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- 2025-12-17 20:28:08
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- Servier Korea appoints Olivier Russo as new General Manager
- by Son, Hyung Min Oct 02, 2025 06:11am
- Olivier Russo, new General Manage of Servier Korea Servier Korea announced that it has appointed Olivier Russo as its new General Manager, effective October 1. Olivier Russo, the new GM, is a pharmacist and R&D expert who earned his PhD in Organic Chemistry and Medicinal Chemistry from the Université Paris-Saclay in France. Since joining the Servier Group in 2006, he has demonstrated leadership across core R&D functions throughout the entire drug lifecycle—from early-stage discovery of novel drug candidates to technology development, industrialization, and post-approval stages. Since 2022, Russo has served as Global Head of CMC, where he led company-wide strategy and operations. He successfully supported the initiation of clinical trials and regulatory approvals for key pipeline candidates in oncology, neuroscience, and immunology/inflammatory diseases, as well as the full lifecycle management program for cardiovascular and metabolic disease treatments. The new GM said, “Korea not only holds a strong presence in key areas for Servier, such as cardiovascular and metabolic diseases, but is also emerging as a new leader in targeted cancer therapy. As part of Servier's Asia-Pacific R&D hub, Korea is also a strategic center for strengthening the clinical development foundation in the region.” He added, “We will strive to combine the strengths of the Korean market with Servier's global expertise to deliver greater value to patients worldwide, while driving sustained innovation.” Servier is an independent global pharmaceutical group managed by a non-profit foundation. Headquartered in France, it has a strong global presence in over 140 countries. Driven by its mission to advance treatments that meet patient needs, it focuses approximately 70% of its R&D budget on oncology, providing innovative medicines primarily in oncology and cardiovascular and metabolic diseases.
- Company
- Will Uplizna be reimbursed this time?
- by Eo, Yun-Ho Oct 01, 2025 06:11am
- Discussions have resumed regarding the inclusion of the twice-yearly administered new drug ‘Uplizna’ for neuromyelitis optica spectrum disorder (NMOSD) in the national health insurance reimbursement list, which had previously been rejected. According to industry sources, Mitsubishi Tanabe Pharma Korea has resubmitted an application for reimbursement of Uplizna (inebilizumab), a treatment for adult patients with AQP4 antibody–positive NMOSD, which is currently under review by the Health Insurance Review and Assessment Service. The drug’s listing process was suspended in October last year during price negotiations with the National Health Insurance Service (NHIS) due to supply issues. At the time, Uplizna accepted the evaluation price set by HIRA’s Drug Reimbursement Review Committee and entered into negotiations. However, no conclusion was reached within the 60-day negotiation period. NHIS attempted to extend negotiations, but the manufacturer was unable to secure a domestic supply, preventing further talks. It remains to be seen whether Uplizna, as a new treatment option for NMOSD, will succeed in being listed this time. NMOSD is caused when disease-specific AQP4 autoantibodies, produced by B cells, bind to AQP4 antigens on astrocytes in the central nervous system, triggering immune responses that lead to neural damage. Uplizna is a novel CD19-targeted humanized monoclonal antibody that selectively binds to the CD19 antigen on B cells, depleting those that produce AQP4 antibodies and thereby preventing disease relapse. The safety and efficacy of Uplizna were demonstrated in the N-MOmentum trial, a monotherapy study involving 230 patients without concomitant immunosuppressants. Study results showed that 89% of patients receiving Uplizna experienced no relapse during the 197-day follow-up period, demonstrating a 77.3% reduction in relapse risk compared to the placebo group. Safety assessments also showed a comparable rate of adverse events to the placebo group. Furthermore, in an extension study of this clinical trial, Uplizna continuously reduced the risk of relapse for at least 4 years, with a relapse-free rate of 87.7%. The long-term safety profile demonstrated generally good tolerability, and there was no increase in infection rates due to B-cell depletion. Meanwhile, NMOSD is a serious autoimmune disease in which most patients experience persistent relapses with incomplete recovery, leading to accumulated nerve damage that causes vision loss, gait impairment, and even death from respiratory failure.
- Company
- Will a new market for presbyopia open up?
