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- 2026-04-30 22:36:08
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- Ozempic supply begins in Korea…co-promo partner 'undecided'
- by Hwang, byoung woo Sep 30, 2025 06:14am
- As discussions on National Health Insurance reimbursement for Ozempic (semaglutide), a diabetes treatment by Novo Nordisk, accelerate, attention has been garnered to the company's sales and marketing strategy in Korea. Product photo of OzempicNovo Nordisk has stated that the company has not finalized a co-promotion partnership with a domestic company in Korea. Yet, the possibility remains open, particularly after signing a co-promotion deal for the same-ingredient obesity treatment, Wegovy, with Chong Kun Dang. According to the pharmaceutical industry, Novo Nordisk Korea has decided to begin supplying Ozempic (semaglutide) to the Korean market on a non-reimbursed basis, starting on September 25, despite ongoing negotiations for National Health Insurance reimbursement. Ozempic, approved in Korea in April 2022, is a long-acting, once-weekly GLP-1 injectable indicated as an adjunct to diet and exercise, either alone or in combination with other diabetes treatments, for adults with insufficiently controlled Type 2 diabetes. Novo Nordisk previously applied for the reimbursement of Ozempic in 2023 but withdrew its application during the final stage of negotiations with the National Health Insurance Service (NHIS) over drug prices. Analysis suggests that uncertainties in domestic product supply have complicated the negotiation process over expected usage volume and prevented reimbursement, ultimately resulting in the failure to obtain reimbursement. Novo Nordisk's decision to initiate non-reimbursed supply now is likely interpreted as a sign of high expectations for a successful reimbursement listing. Novo Nordisk Korea is reportedly preparing to resubmit its reimbursement application to the Health Insurance Review & Assessment Service (HIRA). The company is awaiting deliberation by the Drug Reimbursement Evaluation Committee (DREC) in the near future. An anonymous professor of endocrinology at a major hospital in Seoul said, "Compared to the case in 2023, expectations for Ozempic's reimbursement listing are high," and added, "Although I can't confirm if it will succeed, I understand they proposed a reasonable price, and based on the collective opinion of the pharmaceutical industry and academic societies, I see a high possibility of success." In 2023, the Korean Diabetes Association and the Korean Endocrine Society recommended to the DREC that Ozempic, as a long-acting GLP-1 receptor agonist, should be granted the scope of reimbursement coverage comparable to Trulicity, a drug in the same class that has been subject to a clinical comparative study. The DREC gave conditional approval for reimbursement appropriateness, subject to the condition that the company accepts a price below the evaluated amount. And, Novo Nordisk accepted this condition. Although the DREC approval and negotiation with the NHIS remain, there is speculation that Ozempic's reimbursement price will be set similarly to, or slightly higher than, that of Trulicity. As discussions for Ozempic's reimbursement are imminent, the potential for a co-promotion partnership with a Korean pharmaceutical company is also drawing attention. Indeed, on September 18, Novo Nordisk signed a co-promotion agreement for the obesity treatment Wegovy with Chong Kun Dang. Through this agreement, the two companies will jointly conduct sales and marketing for Wegovy, targeting hospitals and clinics starting October 1. Novo Nordisk stated that it will maintain the same distribution approach for Ozempic as it did during the initial phase of Wegovy's launch. A Novo Nordisk official said, "We plan to distribute Ozempic through Zuellig Pharma in Korea, similar to Wegovy's case," and confirmed that "nothing has been decided regarding co-promotion or additional sales partnerships." However, the pharmaceutical industry predicts that Novo Nordisk will use the same distribution network to stabilize the initial market entry of Ozempic quickly and will discuss the possibility of co-promotion in detail after reimbursement is secured. This is because of a competing treatment, Lilly's Mounjaro (tirzepatide). Lilly is also pursuing reimbursement for Mounjaro's diabetes indication, and discussions about a potential co-promotion partnership are ongoing. The pharmaceutical industry generally believes that Novo Nordisk will pursue a co-promotion strategy for Ozempic, similar to the one used for Wegovy, to focus on the drug's expansion potential. A Novo Nordisk Korea official said, "The priority access of Ozempic is a result of our strong commitment and patient-centric efforts to provide it to Korean patients with Type 2 diabetes and healthcare professionals as quickly as possible," and added, "Simultaneous with the supply commencement, we are closely consulting with regulatory authorities to secure National Health Insurance approval for Ozempic to improve patient access to treatment."
