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- 2025-12-18 08:26:01
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- RED Period Campaign successfully concludes to end HIV stigma
- by Son, Hyung Min Nov 20, 2025 06:14am
- Participants in the RED Preiod Campaign The RED Period Council (RED Council), a joint initiative among academia, patient advocacy groups, and industry aimed at ending stigma and discrimination against HIV, announced that it successfully held the “Red Period Campaign – Citizen Participation Event” at Cheonggye Plaza in Seoul on the 17th. Since the first reported cases over 40 years ago, HIV (Human Immunodeficiency Virus) treatment has progressed dramatically. Today, with consistent medication adherence and regular care, HIV can be managed like other chronic conditions, such as diabetes or hypertension. However, despite these scientific advances in treatment and prevention, people living with HIV and key populations still face significant barriers due to persistent misconceptions, social stigma, and discrimination. To mark World AIDS Day (December 1), the council hosted this public event to deliver accurate information and break down prejudices surrounding the disease. During the event, representatives of the council, including Prof. Beom-Sik Chin (Infectious Diseases, National Medical Center), Seok-Soo Son (President, KNP+), Seung-Hwan Kim (Executive Director, Sinanun Center), Jong-Hyuk Lee (Director, Public Communication Research Institute), and Jae Yeon Choi (General Manager, Gilead Sciences Korea), took the stage to reaffirm their commitment to eliminating HIV-related stigma and discrimination. Participants also read aloud messages of encouragement submitted through the Naver Happy Bean Good Action campaign page, which has been active since October, and urged continued public participation in the RED Period Campaign The event featured several programs, including ▲a calligraphy performance by artist So-Young Kim interpreting the campaign’s core messages, ▲a video highlighting the campaign’s meaning from the perspectives of people living with HIV, supportive video messages from actors, and ▲a celebratory performance by singer Seung Yeon Son delivering messages of hope and comfort. TV personality Seok-Cheon Hong, long recognized for his advocacy on LGBTQ+ and HIV-related human rights issues, hosted the event. Ambassador Philippe Lafortune of the Embassy of Canada to the Republic of Korea, Seung-kwan Im (Commissioner, Korea Disease Control and Prevention Agency), Sun-Hee Lee (President, The Korean Society for AIDS), and Jae Yeon Choi (GM, Gilead Korea) also offered welcome remarks in support of the campaign. Many citizens are participating in various participatory programs held at Cheonggye Plaza to end HIV discrimination and prejudice. Additionally, the ‘HIV Stigma and Bias Elimination Experience Zone’ set up throughout Cheonggye Plaza offered various programs to help citizens improve their accurate understanding and awareness of the disease. Citizens learned accurate disease information by physically breaking apart and reassembling a large puzzle featuring discriminatory and prejudiced statements about HIV. Additionally, they participated in activities like taking photos, pledging support for the RED Period Campaign, writing messages of encouragement, and joining together to place full stops, contributing to the movement for improved HIV awareness and solidarity. Prof. Beom-Sik Chin of the Department of Infectious Diseases at National Medical Center said, HIV is no longer a fatal acute infection but a manageable chronic disease. As treatment has advanced, eliminating stigma-driven declines in quality of life among people living with HIV must be addressed urgently. The medical community will continue to play an active role in ending HIV-related discrimination and prejudice.” Jae Yeon Choi, General Manager of Gilead Sciences Korea, said, “Gilead is leading scientific innovation and improving access to care in the treatment of HIV, one of the world's most deadly diseases. The RED Period Campaign will be a crucial turning point in reducing new infections and ultimately ending HIV transmission. Gilead Korea will spare no effort in supporting this journey.” Includes the Korean Society for AIDS, Hamkke-Seo-Bom Foundation, KNP+, Love for One, Shinnaneun Center, Public Communication Research Institute, and Gilead Sciences Korea. Since its launch in September, the council has focused on improving awareness, strengthening treatment and prevention environments, and driving institutional and policy advancement with the long-term goal of reducing new HIV infections by 50%.
