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- 2026-04-28 23:25:38
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- Domestic approval of high-dose 'Spinraza' imminent
- by Son, Hyung Min Apr 08, 2026 07:46am
- SMA treatment 'Spinraza'Ahead of the introduction of 'Spinraza,' a high-dose regimen of the spinal muscular atrophy (SMA) treatment, to Korea following global approvals, the possibility of a shift in treatment strategy is being raised.The trend of improving effectiveness through dose optimization is evident, moving away from the existing low-dose (12mg) treatment.According to industry sources on the 8th, the domestic approval of Biogen Korea's Spinraza (nusinersen) high-dose formulations (50mg/5mL, 28mg/5mL) is imminent. An approval decision is expected within this month.Previously, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved the high-dose regimen. The strategy involves administering 50mg twice at 14-day intervals during the initial loading phase, followed by a 28mg maintenance therapy at 4-month intervals, thereby maximizing therapeutic effects by increasing the drug concentration compared to the existing regimen.Spinraza is an antisense oligonucleotide (ASO) that continuously increases SMN protein levels. To deliver treatment to the cause of the disease, it can be administered directly into the central nervous system, where motor neurons are located, via intrathecal injection. Since Spinraza allows multiple administrations, it can demonstrate differentiation in its administration method.Spinraza has confirmed a consistent effect and safety profile across all ages and types based on clinical research data and real-world evidence (RWE) accumulated over more than 8 years of treatment.The efficacy of the high-dose Spinraza was confirmed through the Phase 2/3 DEVOTE study. In the primary cohort analysis, the treatment-naïve symptomatic infant patient group showed a statistically significant improvement in motor function assessment (CHOP-INTEND).The treatment group recorded an average increase of +15.1 points, while the comparison group (untreated group) showed -11.1 points, resulting in a mean difference of 26.19 points. While motor function improved in the high-dose regimen group, it worsened in the untreated group, proving a distinct therapeutic effect compared to the natural course of the disease.Regarding safety, a profile similar to the existing low-dose regimen was confirmed. However, pneumonia, aspiration pneumonia, and malnutrition were reported as major adverse reactions in infant SMA patients.The high-dose drug can also be used in patients already receiving treatment. Patients who were maintaining low-dose treatment can continue maintenance therapy at the same 4-month intervals after a single high-dose loading, allowing for a dose increase while maintaining treatment continuity.This high-dose strategy is seen as a variable that can change the SMA treatment paradigm beyond simply adding an option. The approach to maximize treatment response is considered to have begun, given that dose optimization was pursued based on long-term (over 10 years) data from the existing treatment.In particular, as approvals have already been granted in major countries such as the U.S., Europe, and Japan, attention is focused on the timing of introduction and the reimbursement strategy in Korea. If the high-dose drug becomes a differentiated option compared to existing treatments, its impact on the overall SMA treatment landscape is expected to be significant.More treatment options…treatment choice based on mechanisms of action·administration methods·reimbursement The domestic SMA treatment includes Spinraza, Roche's 'Evrysdi (risdiplam)', and Novartis' 'Zolgensma (onasemnogene abeparvovec)'. All share the common goal of improving SMN protein deficiency but differ in their mechanisms of action and administration methods.Spinraza is an ASO-based treatment that acts on the central nervous system via direct intrathecal administration and has dominated the market based on long-term clinical data and prescribing experience. Evrysdi is an oral small-molecule treatment that regulates SMN2 splicing, characterized by its ability to cross the blood-brain barrier and act systemically.Zolgensma is a gene therapy that directly delivers the SMN1 gene, with therapeutic effects expected after a single administration.Recently, with the expansion of reimbursement criteria for Evrysdi, the flexibility of treatment strategies has greatly improved. The introduction of the tablet form, the extension of the prescription period (up to approximately 2 months), and the allowance of bidirectional switching with injections are evaluated as having made treatment choices based on patient conditions much more flexible.Ultimately, the SMA treatment trend is shifting away from a single, treatment-centered approach toward a customized strategy that considers the mechanism, administration method, and reimbursement criteria.
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- Mounjaro reimb for diabetes remains uncertain in KOR
- by Eo, Yun-Ho Apr 08, 2026 07:46am
- Mounjaro, the star of the obesity treatment boom, has encountered a roadblock in its expansion of reimbursement for diabetes in Korea.According to industry sources, Eli Lilly Korea and the National Health Insurance Service (NHIS) failed to conclude pricing negotiations for Mounjaro (tirzepatide), a dual GIP/GLP-1 receptor agonist, within the deadline. A decision has now been made to extend the negotiation period.Whether Lilly and the NHIS will be able to reach an agreement and secure reimbursement listing for Mounjaro remains to be seen. Its competitor, Novo Nordisk’s Ozempic (semaglutide), which contains the same active ingredient as Wegovy, has been listed for reimbursement for diabetes since February.Mounjaro had previously passed the Drug Reimbursement Evaluation Committee (DREC) review under the Health Insurance Review and Assessment Service (HIRA) in December last year.Although it has generated exceptional sales as an obesity treatment, Mounjaro is also indicated in diabetes as an “adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (monotherapy or combination therapy) and for chronic weight management in adults with obesity (initial BMI ≥30 kg/m²) or overweight patients with at least one weight-related comorbidity (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease), in conjunction with a reduced-calorie diet and increased physical activity.”For both indications, the recommended starting dose is 2.5 mg once weekly (intended for treatment initiation, not for glycemic control or weight management). After four weeks, the dose is increased to 5 mg once weekly. If further dose adjustment is necessary, the dose may be increased by 2.5 mg increments after at least 4 weeks at the current dose, up to a maximum of 15 mg once weekly.Meanwhile, Mounjaro is drawing attention as the first treatment to suggest the possibility of “remission” in diabetes.In the Phase III SURPASS study, which became the basis for its approval, Mounjaro demonstrated its potential for diabetes remission by achieving statistically superior improvements in HbA1c and body weight compared to all control groups, including semaglutide (1 mg, brand name Ozempic), insulin degludec, and insulin glargine.Furthermore, at the European Association for the Study of Diabetes (EASD) meeting held last September, the company presented results from the Phase III SURPASS-CVOT clinical trial, which directly compared Mounjaro with Lilly’s GLP-1 receptor agonist Trulicity, thereby reinforcing data on cardiovascular prevention effects and improvements in overall survival.
