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- 2025-12-21 05:01:30
- Policy
- Introduction of AI for drug approval and review in Korea
- by Lee, Hye-Kyung Jul 10, 2025 06:09am
- The Ministry of Food and Drug Safety is conducting follow-up research to introduce generative artificial intelligence (AI) to the domestic drug approval and review field starting next year. The Pharmaceutical and Medical Device Research Department of the National Institute of Food and Drug Safety Evaluation is conducting an ISP project to establish the system, and plans to gradually expand the scope of AI application from chemical drugs to biopharmaceuticals. The Pharmaceutical and Medical Device Research Department of the National Institute of Food and Drug Safety Evaluation met with MFDS press corp reporters at the Jeju National Herbal Resource Management Center presented initiatives including research using AI and big data, the development of impurity analysis methods for pharmaceuticals, evaluation technologies for biological products, and plans to distribute standardized herbal reference substances. (From the left) Kyung-hoon Son, Director of the Drug Research Division;, Cheol-hyun Lee, Director of the Biologics Research Division; Gidae Park, Acting Director, Division of Advanced Biopharmaceutical Research; Jinhee Hwang, Director, Herbal Medicine Research Division; Youngmi Song, Director, Cosmetics Research Division; Haedae Park, Director, Division of Medical Device Research On the day, Jiwon Jeong, Director-General of the Pharmaceutical and Medical Device Research Department, opened the meeting with an explanation of the current status of research related to artificial intelligence and big data. Jeong said that new projects being promoted this year include research on strategies for utilizing AI in drug reviews. Director-General Jeong explained, “It is a two-track approach: the AI system is being developed by the IT team, while we are researching to determine whether AI can be used in medical product reviews.” She added, “The process of introducing AI into medical product reviews requires an enormous amount of data, so it is difficult to initiate everything at once. Starting next year, we will implement the project in phases, beginning with the simple and repetitive task of preparing review materials. We will start with chemical drugs.” Kyung-hoon Son, Director of the Drug Research Division, then discussed research on utilizing big data in the course of developing technology for assessing the safety of overseas manufacturing facilities related to Good Manufacturing Practice (GMP) standards. Director Son explained, “We conduct on-site inspections of overseas manufacturing facilities every year, but since each facility has its own system, there are challenges in organizing the data. Through this research, we aim to develop technology to standardize data related to GMP to assist with overseas inspections.” He also noted, “This research utilizing big data has not yet progressed to the stage of using AI. Even without collaborating with overseas companies, we believe it will be possible to develop and utilize a model that utilizes big data domestically.” In addition, the Pharmaceutical and Medical Device Research Department is promoting research on the development of specialized translation models (Korean-English) for safety management in the field of pharmaceuticals, the application of next-generation advanced pharmaceutical innovation technologies such as AI to manufacturing facilities, and a model for the utilization and dissemination of public data based on adverse drug reaction reports. (from the left) Jiwon Jeong, Director-General of the Pharmaceutical and Medical Device Research Department, Kyung-hoon Son, Director of the Drug Research Division, Cheol-hyun Lee, Director of the Biologics Research Division ◆ Research on impurity analysis methods expanded to include new substances=The National Institute of Food and Drug Safety Evaluation is also conducting research on the safety management of impurities and infectious diseases in pharmaceuticals. This includes developing and providing impurity analysis methods, developing and publishing impurity safety management guidelines, and compiling and distributing case studies on impurity occurrence assessments. In this regard, Director Son said, “The current research focuses on how to reduce single impurities such as N-nitrosodimethylamine (NDMA),” adding, “We are also conducting research on simultaneous analysis methods in consideration of small-sized companies.” He emphasized, “In particular, since the beginning of this year, we have been analyzing and categorizing the characteristics of newly developed substances, not just single substances, to develop analysis methods. Although the results are not yet available, we are striving to manage impurities that did not exist before.” The development of evaluation technologies for biological products is a research area currently being pursued by the National Institute of Food and Drug Safety Evaluation to strengthen infectious disease control. Biological products include mRNA vaccines, antibody-drug conjugates (ADCs), and antibody-based therapeutics such as monoclonal antibodies, bispecific antibodies, and small-molecule–multi-specific antibody combinations. Cheol-hyun Lee, Director of the Biologics Research Division, explained, “We have been conducting research on delivery methods and materials for mRNA vaccines for about 5 years, and we expect to complete the research this year.” He added, “We have not developed evaluation technologies for specific products or indications in the field of antibody drugs, but are creating relevant guidelines and information booklets. We are indirectly supporting companies' relevant research and development through methods such as introducing overseas cases.” Jeju National Herbal Resource Management Center ◆ National Herbal Resource Management Center owns 396 standardized herbal reference materials = The National Institute of Food and Drug Safety Evaluation is also creating standard herbal medicine products through the National Herbal Resource Management Center. Located in three locations, Yanggu-gun, Gangwon-do; Okcheon-gun, Chungcheongbuk-do; and Seogwipo-si, Jeju-do, the National Herbal Resource Management Center serves as a control tower for the preservation, research, and investigation of herbal medicine resources in Korea. According to data from the National Institute of Food and Drug Safety Evaluation, the National Herbal Resource Management Center currently has 396 standardized herbal reference materials, including 273 standard herbal items, 120 marker compounds, and 3 reference materials. This is an increase of 12 items compared to 384 in 2023. Jin-hee Hwang, Director of the Herbal Medicine Research Division, said, “About five standard products are added every year. Although no products have been successfully commercialized, research using standard products is ongoing at Jeju Techno Park and Jeju University laboratories.” Additionally, the distribution of standardized herbal reference materials will not be categorized by sector such as pharmaceuticals, health functional foods, or cosmetics, but rather based on their intended use, such as quality control or research and development. The National Herbal Resource Management Center is currently working to improve the distribution system and plans to implement sector-based distribution, including for pharmaceuticals, starting next year.
