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- 2026-08-08 04:26:42
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- "Streamlining researchers' tedious tasks"...Pluto Labs envisions AI expansion
- by Hwang, byoung woo Aug 06, 2026 05:25pm
- While a researcher's competitiveness is in formulating new hypotheses, a significant portion of research time is spent searching for published research articles, categorizing prior studies, and verifying experimental methods. Pluto Labs, an artificial intelligence (AI)-driven academic technology startup, aims to address this repetitive workload. The company aims to extend beyond searching articles to supporting research topic identification, hypothesis formulation, and experimental validation, thereby expanding researchers' execution capacity. DailyPharm met with Junseon Yoo (38), CEO of Pluto Labs, to discuss the story behind the company's founding, the key differentiators of its research-support AI, and its strategy for expanding into the pharmaceutical and biotech sectors.The startup began with frustrations over research article searchJunseon Yoo, CEO of Pluto LabsPluto Labs originated from the personal frustration CEO Yoo experienced while directly engaging in academic research.Having majored in Industrial Engineering at POSTECH, Yoo participated in authoring research papers in mechanical engineering before expanding his research focus into AI and computer science. Throughout this process, Yoo realized that searching for relevant papers and data consumed as much time as conducting the actual experiments. Yoo began developing the service as a project in 2017 and incorporated the company in 2019. CEO Yoo remarked, "When conducting research, I experienced much greater frustration while trying to find existing information created by others than in formulating hypotheses and running experiments. Pluto Labs is the company founded specifically to solve that problem.”Pluto Labs' core technology relies on analyzing citations and categorizing research areas.Papers within the same discipline repeatedly utilize similar keywords. Simple keyword searches often retrieve papers with entirely different methodologies or research questions. Pluto Labs overcomes this by analyzing how papers cite one another, clustering them according to specific research topics and methodological approaches. Pluto Labs' leading service, Scinapse, analyzes field-specific research trends so that users can search for literature and researchers. Scinapse AI is currently expanding into supporting the process from initial literature reviews to generating and evaluating research hypotheses. Currently, its primary paying customers are universities and research institutions. The platform is utilized in the early planning phase to help researchers identify viable research topics tailored to their existing technologies and equipment, or to check unaddressed research gaps in existing literature. CEO Yoo explained, "The service helps researchers identify which problems will yield the highest impact given their available technologies and equipment, and pinpoints remaining research gaps in a given field," and added, "It functions less like a simple paper search tool and more as a strategic roadmap generator for research direction."Research that can be performed immediately over "Nature-Level" hypothesesGlobal corporates are also entering the AI market for research hypotheses and planning. CEO Yoo cited DeepMind's Co-Scientist as an example attempting to solve problems similar to Pluto Labs. However, Pluto Labs focuses less on generating the highest-level hypotheses for top-tier publication and more on presenting options that most researchers can realistically execute within their current resources and timeframe. Yoo stated, "No matter how exceptional a proposed hypothesis or research plan may be, if it requires unavailable equipment or experiments that take two to three years, it is unusable for a researcher who needs to publish a paper this year," and added, "Pluto Labs focuses on identifying the best possible choices researchers can execute under their present constraints." The company considers securing a leading position advantage in the research institution market as a competitive strategy. Universities and research institutes rarely adopt duplicate software solutions for the same function and instead use established platforms for a long period. Yoo stated, "Institutions and universities are a conservative market that rarely replaces tools once adopted," and added, "Securing domestic paid contracts and overseas pilot projects early on creates a strong barrier to entry." Following the release of Scinapse AI in October 2025, Pluto Labs secured two paid contracts in South Korea within three months. The company is currently running over six pilot projects, including overseas trials. In South Korea, POSTECH officially adopted the service, while KAIST initiated a pilot implementation.Enterprise software targeting universities and research institutes typically involves long sales cycles aligned with institutional fiscal years and budget allocations. Yoo analyzed that securing paid contracts and pilot programs immediately post-launch was a significant milestone proving early market viability.Yoo said, "Institutional research tools operate in a market where sales cycles are estimated at a minimum of one year, yet we secured domestic paid contracts within three months of launch," and added, "Considering this product targets academic institutions, expansion is progressing at a remarkably fast pace."From pipeline analysis to experimental AI agentsPluto Labs is also actively expanding its university and research institute-centric services into the pharmaceutical and biotech industries.The company's AI agent currently under development analyzes information embedded in research literature, such as corporate affiliations, investigators, and funding sources, to map out competitive drug discovery landscapes. The goal is to identify companies researching specific targets or modalities and global pharma firms investing in related fields, thereby supporting business development (BD) strategy formulation. Currently, the company is validating market demand through AI-generated report offerings, with plans to later deliver this functionality as a standalone software tool for direct researcher use. Pluto Labs is also developing an agent designed to minimize trial and error in experimental execution. By analyzing existing literature and quantitative datasets, it evaluates hypothesis relevancy while identifying potential outliers or noise within experimental data. The focus of this AI agent is preventing scenarios where researchers belatedly discover flawed experimental conditions or missing variables, forcing redundant trials. The company aims to unveil this service officially this fall. Yoo noted, "Identifying a drug target does not automatically yield a therapeutic. One needs an experimental design to validate whether the target is truly viable, and the iterative trial cycles consume the most time," and added, "Ultimately, our goal is to build products that reduce repetitive experimental cycles and compress the overall R&D timeline."In the long run, the vision encompasses utilizing not only published literature but also unpublished internal datasets and negative and failed experimental logs accumulated within research institutions.Yoo observed that current Large Language Models (LLMs) face inherent limitations in comprehending numerical data and domain-specific contexts. Even identical quantitative values hold vastly different implications depending on the research field and experimental setup. Nuanced language-centric models struggle to differentiate this sufficiently.Yoo remarked, "A difference of 20 may be negligible in one discipline, but massive in another," and added, "Academic research centers around numbers and symbols, but current models struggle to guarantee sufficient intuition or reliability regarding numerical values."Yoo concluded by noting that "There are tasks that are important yet tedious, and tasks that are minor yet tedious," and added, "I want Pluto Labs to be remembered as a company that resolves these bottlenecks, expanding the scope of what researchers can transform from imagination into research works."
