relief for nocturnal heartburn. Among drugs in the same class, Fexuclue is the only one to have clinically proven its effect in 'alleviating chronic cough' caused by acid reflux. Daewoong Pharmaceutical has set the second half of 2026 as the goal for Fexuclue's launch. The company plans to deploy a full-scale market entry strategy that reflects the characteristics and demand of the local Chinese market. Park Seong-soo, CEO of Daewoong Pharmaceutical, said, "This Chinese product approval will be a very important turning point for Fexuclue's leap to becoming a global blockbuster drug." Park added, "We will strive to ensure that Fexuclue becomes the most trusted treatment option for patients and medical professionals in China, the world's largest anti-ulcer drug market." Fexuclue is the second Korea-developed new P-CAB drug to enter the Chinese market, following K-CAB. In April 2022, HK inno.N's K-CAB was approved in China for the treatment of erosive esophagitis. The local product name was decided as 'Taisinzan (泰欣赞),' meaning 'carrying great joy.' HK inno.N pursued K-CAB's overseas expansion in 2015 by signing a technology export agreement with Chinese pharmaceutical company Luoxin Group and passed the Chinese hurdle in seven years. The agreement with Luoxin Group includes a total of $18.5 million in milestone payments based on upfront payment, clinical development, approval, and commercialization stages. K-CAB has been approved for three indications in China: erosive esophagitis, duodenal ulcer, and Helicobacter pylori eradication therapy. Since January of this year, K-CAB's scope of reimbursement has been expanded with the addition of the duodenal ulcer indication to the China's National Reimbursement Drug List (NRDL). Product photo of K-CAB (left) and Zaqubo (right) Onconic Therapeutics, a subsidiary of Jeil Pharmaceutical, is also accelerating the entry of its new P-CAB drug, Zaqubo, into the Chinese market. In March 2023, Onconic Therapeutics signed a technology export agreement for Zaqubo with Chinese pharmaceutical company Livzon Pharmaceutical Group. The contract value is up to $127.5 million. Onconic Therapeutics received a non-refundable upfront payment of $15 million and is set to receive up to $112.5 million in technology fees based on development, approval, and commercialization milestones. Livzon Pharmaceutical Group began patient dosing for Zaqubo's Chinese Phase 3 clinical trial at the end of last year and successfully completed the trial last month, submitting a product approval application to the China's National Medical Products Administration. Expectations are high for the success of Korea-developed new P-CAB drugs in the Chinese market, building on their commercial success in the Korean market. In the Korean market, K-CAB's prescription sales surpassed KRW 100 billion in 2021, its third year since launch, and has recorded over KRW 100 billion in prescription sales for four consecutive years. In the first half of this year, its prescription sales increased by 14.0% year-on-year to KRW 104.7 billion, possibly leading to an annual prescription sales of KRW 200 billion. Fexuclue, launched in Korea in July 2022, recorded KRW 12.9 billion in prescription sales in its first year, and its sales soared over six times in two years, reaching KRW 78.8 billion last year. Its prescription amount in the first half of this year was KRW 43.2 billion, a 22.5% increase from the same period last year. Zaqubo, which entered the prescription market in earnest after receiving health insurance reimbursement in October of last year, recorded KRW 17.2 billion in outpatient prescription sales in the first half of this year. Last year's pharmaceutical trade deficit with China amounted to KRW 630B...Expectation for improving 'deficit of KRW 5T over 10 years' If Korea-developed new P-CAB drugs achieve commercial success in China, an improvement in the trade balance with China is also expected. The performance of Korean companies' pharmaceuticals in the Chinese market has been low. According to the Ministry of Food and Drug Safety, the value of pharmaceutical exports to China last year was $407.27 million, less than half of the import value of $865.61 million. Last year's pharmaceutical trade deficit with China amounted to $457.34 million (approximately KRW 630 billion). Pharmaceutical Exports and Imports to China (unit: $1,000, source: MFDS). Light Blue-Exports, Blue-Imports Over the past 10 years, from 2015 to last year, the total pharmaceutical trade deficit with China reached $3.66939 billion (approximately KRW 5.1 trillion). The pharmaceutical trade deficit with China expanded by $115.78 million over the past 10 years, from $341.56 million in 2014. During this period, pharmaceutical exports to China increased by $299.88 million, from $107.39 million to $407.27 million. However, imports increased by a significantly larger amount, $415.67 million, from $448.94 million to $864.61 million. This sluggish performance in exporting finished pharmaceutical products from Korea, coupled with the accelerated penetration of Chinese raw materials into the Korean market, is identified as a key factor in the worsening trade balance. Last year, the value of finished pharmaceutical product exports to China was $138.98 million. While this represents a 59.7% increase over 10 years from $87.01 million in 2014, it is a 45.8% decrease compared to the $256.44 million recorded in 2020. The slow progress of Korean companies in the Chinese market is pointed out as a