- Company
- Credit ratings for Samsung Biologics·JW Holdings↑
- by Kim, Jin-Gu Jul 10, 2025 06:08am
- Major pharmaceutical and biotech companies (biopharma companies) are facing varying differing credit ratings and outlooks. While Samsung Biologics and JW Holdings received upward credit ratings, Handok was downgraded. Dong-A ST's credit rating outlook shifted from 'stable' to 'negative'. Credit rating agencies explained that these results to differences in individual company performance and profitability. They anticipated that the disparities among companies will become even more pronounced in the second half of the year. Credit rating adjusted upward for Samsung Biologics and JW Holdings... attributed by improved performance & stable profitability According to industry sources on the July 8, Korea Ratings·Korea Investors Service (KIS) recently upgraded Samsung Biologics' credit rating and outlook from 'AA- positive' to 'AA stable'. Korea Ratings also raised JW Holdings' rating by one grade, from 'BBB- positive' to 'BBB stable'. Samsung Biologics' stable profitability and expanding global orders were reflected in its evaluation, while JW Holdings' recovery in pharmaceutical business profitability and improved financial structure were reflected. In contrast, credit ratings·outlooks for Handok and Dong-A ST were adjusted downward. KIS adjusted Handok's credit rating downward by one grade from 'BBB+' to 'BBB', while converting its outlook from 'negative' to 'stable'. Sluggish performance and increased financial burden were cited as the primary reasons for the credit rating downgrade. Credit rating for Dong-A ST was maintained, but the company's outlook was downgraded. NICE Investors Service kept Dong-A ST's credit rating at 'A+' but adjusted its outlook from 'stable' to 'negative'. Korea Ratings also changed Dong-A ST's outlook to negative. This is analyzed as a result of a complex interplay of factors, including slowing profitability and the burden of research and development (R&D) costs. Other major biopharma companies maintained their existing credit ratings and outlooks. According to Korea Ratings, Chong Kun Dang's credit rating and outlook remained 'AA- stable' as of the end of the first half, identical to the end of last year. Chong Kun Dang Holdings, Green Cross, and Daewoong Pharmaceutical maintained 'A+ stable', while Dong-A Socio Holdings, HK inno.N, and Boryung held 'A stable'. ISU Abxis remained at 'BB- stable', and Korea Union Pharmaceutical stayed at 'CC negative'. KIS and NICE Investors Service also maintained the credit ratings and outlooks of Green Cross Holdings·Chong Kun Dang Holdings·Chong Kun Dang·HK inno.N·Dong-A Socio Holdings·SK Plasma·ISU Abxis·Vivacell Biotechnology at last year's levels. Upward·downward credit rating adjustments·outlook by companies..."It will become more polarized in the second half of the year" Overall, while the fluctuation in credit ratings·outlooks for biopharma companies was not significant, individual companies experienced mixed fortunes depending on their business structure and financial response capabilities. Combined Sales and R&D Spending Trends by Year-High R&D expenditure burden puts pressure on profitability (legend: sales (left), R&D ratio (red line, %), operating profit (blue line, %) Credit rating agencies assessed that while companies successful in external growth and profitability improvement received upward credit ratings, some pharmaceutical companies highly dependent on the domestic market are accumulating factors that burden their credit rating. Korea Ratings assessed, "In the first half, strong exports and new product launches drove overall external growth in the biopharma industry, but profitability improvement was limited due to increasing R&D costs," and added, "By companies, clear performance differentiation is observed based on the presence of high-margin products, the extent of market share secured, the scale of new business investments, and the ability to control R&D costs." This trend is expected to continue into the second half of the year. Notably, new drug development and overseas expansion are projected to have a significant impact on corporate performance. An analysis suggests that the disparity between companies could widen further, depending on the expansion of export proportions, new drug development achievements, and the pursuit of new business opportunities. In particular, the growth momentum in the biopharma sector, including Contract Development and Manufacturing Organization (CDMO), is expected to continue. Korea Ratings predicted, "New drug development, biosimilar growth, and the increasing outsourcing demand from global pharmaceutical companies will drive the growth of the CDMO industry." Combined Borrowings and Coverage Trends-Increased capital requirements expected to drive up borrowings (Legend: Net Borrowings (dark blue, Unit: KRW 100 million), Net Borrowings/EBITDA (orange line, %), Based on Combined performance of 7 companies with our credit ratings, Source: Industry data compilation, estimate from Korea Ratings) Key variables for the second half of the year were identified as 'control over financial stability and the U.S. pharmaceutical trade policy.' The explanation was provided that "the performance gap could widen further depending on how stably companies control their profitability and financial structure" in a situation where R&D burdens are expanding and the business environment is rapidly changing. Concerns also arise that "if the competitiveness of flagship products weakens or investment recovery is delayed, credit rating burden could increase due to deteriorating cash flow." Furthermore, if the U.S. applies tariffs to imported pharmaceuticals, a negative impact on the exports of generics and biosimilars by domestic biopharma companies is anticipated. In response, credit rating agencies advised, "Each company should strengthen its product portfolio and manufacturing competitiveness to review its response strategies."
