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- 2025-12-18 05:26:29
- Company
- RNAi therapeutic 'Amvuttra' enters reimb review
- by Eo, Yun-Ho Dec 04, 2025 09:12am
- 'Amvuttra,' an RNA interference (RNAi) therapeutic, has been put on a test stand for insurance reimbursement entry. According to sources, Amvuttra (vutrisiran), a new drug for the treatment of hereditary transthyretin amyloidosis (hATTR) with polyneuropathy (hATTR-PN), will be considered for the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Evaluation Committee (DREC) today (December 4). Amvuttra was developed by Alnylam Pharmaceuticals and introduced to South Korea by Medison Pharma Korea.Amvuttra obtained an orphan drug designation from the Ministry of Food and Drug Safety (MFDS) in November 2023 and received final approval last year.Amvuttra is administered once every 3 months and is designed to target and silence messenger RNA, thereby blocking the production of wild-type and mutant transthyretin (TTR).The efficacy of Amvuttra was demonstrated through the Phase 3 HELIOS-A study. In the Phase 3 trial, 164 patients with hATTR-PN and accompanying polyneuropathy from 22 countries participated. Participants were randomly assigned to either a subcutaneous injection group receiving Amvuttra 25 mg once every 3 months (Amvuttra group, 122 patients) or an intravenous injection group receiving 'Onpattro (patisiran)' 0.3mg/kg once every 3 weeks (Onpattro group, 42 patients).Furthermore, the effectiveness of Amvuttra was evaluated by comparison with the placebo group in the APOLLO study, which evaluated the efficacy and safety of Onpattro in a patient group similar to that in the HELIOS-A trial.As a result, during the 9-month treatment period, the Amvuttra group experienced less severe neurological damage than the placebo group, and had improved quality of life. Additionally, the 10 Meter Walk Test, which evaluates patients' walking speed and exercise capacity, showed that patients treated with vutrisiran had no change in time. NT-proBNP, a biomarker of heart function, improved.Meanwhile, hATTR-PN, which affects approximately 1 in 100,000 people, is caused by a genetic mutation in the TTR gene. It is characterized by systemic multiple autonomic neuropathy, including symptoms related to the heart, digestive system, and ocular manifestations. Vyndaqel stabilizes the TTR protein.Symptoms typically begin in the lower extremity nerves, where the abnormal protein readily accumulates, presenting as pain, paresthesia, and paralysis before progressing to involve the upper limbs. Complications spread to other organs, including the heart, kidneys, and eyes. The average life expectancy after symptom onset is approximately 7 to 12 years.
- Policy
- Bill banning pharma wholesale platforms
- by Lee, Jeong-Hwan Dec 03, 2025 08:47am
- Minister of Health and Welfare Jeong Eun Kyeong, Rep. Kim Yoon of the Democratic Party of Korea, and Rep. Seo Young-kyo of the Democratic Party of Korea (from left)"This bill is not a second 'Tada Ban Law,' as mentioned by Rep. Shin Dong-uk in the press. It is not intended to prohibit the non-face-to-face healthcare platform itself, but rather to impose restrictions to solve problems arising when a platform operates a pharmaceutical wholesale business. Currently, the establishment of medical institutions and pharmacies is also currently prohibited from engaging in wholesaling."With the formal legislation bill for non-face-to-face healthcare and the bill banning intermediary platforms from establishing pharmaceutical wholesale (the so-called 'Doctor Now Bejin Pharm Prevention Act') passing the National Assembly's Legislation and Judiciary Committee, the evaluation is that "the government has achieved results in legislation that guarantees the safety of public pharmaceuticals."Minister of Health and Welfare Jeong Eun Kyeong addressed questions from both ruling and opposition party members in the Legislation and Judiciary Committee on the afternoon of November 26. It is reported that the Minister said, "The platform wholesale prohibition act is not a second 'Tada Ban Law,' with a firm stance, remaining calm, and giving logical and clear explanation of the potential side effects if the bill failed to pass led to its passage by the Committee.The ruling Democratic Party of Korea also played a major role, directly proposing the regulatory bill (Rep. Kim Yoon) and endorsing the Minister's philosophy and concerns through supportive questioning (Rep. Seo Young-kyo). This combined effort pushed through the necessary legislative act to establish a comprehensive non-face-to-face healthcare environment.The government and the ruling party effectively collaborated to proactively block the potential criticism of having a 'impractical non-face-to-face care bill,' which they would have faced if the platform wholesale prohibition act had not passed.The amendment to the Medical Service Act (institutionalizing non-face-to-face healthcare) and the amendment to the Pharmaceutical Affairs Act (prohibiting intermediary platforms from establishing wholesalers) are expected to be put to a vote and processed in the National Assembly plenary session on November 27.If approved by the plenary session without issue, all necessary parliamentary procedures for the legislation will be complete. Following government transfer and Cabinet Meeting approval, the laws will be announced next month (December). The implementation dates for both the Non-face-to-face Care Act and the Doctor Now Bejin Pharm Prevention Act are set to "one year from the date of government promulgation," meaning they will officially take effect in December 2026.Minister Jeong's firm stance... "Medicine is a public good, platform must not be abused"Throughout the Legislative and Judiciary Committee meeting, Minister Jeong logically persuaded the National Assembly, explaining why non-face-to-face healthcare intermediary platforms