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- 2026-04-04 15:20:53
- Policy
- "No drugs available for pediatric obesity…low dose phentermine combi as an option"
- by Lee, Jeong-Hwan Jan 29, 2026 08:17am
- On January 2, Rep. Seo Mi-hwa of the Democratic Party and the Korean Society for the Study of Obesity (KSSO) co-hosted a policy forum at the National Assembly Hall. Rep. Park Jie-won, a running candidate for the next National Assembly Speaker, attended to give a congratulating remarks.The medical community demanded the establishment of a regulatory track to allow limited prescribing of the psychotropic appetite suppressant phentermine·topiramate combination (Qsymia) in cases where the purpose of treating pediatric diseases, such as high-risk groups for adult-onset diseases, is clear.They argued that while obesity drugs such as GLP-1 analogs that can be used for pediatric patients aged 12 and older exist, they present challenges such as the difficulty of the injectable formulation and high medication costs; therefore, treatment options must be expanded by extending the indication for the low-dose phentermine and topiramate combination to those aged 12 and older.The Ministry of Food and Drug Safety (MFDS) understood the demands of prescribing clinicians and academia. Yet, it stated that the social controversy surrounding 'medical narcotic addiction' cannot be completely ignored.The MFDS explained that if a prescribing physician explains that the administration was for the purpose of treating a disease, the administration of narcotic appetite suppressants is possible even for pediatric patients.At the policy forum for expanding opportunities for pediatric obesity treatment medications, held on the 27th and hosted by the KSSO and Rep. Seo Mi-hwa of the Democratic Party, healthcare experts and the regulatory authority, the Ministry of Food and Drug Safety, met to exchange views on expanding the prescription of the phentermine/topiramate combination.Rep. Park Jie-won of the Democratic Party, the oldest active member of the National Assembly and a leading candidate for the next National Assembly Speaker, also attended the forum to support expanding obesity treatment options and to deliver congratulatory remarks.Rep. Seo Mi-hwa said, "Rep. Park Jie-won is the person who led me into politics," and added, "Along with Rep. Park, I will carefully review the opinions of medical sites and experts who believe that expanding treatment options for severe pediatric obesity is necessary.""Time to consider prescription options for pediatric patients aged 12 and older, even with restricted prescription conditions"Professor Hea Young Cho of the CHA University College of Pharmacy, who serves as the President of the Korean Society of Pharmaceutical Sciences and Technology (KSPST), appealed for the great necessity of creating a regulatory track to allow limited administration to pediatric patients aged 12 and older, highlighting Qsymia's low dependence and its clinically proven weight loss efficacy.In particular, Professor Cho noted that while the approval for phentermine monotherapy is set at age 16 and older, the reality that the low-dose phentermine·topiramate combination is more tightly regulated at age 18 and older has some irrational aspects.Professor Cho explained, "Phentermine monotherapy can be prescribed from age 16, yet the topiramate combination therapy is instead mandated for use in patients aged 18 and older," and added, "I wondered why this was the case. The prescription regulation for the combination is higher despite its lower phentermine content."Professor Cho further added, "Topiramate sustains weight loss effects by increasing satiety or stabilizing eating habits. Psychotropic components were developed as combination drugs to produce synergistic effects while lowering the dosage," and added, "Regarding dependence, the U.S. FDA manages the phentermine combination as Schedule IV, which is classified as having the lowest dependence."Professor Cho emphasized, "Because the weight loss effect of the low-dose phentermine combination has been scientifically proven, a relaxed prescription track must be created so that if necessary for pediatric treatment, the drug can be used while tracking and managing results through clinical monitoring," and added, "One way is to use a flexible prescription policy, such as lowering the prescription age for the phentermine combination by imposing limited prescription conditions and requiring sufficient clinical cases."Professor Hea Young Cho , Professor Park Jung-Hwan , Director Lee Jae Hyuk of the Korea Regulatory Affairs Professionals Society (from left)Professor Park Jung-Hwan of the Department of Endocrinology and Metabolism at Hanyang University Hospital, who serves as a director on the Committee of External Affairs and Policy of the KSSO, also urged the MFDS, the regulatory authority for the phentermine combination, not to take all management responsibility but instead grant obligations to prescribing doctors or selling pharmaceutical companies to operate the prescription age range flexibly.Professor Park said, "The use of low-dose phentermine combinations must be activated for pediatric patients. There is a case of a patient where we prescribed semaglutide up to stage 5, costing millions of won. However, the patient did not lose even 1kg of body weight," and added, "There are cases where phentermine·topiramate works for such patients."Professor Park stated, "Although semaglutide has been approved for use in pediatric patients, the reasons for obesity are diverse, so it would be good to relax the prescription age standards to accumulate and observe the necessary data and safety for the country," and "Rather than posing prescription restrictions, wouldn't it be more appropriate for the regulatory authority to open it up limitedly and present guidelines?"Director Lee Jae Hyuk of the Korea Regulatory Affairs Professionals Society also suggested that we should contemplate expanding medical options in the selection of medications for pediatric patients.The suggestion is that although the question of how to manage habitual and addictive drugs is a long-standing proposition for humanity, there is a great necessity to allow their use for medical or academic purposes.Lee said, "Even if production or distribution is strictly controlled, use should not be restricted as much as possible if medical