- Company
- 'Ebglyss' can be prescribed at general hospitals
- by Eo, Yun-Ho Jul 09, 2025 06:10am
- Product photo of Ebglyss'Ebglyss,' a new drug for the treatment of atopic dermatitis, is now available for prescription at general hospitals. According to industry sources, Lily Korea's interleukin (IL)-13 inhibitor 'Ebglyss (lebrikizumab)' has passed the drug committees (DC) of tertiary general hospitals, including Seoul National University Hospital, Asan Medical Center in Seoul, and Sinchon Severance Hospital, as well as medical institutes, such as Korean University Anam Hospital and Seoul National University Bundang Hospital. Several medical institutes have generated prescription codes through emergency DC. After this drug was included in the insurance reimbursement this month (July), the prescription areas of this drug have expanded quickly. Ebglyss is a new biologic that selectively blocks the cytokine Interleukin (IL)-13, a primary cause of atopic dermatitis. Ebglyss was approved last August for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older (weight over 40kg) who are not adequately controlled by topical therapies or for whom these therapies are not recommended. Existing atopic dermatitis treatments include Dupixent, which inhibits IL-4 and IL-13, JAK inhibitors like Rinvoq,and Adtralza, which targets IL-13. The introduction of Ebglyss further expands the range of treatment options. As atopic dermatitis is a chronic disease that is difficult to cure and requires long treatment periods, a wide range of therapeutic options are essential. The efficacy and safety of Ebglyss have been confirmed through Phase 3 clinical studies, including ADvocate-1, ADvocate-2, and ADhere. In ADvocate-1 and ADvocate-2, which evaluated Ebglyss monotherapy, the Ebglyss group showed Eczema Area and Severity Index (EASI)-75 rates of 58.2% and 52.1% respectively, during the induction period (weeks 0-16), representing an improvement over the placebo group (16.2% and 18.1%). EASI-90 rates for the Ebglyss groups were 38.3% and 30.7% respectively, while placebo groups remained at 9% and 9.5%. EASI is the percentage improvement in eczema severity. Additionally, after one year of maintenance therapy, the Ebglyss group's EASI-75 achievement rate at week 52 was 81.7%, and the EASI-90 rate was 66.4%. These figures were higher than those of the placebo group, at 66.4%. Ebglyss is the third biologic to enter this market. The introduction of this drug has expanded patient choices, following the launch of Sanofi's Dupixent and LEO Pharma's Adtralza. However, some experts say that despite the introduction of various treatments, there are still unmet medical needs. According to Korea's atopic dermatitis guidelines, systemic treatment is strongly recommended for patients with moderate-to-severe atopic dermatitis. However, while the proportion of moderate-to-severe atopic dermatitis patients in Korea increased from 30.9% to 39.7% between 2002 and 2019, the prescription rate of systemic immunosuppressants in this patient group remained at only 5%. Professor Min Kyung Shin of Kyung Hee University Hospital's Department of Dermatology said, "Patients with severe atopic dermatitis may show different effects or side effects from each treatment depending on their age and immune status. We consider reactions to side effects like latent tuberculosis, whether the treatment can help with comorbidities, patient preference, and clinical phenotypes when treating."
- Policy
- Daewoong’s generic version of Migbose approved in Korea
- by Lee, Hye-Kyung Jul 09, 2025 06:09am
- Daewoong Pharmaceutical has been approved to sell a generic version of the diabetes treatment Migbose Film-Coated Tablets (miglitol) in Korea. On the 7th, the Ministry of Food and Drug Safety approved Daewoong Pharmaceutical's Daewoong Miglitol Tab. (miglitol). Like the original Migbose, Daewoong Miglitol Tab is a film-coated tablet indicated for the treatment of non-insulin-dependent diabetes mellitus (NIDDM) whose hyperglycemia cannot be adequately controlled by diet alone or with diet in combination with sulfonylurea therapy. It should be taken once daily with a small amount of water before meals or with a small meal. Although the active ingredient was developed as a diabetes treatment, it is primarily being prescribed off-label in practice for weight management. Approved in 2013, Migbose has a structure most similar to glucose, which stimulates the release of GLP-1 (glucagon-like peptide) and improves gastrointestinal side effects. Migbose regulates blood sugar by inducing the secretion of GLP-1. GLP-1 promotes the secretion of insulin, which lowers blood sugar, and inhibits the secretion of glucagon, which accumulates glucose and raises blood sugar, thereby regulating blood sugar levels. Migbose induces clinically significant levels of GLP-1 release upon intake, thereby regulating blood sugar levels. It also increases satiety by reducing gastrointestinal motility, making it useful for diabetic patients who need to lose weight. In addition, it is absorbed gradually in the small intestine, reducing the amount of carbohydrates that enter the large intestine, and therefore has relatively few gastrointestinal side effects. Daewon Pharmaceutical transferred the rights to Migbose to Daehan New Pharm in 2020. According to the pharmaceutical research institute IQVIA, the outpatient prescription amount for Migbose increased from KRW 0.5 billion in 2022 to KRW 1.2 billion in 2023.
