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- 2026-04-03 16:43:03
- Company
- Minimally invasive 'da Vinci robotic surgery'
- by Whang, byung-woo Jul 22, 2025 06:05am
- As robotic surgery becomes a global standard, the industrial robotics market continues to grow in size. In South Korea, where Intuitive Surgical's first Asian branch was established, the market presence of da Vinci robotic surgery is increasingly broadening as it marks its 20th anniversary since its introduction to the country. Intuitive Surgical Korea (hereinafter referred to as Intuitive) recently held a press conference to share its achievements over the past 20 years and its future vision. Da Vinci Robotic Surgical System-Assisted Surgery Synergy with Korean Medical Professionals' Leadership Since the introduction of the da Vinci Robotic surgical systems (hereinafter referred to as 'da Vinci') to South Korea, Intuitive has conducted a cumulative incidence of robotic surgery of over 370,000 cases until now. As of 2024, this record indicates that a surgery was conducted every 8 minute 15 second in average. Yong-Bum Choi, CEO of Intuitive Surgical KoreaKorea is performing single-port robotic surgery (da Vinci), which makes only one incision, more actively than any other country globally, demonstrating the leadership of Korean medical professionals. Indeed, Intuitive has consistently introduced innovative technologies to the Korean market, such as being the first country outside of the U.S. headquarters to launch the next-generation robotic surgery system, 'da Vinci 5 (dV 5),' last year. Yong-Bum Choi, CEO of Intuitive Surgical Korea, said, "Over the past 20 years, robotic surgery has drawn a new standard for surgery amidst technological advancements and changes in the medical environment." Choi added, "This is the result of Intuitive's philosophy of 'Patient First, Always' combined with the efforts of domestic medical professionals." This exceptional surgical skill and leadership of Korean medical professionals are factors that led Intuitive's headquarters to choose Korea as a key innovation hub, enabling close cooperation, from the establishment of its first Asian branch (in 2012) to the prioritized introduction of its latest models. Globally, approximately 17 million surgeries have been performed using Intuitive's da Vinci over the past 30 years. Of this, Korea's accumulated experience accounts for 370,000 cases, playing a significant role in establishing the global standard. Over 43,000 research papers utilizing Intuitive's technology have been published since 1998, with more than 4,000 in 2024 alone, indicating a significant contribution by Korean medical professionals to the dissemination of knowledge. Choi presented his vision, stating, "Just as we turned imagination into reality 20 years ago when robotic surgery first emerged, the next 20 years will see a future where, fused with digital technology, patients can receive the best standard of care anytime, anywhere." Infographic of Intuitive During the press conference, the latest robotic surgery system, da Vinci 5 (dV5), was highlighted. da Vinci 5 features over 150 improvements compared to previous models, notably including a 'Force Feedback' function that allows surgeons to feel the force applied to tissue during surgery with their fingertips, a higher-resolution 3D vision system, and AI-based surgical data analysis capabilities. Hyo Jung Kang, Team Leader at Intuitive Surgical Korea, said, "da Vinci 5 sets a new, higher standard for providing better surgeries to more patients through data utilization." Kang emphasized, "You can experience various functions that simultaneously enhance operating room efficiency and patient safety." Robotic Surgery Has Elevated Surgical Outcomes…Accessibility Expansion remains a Challenge As robotic surgery becomes established in clinical settings, its medical value is recognized for improving patient outcomes, and its societal value lies in elevating and standardizing surgical outcomes. Evidence from clinical research indicates that robot-assisted surgery significantly improves patient prognosis compared to traditional open surgery or laparoscopy. A meta-analysis of over 230 papers published across 22 countries over 12 years for 7 cancer types showed that robotic surgery demonstrated improvements in key indicators compared to other surgical methods, including conversion rates (rate of conversion to open surgery), blood loss, complication rates, length of hospital stay, and readmission rates. Choi stated, "What is important is not the advancement of the technology itself, but that it ultimately allows patients to be freer from complications and pain, benefit from reduced hospital stays, and return to daily life quickly," and added, "In that regard, robotic surgery significantly contributes to social value by elevating and standardizing surgical outcomes." However, broadening the accessibility of robotic surgery was mentioned as a challenge that needs to be addressed. This is because most robotic surgeries in Korea are currently performed on a non-reimbursed basis, leading to a substantial cost burden for individual patients. Regarding this, Choi stated, "I believe no one would oppose the aim of increasing patient access to treatment. If more patients can benefit from robotic surgery through national health insurance coverage, I would certainly support it," and added, "However, as reimbursement is an issue that requires coordination among various stakeholders ,including the government and the medical community, a careful consultation process will be necessary." Intuitive Choi noted that robotic surgery is becoming the standard of care globally. He explained, "Currently, in Japan, robotic surgery is reimbursed for most cancer types, and in Taiwan, 46 additional surgeries were added last year, with a total of 65 surgeries now reimbursed." He found it interesting that "the UK's National Health Service (NHS) recently announced its plan to convert 90% of surgeries currently performed by laparoscopy to robotic surgery by 2035." Along with this, regarding market entry by competitors, Choi said, "While over 60 global companies are developing robotic surgery technology in various ways, Intuitive is confident in maintaining its competitiveness with its accumulated experience and sophiscated technology." Finally, Choi added, "It is rewarding when I hear stories from medical professionals who, during their rounds the day after surgery, personally witness patients who underwent robotic surgery quickly returning to their daily lives." He concluded, "Rapid patient recovery indicates that the value of robotic surgery can be shared with more people."
