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- 2026-04-21 07:56:09
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- Takeda’s ‘Takhzyro’ listed for reimbursement
- by Son, Hyung Min Mar 26, 2026 09:28am
- Hereditary angioedema (HAE) treatment strategies are showing signs of shifting from an emergency response–centered approach to long-term prevention. With Takeda’s kallikrein inhibitor ‘Takhzyro’ entering the reimbursement list, changes are expected in the existing treatment paradigm that relied on repeated management of acute attacks.On the 25th, Takeda Pharmaceuticals Korea held a press conference at the Glad Hotel in Yeouido, Seoul, announcing the reimbursement listing and domestic launch of the HAE treatment Takhzyro (lanadelumab).Reimbursement criteria include ▲Cases where, despite receiving the androgen-suppressing agent ‘Danazol’ for six months or more, attacks requiring an average of three or more monthly doses of pirazir (acetate) have occurred in the past six months, ▲ases where Danazol administration is contraindicated or cannot be administered due to side effects, provided that emergency treatment was required an average of three or more times per month during the six months prior to administration of this drug.Professor Kyung-min Ahn, Division of Allergy and Clinical Immunology, Ewha Womans University Seoul HospitalHAE is a rare genetic disorder characterized by recurrent severe swelling of the face, hands, feet, abdomen, and especially the airways, caused by a deficiency or dysfunction of C1 esterase. It is characterized by painful swelling without urticaria or itching, and laryngeal edema can lead to fatal asphyxiation.Takhzyro is a treatment used for the routine prevention of symptoms of hereditary angioedema. This medication works by selectively inhibiting the plasma kallikrein (pKal) enzyme, which triggers bradykinin production, thereby preventing angioedema.The efficacy and safety of Takhzyro were confirmed through Globee’s Phase III HELP study. This study enrolled 125 patients with Type 1 and 2 HAE who experienced an average of 3.7 acute swelling episodes per month.In the trial, the group receiving Takhzyro 300 mg every two weeks showed an 83% reduction in moderate-to-severe acute attacks and an 87% reduction in attacks requiring acute treatment compared to placebo.Additionally, in the HELP OLE extension study, which followed 212 patients for approximately 30 months, an average 87.4% reduction in acute attacks was maintained compared to baseline. No new safety concerns were reported in long-term follow-up.Professor Kyung-min Ahn of the Department of Allergy and Clinical Immunology at Ewha Womans University Seoul Hospital stated, “The reduction in acute angioedema and long-term maintenance of efficacy confirmed in clinical studies demonstrate that Takhzyro is a treatment capable of stably managing the disease.”He added, “In major countries such as the U.S. and Europe, prevention-focused treatments have already become the standard of care. In particular, both emergency and preventive treatments are reimbursed, enabling personalized care. The inclusion of Takzyro in the national health insurance reimbursement system aligns with global treatment strategies.”“Fundamental prevention of HAE is needed”Young Joo Cho, Professor of Allergy and Clinical Immunology, Ewha Womans University Mokdong HospitalHAE treatment is divided into preventive therapy and acute treatment. Danazol, an androgen therapy, has primarily been used for prevention.However, danazol has serious adverse effects in women, including hirsutism, acne, voice changes, and amenorrhea. As a result, regular blood tests (liver function, lipid profile) and ultrasound monitoring are essential.Firazyr is used for acute treatment. Approved in 2018, Firazyr is a subcutaneous injection that blocks the action of bradykinin, which causes vasodilation, and relieves acute swelling within two hours. It has the advantage of allowing patients to self-administer the medication.However, experts agree that in order for patients to maintain a normal life, treatment should shift toward prevention-based therapy.The 2021 guidelines from the World Allergy Organization (WAO) and the European Academy of Allergy and Clinical Immunology (EAACI) clearly define the treatment goal for HAE as “complete disease control and normalization of patients’ lives,” emphasizing the need for long-term preventive therapy.Professor Young Joo Cho of the Department of Allergy and Clinical Immunology at Ewha Womans University Mokdong Hospital explained, “Acute attacks significantly affect patients’ quality of life, including work, leisure, and travel. The reimbursement of Takhzyro represents an important step toward shifting Korea’s HAE treatment strategy from acute management to prevention.”She added, “D Although danazol is inexpensive, it causes side effects that make it virtually unusable for women. Danazol is rarely used overseas. It is regrettable that the criteria for domestic reimbursement for Taczyro require the use of danazol first.”