- Company
- Drug pricing re-evaluation lawsuit reverses the situation
- by Kim, Jin-Gu Apr 07, 2026 07:22am
- The lawsuit Medica Korea filed to cancel the price reductions on its existing drugs, challenging the government's re-evaluation of maximum prices, has concluded in the pharmaceutical company's favor. This ruling is expected to have a significant impact beyond the relief to an individual company, influencing the implementation of future government drug price reduction measures.In particular, the significance of this ruling has grown as the government announced a reform plan last month that strengthens the drug price reduction rate from the current 15% to 20% when generic standard requirements are not met. Analysis suggests that pharmaceutical companies facing price cuts due to administrative delays now have a clear justification for pursuing legal action.3-Year Legal Battle Concludes... A Litigation Started by 'Re-evaluation of Listed Drugs'The origin of this case was the "Generic drug price system reform" implemented in July 2020. The government decided to apply differential drug prices based on whether two standard requirements were met: ▲ conducting independent bioequivalence tests and ▲ using registered drug master files (DMF). Additionally, the government conducted a re-evaluation by applying these standards to drugs already listed on the reimbursement list.In September 2023, following the re-evaluation, the Ministry of Health and Welfare (MOHW) announced a price reduction for five items, including Medica Korea's 'Telmisartan Tab,' citing noncompliance with standard requirements.Medica Korea responded immediately by filing a lawsuit to cancel the disposition and an application for a stay of execution. Both the first and second-instance courts ruled in favor of the pharmaceutical company. Subsequently, on the 2nd, the Supreme Court finalized the original verdict by dismissing the government's appeal through a "discontinuation of proceedings." The three-year legal dispute ended in a complete victory for the pharmaceutical company. This is considered unusual, given that cases in which pharmaceutical companies win drug price lawsuits against the government have been very rare.“Violation of Administrative Procedures + Abuse of Discretion”... The Court Highlights Three Illegalities in the Government's MeasureAccording to the Article 8(2) issued by the Seoul High Court's ruling, confirmed by the Supreme Court, the court found that the MOHW's disposition not only violated administrative procedural principles but also constituted a deviation and abuse of discretionary power.◆“Administration Cannot Change Its Word” = The court pointed out the "unauthorized change of grounds for disposition" applied by the government to some items. The MOHW initially issued a price reduction for Medica Korea's five items because they failed to meet 'Standard Requirement 1' (independent bioequivalence testing). However, during the lawsuit, they argued that the items also failed to meet 'Standard Requirement 2' (the use of a registered DMF).Regarding this, the court stated that it is unacceptable to present separate facts that lack identity with the original grounds at the time of disposition. This is interpreted as a reaffirmation of the principle that the executive branch must not infringe upon a party's right to defense by arbitrarily changing the basis for a disposition.◆“Substantial Fulfillment is More Important Than Paperwork” = The court ruled that 'substantial fulfillment of requirements' should take precedence over the 'formal completeness of documents.' Medica Korea was unable to submit the final "DMF Change Authorization Certificate" within the government-set deadline. However, they had already submitted an 'Application for change authorization' before this, clearly indicating their intent to use registered drug master files. Despite this, the government issued the price reduction citing 'failure to submit documents within the deadline.'The court judged that “submitting the authorization certificate is merely one means of proving fulfillment, not the sole evidentiary material,” and that “if a pharmaceutical company has made its best efforts, it should be recognized.”◆A Warning Against ‘Administrative Convenience’ = The court clarified that the situation where the Ministry of Food and Drug Safety's (MFDS) review was delayed due to an explosion of change authorization applications following the drug price reform 'cannot be viewed as the responsibility of the plaintiff (pharmaceutical company).'The court ruled that it is unreasonable to hold a company responsible for document-submission delays caused by external factors beyond its control, to reduce drug prices. This is interpreted as a court warning against the government's drug price reductions driven by administrative convenience.Will 'Second Medica' Cases Follow Amid Concerns of Recurring ‘Administrative Bottlenecks’?This ruling is expected to have a greater ripple effect, as it