- Company
- Remsima-Onbevzi compete for No.1 rank in the biosimilar mkt
- by Chon, Seung-Hyun Nov 19, 2025 06:10am
- Celltrion's Remsima and Samsung Bioepis' Onbevzi are fiercely competing for the top spot in the Korean biosimilar market. Remsima has now surpassed Onbevzi's sales after nine quarters, following its previous lead in Q4 of last year. Both Remsima and Onbevzi generate quarterly revenues exceeding KRW 10 billion, proving the commercial viability of domestically developed biosimilars. The entry of traditional pharmaceutical companies into the sales of these biosimilars is attributed to the stable market growth. According to the Financial Supervisory Service on November 17, Celltrion's Remsima recorded sales of KRW 12.5 billion in the third quarter, up 11.5% year on year. Remsima surpassed Onbevzi's sales of KRW 10.5 billion by KRW 2 billion, marking the highest domestic revenue among domestically developed biosimilars. This record is based on sales figures disclosed by Celltrion Pharm and Boryung, the companies selling biosimilars from Celltrion and Samsung Bioepis, respectively. Quarterly sales of major domestically-developed biosimilars. ORANGE-Remsima, BLUE-Onbevzi, GREEN-Herzuma (unit: KRW 1 million, source: Financial Supervisory Service) Remsima is a biosimilar of Remicade, the treatment for autoimmune diseases. It was approved in 2012 as the first domestically developed antibody biosimilar and is used to treat Crohn's disease, ankylosing spondylitis, ulcerative colitis, and rheumatoid arthritis. Onbevzi is a biosimilar of the anti-cancer drug Avastin. It is used for metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, glioblastoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical cancer. This is the first time in three quarters, since Q4 of last year, that Remsima has surpassed Onbevzi's sales. Remsima led Onbevzi by KRW 1.6 billion in Q4 of last year, with KRW 12.1 billion in sales. However, Onbevzi took the lead in Q1 of this year with KRW 10.9 billion, surpassing Remsima by KRW 1.7 billion. Q2 sales of Onbevzi exceeded those of Remsima by KRW 700 million. Remsima had maintained the sales lead among domestically developed biosimilars for 10 years after its launch. Onbevz first surpassed Remsima in Q1 2023 with KRW 9.2 billion in sales, leading by KRW 1 billion. Remsima retook the lead in Q2 2023 with KRW 13.4 billion, surpassing Onbevz by KRW 3.3 billion, but then conceded the lead to Onbevz from Q3 2023 to Q3 of last year, with sales between KRW 8 billion and KRW 9 billion. Since then, Remsima and Onbevz have repeatedly traded the lead. Sales have reversed a total of five times between Remsima and Onbevz over the past three years since 2023. Onbevzi became a stable cash cow, recording sales of over KRW 10 billion for 10 consecutive quarters since first crossing the KRW 10 billion mark in Q2 2023. However, Onbevzi's growth has slowed slightly since recording KRW 11.7 billion in sales in Q2 of last year. After declining to KRW 11.5 billion in Q3 and KRW 10.6 billion in Q4 of last year, it rebounded to KRW 10.9 billion in Q1 of this year, but its sales in Q2 and Q3 slightly decreased from the previous quarter. In the Avastin market, Samsung Bioepis launched Onbevzi in September 2021, followed by Celltrion and Alvogen Korea. Onbevzi, the first biosimilar to enter the market, was equipped with a customized sales force, thereby maximizing its synergy. Samsung Bioepis signed an exclusive domestic sales agreement with Boryung immediately after Onbevzi's approval in South Korea. Boryung is a domestic company with strengths in oncology. Onbevzi's cumulative sales for the first three quarters were KRW 31.7 billion, a 8.4% year-on-year decrease, but it still led Remsima's sales of KRW 31.3 billion by KRW 400 million. Remsima's cumulative sales for the first three quarters decreased by 1.5% from the previous year. Celltrion's Herzuma, a biosimilar of the anti-cancer drug Herceptin, followed Onbevz and Remsima, recording KRW 4.3 billion in Q3 sales, a 21.0% decrease year-on-year. Herzuma's cumulative sales for the first three quarters totaled KRW 15.7 billion, a 1.6% year-on-year decrease. Recently, traditional pharmaceutical companies have entered the biosimilar market. Domestic biotech companies have successfully commercialized 26 biosimilar products across 15 markets. Domestic companies began actively entering the biosimilar market when Celltrion received approval for Remsima in 2012. Celltrion has received MFDS approval for biosimilars targeting Herceptin, MabThera, Humira, Avastin, Eylea, Stelara, Xolair, Prolia, Xgeva, and Actemra. Samsung