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- 2026-04-21 15:18:28
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- Kisqali attempts reimb in early breast cancer
- by Eo, Yun-Ho Jan 26, 2026 04:39pm
- Following Verzenio's failed attempt to expand coverage for early-stage breast cancer, Kisqali has now stepped forward to tackle the same challenge.According to Dailypharm coverage, Novartis Korea submitted an application last September to expand coverage for Kisqali (ribociclib), a CDK4/6 inhibitor, as adjuvant therapy in patients with high-risk Stage II and Stage III HR+ (hormone receptor positive)/ HER2- (human epidermal growth factor receptor 2 negative) early breast cancer. The company submitted the application last September and is awaiting its application to be reviewed by the Health Insurance Review and Assessment Service's Cancer Disease Review Committee later this year.With Verzenio (abemaciclib), which shares the same CDK4/6 inhibition mechanism, having failed to clear the Cancer Disease Review Committee hurdle, attention is now focused on whether Kisqali can achieve a different outcome.In the early breast cancer setting, Verzenio struggled from its first attempt. After a six-month wait following its application submission, the drug was first reviewed by the Cancer Disease Review Committee in May 2023, but reimbursement criteria were not established. Lilly resubmitted the application 5 months later in October, and the drug was reviewed again in March and July of last year—only to meet the same outcome.This suggests that Kisqali’s reimbursement journey may also be challenging. In particular, the lack of overall survival (OS) data, which proved to be a major stumbling block for Verzenio, remains a key issue. In early-stage cancer, generating OS data is inherently difficult.While Kisqali is expected to improve OS, direct data is not available yet. Invasive disease-free survival (iDFS) is used as a clinically meaningful surrogate endpoint with a strong correlation to OS in early breast cancer due to the disease characteristics. Kisqali demonstrated encouraging results in the NATALEE study.Study results showed that for the primary endpoint, iDFS at 4 years was 88.5% for the Kisqali combination therapy group and 83.6% for the endocrine therapy alone group, representing an absolute improvement of 4.9 percentage points. The risk of invasive disease progression or death was reduced by 28.5% in the Kisqali group compared to the endocrine therapy alone group.Furthermore, according to the 5-year NATALEE data presented at ESMO 2025, the Kisqali combination therapy reduced the risk of invasive disease progression or death by 28.4% compared to endocrine therapy alone. The 5-year iDFS was 85.5% in the Kisqali combination group and 81.0% in the endocrine therapy alone group, demonstrating a clinically meaningful 4.5% improvement.Meanwhile, treatment for early-stage breast cancer patients involves local therapies such as surgery or radiation therapy, along with systemic adjuvant therapies like chemotherapy and endocrine therapy. Endocrine therapy-based treatment is the standard therapy for HR+/HER2- early-stage breast cancer.In the early 2000s, aromatase inhibitor monotherapy or tamoxifen, combined with ovarian function suppression therapy for premenopausal patients, was recommended for HR+/HER2- early breast cancer patients. The goal of adjuvant therapy is to eliminate micrometastases, reduce the risk of recurrence, and prolong patient survival.For high-risk early-stage breast cancer patients (stages II-III) with a high risk of recurrence, the risk of recurrence continues to rise over time even after completing standard endocrine therapy following surgery, presenting limitations in improving long-term prognosis. Reported recurrence rates range from 6–22% within five years and 22–52% over 20 years, highlighting a persistent unmet medical need.