coincides with the government's last month's drug-pricing reform plan. Under the reform, the basic calculation rate for generic drug prices will be reduced from 53.55% to 45%. Concurrently, the reduction rate for failing to meet standard requirements will be raised from 15% to 20%.Under the existing system, if one standard requirement was not met, the generic drug price was applied at 45.52% (53.55 x 0.85); if two were not met, at 38.69% (45.52 x 0.85). Under the new system, it will drop significantly to 36.00% (45.00 x 0.8) for one failure and 28.8% (36.00 x 0.8) for two failures.Upcoming drug-pricing reform plan. Under the reform, the basic calculation rate for generic drug prices will be reduced from 53.55% to 45%. Concurrently, the reduction rate for failing to meet standard requirements will be raised from 15% to 20%.These standards also apply to already-listed generics. Industry concerns are that the chaos of 2023 will repeat itself. In September 2023, the government simultaneously lowered the prices of 7,355 items. This was a measure that applied the drug price system, reformed in 2020, to existing items en masse. However, during the large-scale price reduction process, delays in data submission and review bottlenecks occurred, leading to continuous confusion and administrative conflicts regarding the interpretation of standards.The Medica Korea lawsuit is also analyzed to have occurred against this backdrop. Analysts believe that, in the process of evaluating and disposing of numerous items in a short period, the government failed to adequately review individual cases, leading to 'formalistic judgments' taking precedence.There is a possibility that even more listed items will be subject to price reductions in this reform. In this case, the administrative burden on the government will inevitably increase. It is noted that this process could create a vicious cycle of administrative errors, leading to more lawsuits.Reduction Rate Increased from 15% to 20%... Potential for Mass Recurrence of ‘Defensive Bioequivalence’ TestsThe measures taken by the pharmaceutical industry for 'price defense' are also factors fueling market confusion. Specifically, there is a high possibility that so-called 'defensive bioequivalence' tests to meet standard requirements will flood the market again.After the 2020 system reform, pharmaceutical companies rushed to conduct bioequivalence tests to defend prices. Companies developed generics themselves through internal formulation research and then conducted bioequivalence tests. Based on the equivalence results, they adopted a strategy of shifting from outsourced to in-house manufacturing to meet the 'conducting bioequivalence tests' requirement and maintain drug prices. In fact, the annual number of bioequivalence test approvals, which was 178 in 2018, surged to 323 in 2020 and 505 in 2021.The number of bioequivalence test approvals by month (unit: case, source: MFDS)The cost per bioequivalence test is estimated at KRW 300-500 million. Criticisms have been raised that spending hundreds of millions of won on bioequivalence tests to maintain drug prices, when the drugs are already being sold without issue after the government has recognized their safety and efficacy, is a waste of resources. Nevertheless, because the scale of price reductions has increased, the structure forces companies to increase additional bioequivalence tests to prevent losses."Litigation is Profitable"... The 'Learning Effect' Presented by the Medica Korea PrecedentConcerns are rising in the pharmaceutical industry that the litigation wars that followed the simultaneous reduction of 7,300 items in September 2023 will be repeated.With the Supreme Court's ruling now established, pharmaceutical companies' response is expected to become more aggressive. From a company's perspective, rather than accepting a 20% reduction, it is a rational choice to file a lawsuit to cancel the price reduction and seek a stay of execution under the Medica Korea precedent. Voices are high that unnecessary litigation will proliferate socially.Consequently, the government has a significant administrative burden during the large-scale drug price adjustment process. Following this Supreme Court ruling, the government's mechanical administrative convenience will find it difficult to gain legal legitimacy. Moving forward, the government faces the task of establishing flexible administrative guidelines that take into account realistic factors, such as the MFDS's review status, rather than insisting solely on the 'formal completeness of documents' during the price adjustment process for listed generics.A pharmaceutical industry official stated, "This ruling clearly established that substantial efforts by companies should not be ignored for administrative convenience. This case is expected to serve as an important legal reference for pharmaceutical companies to respond to the government's administration in the upcoming large-scale drug price reductions."