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- Drug price pressure from US…"K-similars may need to join GENEROUS model"
- by Kim, Jin-Gu Mar 25, 2026 07:21am
- As the U.S. pharmaceutical policies under the Trump administration have been rapidly shifting, suggestions have emerged that South Korean biosimilar companies should consider participating in the CMS (Centers for Medicare & Medicaid Services) new drug pricing model, 'GENEROUS,' as a strategic breakthrough.Professor Dong-chul Seo, Professor Emeritus at Chung-Ang University College of Pharmacy, advised this on the 23rd during a seminar held at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) titled 'Changes to Pharmaceutical Policy in the Second Trump Administration and Response Strategies for Domestic Companies in South Korea.'Professor Seo analyzed that the GENEROUS model could offer Korean firms an opportunity amid the unpredictable tariff risks of Trump's second presidency and the pressure for Most Favored Nation (MFN)-based price reductions.The GENEROUS (Generating Cost Reductions for U.S. Medicaid) model is a pilot program designed by CMS to reduce costs for U.S. Medicaid. Scheduled to run for five years starting in 2026, this model's key is the application of MFN pricing based on companies' 'voluntary participation'.Participating companies must provide additional rebates to Medicaid referencing the second-lowest price among eight reference countries (UK, France, Germany, Italy, Canada, Japan, Denmark, and Switzerland). Unlike the Inflation Reduction Act (IRA), which mandates price reductions, this is closer to a negotiation-based model in which companies accept price cuts in exchange for securing status in the nation's public insurance programs.CMS introduced this model to lower patients' out-of-pocket costs by reducing drug prices. CMS calculates the Guaranteed Net Unit Price (GNUP) based on the MFN price. Pharmaceutical companies must meet this standard by adding extra rebates to existing ones. State governments accept the prices negotiated by CMS with manufacturers, and further price-reduction negotiations are restricted.Professor Seo stated, "This system is designed to provide additional rebates to the government if foreign drug prices are lower," adding, "Since it is a voluntary participation method with applications accepted until the 30th of next month, companies can review their participation."Analysis suggests that the GENEROUS model may favor biosimilars, as it secures standing in public insurance on the premise of price reductions.For original drugs, accepting MFN pricing is difficult due to the burden of maintaining global pricing tiers. Conversely, biosimilars, which have already been competing at lower price points, are differentiated by the possibility for additional reductions. Accordingly, this is seen as an opportunity to expand market share in the Medicaid market, where the influence of original drugs is diminishing.There is also the possibility of using this as a tool to counter tariff risks. The Trump administration previously proposed 'tariff exemptions for the next three years' to 16 global pharmaceutical companies that agreed to supply at MFN prices. Other mentioned benefits include the provision of FDA's National Priority Vouchers and the application of 'PreCheck' programs. As the GENEROUS model is also a program predicated on fiscal savings, similar policy incentives may be granted.However, suggestions have been made that precise profit-and-loss calculations are needed, given the inherent unpredictability of the Trump administration's pharmaceutical policies. This means a thorough review is required to see if the volume increase from market share expansion outweighs the price cuts and potential tariff burdens.Professor Seo stated, "It would be beneficial for Korean biosimilar manufacturers to participate in this model and experience the actual price application methods," and suggested, “Since generics and biosimilars are highly price-sensitive and have relatively limited global price-linkage effects, participation in the GENEROUS model can be reviewed."Professor Seo further stated, "Companies must comprehensively consider their Medicaid market dependency and sales proportions, the risk of exposing reference country price in MFN is applied, and the impact of price linkages in other nations," and concluded, "Participation may require systematic management of global price exposure and its subsequent effects.”
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- Imfinzi approved as perioperative gastric cancer therapy in KOR
- by Son, Hyung Min Mar 25, 2026 07:21am
- Immuno-oncology drug ‘Imfinzi’AstraZeneca Korea (CEO Eldana Sauran) announced on the 23rd that Imfinzi (durvalumab) has received approval for perioperative treatment of gastric cancer in Korea.The approved indication is for the treatment of patients with resectable gastric or gastroesophageal junction adenocarcinoma, as perioperative therapy in combination with 5-fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy before and after surgery, followed by Imfinzi monotherapy as adjuvant treatment.Under the approved regimen, Imfinzi is administered in combination with FLOT (5-fluorouracil, leucovorin, oxaliplatin, and docetaxel) for two cycles before surgery, followed by surgery. After surgery, two cycles of Imfinzi plus chemotherapy are administered, and then maintenance treatment with Imfinzi monotherapy is initiated. With this approval, Imfinzi becomes the first immuno-oncology drug approved in Korea for perioperative treatment of gastric cancer.While