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- 2026-03-10 08:28:05
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- Global stage features changes in drugs for metabolic disease
- by Son, Hyung Min Sep 29, 2025 06:08am
- The International Congress of Diabetes and Metabolism (ICDM 2025) took place from September 25 to 27, 2025, at the Grand Walkerhill Hotel in Seoul, Korea. A promotional competition between Korean and international pharmaceutical companies, highlighting the latest treatments for diabetes and metabolic disorders, unraveled at a recent medical conference in Korea. The International Congress of Diabetes and Metabolism (ICDM 2025), held at the Grand Walkerhill Hotel in Seoul over three days starting September 25, featured a promotion focused on a range of topics, including the latest diabetes treatments, centered on GLP-1 and SGLT-2 inhibitors, as well as kidney disease therapies and vaccines. Bayer, Novo Nordisk, GSK, Boehringer Ingelheim, and Daewoong Pharmaceutical participated as diamond sponsors, taking on the key sponsor roles. GLP-1 Rivals Enter Side-by-Side…Shingles and RSV Vaccines Also Garnered Attention Eli Lilly Korea and Novo Nordisk, two leading companies in the GLP-1 market, participated side by side at the event to promote their respective GLP-1 portfolios. Following products like 'Trulicity (dulaglutide)' and 'Victoza (liraglutide),' both companies are seeking market entry for their newer GLP-1 formulations. (from left) Novo Nordisk and Eli Lilly exhibition booths. Currently, Novo Nordisk has secured domestic approval for 'Ozempic (semaglutide),' and Lilly has secured domestic approval for 'Mounjaro (tirzepatide)' in Korea. These companies have recently completed their applications for insurance reimbursement. Ozempic and Mounjaro are Glucagon-like Peptide-1 (GLP-1) class drugs used in patients with Type 2 diabetes and obesity. These two drugs have demonstrated significant effects in lowering blood sugar and reducing body weight in clinical trials. While the weight loss effect of existing DPP-4 inhibitors or SGLT-2 inhibitors was limited to less than 5%, clinical results showed that GLP-1 formulations can achieve weight loss of 10% or more. Consequently, GLP-1 formulations are increasingly included in the latest global R&D trends. Studies have shown that if diabetic patients lose more than 5% of their body weight, not only are their blood sugar, blood pressure, and lipid levels improved, but the incidence and mortality rates of cardiovascular and cerebrovascular diseases can also be lowered. Both companies also expressed their intent to collaborate with domestic pharmaceutical companies. Novo Nordisk recently initiated a co-promotion for the obesity treatment 'Wegovy (semaglutide)' with Chong Kun Dang, and the possibility of an additional contract for Ozempic is also being discussed. Lilly is currently seeking a co-promotion partner for Mounjaro, and a strategy is anticipated that will utilize a single product name to cover both diabetes and obesity indications simultaneously. In addition to diabetes, companies promoted the management of complications and vaccines at the conference. (from left) GSK and Bayer exhibition booth. Bayer prominently featured its kidney disease treatment, 'Kerendia (finerenone).' Kerendia is a drug that targets mineralocorticoid receptor (MR) overactivation, contributing to the treatment of key chronic kidney disease pathologies and heart failure patients with a left ventricular ejection fraction (LVEF) of 40% or more. Kerendia is currently approved in over 95 countries globally and has recently obtained approval for heart failure patients in the U.S. A subgroup analysis of the CONFIDENCE study, presented at the European Society of Cardiology (ESC) this year, reported high hemodynamic compliance when Kerendia was combined with SGLT-2 inhibitors. GSK focused on promoting its shingles vaccine, Shingrix, and the respiratory syncytial virus (RSV) vaccine, Arexvy. The importance of vaccination was highlighted, considering the frequent opportunities for vaccination in endocrinology clinical settings. Shingrix is a recombinant zoster vaccine that has been shown to have a stronger preventive effect than the existing live attenuated vaccine. Arexvy, which officially launched in Korea this year, attracted attention as the world's first RSV vaccine targeting older adults aged 60 and over. The Market Gap Left by Forxiga...Generics Compete with Jardiance and Envlo The promotional competition among SGLT-2 inhibitors was also heated. Following AstraZeneca's announcement of its withdrawal of the market-leading