- Company
- LEO Pharma’s 117-year, single-focus strategy
- by Cha, Jihyun Jul 21, 2025 06:08am
- LEO Pharma is a representative symbol of the success of the Danish biotech industry. It is the oldest pharmaceutical company in Denmark, celebrating its 117th anniversary this year. Originally founded as a pharmacy in Copenhagen, Denmark, the company has grown based on its philosophy of standardizing the quality of medicines and supplying them to everyone. LEO Pharma is recognized as a world-class expert in the development of topical medications such as creams, ointments, gels, and foams that are applied directly to the skin. The wound treatment drug Fucidin, sold by Dong Wha Pharmaceutical in Korea, is LEO Pharma's flagship product. The company has also built a solid portfolio of skin disease treatments, including the psoriasis treatments Enstilum Foam and Xamiol, the non-steroidal atopic dermatitis treatment Protopic, and the eczema treatment Advantan. The reason LEO Pharma has been able to establish itself as a globally respected specialty pharmaceutical company lies in its long-term strategy of selection and concentration. Leveraging its expertise in topical formulations for dermatological conditions, LEO Pharma has remained focused on the field of medical dermatology. This sets it apart from many other companies that prioritize diversifying their drug pipelines and generating quick profits. How has LEO Pharma been able to survive in the global market for over 100 years by pursuing a “single-focus strategy” on a single disease group? Anne Jensen, Vice President of Strategy at LEO Pharma’s headquarters in Ballerup, Denmark, explained that the answer lies in Denmark's unique foundation-centered governance structure. LEO Foundation is the largest shareholder of LEO Pharma with approximately 80% of the shares. The remaining 20% is held by Swedish private equity fund Nordic Capital. Jensen explained that the company was able to consistently invest in specialized areas such as dermatological treatments — which are often difficult to profit from in the short term — because it was shielded from short-term performance pressures and external investor influence. Under the control of the Leo Foundation, which values sustainability over short-term profits, LEO Pharma was able to boldly introduce external innovations and invest in technology. LEO Pharma entered the biopharmaceutical market in earnest in 2016 after acquiring tralokinumab, a candidate drug for the treatment of moderate-to-severe atopic dermatitis from AstraZeneca. LEO Pharma aims to continue building a sustainable growth foundation in the medical dermatology market by pursuing a strategy of securing both internal and external technologies. Anne Jensen, Vice President of Strategy at LEO Pharma - What factors have contributed to LEO Pharma's growth into a global pharmaceutical company specializing in dermatology? LEO Pharma's growth over the past few years has been driven by the success of its atopic dermatitis treatment, Adtralza. This medication, which contains the active ingredient tralokinumab and works by inhibiting IL-13, has significantly strengthened the company’s position in the medical dermatology field. Moving forward, the company plans to drive future growth by leveraging ‘Anzupgo,’ a topical JAK inhibitor for the treatment of chronic hand eczema. Anzupgo is currently available in seven European countries and is awaiting approval under the Prescription Drug User Fee Act (PDUFA) in the United States. - What are LEO Pharma's priorities in terms of expanding its current treatment areas and pipeline? LEO Pharma has established itself as a global leader in medical dermatology. The company is currently focusing on diseases with high unmet medical needs and is pursuing a strategy of jointly developing innovative technologies with partners. Our goal is to leverage the company’s development and commercialization capabilities after introducing new technologies to create maximum value for both patients and companies. For example, we recently began clinical trials to expand the indications for Anzupgo to include palmoplantar pustulosis (PPP) in addition to chronic hand eczema. -What is your outlook for the future of immunology-based skin disease treatments? Over the past 10 to 15 years, the key change in skin disease treatment has been the introduction of immunotherapies. Biologics such as Adtralza, developed by LEO Pharma, have opened up new horizons in the treatment of skin diseases. In the past, skin diseases were considered relatively minor conditions, but now their impact on quality of life is being properly recognized. Skin diseases include more than 1,000 disease groups, and more than 90% of them have no approved treatments. With the advancement of biologics, we predict that the expansion into new disease groups such as atopic dermatitis, psoriasis, and chronic urticaria will accelerate. Our company believes that it can maintain its differentiated positioning based on its agility as a mid-sized pharmaceutical company and its expertise in dermatology by focusing on neglected disease groups that are not addressed by big pharma. -What is LEO Pharma's core strategy in terms of open innovation? We aim to create a “network-based open innovation model.” This strategy involves introducing or jointly developing external assets that have the potential to generate the highest profits for LEO Pharma and provide benefits to patients. From our perspective, this is why it is essential to collaborate with various stakeholders, including academia, patient groups, biotech companies, and pharmaceutical companies. Last year alone, we signed one collaboration agreement each with the Parker Institute and Debra Research, which we expect to play an important role in LEO Pharma's growth. The joint development agreement for STAT6 inhibitors that we signed with Gilead is one of the largest preclinical deals in the industry, with an upfront payment of USD 250 million and a total contract value worth USD 1.7 billion. -What are your thoughts on the Asia-Pacific market that includes South Korea? We are very positive about South Korea and the Asia-Pacific market. South Korea has world-class biotechnology, research capabilities, and an innovative ecosystem, providing an ideal environment for partnerships. We have been covering Korea’s market through excellent distribution partners in South Korea. From a broader perspective of the Asian market, we believe that there are significant opportunities in this region as demand for advanced skin disease treatments is increasing. In fact, China is LEO Pharma's second-largest partner, and we also have a strong local presence in Japan. LEO Pharma plans to further strengthen its position in Asia. - Are there any plans to collaborate with Korean biotech companies, hospitals, or academia? Although we cannot disclose any specific details at this stage, LEO Pharma is always open to opportunities for collaboration with leading Korean companies, hospitals, and institutions. Given Korea's strong reputation in innovation and biotechnology, we believe there is great potential for collaboration. - Does LEO Pharma have any principles that it adheres to in relation to new drug development? Many of the more than 1,000 skin diseases still lack adequate treatment. We believe that innovation requires collaboration, and we are committed to building partnerships with pharmaceutical companies, biotechnology companies, academia, the medical community, and patient organizations. In particular, LEO Pharma is seeking solutions for patients with skin diseases around the world in collaboration with various partners based on five core values: integrity, customer focus, innovation, passion, and adaptability.
