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- 2025-12-17 17:12:25
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- What's the outcome of the 2nd reimb attempt for 'Uplizna'?
- by Eo, Yun-Ho Nov 17, 2025 06:11am
- Attention has been drawn to whether 'Uplizna,' a new treatment for neuromyelitis optica spectrum disorders (NMOSD), will successfully gain insurance reimbursement listing at its second attempt. According to industry sources, Mitsubishi Tanabe Pharma Korea has accepted the conditional price that Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Evaluation Committee (DREC) suggested for Uplizna (inebilizumab), a treatment for adult patients with anti-aquaporin-4 (AQP-4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD). The Ministry of Health and Welfare (MOHW) has ordered the National Health Insurance Service (NHIS) to initiate drug price negotiation. Therefore, the company is expected to begin discussions with the NHIS. The listing process for Uplizna was halted in October of last year during the drug price negotiation stage due to a supply issue. At that time, the company accepted a price below the amount evaluated by the HIRA's DREC and began drug price negotiations. However, a conclusion was not reached within the 60-day negotiation period. Although the National Health Insurance Service (NHIS) intended to enter into an extension negotiation, the renegotiation could not commence because the pharmaceutical company was unable to secure a domestic supply. NMOSD occurs when AQP4 autoantibodies, which are disease-specific markers produced by B cells, bind to the target antigen Aquaporin 4 (AQP4) on astrocytes in the central nervous system, thereby activating an immune response that leads to neurological damage. Uplizna is a CD-19-targeting humanized monoclonal antibody, developed using a novel mechanism, that prevents disease relapse by selectively binding to CD19, a B-cell-specific surface antigen, to deplete AQP4 antibody-producing B cells. Uplizna's safety and efficacy were demonstrated in the N-MOmentum clinical study, a monotherapy study conducted in 230 patients without concomitant immunosuppressants. The study results showed that 89% of patients who received Uplizna did not experience a relapse during the 197-day follow-up period, demonstrating a 77.3% reduction in relapse risk compared with the placebo group. The safety evaluation also showed a similar rate of adverse events to the placebo group.
- Company
- Generic companies win 1st trial on unlisted Jardiance patent
- by Kim, Jin-Gu Nov 17, 2025 06:10am
- Generic drugmakers have scored the first victory in Korea’s ongoing disputes over unlisted patents related to the SGLT-2 inhibitor class diabetes treatment Jardiance (empagliflozin). Industry observers expect this decision to set the tone for similar disputes surrounding Jardiance's unregistered patents that are pending. According to industry sources on the 15th, the Intellectual Property Trial and Appeal Board (IPTAB) ruled in favor of four Korean generics companies, including Chong Kun Dang, Genuone Science, Korea Prime Pharm, and Huons, in an invalidation trial they filed against Boehringer Ingelheim’s unlisted use patent for Jardiance. This is effectively the first conclusion made regarding the disputes surrounding Jardiance's non-listed patents. Since January last year, Chong Kun Dang and the other companies have filed successive invalidation trials against the patent for ‘Therapeutic Uses of Empagliflozin (Patent No. 10-2318207)’. This patent pertains to the treatment and prevention of cardiovascular diseases in diabetic patients using empagliflozin. It expires in April 2034. A total of 7 unregistered patent disputes related to Jardiance are currently ongoing. Generic companies have filed successive trials against unlisted Jardiance-related patents since August 2023. All related patents pertain to the uses of empagliflozin or empagliflozin+linagliptin. Specifically: ▲1 patent expiring November 2027 (10-1463724) ▲1 patent expiring August 2028 (10-1491554) ▲1 patent expiring in February 2030 (10-1694136) ▲1 patent expiring in October 2030 (10-1737142) ▲Three patents expiring in April 2034 (10-1725469/10-2318207/10-2309654), etc. The patent that expires in November 2028 has drawn the most challenges. 13 companies, including Chong Kun Dang, Hanmi Pharm, PharmGen Science, DongKoo Bio&Pharma, Daehan Nupharm, Dongwha Pharm, Youngpoong Pharm, Withus Pharmaceutical, JW Pharmaceutical, Medica Korea, Boryung, Aprogen Biologics, and Korea Pharma filed invalidation trials, while Aju Pharm has filed a passive scope confirmation request. For the 2028 combination-use patent (empagliflozin + linagliptin), 9 companies, including Genuone Sciences, Boryung, Dongkook Pharmaceutical, Medica Korea, Aprogen Biologics, Korea Prime Pharm, Daewha Pharm, GC Biopharma, and Aju Holdings, have each filed for invalidation trials and passive scope confirmation trials. In addition, Hana Pharm and Aju Pharm filed avoidance trials for the 2030 empagliflozin + metformin related use and formulation patent, while Genuone Sciences filed an invalidation trial for the 2030 triple-combination patent (empagliflozin + linagliptin + metformin). However, Genuone Science voluntarily withdrew this trial. For the 3 patents expiring in April 2034, companies including Chong Kun Dang, Genuone Science, Korea Prime Pharm, Huons, and Cosmax Pharma are currently challenging them for invalidation or seeking to circumvent them. With this first trial decision regarding Jardiance's non-registered patents issued, the industry anticipates that similar pending cases will follow with first-instance conclusions. Indeed, in most cases, examiners have been assigned to panels for deliberation. If generic companies prevail in multiple disputes over non-listed patents, they could significantly reduce their patent risks. Non-listed patents are those registered with the Korean Intellectual Property Office but not included in the Ministry of Food and Drug Safety's Green list. Since they are not listed, they have no impact on generic product approvals. However, product launch is a different matter. The original drug’s company can claim infringement of unregistered patents. If the Patent Trial and Appeal Board or the Patent Court finds the generic company in infringement of the patent, the original drug’s company can then seek a preliminary injunction to halt product sales and claim damages for patent infringement. From the generic company's perspective, overcoming all unregistered patents is necessary to fully eliminate patent risk.