must be prohibited from engaging in wholesaling and detailing the anticipated side effects if it were allowed.Minister Jeong's core argument was that the bill prohibiting the concurrent operation of a platform and a wholesale business is not intended to regulate the non-face-to-face care intermediary industry, which is a new and innovative sector. Instead, it is a preventive law designed to prevent platforms from abusing their immense authority to control the distribution, prescribing, and dispensing of pharmaceuticals, which are considered a public good, for unfair profit.In explaining this, Minister Jeong pointed to the precedent of the domestic market-leading platform, Doctor Now, which had already caused controversy by establishing the pharmaceutical wholesaler Bejin Pharm as a subsidiary and by entering the drug distribution market.Doctor Now's operation of Bejin Pharmacy was strongly opposed by the pharmacists' community and caused public controversy over fair pharmaceutical distribution. It ultimately served as a critical justification for the Legislation and Judiciary Committee's amendment to the Pharmaceutical Affairs Act."Platform operators possess far greater influence than doctors or pharmacies," Minister Jeong explained. "They can use their affiliated pharmacies or medical institutions to influence the prescribing or dispensing of specific drugs. A case has already occurred where a platform operator, by concurrently operating a pharmaceutical wholesaler, induced affiliated pharmacies to source drugs through that wholesaler."Minister Jeong added, "This could become a form of unfair trade (illegal pharmaceutical rebates) and serve as an incentive to use specific drugs. The concern is that the platform, with its enormous power and influence, could impact physician prescribing and pharmacy dispensing. This power could be misused, for example, if the platform receives investment from pharmaceutical companies."Minister Jeong stressed, "We sought to address these issues preventively during the introduction of the new system because the misuse of the platform business could affect drug transactions, prescribing, and dispensing, all of which are considered a public good. It would ultimately have a negative impact on patients. This is consistent with the prohibition on medical institution or pharmacy founders from concurrently engaging in wholesaling."Following this explanation, Rep. Shin Dong-uk, who had raised the initial question, concluded his query by saying, "Yes, I understand," which led to the bill's passage by the Committee.Rep. Kim Yoon proposes the Bejin Pharm Prevention Bill...Rep. Seo Young-kyo questions the opening of a wholesale websiteRep. Kim and Rep. Seo of the Democratic Party also played crucial roles in the bill's passage.First, Rep. Kim proposed the amendment to the Pharmaceutical Affairs Act, representing the concern that Doctor Now's direct involvement in drug distribution and sales through the establishment and operation of Bejin Pharm could sharply increase the potential for new types of illegal activities (rebates) and significantly raise the probability of violating the Medical Service Act and Pharmaceutical Affairs Act by guiding patients to specific medical institutions and pharmacies. The legislative intent was to establish a fair pharmaceutical sales order.Immediately following the bill's proposal, Doctor Now publicly criticized the ban on platform-owned wholesalers as unfair legislation, expressing "regret that the bill was proposed despite policy authorities judging it difficult to be viewed as unfair trade."Prior to proposing the bill, Rep. Kim had summoned Doctor Now CEO Jeong Jin-woong to the Parliamentary Inspection last year to directly question him about the side effects of establishing and operating a wholesaler.Later, when the bill faced challenges during the National Assembly Health and Welfare Committee's plenary session, Rep. Kim, Rep. Park Hee-seung, and others strongly advocated for the legislative validity, arguing to their colleagues that the "Doctor Now Bejin Pharma Prevention Act is not a ban on non-face-to-face healthcare, but a regulation on illegal platform rebates."Rep. Seo emphasized the need for the legislation at the Legislation and Judiciary Committee hearing by publicly disclosing a text message that illustrated the potential problems if platforms were allowed to operate wholesale businesses alongside.Based on a text message Doctor Now sent to local pharmacies, Rep. Seo requested that the bill be passed. The Doctor Now text message announced the opening of a pharmaceutical wholesale website as a new function within its Doctornow-Web.The Doctor Now text included details that inventory would be linked based on the pharmacy's purchase history of specialized drugs distributed by Doctor Now, and upon linking, a 'Guaranteed Dispensing' badge would be displayed on the user application.Rep. Seo stated, "There are good startups and others that are not. This bill allows startups and the neighborhood pharmacies across the country to achieve a favorable coexistence."Thus, with Rep. Kim proposing the platform-wide prevention bill, Minister Jeong strongly asserting the legislative necessity, and Rep. Seo providing the final compelling evidence, the bill successfully passed the Health and Welfare Committee and the Legislation and Judiciary Committee, moving closer to final processing in the National Assembly plenary session.Regarding the legislation, Rep. Kim said, "Medical treatment for convenience should not be corrupted into dangerous distribution. The law is designed to prevent illegal rebates, as non-face-to-face platforms can influence the use and prescribing of pharmaceuticals through connections with pharmacies. If we allow non-face-to-face care without preventing this, there is a high risk of another new form of pharmaceutical rebates becoming a major issue, and we must stop it."