- Company
- Omjjara may be prescribed at general hospitals in KOR
- by Eo, Yun-Ho Jul 21, 2025 06:07am
- The new myelofibrosis drug ‘Omjjara’ can now be prescribed in general hospitals in Korea. According to industry sources, GSK Korea's myelofibrosis treatment Omjjara (momelotinib) recently passed review by Drug Committees (DCs) of 13 medical institutions, including Samsung Medical Center, Seoul St. Mary's Hospital, Asan Medical Center Seoul, Kyungpook National University Hospital, Dong-A University Hospital, Seoul National University Bundang Hospital, Ulsan University Hospital, Eunpyeong St. Mary's Hospital, and Ewha Womans University Mokdong Hospital. With the drug’s insurance reimbursement listing in progress, the drug is expected to quickly lead to actual prescriptions once listed. Omjjara passed the Health Insurance Review and Assessment Service's Cancer Review Committee review in March and is currently awaiting submission to the Drug Reimbursement Evaluation Committee. It remains to be seen whether the HIRA process will be completed by the end of this year. The indication currently under review is for the “treatment of myelofibrosis in intermediate- or high-risk adults with anemia.” Omjjara has a triple mechanism of action – it blocks 3 key signaling pathways, not only JAK1 and JAK2 that were inhibited by existing therapies, but also the ACVR1 (activin A receptor type). In the treatment of myelofibrosis, inhibition of JAK1 and JAK2 may contribute to improving systemic symptoms and reducing splenomegaly in patients, while inhibition of ACVR1 may help alleviate anemia by inducing a reduction in hepcidin expression. Anemia management is one of the unmet needs that remain in the treatment of existing myelofibrosis patients. Anemia, which increases blood transfusion dependency, is not merely an issue of dizziness as commonly perceived, but can lead to a life-threatening condition depending on its severity. Omjjara demonstrated significant improvements in key symptoms such as splenomegaly and a reduction in transfusion dependency in patients with anemia-associated myelofibrosis, regardless of prior JAK inhibitor treatment history, in the Phase III SIMPLIFY-1 study and the MOMENTUM study. In the SIMPLIFY-1 study, which evaluated the clinical efficacy and safety of Omjjara in comparison with Jakavi (ruxolitinib) in patients with myelofibrosis and had no prior JAK inhibitor treatment experience, Omjjara demonstrated non-inferiority to ruxolitinib in the primary endpoint of spleen volume response at 24 weeks of treatment. The proportion of patients in each arm who were transfusion-free was 66.5% in the Omjjara arm and 49.3% in the ruxolitinib arm, with significantly lower transfusion dependence (better transfusion independence) in the Omjjara arm. Seo-Yeon Ahn, Professor of Hematology at Chonnam National University Hwasun Hospital, said, “While JAK inhibitors previously used in the treatment of myelofibrosis demonstrated efficacy in reducing splenomegaly and alleviating systemic symptoms, they also posed unmet needs such as worsening anemia or increasing blood transfusion dependency. Omjjara has demonstrated significant clinical value in managing anemia, which is closely linked to the prognosis of patients with myelofibrosis. With its domestic launch, it is expected to contribute to improving treatment outcomes and quality of life for more patients."
- Policy
- Jardiance 10mg price reduced from ₩618 to ₩582
- by Lee, Tak-Sun Jul 21, 2025 06:06am
- The maximum insurance price ceiling for the 10 mg flagship dosage form of the SGLT-2 inhibitor diabetes treatment Jardiance Tab (empagliflozin, Boehringer Ingelheim), will be adjusted as reimbursement will also apply to chronic kidney disease. Jardiance recorded KRW 66.3 billion in outpatient prescriptions (based on UBIST) last year. According to industry sources on the 18th, the insurance price ceiling for Jardiance 10mg will be reduced from KRW 618 to KRW 582 as of August. This is a 5.8% reduction. Along with the price cut, Jardiance 10 mg will also be reimbursed for non-diabetic chronic kidney disease from August. A patient needs to meet all of the following conditions to receive reimbursement for Jardiance 10mg: ▲is on a stable dose of an ACE inhibitor or angiotensin II receptor blocker at the maximum tolerated dose for at least 4 weeks ▲has an eGFR between 20 and 75 ml/min/1.73 m², and ▲urine dipstick test is positive (1+ or higher) or uACR is 200 mg/g or higher. Jardiance is also administered in combination with other standard treatments for kidney disease. Another SGLT-2 inhibitor, dapagliflozin, has also been granted reimbursement for the treatment of chronic kidney disease starting this month. As a result, dapagliflozin-containing drugs and Jardiance, for which no generic versions have been released yet, are now reimbursed not only for diabetes but also for chronic heart failure and chronic kidney disease, greatly expanding their scope of use. In Jardiance’s case, Jardiance Tab 10 tablets will undergo a preemptive price reduction due to its expanded scope of use, resulting in an adjustment of its insurance ceiling price. Originally, the price of Jardiance 10 mg Tab was scheduled to be reduced from KRW 618 to KRW 591 starting in July under the price-volume agreement (Type B, PVA) scheme. However, considering the potential confusion and administrative burden caused by consecutive price reductions, the government decided to adjust the prices unilaterally starting in August. On the other hand, the price of Jardiance 25mg was reduced from KRW 798 to KRW 762 in July under the PVA. Type B of the PVA scheme refers to cases where the insurance price ceiling has been adjusted under Type A, or where the maximum price has not been negotiated under Type A, and the claims amount for the same product group has increased by more than 60% compared to the previous year's claims amount, or has increased by more than 10% with an increase of KRW 50 billion or more, from the date of initial listing or the date the insurance price ceiling was adjusted through negotiation. The insurance price ceiling is adjusted through the company’s price negotiations with the National Health Insurance Service. As Jardiance is a blockbuster drug with annual prescriptions exceeding KRW 60 billion, healthcare institutions are advised to exercise caution with regard to the price reduction. Jardiance is co-marketed in Korea by Boehringer Ingelheim and Yuhan Corp.