Bioepis received approval for Etoloce, its first biosimilar product, in 2015. The original drug for Etoloce is Enbrel. Samsung Bioepis has successfully commercialized biosimilars targeting Remicade, Humira, Herceptin, Avastin, Lucentis, Soliris, Eylea, Stelara, Prolia, and Xgeva. LG Chem received approval for Eucept, an Enbrel biosimilar, in 2018 and a Humira biosimilar in 2023. Chong Kun Dang launched biosimilars in the Nesp and Lucentis markets. Samsung Bioepis initially launched the Enbrel biosimilar Etoloce in 2015 and the Remicade biosimilar Remaloce in 2016 through MSD Korea, but transferred the domestic rights for both products to Yuhan in 2017. Yuhan also secured the rights for Samsung Bioepis' Humira biosimilar, Adaloce, in 2021. However, since March of last year, Samsung Bioepis newly established its own sales organization and began direct sales of three autoimmune disease treatments. Samsung Bioepis selected Daewoong Pharmaceutical as its sales partner for Samfenet in 2017, but replaced the partnering company with Boryung in 2021. In 2021, it signed an exclusive domestic sales agreement with Boryung immediately after the domestic approval of the Avastin biosimilar, Onbevzi. Samsung Bioepis chose Samil Pharm as its sales partner for the ophthalmology treatments Lucentis and Eylea biosimilars. Samsung Bioepis selected Hanmi Pharmaceutical as its sales partner for the Prolia biosimilar, Obodence. Prolia, developed by Amgen, works by inhibiting bone resorption and increasing bone density by suppressing osteoclast activity (cells that break down bone). It prevents bone loss and reduces fracture risk in postmenopausal women, suppresses bone metastasis, and protects bone structure, reducing complications in cancer patients. Samsung Bioepis, as the developer of the Prolia biosimilar, is responsible for product production and supply, while both companies jointly handle marketing and sales activities. Daewoong Pharmaceutical entered a co-promotion and distribution agreement with Celltrion Pharm and began domestic sales of Celltrion's Prolia biosimilar, Stoboclo. Daewoong Pharmaceutical jointly sells Stoboclo with Celltrion Pharm in general hospitals and clinics nationwide. Celltrion previously sold its biosimilars in the domestic market through its affiliate, Celltrion Pharm. Stoboclo is the first Celltrion biosimilar sold by a pharmaceutical company other than Celltrion Pharm. Daewoong Pharmaceutical also joined LG Chem's sales effort for its Humira biosimilar, Xelenka.
- Company
- Leqvio may reshape the mkt for statin-intolerant patients
- by Eo, Yun-Ho Nov 19, 2025 06:09am
- Leqvio, the dyslipidemia treatment administered once every six months, is rapidly expanding its presence by targeting niche patient segments. The treatment is gaining traction, particularly among patients with statin intolerance, those with a family history of dyslipidemia, and those who prefer a biannual, physician-administered injection schedule. Novartis Korea’s Leqvio (inclisiran) is the first-in-class siRNA therapy approved in Korea. It received domestic approval in June 2024 as an adjunct to diet for patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) or mixed dyslipidemia. Leveraging naturally occurring siRNA mechanisms, Leqvio inhibits the production of PCSK9, a protein that increases LDL cholesterol, thereby reducing circulating LDL-C levels. A key advantage is its twice-yearly administration by healthcare professionals, which removes the burden and fear associated with self-injection. Experts note that Leqvio’s introduction brings more than just improved convenience. Professor Young Bin Song of the Department of Cardiology at Samsung Medical Center said, "Leqvio effectively lowers LDL-C with just two injections per year, fundamentally changing the strategy of lipid-lowering therapy (LLT). Maintaining lowered LDL-C levels over the long term plays a crucial role in reducing cardiovascular disease risk. Therefore, the 6-month dosing interval offers value that goes beyond convenience.” Leqvio specifically targets patients with statin intolerance, addressing the unmet need in the existing dyslipidemia treatment market dominated by statins. Currently, 39% of Korean patients with high cholesterol levels do not use lipid-lowering drugs, which inevitably increases their risk of cardiovascular disease. Professor Song said, “High-intensity statins, the first-line LLT, require daily administration. Unfortunately, patient adherence rates are not high. Discontinuation often occurs due to adverse reactions like liver or kidney function impairment, muscle pain, or daily inconvenience from muscle