necessity is recognized," and "Regardless of how the issue of abuse is managed as a separate focus, it is not a solution for abuse countermeasures to simply prohibit use unconditionally. A prescription environment where it can be used reasonably must be established.""No issues with pediatric patients using the phentermine combination if the treatment purpose is clear"Jeong Hyeon-cheol, Director of the Narcotics Policy Division at the MFDS, who participated as a panelist, stated that even now, there is no problem with prescribing the phentermine combination for pediatric patients where the necessity for administration is clear, such as those in high-risk groups for adult-onset diseases.This suggests that the MFDS has a sufficient range of understanding regarding the physician's right to prescribe for treatment purposes, and that simply expanding the administration indication for pediatric patients is difficult to view as the only solution.Jeong emphasized, "Regarding the facts, pediatric patients for whom use is essential due to the urgency of disease treatment risks can essentially be seen as not being restricted by prescription regulations," and "However, an inconvenient situation where a doctor has to provide a justification after prescribing may occur. This is because we operate a pre-notice system for the abuse of narcotics."Jeong highlighted, "For example, we request 4,500 doctors identified over a year as having exceeded the action standards for narcotic abuse to explain their reasons for prescription; afterward, through a committee of experts composed of doctors and pharmacists, we verify if the justification is valid, and the number decreases to units of hundreds or tens," and "The MFDS cannot restrict the physician's right to prescribe. It may be inconvenient, but the MFDS is allowing the prescription of phentermine combinations for pediatric patients."Jeong added, "To explain the questions the general public might have regarding the phentermine combination, the MFDS has approval standards, and the insurance authorities have reimbursement standards. The standards inevitably differ for each," and "After listening to the healthcare professionals, there is a need to allow its use for pediatric patients with metabolic syndrome, but the fundamental administrative goal is to prevent the abuse of psychotropic narcotics. If clinical data is submitted, we will review it."Jeong Hyeon-cheol, Director of the Narcotics Policy Division at the MFDS (left), Professor Jae-Hyuk Lee Professor Jae-Hyuk Lee of the Department of Endocrinology at Myongji Hospital (Director of the General Affairs Committee of the KSSO), who served as the chairperson, expressed concern that the method of 'justification after prescription' has significant irrational aspects and may hinder active treatment.Professor Lee emphasized, "The method of letting it pass if a proper exception is justified is not easy in clinical practice. Doctors try to avoid the task of justifying prescriptions that exceed regulations, which makes treatment difficult from the start," and "If the Ministry writes the prescription indication regulations well, healthcare professionals can accept prescribing according to those regulations."Professor Lee suggested, "If the regulations are excessively broad as they are now, it is difficult to use the drug (for pediatric patients) and post-monitoring regulation becomes complicated," and "It is ideal to manage the administration indications well and strictly regulate those that are exceeded. There are difficulties with the current method of 'do not use for now, but if you did, justify it and if that is correct, we will allow it.' Why not create the prescription regulations well so that doctors can use them properly?"
- Policy
- Generic Tagrisso and Xtandi approved in Korea
- by Lee, Tak-Sun Jan 29, 2026 08:16am
- Chong Kun Dang and Menarini have each received approval for generic versions of the oncology drugs Tagrisso and Xtandi, respectively.Particularly noteworthy is Chong Kun Dang's success in becoming the first in Korea to commercialize a generic version of Tagrisso, raising attention as to whether this will translate into early market entry.On the 27th, the Ministry of Food and Drug Safety approved two dosage strengths of Chong Kun Dang’s ‘Otinib Tab’ as well as Menarini Korea’s ‘Enzalex Soft Cap 40 mg.’CKD’s Otinib is the first approved generic version of osimertinib in Korea. The original product containing osimertinib is AstraZeneca’s Tagrisso.Both Tagrisso and Otinib are indicated for patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.Tagrisso recorded KRW 111 billion in domestic sales in 2023 (IQVIA data). Yuhan’s Leclaza (lazertinib) is its key competing product. Given its high commercial value, multiple later entrants are seeking early access to the market.CKD has taken on the challenge to circumvent Tagrisso’s formulation patent, which is scheduled to expire in January 2035. Avoiding this patent would allow market entry in 2033, when Tagrisso’s compound patent expires. Kwangdong Pharmaceutical is also attempting the same patent challenge.Although Otinib has now received regulatory approval, active market launch is not yet possible due to the remaining compound patent.Nevertheless, analysts suggest that securing a priority marketing approval (generic exclusivity) to capture the generic market first could lead to high sales.Menarini’s Enzalex Soft Cap contains enzalutamide as the active ingredient. The originator product is Astellas’ Xtandi and is used to treat prostate cancer. Xtandi recorded KRW 43.2 billion in domestic sales in 2023, according to IQVIA.This is not the first approval of an Xtandi generic in Korea. Last year, Alvogen Korea and Daewon Pharm received approvals for Anadin Soft Cap and Enzadex Soft Cap, respectively. Earlier this month, HanAll Biopharma also succeeded in listing its enzalutamide generic, Enzaluta Soft Cap, on the MFDS approval registry.With Xtandi’s compound patent set to expire in June, the opening of its generic market later this year is considered a strong possibility.However, a key variable remains the formulation patent for enzalutamide, which is scheduled to expire in September 2033. Generic manufacturers have filed patent invalidation or circumvention actions targeting this formulation patent. Whether they succeed in avoiding the patent will determine if launches occur within the year.