- Company
- Immunotherapy 'Jemperli' enters drug price negotiations
- by Eo, Yun-Ho Jul 21, 2025 06:06am
- Product photo of Jemperli, an immunotherapy for cancer, has entered the last stage for its expanded reimbursement for endometrial cancer. According to industry sources, GSK Korea has initiated the drug price negotiations with the National Health Insurance Service (NHIS) for its PD-1 inhibitor, Jemperli (dostarlimab). The detailed expanded reimbursement indication is to treat 'newly diagnosed recurrent or advanced deficient DNA mismatch repair (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer.' Accordingly, attention has been garnered to whether a new reimbursed medicine for the first-line treatment of endometrial cancer, which lacks treatment options. The standard first-line treatment of endometrial cancer is a platinum-based combination chemotherapy of paclitaxel+carboplatin. One out of four patients who use chemotherapy experience disease recurrence or progression. Despite the increased number of patients at advanced·recurrence stages, the 5-year survival rate is below 20% because no effective treatment options are available. Jemperli was first listed for reimbursement in December 2023 as a second-line treatment for recurrent·progressive (FIGO stage IIIB or higher) endometrial cancer that progressed during or after platinum-based chemotherapy. Subsequently, the first-line therapy indication was added, and it is currently undergoing the relevant procedures. The efficacy of this drug as a first-line treatment for endometrial cancer was confirmed through the Phase 3 RUBY study. The RUBY study compared a combination therapy combining Jemperli with platinum-based chemotherapy (carboplatin + paclitaxel) against a control group of placebo plus platinum-based chemotherapy in 494 patients with advanced or recurrent endometrial cancer. The study was designed to include a treatment period of over 3 years, considering that the average survival period for conventional platinum-based chemotherapy is less than 3 years. The primary endpoints were progression-free survival (PFS) and overall survival (OS), as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). The RUBY clinical study results showed that the Jemperli combination therapy reduced the risk of death by 31% compared to the control group in the overall advanced·recurrent endometrial cancer patient population. During a median follow-up period of 37 months, the median OS for the patient group receiving Jemperli combination therapy was 44.6 months, which was 16.4 months longer than the control group (28.2 months), and it reduced the risk of death by 31%. Dr. Jae Kwan Lee of Korea University Guro Hospital, Professor of the Department of Obstetrics and Gynecology, said, "Endometrial cancer is a disease with a high risk of recurrence even after initial treatment. Effective first-line treatment options are of utmost importance for patients. Jemperli's RUBY study is considered a significant study that has demonstrated the efficacy of immunotherapy in endometrial cancer over a long period." Dr. Lee also explained, "The combination therapy of Jemperli and platinum-based chemotherapy is the only immunotherapy available for endometrial cancer treatment in Korea with confirmed OS improvement. The study demonstrated significant clinical value even though it included patients who experienced recurrence 6 months after chemotherapy and high-risk patients with carcinosarcoma."
- Policy
- [Reporter's View] A separate fund for new orphan drugs
- by Lee, Jeong-Hwan Jul 18, 2025 06:36am
- Will the 'establishment of a separate fund,' considered one of the ways to improve patient access to expensive, rare, and intractable disease drugs, become even more difficult with the inauguration of the Lee Jae Myung administration? Jung Eun-kyung, the candidate for Minister of Health and Welfare (MOHW), who is facing a parliamentary confirmation hearing on July 18, stated that "expanding reimbursement coverage should take precedence over establishing a fund" for drugs exclusively for rare and intractable diseases, separate from the National Health Insurance finances. Jung's statement is interpreted as an intention to maintain the traditional method of determining reimbursement for rare disease patients through national support systems, such as 'special calculation and improvement of standards'and catastrophic medical expense support, within the currently available National Health Insurance finances, rather than creating an additional financial "pocket." This is different from the MOHW's previous stance, where it had agreed with parliamentary legislation aimed at accelerating National Health Insurance reimbursement for high-priced, orphan disease treatments through the establishment of a separate fund. Conversely, candidate Jung showed a completely different attitude regarding the creation of a regional essential medical care fund. Jung presented a clear vision, stating, "If appointed as minister, I will push for the enactment and amendment of relevant laws through consultation with ministries, including the Ministry of Economy and Finance, to ensure the establishment of a regional essential medical care fund." Considering that the frequency of approvals for ultra-high-priced new drugs, such as immunotherapy for cancer and rare disease biologics, has increased incomparably compared to the past, Jung's skeptical expression regarding the establishment of a dedicated fund for rare diseases is disappointing. Suppose expensive new drugs are to be reimbursed within the limited National Health Insurance finances and restricted drug expenditure boundaries. In that case, the responsible authorities will ultimately have no choice but to make innovative efforts to diversify drug reimbursement criteria or to cut drug prices for already approved medicines. Reducing reimbursement for already approved drugs would ultimately increase the likelihood of further drug