- Company
- Adding amiloride effective in resistant hypertension
- by Son, Hyung Min Jul 09, 2025 06:08am
- Sungha Park, Professor of Cardiology, Severance Hospital A new treatment option has been proposed for patients with resistant hypertension that cannot be controlled even with the existing triple combination therapy for hypertension. A regimen combining an olmesartan-based triple combination therapy with the potassium-sparing diuretic ‘amiloride’ demonstrated similar blood pressure-lowering effects to spironolactone, which was previously recommended as a fourth-line treatment, with fewer side effects. The SPARE study, led by Professor Sungha Park of the Department of Cardiology at Severance Hospital, was published in the international medical journal JAMA, attracting significant attention. During an interview with Dailypharm, Professor Park emphasized that the amiloride-based combination therapy has established clinical evidence supporting its broader use in real-world clinical settings for resistant hypertension. Difficult-to-treat ‘Resistant Hypertension’...Need for use of amiloride highlighted There are approximately 12.3 million hypertension patients in South Korea, of whom 10 -15% are classified as having “resistant hypertension,” which is defined as failing to achieve target blood pressure despite the use of three or more antihypertensive medications. Patients who fail to control their blood pressure even with up to 5 antihypertensive medications are classified as having “refractory hypertension,” accounting for less than 1% of all patients. According to National Health Insurance Service data, approximately 7.4% of hypertensive patients in South Korea are diagnosed with true resistant hypertension. Patients with true resistant hypertension have a 1.5 to 2 times higher risk of developing cardiovascular diseases compared to general hypertensive patients, making active blood pressure control crucial for managing their prognosis. Resistant hypertension is treated by adding an antihypertensive drug to the three antihypertensive drugs used to control blood pressure in general hypertensive patients: calcium channel blockers, RAS blockers, and diuretics. For patients whose blood pressure remains uncontrolled even with the four-drug combination, spironolactone is recommended in the fourth line as an additional drug. Spironolactone is a diuretic that acts as an aldosterone receptor antagonist, inhibiting sodium reabsorption to lower blood pressure. If blood pressure remains uncontrolled even then, vasodilators such as beta-blockers, alpha-blockers, minoxidil, and hydralazine may be used. Professor Park stated, “The biggest issue with spironolactone is its side effects. Although spironolactone is an aldosterone antagonist, it can block sex hormones, leading to fatigue, gynecomastia in men, and menstrual irregularities in women. The most serious concern is the high risk of hyperkalemia.” He added, “Due to concerns about such side effects, its use is restricted in elderly patients or those with impaired renal function, and compliance may be low. Although spironolactone is recommended as a fourth-line drug in various clinical guidelines, it is not widely used in practice.” Professor Park said, “While spironolactone has been recognized as a typical potassium-sparing diuretic due to its proven efficacy in reducing the risk of cardiovascular disease after heart failure or myocardial infarction, amiloride has been relatively overlooked. Amiloride is a drug that was widely used in the past, as it acts as a diuretic while also increasing potassium levels.” Amiloride demonstrates non-inferiority to spironolactone To verify this, Professor Park's research team and 14 other domestic institutions conducted a study to confirm the non-inferiority of spironolactone and amiloride. This clinical trial is the first head-to-head trial comparing the two drugs. Professor Park explained, “Guidelines recommend considering amiloride for patients with poor tolerability due to spironolactone’s side effects. However, there was no randomized controlled trial (RCT) data to support this recommendation. Against this backdrop, we decided to conduct a randomized controlled trial comparing spironolactone and amiloride.” He added, “Amiloride is a potassium-sparing diuretic that directly acts on the epithelial sodium channel (ENaC) in the distal convoluted tubule to block sodium reabsorption and preserve potassium. Unlike spironolactone, which blocks aldosterone receptors, its different mechanism of action does not cause hormone-related side effects such as fatigue, gynecomastia, or menstrual irregularities.” The study, named SPARE, targeted patients whose blood pressure remained uncontrolled despite taking existing triple antihypertensive medications. The study focused on patients whose systolic blood pressure remained at or above 140 mmHg after a 4-week introductory treatment with Sevikar HCT (active ingredients: olmesartan, amlodipine, and hydrochlorothiazide), The research team then divided the patients into two groups and compared them for 12 weeks: one group additionally received amiloride 10 mg and the other additionally received spironolactone 25 mg. After 12 weeks of treatment, the average home systolic blood pressure and the rate of achieving target blood pressure in the clinic were measured. Professor Park emphasized the importance of selecting “true resistant hypertension patients” to ensure more accurate results during this process. Professor Park explained, “We focused on patients who had uncontrolled blood pressure despite taking three or more conventional antihypertensive medications. We noted that a single combination therapy drug was effective in improving medication adherence, so we administered Sevikar HCT, a three-drug combination therapy containing olmesartan, amlodipine, and hydrochlorothiazide, at an appropriate dose tailored to each patient's condition for four weeks.” He added, “Sevikar HCT has already been proven to be an effective combination with excellent blood pressure-lowering effects and target blood pressure achievement rates among olmesartan-based triple combination drugs. It is a combination with