surgery is the primary treatment for gastric cancer, recurrence rates have historically been high even after surgical intervention. In fact, about 40% to 60% of gastric cancer patients die from recurrence. It is also reported that among patients who experience recurrence after surgery, 50% recur within two years and 90% within five years.This approval of Imfinzi is viewed as a new therapeutic approach that can reduce the risk of recurrence and provide survival benefits as a perioperative therapy for gastric cancer.The approval was based on results from the global Phase III MATTERHORN study in patients with resectable gastric cancer and gastroesophageal junction adenocarcinoma. The MATTERHORN study evaluated the efficacy and safety profile of Imfinzi plus FLOT chemotherapy followed by Imfinzi monotherapy as perioperative treatment, compared with a control arm that received FLOT chemotherapy and surgery alone.Study results confirmed that Imfinzi demonstrated clinical benefits in terms of the primary endpoint, event-free survival (EFS), as well as the secondary endpoints of overall survival (OS) and pathological complete response (pCR) rates.Perioperative Imfinzi reduced the risk of disease progression, recurrence, or death from any cause by 29%, showing a significant improvement in EFS. At 24 months, overall survival was numerically higher in the Imfinzi perioperative treatment group at 75.7%, compared with 70.4% in the control group, although statistical significance was not established. The pCR rate was also approximately 2.7 times higher, at 19.2% in the Imfinzi group versus 7.2% in the control group.The safety profile of perioperative Imfinzi observed in the MATTERHORN study was consistent with the known safety profiles for each individual agent.Professor Keun-wook Lee of the Department of Hematology and Oncology at Seoul National University Bundang Hospital stated, “Gastric cancer is a type of cancer in which recurrence occurs in a substantial number of patients even when treated at a resectable stage. In particular, it has been reported that a significant number of patients with stage II–III gastric cancer experience recurrence despite receiving adjuvant therapy after surgery, rendering a new treatment strategy encompassing both pre- and post-operative settings urgently needed.”He added, “In the MATTERHORN study, clinical benefit in terms of event-free survival and overall survival versus placebo was confirmed, and the pathologic complete response rate was also 2.7 times higher than with standard treatment, making this a clinically significant finding.”Hyun-joo Lee, Executive Director of the Oncology Business Unit at AstraZeneca Korea, said, “Through the MATTERHORN study, we confirmed, for the first time as an immuno-oncology agent, clinical benefit in perioperative treatment for patients with resectable gastric cancer. Since Imfinzi has been approved for the treatment of gastric and gastroesophageal junction adenocarcinoma based on this study, we are deeply honored to be able to provide a meaningful new treatment option to Korean gastric cancer patients, for whom there has been a significant unmet need.”
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- Evrysdi reimb expansion will improve SMA treatment landscape
- by Son, Hyung Min Mar 24, 2026 08:16am
- The expansion of reimbursement criteria for the spinal muscular atrophy (SMA) treatment Evrysdi is expected to significantly improve treatment convenience for SMA patients in Korea.Experts note that the introduction of the tablet formulation, the extension of the prescription period, and the allowance for switching between therapies have reduced the burden of long-term therapy and increased the sustainability of treatment in daily life.On the 23rd, Roche Korea held a press conference at its headquarters in Gangnam-gu, Seoul, to commemorate the launch of the tablet formulation of its SMA treatment Evrysdi (risdiplam) and the expansion of the drug’s reimbursement criteria.Evrysdi is the only oral treatment among SMA therapies and is regarded as a drug that has brought about a shift in the treatment landscape, which was previously dominated by injectable formulations. This contrasts with Biogen’s Spinraza (nusinersen) and Novartis’s Zolgensma (onasemnogene abeparvovec), both of which are injectable therapies.Since its first approval in Korea in 2020 as a dry syrup formulation and subsequent reimbursement in 2023, a tablet formulation was later approved. Starting this March, the tablet formulation became eligible for reimbursement, and the existing reimbursement criteria were expanded.The key elements of the revised reimbursement criteria include: ▲ allowing one-time bidirectional substitution with injectable therapies ▲ extending the maximum prescription period to approximately 2 months ▲ and refining assessment tools to better reflect the patient’s condition.Previously, prescriptions for the dry syrup were limited to 3 bottles (a 36-day supply), effectively allowing only monthly prescriptions; however, following the revision, the reimbursement criteria have been expanded to a maximum of 5 bottles (a 64-day supply). Prescriptions for tablet formulations can now also be issued for up to 2 packs (56 days’ supply), helping to reduce the treatment burden on patients and their caregivers.Jong-Hee Chae, Professor of Pediatrics at Seoul National University HospitalIn addition, whereas previously only a one-time switch from Spinraza to Evrysdi was allowed, the revision now permits bidirectional switching, greatly expanding flexibility in treatment strategy.Jong-Hee