pain, creating challenges in lipid management.” Meanwhile, the results of the V-DIFFERENCE study, a Phase 4 clinical trial evaluating the LDL-C target achievement rate in patients with hypercholesterolemia who received either LLT optimized for individual patients plus Leqvio or LLT plus placebo, were recently presented at the European Society of Cardiology Congress (ESC 2025). This study holds significance as the first to evaluate Leqvio’s effect on muscle symptoms and pain commonly observed in patients receiving statins and other LLT treatments. Secondary endpoints included the proportion of patients experiencing at least one muscle-related adverse event (MRAE) after 360 days of treatment and the proportion reporting self-reported pain. Results showed that the Leqvio treatment group achieved significantly higher rates of individual LDL-C target attainment compared to the placebo group. Furthermore, the likelihood of muscle-related adverse events (MRAEs) was 43% lower in the Leqvio group than in the placebo group, and numeric improvements were also observed in pain-related quality of life (QoL) scores. Professor Song stated, “Given that some patients undergoing statin therapy suffer from side effects like muscle pain, this study reaffirms that Leqvio can serve as a viable treatment option that can address the unmet needs of existing LLT strategies.”
- Company
- GC Biopharma's U.S. plasma centers are fully operational
- by Chon, Seung-Hyun Nov 19, 2025 06:08am
- ABO Plasma, GC Biopharma's recently acquired U.S. plasma center, is seeing rapid revenue growth, with third-quarter sales exceeding those of the first and second quarters combined. The plasma centers, acquired for KRW 138 billion, has started full operations as its locations received U.S. approvals, leading to expanded sales of GC's blood products in the U.S. market. According to the Financial Supervisory Service on November 19, ABO Plasma recorded sales of KRW 43.1 billion in the third quarter. This represents a fourfold increase from the previous quarter's KRW 9.1 billion. The cumulative revenue for the first three quarters totaled KRW 65.4 billion. ABO Plasma is a U.S.-based plasma center that GC Biopharma acquired in January of this year. Immediately following the acquisition, ABO Holdings was renamed ABO Plasma. GC Biopharma decided to acquire a 100% stake in ABO Plasma for KRW 138 billion in December of last year. ABO Plasma, located in California, operates plasma centers in New Jersey, Utah, and California. The purpose of the acquisition was to expand the business for the blood product Alyglo and secure a stable source of raw materials. Alyglo, which received U.S. Food and Drug Administration (FDA) approval in December 2023, is a liquid immunoglobulin preparation refined from plasma fractionation. It is used to treat primary immunodeficiency diseases, such as congenital immunodeficiency and immune thrombocytopenia. Alyglo was the first blood product developed by a Korean company to enter the U.S. market. GC Biopharma established a system in which it uses plasma supplied by ABO Plasma to manufacture Alyglo at its Ochang plant in Korea, and sells the finished product in the U.S. Previously, GC Biopharma purchased plasma from U.S. plasma centers before manufacturing Alyglo at its Ochang plant. ABO Plasma generated revenues of KRW 13.2 billion and KRW 9.1 billion in the first and second quarters, respectively, and then skyrocketed in the third quarter. The third-quarter revenue alone was about double the revenue of the first half. At the time of GC Biopharma's acquisition of ABO Plasma, three of the total six plasma centers had already received FDA approval. An additional three centers received FDA approval in the second quarter. U.S. plasma centers can collect plasma from donors after opening, but they can only sell the plasma once they receive FDA approval. Since ABO Plasma's centers received FDA approval in succession following the acquisition, plasma sales revenue has gradually expanded. U.S. sales of Alyglo are also gradually increasing. The company explained, "Alyglo has maintained growth every quarter this year, achieving 117% sales growth compared to the same period last year." GC Biopharma proactively secured local inventory by increasing Alyglo export volume in the first half of the year to respond preemptively to changes in U.S. tariff policy. GC Biopharma recorded KRW 133.6 billion in blood product sales in the third quarter. This is similar to the KRW 136.6 billion recorded in the same period last year, but represents a 33.7% increase compared to KRW 99.9 billion in Q3 2023. GC Biopharma