proven clinical evidence.” The study results showed that amiloride demonstrated non-inferiority to spironolactone in terms of blood pressure-lowering effects. More specifically, the average home systolic blood pressure at week 12 compared to baseline was reduced by 14.7 mmHg in the amiloride group and 13.6 mmHg in the spironolactone group. The difference in blood pressure reduction between the two groups was -0.68 mmHg, which was not statistically significant. Additionally, spironolactone was particularly effective in individuals with elevated aldosterone levels, whereas amiloride demonstrated consistent efficacy across all patients, regardless of aldosterone to renin ratio. It is known that an abnormally activated aldosterone-to-renin ratio can lead to elevated blood pressure. Professor Park stated, “Considering drug characteristics such as medication adherence, ease of use, and side effects, amiloride could serve as an alternative to spironolactone. However, further long-term follow-up studies and expanded application in practice would be necessary.” He continued, “It is uncertain whether this study can be directly applied to Caucasians, but at least in East Asian populations such as Koreans and Japanese, amiloride can be expected to provide sufficient blood pressure-lowering effects. Although it was only a three-month study, side effects were significantly reduced. There were no cases of hyperaldosteronism, and the incidence of hyperkalemia was low. These findings also relay an important message. Professor Park noted, “While amiloride has not been actively recommended in the past, major guidelines may likely incorporate this finding in the future.” The Korean Society of Hypertension is currently revising its guidelines, and there is a high likelihood that the updated guidelines will reflect this information next year. Since the study involved domestic patients, the findings will likely be reflected. The guidelines may include recommendations to use amiloride as an option for resistant hypertension when spironolactone cannot be used. I believe it may also be reflected in other guidelines as well.”
- Opinion
- [Reporter's View] The revision of the Commercial Act
- by Kim, Jin-Gu Jul 09, 2025 06:08am
- The bill on revising the Commercial Act has passed the National Assembly. The bill expands the fiduciary duty of directors to include not only the “company” but also “shareholders,” mandates the introduction of electronic shareholder meetings for listed companies with assets of KRW 2 trillion or more, and changes the title of “outside directors” to “independent directors.” The bill also includes a provision limiting the voting rights of the largest shareholder and related parties to 3% when appointing audit committee members. The pharmaceutical and biotechnology industry has been keenly eyeing the change. This is because many companies in the industry have traditionally been owner-managed. Owner-managed companies have the advantage of being able to make quick decisions and establish long-term strategies. Nevertheless, the absence of proper oversight mechanisms has often led to abuses such as unilateral decision-making and the pursuit of private interests. In fact, there are countless cases where internal transactions with special-related companies controlled by the owner's family are approved by the board of directors without any significant opposition. Many companies have not paid dividends for several years while the owners' compensation increases every year. The second and third generations of owners are appointed to key positions without any verification of their expertise, but the board of directors, which should serve as a check on them, fails to fulfill its role. Even when facing major business decisions such as changes in clinical strategies or whether to apply for approvals, management often unilaterally sets the direction without prior explanation or communication with shareholders. There have also been repeated controversies where clinical results are intentionally delayed or distorted information is leaked to boost stock prices, followed by the sale of shares held by owners or management at that time. These structural limitations are also evident in ESG evaluations. Pharmaceutical and biotech companies have consistently received lower ratings in the governance (G) category compared to the environmental (E) and social (S) categories. This is because the board of directors has lost its oversight function, and internal audits are often conducted merely as a formality. In the process of repeated closed and arbitrary decisions being made, general shareholders are pushed out of the decision-making structure. Such closed decision-making increases the risk of business failure, and its impact is not limited to the losses of the company concerned. It also leads to losses for investors, a decline in overall market confidence, increased risks for partner companies, and ultimately impose a burden on patients waiting for new drugs. The recent revision of the Commercial Act addresses these issues. The revision aims to expand the scope of directors' duties to include shareholders, clarify the status of independent directors, and strengthen shareholder participation through electronic shareholder meetings. Although issues such as cumulative voting and mandatory separation of audit committee elections remain as future tasks, the revision is analyzed as providing a clear direction for frontline companies. The pharmaceutical and biotechnology industry must now recognize shareholder oversight and participation not as a “burden” but as a “responsibility.” Owner-centric quick decision-making is not always the right choice. Especially in industries like new drug development, which require extensive time and resources, the initial direction of decision-making can determine success or failure. A governance structure with checks and balances and transparency is the only way to minimize the costs of failure. In the realm of corporate decision-making, direction is more important than speed. Though change is often uncomfortable, it is essential — and the pharmaceutical and biopharmaceutical sectors are no exception.