SGLT-2 inhibitor 'Forxiga (dapagliflozin)' from the Korean market in December 2023, there was intense anticipation that the original drugs 'Jardiance (empagliflozin)' from Boehringer Ingelheim and 'Envlo (enavogliflozin)' from Daewoong Pharmaceutical would gain a significant rebound effect. (upper left, clockwise) Boehringer Ingelheim, Daewoong, HK inno.N, Boryung exhibition booths. Jardiance is highly anticipated for sales growth, as it has secured both the chronic heart failure and chronic kidney disease indications, similar to Forxiga. Consequently, Boehringer Ingelheim focused on promoting Jardiance at this conference. Korean companies prominently featured their generics. HK inno.N, Boryung, and Hanmi Pharmaceutical joined the competition by promoting their Forxiga generics. Among these companies, HK inno.N and Boryung have formed a rivalry for the number one and two spots in market share. After AstraZeneca transferred its indications to HK inno.N's Dapa.N following the withdrawal of Forxiga. Dapa.N rose to become the leader in the monotherapy market. Indeed, Dapa.N recorded KRW 2.3 billion in prescription sales in the first quarter of this year, securing the top spot over Boryung's 'Trudapa' (KRW 1.3 billion), and further widening the gap in the second quarter. Hanmi Pharmaceutical's 'Dapalon' recorded the fourth-largest sales, following HK inno.N, Boryung, and Daewoong Bio, demonstrating its market presence. The competition between the original drugs and generics to fill the void left by Forxiga is now intensifying.
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- CKD and Kwang Dong win Tagrisso formulation patent suit
- by Kim, Jin-Gu Sep 26, 2025 06:14am
- Generic drugmakers challenging AstraZeneca's patent for the non-small cell lung cancer treatment ‘Tagrisso (osimertinib)’ have won their case in the first instance. According to industry sources on the 25th, the Intellectual Property Trial and Appeal Board (IPTAB) on the 24th ruled in favor of Chong Kun Dang and Kwang Donng Pharmaceutical in their request for a negative right scope confirmation trial regarding Tagrisso’s formulation patent (No. 10-2336378). This significantly increases the possibility of an early launch of Tagrisso generics. The two companies have also met 2 key requirements for obtaining exclusive marketing rights (first generic exclusivity): ▲ being the first to file the trial request and ▲ winning the trial/litigation. Now, they only need to satisfy the condition of being the first to file for generic approval to obtain the first generic exclusivity right. CKD and Kwang Dong are the only companies to have challenged the Tagrisso formulation patent. If both secure the first approval for their generics and gain the first generic exclusivity rights, they will be able to sell their product exclusively for 9 months. The key variable is AstraZeneca’s appeal. If AstraZeneca files a lawsuit to overturn the IPTAB decision with the Patent Court, the dispute may be prolonged. AstraZeneca's decision on whether to appeal has not yet been made. Tagrisso is protected by three patents: substance patents expiring in November and December 2033, and a formulation patent expiring in January 2035. CKD and Kwang Dong have successfully avoided the formulation patent. With the formulation patent out of the way, both companies plan to launch their generics as soon as the substance patent expires in 2033. There is also speculation that they could aim for an even earlier launch by targeting the extended duration granted to the substance patent. Tagrisso is a targeted anticancer drug used for EGFR-mutated non-small cell lung cancer (NSCLC) that received domestic approval in 2016. It is used as a first-line treatment for patients with locally advanced or metastatic NSCLC harboring EGFR gene mutations. In Korea, it competes with Yuhan Corp’s Leclaza (Lazertinib). According to the market research institution IQVIA, Tagrisso’s sales in Korea reached KRW 111 billion in 2023. After surpassing KRW 100 billion in annual sales in 2022, growth has continued steadily. With reimbursement expanded last year to include first-line treatment for locally advanced and metastatic NSCLC patients with specific EGFR mutations, sales are estimated to have exceeded KRW 130 billion. Separately, CKD is developing its own new drug for non-small cell lung cancer. The candidate compound, named ‘CKD-702’, is a bispecific antibody targeting both cMET and EGFR. It is currently undergoing global Phase I clinical trial. CKD is seeking to strengthen its foothold in the NSCLC treatment market by developing both a new drug and a generic.