Chae, Professor of Pediatrics at Seoul National University Hospital (Chair, Korean Child Neurology Society), said, “In the past, once a treatment was selected, it was difficult to change, but now we can apply more flexible strategies based on the patient’s age, environment, and treatment response.”She added, “With the assessment tools now more finely subdivided, it has also become possible to evaluate treatment effects more precisely in a way that reflects each patient’s actual condition.”SMA is a rare genetic disorder characterized by the gradual loss of motor neurons due to a deficiency of the survival motor neuron (SMN) protein, affecting respiration, swallowing, and overall motor function. It is classified into Types 1 through 4 based on the age of onset and functional level, with Type 1 being a particularly severe form with high mortality if untreated.Professor Chae said, “Because SMA is a disease that requires long-term treatment, it is crucial to ensure the sustainability of treatment in daily life. The introduction of tablets that can be stored at room temperature and the extension of the prescription period represent meaningful changes in improving the quality of life for patients and their families.”Long-term effects confirmed through real-world dataEvrysdi has also shown sustained effectiveness in real-world data (RWD).This drug is a small molecule that modulates SMN2 gene splicing, and it works by crossing the blood-brain barrier and increasing production of the SMN protein throughout the body, including the central nervous system.Hyungjun Park, Professor of Neurology at Gangnam Severance HospitalConsistent efficacy has been confirmed across 4 global clinical trials, ranging from infants before symptom onset to patients with prior treatment experience. Notably, in Types 1 and 2/3 patients, long-term data spanning over 5 years demonstrated the maintenance of motor function.Similar results were also confirmed in real-world data (RWD) recently published in Europe. In a study of patients in the Czech Republic and Slovakia, early improvements in motor function were observed even in severely affected patients, along with the maintenance of respiratory and motor function for up to 3 years.In another Croatian study, patients who switched from an existing injectable therapy to Evrysdi showed motor function improvement over 12 months comparable to prior treatment, confirming non-inferiority.Hyungjun Park, Professor of Neurology at Gangnam Severance Hospital, said, “Recent real-world data from Europe show that Evrysdi exhibits a pattern of significant functional improvement within the first 6 months of treatment, followed by stable maintenance over the long term. In particular, improvements and maintenance of motor function were confirmed in patients with SMA Types 2 and 3, and results showing stable maintenance without functional decline were also confirmed in Type 1 patients.”He further emphasized, “Given the natural course of SMA, which is characterized by continued functional deterioration, this represents a meaningful change. Because consistent efficacy and long-term durability have been confirmed across a wide range of patient groups, the drug has strong practical value in real-world clinical practice.”
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- Bispecific Ab for biliary tract cancer wins nod in KOR
- by Son, Hyung Min Mar 23, 2026 08:42am
- A targeted therapy with a new mechanism of action has emerged in the treatment landscape for biliary tract cancer. There is a strong trend moving away from the existing chemotherapy-centered approach toward biomarker-based precision medicine strategies.Biliary tract cancer treatment 'Ziihera'On the 19th, the Ministry of Food and Drug Safety (MFDS) approved BeOne Medicines' 'Ziihera (zanidatamab),' a treatment for human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer.Ziihera was approved as a monotherapy for adult patients with unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer who have previously received at least one systemic therapy.It is expected to become a new treatment option for a patient group that has had limited choices following previous therapies.Ziihera is a bispecific antibody that simultaneously binds to two distinct sites (ECD2, ECD4) of the HER2 receptor.The mechanistic characteristic of Ziihera is inducing tumor cell death by more potently inhibiting HER2 signaling while simultaneously activating various immune mechanisms such as antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and antibody-dependent cellular phagocytosis (ADCP).Ziihera is a new drug developed by the Canadian biopharmaceutical company Zymeworks. Subsequently, the U.S. company Jazz Pharmaceuticals licensed the development and commercialization rights for the substance from Zymeworks, and, under the contract, BeOne Medicines holds the commercialization rights in Asian regions, including Korea and China, excluding Japan.This approval is highly significant, as it is the first bispecific antibody approved for biliary tract cancer. Analysis suggests that the treatment strategy targeting HER2 has become an option in clinical settings.The approval was based on the results of the global Phase 2b 'HERIZON-BTC-01' study. According to the clinical results, the confirmed objective response rate (cORR) based on independent central review (BICR) in the HER2-positive IHC 3+ patient group (62 patients) was 52%.The complete response (CR) was 3%, and the partial response (PR) was 48%.The median duration of response (DOR) was 14.9 months, and among responding patients, 