- Company
- First FRα-targeted ADC Elahere approved for ovarian cancer
- by Son, Hyung Min Jan 29, 2026 08:16am
- The antibody–drug conjugate (ADC) class has entered the ovarian cancer field, signaling a potential shift in the treatment paradigm.On the 28th, AbbVie Korea held a press briefing at the Plaza Hotel in Jung-gu, Seoul, to mark the approval of Elahere (mirvetuximab soravtansine) in Korea.Elahere was approved last month for the treatment of high-grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is folate receptor alpha (FRα) positive and resistant to platinum-based chemotherapy, in patients who have previously received one to three prior systemic therapies before the 19th of last month.Jung-yun Lee, Professor of Obstetrics and Gynecology, Severance HospitalElahere is an ADC targeting FRα-positive ovarian cancer. Its mechanism involves delivering the potent cytotoxic drug DM4 directly into cancer cells to destroy the tumor. The drug is drawing particular attention as a new option for patients with ovarian cancer who have developed resistance to platinum-based chemotherapy.Patients with platinum-resistant ovarian cancer often have compromised systemic health due to cumulative toxicity from repeated prior treatments and comorbidities. Therefore, effective later-line treatment options are crucial. However, existing standard treatments like non-platinum-based chemotherapy or certain targeted therapies have shown limited clinical benefits, with low response rates and no statistically significant improvement in survival.In clinical studies, Elahere reduced the risk of disease progression or death by 35% compared with standard non-platinum chemotherapy.The median progression-free survival (PFS) was 5.62 months, an improvement over 3.98 months in the control group. The objective response rate (ORR) reached up to 42.3%, significantly higher than 15.9% observed with standard therapy. The median overall survival (OS) was 16.85 months, versus 13.34 months in the control group, corresponding to a 32% reduction in the risk of death.From a safety perspective, the majority (88%) of adverse events observed in the Elahere treatment group were low-grade and manageable.The Korean Society of Gynecologic Oncology (KSGO) guidelines recommend Elahere for the treatment of FRα-positive platinum-resistant ovarian cancer with the highest level of evidence (Level I) and strongest recommendation grade (Grade A).Jung-yun Lee, Professor of Obstetrics and Gynecology, Severance Hospital, who participated in the pivotal clinical trial, stated, “Elahere demonstrated meaningful improvements across key clinical endpoints in platinum-resistant ovarian cancer, an area with high unmet medical need. It also showed consistent efficacy across subgroups. With an ORR of 42.3%, which is higher than that of the control group, Elahere offers the possibility of improved outcomes even for patients who previously had limited expectations of response. It is the first FRα-targeted therapy to demonstrate an overall survival benefit.”Importance of biomarker testing rises in ovarian cancerProfessor Jae-kwan Lee, Korea University Guro Hospital, Department of Obstetrics and GynecologyWith the approval of Elahere, biomarker-driven personalized treatment strategies are now being more fully implemented in ovarian cancer, raising expectations for meaningful changes in the treatment paradigm.While targeted therapies in ovarian cancer were previously limited to those based on the expression of a few biomarkers like PARP and HER2, the emergence of Elahere has highlighted the importance of FRα biomarker testing.FRα is a protein involved in tumorigenesis and is minimally expressed in normal tissues but highly expressed in ovarian cancer.Approximately 35-40% of all ovarian cancer patients are reported to be FRα-positive. Its expression tends to remain consistent from diagnosis through recurrence, enabling personalized targeted therapy when the cancer progresses to platinum-resistant ovarian cancer.This biomarker is determined positive when membrane staining intensity of 2+ or higher is confirmed in at least 75% of tumor cells using Roche Diagnostics' immunohistochemistry (IHC)-based companion diagnostic assay.Professor Jae-kwan Lee of the Department of Obstetrics and Gynecology at Korea University Guro Hospital said, “Depending on tumor heterogeneity, even cases previously negative for FRα may become positive upon recurrence. For patients without treatment alternatives, retesting should be considered.”