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- Teva-Handok challenges mkt with LAI risperidon, Uzedy
- by Hwang, byoung woo Sep 26, 2025 06:12am
- As the schizophrenia treatment paradigm shifts toward managing medication adherence, Teva-Handok has introduced Uzedy (risperidone), a long-acting subcutaneous containing risperidone, to the Korean market. Uzedy is expected to become a new treatment option, enhancing patient convenience with its 1-month and 2-month dosing options and a design that eliminates the need for a loading dose. This drug has been shown to reduce the risk of relapse by up to 80% compared to placebo. Uzedy logoTeva-Handok recently announced that its long-acting subcutaneous injectable for adult schizophrenia, Uzedy (risperidone), received approval from the Ministry of Food and Drug Safety (MFDS) on September 5. It is assessed as a new treatment option that overcomes the medication adherence issues associated with existing oral therapies and provides convenience for both patients and medical professionals. Notably, it is expected to contribute to securing 'treatment persistence,' which is critical in schizophrenia management. Uzedy is an long-acting injectable that can be administered at 1-month and 2-month intervals, developed specifically to address poor medication adherence, cited as the primary cause of schizophrenia relapse. Schizophrenia is a chronic, progressive mental illness affecting thought, emotion, and behavior, with about 80% of patients experiencing multiple relapses within the first five years of treatment initiation. Since repeated relapses can diminish treatment effectiveness, impair daily functioning, and even cause structural changes in the brain, consistent medication is essential. Uzedy's differentiation lies in its proprietary technology that eliminates the need for a separate high-dose initiation or oral supplementation during the initial treatment phase. Previous long-acting injectables required a high-dose loading dose or co-administration of oral medication for a certain period to reach therapeutic concentration levels. However, Uzedy is designed to achieve an effective blood concentration rapidly within 24 hours of administration using a special polymer technology, allowing for a fast onset of therapeutic effect. Professor A of Neuropsychiatry at a tertiary general hospital in Seoul explained, "The long-acting formulation can resolve the medication adherence issue where patients, due to low insight into their illness, stop taking their medication," and added, "Compared to daily oral medications, it maintains stable drug concentration in the blood, which is beneficial for maximizing therapeutic effect and minimizing the occurrence of side effects." Professor A also said, "This drug alleviates the patient inconvenience of having to take pills daily and the social burden of having to expose one's illness to others, thereby assisting with social reintegration and job retention." Risperidone, Uzedy's active ingredient, is a second-generation antipsychotic developed in the 1990s, with long-proven efficacy and safety in clinical settings. With the introduction of Uzedy, the schizophrenia long-acting injectable (LAI) market in Korea is expected to become a four-way competition. Following existing LAIs based on haloperidol decanoate (1st-generation), paliperidone (2nd-generation), and aripiprazole (3rd-generation), the addition of risperidone-based Uzedy is expected to provide diverse treatment options for schizophrenia patients. Given that some existing treatments offer longer dosing intervals than Uzedy, Uzedy's market establishment and competition will be linked to the overall therapeutic standing of risperidone. However, reimbursement listing is essential for Uzedy to expand its influence in the domestic schizophrenia treatment market. Teva-Handok said, "We have a plan for Uzedy's reimbursement and will follow the standard procedure for securing reimbursement after approval." Additionally, improving the perception of the LAI formulation, which currently has a low prescription rate in Korea, will be a challenge for Teva-Handok. Professor A said, "Research indicates that some clinicians avoid prescribing LAIs due to concerns that it might strain the patient-physician relationship or lead to criticism over forced injections," and stressed, "To increase the prescription rate, we need to eliminate this perception and for physicians to provide treatments they believe are necessary with a sense of responsibility." Hee Kyung Ahn, CEO of Teva-Handok, added, "Uzedy is expected to contribute to improving the quality of life for patients who struggle with long-term treatment due to low medication adherence by offering flexible dosing options and a rapid therapeutic effect simultaneously."