- Policy
- Xofluza, Ongentys generics apply for approval
- by Lee, Tak-Sun Dec 03, 2025 08:43am
- Roche’s flu treatment XofluzaAttention is focused on whether market competition will intensify with approval applications being filed for items where no generic drugs have emerged until now.However, given that the original drugs' patents are registered, overcoming patent barriers is expected to be key for entering the market.According to the Ministry of Food and Drug Safety (MFDS) on the 2nd, applications for generic versions of the influenza treatment Xofluza Tab (baloxavir marboxil, Roche) and the Parkinson's disease treatment Ongentys Cap (opicapone, SK Chemicals) have recently been submitted for approval.MFDS has notified the originator companies of the applications in accordance with Korea’s patent–approval linkage system, since the patents for these originators are registered on the Green List.This gives the originators the right to seek sales injunctions on grounds of patent infringement.Xofluza is Roche's next-generation influenza antiviral, an upgrade from Tamiflu. While Tamiflu requires a 5-day course, Xofluza offers the advantage of treatment and prevention with just a single dose, providing much improvement in terms of dosing convenience.However, since receiving domestic marketing approval in November 2019, Xofluza has not yet been listed for reimbursement and therefore is not being sold properly in the market.Meanwhile, follow-on manufacturers are eyeing the market with generics containing the same active ingredient. Last month, Kwangdong Pharmaceutical filed a passive scope confirmation trial to circumvent Xofluza’s formulation patent (a solid formulation having excellent stability).This marks the first detected application filing following the patent challenge. Should Kwangdong Pharmaceutical succeed in circumventing the formulation patent, an early launch of generics will become possible.Ongentys, which was approved the same month as Xofluza, has also been targeted by generic companies. The drug is used as adjunct therapy for Parkinson’s disease patients experiencing motor fluctuations who do not adequately respond to standard levodopa/dopa-decarboxylase inhibitor (DDCI) regimens.Ongentys was added to the reimbursement list in October last year at KRW 2,515 per capsule. Development of a generic version began less than a year after its reimbursement listing.Myung In Pharm filed a passive scope confirmation trial in May to challenge Ongentys’ composition patent (pharmaceutical composition containing a nitrocatechol derivative and its manufacturing processes).Applications filed for generic versions were detected soon after, accelerating the opening of the follow-on generic market.The market entry of generics for Xofluza and Ongentys hinges on their patents. For Xofluza, 2 substance patents are scheduled to expire in 2031 and 2036, respectively.Even if companies succeed in avoiding the formulation patent expiring in 2039 through patent challenges, the substance patents are expected to delay generic market entry by another 10 years. Therefore, analysis suggests that overcoming the substance patent barrier is necessary for generics to enter the market sooner and start sales in earnest.For Ongentys Cap, the substance patent expires in July 2026 and the use patent in October 2027. Therefore, if the composition patent expiring in 2030 is successfully avoided, a generic launch could occur within 2 years.However, it remains uncertain whether the Patent Trial and Appeal Board will rule in favor of the generic challengers.Meanwhile, another application has been filed for the generic version of Hanmi Pharmaceutical’s AmosartanQ, for which Huons earlier became the first to receive generic approval in September.Huons obtained approval for BesylsartanQ Tab, which contains an “alternative salt form” product containing the same active ingredients (amlodipine camsylate+ losartan + rosuvastatin). However, the formulation patent for AmosartanQ is expected to remain in force until November 2033, making its market launch uncertain. Huons has filed a passive claim scope confirmation trial against this patent, aiming to circumvent it.Amid this situation, another pharmaceutical company has now applied for approval of a generic version.
- Company
- ‘BMS seeks to redesign growth through open innovation’
- by Son, Hyung Min Dec 03, 2025 08:43am
- Bristol Myers Squibb (BMS) defines itself as an ‘open innovation company’ for a reason.Over 60% of the company’s global pipeline now consists of assets sourced through external collaborations, including next-generation platforms such as targeted protein degradation, cell therapy, and radiopharmaceuticals.Steve Sugino, Senior Vice President and General Manager, BMS Asia-PacificSteve Sugino, Senior Vice President and General Manager at BMS Asia-Pacific, recently stated to reporters, “Science knows no borders. BMS goes where the science is.”BMS is one of the global pharmaceutical companies most actively pursuing open innovation and mergers and acquisitions (M&A).The company had faced declining sales due to patent cliffs with the expiry of several major drug patents, including the anticoagulant Eliquis (apixaban) and the blood cancer treatment Revlimid (lenalidomide), and the entry of their generic versions. Furthermore, its global blockbuster immunotherapy drug Opdivo (nivolumab) is also nearing patent expiration.To address this, BMS has expanded its pipeline over the past five years through investments in companies like Karuna Therapeutics (USD 14 billion), RayzeBio (USD 4.1 billion), Mirati Therapeutics (USD 4.8 billion), and SystImmune (USD 8.4 billion).Through its acquisition of