price reductions, which could lead to protests from domestic pharmaceutical companies and a contraction of funds needed for innovative new drug development. This means that a zero-sum game between multinational pharmaceutical companies, which focus on developing new drugs, and Korean pharmaceutical companies, which have a large proportion of generic products, could intensify over National Health Insurance finances. Therefore, establishing a separate fund for rare diseases is a legislative and administrative task that the new government should proactively consider. The MOHW should not exclude the establishment of a separate fund from its policy priorities. Instead, it should actively engage in administrative efforts, gathering wisdom with the National Health Insurance Service, the Health Insurance Review & Assessment Service (HIRA), and the medical community, to persuade the Ministry of Economy and Finance, which opposes the fund for reasons such as uncertainty of efficacy and fairness with other diseases. The National Health Insurance authorities are the only party that should analyze cases from advanced countries, such as the UK's operation of the Cancer Drug Fund (CDF), to ensure patient access to treatments for rare diseases and strive to open the minds of financial authorities. If rare·intractable diseases and rare disease drugs are translated into English, they become 'orphan diseases' and 'orphan drug.' They are pitiful diseases and treatments, like a child who has lost both parents or been abandoned, with no comfortable place to lean on. Currently, bills establishing separate funds to strengthen national responsibility for orphan diseases and treatments are pending in the 22nd National Assembly. These include the package of bills proposed by Representative Seo Myeong-ok of the People Power Party for the establishment of a Cancer Management Fund·Rare Disease Fund (amendments to the Cancer Management Act·Rare Disease Management Act·National Finance Act·Lottery Tickets and Lottery Fund Act), and the package of bills proposed by Representative Jeon Jin-sook of the Democratic Party of Korea for the expansion of National Health Insurance reimbursement for rare and severe disease treatments (amendments to the National Health Insurance Act·Lottery Tickets and Lottery Fund Act). We look forward to a future where Jung, having passed the confirmation hearing and been appointed MOHW, actively engages in persuasion and consultation with the Ministry of Economy and Finance to ensure the passage of the orphan disease fund establishment bills in the National Assembly. In this case, it would be favorable news for patients and caregivers who suffer from the burden of expensive hospital bills and high-priced treatments, as well as for the National Health Insurance finances, which currently bear a heavy burden.
- Policy
- Will the external reference pricing reevals gain momentum?
- by Lee, Jeong-Hwan Jul 18, 2025 06:35am
- Eun-Kyung Jeong, nominee for Minister of Health and Welfare, said that “it is important to manage drug prices at an appropriate level given the limited health insurance resources” regarding the post-marketing price review system to lower generic drug prices through “external reference pricing evaluations,” suggesting the possibility of its introduction upon her final appointment. Jeong also revealed plans to review policies such as improving the certification system for innovative pharmaceutical companies and expanding incentives to encourage pharmaceutical companies to invest in R&D for innovative new drugs. On the 17th, nominee Eun-Kyung Jeong revealed her position on the external reference pricing reevaluation system in written questions during her confirmation hearing with Representative Yoon Kim of the Democratic Party of Korea and Representative Jong-heon Baek of the People Power Party. Representative Yoon Kim pointed out that the external reference pricing reevaluation of generic drug prices, which the MOHW announced last year, has been postponed indefinitely, and raised the need for its prompt implementation. On the other hand, Representative Jong-heon Baek questioned the need to introduce a system to lower drug prices by comparing them with overseas prices, arguing that it is unreasonable to lower domestic generic drug prices solely based on drug prices overseas, given that each country's insurance system, drug price determination process, and level of social consensus differ. On this, Jeong replied, “The demand for drugs is constantly increasing due to the growing number of elderly people and patients with chronic disease. In order to provide optimal drug reimbursement with limited national health insurance finances, it is important to manage drug prices at an appropriate level.” Jeong explained, “We will carefully review the current status of domestic and international drug pricing systems and policy improvements, and consider acceptability by gathering opinions from the field to manage drug prices reasonably after listing. We will also actively gather opinions through regular communication with the pharmaceutical industry, relevant agencies, and experts on the direction of drug pricing system improvements.” Regarding measures to encourage R&D for innovative new drugs, Jeong said, “The pharmaceutical and biotechnology industry is a national strategic industry that can serve as Korea’s next growth engine, so it is time to scale it on a national level. To this end, we will strengthen compensation for the innovative value of new drugs and reform the compensation system to encourage R&D investment, thereby supporting the cultivation of pharmaceutical companies with global new drug development capabilities.” Jeong added, “We plan to improve the certification system for Korea Innovative Pharmaceutical Companies to encourage their R&D investment in innovative new drugs. We will also consider expanding incentives for companies that strengthen their R&D efforts.”