59% maintained the response for 6 months or longer, while 44% maintained it for 12 months or longer. In the overall HER2-positive patient group, the ORR was 41%, and the median overall survival (OS) was 15.5 months.Regarding safety, the most commonly reported adverse events were diarrhea, infusion-related reactions, and anemia. Serious adverse events occurred in 47.7% of the subjects.Biliary tract cancer, low survival rates·treatment gaps... will the shift to targeted therapy accelerate?Biliary tract cancer occurs in the bile ducts through which bile is produced in the liver, and since early symptoms are not clear, a significant number of patients are diagnosed at an advanced stage. Because of this, it is considered a primary intractable cancer with a poor prognosis.According to the South Korea Central Cancer Registry, the number of patients with biliary tract cancer in Korea increased by approximately 40%, from 5,444 in 2011 to 7,617 in 2021. Although the patient population is relatively small, treatment outcomes remain limited due to the difficulty of early diagnosis, rapid metastasis to surrounding organs, and high recurrence rates characteristic of the disease.Targeted therapy for biliary tract cancer 'Tibsovo 'In fact, the 5-year relative survival rate (2017–2021) is only 28.9%, with more than 7 out of 10 patients reported to die.Particularly in patients with unresectable locally advanced or metastatic biliary tract cancer, the limited treatment options available after the failure of first-line therapy have been pointed out as the largest unmet medical need in clinical settings.Amid these treatment gaps, targeted therapy-based strategies have been rapidly expanding. Representative examples include Handok’s targeted therapies 'Pemazyre (pemigatinib)' for patients with FGFR2 fusion or rearrangement, and 'Tibsovo (ivosidenib)' for patients with IDH1 mutations.FGFR genetic abnormalities are known to be involved in tumor cell proliferation, survival, angiogenesis, and drug resistance, while IDH1 mutations are reported with relatively high frequency in intrahepatic cholangiocarcinoma.In fact, Tibsovo, which targets IDH1, improved progression-free survival (PFS) in the global Phase 3 ClarIDHy study, establishing itself as the first targeted therapy to succeed in a Phase 3 clinical trial in the biliary tract cancer field. However, unlike Pemazyre, there has been no news regarding reimbursement for Tibsovo since its domestic authorization in 2024.As treatments targeting specific genetic mutations are introduced one after another, the addition of a HER2-targeted treatment strategy is shifting biliary tract cancer treatment toward a biomarker-based, multi-layered approach.Furthermore, additional bispecific antibodies are awaiting commercialization. The bispecific antibody candidate 'tovesimig (HDB001A)', being developed by Compass Therapeutics in the U.S., recently achieved efficacy in the topline results of its global Phase 2/3 study.Tovesimig is a new biliary tract cancer drug candidate developed by the Korean company ABL Bio. Handok holds the domestic rights, and Compass holds the global rights. This drug candidate is a bispecific antibody that simultaneously targets delta-like ligand 4 (DLL4) and vascular endothelial growth factor (VEGF), both of which promote the formation of new blood vessels in the tumor microenvironment.According to the topline results, the ORR set as the primary endpoint was 17.1% for the tovesimig + Paclitaxel group, which was higher than the 5.3% of the Paclitaxel group. Additionally, progressive disease (PD) was 16.2% in patients co-administered tovesimig + Paclitaxel, whereas it was 42.1% in patients administered Paclitaxel alone.
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- Diabetes drug 'Ozempic' prescriptions available at general hospitals
- by Eo, Yun-Ho Mar 23, 2026 08:42am
- 'Ozempic,' a diabetes treatment version of 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 'Big 5' tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital.Since it was added to the insurance reimbursement list in February, Ozempic has continued to expand prescription areas.Ozempic 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 Ozempic, with many limitations, will perform in the diabetes treatment market.Jang Won Son, a professor of the Department of Internal Medicine at Bucheon St. Mary's Hospital, stated, "Since Ozempic's domestic reimbursement criteria have some partial limitations, compared with the current guidelines, proactive discussions regarding flexible application that comprehensively consider potential complications are needed. Whether an initial measure that excessively considers misuses can be reassessed later is important."Meanwhile, Ozempic demonstrated superior 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.
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- En masse designation of quasi-innovative pharmas?
- by Kim, Jin-Gu Mar 20, 2026 08:55am