- Company
- Pharma in Hyangnam "Unstable employment cannot yield good medicine production"
- by Chon, Seung-Hyun Jan 23, 2026 08:39am
- Landscape of Hyangnam Pharmaceutical ComplexThe pharmaceutical industry gathered at the Hyangnam Pharmaceutical Complex to appeal for a halt to the government's drug price reduction plans. Workers at the complex, where many small and mid-sized pharmaceutical companies are located, expressed fears of job instability, and the possibility of future labor struggles was raised.The "Emergency Response Committee for Drug Price System Reform for the Development of the Pharmaceutical and Biotech Industry" (the Committee), composed of major industry organizations, held a labor-management meeting on the 22nd at the Hyangnam Pharmaceutical Complex in Hwaseong, Gyeonggi Province. The Committee requested a reconsideration of the government's reform. The committee is consisted of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), the Korea Biomedicine Industry Association, the Korea Pharmaceutical Traders Association, the Korea Drug Research Association, and the Korea Pharmaceutical Industry Cooperative.The event was organized for the Committee and the labor-management of the Hyangnam complex to review the risks and impact that the reform plan, which includes large-scale price cuts, would have on the industry and production sites.The event's participants warned, "The large-scale drug price cuts pushed by the government are a declaration of abandonment of the future of the domestic pharmaceutical industry, run counter to the demand of these days for job stability, and collapse the national health safety net."In November last year, the MOHW reported to the Health Insurance Policy Review Committee its plan to lower the price calculation rate for generics and patent-expired drugs from 53.55% to around 40%. The reform is scheduled to be finalized by the Health Insurance Policy Review Committee in February and implemented in July. A month after a press conference held at the KPBMA in Seocho-gu on the 22nd of last month, the pharmaceutical industry once again publicly stated dissatisfaction against the government.The "Emergency Response Committee for Drug Price System Reform for the Development of the Pharmaceutical and Biotech Industry" (the Committee), composed of major industry organizations, held a labor-management meeting on the 22nd at the Hyangnam Pharmaceutical Complex in Hwaseong, Gyeonggi Province. Participants stated, "If the government's reform is implemented as is, it will result in the virtual collapse of the domestic pharmaceutical industry and lead to fatal consequences that jeopardize the health and lives of the public." Hyangnam Pharmaceutical Complex is Korea's largest pharmaceutical production hub, housing 39 business sites from 36 companies.Attendees unanimously agreed that rapid price cuts could deal a severe blow to the entire industry, including job instability, a contraction in R&D investment, and a weakened production base.Participants stated, "If rapid and unprecedented price cuts are implemented, the damage will be concentrated on domestic pharmaceutical companies, including those in Hyangnam, making a loss of up to KRW 3.6 trillion." The industry fears that deteriorating profitability will hinder investment in facilities for quality innovation, infrastructure improvements, and R&D.Oh Sang-jun, Chairman of the Southern Gyeonggi branch of the Chemical Workers' Union under the Federation of Korean Trade Unions (FKTU), voiced his opinion, saying, "Workers may fear job instability due to the government's price cuts. If employment is unstable, good medicine cannot be produced. The government should stop pushing unilaterally and instead consult with pharmaceutical workers to implement an effective drug pricing policy. If necessary, we will resort to struggle."Labor and management representatives from the five organizations in the Committee predicted that more than 10% of the industry's 120,000 workers would inevitably face unemployment. They also pointed out that a contraction in the production of low-profit essential medicines and domestic ethical drugs would ultimately increase reliance on expensive imported drugs, causing serious problems for public health.The labor-management representatives emphasized, "Stop the unilateral push for drug price cuts and guarantee job stability in the domestic pharmaceutical industry," and added, "Officials in charge of healthcare safety should actively foster the industry." Officials from companies in the Hyangnam complex also repeatedly highlighted the side effects.Wonsuk Lee, CEO of Daehan Nupharm, urged, "The reform plan is becoming a profitability shock to small and mid-sized domestic pharmaceutical companies, highly dependent on generics. Small businesses will be unable to handle even the fixed costs for facility investment and quality control. Before pushing an unreasonable plan that ignores the industry's reality, please prepare a reasonable alternative through communication."Lee Deok-hee, Chairman of the Il-dong Pharmaceutical labor union, said, "We have had the unfortunate experience of conducting restructuring due to liquidity limits while continuously making bold investments of 20% of sales to grow future competitiveness," and added, "Price cuts will lead to permanent workers becoming temporary workers and indirect employment leading to dismissals, which could greatly shake the job stability and the very existence of the pharmaceutical industry."On this day, the Medicine and Cosmetics Division of the National Federation of Chemical Workers' Unions under the FKTU issued a statement calling for a "full reconsideration of the drug price system reform and the protection of pharmaceutical jobs."The Medicine and Cosmetics Division urged: ▲reconsideration of the reform, ▲the establishment of a social discussion body involving pharmaceutical workers and unions, and ▲the preparation of measures to protect jobs and ensure employment stability.Lee Dong-in, Executive Secretary of the division, suggested the possibility of a struggle, stating, "We will respond strongly against job instability and restructuring caused by the reform," and added, "We will inform the public of the voices of pharmaceutical workers through various means and continuously raise issues regarding the reform plan."Yunhong Noh, President of the KPBMA, argued, "If the reform is forced through in its original form, the industrial foundation will collapse, and the production of essential medicines will contract. Hyangnam, which is home to small- and mid-sized companies, could face job instability and economic contraction due to changes in the business environment," and "A policy that ignores the voices of the industrial field can never succeed."Cho Yong-jun, Chairman of the Korea Pharmaceutical Industry Cooperative, appealed, "The generic drug price reform plan could pose serious business risks to small and mid-sized pharmaceutical companies," and added, "Rather than a unilateral cut, a phased approach is needed after analyzing the practical impact on employment and investment. Rapid change destroys even the best policy's ecosystem. Companies should be allowed enough time to improve their system."