- Policy
- KSPST 'Generic drug price cuts not right for fiscal savings'
- by Lee, Tak-Sun Jan 29, 2026 08:16am
- Cheong-won Cho, the newly appointed president of the Korean Society of Pharmaceutical Science and Technology (KSPST), expressed a critical view of the government’s policy to lower generic drug prices, stating that such an approach is not logically consistent if the objective is to reduce National Health Insurance (NHI) spending. She argued that to reduce NHIS spending, the use of generic drugs should be promoted rather than cutting their price.Cho made the remarks during a press briefing held on the 28th at a restaurant in Yeoksam-dong, Seoul. “Given concerns about the depletion of the NHI fund, policies aimed at narrowing financial gaps are necessary. However, lowering generic drug prices as a means of reducing NHI expenditure seems illogical.”“Lowering generic drug prices would have a devastating impact on pharmaceutical companies' profits, leading to workforce reductions and decreased R&D investment. The government claims that lowering generic drug prices will encourage increased investment in new drug development, but I believe the government and the pharmaceutical industry are heading in different directions on this point.”“It's not that the government's position is wrong, but rather than focusing on lowering generic drug prices, they should seek various methods to prevent the depletion of the national health insurance fund. I think it would be good if the government held a close ear to the input from relevant academic circles and organizations and considered the overall situation to restructure the system based on a predictable scenario.” President Cho explained that activation of generics following patent expiration of originator drugs is, in itself, beneficial to NHI finances.This was Cho's first meeting with the press after being appointed President of KSPST. Currently a professor at Chungnam National University College of Pharmacy, she expressed her ambition for strengthening the society’s internal capabilities while expanding its external influence.Cho said, “As pharmaceutics advances, regulatory environments are becoming more complex and global competition more intense. We will establish a robust academic framework and build effective R&D programs. To expand our reach, we will form consortia with domestic and international academic societies and foreign journals, and establish a systematic framework to support the society's sustained growth.”The newly appointed executive board of the Korean Society of Pharmaceutical Science and Technology poses for a commemorative photo after concluding a press conference on the 28th. (From left: Scientific Program Committee Chair Jin-wook Yoo, General Affairs Committee Chair Sangkil Lee, President Cheong-won Cho, Secretary General Yu Seok Yoon, Public Relations Committee Chair Jun-Bom Park)Yu Seok Yoon, Secretary General of KSPST, who also attended the event, said, “The society must serve as a bridge between basic science and clinical practice. We will continue to expand into areas where social and academic demand exists.”Founded in 1971, KSPST is a reputable academic organization that has dedicated 54 years to advancing pharmaceutical research and scholarship. It has approximately 1,200 members and has contributed to the development of the pharmaceutical industry and the promotion of public health through the dissemination of pharmaceutical R&D achievements and industry collaboration.Last year, the society shared the latest developments in pharmaceutics through the Formulation Technology Workshop and an International Academic Conference. The Formulation Technology Workshop drew participation from approximately 500 experts from industry, academia, and research institutes. Its International Academic Conference also gathered over 650 attendees, including 36 domestic and international speakers from 11 countries, marking its largest-ever participation.This year’s major events include a Science Month symposium on April 10, a Formulation Technology Workshop on September 18, and the Society’s General Assembly and International Conference from November 25 to 27.Jin-wook Yoo, Chair of the Scientific Program Committee, noted, “Through our academic conferences, we aim to strengthen industry-academia-research collaboration by pursuing both academic depth and industrial applicability. We plan to establish an academic foundation for the pharmaceutical-biotech sector's leap forward and organize conference sections reflecting the latest technological trends.”
- Company
- 'Ozempic' prescriptions available at general hospitals
- by Eo, Yun-Ho Jan 28, 2026 08:12am
- Product photo of Ozempic'Ozempic,' the diabetes treatment containing the same active ingredient as the obesity drug Wegovy, is entering the general hospital prescription areas.According to industry sources, Novo Nordisk Korea's GLP-1 receptor agonist (GLP-1 RA) Ozempic has passed the drug committees (DC) of major tertiary general hospitals, including Samsung Medical Center and Seoul National University Hospital. Ozempic is currently securing its prescription area ahead of the implementation of insurance reimbursement in February.Ozempic, which will be listed next month, can be prescribed as part of a triple therapy including metformin and sulfonylurea (SU), or in combination with insulin. However, unlike existing GLP-1 analogs, the reimbursement criteria have been restricted to 'Type 2 diabetes patients whose glycated hemoglobin (HbA1C) levels remain at 7% or higher despite at least 2 to 4 months of combination drug therapy.'While analysis suggests that this is Ministry of Health and Welfare's measure to prevent misuse or abuse of Ozempic, some critics argue it limits patient access. It remains to be seen how much Ozempic, with many limitations, will demonstrate in the diabetes treatment market.Competition within the GLP-1 class is expected to intensify further, as Eli Lilly Korea’s GIP/GLP-1 dual receptor agonist 'Mounjaro (tirzepatide)' is also currently undergoing price negotiations with the National Health Insurance Service (NHIS) for diabetes reimbursement listing.Meanwhile, Ozempic demonstrated powerful blood sugar-lowering and weight loss effects compared to various diabetes medications, including DPP-4 inhibitor Januvia (sitagliptin), the exendin-4-based GLP-1 RA Byetta (exenatide), and the GLP-1 RA Trulicity (dulaglutide), through six Phase 3 studies (SUSTAIN 1–5 and 7). Notably, Ozempic showed superior blood sugar-lowering effects compared to insulin while maintaining a lower risk of hypoglycemia.The 'SUSTAIN 9' study confirmed additional blood sugar and weight reduction effects in Type 2 diabetes patients who did not achieve sufficient control following treatment with SGLT-2 inhibitors, a leading class of oral diabetes medications. In the 'SUSTAIN 6' Phase 3 trial, the drug reduced the risk of major adverse cardiovascular events (MACE) by 26% in adult patients with Type 2 diabetes and high cardiovascular risk.