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- Vadanem launches in Korea…draws attention as oral option
- by Son, Hyung Min Apr 07, 2026 07:22am
- The treatment paradigm for renal anemia may shift from a traditional ESA-centered approach to a multi-layered structure that includes oral treatment options. Amid this trend, Tanabe Pharma Korea and HK inno.N announced the domestic launch of the renal anemia treatment ‘Vadanem (vadadustat),’ signaling potential changes in treatment strategy.The two companies recently held a launch symposium titled ‘New Paradigm VADANEM Symposium’ at the Lotte Hotel Busan. The event featured a wide range of discussions on the mechanism of action and clinical data of HIF-PHI class therapies, as well as strategies for their application in real-world clinical practice.A view of the ‘Vadanem’ launch symposium.Renal anemia is a common complication in patients with chronic kidney disease (CKD), primarily caused by reduced erythropoietin (EPO) production due to impaired kidney function. Consequently, current treatment primarily relies on recombinant erythropoiesis-stimulating agents (ESAs) administered via injection.However, since ESAs are administered subcutaneously or intravenously, limitations have been pointed out, including treatment inconvenience, adverse reactions such as increased blood pressure and vomiting, as well as storage constraints. Although long-acting formulations with improved half-lives have emerged, the inconvenience of injection-based administration remains unresolved.Against this backdrop, oral HIF-prolyl hydroxylase inhibitors (HIF-PHIs) are emerging as a new alternative. This class of drugs works by inhibiting the enzymes that degrade hypoxia-inducible factors (HIF), thereby stimulating endogenous EPO production while simultaneously regulating iron absorption and utilization. They also offer advantages in administration convenience and storage compared to injectables.Vadanem is an oral HIF-PHI that regulates the HIF pathway. It induces endogenous erythropoietin production and improves iron utilization efficiency through a mechanism distinct from that of conventional ESAs.The symposium reflected this shift, highlighting the potential transition from ESA-centered treatment to a multi-layered approach that includes oral therapies.The first day’s session focused intensively on the mechanisms of HIF-PHI-class therapies and the clinical evidence for Vadanem. Chaired by Professor Jong-soo Lee of Ulsan University College of Medicine, presentations were delivered by Professor Bong Soo Park of Inje University College of Medicine and Professor Eun-sil Koh of The Catholic University of Korea College of Medicine.Professor Bong Soo Park of Inje University College of Medicine explained, “While ESAs supplement exogenous EPO, HIF-PHIs activate the hypoxia response pathway to induce endogenous EPO production. This represents a more physiological treatment strategy, as it also regulates iron metabolism.”Professor Eun-sil Koh of the Catholic University of Korea College of Medicine introduced the clinical results of Vadanem, stating, “In the INNO2VATE 1 and 2 clinical trials involving dialysis patients, Vadanem demonstrated non-inferiority in terms of hemoglobin (Hb) improvement compared to the injectable drug darbepoetin alfa (brand name Nesp).”In fact, during the primary efficacy evaluation period (weeks 24–36), the change in hemoglobin (Hb) was 10.36 g/dL for Vadanem and 10.61 g/dL for darbepoetin alfa, and in INNO2VATE 2, these values were 10.36 g/dL and 10.53 g/dL, respectively. Vadanem met the predefined non-inferiority criteria in both studies. Hb levels remained stable and showed similar trends during the long-term evaluation from weeks 40 to 52.It also demonstrated non-inferiority compared to darbepoetin alfa in terms of the risk of major adverse cardiovascular events (MACE). In the overall population, the hazard ratio (HR) for MACE was 0.96, meeting the predefined non-inferiority criteria (FDA 1.25, EMA 1.3).Professor Koh explained, “Consistent results were observed for individual cardiovascular events such as death, myocardial infarction, and stroke. We have established clinical evidence regarding both efficacy and safety.”VADANEM launch symposiumDuring the second day’s session, titled ‘VADANEM in Practice and Beyond,’ discussions focused on how to apply the mechanisms and clinical evidence presented the previous day to actual clinical practice.In particular, given the confirmed clinical efficacy and safety data for Vadanem, attention centered on which patient groups should be prioritized for treatment.Professor Sungjin Chung of the Catholic University of Korea College of Medicine stated, “In patients with CKD-related anemia, various factors such as ESA hyporesponsiveness, iron deficiency, and inflammation interact in a complex manner. For this patient population, HIF-PHI agents could serve as a new treatment alternative.”He added, “In patients with reduced ESA responsiveness, Hb control is often difficult with existing treatments. HIF-based approaches provide a clinically meaningful option.”He further noted, “Depending on the patient’s condition, we can adopt a more flexible treatment strategy, such as switching from ESA or considering oral therapy from the outset. Given the nature of the disease, which requires long-term treatment, oral formulations are also significant in terms of adherence. Their scope of application is expected to gradually expand in practice.”With the launch of Vadanem, attention is focused on whether HIF-PHI therapies will establish themselves as a mainstream option in Korea. The convenience of oral administration and regulation of iron metabolism are considered key factors in future changes to CKD anemia treatment strategies.Professor Sehoon Park of Seoul National University College of Medicine predicted, “We are entering an era that requires patient-tailored approaches based on multiple options rather than a single treatment strategy. The role of HIF-PHI class therapies will expand within this trend.”
- Company
- ‘Padcev + Keytruda’ reimbursement imminent in KOR
- by Son, Hyung Min Apr 07, 2026 07:22am