- Company
- "Expanded access to Pergoveris…for older infertile women"
- by Son, Hyung Min Nov 14, 2025 06:12am
- The paradigm of infertility treatment is shifting amid the increased age of mothers and the expansion of the patient population with poor ovarian response (POR). Notably, the utilization of FSH (Follicle-Stimulating Hormone) and LH (Luteinizing Hormone) combination therapy has surged since the reimbursement criteria for 'Pergoveris inj (follitropin alfa, lutropin alfa)' were eased last year. Consequently, a personalized ovulation induction strategy focused on older and low-responder patients is emerging as the core of domestic infertility treatment. In response to this change, Merck Korea held a 'Fertility Academy' on November 13 at the Parnas Hotel in Gangnam-gu, Seoul, to share the clinical value of Pergoveris and emphasize the importance of personalized treatment strategies. The event was held to commemorate Infertility Family Day (November 11), which was established to encourage infertile couples, raise social awareness, and share the clinical value and personalized treatment strategies associated with Pergoveris. The expanded insurance reimbursement for Merck's ovulation induction injection last April provided new treatment opportunities for many infertility patients. Professor Hee Jun Lee of CHA Gangnam Medical CenterPreviously, Pergoveris was only reimbursed (up to 2 vials/day) for assisted reproductive technology in patients with severe endogenous Luteinizing Hormone (LH) deficiency (concentration below 1.2 IU/L). However, the reimbursement criteria were expanded to cover 'cases where Pergoveris is administered (up to 2 vials/day) for ART in patients with LH deficiency.' Consequently, patients can now receive reimbursement benefits for Pergoveris without restriction based on LH levels. Pergoveris is the only approved combination product in Korea that mixes recombinant rFSH and r-hLH. It has shown significantly improved results across all indices, including pregnancy rate, cumulative pregnancy rate, and pregnancy rate per embryo transfer, compared to FSH monotherapy. These data were consistent in the real world. A large-scale analysis involving 10,000 poor ovarian response patients showed that Pergoveris resulted in a higher cumulative live birth rate compared to FSH monotherapy. The effect of Pergoveris was particularly pronounced in cases of severe poor ovarian response. Professor Hee Jun Lee of CHA Gangnam Medical Center's Department of Obstetrics and Gynecology assessed, "In older mothers and those with poor ovarian response, a treatment strategy that considers the balance of FSH and LH is paramount." He added, "It has been confirmed across multiple clinical trials and international expert consensus that co-administering recombinant LH from the beginning of ovulation induction improves both implantation and pregnancy success rates." Professor Lee added, "Given the high proportion of older mothers in Korea, the preference for combination therapy is increasing in actual clinical practice. The FSH + LH combination, primarily with Pergoveris, is becoming a key treatment strategy. The expanded reimbursement for Pergoveris has been a great help to patients. However, support for oocyte cryopreservation is still lacking, and there is room for improvement." Professor Lee emphasized, "The importance of early treatment for infertility is continuously stressed. As the efficacy and safety of these injectable agents have been confirmed, it is necessary to start treatment early." Merck's efforts to improve access for Korean infertility patients The infertility sector is particularly important due to the unique situation of low birth rates and aging demographics. Korea's fertility rate was 0.75 last year, the lowest in the world, and the population is expected to halve by the end of this century. The country remains at the lowest level among OECD nations. Demand for infertility treatment is also rapidly increasing due to the rise in older mothers. As of 2022, women aged 35 and over accounted for 70% of those receiving infertility procedures. Female fertility rapidly declines after age 35, often leading to Low Ovarian Reserve (LOR). When ovarian function is reduced, ovulation is less regular, and oocyte quality decreases, lowering fertilization and implantation rates. Merck is involved in social activities to address the low birth rate, going beyond simply supplying treatments. Kim Wook, Healthcare Fertility Unit Head at Merck KoreaMerck currently supplies the ovulation inducers 'Gonal-F' and 'Luveris,' in addition to Pergoveris, and has developed treatments for preventing premature ovulation. Merck launched the 'Fertility Counts' initiative in 2023 to discuss and respond to the socioeconomic challenges arising from declining birth rates in the Asia-Pacific (APAC) region. Fertility Counts was established to support effective policy intervention by authorities in building a family-friendly society through relevant research and resource provision, emphasizing the need for improved fertility-related policies to help those who wish to have children. In particular, Merck plans to continue its environmental, social, and governance (ESG) activities in Korea through its Infertility Awareness Campaign. Last year, Merck and the Korean Infertility Family Association signed an MOU to address the growing social problem of infertility rates. Kim Wook, Healthcare Fertility Unit Head at Merck Korea, stated, "We are conducting various activities in collaboration with multiple stakeholders, including the Fertility Counts initiative, the Family-Friendly Future Forum, a network of companies, government, and academia, as well as collaboration with infertility patient groups," and added, "We will continue our efforts, focusing on Pergoveris, to contribute to healthy births for Korean mothers."