- Policy
- “What we need is competition, not rebates”
- by Lee, Jeong-Hwan Jan 28, 2026 08:12am
- “Stop the meaningless debate on what percentage the government is willing to adjust the generic drug calculation rate. Lowering drug prices will simply increase prescription volume, so it won't lead to savings in drug expenditures. The government must regulate rebates to create an environment where lower-priced drugs are prescribed more frequently. That's how we achieve savings in the national health insurance budget.”Academic experts view that lowering generic drug reimbursement rates alone, even if the government reduces the generic pricing formula from 53.55% to the 40% range, will not lead to savings in the National Health Insurance (NHI) budget.In other words, simply lowering the generic drug calculation rate, which has led to repeated battles between the MOHW and the industry, will not lead to actual drug cost savings. Rather, the government should focus on eliminating illegal rebates and establishing a market-driven drug pricing environment to save the National Health Insurance and foster the growth of the domestic pharmaceutical industry.At a National Assembly policy forum on drug pricing reform held on the 26th, Professor Hye-young Kwon of the Department of Health Administration at Mokwon University said, “Creating an environment where lower-priced, cheaper drugs are more widely prescribed in the market is what will save NHI finances.”According to Kwon, the ongoing standoff between the government and the pharmaceutical industry over generic pricing percentages will not translate into actual reductions in pharmaceutical expenditure.Kwon also expressed “serious concern” on how the MOHW’s drug pricing reform proposal was announced without sufficient social consensus or prior consultation with stakeholders in the pharmaceutical industry.She further stated that discussing NHI fiscal sustainability solely through adjustments to generic pricing formulas is inherently unreasonable and significantly ineffective.Her logic is that even if the generic drug price calculation rate is drastically lowered from 53.55% to 40%, the amount of drugs prescribed in the market will increase substantially due to lower prices. Consequently, the NHI funds spent on drug costs will remain at the same level before and after the reduction.Kwon advised the Ministry of Health and Welfare that instead of targeting NHIS savings through the generic drug calculation rate, it should devise and implement policies enabling low-cost generics to gain market share. Only then can NHIS savings be successfully achieved.She argued that the current situation, where pharmaceutical companies manipulate prescription volumes through illegal rebates, must be aggressively addressed, stressing the need to create an environment where generics that offer lower prices and higher quality can increase market share.Kwon stated, “There was no social consensus or public deliberation process before the Ministry of Health and Welfare announced the drug pricing system. Personally, it was a very disconcerting announcement. "Reducing health insurance expenditures depends on policies leveraging generics. I find it incomprehensible that they are discussing pricing cuts like lowering the reimbursement rate to the 40% range.““No matter how much you lower generic prices, NHI spending will not decrease. As prices fall, prescription volumes rise proportionally. To date, the MOHW has never successfully reduced healthcare spending through generic pricing policies. Drug prices only fall meaningfully when they are subjected to genuine market competition, guided by the invisible hand.”“The reason Korea has failed to let market forces work is that prescriptions are driven not by lower prices, but by the amount of rebates. The MOHW has failed to establish policies that ensure lower-priced generics gain greater market share, resulting instead in the proliferation of increasingly small-scale, mom-and-pop-style pharmaceutical companies.”“Domestic drug costs are driven by the extremely high prices of off-patent originator drugs. Yet, no advanced country allows originator drugs after patent expiry to generate such high profits. That value should be captured through price competition by domestic generic manufacturers. Only by replacing rebate competition with price competition can Korea simultaneously strengthen its pharmaceutical industry and ensure the long-term sustainability of the national health insurance system.”