- Company
- Denmark's non-profit foundation's virtuous governance cycle
- by Jul 18, 2025 06:35am
- In 1922, Dr. August Krogh paid just $1 to introduce insulin production technology from the University of Toronto in Canada. At the time, he made two promises to the University of Toronto research team: to make insulin available to all patients at an affordable price and to use insulin for public healthcare rather than for commercial gain. And Leo Pharma delivered on this promise. Despite the uncertain profitability of insulin production, Leo Pharma participated in its production, laying the groundwork for the first commercialization of insulin in Northern Europe. Following this, Dr. Krogh established the non-profit organization Nordic Insulin Laboratory to ensure a stable supply of insulin. The two brother researchers who worked with him at the laboratory later spun off to form Novo Insulin Research Institute. The two organizations merged in 1989, giving rise to today's Novo Nordisk. Denmark's public-interest-driven medical philosophy did not end as a single generation’s promise. The spirit was carried forward through the corporate governance structure of foundation ownership. Major Danish pharmaceutical companies such as Novo Nordisk, Leo Pharma, and Lundbeck all have a structure in which a non-profit foundation serves as the top shareholder. These foundations support the long-term stability of the companies and return profits to society and science, thereby putting into practice the public values emphasized by Dr. Krogh even today. 'Foundation is the largest shareholder'... A sustainable management model created by society, institutions, and culture According to industry sources on the 15th, Denmark has the most structured ‘foundation-owned model’ in Europe. Approximately 1,300 companies in Denmark are operated as foundations. According to research by Børsting and Thomsen (2017), foundation-owned companies account for approximately 70% of the total market capitalization of the stock market in Denmark, demonstrating the overwhelming influence of foundation-owned companies. Pharmaceutical companies such as Novo Nordisk, Leo Pharma, and Lundbeck, as well as toy company Lego, beer company Carlsberg, and shipping company Maersk, all adopt a governance structure where a foundation is the majority shareholder. Novo Nordisk's governance structure is organized as a “foundation → holding company → operating company” structure. At the top is the non-profit public interest foundation Novo Nordisk Foundation, established with the goal of realizing corporate social responsibility and public value. Rather than directly managing the company, it owns Novo Holdings, a holding company and professional investment firm, as a 100% subsidiary. Novo Holdings, in turn, holds shares in major pharmaceutical companies such as Novo Nordisk and Novozymes. This structure effectively allows the foundation to control Novo Nordisk through Novo Holdings. Novo Holdings holds approximately 28% of Novo Nordisk's shares. Although the surface ownership ratio is relatively low, Novo Holdings secures approximately 77% of the total voting rights of Novo Nordisk through a dual-class share structure, enabling it to maintain stable management control. Under the dual-class share structure, the number of voting rights varies depending on the type of shares. The shares held by Novo Holdings are designed to allow the exercise of more voting rights per share than ordinary shares. Novo Holdings Ownership Structure (Source: Novo Holdings) Lundbeck is another publicly listed pharmaceutical company with a foundation-based governance structure. The Lundbeck Foundation is the largest shareholder, holding approximately 70% of Lundbeck's shares. Another pharmaceutical company, Leo Pharma, is approximately 80% owned by the Leo Foundation. The remaining shares of Leo Pharma are held by private equity fund Nordic Capital. Leo Pharma plans to go public as early as next year, with the Leo Foundation maintaining a majority stake even after the IPO. Denmark's foundation-based governance structure is different from Germany's family ownership and South Korea's holding company-based structures, as it is based on social values. In this structure, the foundation functions as the core entity that designs the company's direction and strategy, going beyond the role of the largest shareholder. The foundation prioritizes long-term research and development and the realization of social value, rather than being swayed by short-term profits. The foundation reinvests profits from dividends received from the company and its own investment activities into public welfare projects. The establishment of a foundation-based governance structure in Denmark is not simply due to the philosophy of founders or historical coincidence. It is a structural product of the interplay between social, economic, institutional, and cultural factors. Many Danish companies began as family businesses, but instead of passing on shares to their children, founders often chose to transfer them to public interest foundations. For example, the founder of Novo Nordisk, Dr. Krogh, did not pass on shares to his family even after the Nordic Insulin Laboratory grew into a corporation, instead transferring ownership to a public foundation. Leo Pharma, a company founded by a pharmacist who accumulated capital to grow the business, also passed on shares to a foundation rather than to his children, continuing the founding philosophy. Novo Nordisk Foundation, Lundbeck Foundation, Leo Pharma Foundation Denmark's characteristics as a small open economy also influenced the establishment of foundation-based governance structures. In Denmark, external capital inevitably held significant influence, leading to the natural adoption of foundation-based governance structures. Since foundations function as a means of defending corporate control, even if external parties attempt to suddenly acquire a large amount of shares or engage in hostile mergers and acquisitions (M&A), they cannot effectively seize control of management. Government policy support also played a crucial role in the establishment of a foundation-based governance structure. Under Danish law, companies owned by foundations are eligible for corporate tax exemptions if they distribute a certain percentage of their annual net profits for public welfare purposes. For example, if a foundation allocates more than 4% of its annual revenue to social welfare, it is exempt from taxation. This enables foundations to actively disburse subsidies and research funds. The legal framework enabling foundations to stably own companies is another core factor enabling public interest-centered management. Denmark restricts the easy sale of shares owned by foundations. This is to ensure that foundations are not swayed by short-term market fluctuations or external pressures, and can execute long-term corporate strategies in line with the founder's philosophy and public interest objectives. In other words, policy support has provided a foundation for the founders' philosophy to be institutionalized and sustainably implemented, rather than remaining a one-time legacy. Long-term perspective rather than short-term performance... Foundation-based governance proves with results The most distinctive feature of the Danish foundation-based governance structure is the clear separation of ownership and management and the simplicity of the structure itself. For example, the Novo Nordisk Foundation's board of directors consists of 11 members, including Chairman Lars Rebien Sørensen. Three of the board members are employee representatives. Employee representatives are elected by Novo Nordisk or Novonesis employees for a four-year term. It is also noteworthy that there are no issues of dual listing within the governance structure. In the Novo Nordisk model, the foundation controls the listed operating company through a non-listed holding company, creating a single stakeholder structure that minimizes the potential for conflicts of interest and external interference. This distinguishes it from the domestic model, where the holding company and operating company are listed separately, leading to recurring issues such as conflicts of interest between the holding company and subsidiary shareholders and allegations of profit diversion from subsidiaries. Jun-beom Cheon, Vice Chairman of the Korean Corporate Governance Forum (Attorney), explained, “The fact that the foundation holds 100% of the holding company's shares means that the holding company is unlisted. This structure allows for the continuous pursuit of business under the same interests without duplicate listings of the operating company.” Ultimately, the core is the “single governance structure without duplicate listings” formed around the foundation. This structure provides a foundation for companies to consistently execute long-term strategies without being overly concerned about short-term results. As they are relatively free from the short-term profit demands of external investors or shareholders, they can focus on tasks such as long-term research and development (R&D) or the realization of public value. Also, the foundation can demonstrate