began full-scale sales after completing the initial shipment of Alyglo in July of last year. Blood product sales recorded KRW 90.6 billion in Q2 last year, expanded by 50.8% to KRW 136.6 billion in Q3 with Alyglo's launch, and rose to KRW 161.7 billion in Q4. This year, Q1 and Q2 recorded KRW 127.2 billion and KRW 152.0 billion, respectively. ABO Plasma is accelerating its facility expansion. On November 16, ABO Plasma opened the Laredo Plasma Center in Texas. ABO Plasma plans to start recruiting plasma donors immediately upon the center's launch. Collected plasma can be stored for 24 months, and the company plans to begin sales as soon as FDA authorization is complete. The FDA approval process for a plasma center typically takes nine months, and ABO Plasma expects to complete approval by the first half of next year. The Laredo Plasma Center was initially scheduled for completion in 2026, but expansion was accelerated to keep pace with Alyglo's growth and the domestic plasma fractionation products. The Eagle Pass Plasma Center in Texas is also expected to open in 2026. ABO Plasma recorded a net loss of KRW 5.7 billion in the third quarter. The company's deficit slightly increased, following net losses of KRW 5.1 billion and KRW 5.5 billion in the first and second quarters, respectively. The increased deficit compared to the previous quarter is attributed to higher costs associated with the early opening of the Laredo Plasma Center in Texas and to the recognition of one-time investment costs to build a foundation for mid- to long-term growth. The cumulative net loss for the first three quarters is KRW 16.2 billion. GC Biopharma utilized its internally established investment vehicle to acquire ABO Plasma. The acquisition involved investing GC Biopharma's existing cash reserves of KRW 55.7 billion and disposing of its stake in of the private equity firm 'For Human Life Private Equity Joint Venture No. 1' for KRW 82.3 billion. GC Biopharma Holdings and GC Biopharma jointly established For Human Life in March 2021, each investing KRW 6.4 billion. For Human Life subsequently launched 'For Human Life Private Equity Joint Venture No. 1' after receiving an investment of KRW 67.0 billion from GC Biopharma.
- Policy
- 'Photos' to be excluded from files for negotiated drugs
- by Jung, Heung-Jun Nov 19, 2025 06:08am
- "Some companies submitted product photos and test certificates, but their production records were not found the following year. This must not happen." The National Health Insurance Service (NHIS) made this statement during a recent drug price consultation session with pharmaceutical industry stakeholders, announcing future institutional changes. According to industry sources on November 18, the NHIS is gathering opinions on changes to the documentation required for negotiated drugs and the scope of disclosure for Risk-Sharing Agreement (RSA) drugs, until November 21. The main point of the changes to the negotiated drug documentation is to replace product photos with the Manufacturing Instruction Record. The goal is to prevent instances such as the submission of a semi-finished product test certificate or the forgery of a finished product test certificate when no finished product inventory is actually available for shipment. Consequently, product photos will not be required unless requested. The primary objective is to substitute these with the Manufacturing Instruction Record to secure credibility. The NHIS plans to conduct an internal review in December and apply these changes starting with the main negotiations for negotiated drugs in January next year. The NHIS is also pursuing the disclosure of information regarding RSA drugs. The NHIS is also seeking opinions on the scope of information to be disclosed, including the drug name and type, within the same deadline. Some in the National Assembly have argued that related information must be disclosed to ensure the transparent operation of the RSA system. The NHIS is seeking opinions on two options: Option 1, which discloses only the drug name, and Option 2, which discloses both the drug name and the RSA type. The NHIS is also gathering general opinions on the overall disclosure of RSA drug information. The NHIS plans to disclose drug name and the contractually set refund rate to subsequent reimbursement applicants. An NHIS official previously stated, "We believe it is right to disclose the refund rate information for RSA drugs. We will ensure that this information is provided upon request when a reimbursement application is submitted to HIRA. However, the requesting applicant must sign a non-disclosure agreement."