- The government is reviewing a pricing incentive scheme for companies deemed equivalent to innovative pharmaceutical firms (“quasi-innovative” companies). Although more than 30 companies are expected to meet the criteria, the actual level of preferential treatment granted to the companies appears limited, leading to criticism that the policy is merely a publicity stunt.According to industry sources on the 19th, the government is considering establishing a new preferential pricing track for “companies equivalent to innovative pharmaceutical firms (quasi-innovative firms).”The government’s policy is to review price preferences to enable solid pharmaceutical companies with potential to advance to the level of innovative pharmaceutical firms at an early stage. These details were revealed during the Health Insurance Policy Deliberation Committee subcommittee meeting on the 11th.The government has proposed R&D investment ratios relative to revenue as the key criterion. Companies with revenue above KRW 100 billion must have an R&D ratio of at least 5%, and companies below KRW 100 billion must have at least 7%. Companies that have received administrative sanctions within the past 5 years under the Pharmaceutical Affairs Act, Fair Trade Act, or Pharmaceutical Industry Act due to rebate-related issues will be excluded.Companies that meet these requirements will receive preferential drug pricing. Preferential pricing will be applied to newly listed generics, and the duration of this preferential treatment is currently under review to be similar to that for innovative pharmaceutical companies. The government also plans to grant temporary special exemptions when adjusting the prices of already listed drugs.This plan is interpreted as a response to the pharmaceutical industry’s backlash against the drug pricing system reform draft released last November. At that time, the government proposed applying price discounts of 68%, 60%, and 55% to innovative pharmaceutical companies based on their R&D ratios. However, criticism arose that the benefits would be concentrated among a select few top companies, while most companies would find it difficult to avoid price reductions.Applying the new criteria would significantly increase the number of companies eligible for preferential pricing.An analysis of 98 listed pharmaceutical companies classified as pharmaceutical firms on the KOSPI and KOSDAQ that will be affected by price cuts found that 32 companies would newly qualify. This excludes holding companies, R&D-focused biotech ventures, and medical device firms that are not affected by price cuts.Conversely, 45 companies failed to meet the criteria. The remaining 21 are companies that had previously been designated as innovative pharmaceutical companies.Among companies with revenue above KRW 100 billion, those meeting the ≥5% R&D ratio include firms such as ▲CMG Pharmaceutical, J▲W Pharmaceutical, ▲SK Bioscience, ▲SK Biopharmaceuticals, ▲Kyungdong Pharm, ▲Kyungbo Pharm, ▲Daehan New Pharm, ▲Dong-A ST, ▲Myung-In Pharm, ▲Samjin Pharm, ▲Sam Chung Dang Pharm, ▲Ahn-Gook Pharmaceutical, ▲Withus Pharmaceutical, ▲Korea United Pharm, ▲Il-Yang Pharm, ▲Jeil Pharmaceuticval, ▲Chong Kun Dang, ▲Kolon Life Science, ▲Hana Pharm, ▲ Hanall Biopharma, ▲Whanin Pharm, ▲Humedix, and ▲Huons. These companies will likely be included as quasi-innovative pharmaceutical companies.On the other hand, companies such as ▲HLB Pharma, ▲Kwang Dong Pharmaceutical, ▲Kukjeon Pharmaceutical, ▲Kukje Pharm, ▲Dai Han Pharm, ▲Dongkook Life Science, ▲Myungmoon Pharm, ▲Binex, ▲Samsung Biologics, ▲Samil Pharm, ▲Celltrion Pharm, ▲Sinsin Pharmaceutical, ▲CTC Bio, ▲Arlico Pharm, ▲RP Bio, ▲Yungjin Pharm, ▲Yuyu Pharma, ▲Reyon Pharmacuetical, ▲ Jinyang Pharm, ▲Kips Pharma, ▲Theragen Etex, ▲Pharmgen Science, ▲Hawil Pharm, ▲Hugel have R&D rations belos 5% as of the end of last year or Q3 last year, and fail to meet the threshold. It will be unlikely for these companies to receive preferential treatment during price cuts.Among companies with revenue below KRW 100 billion, relatively few meet the ≥7% R&D threshold, with only a handful such as ▲Samsung Pharmaceutical, ▲Sam-A Pharmaceutical, ▲Samyang Biopharm, ▲Cellbion, ▲Onconic Therapeutics, ▲ENCell, ▲GL PharmTech, and ▲Prestige Biologics.In fact, within the same revenue bracket, many companies do not meet the criteria for quasi-innovative pharmaceutical firms. These include ▲JW Shinyak, ▲Kyungnam Pharm, ▲Korean Drug Pharm, ▲Dongsung Pharmaceutical, ▲DuChemBio, ▲Vaskan Bio Pharm, ▲Vivozon Pharmaceutical, ▲Samik Pharmaceutical, ▲Seoul Pharma, ▲Sinil Pharmacuetical, ▲Icure, ▲Aprogen Biologics, ▲L&C Bio, ▲Optus Pharmacuetical, ▲Ilsung IS, ▲Cho-A Pharm, ▲Telcon TF Pharmaceutical, ▲TDS Pharm, ▲BNC Korea, ▲ Union Korea Pharm, ▲ Korea Pharma, among others, which have R&D ratios below 7%, making it highly likely they will not receive preferential treatment in the event of drug price reductions.Industry observers emphasize that the actual level of pricing incentives matters more than the number of eligible companies. Even if many firms qualify, limited incentives could render the policy merely symbolic.In the revised reform plan, the government proposed a 60% pricing premium for innovative pharmaceutical companies when listing new generics, with the preferential period extended to up to 4 years. For quasi-innovative companies, a lower level of benefit is expected.It is reported that the government is considering a preferential level of around 50% for quasi-innovative companies. Given that generic prices are currently set at around 58.55%, this implies that price reductions would still be unavoidable even with preferential treatment. The relatively short preferential period of 1+3 years is also criticized as insufficient to provide meaningful incentives.An industry official commented, “The introduction of criteria for quasi-innovative pharmaceutical companies and pricing incentives is positive in itself. However, in reality, it is more of a structure that reduces the extent of price cuts and is far from being a true incentive. It is a scheme designed to include a large number of companies for the sake of appearances, while in reality, it forces them to lower drug prices.”