- by Kim, Jin-Gu Oct 01, 2025 06:10am
- The market for age-related blurry near vision (presbyopia) treatment is emerging as a blue ocean for Korean pharmaceutical and biotech companies. Following a series of new drug approvals by the U.S. Food and Drug Administration (FDA), ophthalmic specialized pharmaceutical companies, including Dae Woo Pharmaceutical, OPTUS Pharma, and Kwangdong Pharmaceutical, are accelerating their efforts to introduce and develop treatments for presbyopia. Pilocarpine containing eye drop is expected to treat presbyopia...Dae Woo "We will also conduct clinical trials for expanded indication" According to the pharmaceutical industry on September 30, Dae Woo Pharmaceutical plans to concurrently conduct clinical trials to add presbyopia indication to its recently launched product, 'Pilostar Eye Drops 1%'. Dae Woo Pharmaceutical anticipates that the main component, pilocarpine, will be effective not only in treating glaucoma but also in improving presbyopia. Pilocarpine is a parasympathetic agonist that reduces intraocular pressure by promoting aqueous humor outflow through the trabecular meshwork. It also has a mechanism that contracts the iris sphincter muscle. This process reduces the pupil size, creating a pinhole effect that improves presbyopia, a principle similar to how an object becomes clearer when a camera's aperture is narrowed The U.S. FDA has actually approved an eye drop with the same ingredient as a presbyopia treatment. The U.S. FDA approved Vuity (developed by Allergan) as the first presbyopia treatment in 2021. Vuity, a presbyopia treatment with a 1.25% concentration of pilocarpine, improves presbyopia symptoms within 15 minutes of once-daily administration, with effects lasting for about 6 hours. Recent research results presented at the European Society of Cataract and Refractive Surgeons (ESCRS) are also increasing the success potential of pilocarpine-based presbyopia treatments. A research team from the Presbyopia Study Center in Buenos Aires, Argentina, presented results from administering pilocarpine-containing eye drops to 766 patients with presbyopia at the ESCRS conference in Copenhagen, Denmark, on September 8. The research team divided the clinical participants into three groups, administering 1%, 2%, and 3% concentrations of pilocarpine eye drops, respectively. Administered twice daily at 6-hour intervals, 99% of the group receiving the 1% concentration eye drops (148 participants) were able to read two or more additional lines on a vision test chart. A Dae Woo Pharmaceutical official stated, "We are paying close attention to the research results presented at recent global academic conferences. We are preparing clinical trials to add the presbyopia treatment indication." He added, "The clinical trial is expected to take 2-3 years." U.S. FDA approves treatments for presbyopia one after another…Korean companies, such as Kwangdong and Optus, compete for domestic launch Other pharmaceutical companies are also pursuing treatments for presbyopia. In particular, interest is growing in 'Vizz,' a new active ingredient presbyopia treatment approved by the U.S. FDA last month. This product is an ophthalmic solution with a 1.44% concentration of aceclidine, developed by LENZ Therapeutics, a U.S.-based company. The emergence of a new active ingredient for treating presbyopia has sparked competition among Korean pharmaceutical companies for its domestic launch. It is reported that 3-4 companies initiated discussions with LENZ Therapeutics for the domestic introduction of this product immediately after the FDA approval. (from left) Product photos of Vuity, Qlosi, and Vizz. OPTUS Pharma and Kwangdong Pharmaceutical have also actively pursued the introduction of presbyopia treatments. OPTUS Pharma signed a licensing agreement for the presbyopia treatment 'Qlosi' with Orasis Pharmaceuticals (U.S./Israel) in September of last year. This drug was the second presbyopia treatment approved by the U.S. FDA in October 2023. Its main component, like Vuity, is pilocarpine, but the concentration differs at 0.4%. Its domestic commercialization is expected as early as 2026. Kwangdong Pharmaceutical signed an agreement last January to introduce the presbyopia treatment candidate BRIMOCHOL from the Hong Kong pharmaceutical company Zhaoke Ophthalmology. Through this contract, Kwangdong Pharmaceutical secures exclusive domestic import, distribution, and sales rights for BRIMOCHOL. The original developer is the U.S. biotech company Visus Therapeutics, and global Phase 3 clinical trials have been completed. Kwangdong Pharmaceutical signed an agreement last January to introduce the presbyopia treatment candidate BRIMOCHOL from the Hong Kong pharmaceutical company Zhaoke Ophthalmology. Through this contract, Kwangdong Pharmaceutical secures exclusive domestic import, distribution, and sales rights for BRIMOCHOL. This drug is a combination drug containing carbachol (2.75%) and brimonidine tartrate (0.1%), which alleviates symptoms of presbyopia. It activates the parasympathetic nervous system while simultaneously inhibiting the sympathetic nervous system. Like other treatments, its mechanism improves presbyopia by constricting the pupil. The pharmaceutical industry is focusing on the growth potential of the presbyopia treatment market. Presbyopia is a typical degenerative eye disease in which the elasticity of the lens decreases, making it difficult to focus on near objects. While 70% of adults aged 40 and over experience discomfort due to presbyopia, there have been no dedicated treatments other than vision correction using specialized glasses or contact lenses. The introduction of new drugs in the form of eye drops is expected to become a new alternative to satisfy patients' unmet needs. A pharmaceutical industry official predicted, "Since there have been no treatment options in the presbyopia treatment area, the market presence is expected to be significant when new drugs emerge," and added, "Competition among Korean pharmaceutical companies for new drug introduction and development will intensify in the future."