- Company
- Generic company challenges flu drug Xofluza’s patent
- by Kim, Jin-Gu Nov 14, 2025 06:12am
- Roche's influenza treatment Xofluza (baloxavir marboxil) has become a generic company’s target for patent challenge. This marks the first patent challenge against Xofluza. Industry observers predict related patent challenges will continue in the near future. According to industry sources on the 13th, Kwangdong Pharmaceutical recently filed a passive scope of rights confirmation trial against Shionogi & Co. regarding Xofluza’s formulation patent. Shionogi is the original developer of Xofluza, and Roche Korea is currently in charge of its domestic sales. A total of 4 patents related to Xofluza are currently registered. These include two substance patents expiring in 2031 and 2036, respectively, and two formulation patents expiring in 2038 and 2039, respectively. Among these, Kwangdong Pharmaceutical has filed a circumvention trial against the formulation patent (for a solid formulation with excellent stability) that expires in April 2039. The industry anticipates that patent challenges against Xofluza will likely expand in the future. Kwangdong Pharmaceutical is expected to file an additional challenge against one of the remaining formulation patents. If Kwangdong Pharmaceutical successfully avoids both formulation patents, it could bring forward the launch date for Xofluza generics to September 2036. There is also speculation that other generic companies may follow suit with patent trial applications. Under current regulations, to satisfy the requirement of being the “first to file a trial request” and obtain exclusive marketing rights (first generic exclusivity rights), companies only need to file the same trial request within 14 days. As a result, it is projected that patent challenges from other generic companies besides Kwangdong Pharmaceutical will continue until the end of this month. Previously, a total of 10 companies participated in the patent challenge against another influenza treatment, Peramiflu inj (Peramivir). Xofluza is an influenza treatment approved in Korea in 2019. Roche introduced Xofluza as a successor to its existing influenza treatment Tamiflu (oseltamivir). Unlike Tamiflu, which requires oral administration over 5 days, Xofluza offers improved convenience in administration by enabling treatment with a single injection. However, Xofluza is currently a non-reimbursed drug, resulting in limited domestic sales performance. If it succeeds in gaining reimbursement status, projections indicate it could absorb Tamiflu's sales. According to the Ministry of Food and Drug Safety, Xofluza’s domestic import sales were around USD 1.6 million in 2022-2023 but surged significantly to USD 7.38 million (approximately KRW 10.8 billion) last year.