- Company
- 'Drug pricing reform will improve patient access'
- by Son, Hyung Min Jan 22, 2026 08:22am
- As global pharmaceutical R&D trends rapidly shift toward high-priced anticancer and rare disease therapies, attention is focused on how the government's proposed drug pricing system reform will impact domestic patient access and the competitiveness of the pharmaceutical industry.On the 21st, Dailypharm held a Future Forum at the Catholic University of Korea's Songeui Campus Institute of Biomedical Industry. At the forum, Jaeho Jung, Head of Value and Access at Novartis, presented the perspective of multinational pharmaceutical companies on the proposed drug pricing reform.Jung said, “The reform plan is in line with global R&D trends. If appropriate value-based compensation and faster reimbursement listing are achieved, it will send a positive signal not only for patient access but also for Korea’s R&D ecosystem.”On the 21st, Dailypharm held its 55th Future Forum at the Catholic University of Korea's Songeui Campus Institute of Biomedical Industry.Development of high-cost anticancer drugs and rare disease treatments active... “Current drug pricing and reimbursement systems struggle to accommodate innovation.”Jung first highlighted the scale of clinical development in oncology and rare disease therapies. Currently, oncology accounts for 41% of all global clinical trials, of which 35% involve innovative drugs.The rare disease treatment market is expected to reach KRW 542 trillion by 2023, while rare cancer trials account for 74% of all ongoing rare disease studies.Despite this projected expansion of the high-cost new drug market, securing insurance coverage, which is a core value for patient access in Korea, remains inadequate. Among 460 new drugs approved in major countries from 2012 to 2021, the coverage rate averaged 28% across G20 nations and 29% in OECD countries, while Korea lagged at just 17%.Jung said, “Korea is facing a triple burden of ensuring universal welfare with limited resources, expanding access to new drugs, and guaranteeing patients’ right to treatment. The government has not been idle. The system has been continuously revised since 2007, but it has now reached its limits.”Examining the time required for reimbursement by treatment type, rare disease treatments took 23.6 months, anticancer drugs 31.6 months, and general new drugs 18.3 months. Even after new drug approval, a lengthy period remains before patients really gain reimbursement.At the same time, global R&D trends have driven the rise of antibody-drug conjugates (ADCs), bispecific antibodies, and biologics, many of which now hold multiple indications. Some immuno-oncology drugs have more than 20 approved indications.In response, the government has proposed reforms aimed at improving access to new drugs. These include an indication-based pricing, strengthening value-based drug reimbursement, and shortening the reimbursement listing period for rare diseases. In particular, the reimbursement listing period for rare disease therapies is expected to be reduced from an average of 240 days to within 100 days.Jung assessed, “With the proportion of high-cost new drugs rapidly increasing, it is difficult to guarantee patient access solely with limited national health insurance funds. As more drugs secure multiple indications, an indication-based pricing system is in line with global standards”He added, "The current system focuses on increasing reimbursement rates within the existing framework; it remains finance-centered from a patient access perspective. Although the government’s approach is understandable given budget constraints, the system must be operated with the patients in mind.”