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- Three Korean Pharmas avoid Equfina patent
- by Kim, Jin-Gu Sep 30, 2025 06:12am
- Generic companies have succeeded in avoiding the patent of Eisai Korea’s Parkinson’s disease treatment Equfina (safinamide). With early generic launches drawing closer, competition for the first-generic exclusivity among patent challengers is expected to intensify. According to industry sources on the 29th, the Intellectual Property Trial and Appeal Board recently ruled in favor of three companies—Bukwang Pharm, Myung In Pharm, and Samil Pharmaceutical—by granting their requests for a negative scope confirmation trial against NurrOn Pharmaceuticals concerning Equfina’s patent (No. 10-1491541). Equfina is Eisai Korea’s adjunctive therapy for patients with idiopathic Parkinson’s disease experiencing motor fluctuations. It is used alongside levodopa-containing regimens. The patent holder is NurrOn Pharmaceuticals. Two patents related to Equfina are listed in the Ministry of Food and Drug Safety’s green list. Of these, the “method of treating Parkinson’s disease” patent expired in December last year. The patent expiring in 2028 has now been avoided by generics, and this recent victory reduces the burden for patent challengers applying for generic product approvals. The three companies that successfully avoided the patent are expected to compete for exclusive marketing rights. They have simultaneously satisfied two of the three requirements for obtaining exclusive rights: ‘filing the first patent invalidation petition’ and ‘winning that petition’. If they meet the remaining requirement of ‘being the first to apply for generic approval’, they can monopolize the generic market and exclusively sell their generics for 9 months. Among them, Myung In Pharm is known to be closest to securing exclusivity. The company began a bioequivalence trial in July and has already completed subject enrollment. Bukwang Pharm received approval for a bioequivalence study earlier this month. Samil Pharm has not yet initiated such a trial. All three companies have strong CNS portfolios, suggesting intense competition upon their generics’ launch. Given that the drug is used as adjunctive therapy with levodopa, synergy with existing products is also anticipated. Myung In Pharm already markets Parkinson’s treatments such as Myungdopar (levodopa/benserazide), Perkin (levodopa/carbidopa), and Trilevo (levodopa/carbidopa/entacapone). Samil Pharm sells Onedopa (levodopa/benserazide). Bukwang Pharm launched the schizophrenia/bipolar disorder drug Latuda last year, strengthening its CNS portfolio. Equfina is a third-generation MAO-B (monoamine oxidase-B) inhibitor that acts on both dopaminergic and non-dopaminergic pathways. Eisai received marketing approval in Korea in June 2020 and launched with reimbursement in February 2021. Import sales grew from USD 770,000 in 2021 to USD 2,070,000 in 2023, a 2.7-fold increase in just 2 years.
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- ‘Need to strengthen access to NMOSD treatments’
- by Son, Hyung Min Sep 30, 2025 06:12am
- Rep. Mi-hwa Seo (Democratic Party of Korea, Health and Welfare Committee), Korea NMOSD Patients’ Association, and the Korea Organization for Rare Diseases held a policy discussion forum at the National Assembly on improving access to neuromyelitis optica treatment. On the 25th, Rep. Mi-hwa Seo (Democratic Party of Korea, Health and Welfare Committee) held a policy forum at the National Assembly Hall to strengthen treatment access for neuromyelitis optica spectrum disorder (NMOSD). The forum was co-hosted by Rep. Seo, the Korea NMOSD Patients’ Association, and the Korea Organization for Rare Diseases. NMOSD is a rare disease where even a single relapse can lead to irreversible disabilities like blindness or paralysis. However, domestic reimbursement criteria require conditions such as experiencing two or more relapses within a year after using ‘MabThera (rituximab)’, meaning patients must experience a relapse before they can use the new drug. This has drawn criticism from both patients and experts. This forum was held to address these systemic limitations and discuss ways to expand early treatment access. In the first presentation, Professor Ki-hoon Kim of the Department of Neurology at Severance Hospital, pointed out the issues present in the domestic reimbursement environment through the ‘Proposals for Improving Treatment Accessibility for Neuromyelitis Optica Spectrum Disorder.” Professor Kim said, “Although these therapies can prevent relapses, the unreasonable reimbursement criteria prevent patients from accessing them early. Early use of new drugs must be guaranteed to prevent unnecessary relapses and the accumulation of disabilities.” Patient Bo-ram Park followed with a presentation conveying patients' realities through ‘A Relapse-Free Life and Challenges for Early Treatment: Insights from Patient Experience’. Park appealed, “After a long diagnostic odyssey, treatment begins, but patients often resort to off-label drugs or discontinue treatment due to side effects. While there are new drugs with a 0% relapse rate, they remain outside the reimbursement scope, leaving patients at continued risk of relapse.” The subsequent panel discussion was chaired by Professor Yong-jin Kwon of Seoul National University Hospital's Public Healthcare Center. Participants included: ▲ Jong-cheol Choi, caregiver for a patient with neuromyelitis optica spectrum disorder (NMOSD); ▲Eung-gyu Park, caregiver for a patient with NMOSD; ▲ Yeon-sook Kim, Director of the Pharmaceutical Benefit Division at the Ministry of Health and Welfare; ▲ Kook-Hee Kim, Director-General of Pharmaceutical Management at the Health Insurance Review and Assessment Service (HIRA); and ▲Yoon-Ho Eo, Dailypharm reporter, who discussed directions for improving the system for NMOSD. Participants highlighted common goals: alleviating patient and caregiver suffering caused by repeated relapses, introducing relapse-preventing drugs at earlier stages, and improving reimbursement standards to reduce long-term care and treatment costs. Rep. Seo concluded, “Although NMOSD has only been recognized as an independent disease for about 20 years, advances in medical technology now allow us to prevent relapse-related disabilities. Major countries have already reformed their systems so patients can use approved therapies from the outset. Korea must also make institutional improvements so patients don’t have to endure unnecessary relapses.”
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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."