- Company
- AZ runs Lung Health Check Bus…screens Changwon residents
- by Son, Hyung Min Nov 14, 2025 06:11am
- The ‘Lung Health Check Bus’ was operated in the ‘2025 Anti-Aging BIOHealth Expo’ that was held at the Changwon Exhibition and Convention Center (CECO) from the 6th to 8thAstraZeneca Korea announced on the 12th that it operated a ‘Lung Health Check Bus’ equipped with AI-based chest X-ray technology at the ‘2025 Anti-Aging BIOHealth Expo (ABEXPO 2025)’, which was held at the Changwon Exhibition and Convention Center (CECO) in Gyeongsangnam-do from the 6th to the 8th, in collaboration with the Korea Tuberculosis Association and Maihub. ABEXPO 2025 is Korea’s premier healthcare exhibition dedicated to advancing healthy longevity and innovation in the anti-aging industry in response to an aging society. The event showcased next-generation anti-aging solutions that integrate cutting-edge technologies such as AI, biotechnology, and digital healthcare. The Lung Health Check Bus was showcased as a representative example of digital healthcare applying AI to enable early screening of lung diseases, embodying the starting point of anti-aging medicine, “disease prevention through early detection.” Notably, Changwon, the host city of the exhibition, officially entered a super-aged society in June, with more than 20% of its population aged 65 or older, a demographic particularly vulnerable to cardiovascular and pneumonia-related risks. AstraZeneca Korea participated in this expo with the aim of expanding healthcare access beyond the capital region to rural areas. Moving forward, it plans to continue touring the nation with the Lung Health Check Bus, supporting diverse citizens to easily check their lung health. During the expo, approximately 570 visitors came to the booth to experience AI-based chest X-ray screening. Visitors were able to directly check their lung health status through the interpretation reports provided on-site. Fifty-seven percent of the examinees were aged 50 or older. The AI reports detected abnormal findings, such as lung nodules (165 individuals), in 238 people (42%). Among those with abnormal findings, 11% (26 individuals) had a family history of lung cancer. The results of the specialist's detailed interpretation were sent to each individual within a week. Abnormal findings detected on chest X-rays can be associated with various lung and cardiovascular diseases, including lung cancer, making early detection and prompt management crucial. Confirming uncertain lung nodules is also essential for the early diagnosis of lung cancer. Lung cancer was the leading cause of cancer-related mortalities in Korea in 2023. Beyond smoking, it can arise from various factors, including family history, secondhand smoke, and environmental exposures like air pollution. Lung cancer often presents with minimal early symptoms or, even when the disease has progressed, may show no significant symptoms beyond coughing and sputum production. At the time of diagnosis, 41.4% of patients already have distant metastases. According to 5-year relative survival rate statistics from 2018-2022, the survival rate is only 12.9% when lung cancer metastasizes to other sites. However, if detected at a localized stage, the survival rate significantly increases to 79.8%. The current national lung cancer screening program targets high-risk individuals aged 54 to 74 with a smoking history of 30 pack-years or more, utilizing low-dose chest CT scans. Additionally, AI-based chest X-rays are being regarded as an effective tool for lung cancer diagnosis due to their high detection rate of pulmonary nodules. At the Changwon ABEXPO, a Lung Health Check Bus was operated as a way for non-smokers and low-risk citizens to check their lung health through AI chest X-rays. Jiyoung Ahn, Executive Director of Strategy and External Cooperation at AstraZeneca Korea, stated, "AstraZeneca Korea is creating practical solutions to enhance access to early diagnosis and treatment through collaboration with domestic AI healthcare companies. The Lung Health Check Bus is a prime example demonstrating how cutting-edge AI technology can directly contribute to public health.“ She added, ”We hope the AI-integrated Lung Health Check Bus will address the screening gap for lung cancer in non-smokers and serve as an opportunity to spread awareness about the importance of early screening. AstraZeneca Korea will continue to contribute to raising awareness for early lung cancer diagnosis and improving the quality of public health through science-driven collaboration and practice." Min-seok Shin, President of the Korea Tuberculosis Association, stated, “We hope this campaign enables more citizens to easily check their lung health and detect diseases early. The Korea Tuberculosis Association will continue its efforts to promote nationwide lung health and expand screening accessibility.” Hyeok Yang, CEO of Maihub, said, “Digital healthcare technology is a crucial means of innovating personal health management and increasing access to medical services. The Lung Health Check Bus, which utilizes AI chest X-ray technology, holds significance as it demonstrated how advanced technology can contribute to actual public health improvement. We will continue to strive to build a healthy society based on public benefit and innovation.” Visitors to the ‘2025 Anti-Aging BIOHealth Expo’ held at the Changwon xhibition and Convention Center from the 6th to the 8th are receiving on-site lung health interpretation reports after having AI-equipped chest X-rays taken at the Lung Health Check Bus. As a member of the global non-profit collaboration ‘Lung Ambition Alliance (LAA)’, AstraZeneca Korea has been continuing various initiatives to create ‘a world where lung cancer is no longer a cause of death’. Last year, AstraZeneca Korea and the LAA launched the ‘Lung Cancer Zero’ campaign. In collaboration with the British Chamber of Commerce in Korea and the British Embassy Seoul, they expanded the reach of lung cancer awareness activities across various sectors of society. Last June, AstraZeneca Korea signed a tripartite Memorandum of Understanding (MOU) with the Korea Tuberculosis Association and Maihub to successfully operate the ‘Lung Health Check Bus’ campaign. It is leading the way in early detection of lung diseases by operating mobile screening buses nationwide, equipped with AI chest X-ray imaging capabilities. Participating in this Changwon Expo is part of the effort to create an early screening environment accessible to everyone, extending beyond the capital region to local communities. AstraZeneca Korea has been expanding its collaboration with Korea’s AI and digital healthcare ecosystem. Specifically, it is conducting joint research and pilot projects with various domestic startups across diverse fields, including: ▲AI image analysis (OncoSoft, AVIS), ▲Precision medicine and genomic analysis (3Billion), and ▲digital patient community and health data-based management solutions (Humanscape, Maihub), to build innovative healthcare models applicable in real clinical settings.