- Company
- US tariffs on pharmaceuticals forecast…K-bio closely monitors
- by Chon, Seung-Hyun Jan 28, 2026 08:12am
- U.S. President Donald Trump showed his intent to impose a 25% tariff on pharmaceuticals. Korea's major pharmaceutical companies devised countermeasures by acquiring U.S.-based manufacturing plants. The Korean pharmaceutical industry is also closely watching the continuously changing imposition of tariffs.ChatGPT-generated imageOn January 26, 2026, President Trump posted on Truth Social, "The South Korean National Assembly has failed to implement previously agreed trade measures," adding, "An immediate increase in tariffs on Korean woods, pharmaceuticals, and all other reciprocal goods from 15% to 25%.In October 2025, during the APEC summit in Gyeongju, Korea and the U.S. reached a Most Favored Nation agreement for pharmaceuticals. This deal detailed that tariffs on South Korean medicines would not exceed 15%.According to the details of the agreement disclosed last month, the White House released a South Korea-U.S. Summit Joint Fact Sheet (JFS) that includes an agreement to ensure that tariffs on South Korean pharmaceutical products do not exceed 15%. It was finalized that in any case where tariffs are imposed on pharmaceuticals, the rate will not exceed 15%. For generics, it was decided to apply zero tariffs.The KoreaBIO Association stated, "While it was agreed in the Korea-U.S. trade agreement to apply a maximum of 15% if Section 232 tariffs are applied to pharmaceuticals, it will be difficult to rule out the possibility of a tariff increase to 25% through future amendments to the trade agreement."President Trump has also mentioned the possibility of imposing 100% tariffs on branded pharmaceuticals since October of last year.Through Truth Social on September 25 last year, President Trump stated, "Starting the 1st of next month, a 100% tariff will be imposed on all branded and patented pharmaceuticals from companies that are not building pharmaceutical production plants within the United States." adding, "'IS BUILDING' means a state where groundbreaking has occurred or construction is underway," and "In cases where construction has started, no tariffs will be imposed on the corresponding pharmaceuticals." However, no official tariff measures regarding pharmaceuticals have been announced to date.Korean pharmaceutical and biotech companies with high export volumes to the U.S. are in a state of high alert regarding pharmaceutical tariff rates. Domestic pharmaceutical and biotech companies without local plants in the U.S. have no choice but to closely watch the trend, as U.S. pharmaceutical tariff rates can impact their market penetration.However, it has been suggested that even if tariff rates rise, the direct blow will not be significant for Celltrion and Samsung Biologics, which export the most pharmaceuticals from Korea to the U.S., as they have established countermeasures by acquiring local plants.Celltrion has shown the most preemptive movement in preparation for U.S. tariffs. In September last year, Celltrion's subsidiary, Celltrion USA, signed a formal contract to acquire a biopharmaceutical production plant located in Branchburg, New Jersey, from ImClone Systems Holdings, a subsidiary of Eli Lilly. The acquisition amount is approximately $330 million (about KRW 460 billion). Celltrion received approval from Irish competition authorities in October last year and finally completed the acquisition process in November after the finalization of the business combination review by the U.S. Federal Trade Commission (FTC).Celltrion USA production facility opening ceremony held in June (from left: Kee Woo-sung, Vice Chairman of Celltrion; Todd Winge, CEO of Celltrion Branchburg; Park Kyung-ok, Senior Vice Chairman of Celltrion Holdings; Seo Jung-jin, Chairman of Celltrion Group; U.S. Senator Andy Kim of New Jersey; U.S. Representative Thomas Kean Jr. of New Jersey; Thomas Young, Mayor of Branchburg Township; Seo Joon-seok, Head of Celltrion North America Headquarters).The U.S. production facility acquired by Celltrion is a large-scale campus equipped with a total of four buildings, including production facilities, logistics warehouses, a technical support building, and an operation building on a site of approximately 148,500㎡, capable of producing about 66,000 liters of drug substance (DS). Celltrion plans to enter into an immediate expansion process and invest an additional KRW 700 billion to expand production capacity to a total of 132,000 liters.A Celltrion official explained, "By securing the production facility in Branchburg, New Jersey, we have prepared a fundamental solution regarding tariffs and have structurally escaped from all risks.Samsung Biologics signed a contract last December with GlaxoSmithKline (GSK) to acquire the Human Genome Sciences (HGS) biopharmaceutical production facility located in Rockville, Maryland. This involves an investment of $280 million (approximately KRW 410 billion) by Samsung Biologics America, the U.S. subsidiary of Samsung Biologics, to acquire the plant. The asset acquisition process is scheduled to be completed within the first quarter of this year.View of the Human Genome Sciences biopharmaceutical production facility located in Rockville, Maryland. The Rockville production facility is a drug substance production plant with a total capacity of 60,000 liters located in the center of the Maryland bio-cluster, consisting of two manufacturing buildings. The facility is equipped with infrastructure capable of supporting the production of antibody drugs at various scales, from clinical stages to commercial production.This is Samsung Biologics' first acquisition of an overseas plant. Samsung Biologics operates five plants in Songdo, Incheon. All five plants were constructed using internally procured funds.It appears that biotech companies with large U.S. export volumes have completed preparations for tariff risks by investing a total of over KRW 1 trillion to acquire local plants.According to the Ministry of Food and Drug Safety, South Korea's pharmaceutical export volume to the U.S. in 2024 was $1.49117 billion (approximately KRW 2 trillion), accounting for 16.1% of the $9.28987 billion total export volume of domestically produced pharmaceuticals. Among pharmaceutical exports to the U.S. in 2024, finished pharmaceutical products accounted for $1.29899 billion, or 87.1%, while active pharmaceutical ingredients (API) were only $192.19 million, or 16.9%. Samsung Biologics and Celltrion in the U.S. export of domestically produced pharmaceuticals occupy the most.For Samsung Biologics, U.S. regional sales accounted for KRW 1.1741 trillion, or 25.8% of its KRW 4.5473 trillion total revenue in 2024. Samsung Biologics' U.S. revenue share recorded 28.5% and 26.3% in 2022 and 2023, respectively. Samsung Biologics calculates regional revenue based on the location of its CDMO clients. Samsung Biologics' cumulative U.S. revenue for the third quarter reached KRW 1.6482 trillion, surpassing last year's export volume. U.S. sales accounted for 38.8% of Samsung Biologics' KRW 4.2484 trillion cumulative revenue through the third quarter. For Celltrion, biopharmaceutical sales in the North American market reached KRW 1.0453 trillion in 2024. Celltrion's North American market sales decreased 11.3% from KRW 709.5 billion in 2022 to KRW 629.2 billion in 2023, but increased by 66.1% in 2024 compared to the previous year, surpassing KRW 1 trillion for the first time.