- Policy
- Industry requests postponement of drug reimbursement reevals
- by Lee, Tak-Sun Jul 08, 2025 06:37am
- The pharmaceutical industry has expressed the need to postpone next year's drug reimbursement reevaluations to the government. The reason is that the reevaluation targets have not been decided by the second half of the year, leaving insufficient time for the target companies to prepare the necessary data. As a result, some are even suggesting that the reevaluations be skipped next year. According to industry sources on the 7th, the Health Insurance Review and Assessment Service held a meeting with pharmaceutical organizations, including the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, on the 4th to discuss the drug reimbursement adequacy reevaluations for 2026 and thereafter. The first phase of the drug reimbursement adequacy reevaluations will be completed this year. A pilot project was launched in 2020 targeting choline alfoscerate, for which reevaluations have been ongoing for 6 years. The ingredients subject to reevaluation were drugs that were listed for reimbursement from 2006 to 1990, before the implementation of the positive listing system. Accordingly, it is expected that the second phase of reimbursement reevaluation will focus on ingredients registered after the positive listing system was implemented. In fact, in a study on “Measures to Rationalize the Drug Reimbursement Adequacy Reevaluations” that was conducted by HIRA, the researchers presented a plan for the second phase of reimbursement adequacy reevaluations, focusing on ingredients registered between 2007 and 2013. However, it is known that some government officials are planning to strengthen the selection criteria and re-examine products that were registered before the positive listing system was introduced. The current criteria for drugs with annual claims of KRW 20 billion or more may be lowered to KRW 10 billion or more, and drugs whose reimbursement adequacy was controversial will be selected. However, as discussions with the pharmaceutical industry have only just begun, it is expected to take more time before the target ingredients are finalized. The pharmaceutical industry believes that it will be difficult to conduct a normal drug reimbursement adequacy reevaluation next year due to delays in discussions on target ingredients. An industry official said, “In the first phase, the ingredients to be reviewed for the following year were announced in March of the previous year, but this year, the ingredients have not been decided even after the start of the second half of the year, so it will be difficult to prepare data. The industry hopes that the data submission period will be extended or that the review will be postponed until the year after the next.” The ingredients to be reviewed for reimbursement adequacy in 2025 were announced in March last year. These opinions were delivered to HIRA by industry representatives at a meeting held on the 4th. Meanwhile, the first results of this year's reimbursement adequacy reevaluation will likely be announced after the DREC meeting in August. This year's reevaluation includes domestically produced natural drugs such as styrene and Joins, and the industry is paying close attention to the first results.
- InterView
- V-olet challenges to become a blockbuster fat-destroying inj
- by Nho, Byung Chul Jul 08, 2025 06:36am
- Kim Seul-ki, PM of Daewoong Pharmaceutical Daewoong Pharmaceutical's V-olet Inj, a deoxycolic acid (DCA)-based fat-destroying injectable, is garnering attention as it implements an external expansion strategy to become a global blockbuster drug, following Nabota Inj. Launched in 2021, V-olet Inj is an injectable that demonstrates significant improvement in moderate-to-severe bulging or excessive submental fat in adults through its mechanism of irreversible fat cell destruction and collagen synthesis. It currently holds a 90% market share in the Korean market. Deoxycholic acid (DCA) is a secondary bile acid that emulsifies and breaks down fat in the body. The active ingredient used in V-olet Inj is 100% chemically synthesized DCA, not derived from human or animal sources. Kim Seul-ki, PM of Daewoong Pharmaceutical's Nabota Business Team, stated, "V-olet Inj demonstrated significant submental fat improvement and safety in Koreans through a domestic Phase 3 clinical study." Kim added, "It is currently regarded as the only original product among related products launched in Korea." Notably, 72.1% of V-olet Inj recipients showed significantly higher satisfaction (compared to 25.4% for placebo), and not a single serious adverse event (SAE) occurred. Currently, V-olet Inj's domestic sales are handled by DNC Aesthetics and approximately 500 Daewoong Pharmaceutical sales representatives, and it is highly likely to surpass KRW 10 billion in annual sales soon. Kim stated, "Marketing approval for V-olet Inj was granted in the Philippines, and the company plans to seek approvals and launches in other Asia-Pacific countries, including China, Indonesia, and Thailand. Nabota, a blockbuster drug, is currently marketed in over 80 countries globally, and we are pursuing a product expansion strategy like Nabota." Q&A with Kim Seul-ki, PM, Daewoong Pharmaceutical. -Please introduce yourself. =Hello. I am Kim Seul-ki, overseeing the marketing of Daewoong Pharmaceutical's medical aesthetics pipeline, Nabota, and V-olet Inj. I was solely responsible for the launch of V-olet Inj in 2021, so it has already been five years since its release. -Belkyra was withdrawn from the Korean market, and there was a period without DCA-component products.What was the motivation for Daewoong Pharmaceutical to launch V-olet Inj in 2021? =Daewoong Pharmaceutical strives to develop and market differentiated, high-quality products. I believe DCA fat reduction was one of them. DCA is the only ingredient approved for fat improvement, so its efficacy is not disputed. The problem was that Belkyra was too expensive, which led to its failure in the Korean market. 