- Product
- Discussions on expanding emergency OTC drugs gain momentum
- by Kang, Hye-Kyung Nov 19, 2025 06:08am
- As civic groups continue to demand the expansion of emergency OTC medicines available in convenience stores, the National Assembly will hold a policy forum on the issue on the 28th. According to industry sources on the 18th, Rep. Ji-a Han of the People Power Party, a member of the National Assembly's Health and Welfare Committee, will host a ‘Policy Discussion on Convenience Store Over-the-Counter Medicines to Promote Public Health’ on the 28th. Participants will include Soon-hyuk Kang, Director of the Division of Pharmaceutical Policy at the Ministry of Health and Welfare; Hye-ri Ahn, Secretary-General of the Consumer Network for Public Interest; and Chun-bae Park, Vice President of the Korean Pharmaceutical Association, who will represent the positions of their respective groups – the government, consumer groups, and the pharmacy community. Civil society groups advocating for expanding the list of over-the-counter emergency medicines and the convenience store industry are also showing great interest in the upcoming forum. Under a relevant system introduced in November 2012, up to 20 types of emergency OTC medicines may be designated for sale at convenience stores. However, civil society groups and the industry claim that only 13 items are actually designated as OTC medicines, and even among those, 2 items are currently suspended from sale. Although the system was initially designed to re-evaluate the designated items every 3 years, the Emergency OTC Medicines Review Committee has not convened since 2018, reportedly due to opposition from the Korean Pharmaceutical Association. At this year’s National Assembly audit, Rep. Han already highlighted both the need to expand the list and the prolonged delay in convening the review committee. Han argued that the system should be improved by easing the requirement for 24-hour year-round sales, removing the cap of 20 designated items, and establishing a solid legal basis for committee operations to prevent conflict between professional groups. In response, Minister of Health and Welfare Eun-kyeong Jeong stated, “The emergency OTC medicine system has been in place for over 10 years and must be updated to reflect current circumstances. We should first adjust the list of items or discontinue products that are no longer sold. Also, since there are no 24-hour convenience stores in areas without pharmacies, the 24-hour operation restrictions should be relaxed. We are preparing a comprehensive plan and are also consulting with organizations like the Korean Pharmaceutical Association.” The KPA maintains that issues in pharmacy-desert regions can be resolved through the “Special Locations for Pharmaceutical Handling” notice. This policy allows designated individuals to dispense or provide medications in locations with limited access to pharmacies—such as ships, aircraft, remote islands, or military bases.
- Policy
- World’s first dutasteride+tadalafil combo to launch in Dec
- by Lee, Tak-Sun Nov 19, 2025 06:07am
- The world’s first dutasteride and tadalafil combination approved for benign prostatic hyperplasia (BPH) is expected to be released next month as a non-reimbursed product. This effectively confirms that the companies failed to secure reimbursement for their respective products. According to industry sources on the 17th, the dutasteride+tadalafil fixed-dose combination will begin sales next month at an expected price of KRW 1,300. Four products from four companies received approval: Dong-A ST's Dutana Tab 0.5/5mg, Shinpoong Pharm’s Avocial Tab 0.5/5mg, Dongkook Pharmaceutical's Uresco Tab 0.5/5mg, and DongKoo Bio&Pharma's Uroguard Tab 0.5/5mg. The four drugs were approved on January 23rd through joint development. The approved indication is the treatment of moderate to severe symptoms of benign prostatic hyperplasia. Dongkook Pharmaceutical is the manufacturer. These companies received approval in January and have been pursuing reimbursement listing. However, because tadalafil is a non-reimbursed ingredient, the combination could not be priced under standard calculations and would have had to enter the new drug reimbursement track, which requires substantial data submission and a prolonged evaluation period. Ultimately, manufacturers agreed to proceed with a non-reimbursed market launch. Some companies are informing distributors and retailers of their new product launch plans for December. The KRW 1,300 price is viewed as reasonable. Currently, the maximum price for dutasteride tablets 0.5mg is KRW 709. Given that the lowest price for tadalafil 5mg is around KRW 700, the combination drug’s price is lower than the sum of the two components. Still, since most BPH treatments in Korea are reimbursed, it remains uncertain how much demand there will be for a non-reimbursed option. Industry observers note that manufacturers may lean toward highlighting tadalafil’s erectile dysfunction benefits as a marketing angle.