“Reform will create synergy, not suppress R&D”Jaeho Jung, Head of Value and Access at Novartis KoreaHe also expressed the view that the drug pricing reform could improve the domestic investment environment.Korean pharmaceutical companies, whose portfolios are largely centered on generics, have repeatedly voiced concerns that the proposed drug pricing reform could significantly stifle R&D.However, Jung emphasized the potential advantage that improved access to new drugs could expand investment by global pharmaceutical companies.He explained that currently, only two global pharmaceutical companies have production facilities in Korea, and attracting global-level R&D centers remains challenging.Jung stated, “Even when reviewing potential sites for our flagship one-shot treatment Kymriah, we received feedback that Korea was not suitable. If the system becomes more predictable and the value of R&D is properly recognized, direct investment and partnerships with Korean companies will expand.”He added, “If drug pricing improves in terms of value recognition and patient access, direct investment by global pharmaceutical companies will increase, as well as partnerships with Korean companies.”“Looking at Boston or New Jersey, which have rapidly emerged as global bioclusters, their R&D centers are well-established. This is because they are clustered together in terms of the collaborative R&D value. Looking at the domestic R&D environment, it feels like everyone is working hard, but individually. If the drug pricing reform system is well-established, I believe synergies will grow further, including joint R&D centers between global and domestic companies.”Furthermore, Jung pointed out that discussions on reimbursing high-value new drugs like ADCs and one-shot gene therapies have repeatedly faced difficulties within the existing framework. “The reform plan has a high potential to contribute to improving patient access, aligning with future global R&D trends.”Jung stated, “Operational execution is as crucial as the system's design. I hope a patient-centered system can take root through continuous dialogue between the government and industry.”
- Company
- Medtronic Korea launches new spine portfolio, Kanghui
- by Hwang, byoung woo Jan 22, 2026 08:22am
- 메드트로닉 신규 척추 포트폴리오 강휘Medtronic Korea (CEO Seung-rok Yoo) announced on the 21st that it has launched a new spine portfolio, “Kanghui,” aimed at expanding access to spine solutions.Kanghui is a new brand designed to deliver Medtronic’s accumulated technological expertise and quality management capabilities built across a broad range from the cervical spine to the lumbar spine at more affordable price points.With the introduction of Kanghui, Medtronic has established a comprehensive spine portfolio in Korea, ranging from standard models to premium models.The first product introduced within the Kanghui portfolio is the ‘ECO MIS’ system, an interbody fixation device.It consists of screws and rods in various shapes and lengths, along with fixation set screws, to provide patients with the appropriate size, shape, and design.It is used for minimally invasive surgery to stabilize and fixate the posterior thoracic, lumbar, or sacral spine in patients with unstable spinal fractures, spinal deformities (such as scoliosis), degenerative spinal disorders, spinal stenosis, degenerative disc disease (such as disc herniation), and segmental instability.Seung-rok Yoo, CEO of Medtronic Korea, said, “The introduction of Kanghui is part of a customized portfolio strategy reflecting the growing number of spinal disease patients in Korea and the expansion of specialized spine hospitals. Medtronic will continue to optimize and expand its portfolio to strengthen its competitiveness in the domestic spine market, while also contributing to the advancement of surgical techniques and the creation of a better treatment environment through partnerships with Korean medical professionals.”Meanwhile, the number of spinal disease patients in Korea increased by 9.1% over five years, from 8,912,158 in 2020 to 9,723,544 in 2024. The number of spinal surgery patients increased by 16.7% during the same period.Medtronic is a market leader with a total spine solution portfolio covering spinal disorders across the entire spine, from the cervical to the lumbar region.Through its extensive portfolio, which includes spinal fixation devices (Solera, Infinity, Zevo), minimally invasive spinal fixation systems (Sextant II, Longitude II), interbody fusion devices (Capstone, Clydesdale), and artificial discs (Prestige LP), it provides diverse minimally invasive treatment options.In addition, Medtronic integrates advanced technologies such as surgical navigation systems, contributing to improved surgical precision and enhanced patient safety.