'PPC (phosphatidylcholine),' which is currently suspended from sale but was previously used, and 'combination contour injections,' which most aesthetic clinics still offer, remain very popular fat-dissolving procedures. We assessed that the obesity market and fat-dissolving market would continue to grow, just as GLP-1 drugs like Wegovy are gaining attention today. As everyone is aware, Daewoong Pharmaceutical has been manufacturing and selling Nabota for over ten years. We believed that Nabota, indicated for wrinkle and muscle hypertrophy improvement, and V-olet Inj, focused on fat improvement, could create good synergy, and that V-olet Inj could establish itself as the next-generation product following Nabota. -V-olet Inj's initial launch reaction was significant, and I understand it quickly revitalized the DCA market in a short period. What's the secret to its rapid market impact? =It's thanks to our efforts to build trust as the first domestically produced DCA injectable. Notably, its approval as the only specialized pharmaceutical for fat improvement, along with its differentiated mechanism of action for fat cell destruction, was well communicated to medical professionals through significant effort. I believe that actively sharing the experiences of medical professionals with extensive clinical experience in the DCA field, and continuously conducting research to build trust, so that medical professionals can use it confidently, has played a significant role. Initially, concerns arose about potential side effects due to the word 'destruction.' Still, by emphasizing and educating on 'proper injection techniques,' many medical professionals are now using it with peace of mind. Additionally, when V-olet Inj was launched, some individuals were using DCA products with cosmetic approval that were not intended for internal body injection. By emphasizing the importance of approved specialized pharmaceuticals even more, those products seem to have largely disappeared now. I believe we played a significant role in changing market perception as well. -With V-olet Inj's success, many competing products are being launched. There are products like Bellacholine, which was launched last year. What are V-olet Inj's unique advantages? =The biggest differentiator is that V-olet Inj has undergone Phase 1-3 clinical studies and post-marketing surveillance (PMS), which current competing products have not. This allowed us to confirm its efficacy and safety in real-world clinical settings. Since DCA is currently the only approved ingredient in the fat-dissolving market, it was important for us to have clinical data to support its more widespread use, similar to toxins or fillers, in Korea. We have results from clinical studies involving over 960 Koreans. Now, in 5th year since launch, we have accumulated tens of thousands of treatment cases, which is another advantage. -It seems there are many more products available now for obesity and body contouring. Considering the mechanistic characteristics of fat-destroying injectables, what differentiates them from other products?. =Body contouring has become much easier thanks to drugs like Wegovy and various EBD (Energy-Based Device) products available today. However, DCA, meaning V-olet Inj, is the only injectable that can precisely target and destroy fat. There are also fat-destroying devices, such as InMode, but it's challenging to predict which fat layer those devices will target. In contrast, V-olet Inj is injected directly into the middle layer of fat, so it can be said to destroy the core of the fat. Additionally, one might worry about skin sagging as fat disappears, but V-olet Inj promotes collagen synthesis, which also improves skin elasticity. Compared to appetite suppressants like GLP-1 drugs, if you've ever tried dieting, you know that even if you lose weight, areas like a double chin or arm fat don't easily go away. V-olet Inj's advantage lies in its ability to target such areas and smoothly sculpt the body precisely. -In addition to submental fat improvement, research on body procedures seems to be active both domestically and internationally. Do you have plans for indication expansion? =V-olet Inj's approved indication is for improving moderate-to-severe bulging or excessive submental fat in adults. However, based on DCA's mechanism of action in improving fat, we conducted case studies with clinical research on various body areas. The results of a study on arm fat (upper arm) improvement using DCA were published in March. We confirmed for the first time in Koreans the effect of improving fat thickness and circumference in the upper arms. Overseas, research using DCA injectables on various fat-containing areas (e.g., jowls, abdomen, flanks, thighs, accessory breasts [axillary fat], under the buttocks, above the knees, "buffalo hump" neck, under-eye fat, lipomas, etc.) is already actively reported. Internally, we are viewing the market demand and potential for indication expansion positively. Currently, we are starting with small-scale studies, such as case studies. Thanks to its fat-destroying mechanism, its expandability seems limitless. -Daewoong Pharmaceutical plays a pioneering role in the domestic DCA market; however, competition is likely to intensify further. As the leading company in the fat-destroying injectable market, what are Daewoong's future aspirations and plans? =As you mentioned, competition in the domestic DCA market will indeed become very fierce. As various competing products emerge, the DCA market itself is expected to grow, which I view as a positive development from a marketer's perspective. V-olet Inj demonstrated trustworthiness in Korea. To help the DCA market grow to the size of the KRW 100 billion toxin market in Korea, as a pioneer of DCA, we plan to continue research on usage methods to help medical professionals utilize V-olet Inj more effectively. Furthermore, through various activities to deliver correct awareness and knowledge about fat improvement procedures to the public, we aim to create a more valuable market.