- Immunotherapy ‘Keytruda’ and ADC ‘PadcevWith combination therapy using antibody-drug conjugates (ADCs) and immuno-oncology drugs on the verge of being reimbursed in Korea, the treatment landscape for bladder cancer (urothelial carcinoma) is increasingly likely to undergo a structural shift.According to industry sources, the Health Insurance Review and Assessment Service (HIRA)’s Drug Reimbursement Evaluation Committee recognized the appropriateness of reimbursement for the combination therapy of Padcev and Keytruda as a first-line treatment for adults with locally advanced or metastatic urothelial carcinoma on April 2. Padcev monotherapy, however, did not receive reimbursement approval.This decision comes approximately 6 months after the combination regimen passed the Cancer Drug Deliberation Committee last October. If price negotiations with the National Health Insurance Service (NHIS) are concluded successfully, Padcev + Keytruda will be listed for reimbursement.Padcev is an ADC that targets Nectin-4, comprised of a fully human anti-Nectin-4 immunoglobulin G1 kappa monoclonal antibody conjugated to the small molecule microtubule-disrupting agent monomethyl auristatin E (MMAE), via a protease-cleavable maleimidocaproyl valine-cituline (vc) linker. Its mechanism of action involves selectively binding to tumor cells, internalization, and the release of MMAE via proteolytic cleavage, which subsequently induces cell death.Its key feature is the expected synergistic effect when used in combination with PD-1 inhibitors. This mechanism maximizes antitumor efficacy by simultaneously inducing direct cytotoxicity via MMAE and immune activation.These mechanistic strengths have also been confirmed in clinical trials. In the EV-302/KEYNOTE-A39 Phase 3 study, the combination therapy of Padcept and Keytruda achieved a median overall survival (OS) of 31.5 months in treatment-naïve urothelial carcinoma patients. This figure is approximately double that of the chemotherapy group, which recorded 16.1 months.Based on these results, the National Comprehensive Cancer Network (NCCN) recommends Padcev + Keytruda as a Category 1 preferred first-line regimen, positioning it as an option capable of replacing existing immuno-oncology drug + chemotherapy focused treatment strategies.ADC + Immuno-oncology drugs take center stage… shifts maintenance therapy-centric structureIf the Padcev + Keytruda combination regimen is actually reimbursed, there is a high likelihood that the combination could shift the treatment axis in urothelial carcinoma.Currently, various options coexist in the first-line treatment setting for urothelial carcinoma, including the combination of ‘Opdivo (nivolumab)’ and GemCis (gemcitabine + cisplatin) and the ADC + immuno-oncology drug combination.In addition, a sequencing strategy, which involves maintenance therapy with Merck’s ‘Bavencio (avelumab)’ after chemotherapy, has also established itself as a major pillar. Among the therapies, Bavencio is currently the only reimbursed option.Merck has emphasized adopting a sequencing strategy in which Bavencio maintenance therapy is administered after chemotherapy, followed by Padcev upon disease progression.In fact, real-world data (RWD) from multinational studies such as Japan’s JAVEMACS, the U.S.’s PATRIOT-II, and France’s AVENANCE showed that the median overall survival (OS) with Bavencio maintenance therapy exceeded 30 months, with some analyses reporting survival extended to over 40 months.Furthermore, in strategies where ADC is used following Bavencio maintenance therapy, OS exceeded 41 months, supporting long-term survival through sequential treatment.Ultimately, the future treatment landscape is likely to evolve into competition between potent combination therapy in the first-line setting and maintenance-based sequencing strategies.Whether or not reimbursement is approved is expected to serve as a key factor that goes beyond the simple addition of a treatment option. It is likely to reshape the very paradigm of bladder cancer treatment.
- Company
- Medtronic, 2nd generation Micra landing shifts the system
- by Hwang, byoung woo Apr 06, 2026 03:51pm
- Leadless pacemakers are shifting from a 'supplementary technology' to a variable that is fundamentally changing treatment structures in South Korea.The trend points to a convergence of technological advancements (improved battery life and procedural safety) and institutional changes, such as expanded insurance reimbursement. These factors are transforming access to treatment from a limited scope to a mainstream clinical reality.Medtronic Korea held a press conference on the 2nd for domestic launch of the 2nd generation Micra (Micra AV2), presenting these significant shifts.(From left: Ji Eun Song, Director at Medtronic Korea; Professor Hee Tae Yu, Cardiology, Severance Cardiovascular Hospital; Kangho Park, Marketing Manager at Medtronic Korea)Battery·Algorithm Improvements…The 2nd Generation EvolutionThe presentation explained the new product not merely as a new model, but as a turning point where leadless pacemaker technology, having been clinically validated, moves to its next stage.Since its introduction in 2015, Micra has been used to treat over 400,000 patients worldwide, accumulating data from 50,000 patients and over 450 studies. A 5-year follow-up study showed a major complication rate of approximately 4.5%, with no reported cases of device removal due to infection.Ji Eun Song, Senior Marketing Director of Cath Lab at Medtronic KoreaJi Eun Song, Senior Marketing Director of Cath Lab at Medtronic Korea, stated, "We are no longer at the stage of discussing whether the technology is possible. We are now at the stage of considering how far its application can be extended."The advancements in Micra AV2 can be summarized in three areas: battery, algorithms, and the delivery system.The most significant change is the battery life. The Micra AV2 lasts approximately 15.6 years and the VR2 approximately 16.7 years, representing improvements of 44% and 36%, respectively.Song emphasized. "Considering that we mostly have elderly patients, the reported figure indicates 80% of patients can maintain their treatment with a one-time treatment," adding, " This is not just a performance improvement; it is a change that impacts the treatment strategy itself."We have also improved algorithm. Atrial mechanical sensing has been refined, allowing for stable atrioventricular (AV) synchrony even at high heart rates, with the maximum tracking rate expanded to 135 bpm.Furthermore, the delivery