- Company
- Yorvipath for chronic hypoparathyroidism, addressing limited trt options
- by Lee, Jeong-Hwan Aug 06, 2026 05:25pm
- Product photo of YorvipathThere is an urgent need to raise social and medical awareness of chronic hypoparathyroidism, a rare disease caused by parathyroid hormone (PTH) deficiency.The recent emergence of Yorvipath (palopegteriparatide), an innovative drug that directly replaces parathyroid hormone, is driving a paradigm shift in treatment for patients who previously relied solely on high-dose calcium supplements and active vitamin D due to the lack of disease-modifying therapies. The need to improve disease awareness is also being highlighted.Developed by Denmark-based Ascendis Pharma, Yorvipath obtained marketing approvals in Europe in 2023, the U.S. in 2024, and Japan in 2025, and subsequently obtained orphan drug designation in South Korea for the active ingredient palopegteriparatide this past March.Currently, Kolon Pharma, which entered into an exclusive domestic distribution agreement with Ascendis Pharma, submitted a marketing authorization application to the Ministry of Food and Drug Safety (MFDS) in May, and as of the 4th, Yorvipath is undergoing the MFDS approval review process.Chronic hypoparathyroidism is a rare condition that often suffers from a lack of awareness about the disease, leaving patient diagnosis and treatment in a blind spot. Chronic hypoparathyroidism is a rare endocrine disorder where deficient secretion or impaired function of parathyroid hormone (PTH) leads to severe hypocalcemia and hyperphosphatemia.Patients suffer from various physical and mental symptoms, including numbness and tingling in the extremities, muscle cramps, tetany, extreme fatigue, and cognitive impairment. However, low awareness of the disease among both the public and healthcare professionals often leads to initial symptoms being dismissed as simple fatigue, eye twitching, or nutritional imbalance, failing to lead to proper specialized diagnosis.Medical experts advise, "If left untreated, chronic hypoparathyroidism can progress to life-threatening severe hypocalcemic crises or chronic complications, making proactive outreach and heightened disease awareness a priority."Until now, the standard of care for chronic hypoparathyroidism has involved daily administration of active vitamin D and high-dose calcium supplements. However, these symptomatic treatments fail to replace the deficient PTH hormone itself and impose a heavy pill burden on severe patients, who must ingest dozens of calcium and active vitamin D tablets daily.A greater issue involves long-term complications. While administering excessive calcium and active vitamin D under PTH-deficient conditions may temporarily maintain serum calcium levels, it fails to restore PTH's role in regulating renal calcium reabsorption, potentially leading to hypercalciuria (excessive urinary calcium excretion). If persistent, this significantly elevates the risk of severe secondary renal damage, including nephrolithiasis, nephrocalcinosis, and chronic kidney disease (CKD).Disease-modifying drug Yorvipath, a paradigm shift via 24-hour physiological hormone replacementYorvipath, developed by global biopharmaceutical company Ascendis Pharma, has been evaluated as opening a new era in the treatment of chronic hypoparathyroidism.Yorvipath is a PTH replacement therapy engineered to continuously provide active PTH(1-34) within physiological ranges over 24 hours. Administered once daily via subcutaneous injection, it is designed to physiologically address the underlying PTH deficiency, the underlying cause of hypoparathyroidism, by maintaining continuous systemic exposure to active PTH.In the pivotal global Phase 3 PaTHway trial, a randomized, double-blind, placebo-controlled study in adult patients with chronic hypoparathyroidism, 79% (48/61) of patients in the Yorvipath arm met the primary composite endpoint at 26 weeks, maintaining albumin-adjusted serum calcium within normal ranges and maintaining a stable Yorvipath dose while achieving independence from conventional therapy. Furthermore, 93% (57/61) of Yorvipath-treated patients achieved independence from conventional calcium and active vitamin D therapy.Additionally, the Yorvipath group demonstrated improvements in estimated glomerular filtration rate (eGFR) from baseline and achieved normalization of mean 24-hour urinary calcium excretion levels (250 mg/day or lower). This suggests the potential to substantially reduce the risk of nephrocalcinosis and progression to chronic kidney disease, which remain major concerns under conventional care.Moreover, assessments using the Hypoparathyroidism Patient Experience Scale (HPES) demonstrated significant reductions in physical symptom burden alongside marked improvements in overall quality of life.To date, Chronic hypoparathyroidism has been a neglected disease where patients had to ingest large amounts of calcium supplements at the risk of renal complications due to the absence of hormone replacement therapy. As Yorvipath has demonstrated clinical efficacy and safety, calls to raise disease awareness and prioritize public health policy support are growing.Healthcare experts stress that to ensure patients with chronic hypoparathyroidism receive timely, accurate diagnoses and benefit from advanced hormone replacement therapies like Yorvipath, efforts must concurrently focus on ▲public and primary care disease awareness campaigns, ▲dissemination of accurate diagnostic guidelines, and ▲institutional support to enhance treatment access.A representative from Kolon Pharma stated, "Chronic hypoparathyroidism has represented a major unmet medical need where patients had no choice but to manage symptoms via calcium and active vitamin D supplementation due to the lack of hormone replacement therapy directly treating the root cause of PTH deficiency," and added, "We will do our utmost to secure marketing authorization and reimbursement for palopegteriparatide inj so that it can be supplied to patients as swiftly as possible."