- Policy
- Low-strength salt-modified Pristiq now available
- by Lee, Tak-Sun Jul 08, 2025 06:35am
- Companies with salt-modified formulations of the antidepressant Pristiq (desvenlafaxine succinate monohydrate) are strengthening their market competitiveness with a 25mg low-strength product that had not been available in the original or generic formulations. With price adjustments near due to the entry of generics, attention is focused on whether the release of these salt-modified formulations will bring success. According to industry sources on the 6th, three items, including Nexpharm Korea's Desvela SR Tab 25mg, Myung In Pharmaceutical's S-Ven ER Tab 25mg, and Han Lim Pharm’s Prinexor ER Tab 25mg, were listed for reimbursement this month. The active ingredient in these products is desvenlafaxine benzoate, and the drugs are salt-modified versions of the original Pristiq. Neither the original nor the generic products have been available in a 25mg dosage until now. Prior to this, Whan In Pharm launched Defaxine SR Tab 25mg (desvenlafaxine) in June 2022. When patients suddenly discontinue taking antidepressants, withdrawal symptoms such as nausea, dizziness, anxiety, and other adverse reactions may occur. Therefore, a gradual reduction in dosage is necessary. In this context, the 25mg low-dose formulation of desvenlafaxine is expected to be useful for gradual dosage reduction. With a year passing since the launch of generic versions of desvenlafaxine benzoate preparations, drug price adjustments are scheduled for August this year to a level of 53.55%. As a result, drug prices for salt-modified drugs that have received premium prices may also be reduced. The 25 mg desvenlafaxine benzoate preparation, which has been added to the reimbursement list, is also scheduled to undergo a drug price adjustment one month later. With price adjustments imminent, companies need to preoccupy the market at its current price in just a month. The current maximum prices are KRW 469 for Nexpharm Korea's Nexpharm Korea's Desvela SR Tab 25mg, KRW 468 for Myung In Pharmaceutical's S-Ven ER Tab 25mg, and KRW 450 for Han Lim Pharm’s Prinexor ER Tab 25mg. Hanlim voluntarily lowered its price below the assessed price. A month later, the price of Desvela SR Tab 25mg will be adjusted to KRW 359, and the other 2 products will be priced similar at KRW 358. Last year, based on UBIST data, the three brands recorded the following outpatient prescription sales: Myung In Pharmaceutical's S-Ven ER Tab KRW 11.2976 billion, Nexpharm Korea's Desvela SR Tab KRW 50,981 million, and Han Lim Pharm’s Prinexor KRW 393.8 million. The original Pristiq SR TAb recorded KRW 2.2 billion, and Whan In Pharm launched Defaxine SR TAb recorded KRW 1.6 billion, and is leading the market.
- Company
- Novo Nordisk's injectables are in short supply
- by Nho, Byung Chul Jul 08, 2025 06:35am
- Product photo of NovoRapid injNovo Nordisk's diabetes insulin injections are experiencing a short-term shortage, causing supply difficulties in prescribing settings in Korea. The products with limited supply include NovoRapid Flexpen·Novomix Flexpen·Levemir Flexpen. Novo Nordisk sent a notice to distributors, pharmacies, hospitals, and clinics late last month, informing them of the supply limited period (April·May) and the expected resolution period (August·September). According to pharmacies, product supply has been inconsistent since around March, and despite efforts to secure stock, safety reserves are already depleted. Consequently, even if prescriptions are issued over the next two months, a substitute prescription will be unavoidable. Considering that diabetic patients are typically sensitive to medication changes, the inconvenience for doctors, pharmacists, and patients due to alternative dispensing is expected to increase significantly. One anonymous pharmacist in Yongsan-gu, Seoul, stated, "The current shortage seems to be caused by adjustments in production volume of existing products due to the explosive increase in demand for Wegovy." He asked Novo Nordisk to provide clear explanation. The basis for this speculation among medical professionals lies in the phenomenal popularity of the obesity drug Wegovy, which was launched domestically in October of last year. According to IQVIA data, Wegovy's sales of KRW 60.3 billion in Q4 of last year quickly climbing up to the top of the obesity drug market. The obesity drug market size in Q3 2024 was KRW 47.4 billion, but it surged by 97.9% to KRW 93.8 billion in just one quarter following the launch of Wegovy. In Q1 of this year, Wegovy's sales reached KRW 79.4 billion, capturing a 73.2% share of the overall obesity drug market. Wegovy, which received FDA approval in April 2023, is a GLP-1 analog containing semaglutide, confirmed to reduce HbA1c. Novo Nordisk developed Wegovy, a once-weekly obesity treatment using semaglutide, after observing weight loss effects in patients during clinical trials of GLP-1 class diabetes drug candidates. Wegovy, which received FDA approval in April 2023, is a GLP-1 analog containing semaglutide, confirmed to reduce HbA1c. Novo Nordisk developed Wegovy, a once-weekly obesity treatment using semaglutide, after observing weight loss effects in patients during clinical trials of GLP-1 class diabetes drug candidates. Regarding the overall situation, Novo Nordisk stated, "This supply shortage is due to reduced production at a filling plant caused by technical issues at some overseas manufacturing facilities and is unrelated to quality·safety." Novo Nordisk added, "We are making our utmost efforts to normalize product supply as soon as possible through close and active cooperation between the headquarters and our Korean subsidiary."