- Company
- Drug price cuts without support disturb pharma independence
- by Hwang, byoung woo Jan 22, 2026 08:22am
- The Korean pharmaceutical industry has voiced strong concerns regarding the government's proposed drug price reform plan.Dailypharm 55th New Year Special Future ForumIt is a warning that repeated drug price cuts are depleting the foundational R&D strength of the domestic pharmaceutical industry and could ultimately lead to a health security crisis, such as the discontinuation of essential medicine supplies.On the 21st, DailyPharm hosted its 55th New Year Special Future Forum at the main auditorium of the The Catholic University of Korea Institute of Biomedical Industry under the title, "Our Attitude in Facing the Era of Great Transformation in Drug Pricing," to collect frontline opinions.The forum was attended by key figures including Yeon-sook Kim, Head of the Division of Pharmaceutical Benefits at the Ministry of Health and Welfare (MOHW); Jun-seop Park, Board of Director at Jeil Pharmaceutical; Jaeho Jung, Head of Department at Novartis Korea; and members of the Healthcare Team from the law firm Lee & Ko. They shared various views on the contents, analysis, and response strategies related to the drug price reform plan."KRW 63T in Cumulative Price Cuts… Unpredictability is the Greatest Risk"Jun-seop Park, Board of Director at Jeil Pharmaceutical, who delivered a presentation representing the domestic pharmaceutical industry, emphasized that repeated drug price reduction policies are forcing the industry to face a crisis of an unpredictable investment environment.According to Park, starting with the introduction of the actual transaction price reimbursement system in 1999, followed by the 2012 blanket price cuts and the 2020 differential requirement system, continuous reductions through 2023 are estimated to have resulted in a cumulative decrease of approximately KRW 63 trillion.The industry's greatest concern regarding these continuous cuts is 'uncertainty.'Park said, "This unpredictable policy environment makes it virtually impossible for pharmaceutical companies to establish long-term survival strategies."However, it was also emphasized that despite the repeated price-cutting environment, the domestic pharmaceutical industry has continued to build achievements in new and incrementally modified drugs (IMDs).Jun-seop Park, Board of Director at Jeil PharmaceuticalAccording to growth indicators for 2024 compared to 2000 presented by Director Park: ▲ Industry scale: KRW 7.9 trillion → KRW 29.8 trillion (277% growth); ▲ Number of employees: 55,000 → 120,000 (118% growth).In particular, R&D investment surged 18-fold (1727%) from KRW 0.197 trillion to KRW 3.6 trillion. Since the launch of the first domestically developed new drug in 1999, the industry has produced 41 new drugs and 142 IMDs, establishing advanced clinical and quality systems.However, Park warned that this virtuous cycle of growth is coming to a halt.As the basis, he cited the "essential medicine supply discontinuation" crisis. According to data from the Ministry of Food and Drug Safety (MFDS), the number of reported cases of drug supply discontinuation and shortages has nearly tripled over the five years since 2020."While prices have risen by 20%, the standards for low-priced medicines have been frozen for over 10 years, threatening the sustainability of manufacturing basic medicines," Park said. "In Europe, unsustainable pricing policies are also acting as one of the primary causes of drug shortages."The issue of equity in government support was also brought to the fore. While the government's R&D investment ratio for all industries stands at 21–24%, the ratio for the pharmaceutical industry was a mere 5.5% as of 2023."While companies cover 94.2% of pharmaceutical R&D with their own profits, slashing the profitability of generics and IMDs, which form that financial base, is like cutting off a runner's supply line during a marathon for new drug development," Park compared."Instead of short-term indicators like the R&D investment ratio of the past three years, we must comprehensively evaluate cumulative investment amounts, continuity, and substantial outcomes," Park suggested. "It is time to consider drug price preferences through the designation of 'Research-Oriented Pharmaceutical Companies' for those who continue substantial investment, in addition to the existing 'Innovative Pharmaceutical Companies' certification."Park urged, "What the pharmaceutical industry needs right now is not drug price cuts, but the breathing room and support to prepare for the next 10 years. Instead of securing finances by cutting drug prices, we need policies that strengthen self-sustainability, allowing the industry to create jobs and reinvest in global competitiveness through appropriate drug pricing.""Cutting Generic Prices to Approximately 40%, Legal Rationality in Question"Following this, Attorney Jin-hwan Jeong from the law firm Lee & Ko presented a legal and industrial analysis of the drug price reform plan announced by the MOHW last November.Member of the Healthcare Team from the law firm Lee & KoHe also questioned the government's plan for drug price cuts related to the generic drug price estimation criteria."The government cites cases from Japan and France, but it is worth considering whether a horizontal comparison is possible given the industrial