- Company
- "Life-cycle prevention system completed with Prevenar 20"
- by Son, Hyung Min Nov 13, 2025 06:07am
- "As pneumococcal infections occur in both adults and children, the need to establish a full-life-cycle prevention is growing. Especially given the high mortality rates in children, the elderly, and chronic disease patients, prevention-centered management is considered important. With the recent launch of 'Prevenar 20,' the 20-valent pneumococcal conjugate vaccine (PCV20), in Korea, a vaccination strategy that does not vary by age is once again drawing attention." On November 12, Pfizer Korea held a press conference at its headquarters in Jung-gu, Seoul, to commemorate the domestic launch of the pneumococcal vaccine Prevenar 20, emphasizing the vaccine's utility. Prevenar 20 is the first new pneumococcal vaccine introduced by Pfizer in approximately 15 years since Prevenar 13. The vaccine includes the 13 serotypes common to the existing Prevenar 13, plus 7 additional serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F). Prevenar 20 was officially launched on the market approximately one year after receiving domestic approval last November. Comparison table for different serotypes in various pneumococcal vaccines. Prevenar 20 can be used for ▲the prevention of invasive disease, pneumonia, and acute otitis media caused by pneumococcus (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) in infants, children, and adolescents aged 6 weeks to under 18 years ▲the prevention of invasive disease and pneumonia caused by pneumococcus in individuals aged 18 and older. Among these serotypes, 10A and 15B are the most common causes of invasive pneumococcal disease in Korean children. According to a study tracking IPD in 20 domestic hospitals between 2016 and 2023, serotypes 10A and 15B were the most frequently isolated vaccine serotypes, and those serotypes included in Prevenar 20 accounted for over half (54%) of all pediatric infections. Professor Dong Hyun Kim of the Department of Pediatrics at Inha University Hospital A pneumococcal serotype analysis study conducted by the Korea Disease Control and Prevention Agency (KDCA) from July 2018 to July 2021 confirmed the same results. Of the total 67 pediatric infection cases, 36 cases (approx. 54%) were due to the 10A and 15B serotypes included in Prevenar 20. The 20 serotypes included in Prevenar 20 also accounted for approximately 51% of adult cases during the same period. Professor Dong Hyun Kim of the Department of Pediatrics at Inha University Hospital explained, "In pediatric infection cases, the 10A and 15B serotypes are most prevalent, and this trend continues into adult infections. " NIP inclusion reduces 'Infection Blind Spots' With Prevenar 20 recently included in the National Immunization Program (NIP), the infection management system is shifting. While the existing 13-valent vaccine focused on pediatric prevention, the expanded serotype coverage now enables protection across all generations. According to the healthcare big data of Health Insurance Review & Assessment Service (HIRA), the number of patients with pneumococcal pneumonia increased about 9-fold, from 1,063 in 2021 to 10,191 in 2024. Of these, over half (51.9%, or 5,292 cases) were in infants and young children under the age of five, indicating that the primary infection remains in the pediatric population. Pneumococcus is a bacterium that can reside in the upper respiratory tract of healthy people and is a major cause of bacteremia, meningitis, pneumonia, and otitis media in infants and young children. It also acts as a primary cause of secondary bacterial infections following influenza, playing a significant role in other respiratory viral infections. The KDCA expects that this NIP inclusion will achieve both higher pediatric vaccination rates and reduced community infections. Since the introduction of the 13-valent vaccine previously resulted in an approximate 70% reduction in the incidence of invasive disease, the vaccination effect of this 20-valent vaccine is also expected to appear quickly. Pfizer Korea held a press conference to commemorate the launch of Prevenar 20 in South Korea. Song Chan-woo, Vice President of Pfizer Korea, said, "Pneumococcus is an infectious disease that has a fatal impact not only on the elderly but also on healthy children," and emphasized, "Prevenar 20 is an integrated solution that offers expected preventive efficacy regardless of age, and will contribute to enhancing the efficiency of infection management at the national level." Professor Kim said, "Over half of the confirmed invasive pneumococcal infections in Korea are caused by serotypes included in Prevenar 20," and emphasized, "Ultimately, vaccination itself is more important than distinguishing by age." Professor Kim explained, "While a 21-valent vaccine has also been developed recently, it is difficult to determine which one is superior in terms of efficacy as sufficient clinical data have not yet been accumulated," and said, "Although the vaccination schedule was changed during the COVID-19 pandemic, some aspects are not yet fully reflected in the epidemiological analysis."