Karuna, BMS developed the schizophrenia drug ‘Cobenfy (xanomeline /trospium chloride). It also entered the radiopharmaceutical market by acquiring RayzeBio and plans to develop new anticancer drugs through Mirati and SystImmune.This principle is also evident in APAC. One prime example is the agreement with Orum Therapeutics in Korea.In 2023, BMS paid Orum Therapeutics USD 180 million (approximately KRW 260 billion) and successfully secured its degrader antibody conjugate (DAC) technology.Sugino stated, “Protein degradation is an area where BMS holds a strategic advantage, and Orum's technology had clear global scalability. This is a landmark case of Korean technology becoming a global standard.”Sugino also emphasized that manufacturing and supply chain (M&SC) collaboration with domestic companies is a core pillar of BMS's strategy.He explained, “Amid complex global circumstances, a stable supply chain is an essential competitive capability for global pharmaceutical companies. BMS is strengthening its global supply chain not only through its own production but also through collaborations with Samsung Biologics and Lotte Biologics. Based on the collaborations, BMS is reliably supplying innovative therapies to patients worldwide.”BMS is working to systematically implement its collaborative framework with companies in Korea. One flagship program is the ‘Seoul–BMS Innovation Square Challenge,’ which BMS has operated since 2022. Through this program, companies like Prazer Therapeutics (proteasome inhibitors), Illimis Therapeutics (Alzheimer's disease drug), and Galux (AI-driven protein design) have been selected and are growing, leveraging BMS's global network and commercialization expertise. This serves as an incubator, placing Korean biotech companies on a global growth trajectory.BMS's criteria for evaluating external collaborations are straightforward: scientific excellence, commercial potential, strong intellectual property (IP), and ideally, both first-in-class and best-in-class potential.Sugino advised, “While excellent science is adequate, companies also must further develop global commercialization capabilities. Articulating how science translates into patient value is key to partnering.Organization dedicated to APAC established… BMS's growth axis shifts to AsiaBMS's open innovation strategy and manufacturing/supply chain collaborations ultimately align with the strategic question of ‘where to create innovation and where to execute it.’Sugino stressed, “APAC, which includes Korea, is one of the most dynamic regions, with strengths across science, clinical infrastructure, manufacturing, and commercial potential. Asia’s role will only continue to grow.”This assessment is directly reflected in BMS's global reorganization. In January this year, BMS created a dedicated APAC division through a structural reorganization. Sugino explained, “This strategic realignment was made to support key markets like Korea, Japan, China, and Australia from a closer location.”He explained that this organizational change is not merely a restructuring but the result of a company-wide decision recognizing APAC as the next-generation growth engine. BMS determined that the core APAC countries—Korea, China, Japan, and India—would be the central axis after questioning ‘Where should we invest and where should we expect growth?’BMS is seeking to expand partnerships with domestic companies. Vice President Steve Sugino and BMS Korea Country Manager Hye Young Lee at the Global Open Innovation Week held last month in Seocho-gu, Seoul.APAC has already established itself as a major clinical base for BMS. BMS has set a long-term goal of securing 40% of patients enrolled in Phase III clinical trials from APAC. In fact, Korea is included as a ‘priority country’ across all phases of development, from Phase 1 to Phase 3.Sugino noted, “Korea's medical infrastructure, clinical execution capabilities, and patient accessibility are among the best globally. There is a reason Korea has become an essential region for pivotal trials.”Since 2022, BMS has acquired 8 approvals and 6 insurance reimbursement listings in Korea alone, across key therapeutic areas including solid tumors, hematologic malignancies, and rare cardiovascular diseases.Sugino assessed, “The Korean government and regulatory authorities are making significant contributions to expanding access to innovative therapies. This is an important signal that goes beyond short-term results, earning Korea the trust of global pharmaceutical companies.”However, he clearly pointed out structural challenges. The one-year introduction rate for new drugs is only 5% in Korea compared to 78% in the US, and the health insurance coverage rate is also significantly lower at 22% in Korea versus 85% in the US and 48% in Japan. The average 46-month timeframe from approval to coverage was also highlighted as a problem.Sugino emphasized, "My father also battled cancer. If he had to wait 46 months for treatment, he would have lost his chance. Innovation only matters when it reaches patients in time."Ultimately, BMS’s goal is clear: Deliver innovative therapies to patients with serious diseases faster and more widely. AI-driven R&D, open innovation, and APAC-centric strategies are simply means to achieve that goal, with Korea at the strategic core.Sugino concluded, “BMS exists to discover, develop, and deliver innovation. For these values to be properly realized, we need an environment where new therapies are approved and reimbursed in a timely manner.“Ensuring innovation reaches patients worldwide, including those in Korea, rather than remaining confined to specific countries—that is the challenge BMS must address.”