structures and the proportion of global new drugs in those countries," Jeong said. "We need to examine whether there is rationality in how a cut to the 40% range contributes to stimulating new drug development by domestic pharmaceutical firms."Furthermore, he raised questions regarding the 'differentiation of the price addition system,' a core part of the reform. The government's plan grants high price additions only to the top 30% of Innovative Pharmaceutical Companies in terms of R&D ratios."It is difficult to see a substantial difference in R&D capabilities between a company at the 30th percentile and one at the 31st, and a structure where rankings change every year based on sales fluctuations hinders corporate predictability," Jeong said. "Evaluating companies primarily by ratios without considering comprehensive indicators, such as cumulative R&D investment or technology transfer achievements, may be irrational."Jeong added, "There may be grounds for claims regarding the deviation or abuse of discretionary power under the Administrative Litigation Act. The collapse of an industry happens in an instant, but its revival takes a long time. We need a detailed institutional design where welfare and industry can coexist."Predictability over Speed… Issues of Scope and Timing for Listed DrugsIn the subsequent Q&A session, questions focused on the 'speed' and 'predictability' of the policy.Attendees expressed concern that, as the reform is being pushed forward rapidly, a 'big picture timeline' for when and to what extent the system will be applied must be presented first so companies can prepare.There were also questions reflecting anxiety about the uncertainty of policy implementation, specifically about which of the currently listed medicines will be subject to price cuts and when.(from left) Yeon-sook Kim, Head of the Division of Pharmaceutical Benefits at the Ministry of Health and Welfare (MOHW), ; Jaeho Jung, Head of Department at Novartis Korea, Jun-seop Park, Board of Director at Jeil PharmaceuticalThe standard view among the domestic pharmaceutical industry was that, since each company had already established mid- to long-term business plans, an accelerated implementation date could destabilize management, employment, and decisions on development and investment.In response, Yeon-sook Kim, Head of the Division of Pharmaceutical Benefits at the MOHW, expressed a commitment to setting specific targets as soon as possible to increase industry predictability."The government also fully recognizes that policy predictability is important," Director Kim explained. "We will quickly finalize and announce the targets for listed drug adjustments, and we are reviewing measures for a soft landing, considering the impact on the industry."Kim emphasized that rather than a unilateral speed race, the government would ensure detailed adjustments through communication with the industry, stating, "We will not focus simply on cutting prices, but will sufficiently examine areas for supplementation by taking the voices of the industrial field into account."In conclusion, Kim added, "We are considering a phased implementation, starting with a primary review of medicines listed before 2012. We plan to finalize the specific targets and scope through technical verification and close communication with associations to avoid confusion."
- Company
- Major hurdles still remain for Entresto generics
- by Kim, Jin-Gu Jan 21, 2026 09:07am
- Patent risks surrounding Novartis’ heart failure drug Entresto (sacubitril/valsartan) have effectively been resolved with the recent Supreme Court ruling. Although patent disputes concluded in favor of generic companies and the patent barriers have now been lifted, the launch of generic versions remains far from straightforward.Now firmly established as a blockbuster with annual prescriptions of nearly KRW 80 billion, Entresto presents a structural challenge in which generic manufacturers have successfully defeated the patents but are still unable to enter the market due to approval delays.Entresto’s repeated surge in prescription sales drives the generic companies’ patent challengesAccording to the pharmaceutical market research firm UBIST on the 20th, Entresto recorded KRW 79.4 billion in outpatient prescriptions last year.Entresto rapidly expanded its prescription sales since its launch in 2018. After recording KRW 6.3 billion in prescription sales in its first year (2018), it surged to KRW 15 billion in 2019 and KRW 22.4 billion in 2020.This rapid expansion of its presence in the heart failure treatment market led to patent challenges from generic companies. Starting with Elyson Pharm in January 2021, over 20 companies filed comprehensive patent invalidation lawsuits against Entresto's five patents.Novartis ‘Entresto’ annual prescription sales (Unit: KRW billion, Source: UBIST)The generics companies' judgment ultimately proved correct. Over the past five years of patent disputes (2021-2025), Entresto's prescription sales surged 2.5-fold in just four years, from KRW 32.4 billion in 2021 to KRW 79.4 billion last year.Not a simple combination drug but a ‘co-crystal complex’... Generic approvals remain at ‘0’Despite the favorable court ruling, generic launches are unlikely anytime soon. The regulatory approval for generic products is holding things back.To date, there have been zero approvals for Entresto