- Company
- Former AZ Director Do to lead New Business at Lilly Korea
- by Eo, Yun-Ho Nov 13, 2025 06:07am
- AstraZeneca Commercial Director David H. Do Former AstraZeneca Commercial Director David H. Do (39) has taken on a new leadership role at Lilly Korea. According to industry sources, Lilly Korea recently appointed AZ Commercial Director Do to lead its newly launched Neurology Business Division. .As a result, Director Do will oversee sales and marketing for Lilly's neurology product portfolio, including ‘donanemab,’ a next-generation Alzheimer's treatment gaining global attention .Director Do joined AstraZeneca Korea in 2020 as Executive Director of External Affairs, where he led negotiations with the Korean government during the early stages of the COVID-19 pandemic, successfully securing the supply of vaccines and antibody therapies .He also contributed to stabilizing the global supply chain through a manufacturing partnership with SK Bioscience .His contributions were recognized with the Minister of Health and Welfare Award .From 2023, Director Do worked at AstraZeneca’s global headquarters in Cambridge, UK, where he helped establish the Vaccines & Immune Therapies Division and developed strategies for the GLP-1 portfolio, playing a key role in the development and commercialization of next-generation therapies .Before entering the pharmaceutical industry, Do served as a Project Leader at the Boston Consulting Group (BCG), where he led numerous projects across the technology and healthcare sectors, including new business development, performance improvement, and due diligence .Do holds a Bachelor’s degree in Neuroscience from King’s College London, a Master’s degree from Imperial College London, and a Ph.D .in Clinical Medicine (Endocrinology & Diabetes) from the University of Oxford.
- Company
- UCB Korea appoints Edward Lee as new GM
- by Son, Hyung Min Nov 13, 2025 06:07am
- Edward Lee, new General Manager of UCB Korea UCB Korea announced that Edward Lee has been appointed as its new General Manager, effective November 1. Edward Lee is an expert with over 15 years of experience in the global pharmaceutical industry, in areas ranging from Market Access, Medical Affairs, to Health Economics & Outcomes Research (HEOR). Lee has a strong background in driving patient-centered innovation and advancing sustainable healthcare ecosystems. Since joining UCB in 2016, Lee has held key leadership positions at the US and UK subsidiaries, as well as at the Intercontinental Headquarters. Most recently, he served as Head of Access, Sustainability, and External Engagement at the Intercontinental Headquarters, where he led strategies to improve healthcare access and promote health equity. Prior to joining UCB, he worked at Astellas and Boehringer Ingelheim, leading multiple drug value assessment and patient access initiatives. He earned a Doctor of Pharmacy degree from the University of Illinois at Chicago and completed a Health Economics and Outcomes Research (HEOR) program through a joint fellowship with Thomas Jefferson University and Daiichi Sankyo. The new GM said, “UCB Korea will continue to advance change and innovation by enhancing access to innovative therapies based on patient-centric principles and building a sustainable healthcare ecosystem. We will strengthen collaboration with patients, healthcare professionals, the government, and various partners throughout the approval and reimbursement listing processes for new products, to ensure Korean patients can benefit from new treatments as quickly as possible.” UCB Pharma is the Korean subsidiary of UCB, a global biopharmaceutical company headquartered in Belgium, which is dedicated to continuous research and development in neurology and immunology. Recently, the company obtained local approvals for Bimzelx (for plaque psoriasis), Zilbrysq, and Rystiggo (for generalized myasthenia gravis). Its treatment for Dravet syndrome, an extremely rare and severe pediatric intractable disease, was designated as the 30th GIFT (Global Innovative product on Fast Track) item in May 2024. It was also selected for the Approval-Evaluation-Negotiation pilot program in December of the same year and is currently undergoing the domestic approval process and reimbursement review by the Health Insurance Review and Assessment Service (HIRA).