system was upgraded with a rounded catheter tip, reducing pressure on the heart wall by up to 66%. Simulation-based analysis also suggested a potential reduction in perforation risk.Song stated, "As the heart-mechanical signaling monitoring function is improved, the device can now stably relay signals in a wider range of heart rates," adding, "Previously, device selection depended on patient conditions. Now, the latest improvement widened the range that a sing device can cover."Impact of expanded reimbursement…changes brought by clinical introductionClinical experts have also offered positive evaluations regarding the expanding role of leadless pacemakers.Professor Hee Tae YuProfessor Hee Tae Yu of Cardiology at Severance Cardiovascular Hospital stated, "Leadless pacemakers have opened up treatment possibilities for patients for whom conventional transvenous pacemakers were difficult. They are effectively an essential option for patients at high risk of infection or those with difficult venous access."Yu added, "The extended battery life and improved algorithms increase the consistency and predictability of treatment outcomes," and explained, "It is meaningful for long-term strategies."The domestic launch of Micra AV2 is particularly noteworthy as it coincides with the reform of the insurance coverage criteria for leadless pacemakers.As of December 1 last year, the Ministry of Health and Welfare limited the patient co-payment rate to 5% for cases where transvenous electrode insertion is impossible or has failed (e.g., venous stenosis, occlusion, or congenital malformations) and for patients with a current or past history of Cardiac Implantable Electronic Device (CIED) infection.Professor Yu noted, "With reimbursement currently applied to high-risk groups, the range of choices for leadless pacemakers in clinical settings has clearly widened. As more clinical data accumulates, there is a possibility that the target population will gradually expand."Future scope of application…coexistence with transvenous systemsDespite the system's expansion, reimbursement limitations remain a key issue. During the Q&A session, the scope of application emerged as a more central topic than the technology itself.Photos of Medtronic's implantable cardiac devicesProfessor Yu stated, "From a purely medical judgment perspective, it would be ideal to have no reimbursement restrictions. There are cases where a leadless pacemaker is more suitable, yet criteria limit the choice."In particular, Yu noted that elderly patients could be important candidates and emphasized the need for ongoing discussions on expanding coverage as clinical experience grows. However, the current application of essential coverage for high-risk groups was evaluated as a meaningful institutional starting point.Regarding traditional pacemakers, a period of coexistence is expected for leadless pacemakers and "At this stage, leadless pacemakers are not the primary choice for all patients," Professor Yu explained. "The role of transvenous pacemakers still exists." The transvenous method allows adjustment of electrode positions to maintain a more physiological conduction path, remaining a crucial option for younger patients or those who will be dependent on a pacemaker for a long time.In conclusion, Yu noted, "While leadless pacemakers are advancing rapidly, the current structure where they share purposes and coexist with transvenous pacemakers will be maintained for now. However, if leadless technology capable of physiological pacing is secured in the future, the scope of application could expand even further."
- Company
- Bayer "Pipeline growth accelerate…back on the growth chart"
- by Son, Hyung Min Apr 03, 2026 08:03am
- Bayer is signaling a return to growth trajectory, delivering a series of achievements across its major pipelines. With recent new product approvals and late-stage clinical successes, Bayer's R&D strategic transformation is proving effective.On the 1st (local time), Bayer held its '2026 Pharma Media Day' and announced a medium-to-long-term growth plan based on a science-centered strategy and operational innovation.Stefan Oelrich, Member of the Board of Management of Bayer AG and President of the Pharmaceuticals Division, stated, "Our growth foundation is strengthening based on our focus on strategic priorities and scientific rigor. Through a multimodal pipeline and an AI-based operating model, we aim to recover a growth rate of 4% to 6% starting in 2027 and achieve an operating profit margin of 30% by 2030."Bayer held its '2026 Pharma Media Day'As of 2025, Bayer has secured five approvals, including three new products and two label expansions, and has achieved pipeline milestones by delivering positive results from six Phase 3 clinical trials.Bayer proposed ▲cardiovascular ▲oncology ▲immunology ▲rare diseases ▲women's health as the core pillars that will drive growth over the next decade.In particular, the Factor XIa inhibitor 'Asundexian' secured positive results in reducing the recurrence of ischemic stroke and was designated for Fast Track by the U.S. Food and Drug Administration (FDA), while the prostate cancer treatment 'darolutamide' is undergoing additional clinical trials to expand its treatment lines.Furthermore, 'Kerendia (finerenone)' is now a core growth product, demonstrating clinical utility across multiple Phase 3 studies and a mechanism that simultaneously targets heart and kidney diseases.Bayer also presented precision medicine-based anti-cancer agents and gene·cell therapies as next-generation growth engines.Various drug candidates, such as radiopharmaceutical-based Targeted Alpha Therapy (TAT), WRN inhibitors, and treatments for HER2-mutant lung cancer, are advancing toward clinical trials, while gene and cell therapies targeting Parkinson's disease and heart failure are also under development.In conjunction with this, Bayer is strengthening its integrated therapy-diagnosis strategy by expanding its innovation in diagnostics, including low-dose MRI contrast agents and molecular imaging technology.Bayer's strategy is to increase productivity by integrating AI throughout the entire R&D process.By combining global medical data with AI analysis platforms, Bayer is optimizing the entire process from drug candidate discovery to clinical development, aiming to improve R&D productivity by 40% by 2030.