generics. More than 10 patent challengers filed marketing authorization applications between April 2022 and July 2023, based on their first-instance patent victories.However, nearly three years later, there is still no news of Entresto's generic product approvals. Considering that generic product approvals typically take about a year and a half after application, this is considered unusual.According to industry sources, the Ministry of Food and Drug Safety (MFDS) has requested multiple rounds of supplementary data. The root cause lies in Entresto’s unique solid-state structure. The pharmaceutical industry points to Entresto's unique crystalline structure as the reason behind these supplementary requests. Entresto works by having its two components, sacubitril and valsartan, act on cardiac neurohormones via separate pathways. What is unique is that these two components form a single crystalline structure in a ‘co-crystal’ form.Most fixed-dose combinations consist of two separate crystalline APIs physically blended together. In contrast, a cocrystal involves two or more components bonded at the molecular level like a single compound, exhibiting properties similar to a single compound, right up until absorption in the body. For this reason, the industry describes Entresto not as a simple ‘combination drug’ but as a molecular ‘complex’ with its own distinct characteristics.The problem is that there are almost no precedents for approving drugs in this co-crystal form. Entresto is known to be the only drug approved as an API-API co-crystal complex, not only in Korea but also in the US and Europe. There are also no known cases worldwide of generic approval for co-crystal complex drugs. This is where the MFDS's dilemma begins. It is reported that they are struggling to find an appropriate analytical method for generic approval. The differing physicochemical properties of co-crystal structures compared to conventional compounds are cited as a burden in the approval review process, making it difficult to apply existing analytical methods directly.Approval Variables remain despite supreme court bictory... early launch may be delayedEntresto has five patents listed in Korea’s patent registry. Following the Supreme Court’s rulings, all five patent barriers have effectively been removed. From a patent perspective, generic manufacturers are now free to launch their products once marketing authorization is granted.However, regulatory approval has emerged as a new bottleneck. Despite the elimination of patent risk, prolonged MFDS review has made it difficult for generic firms to predict their market entry timelines.The pharmaceutical industry interprets this as Entresto's structural uniqueness, creating a new barrier at the approval stage. This means that even with a blockbuster market worth KRW 80 billion annually within reach, a regulatory hurdle separate from the patent dispute remains. Ultimately, the timing of generic approval and actual launch will depend on the regulatory authority's judgment and review direction.
- Company
- "Pharma consignment business faces difficult times"
- by Chon, Seung-Hyun Jan 21, 2026 09:07am
- The survival of consignment production businesses for pharmaceutical companies is threatened. As joint development regulations and the tiered drug pricing system block the entry of late-comer generics, contract manufacturers are struggling to maintain their operations. Concerns are growing that the market will freeze further as the new drug price reform lowers the criteria for generic price calculation and strengthens the tiered pricing system. An increasing sense of poor treatment is being expressed as the government expands support for the biopharmaceutical Contract Development and Manufacturing Organization (CDMO) sector while neglecting synthetic drug consignment.ChatGPT-generated imageAccording to industry sources on the 19th, Korea's domestic pharmaceutical companies are facing concern that the upcoming drug price reform could determine the survival of their consignment businesses. In the reformed system scheduled for implementation this July, the price calculation criteria for generics will drop from 53.55% of the original drug's price before patent expiration to about 40%. The final figure is expected to fall between 40% and 45%. If the maximum generic price drops to 40%, a 25% decrease in profit is expected.A decrease in the generic price criteria inevitably leads to a downturn in the consignment business. Contract manufacturers typically set their supply prices at a certain percentage of the product's insured drug price.For example, if a product is priced at KRW 1,000, the supply price is set around KRW 300–500. Consequently, lower generic insurance prices result in lower supply prices for contract manufacturers. The more unfavorable the cost structure, the higher the supply price becomes.If the insurance price of a generic supplied by a contract manufacturer drops, the consigning company is forced to demand a lower supply price due to its own falling profitability. However, pharmaceutical companies argue they have limited capacity for such cuts due to continuous prior price reductions.Recently, as regulations on authorization and pricing have tightened, more companies are reportedly considering scaling back or abolishing their consignment operations.The tiered drug pricing system, implemented during the 