- Company
- Homegrown drug powers SK Biopharm to 39% operating margin
- by Cha, Ji-Hyun Aug 06, 2026 05:25pm
- SK Biopharmaceuticals maintained an operating margin of approximately 39% in Q2, once again demonstrating the profitability of its homegrown innovative drug business. Despite lower one-off licensing revenue and increased marketing investment, the company continued to grow earnings on the strength of epilepsy drug sales alone, highlighting the improving quality of its earnings.According to the Financial Supervisory Service on Aug. 5, SK Biopharmaceuticals posted KRW 97.1 billion in consolidated operating profit for Q2, up 56.9% year over year. Revenue rose 40.3% year over year to KRW 247.4 billion. The operating margin remained stable at 39.2%, compared with 39.4% in the previous quarter.The company's epilepsy treatment cenobamate (marketed as Xcopri in the U.S.) drove earnings growth. Cenobamate is an innovative epilepsy drug independently developed and commercialized by SK Biopharmaceuticals, with the company taking charge of the entire process from discovery and clinical development to regulatory approval and commercialization. The company obtained U.S. Food and Drug Administration (FDA) approval in November 2019 and has marketed the drug directly in the United States through its subsidiary SK Life Science since May 2020.Q2 U.S. sales of cenobamate reached KRW 224.4 billion, up 45.6% from the same period last year. Cumulative U.S. sales for the first half totaled KRW 422.1 billion. Prescription growth also continued. Total prescriptions (TRx) in the United States increased 8.4% quarter over quarter to approximately 143,000 in the second quarter, while new-to-brand prescriptions (NBRx) remained above 1,800 per month on average. Monthly prescriptions reached a record 49,155 in June.Change in quarterly SK Biopharmaceuticals performance (Source: SK Biopharmaceuticals)The company said the latest results were particularly meaningful because earnings growth was achieved without one-off gains. Profit growth was sustained solely through the sales of Xcopri, even in a situation where the contribution of technology fee revenues decreased, and expenses increased.In Q1, one-off milestone payments related to overseas approvals of cenobamate contributed KRW 17.1 billion in service revenue. No comparable milestone revenue was recognized in Q2, resulting in a KRW 7.4 billion sequential decline in service revenue.Selling and administrative expenses also increased during the quarter. SG&A expenses rose 9.3% from the previous quarter to KRW 135.3 billion, reflecting expanded marketing activities, including the resumption of direct-to-consumer (DTC) advertising in April and the launch of a new DTC campaign in June.SK Biopharmaceuticals attributed its strong profitability to operating leverage. While fixed costs associated with establishing its U.S. commercial infrastructure and sales organization were substantial during the early launch period, rapidly increasing prescriptions have driven revenue growth while SG&A and other fixed costs have remained relatively stable. As a result, incremental revenue has translated directly into earnings growth, allowing profits to increase faster than sales.During the company's earnings conference call held the same day, Hyungrae Cho, Head of Communications at SK Biopharmaceuticals, said, "The fact that operating profit increased despite the absence of one-off milestone revenue and higher SG&A expenses once again demonstrates that expanding U.S. sales of cenobamate directly translate into earnings growth.”In addition to seeking sales growth of cenobamate, SK Biopharmaceuticals is also accelerating development of its pipeline.First, the company is seeking to expand the presence of cenobamate in the global market through label expansions across additional indications and age groups. A New Drug Application (NDA) for an oral suspension formulation of cenobamate was submitted to the FDA in March. The liquid formulation is expected to improve treatment convenience for patients who have difficulty swallowing tablets, including pediatric patients. The company anticipates its approval in early 2027.The company also plans to submit a supplemental NDA (sNDA) later this year to expand indications to include primary generalized tonic-clonic seizures (PGTC) and pediatric patients. In Asia, cenobamate has already been approved in Korea and launched in China. The regulatory process for its approval is ongoing in Japan, with approval targeted for within the year. In Latin America, launches have already taken place in Peru and Chile, with Brazil scheduled to follow this month.SK Biopharmaceuticals’ early-stage pipeline review (Source: SK Biopharmaceuticals)The company is also actively working to secure its next growth engine. Beyond cenobamate, SK Biopharmaceuticals is building its next-generation pipeline around three strategic areas: central nervous system (CNS) small molecules, radiopharmaceutical therapy (RPT), and targeted protein degradation (TPD).In RPT, the company is pursuing both in-licensed assets and internally discovered candidates. SKL35501 (FL-091), an Actinium-225-based NTSR1-targeted radiopharmaceutical, is currently in a Phase I clinical trial in the United States. Another candidate, SKL37321 (WT-7695), a Lutetium-177-based CA9-targeted radiopharmaceutical, is undergoing preclinical development with an Investigational New Drug (IND) application planned for 2027. The company is also developing its proprietary Noble Chelator platform, designed to overcome the stability and scalability limitations of existing chelators while enabling compatibility with a broader range of radioisotopes and targeting molecules. The platform is intended to support repeated generation of multiple RPT candidates rather than a single candidate.In TPD, SK Biopharmaceuticals is advancing SKT-18416, a selective p300 degrader. This TPD is designed to target the p300 protein involved in cancer cell growth and survival. Unlike conventional dual p300/CBP inhibitors, which have raised safety concerns such as thrombocytopenia because they inhibit both proteins simultaneously, SKT-18416 is designed to selectively degrade p300 while minimizing effects on CBP. An IND submission is targeted for the first half of 2027.The company has also established MOPED, a molecular glue discovery and analysis platform, to generate additional TPD pipeline candidates. In June, SK Biopharmaceuticals entered into an AI-driven drug discovery collaboration with Insilico Medicine, aiming to shorten early-stage candidate discovery timelines, reduce development costs, and improve the probability of success.Cho said, “Insilico Medicine signed AI-based drug discovery partnerships with global top-tier pharmaceutical companies for other disease areas in both March and July this year. By combining our in-house AI drug discovery platform with our collaboration with Insilico Medicine, we expect to significantly reduce both the time and cost required for early-stage candidate discovery."Cho added, “The company plans to provide updates on pipeline progress and R&D achievements over the first 9 months of the year during our Q3 earnings announcement in early November. We will continue reinforcing a virtuous cycle in which cash generated from cenobamate funds development costs and risks, with the resulting returns reinvested into future innovative drug development."