- Company
- New AML drug Vanflyta approved in Korea
- by Son, Hyung Min Jan 28, 2026 08:12am
- Daiichi Sankyo Korea (CEO Jeong-tae Kim) announced on the 26th that its acute myeloid leukemia (AML) targeted therapy Vanflyta (quizartinib) has been approved in Korea.With this approval, Vanflyta can now be used in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation therapy, and as a maintenance mono therapy following consolidation therapy, for adult patients with newly diagnosed acute myeloid leukemia that is FLT3-ITD-positive.AML accounts for approximately 23.1% of all leukemia cases worldwide, and around 2,000 adults are newly diagnosed with AML each year in Korea. FLT3 mutations are the most commonly reported genetic alterations in AML, with approximately 25% of newly diagnosed AML patients harboring the FLT3-ITD mutation. The FLT3-ITD mutation is associated with a high disease burden and poor prognosis, including shortened overall survival.The efficacy and safety of Vanflyta were evaluated over a long-term period of more than five years in the Phase III QuANTUM-First trial, a randomized, double-blind, placebo-controlled study involving 539 patients with newly diagnosed FLT3-ITD–positive AML.Patients enrolled in the study received induction and consolidation combination therapy followed by up to 3 years of maintenance monotherapy with Vanflyta, regardless of whether they underwent allogeneic hematopoietic stem cell transplantation.Results showed a 22% reduction in the risk of death in the Vanflyta group compared with the placebo group. At a median follow-up of 39.2 months, the median overall survival (mOS) was 31.9 months in the Vanflyta group, an extension compared with 15.1 months in the placebo group.Jeong-tae Kim, CEO of Daiichi Sankyo Korea, stated, “We are very pleased to be able to provide a new first-line treatment option for patients with poor prognosis FLT3-ITD mutation-positive AML with the approval of Vanflyta. Following solid tumors, we are now introducing a therapy that can improve treatment outcomes in hematologic malignancies as well. We will continue our endeavors to make meaningful progress to expand treatment access for more patients in Korea.”Byung-sik Cho, Chair of the Acute Myeloid Leukemia/Myelodysplastic Syndrome Working Group of the Korean Society of Hematology (Professor of Hematology at Seoul St. Mary’s Hospital), said, “Vanflyta has been confirmed to extend both complete remission duration and overall survival when administered as maintenance therapy following induction and consolidation therapy, added to standard chemotherapy in newly diagnosed FLT3-ITD mutation-positive AML patients based on its mechanism that selectively targets the FLT3-ITD mutation. This is expected to bring an important change to AML treatment strategies in Korea.”
- Company
- Rhapsido soon to be launched in Korea
- by Son, Hyung Min Jan 28, 2026 08:11am
- A shift in the treatment landscape for chronic spontaneous urticaria (CSU) is imminent. With Novartis positioning an oral BTK inhibitor as a successor to Xolair, competition over treatment options for antihistamine-refractory patients is entering a new phase.Novartis’s Rhapsido (remibrutinib)According to industry sources on the 28th, Novartis Korea has recently completed its regulatory submission for Rhapsido (remibrutinib). Approval is expected within the first half of this year.Rhapsido is an oral targeted therapy that inhibits Bruton’s tyrosine kinase (BTK), a key pathway in the pathophysiology of CSU, thereby blocking the release of histamine and inflammatory mediators. The drug was approved in the United States last September for the treatment of adult CSU patients whose symptoms persist despite second-generation H1 antihistamines.One of Rhapsido’s most notable features is its oral formulation, taken twice daily. Until now, treatment options for patients unresponsive to first-line antihistamines have been largely limited to the injectable biologic Xolair (omalizumab). The arrival of Rapsido opens a new option, an oral targeted therapy.According to the Phase III REMIX-1·2 clinical trial results, which formed the basis for its U.S. FDA approval, Rhapsido demonstrated superiority over placebo in improving itch severity (ISS7), hive severity (HSS7), and total urticaria activity score (UAS7) starting from Week 2. Approximately one-third of patients achieved complete remission (defined as zero itch and zero hives) by Week 12.In terms of safety, the drug showed a favorable profile, being stable enough not to require laboratory monitoring. Common adverse events were mild and included nasopharyngitis, headache, and abdominal pain.Following the US approval, Novartis has submitted Rhapsido for approval in major markets, including the EU, Japan, and China, where it has received priority review status. With formal submission completed in Korea as well, the entry of the first oral targeted therapy for CSU is imminent.Beyond CSU, Novartis is also expanding clinical development of Rhapsido across a range of immune-mediated diseases, including chronic inducible urticaria (CIndU), hidradenitis suppurativa (HS), food allergy, and multiple sclerosis.BTK inhibitors emerge as a successor to biologics in CSUCompetition in the CSU treatment market is rapidly intensifying around BTK inhibitors.BTK inhibition was first established in hematologic malignancies such as B-cell lymphomas and leukemia. Starting with the first-generation agent Janssen’s Imbruvica (ibrutinib), second-generation drugs