high flexibility in terms of equity ownership and investment methods. It can secure a majority stake to deeply engage in management or, conversely, hold a minority stake while focusing on long-term support and public interest objectives. Since the timing of investment exit is not strictly predetermined, it follows a distinctly different trajectory from private equity funds that pursue short-term exits based on the premise of achieving a certain level of returns. The most notable product of foundation-based governance is “Wegovy.” Thanks to an environment that enabled sustained R&D, Novo Nordisk has grown into the world's leading GLP-1 antidiabetic and obesity treatment company. Lundbeck and Leo Pharma are no exceptions. Thanks to their stable foundation-based governance structures, these companies have been able to maintain consistent strategies over the long term, even in low-profit or market-uncertain fields such as mental health treatments and rare/chronic skin disease therapies, despite incurring losses. Lan Ding, Vice President of Lundbeck, stated, “We have pursued a strategy focused solely on a specific disease group, neurological disorders, similar to Lundbeck. If a company has a structure where the foundation holds 70% of the shares, like Lundbeck, it can prioritize long-term value over short-term results.” Trend and portfolio of Novo Holdings The foundation is not bound by short-term performance, but it does not neglect profit generation. Last year, Novo Holdings earned 8 billion euros (approximately KRW 13 trillion), doubling its sales from the previous year. The portfolio return rate jumped from 9.4% in 2023 to 18% last year. This is the result of Novo Holdings' strategic investments based on its expertise in life sciences and its ability to connect ecosystems. Denmark Foundation returns profits to society... Attracting global talent through investment in basic sciences The Danish pharmaceutical company's foundation also plays the role of an investor in the national medical and basic science ecosystem. All profits generated by Novo Holdings are transferred to the foundation. As a 100% non-profit organization, the Novo Nordisk Foundation redistributes these funds in the form of grants for the benefit of society. This creates a cycle structure where corporate profits are reinvested through the foundation for public purposes such as science, health, and education. The Novo Nordisk Foundation executes public-interest investments across a wide range of fields, from promoting science, technology, engineering, and mathematics (STEM) education to vaccine development, infectious disease response, and AI supercomputing infrastructure construction. The foundation allocates an annual grant budget of USD 1 billion for these activities and plans to expand its investment to USD 2 billion over the next decade. Novo Nordisk Foundation These investments have strengthened the scientific base throughout Denmark and attracted top talent from around the world to the country. In fact, many scientists from around the world have flocked to major Danish universities such as the University of Copenhagen and the Technical University of Denmark, which in turn has led to an influx of talent to Danish biotech companies, including Novo Nordisk. A representative from Novo Holdings explained, “There was a shared awareness that without attracting overseas talent, both Novo Nordisk and Danish universities would struggle to maintain their current level of research capabilities. Through the Novo Nordisk Foundation and Novo Nordisk actively supporting research infrastructure centered in Copenhagen, we have created a virtuous cycle where talented researchers and professors from around the world are drawn to Denmark.” The foundation is also recognized as the hub of Denmark's bio-industry innovation ecosystem. This is because the foundation directly designed and led the structure that connects early-stage science and technology with entrepreneurship. The BioInnovation Institute (BII) is one representative example. BII is a non-profit startup support organization established with full funding from the Novo Nordisk Foundation. The BioInnovation Institute (BII), a world-class life science startup support organization based in Denmark, provides various dedicated spaces and infrastructure to nurture startups. BII provides up to NKR3 million (approximately KRW 600 million) in grants to early-stage technology-based startups without requiring equity. In addition, it operates a full-cycle support system that includes shared laboratory infrastructure, dedicated mentoring, investor connections, and business development strategy planning. Currently, BII accounts for about 80% of Denmark's life science and bio sectors, playing a central role in the overall bio ecosystem. Startups incubated by BII attract follow-up investments from Novo Holdings' venture funds and global investors. Some form strategic partnerships with Novo Nordisk and Leo Pharma. A BII representative stated, “To date, 80 companies that have received BII support have successfully secured external funding. For every 1 euro invested by BII, companies secure an average of 7 euros in additional grants or investments.” This virtuous cycle has solidified the foundation-based governance structure as the backbone connecting Denmark's bio industry ecosystem.
- Opinion
- [Reporter's View] Bio policy should remain consistent
- by Kim, Jin-Gu Jul 17, 2025 06:13am
- In November 2024, the Yoon Suk Yeol government officially announced the launch of the National Bio Committee. The government aimed to operate a 'presidential' governance body in a preparatory response to the global bioeconomy era. Considering that the previously established 'Bio-health Innovative Committee' was chaired by the Prime Minister, the National Bio Committee was regarded as an advancement in terms of its rank and role. The establishment of a governance body overseeing the pharmaceutical and biotech industries, directly under the President, has long been a goal of the pharmaceutical and biotech industries. Previously, the pharmaceutical and biotech industry operated with separate development strategies fragmented across different divisions. The wall between regulations and support policies, as well as the lack of a central coordinating point for strategic discussions, had been a long-standing concern for the industry. When the government took an initiative to 'unify policies scattered across divisions and manage them,' the industry welcomed it with open arms. There was great anticipation that a policy control tower would enable coordination of regulatory improvements, industrial support, and technological development at a governmental level. However, just about a month after the committee's launch plan was announced, a state of emergency was declared, followed by martial law. A continuous political chaos followed this. Former President Yoon Suk Yeol faced an impeachment trial. Ultimately, the Constitutional Court of Kora upheld his impeachment. Following an early presidential election, President Lee Jae Myung took office on May 4th last month. Even during the political turmoil, the National Bio Committee carried out two official schedules. At its launch ceremony in January this year, the committee unveiled the "Republic of Korea Bio Grand Transformation Strategy." In its second meeting in May, it selected 10 key R&D areas, including AI-driven drug discovery·radiopharmaceuticals·gene therapies, and discussed development strategies. However, there was insufficient time to yield accomplishments. With the new administration taking power, the committee's existence became uncertain. As an organization established by presidential decree, it is not an independent body under law. It lacks authority in terms of organization, budget, and personnel. In other words, it can be abolished at any time with the new government. It is not uncommon for presidential committees to be abolished with the new administration. New governments often introduce new slogans, and various committees have also disappeared with changes in power. Will the National Bio Committee follow the same path? This is a point of concern for the industry. Given that the pharmaceutical and biotech industry development strategies proposed by the National Bio Committee were recognized for their industrial validity regardless of the administration, the potential disappearance of this newly launched committee is frustrating. In the biotech industry, sustainability is more important than speed. It typically takes over 10 years to develop a new drug and bring it to the global market. This industry operates on a different timeline than a government's five-year term. If industrial strategies are reset every time the government changes, it will be difficult for the Korean pharmaceutical and biotech industry to advance its global competitiveness. Even if the government changes, the core axis of industrial strategy must be maintained. The direction of breaking down walls between ministries and consolidating public and private capabilities should not disappear. Even if a committee is renamed, its symbolism and status as a direct presidential committee should be preserved.