- Company
- AZ launches triple-combination COPD inhaler Breztri in KOR
- by Son, Hyung Min Apr 03, 2026 08:02am
- Breztri AerosphereAstraZeneca Korea (Country President: Eldana Sauran) announced the launch of ‘Breztri Aerosphere (budesonide, glycopyrronium, formoterol),’ as a maintenance therapy for moderate-to-severe chronic obstructive pulmonary disease (COPD).Breztri Aerosphere is a single-inhaler triple-combination therapy that combines an inhaled corticosteroid (ICS), a long-acting beta-2 agonist (LABA), and a long-acting muscarinic antagonist (LAMA) in a single inhaler. It is indicated as a maintenance treatment for adult COPD patients to control symptoms and reduce exacerbations, and is administered twice daily.The clinical efficacy and safety profile of Breztri Aerosphere have been established through global Phase III trials, including ETHOS and KRONOS.The ETHOS (The Efficacy and Safety of Triple Therapy in Obstructive Lung Disease) study was a 52-week, multicenter, randomized, double-blind Phase III trial involving 8,588 patients aged 40–80 with moderate-to-very severe COPD.Results showed that Breztri Aerosphere reduced the annual rate of moderate or severe COPD exacerbations by approximately 24% compared with LAMA/LABA dual therapy, and by about 13% compared with ICS/LABA, demonstrating statistically significant results.A post-hoc analysis of ETHOS also demonstrated a significant reduction in all-cause mortality in the Breztri treatment group compared with LAMA/LABA.In another pivotal trial, KRONOS, Breztri Aerosphere demonstrated improvements in lung function.The 24-week global Phase III study enrolled 1,902 patients with moderate-to-very severe COPD. At Week 24, Breztri improved lung function by 22 mL compared with LAMA/LABA and by 74 mL compared with ICS/LABA (BFF MDI).COPD is a representative chronic respiratory disease caused by abnormalities in the airways and alveoli, such as bronchitis, bronchiolitis, and emphysema. It is characterized by chronic respiratory symptoms such as shortness of breath and coughing, and is a heterogeneous disease involving persistent and progressive airway obstruction. Compared to the general population, patients with COPD tend to develop various comorbidities at an earlier age. Factors such as smoking, aging, and chronic conditions associated with the disease itself, which include cardiovascular disease, musculoskeletal disorders, and diabetes, further increase disease burden.The 2026 Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend triple therapy with ICS, LAMA, and LABA in patients receiving ICS+LABA who are currently not experiencing an exacerbation but have a high symptom burden, or who are experiencing an exacerbation and have a blood eosinophil count of 100 cells/μL or higher.The guidelines also note that using a single inhaler can improve treatment convenience and adherence compared with multiple inhalers.Ji-young Kim, Executive Vice President of the Respiratory Business Unit at AstraZeneca Korea, stated, “Breztri Aerosphere is a treatment option that has demonstrated reductions in exacerbations and improvements in lung function in global clinical trials, offering a new treatment option for COPD patients in Korea. AstraZeneca Korea will continue to strive to improve the treatment environment and disease management for patients with respiratory diseases.”Breztri Aerosphere is a pMDI (pressurized metered-dose inhaler) designed to uniformly disperse drug particles using Aerosphere delivery technology, ensuring that the medication is delivered throughout both the large and small airways.pMDIs can be used by patients with insufficient inhalation flow rates and offer the advantage of delivering a consistent dose with each actuation. Additionally, as a single inhaler capable of administering three medications simultaneously, it can help improve treatment convenience and medication adherence for patients.
- Company
- "Finished drug firms·API suppliers suffer from high exchange rate"
- by Chon, Seung-Hyun Apr 03, 2026 08:02am
- The pharmaceutical industry is facing significant challenges conducting business amid high exchange rates and the war in the Middle East. As the KRW/USD exchange rate surpasses KRW 1,500, the cost pressure on imported Active Pharmaceutical Ingredients (APIs) is intensifying. Furthermore, with upcoming generic drug price cuts, seeking cheaper imported APIs is becoming increasingly difficult. The high exchange rate and price reductions are also major issues for API manufacturers.According to industry sources on the 2nd, the KRW/USD exchange rate in the Seoul foreign exchange market reached 1,501.5 KRW on the 1st. Compared to KRW 1,352.6 on July 2 of last year, this represents an increase of more than KRW 150 in just eight months.The KRW/USD exchange rate trend (unit: KRW, source: SMB)The exchange rate first surpassed KRW 1,500 on the 24th of last month and briefly stayed in the KRW 1,400 range for two days before surpassing KRW 1,500 again on March 29, continuing to increase. Amid concerns over a prolonged conflict stemming from the high-intensity standoff between the U.S. and Iran, the rate even surged past KRW 1,530 during intraday trading on the 31st, the highest level in 17 years since the global financial crisis in 2009.The decline in the value of the Korean won directly translates to cost-push pressure for pharmaceutical companies. Since these companies are highly dependent on imported APIs, the core raw materials for medicines, the rise in the KRW/USD exchange rate directly increases production costs.In 2024, the self-sufficiency rate for APIs was recorded at 31.4%, calculated using an average exchange rate of KRW 1,367. Self-sufficiency refers to the ratio of domestically produced products within the total market.With 69.6% of APIs used domestically being imported, the reliance on foreign raw materials is absolute. Since US dollars are used even when purchasing APIs from China and India, the largest sources of imports, the impact of the rising exchange rate is unavoidable.Recently, domestic pharmaceutical companies have also been considering switching API suppliers to reduce costs in response to the government's announced price cuts for generic drugs.Under the reformed drug pricing system discussed by the Ministry of Health and Welfare (MOHW) at the Health Insurance Policy Review Committee on the 26th of last month, the price for both off-patent drugs and generics will decrease from 53.55% to 45% of the pre-patent-expiry price of the new drug. Mathematically, this is a 16.0% cut in generic prices.Under the reformed drug pricing system discussed by the Ministry of Health and Welfare (MOHW) at the Health Insurance Policy Review Committee on the 26th