- Company
- Why JP's distribution giant 'Suzuken' pushes dual innovation
- by Kim, Jin-Gu Dec 03, 2025 08:42am
- The challenges facing Suzuken, the Japanese pharmaceutical distribution giant with annual sales of ¥2.4 trillion (approximately KRW 21 trillion), are similar to those facing the South Korean pharmaceutical distribution industry.Despite the Japanese market being dominated by four major companies, including Suzuken, which controls 80% of the market, these firms face structural difficulties: low operating profit margins coupled with soaring labor and logistics costs.Suzuken's chosen solution is 'Dual Innovation'. The company is aiming for a fundamental change in the industry's structure by combining hardware innovation, such as smart logistics and the Cubixx system, with software innovation, focused on building the COLLABO Portal for healthcare professionals.The distribution giant's experiment to overcome low marginsHeadquartered in Nagoya, Suzuken is one of Japan's 'Four Giants' of pharmaceutical distribution, alongside Medipal, Alfresa, and Toho Yakuhin. They all commonly suffer from chronic low distribution margins, despite their massive size and market dominance. Recently, companies are facing increased labor and logistics costs due to inflation in Japan and the 'Logistics 2024 problem,' which is a regulation limiting working hours for transport workers.Suzuken's sales structure (2024): pharmaceutical wholesale (82.7%), specialty pharmaceutical distribution consignment (10.5%), regional medical·nursing support (3.4%), and healthcare product development (1.9%).As of last year, 82.7% of Suzuken's revenue was pharmaceutical wholesale. However, the company is continuously expanding into areas such as specialty drug distribution consignment (10.5%) and regional medical·nursing support (3.4%), interpreted as efforts to diversify its business.Takafumi Ogawa, Chief Operating Officer of Suzuken's Management Planning Department, explained, "The goal of pharmaceutical distribution is stable supply, but the challenge for sustained growth is overcoming the low operating profit margin," and added, "Suzuken is emplying a dual innovation strategy, by upgrading the core pharmaceutical distribution business through 'Smart Logistics' as well as by installing a new growth engine through 'Digital Healthcare.''Smart Logistics': hardware innovation through integrating manufacturing, logistics, and wholesaleThe first pillar of Suzuken's innovation is the construction of 'Smart Logistics.' This strategy goes beyond simple automation to tie the entire Supply Chain Management (SCM) by integrating manufacturing, logistics, and wholesale into a single flow, thereby maximizing cost efficiency.The 'Metropolitan Integrated Logistics Center,' becoming operational in April of last year, is a result of this hardware revolution. It is the first facility in Japan to house pharmaceutical contract manufacturing facilities alongside pharmaceutical logistics and wholesale logistics facilities in one location. This integration drastically reduces unnecessary transportation steps between the pharmaceutical company's manufacturing·shipping and the distributor's receiving·delivery process, simultaneously shortening lead times, shipping costs, and time.Suzuken's 'Metropolitan Integrated Logistics Center,' becoming operational in April of last yearSuzuken utilizes advanced robotics and image recognition technology to automate processes such as slip entry, inventory organization, and intra-facility delivery. This design enables stable operation with fewer personnel, serving as a practical countermeasure against soaring delivery costs and intensifying labor shortages exacerbated by Japanese limits on driving work hours.Furthermore, the company actively uses the 'Cubixx' system, adopted from U.S.-based Cencora, to enhance inventory management for high-value pharmaceuticals. This system enables data-driven tracking, monitoring, and the recovery·resale of unused 'Inactive Inventory.' Suzuken reported saving ¥5.7 billion (approximately KRW 53 billion) in pharmaceutical disposal costs last year alone through the Cubixx system.Suzuken's automated logistics system using robotsFrom distribution margin to data margin…software evolution through 'COLLABO Portal'The second pillar of Suzuken's innovation is its 'Digital Healthcare' business, whose key strategy is to convert the data secured through its distribution network into value for clinical practice. At the center of this strategy is the dedicated platform for healthcare professionals, the 'COLLABO Portal.'The portal has 380,000 registered healthcare professionals. Suzuken has been digitally reconstructed to include individual doctors and pharmacists utilizing its existing hospital and pharmacy network. The portal acts as a 'data hub,' structuring and delivering necessary information to healthcare institutions and practitioners based on data uniquely secured by the distribution company, moving beyond simple information provision.Through this platform, the initial response time for call center inquiries (e.g., scheduled delivery times) previously handled by phone, fax, and email has been reduced from an average of 30 minutes to 5 minutes. This frees field sales representatives from repetitive tasks, allowing them to dedicate time and capabilities to high-value solution proposals. The role of the sales agents is thus shifting from a 'order taker' to a 'digitally-enabled consultant.'Suzuken's 'COLLABO Portal,' a platform specifically designed for healthcare professionals.The platform is also beneficial to pharmaceutical companies. The COLLABO Portal serves as a channel for drug manufacturers to provide information and digital marketing outreach to medical institutions and practitioners. Suzuken expects this strategy, aiming to generate 'information margin' over 'distribution margin', to be a key component in overcoming its low-margin structure.Suzuken's case is gaining attention for its approach, which reduces cost burdens through automation-based supply chain innovation and establishes new value through a digital platform. This strategy of integrating manufacturing, logistics, and wholesale, along with data utilization, aims to mitigate the inherent limitations of the low-margin distribution industry. Given that the South Korean pharmaceutical distribution sector faces similar structural challenges, including low margins and rising labor·logistics costs, Suzuken's dual innovation strategy is considered a valuable case study for gauging the direction of future industry change.