- Company
- Olumiant receives reimbursement for severe alopecia areata
- by Hwang, byoung woo Aug 06, 2026 05:25pm
- For the first time, patients with severe alopecia areata have gained access to an evidence-based targeted therapy reimbursed by Korea's National Health Insurance system.With reimbursement now granted for Eli Lilly Korea's Janus kinase (JAK) inhibitor Olumiant (baricitinib), the treatment landscape is expected to shift away from reliance on conventional immunosuppressants and non-reimbursed therapies.However, given the chronic, relapsing nature of alopecia areata, several issues remain unresolved, including the two-year reimbursement limit, reimbursement eligibility requirements for patients previously using non-reimbursed treatments, and coverage for adolescents.Lilly Korea held a press conference on the 5th to mark the reimbursed launch of Olumiant for adults with severe alopecia areata. The drug was granted National Health Insurance reimbursement from July 1 for severe alopecia areata.(from the left) Chang Hoon Huh (Dermatology, Seoul National University Bundang Hospital); Sang Seok Kim (Dermatology, Kangdong Sacred Heart Hospital); Yong Hyun Jang (Dermatology, Kyungpook National University Hospital)Alopecia areata is an autoimmune disease, not a cosmetic condition… marks first step for reimbursement of targeted therapiesAlopecia areata is an autoimmune disease in which immune privilege around hair follicles collapses, allowing immune cells to attack the follicles. The disease follows an unpredictable course, with repeated cycles of relapse and remission.In severe cases, patients may lose not only scalp hair but also eyebrows, eyelashes and body hair. The resulting changes in appearance often lead to reduced self-esteem, social withdrawal and difficulties in daily life.Chang Hoon Huh, Professor of Dermatology at Seoul National University Bundang Hospital (President of Korean Hair Research Society), said, "Reimbursement for alopecia areata treatment has been one of the Korean Hair Research Society's key priorities for many years. Olumiant’s reimbursement marks an important first step."Sang Seok Kim, Professor of Dermatology at Kangdong Sacred Heart Hospital (Secretary General, KHRS), also highlighted the limitations of existing treatments. Systemic corticosteroids and cyclosporine, which have long been used for severe cases, lack robust large-scale clinical evidence specifically in alopecia areata and are associated with significant safety concerns during long-term use.JAK inhibitors are targeted therapies that block intracellular signaling pathways involved in the pathogenesis of alopecia areata. Professor Kim said, "The introduction of JAK inhibitors is changing the treatment paradigm for severe alopecia areata. Olumiant’s reimbursement opened an opportunity for patients to reduce financial burden."Under the reimbursement criteria, coverage is available for patients whose Severity of Alopecia Tool (SALT) score has not improved by at least 30% after three months or more of treatment with systemic corticosteroids or cyclosporine, or for those unable to continue treatment because of adverse events.Eligible patients generally include those with SALT scores of 50 or higher, indicating at least 50% scalp hair loss. Patients with SALT scores between 20 and 50 may also qualify if they show eyebrow or eyelash loss, or obvious interruption of hair growth.Yong Hyun Jang, Professor of Dermatology at Kyungpook National University Hospital, said, “In most countries, reimbursement is limited to patients with SALT scores of 50 or above. Korea's decision to include patients with SALT scores between 20 and 50 who also have eyebrow or eyelash loss is particularly meaningful," he added.Clinical benefits continue beyond 36 weeks… support long-term treatmentThe clinical evidence supporting Olumiant comes from the Phase III BRAVE-AA1 and BRAVE-AA2 trials in adults with severe alopecia areata.More than half of participants had lost over 95% of their scalp hair. The mean SALT score was 96, and the average disease duration was approximately 12 years, indicating that most participants had long-standing, severe disease.At Week 36, the proportion of patients achieving SALT 20 or lower, corresponding to no more than 20% scalp hair loss, was 38.8% in BRAVE-AA1 and 35.9% in BRAVE-AA2 among patients receiving Olumiant 4 mg. Hair regrowth was also observed in the eyebrows and eyelashes.Treatment responses continued to improve beyond Week 36. While some patients responded early, others experienced gradual improvement or showed meaningful responses after Week 36.Professor Jang said, "Because hair regrowth takes time, some patients show better outcomes at Week 52 than at Week 36. We need reimbursement criteria that allow both early and late responders to continue receiving treatment."Reimbursement is only the beginning, not the end… 2-year limit and progress rules remain challengesSeveral challenges remain following reimbursement approval. To maintain reimbursement, patients must achieve a SALT score of 20 or below at Week 36. Treatment response is then reassessed every 6 months, and reimbursement is currently limited to a maximum of 2 years.The concern is that alopecia areata is a chronic disease characterized by repeated relapses and remissions. Even after successful hair regrowth, discontinuing treatment may lead to renewed hair loss, meaning some patients could require therapy beyond the current reimbursement period of 2 years.Professor Jang argued that extending reimbursement for patients who continue to respond is unlikely to place a substantial additional burden on the healthcare budget, given that treatment effectiveness is already reassessed every 6 months. He said a formal pathway is needed to allow continued reimbursement beyond 2 years for patients who maintain treatment benefit.The transition rules for patients already using non-reimbursed Olumiant were also identified as an issue. To receive reimbursement, these patients must objectively demonstrate through historical medical records, photographs, and SALT assessments that they met the current reimbursement criteria when treatment began. Patients treated for more than 36 weeks must also submit their Week 36 evaluation results.However, before reimbursement criteria existed, neither physicians nor patients had any reason to collect or preserve such documentation. Patients who have already responded to treatment may find it difficult to prove the severity of their previous condition based on their current clinical status, while those who changed hospitals may struggle to obtain earlier records.Professor Jang said, "Applying today's reimbursement criteria to treatment that began before those criteria existed and requiring historical documentation is problematic. The evidentiary requirements should be relaxed, and a separate pathway must be established to ensure that patients who have already improved are not excluded from coverage."Expanding reimbursement to adolescents also remains an outstanding issue. Although Olumiant's indication was recently extended to include patients aged 12 years and older with severe alopecia areata, reimbursement currently applies only to adults. Experts also noted that as additional JAK inhibitors enter the alopecia areata market, reimbursement criteria should allow physicians to switch therapies based on individual patient response and safety profiles.Professor Jang said, "Reimbursement for Olumiant should not be the final improvement; rather, it should be the starting point for improving treatment in alopecia areata. Future efforts should focus on enabling continued treatment beyond 2 years, extending reimbursement to adolescents, improving transition rules for existing patients and providing greater flexibility in treatment selection."