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- Twice-yearly 'lenacapavir' for HIV expected to land in KOR
- by Eo, Yun-Ho Sep 25, 2025 06:12am
- Product photo of lenacapavir 'Lenacapavir,' a HIV prevention drug taken twice a year, is expected to be marketed in Korea. According to industry sources, the Ministry of Food and Drug Safety (MFDS) is currently reviewing the approval of lenacapavir from Gilead Sciences Korea. The drug was designated as an orphan drug in January. Its specific indication is "a combination therapy with other antiretroviral agents for the treatment of multidrug-resistant HIV-1 infection in adults who are not being treated with their current antiretroviral therapy." This drug, marketed overseas under the brand name Sunlenca, is the first long-acting HIV-1 capsid inhibitor and is administered as a subcutaneous injection every six months. It was approved in countries like the United States and Europe in 2022 and is currently being prescribed. Current HIV treatment is maintained through daily oral administration of antiretroviral drugs. However, with the development of long-acting formulations, the administration frequency is advancing to once every two months or once every six months. Lenacapavir is also garnering more attention for its potential in HIV 'prevention,' not just treatment. In June, this drug received approval in the U.S., and more recently in Europe, for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing at least 35 kg. The product name for lenacapavir used in prevention is 'Yeytuo.' The efficacy of lenacapavir for prevention was proven through the Phase 3 PURPOSE 1 and PURPOSE 2 studies. The PURPOSE 2 study results showed that lenacapavir reduced HIV infection by 96% compared to the background HIV incidence (bHIV). In the study, 2 cases occurred among 2,180 participants, meaning that 99.9% of the lenacapavir arm did not contract HIV. Last year, Gilead also prematurely unblinded its PURPOSE 1 trial, which evaluated lenacapavir as PrEP in cisgender women in Sub-Saharan Africa, after it met its primary efficacy endpoint. Meanwhile, the international science journal and news Science selected lenacapavir as its 'Science Innovation of the Year' last year based on these research results.
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- 'Drug pricing reform is overdue in Korea'
- by Son, Hyung Min Sep 25, 2025 06:11am
- KRPIA held a commemorative meeting marking its 25th anniversary on the 24th at Some Chavit in Banpo, Seoul. During the panel discussion held that day, experts raised the opinion that the industry and government must work together to improve patient-centered access to new drugs Concerns persist that domestic patients still face slow progress in accessing global new drugs. Although the government has introduced system reforms such as expansion of the risk-sharing scheme and pilot projects linking regulatory approval and reimbursement evaluation, experts argue that the current incentive system for innovative drugs is still insufficient, hindering both industry growth and patient treatment opportunities. On the 24th, the Korean Research-based Pharmaceutical Industry Association (KRPIA) held a roundtable to mark its 25th anniversary at Some Chavit in Banpo, Seoul. During the panel discussion, domestic and international pharmaceutical experts emphasized the need to improve patient-focused access to innovative drugs, pricing systems, and value recognition structures. Dong-ho Yeo from LG Chem, who has experience in both multinational and Korean pharmaceutical companies, stressed the importance of properly recognizing the value of innovative new drugs. Yeo said, “Although Korean companies don’t yet have many achievements that can truly be called innovation, they are continuing development. How the global innovative new drugs are evaluated will serve as an important signal for Korean companies as well.” “For Korean companies to move from being fast followers to first movers, innovative drugs must be appropriately valued. It would be difficult for a domestic drug to prove competitiveness in overseas markets if its innovativeness is not even recognized in its home country.” Panelists noted that despite systems being in place, it still takes a long time before actual patients gain treatment opportunities. They added that price negotiations and the financial savings logic often delay companies’ local launch strategies. Jae-min Cho, Senior Director at Eli Lilly Korea, said: “It’s encouraging that the government has designated biotechnology as a strategic national industry. However, the conservative value assessment practices of innovation hinder access for patients.” Cho pointed to ▲ Conservative evaluations that focus on price cuts rather than value recognition; ▲ Short evaluation periods (5–10 years) that fail to reflect long-term drug value; and ▲ even groundbreaking drugs developed after decades are often compared against the cost of outdated, low-priced drugs, as main challenges that hinder “Social consensus is needed on setting appropriate