- Opinion
- [Reporter's View] New obesity drug sparks dilemma
- by Son, Hyung Min Nov 18, 2025 06:13am
- Following approval of an expanded indication for Wegovy (semaglutide), a Glucagon-like Peptide-1 (GLP-1)- based obesity treatment, to include adolescents aged 12 and older in South Korea, the discussion surrounding pediatric and adolescent obesity has once again come into the spotlight. While the global market already defines pediatric obesity as a medical disease requiring early intervention, South Korea is still lagging in both social awareness and institutional support. Obesity cannot be explained merely as an aesthetic or lifestyle issue. In particular, obesity during the growth period is highly likely to persist into adulthood. It serves as the starting point for chronic diseases such as Type 2 diabetes, hypertension, non-alcoholic fatty liver disease, and cardiovascular disease. The Obesity Fact Sheet 2025, published by the Korean Society for the Study of Obesity (KSSO), demonstrates this reality. Although the obesity rate in children and adolescents has slightly decreased in the last five years, approximately three out of 10 are still classified as obese. The obesity rate peaked at age 14 for boys and after age 16 for girls. It was also confirmed that the probability of obesity in children is five times higher if their parents are in obesity class 2 or higher. The problem is that it does not end with simple weight gain. Adult chronic diseases such as Type 2 diabetes, hypertension, and liver disease are actually increasing among obese and overweight children and adolescents. The pace of change has accelerated to the point where Type 2 diabetes in adolescents is no longer considered a rare condition in modern clinical practice. Experts note that obesity during the growth period is not a short-term problem; instead, the timing of exposure determines the severity of the disease. Obesity starting early in life has a prolonged duration, increasing the risk of complications and potentially exploding lifelong management costs and medical burden. The current situation is different from the era when obesity was dismissed as merely an aesthetic concern. Despite this severe situation, the treatment environment in South Korea remains stagnant. While innovative treatments like GLP-1 drugs have emerged, the perception that obesity is a treatable disease is spreading among adult patients. Conversely, in the U.S., major new obesity drugs have already been approved for adolescents and are actively used in clinical practice. Although South Korea tends to tighten regulations due to concerns over misuse and abuse, some critics suggest that patients in need are being deprived of the right to choose treatment. Obesity cannot be explained solely by willpower or lifestyle choices. Appetite is a biological system involving the pituitary-hypothalamic axis, adipose tissue, and various hormones. It is structurally harder for growing adolescents to control their appetite than it is for adults. Without addressing the underlying physiological factors, lifestyle modifications alone will inevitably face apparent limitations. However, drug therapy is not an answer for everyone. The effectiveness of obesity treatments is maximized when combined with healthy lifestyle modifications. Especially during the growth period, lifestyle education, continuous counseling, and long-term management are essential. However, experts are deeply concerned that delaying drug treatment for adolescents who already show signs of complications, such as hypertension, elevated liver enzymes, or pre-diabetes, will exponentially increase the future disease burden. The core of the problem is the social frame through which obesity is viewed. Many still interpret obesity as a failure of lifestyle or lack of willpower, and the perception exists that obesity during childhood and adolescence will 'naturally resolve itself as individuals grow.' However, obesity during the growth period cannot be solved by time. Delayed early intervention exponentially increases long-term health risks and places an even greater medical and social burden on the patient than adult obesity. While the perception of obesity as a disease is slowly being built, regulations remain overly strict, and access to treatment is restricted. While preventing misuse is critical, a situation where even patients in need cannot access medication is another form of neglect. What is needed now is not more regulation, but balance. Ensuring safety and preventing misuse must be fundamental policy goals, but those principles should not stand in the way of timely treatment. Obesity during childhood and adolescence is a key turning point that determines lifelong health. The treatments are available. The remaining challenge is for social awareness and institutional support to catch up so that these treatments can reach the patients who need them.
- 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.
- Company
- Will the 53.55% generic drug pricing system be overhauled?