- Company
- Voranigo under review for reimbursement in Korea
- by Eo, Yun-Ho Aug 06, 2026 05:24pm
- Voranigo, the first new brain tumor therapy approved in nearly two decades, is making progress toward National Health Insurance reimbursement listing in Korea.According to industry sources, Voranigo (vorasidenib), Servier Korea's treatment for IDH-mutant diffuse glioma, is expected to be reviewed by the Cancer Disease Deliberation Committee (CDDC) of the Health Insurance Review and Assessment Service (HIRA) on Aug. 19.After being granted marketing authorization in January, Servier launched Voranigo as a non-reimbursed treatment in May and submitted its reimbursement application during the same month.As a result, attention is rising on whether the first IDH-targeted therapy for low-grade glioma will become available under the national reimbursement system.Voranigo is indicated for adolescents aged 12 years and older who weigh at least 40 kg, and for adults with grade 2 astrocytoma or oligodendroglioma harboring an IDH1 or IDH2 mutation.Low-grade glioma is a slowly growing brain tumor that carries a high risk of recurrence and can eventually progress to a high-grade malignant tumor. The disease is often first detected following seizures, and surgical resection has long been the standard treatment.However, complete tumor removal is frequently not feasible, while subsequent radiotherapy and chemotherapy are associated with substantial risks of cognitive impairment and neurological adverse effects, leaving significant unmet treatment needs.IDH mutations are recognized as a key biomarker in approximately 80% of patients with grade 2 glioma. Both the World Health Organization (WHO) and the National Comprehensive Cancer Network (NCCN) now recommend testing for IDH mutations as part of the diagnostic workup.The efficacy of Voranigo was demonstrated in the Phase III INDIGO trial, which enrolled patients with low-grade IDH-mutant glioma who had undergone surgery but had not yet received radiotherapy or chemotherapy.Study results showed that Voranigo reduced the risk of disease progression or death by 65% compared with placebo. Median progression-free survival (PFS) was 11.4 months in the placebo group, whereas the median was not reached in the Voranigo group. Voranigo also significantly delayed time to next intervention (TTNI). In addition, the annual seizure rate during treatment was reduced by 64% compared with placebo.Jong Hee Chang, Professor of Neurosurgery at Severance Hospital. said, "Voranigo is the first newly approved brain tumor therapy since temozolomide was approved for glioblastoma in 2006. The arrival of Voranigo represents a major advance, given that most drugs have failed development because they were unable to adequately cross the blood-brain barrier (BBB).”
- Company
- Is there a separate 'drug price premium' track for companies other than innovative firms?