weighting factors and premiums that meet the Korean context. Only through continuous institutional improvements by the government, academia, and industry can we simultaneously achieve patient accessibility and industrial innovation.” Panels at the KRPIA 25th Anniversary Commemorative Panel Discussion “New drugs pushed out of priority lists... industry bears responsibility too” Responsibility within the industry itself was mentioned, alongside systemic limitations. Calls continued for the pharmaceutical industry to prioritize patient access as its foremost value. Dailypharm journalist Yoon-ho Eo remarked, “While the government and industry engage in reimbursement battles, many drugs are being pushed out of the priority list and disappearing. As a result, patients are losing timely access to essential medicines.” He added, “Companies tend to concentrate reimbursement strategies only on flagship products. Alongside government efforts, the industry must itself prioritize expanding patient access.” Specific improvement tasks were also proposed. Tae-Kyung Kim, a specialist at Yoon&Yang criticized the practice of cost-effectiveness-centric evaluations and stressed the need for new approaches. Kim noted, “It's a positive change that various values beyond cost-effectiveness are now reflected in evaluations, leading to higher reimbursement rates for new drugs that would have struggled to gain listing in the past. However, in practice, rather than recognizing the value of new drugs, the structure has solidified into one where the government reduces uncertainty through risk-sharing agreements (RSAs).” “The transfer of uncertainty via risk-sharing agreements is effectively resulting in ‘self-pay by pharmaceutical companies. Health technology assessments must become more flexible to reflect realistic real-world treatment patterns.” Moderator Eui-Kyung Lee, Professor at Sungkyunkwan University’s College of Pharmacy, said, “Post-COVID-19, two values—patient safety and speed—have simultaneously come to the fore. It is essential to find a balance between health insurance finances, timeliness, and safety, while adopting a more multi-dimensional and flexible approach for evaluating the value of innovative medicines.”
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- Xeomin marks 20 years since launch…'pure toxin'
- by Hwang, byoung woo Sep 25, 2025 06:10am
- Celebrating the 20th anniversary of Xeomin's global launch, Merz Aesthetics is emphasizing the importance of 'pure toxin' for managing botulinum toxin resistance. The company explains that in an era of repeated procedures, a highly purified toxin can inhibit antibody formation and become as a sustainable treatment option. Merz Aesthetics Korea held a press conference on September 24 to commemorate the 20th global anniversary of its botulinum toxin type A product, Xeomin, highlighting its scientific value and global leadership. Professor Michael Martin (Retired from Justus Liebig University, Germany)Firstly, Professor Michael Martin (Retired from Justus Liebig University, Germany), an immunology expert from Germany, said that in the global botulinum toxin market, the issue of resistance is no longer optional but a necessary management task. Professor Martin explained, "Only a highly purified toxin free of complexing proteins, inactive neurotoxins, and other impurities can be defined as a true pure toxin. While there are many products on the market, it is challenging to meet all these criteria." He emphasized the importance of pure toxins, citing the consensus of the ASCEND (Aesthetic Council for Ethical use of Neurotoxin Delivery) panel, which includes experts from around the world. The ASCEND panel was formed to systematically review literature and share clinical cases to establish a better standard for botulinum toxin use, as resistance has become an issue with its widespread use in aesthetics beyond therapeutic purposes. Professor Martin said, "To ensure the safe use of botulinum toxin, the key criteria for preventing resistance are to select a highly purified product with a low risk of resistance and to use the minimum effective dose at appropriate intervals." Dr. Juergen Frevert (Merz Pharmaceuticals Consultant)Dr. Juergen Frevert (Merz Pharmaceuticals Consultant), the developer of Xeomin, mentioned that the product is manufactured using Merz's stringent purification technology and a biotechnological production process that is approved by the U.S. Food and Drug Administration (FDA). Dr. Frevert said, "Merz's proprietary purification technology removes complexing proteins that can trigger antibody formation. By using only the active neurotoxin (150kDa) with approved excipients like human serum albumin (HSA) and sucrose, it minimizes the risk of resistance." He added, "In the global botulinum toxin market, pure toxin and resistance prevention are emerging as key keywords. Patients are significantly considering safety, long-term efficacy, and the ease of repeated procedures," and concluded, "Based on scientific evidence, Xeomin provides differentiated value