- Product
- Resolving patient data transparency
- by Jung, Heung-Jun Dec 03, 2025 08:42am
- Starting March next year, when the Integrated Care Support Act comes into effect, pharmacists participating in the polypharmacy management program will be able to access real-time medication histories for eligible patients.This addresses a previously noted limitation by enabling access to real-time patient information. Until now, information has been based on claims data, resulting in a time lag compared to actual prescription and dispensing information.Access to DUR-based real-time data is expected to mark a major turning point for multidisciplinary team-based care involving pharmacists.On the 26th, the Seoul Pharmaceutical Association co-hosted a National Assembly policy discussion forum with the offices of Democratic Party lawmakers Yoon Kim and In-soon Nam, focusing on medication management services in a super-aged society.During the general discussion session, the need to expand access to real-time patient information and increase pharmacist participation in multidisciplinary teams was raised to strengthen pharmacists’ medication management services.Jin-mi Jang, Director of the Seoul Pharmaceutical Association, said, “A government-led public data-based medication management system needs to be established. The issue can be resolved by enabling easy access to the excellent data held by the National Health Insurance Service and the Health Insurance Review and Assessment Service. Patient information must be viewable before visits.”Jang added, ” Sharing medication counseling results with medical institutions is also crucial. In the community-based model, prescription intervention through communication with medical institutions is impossible. System improvements are clearly needed."Jang also suggested expanding eligibility to basic livelihood security recipients and high-risk patients who receive prescriptions from multiple hospitals.Park Sang-won, CEO of Neulpum Value, who participated in Gwanak-gu’s integrated care pilot project, highlighted the need for robust data integration and the pharmacist’s role within multidisciplinary teams. Park said, “The patient's medication list is not being brought to the integrated support meetings. This makes it difficult for pharmacists to play their role within the meetings. Medication management must be part of the case review from the beginning.”Park also noted that integrated care frequently involves socially vulnerable individuals who are severely immobile or have limited health literacy, meaning pharmacists must be thoroughly prepared.Park added, “Data often differs from reality. Therefore, pharmacists' roles are essential on-site. Furthermore, managing performance indicators will be crucial starting next year, so we must determine how to demonstrate that pharmacist counseling contributed to patient health outcomes.”The National Health Insurance Service (NHIS), the operational agency for the polypharmacy management program, also recognized the need for patient information verification.Hyang-jung Park, Director of Health Support Programs at NHIS, stated, “We will link DUR-based medication history data to public MyData, enabling consulting pharmacists to access real-time information starting in March next year.”Park emphasized, "We need many pharmacists with advanced expertise. There is a specialized pharmacist for integrated medication management (in the national specialist pharmacist subjects). If it becomes reimbursable, qualifications may be required for fee-for-service pricing. We will communicate with relevant departments at the Ministry of Health and Welfare and strive to make the polypharmacy management project a pilot reimbursement program,“ and asked for pharmacists’ active participation.Hyun-jin Kang, Deputy Director at the Ministry of Health and Welfare’s Pharmaceutical Policy Division, commented: “We agree on the importance of comprehensive medication management. However, we must continue discussing how to standardize and institutionalize it,” adding that the ministry will review the forum’s proposals with relevant departments.
- Company
- ROS1-targeting 'Augtyro' under consideration for reimb
- by Eo, Yun-Ho Dec 03, 2025 08:42am
- A ROS1-targeting cancer agent, 'Augtyro,' will be considered for the insurance reimbursement listing.According to sources, Bristol Myers Squibb (BMS) Korea's Augtyro (repotrectinib) is expected to be considered for review by the Health Insurance Review and Assessment Service (HIRA)'s Cancer Drug Review Committee (CDRC), which will be this year's last.The submitted application for listing includes the drug's indication for ▲the treatment of adult patients with ROS-1 positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) ▲the treatment of patients (adults and children aged 12 years and above) with NTRK (Neurotrophic tyrosine receptor kinase) fusions in solid cancers.Augtyro is classified as a next-generation Tyrosine Kinase Inhibitor (TKI) designed to overcome the limitations of prior treatments. It was approved based on the TRIDENT-1 trial, which included four cohorts of patients with ROS1 or NRTK fusions, assigned to groups based on prior TKI treatment history.The ROS1 data were published in the New England Journal of Medicine (NEJM), and the latest follow-up results were presented at the World Conference on Lung Cancer (WCLC) in September. Notably, 58% (41/71 patients) in the patient group without prior therapeutic experience ("no prior experience") and 41% (23/56 patients) in the group with prior therapeutic experience.In the TRIDENT-1 trial, Augtyro demonstrated clinically significant effects in both first- and second-line settings for ROS1-positive NSCLC. Favorable clinical results were reported, including Progression-Free Survival (PFS) of 31.1 months and Overall Survival (OS) of 74.6 months in 'no prior experience' patients, and a PFS of 8.6 months and OS of 25.1 months in patients previously treated with a ROS1-targeting agent.Furthermore, Augtyro has a molecular structure that facilitates penetration of the Blood-Brain Barrier (BBB), showing effectiveness even in patients with brain metastases. The 12-month intracranial PFS rate was 91% in the first-line setting, and the intracranial Objective Response Rate (ORR) was 38%, with a 12-month intracranial PFS rate of 82% in the second-line setting.Although it was a single-arm clinical trial, resultan indirect comparison against approved agents for ROS1-positive advanced NSCLC showed that Augtyro achieved statistically significant improvements in ORR, Duration of Response (DOR), and PFS compared to existing therapies.Based on these clinical results, Augtyro is strongly recommended as a first- and second-line treatment option for patients with ROS1-positive NSCLC in all major guidelines, including NCCN, ESMO, and ASCO.Professor Sang-We Kim of the Department of Oncology at Asan Medical Center stated, "The TRIDENT-1 clinical trial showed superior results compared to existing treatment in both the 1st and 2nd line settings for ROS1-positive NSCLC. The results indicating that the use of Augtyro as a first-line treatment could potentially enable patients to survive for over five years are highly encouraging. We hope it will be added to the reimbursement list so that patients in need can benefit quickly."