- by Kim, Jin-Gu Aug 05, 2026 01:17pm
- Following the adjustment of the generic drug price calculation rate from 53.55% to 45%, the 'drug price calculation system' is emerging as a critical exit strategy for the pharmaceutical industry to defend profitability.The drug price bonus tracks under the revised drug pricing system are broadly divided into 'company-level premium' and 'product-level premiums.' While the pharmaceutical industry's focus was previously concentrated on company-level premiums, such as for Innovative Pharmaceutical Companies, the 'in-house API production' premium track granted to individual products is recently surfacing as a new mechanism for price defense. According to the pharmaceutical industry on the 4th, supplier-based company-level premiums determine the generic price caps for a given company across the board depending on whether specific eligibility criteria are met. Companies certified as Innovative Pharmaceutical Companies based on metrics such as R&D investment relative to revenue receive a premium rate of 60%, while semi-innovative pharmaceutical companies receive 50%. Additionally, pharmaceutical manufacturers maintaining a designated threshold of essential/low-profit drugs (anti-withdrawal drugs) are categorized as supply-stabilization leader companies, qualifying for a 50% price calculation rate premium. During discussions surrounding the reform of the drug pricing system, these company-level premiums drew significant attention from the pharmaceutical industry. Frontline drugmakers deployed exit strategies such as re-evaluating their R&D investment ratios and restructuring research and development expense line items on their financial statements.68% Price Cap + Up to 10 Years… Why the Pharma Industry Is Focusing on "In-House API Production"Recently, in addition to securing eligibility for company-level premiums, interest is mounting in "product-level premiums" tailored to the specific characteristics of individual drugs.Product-level premiums are granted based on individual product attributes, such as drugs utilizing ▲in-house manufactured APIs, ▲national essential drugs using domestic APIs, ▲injectable antibiotics and essential pediatric medications, and ▲designated pharmaceuticals to resolve supply instability. The underlying objective is to provide preferential pricing benefits for products that contribute to health security and pharmaceutical supply chain stability. Among these, the track attracting the most focus from the pharmaceutical industry is 'in-house API production.' The government has agreed to guarantee a drug price equivalent to 68% of the original price cap for a baseline period of 5 years if a generic is produced by directly synthesizing active pharmaceutical ingredients in the manufacturer's own facility. Furthermore, if eligibility conditions are continuously met, an additional 5-year extension is granted, allowing drugmakers to maintain elevated drug prices for up to 10 years or more (5 years + 5 years + α).AI-generated image.Under the previous drug pricing system, the premium duration was limited to just 1 year, yielding minimal practical benefits. However, under the new pricing framework, sentiment has shifted dramatically, as the premium period has been expanded to 10 years and the premium rate is applied at the highest level (68%). Because companies can secure a price 23 percentage points higher than the baseline calculation rate (45%) over an extended timeframe, certain products can yield even higher profitability than the Innovative Pharmaceutical Company premium rate (60%). Of course, for companies lacking internal API manufacturing infrastructure, the in-house API production premium track is not an easy path. It requires equipping in-house manufacturing plants with chemical synthesis facilities compliant with ICH Q11 standards, and it consumes substantial time, capital, and administrative resources for manufacturing process development and marketing authorization variations. The government also strictly enforces criteria for recognizing in-house API production, limiting eligibility strictly to "production within the marketing authorization holder's (drugmaker's) own manufacturing site," while excluding facilities owned by parent companies, subsidiaries, or affiliates.Nevertheless, analysts suggest that the ability to maintain a 68% price cap over an extended duration in an environment where the baseline generic pricing rate has dropped to 45% offsets these entry barriers.'10-Year Rule' and 'Cost Burden' Variables… Targeting Products with Patent Expirations in 2 to 3 YearsIndeed, drug pricing managers across numerous domestic pharmaceutical companies are reportedly engaging in meticulous return-on-investment calculations regarding entry into the in-house API production track.The single biggest variable is the 'timing of the first generic listing.' Under the regulations, the starting point for the 10-year premium period is calculated based on the 'listing date of the first generic in the market,' rather than the 'listing date of the company's own product.'For instance, for hypertension and hyperlipidemia active ingredients where generics were already listed en masse in the mid-2010s, the 10-year limit following the first generic listing has either already passed or is imminent. Even if a drugmaker invests billions of KRW immediately to establish an API synthesis process, there is little practical benefit, as the premium duration has already expired or has only a few months remaining.Conversely, the situation is different for molecules whose patents expired within the last two to three years or where the generic market has just opened. A prime example is the diabetes treatment market for DPP-4 inhibitors or SGLT-2 inhibitors, where major originator patents expired in or after 2023. Because the timing of the first generic listing in the market is recent, there remains a window of mathematically 7 to 10 years to receive the 68% drug price premium. This structure allows companies to recover facility investment costs and enhance profitability.Another variable is the "cost burden." Pharmaceutical companies must meticulously weigh the manufacturing cost of using lower-cost Chinese or Indian APIs against the operational and maintenance costs of running their own synthesis facilities versus the profit yielded by the 68% drug price premium.Under this current structure, rather than indiscriminately applying the in-house API production track to all products, drugmakers are evaluating a selective-and-focused strategy—targeting API synthesis investments specifically toward major products with recently expired patents. This represents a two-track strategy: defending overall generic pricing through company-level premiums like Innovative or Semi-Innovative status, while evaluating in-house API production premiums for core flagship products.An official from a major pharmaceutical company explained, "If company-level premiums serve as a track to defend the baseline drug prices across the entire company, in-house API production is a targeted strategy to maximize revenue for key products," and added, "The practical benefits of the in-house API production track will be substantially greater for pharmaceutical companies with a high revenue reliance on specific products."A drug pricing manager at another pharmaceutical company also noted, "For major chronic disease products whose patents have recently expired, we judge that defending a 68% drug price cap for several years is advantageous," and concluded, "We are currently evaluating whether to apply the in-house API production track centered around our key major products."