that meets these patient expectations." Xeomin, Strengthening market leadership and ESG commitment In the subsequent presentation, Managing Director So Young Kim of Merz Aesthetics Korea's Brand Marketing Department shared Xeomin's 20-year journey and achievements under the theme of "Xeomin Global Heritage and Leadership." Kim said, "Since its approval by the European Medicines Agency (EMA) in 2005, Xeomin has been approved in 81 countries worldwide, with over 35 million vials supplied cumulatively. In Korea, since its launch in 2009, it has ranked first in import performance for six consecutive years, starting in 2018." Kim added, "Xeomin is a pure toxin that leads the botulinum toxin market and has built a strong trust with medical professionals and patients for a long time since its launch in 2009," and highlighted, "With its room-temperature storage approval in 2023, it contributes to long-term environmental protection by reducing the need for coolants and energy used for refrigeration. We also plan to introduce a new eco-friendly product package." Su Yeon Yu, CEO of Merz Aesthetics Korea, added, "Xeomin has been able to achieve significant results in the global and Korean market over the past 20 years, thanks to the trust of medical professionals and consumers," and concluded, "Merz will continue to meet the expectations of patients and medical professionals through innovative, science-based solutions, while leading the right future of medical aesthetics through ESG management and social responsibility.
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- 'Drug access still stagnant despite improved survival'
- by Son, Hyung Min Sep 25, 2025 06:10am
- While innovative new drugs have raised survival rates for patients with cancer, rare diseases, and other difficult-to-treat conditions and are transforming the treatment paradigms, industry voices argue that domestic patients' access to such drugs remains limited. Both the introduction rate and approval rate of global new drugs fall short of the OECD average, highlighting the urgent need for fundamental institutional reforms. On the 24th, the Korean Research-based Pharmaceutical Industry Association (KRPIA) held a commemorative event at Some Chavit in Banpo, Seoul, to celebrate its 25th anniversary. At this event, KRPIA held a roundtable event to share the current status of patient access to global new drugs in Korea. Just 20 years ago, cancer was considered untreatable. However, with the rise of innovative drugs from multinational pharmaceutical companies—including immuno-oncology therapies, targeted therapies, antibody-drug conjugates (ADCs), and bispecific antibodies—the landscape has changed dramatically. In some cancer types, survival rates have now improved to 70–80%, rendering the new drugs a prime example of extending patient life. In-hwa Choi, Executive Director of KRPIA 20 million people are newly diagnosed with cancer globally each year, and this number is projected to nearly double by 2050. The number of deaths is also expected to reach 18 million. Consequently, sustained and equitable access to innovative cancer drugs is more critical than ever. In-hwa Choi, Executive Director of KRPIA, stated, “Fundamental system improvements that prioritize patient access are necessary. While Korea’s health insurance system is exemplary, its single-payer structure creates inherent complexity and delays in reimbursement decisions for new drugs.” Choi acknowledged recent policy efforts—including expanded risk-sharing arrangements, exemption of pharmacoeconomic evaluations, and pilot programs linking drug approval with reimbursement—as positive developments. Choi noted, “Patients are still left with a long await.” KRPIA member companies supply around 1,450 innovative medicines in Korea, accounting for 83% of all new drugs in the domestic market. They also provide 92 treatments for rare and intractable diseases, expanding access for vulnerable populations such as the elderly, women, and children. KRPIA analyzed that new drugs extend patients' life expectancy by over 35%, reduce cancer mortality rates, and facilitate social reintegration, yielding annual socio-economic cost savings of KRW 126 trillion. Young-Shin Lee, Vice Chairman of KRPIA Nevertheless, patient access to new drugs in Korea remains stagnant. Only 5% of global innovative drugs are introduced in Korea within a year of launch, just one-fourth of the OECD average. Korea’s drug approval rate (30%) also falls below the OECD average (49%) and the G20 average (46%). Young-Shin Lee, Vice Chairman of KRPIA, stressed, “Innovation cannot be achieved by merely altering existing garments. The link connecting innovation to patients is the system; without systemic improvements, new drugs cannot meaningfully reach patients.“ The government, National Assembly, academia, media, and patients must jointly seek institutional solutions to ensure the social value of innovative drugs is properly conveyed to patients. KRPIA will also continue communication and cooperation as a responsible policy partner."