of last month, the price for both off-patent drugs and generics will decrease from 53.55% to 45% of the pre-patent-expiry price of the new drug.The price reduction range increases further when "top-tier price requirements," such as conducting bioequivalence (BE) studies and using registered drug substances (DMF), are applied to existing listed generics. Under the reform, the penalty for failing to meet these requirements will expand from 15% to 20%. Since July 2020, requirements have been in place that generics can receive the 53.55% maximum price only if they meet both the direct BE study and DMF criteria. For each unmet requirement, the ceiling price drops by 15%.Applying the new 45% standard and the 20% cut for unmet requirements, generics failing one requirement drop to 36%, and those failing both drop to 28.8%. This means the price for a generic failing one requirement will be 20.9% lower than current levels, while those failing both will see a 25.6% decrease.Due to these price-reduction pressures, pharmaceutical companies are forced to seek cheaper imported products rather than relatively expensive domestic APIs to save costs.The value of API imports from China is already increasing. In 2024, Chinese API imports reached USD 816.32 million, up 110.2% from USD 388.31 million in 2014. In 2014, China was the 6th-largest source of drug imports for Korea, but it rose to 3rd place by 2024.Chinese API Import Amounts by Year (USD 1,000)In 2024, the value of Chinese APIs used in Korea was KRW 1.1159 trillion. Of the KRW 4.4007 trillion in APIs produced in Korea, only KRW 1.43 trillion was used in the domestic market. This indicates that the amount of Korean and Chinese APIs used in the local market is roughly equal. Considering that Chinese APIs are generally cheaper than domestic ones, this suggests that the actual volume of Chinese APIs used by domestic companies overwhelms that of domestic APIs.Under these circumstances, there are concerns that if generic prices drop further, more companies would refrain from using relatively expensive domestic APIs. Both finished drug manufacturers and API suppliers are structured in a way that could lead to simultaneous losses under pressure to reduce drug prices.For API manufacturers, the high exchange rate and price cuts act as major setbacks. Even for domestically produced APIs, starting materials are often imported, so they must worry about rising costs due to exchange rates. As pharmaceutical companies search for cheaper imported alternatives, the concerns of domestic API firms are further compounded.A pharmaceutical industry official stated, "If generic prices fall further, the movement to replace raw materials with cheaper alternatives to save costs will spread. As the dependency on imported APIs increases, domestic API companies find themselves in a position where they must worry about survival."Critics pointed out the ineffectiveness of the government's API preferential pricing policy. The government plans to apply price preferences to listed "essential national medicines" that use domestic APIs. This involves granting a price preference of up to 68% of the pre-patent-expiry price of new drugs for essential medicines made with domestic raw materials.However, pharmaceutical companies complain that the proportion of essential medicines within total drug sales is negligible, and even if prices are raised, there is insufficient incentive to switch to domestic APIs. To receive the preferential designation for domestic raw materials, a company must prove that all raw materials were synthesized at a domestic manufacturing site. Required documents include the ▲API Registration Certificate ▲Common Technical Document (CTD) ▲Manufacturing Instructions and Records.During a parliamentary audit last October, Rep. Baek Jonghean of the People Power Party pointed out, "The fact that not a single pharmaceutical company has applied for the price preference for essential national medicines using domestic raw materials for seven months is proof that the system exists in name only," adding, "Despite industry-wide complaints that the application criteria are too stringent, the MOHW's failure to recognize that the regulations will undermine the policy's ability to foster the domestic API industry."An industry source stated, "Due to the recent aftermath of the war in the Middle East, there are concerns over the supply instability of various raw materials, and with the added burden of costs from the high exchange rate, it is difficult to predict business plans for this year," adding, "In addition to the government's drug price reduction policy, it has become difficult to guarantee the business sustainability of both domestic finished drug and API manufacturers."
- Company
- AstraZeneca Korea appoints Ohad Goldberg as new Country President
- by Son, Hyung Min Apr 03, 2026 08:02am
- Ohad Goldberg, new Country President of AstraZeneca KoreaAstraZeneca Korea announced that it has appointed Ohad Goldberg, Country President of AstraZeneca Israel, as the new Country President of AstraZeneca Korea, effective May 1, 2026.As the new Country President, Goldberg will oversee the company’s business operations in Korea. He plans to expand patient access to AstraZeneca’s medicines and continue to enhance AstraZeneca’s standing as a top-tier partner dedicated to strengthening the domestic life sciences ecosystem for the benefit of Korean patients and society.During his tenure as Country President of AstraZeneca Israel, Goldberg led significant organizational growth and strengthened partnerships across the healthcare ecosystem. With over 20 years of international leadership experience across life sciences, biotech, and ag-tech, he possesses proven capabilities in commercial operations, market access, and external affairs.He has led AstraZeneca Israel’s external partnerships with government, healthcare stakeholders, academia, and innovation platforms. He also served as Chairman of the Board for AION Labs and as a board member of Pharma Israel, representing AstraZeneca in multiple leadership roles.Ohad Goldberg, the new Country Manager of AstraZeneca Korea, said, “It is a great honor to take on this role at a pivotal time for healthcare reform in Korea. Together with our talented team, I look forward to contributing to the advancement of healthcare policy and to creating sustainable, long-term value for Korean patients and society by expanding equitable access to breakthrough medicines.”Goldberg has held senior leadership roles at AstraZeneca, including Global Launch Leader for Respiratory Biologics, Market Access Director, and Respiratory Business Unit Director for Israel, and senior roles in commercial strategy across Europe.