- Policy
- Warehouse-style pharmacy ad bill clears judiciary committee
- by Lee, Jeong-Hwan Aug 05, 2026 01:17pm
- A proposed revision to the Pharmaceutical Affairs Act aimed at regulating exaggerated signage and advertising by warehouse-style pharmacies has passed the National Assembly’s Legislation and Judiciary Committee, raising expectations that the Ministry of Health and Welfare may be able to move forward with an enforcement rule revision it previously announced.The Ministry of Health and Welfare has expressed concern that over-the-counter medicines are being sold and consumed with few barriers amid the proliferation of warehouse-style pharmacies, and has argued for tighter regulation and oversight. It preemptively announced a revision to the enforcement rules under the Pharmaceutical Affairs Act, but the proposal has remained stalled for a long period without any progress.The Fair Trade Commission had challenged shortcomings in the ministry’s regulatory approach to promotional terms such as “largest,” “best” and “warehouse-style pharmacy,” increasing the likelihood that the enforcement rule revision would be put on hold.The situation has now entered a new phase after the related Pharmaceutical Affairs Act amendment cleared the Legislation and Judiciary Committee.As of the 3rd, the bill regulating advertising and promotion by warehouse-style pharmacies is poised to become law if it passes the National Assembly plenary session and is subsequently promulgated by the government.The ministry has sought to revise the enforcement rules to restrict displays and advertisements using expressions such as “warehouse-style,” “factory-style,” and “pharmacy mecca,” which could encourage excessive medicine purchases and misuse.The ministry determined that exaggerated advertising portraying medicines as mass-market consumer goods or discount products could undermine public health.However, the Fair Trade Commission concluded that restricting freedom of business and price competition solely through subordinate regulations would be excessive, bringing the proposed enforcement rule revision to a stop.Against this backdrop, the passage of a Pharmaceutical Affairs Act amendment sponsored by Rep. In-soon Nam through the Legislation and Judiciary Committee has changed the regulatory outlook.Rep. Nam’s bill ▲explicitly prohibits displays that could cause a pharmacy to be mistaken for a pharmaceutical wholesaler or manufacturing establishment, as well as ▲displays and advertising that could mislead consumers or encourage excessive medicine purchases. At the same time, it expressly delegates the detailed prohibited criteria and scope to an ordinance of the Ministry of Health and Welfare (enforcement rules).Should the bill clear the plenary session following its passage through the Judiciary Committee, the ministry is expected to be in a position to reannounce the proposed enforcement rule revision regulating warehouse-style pharmacies.The legislation would address the Fair Trade Commission’s concern over the lack of a statutory basis and provide explicit legal authority to prohibit pharmacy advertising and promotional expressions such as “largest,” “best,” “warehouse-style” and “factory” through the enforcement rules.An official from the Health and Welfare Committee said, “If Rep. In-soon Nam’s amendment to the Pharmaceutical Affairs Act passes the plenary session and is promulgated by the government, the enforcement rules regulating advertising and promotion by warehouse-style pharmacies are more likely to be revised following a renewed legislative notice. This would be different from the previous situation, in which the ministry independently preannounced an enforcement rule revision without first amending the parent statute. By securing a statutory basis, the government may create the conditions needed to overcome the opposition of the Fair Trade Commission."
- Company
- Bertis introduces SURF platform at MSD Summit
- by Hwang, byoung woo Aug 05, 2026 01:17pm
- Bertis has demonstrated the global partnering potential of its AI-powered drug target discovery platform, SURF, by being selected as a finalist at the MSD Health Innovation Summit.Bertis, a proteomics technology platform company co-led by CEOs Dong-young Noh and Seung-man Han, announced on Aug. 4 that it had been selected as one of the judges' award recipients at the MSD Health Innovation Summit, jointly hosted by the Korea Health Industry Development Institute (KHIDI) and MSD Korea.At the event, the company unveiled its AI-based drug target discovery and validation platform SURF for the first time. Among eight companies selected through a preliminary review to deliver presentations, Vertis was named one of three companies selected by the judging panel.According to the company, Vertis was the only drug target discovery platform that was selected for the award. The company was recognized for presenting a platform that leverages its proteomics expertise, built through its cancer diagnostic solutions and protein analysis services, to improve the efficiency and success rate of drug development.The summit, held on July 14 under the theme “Next-generation healthcare powered by evidence-based AI: From prevention to personalized care," brought together experts from KHIDI, MSD Korea, the MSD Global Health Innovation Fund, MSD Asia-Pacific's innovation team IDEA Studio, and the global healthcare innovation platform HITLAB as members of the judging panel.SURF is a platform designed to generate and analyze data on cell surface and surface-adjacent proteins to identify novel therapeutic targets. It is structured to materialize these into new drug target packages capable of collaborative research or technology transfer through AI analysis and experimental validation.Rather than focusing solely on previously identified targets, the platform is designed to discover novel therapeutic targets. By mapping cell surface and neighboring proteins, SURF comprehensively evaluates target surface accessibility, disease relevance, expression in normal tissues, and suitability for specific therapeutic modalities of candidate targets for prioritization.The company said the platform provides target discovery and validation solutions that can support next-generation therapeutic modalities, including antibody-drug conjugates (ADCs) and bispecific antibodies. Bertis emphasized that SURF is a hybrid platform that complements purely in silico prediction approaches by integrating experimental data generation, AI-based analysis and biological validation.Target discovery focused on the cell surface proteome has become an area of growing interest for global pharmaceutical companies. In January this year, Disco Pharmaceuticals signed a licensing agreement with Amgen covering novel surface protein targets, while InduPro entered into a collaboration with Eli Lilly to develop multispecific antibody cancer therapies.Bertis plans to combine its proprietary AI analytics engine, proteomics data-generation capabilities and clinical sample-based validation expertise to expand from target discovery to comprehensive target packages suitable for collaborative research and technology licensing.Seung-man Han, co-CEO of Bertis, said, "It is particularly meaningful that the innovation of our proteomics-based drug target discovery platform has been recognized by global pharmaceutical companies and investment and research experts.”He added, " Having confirmed the strong industry interest in surface protein target discovery, we will continue to expand collaborative research and licensing partnerships with global pharmaceutical and biotechnology companies through the SURF platform."