BeiGene’s Brukinsa (zanubrutinib) and AstraZeneca’s Calquence (acalabrutinib), and third-generation Lilly’s Jaypirca (pirtobrutinib), have rapidly expanded their market share as later entrants.With the mechanistic advantages of BTK inhibition having also been confirmed in autoimmune diseases, later entrants are increasingly targeting these indications in drug development.Sanofi’s WayrilzNotably, Sanofi is strengthening its BTK inhibitor lineup in addition to its IL-4/13 inhibitor Dupixent (dupilumab).In September last year, Sanofi received US approval for the BTK inhibitor Wayrilz (rilzabrutinib) for immune thrombocytopenia (ITP). The drug has now advanced into Phase III trials for chronic inducible urticaria(CIU) and CSU.While Rhapsido achieves sustained BTK inhibition through irreversible binding, Wayrilz employs a hybrid mechanism combining reversible and irreversible binding.Sanofi is also developing another BTK inhibitor, tolebrutinib. However, development has recently been put to a stop after the FDA issued a Complete Response Letter (CRL).This treatment had garnered expectations for its mechanism of action, which selectively suppresses the immune response in multiple sclerosis by regulating B lymphocytes and disease-associated microglia. However, the requirement for additional data has rendered the approval timeline uncertain.
- Opinion
- [Reporter's View] On downsizing global pharma sales force
- by Son, Hyung Min Jan 27, 2026 06:56am
- The notable change currently observed in the global pharmaceutical industry is a series of organizational restructurings, commonly referred to as Early Retirement Programs (ERP).Major global pharmaceutical companies have already implemented large-scale ERPs centered on sales positions, and the trend of downsizing continues even in traditional areas where sales force strength was historically critical, such as chronic diseases. This trend is similarly impacting the South Korean subsidiaries of multinational corporations.The most apparent reason for this trend is cost efficiency; however, the term "Role Redesign" is increasingly used within these organizations. These adjustments are not intended merely to reduce the workforce; instead, job functions are being restructured as AI-based sales models become fully operational.For several years, global headquarters have been building AI-based systems for visibility optimization, digital channel automation, and prescription-prediction models, while downsizing sales organizations. The information that was previously gathered through field-based sales activities is now presented first by the system, which even recommends specific behavioral strategies.Multinational subsidiaries in Korea and domestic pharmaceutical companies find themselves at a similar crossroads, having reviewed or implemented ERPs in recent years. However, a persistent issue is that ERP in the pharmaceutical sector is still often interpreted as a short-term efficiency measure to improve sales productivity.Global trends indicate that ERP is linked to organizational redesign, job redefinition, and the acceleration of AI and digital transformation. The era where simply reducing staff created efficiency has ended. The more critical question now is which roles should remain.Specifically, the functions of a sales organization are beginning to be divided into tasks AI can perform and those it cannot. The first category includes repetitive and standardized tasks that AI and data can replace. Systems now provide visibility ranking, channel mixes, and basic messaging faster and more accurately than humans.The second category involves high-difficulty roles that AI cannot replace. This includes areas requiring qualitative judgment, such as understanding hospital decision-making structures, regional characteristics, differences in patient distribution, subtle market fluctuations at the time of competing drug launches, and identifying the actual needs of medical professionals.These are the underlying reasons why global firms have expanded Key Account Management (KAM), Hospital Access, and Medical collaboration organizations following their restructurings. Traditional sales are cut down, not strategic sales.As ERP becomes more prevalent in the Korean market, the most significant challenge lies in updating Key Performance Indicators (KPIs) and job standards simultaneously. If an organization implements AI-based strategies but continues to evaluate employees based on legacy metrics, such as the number of visits, simple sales volume, or regional distribution, ERP will only serve to make the organization more inefficient.ERP must be a process of redefining what the organization considers "performance," rather than just adjusting headcount. Immediately following downsizing, global companies transitioned their KPIs to focus on strategy execution, targeting appropriateness, and multi-channel utilization. Conversely, many domestic companies remain tethered to past metrics.Ultimately, ERP is the starting point of change. Whether that change becomes a foundation for new competitiveness or remains a short-term cost-cutting exercise depends on how quickly an organization can redefine roles and standards.In the era of AI, a salesperson's status is determined not by who has accumulated the most data, but by who interprets it correctly. As global restructuring accelerates, pharmaceutical companies must redesign the future of their sales organizations. What remains is more important than what is cut down.