- Company
- Antengene's 'Xpovio' passes the DREC
- by Eo, Yun-Ho Dec 02, 2025 12:38pm
- Xpovio (selinexor), an oncology drug and the first product introduced in South Korea by the Chinese pharmaceutical company Antengene Corporation Limited ("Antengene"), is entering the final stage for expanded reimbursement.According to sources, Antengene Korea has accepted the condition of 'below the evaluated price' set by the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Evaluation Committee (DREC) on November 6 for the oral Multiple Myeloma treatment, Xpovio (selinexor). The company is currently awaiting the Ministry of Health and Welfare (MOHW)'s order for price negotiation.The specific indication for the expanded reimbursement process is: 'In combination with bortezomib and dexamethasone for adult patients with Multiple Myeloma who have received at least one prior therapy.'Designated as an orphan drug in Korea and approved in August of last year, Xpovio is a novel mechanism drug that selectively inhibits the nuclear export protein, XPO1.XPO1 inhibitors are anticipated to be used in combination with other treatments (drugs, etc.) to improve the treatment of various diseases. Currently, five treatments, including Xpovio, are recommended in the National Comprehensive Cancer Network (NCCN) guidelines.Most Multiple Myeloma cases are characterized by having repeated recurrent/refractory responses to treatment. Similarly, in Diffuse Large B-cell Lymphoma (DLBCL) patients who fail systemic therapy, the opportunity for cure or long-term disease-free survival diminishes with each subsequent relapse.Consequently, there is an urgent need for safer and more effective treatments for both relapsed/refractory Multiple Myeloma and relapsed/refractory DLBCL.However, the final listing of Xpovio for insurance reimbursement is expected to take additional time. Xpovio was submitted to HIRA's Cancer Drug Review Committee (CDRC) in January but failed to secure the reimbursement criteria.The reason for failing at the CDRC is reportedly the failure to meet the required number of launched A7 countries (countries where the drug has been approved and marketed). As a result, the company must monitor the status in other countries before proceeding with a renewed reimbursement challenge.Meanwhile, the efficacy of Xpovio has been demonstrated through two Phase 2 studies: STORM and SADAL.In the STORM study, Xpovio in combination with dexamethasone showed an Objective Response Rate (ORR) of 26% and a Clinical Benefit Rate (CBR) of 39.9% in patients with relapsed or refractory Multiple Myeloma who had received four or more prior therapies.The SADAL study, which enrolled patients with relapsed DLBCL who had received two or more prior therapies, demonstrated an ORR of 28.3% and a Complete Response (CR) rate of 11.8% with Xpovio monotherapy.
- Policy
- First Migard generic listed in KOR
- by Jung, Heung-Jun Dec 02, 2025 12:37pm
- The first generic version of Migard will be listed for reimbursement in Korea next month.Frotriptan Tab, Myung In Pharm’s first generic version of SK Chemicals' Migard Tab, will be listed for reimbursement next month, marking the beginning of full-scale competition.With this listing, Myung In Pharm strengthened its position in the migraine market, alongside its existing products such as Sumatran (sumatriptan succinate) and Topamate (topiramate).According to industry sources on the 28th, Myung In Pharm’s Frotriptan Tab 2.5 mg (frovatriptan succinate monohydrate) will be reimbursed starting next month. As the first generic, it receives a 59.5% premium, with the upper reimbursement limit set at KRW 2,038.Last year, Myung In Pharm became the first domestic company to conduct a bioequivalence study for the launch of a generic version of Migard. It obtained the first generic approval this June.Migard is a migraine treatment containing frovatriptan that received domestic approval in 2009. It is used for the acute treatment of migraine with or without aura.According to the market research firm UBIST, Migard recorded KRW 2.5 billion in sales last year, representing a 16% increase from the previous year.With the entry of generics, SK Chemicals and Myungin Pharmaceutical will now compete in the previously uncontested misgraine treatment market.While Migard’s standalone sales may not suggest a large market, the broader triptan-class market, including agents such as sumatriptan, is not small. The acute migraine treatment market is estimated to be worth approximately KRW 23 billion.Several pharmaceutical companies, including Yuyu Pharma, Daewoong Bio, Han Wha Pharma, and Reyon Pharmaceutical, already market products containing sumatriptan, naratriptan, and other triptan-class ingredients.Myung In Pharm, known for its strong CNS portfolio, continues to expand its migraine lineup, adding Frotriptan to its existing line of products such as Sumatran (sumatriptan succinate), Topamate (topiramate), and Poxen (naproxen sodium).SK Chemicals, its direct competitor, has also been strengthening its migraine portfolio. In addition to Migard, it launched Suvexx, a combination of sumatriptan and the anti-inflammatory agent naproxen, last year. Also, in October last year, it further expanded its lineup by acquiring the original zolmitriptan product Zomig Tab from AstraZeneca.