- Policy
- 'Drug efficacy classification number' reform has been initiated
- by Lee, Jeong-Hwan Aug 05, 2026 01:17pm
- The South Korean government is initiating preliminary research to revise and modernize the domestic drug efficacy classification number system, which has remained largely unchanged since its establishment in the 1960s.Beginning with a comparative study against the global standard, the World Health Organization's (WHO) Anatomical Therapeutic Chemical (ATC) classification system, the government aims to enhance the international compatibility of the South Korean classification system and establish precise classification criteria aligned with drug efficacy and indications.On the 4th, the Ministry of Food and Drug Safety (MFDS) announced that it is initiating a comparative study between domestic drug classification numbers and WHO-ATC classification codes.The framework of the current domestic drug efficacy classification number system has been maintained without significant alteration since its introduction in the 1960s.Defined as a numerical structure under the MFDS administrative rule "Guidelines on Barcode Display and Management of Pharmaceuticals," the system assigns 3-digit or 4-digit numerical codes to classify all drugs authorized and distributed in Korea based on their therapeutic efficacy and intended use.The problem is criticism that the system, owing to its outdated origins and misalignment with global classification standards, fails to accurately reflect the diverse efficacy and mechanisms of action (MoAs) of modern therapeutics.Because its hierarchy is overly simplistic and lacks granular differentiation, accurately categorizing drugs by actual clinical efficacy remains difficult. Furthermore, persistent compatibility issues have been raised regarding international market expansion and data exchanges with overseas regulatory agencies.In response, the MFDS plans to overcome the limitations of the current framework and evaluate the feasibility of system improvements from multiple angles by conducting a comparative review against the globally utilized WHO-ATC classification system.First, the agency will investigate current labeling practices across major overseas regulatory authorities and assess the potential ripple effects on other domestic institutions, beginning with a comprehensive examination of how the WHO-ATC classification system is currently utilized domestically and internationally.The study will analyze overall regulatory systems where major overseas authorities, such as the European Medicines Agency (EMA), assign ATC codes to newly approved products and explicitly mandate them in drug labeling (package inserts).To analyze domestic impacts and cross-agency ramifications, the MFDS will survey the operational use of existing classification numbers across relevant organizations, including the Ministry of Health and Welfare (MOHW), the Health Insurance Review and Assessment Service (HIRA), and the Financial Supervisory Service (FSS), while evaluating the systemic and institutional effects of a transition to ATC codes from various perspectives. Additionally, the scope of HIRA's current operations related to ATC classification will be explicitly defined.Specific criteria and procedures will also be established to perform precise comparative analysis between existing drug classification numbers and ATC classification codes.The MFDS plans to minimize confusion in the field by systematizing mapping methodologies between legacy classification numbers and ATC codes, verifying data consistency, and conducting preliminary surveys on drugs that would be reclassified into different or entirely distinct categories compared to current listings.A standardization plan will be formulated to provide guidelines or assign preliminary in-house ATC classification codes for existing approved drugs or newly authorized products that have not yet been assigned official ATC codes.The MFDS intends to conduct this research through November of this year. The Pharmaceutical Approval Management Division has been appointed as the lead department.The MFDS explained, "The current drug efficacy classification number system was established in the 1960s and has been used for a long time without major updates," and added, "There have been some cases where proper classification by efficacy and indication is difficult due to incompatibility with international standards and a limited number of hierarchical levels. This is the rationale behind launching a comparative review with the internationally recognized WHO-ATC classification system."
- Company
- Fintepla to receive rapid reimbursement listing in Korea
- by Eo, Yun-Ho Aug 05, 2026 01:17pm
- ‘Fintepla,’ one of the drugs included in the second phase of Korea's Approval–Assessment–Negotiation Parallel Review Pilot Program, is expected to enter the National Health Insurance reimbursement system at an accelerated pace.According to industry sources, UCB Korea recently reached a final agreement with the National Health Insurance Service (NHIS) on the reimbursement price for Fintepla (fenfluramine), a treatment for Dravet syndrome. Given that negotiations began in early July, the process has been completed within the program's targeted 30-day timeline.The only remaining step is deliberation by the Health Insurance Policy Deliberation Committee (HIPDC). Barring any unexpected developments, Fintepla is expected to be listed for reimbursement in September.After being approved in Korea in December last year, Fintepla was designated an orphan drug and selected for the second phase of the government's Approval–Assessment–Negotiation Parallel Review Pilot Program. The statutory timeline for NHIS drug price negotiations (60 days) is reduced to 30 days for drugs subject to the program.Dravet syndrome is an ultra-rare, intractable childhood epilepsy that typically begins during infancy. According to experts, approximately 80% of cases are caused by mutations in the SCN1A gene.The disease usually develops around 12 months of age, and up to 15% of patients die during infancy or adolescence. Patients face an increased risk of numerous neurological and developmental comorbidities, including tonic-clonic seizures, delayed language development, autism, intellectual disability, and attention-deficit/hyperactivity disorder (ADHD).The disease also places a substantial burden on caregivers, as they are required to provide around-the-clock care while coping with career disruption and loss of income, resulting in high caregiving stress and reduced quality of life.Frequent seizures occurring over a long period in patients with Dravet syndrome not only degrade the quality of life for patients and caregivers but also carry the risk of sudden unexpected death in epilepsy (SUDEP), making reducing or stopping seizures the primary treatment goal.However, substantial unmet medical needs remain in Korea as there are limitations in controlling seizures with currently used antiepileptic drugs alone, and some therapies even exacerbate seizures. Fintepla is regarded as a valuable treatment option because it not only reduces seizure frequency but also has the potential to achieve seizure freedom in some patients.Meanwhile, Fintepla demonstrated its clinical value through three randomized Phase III trials (STUDY 1–3).In a pooled analysis of Study 1, which enrolled 119 patients, and Study 3, which included subsequently enrolled patients, treatment with Fintepla reduced monthly convulsive seizure frequency (MCSF) by 62.3% and 64.8%, respectively. Notably, near-complete seizure freedom was observed only in patients treated with Fintepla.In Study 2, patients receiving standard therapy with stiripentol (plus clobazam and/or valproate) were randomized 1:1 to receive either Fintepla or placebo during a 15-week study consisting of a six-week baseline period, a three-week titration period, and a 12-week maintenance period. The study showed that 54% of patients receiving Fintepla achieved at least a 50% reduction in monthly convulsive seizure frequency from baseline, compared with 5% in the placebo group.