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- Medical device companies gather for KIMES2026
- by Hwang, byoung woo Mar 20, 2026 08:55am
- A four-day Korea International Medical & Hospital Equipment Show (KIMES) 2026 takes off on March 19At the medical device exhibition, the primary topic has emerged from the 'whether to adopt Artificial Intelligence (AI)' to the question of 'how to implement it.'At 'KIMES 2026,' which opened on the 19th, a clear shift in hospital views toward AI acceptance was observed, signaling a rapid migration of the industry's competitive axis.KIMES, celebrating its 41st anniversary, is South Korea's largest medical device exhibition, reflecting global healthcare trends and encompassing the entire industrial ecosystem. This year's event featured 1,490 manufacturers from 41 countries, including 846 domestic and 644 international companies.In this exhibition, major players in ultrasound, diagnostic imaging, endoscopy, and patient monitoring moved beyond standalone hardware to showcase integrated solutions linking diagnosis, treatment, and management. Notably, a 'platform war' is intensifying, with AI serving as the nexus connecting medical data and clinical workflows.Beyond hardware to 'platform' competition…AI-Driven industrial restructuringFirst, global medical device companies presented 'Life-cycle Patient Management' as their core strategy this year.GE HealthCare Korea emphasized a structural continuum from diagnosis to treatment and monitoring by unveiling integrated solutions that combine ultrasound, MRI, and patient monitoring technologies. By presenting ultrasound for quantitative fatty liver analysis, AI-based MRI image reconstruction, and pain-response monitoring during surgery, the company showcased its direction toward data-driven precision medicine.Samsung Medison also placed its platform strategy at the forefront by revealing its next-generation ultrasound brand, 'One Platform.' This structure ensures consistency across the entire examination process through a unified User Interface (UI) and automated features through AI to enhance diagnostic efficiency.These industry leaders are moving past performance competition of individual devices to engage in a full-scale platform battle, one that connects diverse medical data points to facilitate clinical decision-making.The direction of change was also distinct in the diagnostic imaging sector. While the transition from film-based X-rays to digital detectors is complete, advanced equipment such as CT and CBCT (Cone Beam Computed Tomography) is now becoming the standard for medical institutions.Specifically in dentistry, CBCT has effectively become the standard, making 3D-based diagnostics a common practice.Furthermore, the utility of portable X-rays and C-arm systems is expanding into operating rooms and emergency sites, evolving from simple diagnostic tools into procedural support equipment.The most notable change is the improvement in diagnostic efficiency enabled by AI.In the MRI field, there is a clear trend of using AI-based image reconstruction technology to shorten scan times. This is considered a critical factor that not only reduces patient wait times but also increases the number of scans, thereby directly impacting hospital operational efficiency and profitability.An official from SG HealthCare stated, "Reducing MRI scan times is more than just a convenience. It is directly linked to hospital operational efficiency," and "With the introduction of AI, demand for simultaneously improving scan speed and quality is rising rapidly."(Clockwise from top left) Booths of GE HealthCare, Samsung Medison, SG HealthCare, and Waycen"The necessity of AI adoption has grown"…a shift in fieldThe most significant change from this exhibition is the shift in how hospitals perceive medical AI. Industry representatives on-site unanimously noted that the nature of visitor inquiries has changed.In the past, questions primarily focused on hardware specifications or pricing. This year, however, there was a surge in inquiries regarding "whether AI features are applied," "where they are used in practice," and "what effects are observed."Analysis suggests that interest in AI has moved beyond the exploratory phase to the actual implementation review stage. A consensus on the necessity of AI adoption is spreading quickly, particularly among large-scale tertiary hospitals.Questions were raised regarding actual use cases and efficacy in various fields, including AI endoscopy, patient monitoring, and clinical support software, shifting the focus from technical validation to 'practical utility.'However, the market is still in its early stages, with variations in adoption rates among institutions. While some hospitals show aggressive intent to adopt, many others maintain a cautious approach, weighing costs against clinical utility.An official from an AI firm at the site commented, "The necessity for AI is becoming clear, starting with large hospitals. Once this trend solidifies, it is highly likely to influence small and medium-sized hospitals."Numerous technologies that incorporate AI, the current industry mainstay, were on display at medical device booths.Platform competition intensifies…reshaping hospital operationsKIMES 2026 demonstrated that the medical device industry is transitioning from a hardware-centric industry to a 'data-driven platform industry.'While performance and price were the core competitive factors in the past, ▲the new competitive axes include AI-based automation ▲data integration, workflow optimization ▲ensuring continuity of patient care.InBody showed a trend of expanding into primary points of contact, such as pharmacies, by combining digital technology with its body composition analysis solutions. They introduced cases in which measurement data is analyzed in real time and results are presented through visualization, a structure that connects simple measurement to consultation and health management.A view of the InBody booth.This is evaluated as an example of medical devices evolving beyond diagnostic tools into 'data-driven health management platforms.'In particular, AI technology has become a key factor influencing not only diagnostic assistance but also the operational efficiency and revenue structures of hospitals and pharmacies.The industry anticipates that future competition in the medical device market will likely be reorganized around 'platform units' rather than individual equipment.An industry insider stated, "AI is not just a technology. It is an element that changes how hospitals operate," and concluded, "Corporate competitiveness will be determined by how effectively a company can connect and utilize data."