- Opinion
- "Personalized first-line therapy for EGFR-mutated NSCLC"
- by Hwang, byoung woo Dec 02, 2025 12:37pm
- The treatment paradigm for EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) is changing.Given the high incidence of brain metastases at diagnosis in EGFR-mutated NSCLC, the key criteria for first-line treatment selection are now centered around Central Nervous System (CNS) inhibition and a favorable toxicity for long-term administration.The integrated analysis of LASER201 and LASER301, published recently in 'Clinical Lung Cancer,' provides additional evidence supporting the intracranial efficacy of the domestically developed third-generation EGFR TKI, Leclaza (lazertinib). The study is providing evidence for redefining the treatment strategy for patients with EGFR mutations.DailyPharm met with Professor Ji-Youn Han, from the Division of Hematology-Oncology at the National Cancer Center, a co-author of the paper mentioned above, to hear about the latest trends in the treatment of EGFR-mutated Non-Small Cell Lung Cancer (NSCLC), the CNS strategy, and the direction of customized therapy in the era of combination therapies."Brain metastases account for 40% at diagnosis…key determining factor for prognosis"Professor Ji-Youn Han, Division of Hematology-Oncology at the National Cancer CenterFirst, Professor Han emphasizes that "CNS management is now the starting point of treatment, rather than simply an additional factor."Professor Han stated, "Approximately 20-25% of all lung cancer patients already have brain metastases at diagnosis, but this rate rises to as high as 40% in patients with EGFR·ALK·HER2 mutations or who are non-smokers," and added, "Recent global Phase 3 (MARIPOSA·FLAURA2) trials also reported that 40% of patients have baseline brain metastases."These data indicate that not only are baseline brain metastases common, but a significant number of participating patients with good performance status have accompanying brain metastases.However, the prognosis varies significantly depending on symptom status. While approximately 40% of brain metastases cases are detected while still asymptomatic, the prognosis rapidly worsens once neurological deficits occur.Professor Han stated, "Symptoms of brain metastases include persistent headaches, nausea/vomiting, visual impairment, dizziness, and stroke-like symptoms, which severely limit daily life. Ultimately, symptomatic brain metastases is regarded as a major worsening factor that significantly decreases the patient's Quality of Life."Integrated Analysis of LASER201/301...reconfirming Leclaza's effect on suppressing the CNSProfessor Han summarized the limitations of existing first- and second-generation EGFR TKIs as being 'not initially designed to target the EGFR mutation itself.'Professor Han explained that side effects from inhibiting normal EGFR made it difficult to achieve sufficiently high drug concentrations, resulting in restricted BBB permeability and, consequently, a structural limitation in CNS management.In contrast, third-generation EGFR TKIs were developed from the start to enhance mutant EGFR selectivity and BBB permeability. This gained attention because it opened an era where much more stable and consistent effects on CNS can be expected, even in patients with brain metastases.Furthermore, the differences in toxicity profiles are evident. Professor Han said, "If the clinically perceived toxicity severity of first·second generation agents is rated at 10, the third generation is at the 2–3 level, which significantly improves their suitability for long-term use."Regarding the results of the LASER201 and LASER301 integrated analysis released, Professor Han evaluated them as additional evidence supporting Leclaza's global competitiveness.Professor Han stated, "The key finding is that this study provided objective data confirming that Leclaza has intracranial efficacy comparable to Tagrisso (osimertinib), the Korean standard of care, in EGFR-mutated lung cancer patients with brain metastases." She found this consistent with the trend from the MARIPOSA study, in which lazertinib monotherapy showed a Hazard Ratio (HR) of less than 0.9 compared to osimertinib in this patient group.Professor Han also mentioned, "Although the two drugs have generally similar efficacy, their side effect profiles do not entirely overlap. The fact that an option exists for patients to switch to the other drug if they cannot tolerate a specific adverse event is a major clinical advantage."Consequently, the availability of two third-generation EGFR TKIs is viewed as having significance for expanding the treatment strategy.Leclaza has a demonstrated advantage for suppressing brain metastases, supported by clear data proving the BBB permeability in preclinical studies.Professor Han stated, "This integrated analysis strengthens Leclaza's intracranial evidence, enhancing its global credibility, and expands the treatment strategy by enabling customized drug selection based on the patient's side effects and status. It is significant because it lays the foundation for broadening the scope of clinical judgment amid the future flow of combination therapies and new drug development."Toxicity management and drug switching...differentiating strategy garners attentionProfessor Han stressed that 'toxicity management' is a critical factor in determining the actual clinical treatment strategy, as EGFR-mutated lung cancer is a disease that requires long-term use of agents from the same class.In the case of Tagrisso, specified severe side effects, such as thrombocytopenia, ILD (interstitial lung disease), and cardiac toxicity like QTc prolongation, may necessitate dose reduction."According to the current guidelines, dose must be reduced to 40 mg if the same adverse event recurs. However, the evidence for maintaining drug efficacy at the 40 mg reduced dose is extremely limited, and the lack of data ensuring sufficient CNS control in patients with brain metastases is the biggest concern in the clinical setting," she said.Professor Han said, "Since CNS progression in EGFR-mutated lung cancer is directly linked to treatment failure, disease progression during dose reduction significantly limits the scope of subsequent drug switching strategies." She emphasized, "The medically recommended option in this scenario is a switch to Leclaza monotherapy, whose efficacy and tolerability have already been proven at the standard dose (240 mg)."Professor Han also suggested that the reimbursement criteria need be improved.The current reimbursement criteria require a Tagrisso dose reduction before switching to Leclaza, forcing the patient to risk the same side effects again. Professor Han also pointed out that if the disease progresses during the dose reduction, reimbursement for the subsequent switch to Leclaza may be denied.Professor Han concluded, "Since there is little difference in the drug price between the two agents, and Leclaza is sometimes even cheaper, there is insufficient evidence to mandate dose reduction for financial reasons," and added, "Ultimately, these regulations are criticized as being unreasonable from the perspectives of patient safety, treatment continuity, and insurance finances."