- by Kim, Jin-Gu Nov 18, 2025 06:12am
- The Korean government is moving toward a full-scale overhaul of the national drug pricing system Structural overhauls of the overall domestic drug pricing system are materializing, including adjustments to the generic drug pricing calculation rate, reform of the tiered pricing system, consolidation of post-marketing control systems, expansion of risk-sharing agreement and dual pricing systems, and introduction of R&D investment-linked drug pricing premiums. According to industry sources on the 18th, the Ministry of Health and Welfare is scheduled to attend the Korea Pharmaceutical and Bio-Pharma Manufacturers Association’s board meeting this afternoon to explain the direction of the drug pricing system reform. It is understood that Lee Jung-kyu, Director-General of the Bureau of Health Insurance Policy, will personally explain the reform's purpose and direction and request the pharmaceutical industry's participation. The Ministry has been continuously discussing the reform of the drug pricing system. Discussions have accelerated, particularly since the inauguration of the Lee Jae-myung administration. The outline has been shaped to simplify an overly complex system, making it more predictable, while simultaneously encouraging R&D investment by domestic pharmaceutical and biotech companies. A draft of the reform plan is reportedly already prepared. Following the ministry's briefing to the KPBMA, the discussions on drug pricing system reform, which have been progressing behind the scenes, are expected to move into the official phase. The focal point of interest is the generic drug price calculation rate. Lowering the current 53.55% rate is understood to be one of the core elements of the reform plan. Under the current system, the generic drug price is set at 59.5% of the original drug's highest price for the first year after initial listing. From the second year onward, the price is maintained at a reduced rate of 53.55%. To qualify for the 53.55% rate, both conditions must be met - ‘conducting its own bioequivalence test’ and ‘using a registered Drug Master File registered API.’ Meeting only one condition results in an additional 15% reduction (45.52% of the original price). Failing to meet both conditions leads to a further 15% reduction (38.69% of the original price). The government believes the current 53.55% benchmark is excessively high. Although the exact adjustment level has not been disclosed, industry insiders expect a considerably lower figure, potentially around 40%. An industry official stated, “If the discussion were merely about lowering the 53.55% calculation rate to 50%, the reform talks wouldn't have even started. The consensus is that the final figure will be below 50%.” The tiered generic pricing system is also expected to face revisions. Currently, the first 20 generic products maintain the 53.55% price level, and after the 20th, the price is reduced by 15% sequentially. The 21st generic is priced at 85% of the lowest price among the first 20 products, and the 22nd generic is priced at 85% of the 21st generic, and so on. In this regard, the Ministry of Health and Welfare considers the ‘20-product’ range as excessively broad. It is reported that a plan to reduce this to around 10 products is under review. However, it is understood that discussions are also underway to moderate the structure where prices drop by 15% after the 20th product, meaning fewer generics per tier, but smaller price drops per step. A major consolidation of post-management regulations is also underway. Current systems, including the ▲ Actual Transaction Price (ATP) reduction, ▲ reassessment of reimbursement adequacy, and ▲ the Price-Volume Agreement system, run simultaneously. The government has also previously considered introducing an external reference pricing-based reevaluation. The Ministry of Health and Welfare plans to consolidate these systems to enhance predictability. To this end, the Ministry commissioned a study titled “Integrated Framework for Post-Management of Drug Pricing” to the Daegu Catholic University Industry-Academic Cooperation Foundation in March this year. Once the results are released at the end of the year, related discussions are expected to accelerate. The drug price premium system is also likely to undergo a significant overhaul. Given persistent criticism that the current premium system is overly complex, the government is considering a method to determine drug price premiums and preferential treatment based on the R&D investment ratio of pharmaceutical and biotech companies. A pharmaceutical industry insider stated, “It is clear that the government intends to overhaul the multi-product, generic-centered market structure. Based on the judgment that the system has become excessively complex due to additions made as needed over time, discussions are proceeding toward streamlining it within a broad framework to enhance predictability. The government intends to strongly convey the message that growth is no longer feasible solely through a generic-centered market.” A government-ruling party official explained, “The focus of this reform is not on cutting healthcare spending. The goal is to create an environment where pharmaceutical innovation can function properly. We are reviewing options such as linking pricing premiums to the company’s R&D investment ratio. The intent is to make R&D investment a key determinant of reward.”