- Company
- MedTech–Pharma alliances intensify as remote monitoring turns profitable
- by Hwang, byoung woo Mar 19, 2026 12:39pm
- As the remote patient monitoring (RPM) market enters a profit-generating phase, competition in the form of alliances between medical device companies and pharmaceutical firms is intensifying.Currently, the domestic RPM market is developing within a framework of alliances between medical device companies and pharmaceutical firms. Seers Technology is partnering with Daewoong Pharmaceutical, Mezoo with Dong-A ST, Huinno with Yuhan Corp, and Wellysis with Samjin Pharmaceutical, forming a competitive landscape among these alliances.Seers Technology is rapidly building references by targeting hospitals with its ward monitoring platform thynC. Mezzue, which is set to list on KOSDAQ in March, is targeting the ward monitoring market with its mobile patient monitoring platform, HiCardi. Wellysis is expanding through wearable ECG devices, while Huinno is growing its business around ECG-based digital healthcare solutions.This surge in collaboration is interpreted as a sign that the RPM market has entered a phase where it is generating revenue. Pharmaceutical companies can expand patient management services based on therapeutic expertise and sales networks, while digital healthcare firms can strengthen data acquisition and platform competitiveness. These aligned interests are accelerating collaboration.RPM market expands beyond ECG to patient management platformsRPM is a digital healthcare technology that continuously measures and manages patients’ vital signs outside hospitals or within general wards.While the initial market was centered on wearable ECG-based arrhythmia detection technology, it has recently been rapidly evolving into a platform format that simultaneously analyzes various vital signs such as heart rate, respiration, body temperature, and physical activity levels.According to market research firm Markets and Markets, the global RPM market is expected to grow from USD 27.7 billion (KRW 41 trillion) in 2024 to USD 56.9 billion (KRW 85 trillion) by 2030, with an estimated annual growth rate of approximately 12–13%.RPM market prospect: Rise from USD 27.7 billion (2024) to USD 56.9 billion (2030) In fact, as hospitals increasingly adopt ward-based monitoring systems, related companies are seeing rapid revenue growth.Industry observers assess that the RPM market is now transitioning from the technology validation phase to the actual commercialization phase.An industry source stated, “Pharmaceutical companies are expanding the market by applying specialized strategies aligned with their therapeutic areas and sales environments. Even those not currently collaborating with medical device companies are closely watching as successful cases emerge.”Hospitals adopt multiple platforms …market expansion phaseHowever, many in the industry view the competition in the RPM market as being closer to a phase of market expansion rather than a zero-sum game for the time being.In fact, some hospitals are adopting multiple RPM platforms simultaneously.An industry insider noted, “While some hospitals adopt only a single solution, others adopt two platforms simultaneously after proof of concept (PoC) has been validated. Since the RPM market is still in its early stages, the structure allows multiple companies to grow together.”Similar to how markets expand when new mechanisms of action enter therapeutic areas, insiders believe the key factor for the RPM market is in increasing the number of hospital beds adopting the technology.As a result, analysts expect the RPM market to grow rapidly over the next 3–5 years, with multiple players expanding simultaneously.Competition in the RPM market is expected to intensify further following upcoming initial public offerings (IPOs) and global expansion.For example, Daewoong Pharmaceutical is pursuing a platform expansion strategy involving multiple partners in addition to Seers Technology, such as Skylabs, iKooB, and Puzzle AI, suggesting that competition may evolve beyond simple partnerships between medical device companies and pharmaceutical firms, into broader digital health alliances.Ultimately, the RPM market may evolve beyond mere collaboration between medical device companies and pharmaceutical firms into a data-driven patient management platform industry.An industry insider stated, “The RPM market is now moving beyond technological competition into a phase of platform competition. How companies build service models based on patient data will determine their future competitiveness.”
- Company
- Se Eun Hwang appointed as the new general manager of CSL Korea.
- by Son, Hyung Min Mar 19, 2026 12:39pm
- Se Eun Hwang, new General Manager of CSL KoreaCSL announced the appointment of Se Eun Hwang, former general manager of Biogen Korea, as the new General Manager of its Korean subsidiary.Effective the 17th, Hwang will oversee overall operations of CSL Korea, leading domestic business strategy, strengthening organizational capabilities, and driving patient-centric corporate operations.Hwang has extensive leadership experience across Korea’s pharmaceutical and biotech industry, covering commercial strategy, market access, and medical affairs.She has successfully driven business growth by building competitive organizations and successfully launching products in Korea’s complex regulatory environment.Before joining CSL, Hwang served as general manager of Biogen Korea, where she established the local organization and led its expansion. During her tenure, she successfully developed reimbursement strategies and achieved market entry for rare disease therapies.Previously, she served as Head of a Rare Disease Franchise at Handok and as Head of Marketing at Abbott Korea, and she also held key positions at JW Pharmaceutical and Hanil Pharmaceutical, gaining experience across the entire pharmaceutical industry. Hwang is a pharmacist by training. She earned an MBA from Sogang University and subsequently obtained a Ph.D. in Clinical Pharmacy from Chung-Ang University, specializing in Social and Health Pharmacy.The newly appointed general manager said, “I am both delighted and feel a strong sense of responsibility taking on this important role, which will allow me to contribute to the lives of patients with rare and severe diseases in Korea through CSL’s innovative portfolio. We will prioritize patient-centric values, maximize organizational capabilities, and work closely with partners to drive new growth at CSL Korea.”Through the leadership appointment, CSL plans to further strengthen its business foundation in Korea and continue efforts to improve the quality of life for patients with rare and severe diseases.