reason for the worsening trade balance. In contrast, imports of Chinese active pharmaceutical ingredients (APIs) reached $816.32 million last year, a 110.2% jump from $388.31 million 10 years ago. Finished pharmaceutical product exports to China (unit: $1,000, source: MFDS) The continuous increase in imports from China is analyzed to be due to Korean pharmaceutical companies' preference for cheaper imported APIs for cost reduction. In 2014, China was the 6th largest country of origin for pharmaceutical imports, but it has now jumped to the 3rd position last year. In 2014, China was the second-largest country in terms of pharmaceutical exports, following Japan, but it fell to 9th place last year. An industry official said, "The continuous decrease in the cost structure of finished pharmaceutical products due to the government's sustained drug price reduction policy inevitably leads to a higher demand for cheaper imported APIs for cost reduction," and added, "If Korean companies' efforts into entering the Chinese finished pharmaceutical product market are initiated, an improvement in the trade balance can be expected."
- Company
- KIPO, IPTAB to introduce ‘advance invalidation notice’
- by Hwang, byoung woo Sep 09, 2025 06:13am
- The Korean Intellectual Property Office (KIPO) and the Intellectual Property Trial and Appeal Board (IPTAB) announced a reform plan introducing a pre-announcement system for invalidation decisions (“advance invalidation notice”) in patent invalidation trials, dividing opinions within the pharmaceutical industry. Led by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), the domestic pharmaceutical companies expressed concern that this system could inadvertently delay the launch of domestic generic drugs, hindering market competition. Conversely, the Korean Research-based Pharmaceutical Industry Association (KPBMA), led by multinational pharmaceutical companies, welcomes the change, viewing it as a positive step toward strengthening patent holders' defense rights. Amid these conflicting views, IPTAB recently held an industry meeting to hear the pharmaceutical sector's concerns and is considering supplementary measures, including new exception clauses. Notably, it is considering exceptions for the link between drug approvals and patents. Patent trials to institutionalize additional correction opportunities, pharmaceutical industry on high alert In April, KIPO and IPTAB introduced improvements to the ‘advance invalidation notice’ system. This procedure informs parties in advance of the final decision outcome, aiming to strengthen patent holders' defense rights by granting them one more opportunity for correction (patent amendment). By ensuring patent holders sufficient time to defend themselves during the trial process, the reliability and stability of patents will be enhanced. KIPO emphasized that this change will “contribute to creating ‘premium patents’ that enjoy broad exclusive rights for high-value innovative technologies, with clear rights that are also effective against third parties.” In current practice, when a patent is ruled invalid, the patent holder has to separately file a lawsuit to overturn the decision or request a correction trial afterward. However, under the new system, if the trial division finds grounds to invalidate the patent, it will not immediately finalize the decision but will instead issue a prior notice stating it ‘will issue an invalidation decision’. Upon receiving this notice, the patent holder gains an additional opportunity to supplement the patent through a correction request within a specified period. In essence, it offers one more chance to save the patent. This is interpreted as part of the recently emphasized policy to foster premium patents, an effort to protect high-quality patents and support the technological competitiveness of domestic companies. The IPTAB also stated it will enhance the burden of proof for petitioners and improve procedural aspects like strict adherence to evidence submission deadlines, aiming to operate patent disputes more transparently and predictably. Domestic pharmaceutical companies express concern, “Generic launch delays... may be disadvantageous when obtaining first patent exclusivity ” The system for notifying patent invalidation decisions is not going to be implemented by the industry sector. However, while the domestic pharmaceutical industry agrees with the system's intent, it maintains that the unique characteristics of the pharmaceutical sector must be considered. Particularly, it is pointed out that if this system interacts with the drug approval-patent linkage system, it could cause critical delays for domestic pharmaceutical companies (generic manufacturers). Under the current approval-patent linkage system, the first generic company to successfully challenge a patent is granted a 9-month exclusive marketing authorization right (first generic exclusivity). However, during the patent dispute, the original drug’s company can apply for a sales ban to block the generic's launch for up to 9 months. If the generic company obtains a favorable ruling, such as patent invalidation, within the 9-month period, the sales ban is immediately lifted, allowing the early launch of generics. However, if no favorable ruling is obtained, the generic company must wait up to 9 months until the ban is lifted. Domestic firms believe that an advance invalidation notice may critically affect this timing. The original drug’s companies may amend patents at the