- Company
- Celltrion acquires Eli Lilly's U.S. plant for $460M
- by Sep 25, 2025 06:09am
- Celltrion has signed an agreement with Eli Lilly and Company (United States) for the acquisition of a biopharmaceutical manufacturing plant in Branchburg, New Jersey, for approximately $460 million. According to the Financial Supervisory Service, on September 23, Celltrion plans to make a total investment of KRW 700 billion, covering costs such as the factory acquisition price and initial operational expenses. The company plans to pursue facility expansion on the plant's idle land, which would require at least an additional investment of over KRW 700 billion. The total investment for the acquisition and expansion will be at least KRW 1.4 trillion. The company explained that the acquiring entity is the U.S. subsidiary, considering its local operations and strategic geographic location. Both companies will cooperate to finalize the factory acquisition procedures by the end of the year. The plant to be acquired is a large-scale campus spanning approximately 150,000 square meters, comprising four buildings: a manufacturing facility, a warehouse, and technical and operational support buildings. The facility is a fully operational, cGMP-compliant drug substance (DS) production plant that can be operated immediately upon acquisition. This will significantly shorten the time to production and reduce costs compared to building a new plant, which would take more than five years and cost over a trillion KRW. The plant also has approximately 36,000 square meters of idle land for capacity expansion, allowing the company to respond to future market demand. Celltrion plans to quickly begin expanding its facilities for the production of key products on the secured, idle land. Once the expansion is complete, the company anticipates having a production capacity that is 1.5 times that of its Plant 2 in Songdo, Incheon. Celltrion stated that this acquisition agreement completes its comprehensive plan to address U.S. tariff risks. "We have already taken short- to medium-term measures to counter tariffs, such as relocating two years' worth of inventory to the U.S. and expanding contracts with local Contract Manufacturing Organizations (CMOs)," a Celltrion official said. "With the addition of a fundamental solution, securing a local production plant, Celltrion is now poised to be free from all potential tariff risks in the future." The company explained that once the facility changes and expansions are realized, its flagship products supplied in the U.S., as well as future products, will be exempt from tariff impacts early on. Notably, the agreement also includes the complete employment transfer of local personnel with expertise and experience in plant operations. This agreement will enable the company to maintain seamless plant operation, ensuring the continuation of operational stability and productivity. A company official said, "Constructing a new plant requires a massive investment and several years just to prepare for initial operations and secure and train personnel. In contrast, by acquiring an existing cGMP-compliant plant with a skilled local workforce, Celltrion can significantly reduce this burden," and added, "During future expansion, we will also be able to actively utilize the talent infrastructure of New Jersey, which has a large pool of pharmaceutical and biotech professionals." The official continued, "By signing a CMO contract with Lilly at the same time, we have not only secured a local production base in the U.S. but also a powerful growth engine," and added, "Under the agreement, Celltrion will steadily supply drug substance produced at the plant to Lilly, which will enable us to expand our revenue and recover our investment early."
- Company
- Concurrent reimb review likely for Mounjaro and Ozempic
- by Eo, Yun-Ho Sep 24, 2025 06:25am
- Two anti-obesity drugs that have drawn intense attention may soon undergo reimbursement evaluations for their diabetes indications at the same time. With Novo Nordisk Korea’s Ozempic (semaglutide) already scheduled for review at the upcoming October meeting of the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee, there is growing speculation that Eli Lilly Korea’s Mounjaro (tirzepatide), which submitted its reimbursement application more recently, may also appear on the agenda. In fact, HIRA recently requested Lilly to promptly submit additional supplementary data for Mounjaro’s reimbursement evaluation. Novo Nordisk had already submitted its supplementary data earlier this month. As in all other markets, when supply increases while demand remains constant, prices fall. The pharmaceutical market is no exception. In the era of high-priced medicines, the government has shown a tendency to review two or even three new drugs simultaneously if multiple drugs in the same class are expected to seek reimbursement around the same time. Because of the high cost of these drugs, price competition between manufacturers allows the government to leverage the market’s natural mechanism. Under the national health insurance system, any savings can create opportunities to expand coverage elsewhere. Thus, given Mounjaro’s reimbursement application was filed in July, the government may likely wish to conduct reimbursement evaluations for the diabetes indication simultaneously for the two drugs. It remains to be seen how the fierce competition between the two drugs in the obesity market will extend into the diabetes market. A Novo Nordisk representative said, “We decided to initiate supply of Ozempic in Korea prior to reimbursement to address the unmet needs in type 2 diabetes treatment. We are working closely with the authorities to secure prompt reimbursement approval and further improve patient access.” A Lilly representative said, “We applied for reimbursement listing in order to provide Mounjaro to patients in a fast and sustainable way. We are currently doing our utmost to secure reimbursement for Mounjaro and are continuously collaborating with health authorities.”