- Company
- Korea’s bio-industry production hits ₩22.9 trillion
- by Kim, Jin-Gu Nov 12, 2025 06:19am
- Last year, the domestic bio industry's production scale reached KRW 22.9216 trillion, a 9.8% increase compared to the previous year. Exports rose 17.1% year-on-year, driven by existing key export items such as antibody drugs and CMO for biopharmaceuticals. R&D investment increased by 3.2%. The Ministry of Trade, Industry and Energy, in collaboration with the Korea Biotechnology Industry Association, announced the results of the ‘2025 Domestic Bioindustry Status Survey’ on the 11th. The survey includes the status of production, exports/imports, employment, and investment in the bio industry as of 2024. According to the survey results, the domestic bio industry's production scale reached KRW 22.9216 trillion, a 9.8% increase compared to the previous year. By year, the figures were KRW 17.1983 trillion in 2020, KRW 21.3971 trillion in 2021, KRW 23.8160 trillion in 2022, and KRW 20.8713 trillion in 2023, showing a sustained high average annual growth rate of 7.4% over the last 5 years. The biopharmaceutical sector holds the largest share of production scale. As of 2024, the biopharmaceutical sector's production scale reached KRW 8.4305 trillion, accounting for 36.8% of the total biotechnology industry production scale. This is followed by the bio-food sector (including health functional foods and fermented foods) at 20.0%, and the bio-service sector (including contract manufacturing and bio-analysis) at 17.4%. The production scale of the biopharmaceutical sector increased by 33.2% from KRW 6.3313 trillion in 2023. By specific product category, therapeutic antibodies and cytokine preparations led the production expansion, growing 53.7% year-on-year to KRW 4.8645 trillion. Additionally, biomanufacturing and contract services recorded KRW 3.2179 trillion, a 5.2% increase from the previous year. Biotech exports grew by 17.1% from KRW 11.7081 trillion in 2023 to KRW 13.7109 trillion in 2024. During the same period, imports increased by 10.4% from KRW 3.3452 trillion to KRW 3.6917 trillion. Growth in the biopharmaceutical sector was particularly notable in exports. Biopharmaceutical exports, which were KRW 4.2978 trillion in 2023, increased by 46.0% to KRW 6.2740 trillion last year. Therapeutic antibodies and cytokine preparations, in particular, showed an increase of KRW 1.5939 trillion won over one year. The workforce in the biotech industry reached 65,818 people in 2024, a 1.5% increase from the previous year. Compared to 52,297 people in 2020, this represents an average annual growth rate of 5.9% over the past 5 years. By job type, research positions increased by 1.8% from 19,432 to 19,877. Production roles grew by 1.9% from 21,746 to 22,151. Sales, management, and other positions rose by 0.8% to 23,879. Total investment in 2024 reached KRW 5.4821 trillion, a 46.1% increase compared to KRW 3.752 trillion in 2023. During this period, R&D expenses rose 3.2% from KRW 2.6188 trillion to KRW 2.7024 trillion, while facility investment costs surged approximately 2.5-fold from KRW 1.1332 trillion to KRW 2.7797 trillion. Woo-hyuk Choi, Director-General for Advanced Industry Policy at the Ministry of Trade, Industry and Energy, stated, “Despite the uncertain global trade environment, the bio industry is recovering its growth momentum. We will strengthen support for companies to boost their R&D, production, and exports so that the sector can make an even greater contribution to our economy and employment.”
- Company
- Biotech firms with net loss overestimate their performance
- by Cha, Jihyun Nov 12, 2025 06:19am
- While Korean biotech and healthcare companies are using the Technology Exception Listing system to challenge the Initial Public Offering (IPO) market, there have been concerns over their valuation methods. Critics argue that some companies are excessively inflating their valuations by presenting overly optimistic estimates of future performance or by selecting comparables that are significantly larger and established at the public offering price. All 2024 listed biotech companies are in deficit, but the futue estimated earnings used for IPO price show tens of billions in surplus According to the Financial Supervisory Service (FSS) on the 12th, a total of 10 biotech and healthcare companies have been listed through the Technology Exception Listing system this year. Starting with Orum Therapeutics in February, OrganoidSciences, ROKIT Healthcare, ImmuneOncia, and IntoCell were listed in May. GC Genome debuted on the stock market in June, followed by Neurofit and Protina in July. G2GBIO and Graphy entered the KOSDAQ market in August. Other companies are also pursuing listings through the Technology Exception Listing system, with Curiosis, AimedBio, Rznomics, QuadMedicine, and LivsMed having submitted IPO registration statements to the Financial Services Commission. The Technology Exception Listing system is a regulatory measure designed to lower the listing barrier for companies with technology and growth potential but that lack profitability. It is considered the primary IPO channel for biotech companies that invest massive amounts in new drug development without clear revenue streams. Most companies listed via the Technology Exception Listing system use the Relative Valuation Method to calculate their public offering price. The prevalent method involves applying the Price-to-Earnings Ratio (PER) of comparable listed companies in the same industry to the listing applicant's estimated future earnings. The PER, calculated by dividing the stock price by earnings per share, is an index that comprehensively reflects a company's profitability, risk, and market valuation from its operating activities. Thus, future growth potential, rather than current earnings, becomes the core criterion for the public offering price. However, the problem is that the public offering price is often calculated higher than its actual value due to questionable practices in estimating future earnings and selecting comparable companies. An analysis of the registration statements of 15 biotech and healthcare companies that listed or