- Company
- Pharmaceutical exports to U.S. have surged by 46%
- by Kim, Jin-Gu Jul 17, 2025 06:13am
- Korea-made pharmaceutical exports to the United States have surged. In the first half of this year, exports to the U.S. amounted to approximately KRW 1.53 trillion, a 46% increase compared to the same period last year. Notably, exports to the U.S. saw an exceptional surge in June. The export in June alone was almost the total of the preceding four months. This surge is interpreted as a precautionary measure to prepare for the potential impact of pharmaceutical tariffs. Korean pharmaceutical and biotech companies are preparing for tariff shocks by pre-stocking inventory in the U.S. Driven by increased exports to the U.S., South Korea's pharmaceutical export performance has broken previous records. In the first half, Korea-made pharmaceutical exports reached KRW 6.38 trillion, a 29% year-on-year (YoY) increase. Exports to U.S. surged… June alone accounts for half of total pharmaceutical exports According to the Korea Customs Service on July 17, South Korea's pharmaceutical exports to the U.S. in the first half of this year amounted to USD 1.11051 billion (approximately KRW 1.53 trillion). This is a 46% increase compared to USD 758.43 million in the first half of last year. Pharmaceutical export sales to U.S. over the past two years (unit: USD 1 million, source: Korea Customs Service; dotted boxes show an increase from USD 758.43 million in 2024 to USD 1.11051 billion in 2025) Exports notably surged in June. Exports to the U.S. in a single month reached USD 458.38 million (approximately KRW 630 billion). This volume is equivalent to the export performance of the preceding four months (USD 475.82 million). The proportion of total pharmaceutical export performance accounted for by the U.S. also significantly expanded in June. Until then, the monthly share of exports to U.S. had been limited to 18% for two years, but it soared to 49% in June. This means nearly half of all pharmaceutical exports in June went to the U.S. Are they preparing for pharmaceutical tariff shock?… Enhanced stockpiling movement in the U.S. The pharmaceutical industry attributes the surge in pharmaceutical exports to the U.S. to the potential pharmaceutical tariffs by the U.S. government. U.S. President Donald Trump recently stated in a cabinet meeting that tariff of up to 200% could be imposed on imported pharmaceuticals. He estimated the tariff imposition timeline to be "1 to 1.5 years from now." Specific tariff rates and targeted items are expected to be announced by the end of this month. U.S. Commerce Secretary Howard Lutnick said, "Whether tariffs will be imposed on the pharmaceutical and semiconductor sectors will be determined after the investigation under Section 232 of the Trade Expansion Act concludes at the end of this month." Section 232 of the Trade Expansion Act details the Commerce Department to investigate the impact of imports on national security and enables the President to take responsive action. The U.S. government initiated an investigation related to this in April. Korean pharmaceutical and biotech companies have begun proactive responses. Notably, their response efforts are reported to have intensified since the U.S. government initiated the Section 232 investigation in April. A strategy of pre-exporting pharmaceuticals to U.S. local entities is being employed to stockpile inventory. For example, Celltrion plans to secure and maintain a two-year inventory in the U.S. in the short term. Separately, it has moved to secure a production base in the U.S., having signed contracts for local contract manufacturing (CMO) of products sold in the U.S., and is also considering acquiring companies with U.S. production facilities. Other companies with a significant share of exports to U.S. are also reported to have prepared similar strategies. An analysis suggests that the short-term surge in exports to U.S. is due to intensified efforts by these companies to stockpile local inventory. Pharmaceutical exports totaled USD 4.62 billion in the first half of the year… 29% increase YoY The expansion of exports to U.S. has driven the increase in overall pharmaceutical export performance. In the first half of this year, South Korea's pharmaceutical exports amounted to USD 4.6166 billion (approximately KRW 6.38 trillion). This is a 29% increase compared to USD 3.57795 billion in the first half of last year. This is the highest record for a half-year period. The previous record was USD 4.21219 billion in the second half of 2021. That period was most heavily influenced by the COVID-19 pandemic, with special demand, as exports surged with the full export of domestically produced COVID-19 vaccines. After that, exports returned to previous levels. Although there was a steady increase every half-year, half-yearly figures had never exceeded USD 4 billion until now. Half-yearly pharmaceutical performance changes (unit: USD 1 million, source: Korea Customs Service) Pharmaceutical imports saw a slight increase from USD 4.45176 billion in the first half of last year to USD 4.6166 billion in the first half of this year. With exports increasing significantly and imports remaining at previous levels, the pharmaceutical trade balance has improved substantially. In the first half, the pharmaceutical trade balance recorded a surplus of USD 419.62 million. Previously, the only half-yearly pharmaceutical trade balance surplus was in the second half of 2020 (a surplus of USD 86.11 million).