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- ‘COVID-19 vaccination essential for high-risk groups’
- by Son, Hyung Min Oct 01, 2025 06:09am
- Professor Jacob Lee, Division of Infectious Diseases at Hallym University Kangnam Sacred Heart Hospital The number of hospitalized COVID-19 patients over the past six months has been about threefold that of influenza, underscoring the renewed importance of vaccination, particularly for high-risk groups. Leading experts pointed out that vaccination not only prevents hospitalization and death but also lowers the risk of long COVID, recommending active participation in the simultaneous flu and COVID-19 vaccination campaign starting on the 15th of next month. On the 30th, Moderna Korea held a press briefing at the Novotel in Gangnam-gu, Seoul, emphasizing the importance of COVID-19 vaccination. COVID-19, a global acute respiratory infection since 2019, is now perceived largely as a mild illness thanks to the availability of vaccines and treatments. However, it still poses a threat to certain high-risk groups. High-risk groups for COVID-19 are those requiring special management due to a higher risk of severe illness or death upon infection. These primarily include the elderly (aged 65 and older), individuals with chronic conditions (hypertension, diabetes, cardiovascular disease, kidney disease, cancer, etc.), and immunocompromised individuals. The number of COVID-19 hospitalizations has been steadily increasing this year. In the past six months, COVID-19 hospitalizations have been about three times higher than influenza. Experts note that a large proportion of hospitalized COVID-19 patients are aged 65 or older, classified as high-risk. In 2024, 19,562 elderly patients (65+) were hospitalized with COVID-19, compared with 6,205 influenza patients—roughly a threefold difference. Because high-risk groups face greater risks of severe disease when infected, vaccination and careful health management remain crucial. Leading experts, including the Korean Society of Infectious Diseases, recommend regular updated COVID-19 vaccinations for high-risk groups. This is because immunity acquired through infection or vaccination diminishes over time, and new variants emerge. Professor Jacob Lee of the Division of Infectious Diseases at Hallym University Kangnam Sacred Heart Hospital said, “Vaccination not only prevents hospitalization and mortality but also reduces the risk of long COVID by 58% according to reports. COVID-19 is a disease with long-term sequelae. Like influenza, it requires ongoing management.” He added, “COVID-19 and influenza vaccinations will begin simultaneously on October 15. Vaccination this year is necessary to control infectious disease outbreaks next winter.” Sang-Pyo Kim, CEO of Moderna Korea, stated, “We will prioritize the stable supply of COVID-19 vaccines, with the primary goal of protecting high-risk patients, including the elderly aged 65 and above.” Moderna will continue supply of vaccines targeting new variants Francesca Ceddia, Chief Medical Affairs Officer, Moderna Korea Moderna has been continuously supplying vaccines in Korea that target new variants. Recently, a new variant-specific vaccine also received domestic approval. In May, the Ministry of Food and Drug Safety authorized “Spikevax LP Inj,” a COVID-19 vaccine targeting the LP.8.1 variant. Spikevax targets the spike protein on the surface of the coronavirus. This protein binds to ACE2 receptors in the body, enabling viral entry and causing COVID-19 symptoms. Spikevax's mechanism involves injecting the viral antigen gene in mRNA form, causing the body to synthesize an antigen protein with the same spike structure. This protein induces the production of neutralizing antibodies, preventing the coronavirus from binding to the ACE2 receptor when it invades the human body, thereby neutralizing and eliminating the virus. The newly approved Spikevax LP Inj has shown continued effectiveness in Phase IV real-world data. In clinical studies involving adults aged 12–64 with underlying conditions and seniors aged 65+, neutralizing antibody levels against the LP.8.1 variant increased more than eightfold following vaccination. Francesca Ceddia, Chief Medical Affairs Officer at Moderna Korea, emphasized, “Moderna’s COVID-19 vaccines have been administered to patients worldwide, with both efficacy and safety confirmed. We also observed high immunogenicity comparable to that of the COVID-19 vaccine alone when administered concurrently with the flu vaccine.”
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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."