are pursuing listing via the Technology Exception Listing system this year showed that not a single company was profitable in 2024. All 15 surveyed companies were in a net loss position. Despite this, most of these companies projected they could achieve a net profit of KRW 10-90 billion within 2-3 years. They claim significant results can be achieved through early technology exports from underdeveloped pipelines, product approvals, and product sales. "2025 Biotech and healthcare companies that were listed using the Technology Exception Listing system. Their estimated profit and the actual net profit when listed"; COLUMN1 (COMPANIES): Orum Therapeutics, OrganoidSciences, ROKIT Healthcare, ImmuneOncia, IntoCell, GC Genome, Neurofit, Protina, G2GBIO, Graphy, Curiosis, AimedBio, Rznomics, QuadMedicine, and LivsMed; COLUMN2 (2024 NET PROFIT in KRW 100M); COLUMN3 (FUTURE ESTIMATED NET PROFIT). (source: Financial Supervisory Service) AimedBio reported the highest future estimated net profit, projecting KRW 87.1 billion by 2029. This is an aggressive target, considering AimedBio recorded a consolidated net loss of KRW 3.3 billion last year. LivsMed, which recorded a consolidated net loss of KRW 13.9 billion last year, projected an estimated net profit of KRW 71 billion by 2027. Rznomics, which recorded a separate net loss of KRW 18.9 billion last year, projected net profits of KRW 35.3 billion in 2027, KRW 2.9 billion in 2028, and KRW 67.2 billion in 2029. G2GBIO showed the largest gap between current earnings and future estimates. G2GBIO reported a separate net loss of KRW 83.3 billion last year, yet the company projected a net profit of KRW 40 billion by 2029. ImmuneOncia projected KRW 51.7 billion by 2028; Neurophit projected KRW 9.1 billion in 2027 and KRW 28.9 billion in 2028; and IntoCell projected KRW 24 billion in net profit by 2027, all of which were used as bases for calculating their public offering prices. Orum Therapeutics was the only surveyed company that reflected actual earnings, not future estimates, in its public offering price calculation. The company calculated its corporate value using net profit based on its Last Twelve Months (LTM) ending Q3 2024 (which combined performance from Q4 2023 to Q3 2024). This allowed the company to set its public offering price based on actual earned revenue, primarily driven by technology fees from a large-scale technology export agreement with a global big pharma, rather than on mere projections. However, whether the proceeds from technology exports are one-time or sustainable still needs to be assessed. Although not included in the public offering price calculation, Orum Therapeutics projected it could achieve KRW 75.2 billion in sales and KRW 34.7 billion in net profit in 2026. This calculation is based on the premise of securing additional technology export agreements alongside the inflow of milestones from existing contracts. Comparison to big pharma, multi-trillion-won global firms included...overvaluation has been pointed out Analysis suggests that not only are the future earnings projections presented by the listing companies overly optimistic, but the selection of comparable companies also lacks justification. A review of the similar companies selected by the 15 surveyed firms shows a high proportion of major pharmaceutical companies like Hanmi Pharmaceutical, Chong Kun Dang, and Daewoong Pharmaceutical. Unlike the pre-listing companies, which are not generating profit, these comparables boast annual revenues exceeding KRW 1 trillion. A significant number of firms also presented overseas companies as comparables. GC Genome, the genomics analysis affiliate of Green Cross Group, selected four comparable companies, including the domestic firm Boditech Med, along with Revvity, Hologic, and Diasorin. Except for KOSDAQ-listed Boditech Med, the other three companies in GC Genome's peer group are overseas-listed global diagnostic firms with annual revenues in the trillions of KRW. Protina also included Danaher and Revvity in its peer group, and Graphy selected all overseas firms as comparables, including Align Technology, Straumann Holding AG, and Modern Dental Group. Curiosis and LivsMed also included a large number of major global companies with net profits in the trillions of KRW in their comparable groups. Comparables and PER discount rate of biotech and healthcare companies listed in 2025 using the Technology Exception Listing system. COLUMN1 (COMPANIES): Orum Therapeutics, OrganoidSciences, ROKIT Healthcare, ImmuneOncia, IntoCell, GC Genome, Neurofit, Protina, G2GBIO, Graphy, Curiosis, AimedBio, Rznomics, QuadMedicine, and LivsMed; COLUMN4 (per-share valuation calculation). (source: Financial Supervisory Service) The inclusion of conglomerate companies in the comparable groups also led to higher PERs in the per-share valuation calculation. LivsMed's calculated PER, based on the market value of its peer group, was 45.5 times, the highest applicable PER among the 15 surveyed companies. This was followed by Rznomics (29.6 times), Graphy (29.0 times), G2GBIO (28.1 times), and QuadMedicine (27.5 times). Emerging-technology companies cannot set the public offering price on their own. The estimated earnings and comparable companies are determined through consultation between the company and the listing underwriter, based on a comprehensive consideration of the listing applicant's technology and market outlook. Furthermore, the final public offering price is confirmed only after a second step involving institutional investor demand forecasting, followed by applying a discount rate to the estimated earnings to determine the desired public offering price range. However, the market assessment is that the public offering prices for biotech and healthcare companies are being set at an excessively unrealistic level. Indeed, the majority of emerging-technology biotech companies fail to achieve the earnings estimates presented in the public offering price calculation. Experts commonly point out that biotech companies, which lack visible earnings such as sales or profits, are more likely to overestimate their public offering price than conventional companies.