last moment to avoid invalidation, which could rob generic drug manufacturers of their exclusivity, delay market entry by up to a year, and allow originals to maintain higher drug prices longer. The head of the patent team at domestic pharmaceutical company A pointed out, “This system could create an unreasonable situation where a generic drug that could have been approved and sold immediately ends up being released a year later. There is also the potential for some original drug companies to exploit this to maintain their drug prices for an extra year.” Such concerns were raised at an explanatory session held by IPTAB with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, leading to additional discussions. Domestic companies also raise concerns about the fairness of the system's application. This is because the advance invalidation notice system is highly likely to effectively favor multinational pharmaceutical companies. They argue that while domestic pharmaceutical companies hold fewer patents and have grown through generic patent challenges, multinational pharmaceutical companies hold numerous new drug patents in Korea. An industry insider stated, “While we agree with the intent, if implemented without exception clauses considering the unique characteristics of the pharmaceutical and biotech industry, domestic companies could be at a relative disadvantage.” Multinational pharmaceutical companies, “Expanded opportunity to amend patents... Expect it to enhance rights protection” Global pharmaceutical companies are welcoming the move. According to KRPIA, which represents multinational pharmaceutical companies, the introduction of the advance invalidation notice system is viewed as a positive measure that further strengthens the patent holder's right to defend. KRPIA assessed, “Receiving advance notice of the decision and being granted an additional opportunity for correction can clearly work to the patent holder's advantage.” Under the current Patent Act, opportunities for amendment requests are limited, mostly only possible during the early stages of invalidation trials (such as when submitting the first response). Consequently, there have been cases where patents were invalidated because amendments couldn't be made when clear issues emerged later in the proceedings. In such cases, patent holders were forced to bear the cost and time burden of filing a lawsuit to overturn the decision and separately requesting a correction trial. The introduction of the advance notice system would allow them to rectify the situation immediately during the trial stage through additional corrections, making the process more efficient. A KRPIA official stated, “Even a single opportunity for additional amendments could become a highly significant strategic option for patent holders in their defense. Receiving advance notice of the anticipated decision from the IPTAB to prepare tailored amendments will also substantially aid in protecting rights.” However, multinational companies also anticipate that the effectiveness will vary depending on the detailed design of the system. KRPIA stated, “We must await the final system design to judge, but if the structure provides an additional unconditional amendment opportunity after the anticipated decision notice, it is highly likely to positively impact patent holder rights protection. The precise effect can only be assessed upon reviewing the specific details of the system design to be released later.” IPTAB shares concerns with the pharmaceutical industry...reviews supplementary measures The IPTAB stated it is discussing the creation of new exception clauses as a supplementary measure to address concerns from the domestic pharmaceutical industry. In response to Dailypharm's inquiry regarding this matter, the IPTAB’s Adjudication Policy Division stated, “We have internally discussed measures to provide exceptions to prevent domestic pharmaceutical companies from suffering disadvantages.” Specifically, it is reviewing a proviso clause that would allow the omission of the advance notice-and-hearing procedure for invalidation trials related to the Ministry of Food and Drug Safety's approval-patent linkage system. Given that swift rulings are particularly crucial in pharmaceutical patent disputes, the plan is to allow the trial division to issue a ruling immediately without the notice procedure upon request by interested parties, after assessing the nature of the case. The IPTAB stated that it plans to explicitly include these details in the upcoming Patent Act amendment. If such an exception clause is introduced, the procedure for issuing immediate decisions will be maintained in patent disputes that could affect the future launch of generic drugs, as was previously the case. An IPTAB official emphasized, “We will ensure the intent established by other statutes is not undermined,” stressing that the implementation of the notice system will be harmoniously designed so as not to undermine the principle of concluding trials under the approval-patent linkage system within 9 months. In practice, the MFDS and the IPTAB have long operated systems like advance trials to harmonize generic drug approvals and patent disputes. This time, they are expected to refine the scope and requirements for applying exceptions through inter-agency consultations. The IPTAB official added, “We will supplement the system by reflecting field feedback, but we will find a balance point that does not derail the system's implementation itself.”