- Company
- LEO Pharma’s topical JAKi Anzupgo approved in KOR
- by Son, Hyung Min Sep 24, 2025 06:24am
- 레오파마 Global dermatology specialized pharmaceutical company LEO Pharma (General Manager Jung-Bum Shin) announced on the 23rd that its chronic hand eczema treatment Anzupgo (delgocitinib) was officially approved by the Ministry of Food and Drug Safety on the 8th. With the approval, adult patients in Korea suffering from moderate-to-severe chronic hand eczema (CHE) will now have access to a new treatment option that offers both efficacy and convenience. Chronic hand eczema is a multifactorial inflammatory skin disease characterized primarily by itching and pain, defined as eczema persisting for more than 3 months or recurring at least twice within a year. It is among the most common skin disorders affecting the hands, and a significant proportion of cases progress to chronic disease. Globally, CHE affects about 1 in 10 adults and can severely impair quality of life by imposing functional, occupational, and psychological burdens. Approximately 70% of patients with severe CHE struggle with daily activities, which directly affects their employment and income. Anzupgo is the only non-steroidal topical cream formulation approved for adult patients with moderate-to-severe CHE who do not respond to or are unsuitable for topical corticosteroids. The product contains no parabens or steroids and works by inhibiting the JAK-STAT signaling pathway involved in various inflammatory responses. By blocking the activity of JAK1, 2, 3, and TYK2, the drug helps reduce skin inflammation and itching. Multiple clinical trials have demonstrated broad efficacy across all subtypes of moderate-to-severe CHE. Until now, treatment options for CHE have been limited, with strong topical corticosteroids used most frequently. However, long-term use carries risks such as skin barrier damage, atrophy, and telangiectasias. Due to this reason, in cases that show insufficient short-term improvement, guidelines have recommended combining topical calcineurin inhibitors or systemic corticosteroids. Currently, the only approved oral therapy for severe chronic hand eczema is alitretinoin, used for patients unresponsive to at least 4 weeks of potent topical corticosteroids. It improves symptoms through skin regulation, anti-inflammatory, and immunomodulatory actions, and is known to be effective for the long-term management of chronic severe hand eczema with a high risk of recurrence. However, its use has been constrained by risks including hepatotoxicity, thyroid dysfunction, dyslipidemia, and teratogenicity. In the head-to-head DELTA FORCE trial that directly compared oral alitretinoin with Anzupgo, the Anzupgo group achieved a statistically superior improvement in HECSI scores at week 12 (-67.6). It also demonstrated higher achievement rates in HECSI-90 and IGA-CHE TS (score 0/1). Over the 24-week treatment period, Anzupgo showed a better safety profile and lower incidence of adverse events compared to alitretinoin, confirming both strong efficacy and good tolerability. Jung-Bum Shin, General Manager of LEO Pharma Korea, stated: “Chronic hand eczema not only causes physical suffering but also serious social and emotional challenges. We are pleased to be able to provide the much-needed treatment option, Anzupgo, in Korea with its approval.” Shin added, “We will do our best to ensure Anzupgo contributes to changing the treatment paradigm for chronic hand eczema and improving patients’ quality of life in Korea.” LEO Pharma has been continuing the global launch of Anzupgo, having secured official approval in Korea following approvals in Europe, the UK, Switzerland, the UAE, Canada, Australia, and the US.