2020 reform, has blocked latecomer generics.Under the tiered drug pricing system, the upper price limit decreases each month as a generic enters the market later. Reintroduced in 2020 after being abolished in 2012, it mandates a 15% price reduction for any generic entering a market with over 20 identical listed products. This makes it difficult for latecomers to enter the market at such low prices. Contract manufacturers, in turn, struggle to expand as they cannot recruit additional consigning companies for their current products.Before the tiered drug pricing system was implemented, the first 20 companies to enter a market would quickly reach their full quota, leaving latecomers without any incentive to join.Additionally, joint development regulations acted as a catalyst for the scale down. Since the revised Pharmaceutical Affairs Act took effect in July 2021, the so-called '1+3' regulation has limited the number of incrementally modified drugs (IMDs) and generics that can be authorized using a single clinical trial.If a product is manufactured at the same site using the same formula and process as the drug used in the bioequivalence study, the bioequivalence data may be used only 3 times. This means only four generics (one original and three others) can be authorized per study. The same '1+3' rule applies to clinical trial data.These regulations also apply to generics already authorized and on sale. After the regulation took effect, only up to three additional consigning products can be added. For instance, a contract manufacturer that previously produced 10 generics can add only 3 more, for a total of 13. Since contract manufacturers can only recruit new clients if an existing one leaves, expanding business regardless of production capacity has become nearly impossible.A consignment manager at a pharmaceutical company commented, "In the past, the government actively encouraged consignment, expecting that specialized mass production would improve quality control," adding, "If they treat the consignment business as the cause of the proliferation of generics and pursue only restrictive policies, we will have no choice but to consider job cuts due to business scaling down or withdrawal."Tiered drug pricing system (different pricing based on the order of listing)The strengthening of the tiered drug pricing system in the upcoming reform is also cited as a factor that will aggravate these difficulties.The Ministry of Health and Welfare (MOHW) has proposed a plan to reduce the price by 5 percent (p) for each subsequent item listed, starting with the 11th product of the same formulation. Because the stepped system will trigger at the 11th product instead of the 21st, the system for additional price cuts will activate much faster across the generic market. Analysis suggests that changing the reduction standard from a flat 15% to a 5%p decrease will disadvantage latecomers in terms of drug pricing cuts.For example, under the current system, if the maximum generic price is KRW 53.55, the 21st generic cannot exceed KRW 45.52 (a 15% drop). The 22nd and 23rd generics fall to KRW 38.69 and KRW 32.89, respectively. The 24th is KRW 27.95, and the 25th is KRW 23.76. The reduction amount decreases as more products enter.Under the reformed system, if the maximum price is 40 KRW, the 11th and 12th generics would drop to KRW 35 and KRW 30 due to the 5%p reduction (representing cuts of 12.5% and 14.3%, respectively). The 13th generic would drop another 5%p to KRW 25, a 16.7% cut. Even at the third step, the rate of reduction is already higher than under the current system.As the 14th and 15th generics drop to KRW 20 and KRW 15, the reduction rates accelerate exponentially to 20% and 25%. Even after only five steps, the price cap falls to about 15% of the original drug's pre-patent price, effectively abolishing the incentive for any further entries and blocking the expansion of consignment businesses.The government's recent active support for the biopharmaceutical CDMO industry further increases the sense of poor treatment among those in the synthetic drug consignment.On December 30 last year, the "Special Act on Regulatory Support for Biopharmaceutical Contract Development and Manufacturing Organizations" was announced. The core of this law includes establishing a registration system for biopharmaceutical export manufacturing, which was not defined in the Pharmaceutical Affairs Act, setting facility standards for export-specialized sites, and institutionalizing GMP certification and raw material certification for CDMO sites.The Ministry of Food and Drug Safety (MFDS) plans to prepare detailed criteria for customized regulatory support, including simplifying import procedures for raw materials used by CDMOs, providing prior GMP consultations, and offering technical advice on manufacturing facilities.An industry official stated, "Previously, there was a strong perception that the consignment business contributed to improving production capacity and creating new revenue streams, but business scaling down has become inevitable due to continuous regulations and price cuts," adding, "It is currently impossible to predict future profit changes, making even this year's business plans unclear."
- Company
- Paxlovid’s prescription market uniquely volatile
- by Chon, Seung-Hyun Jan 21, 2026 09:07am
- The COVID-19 treatment ‘Paxlovid’ recorded approximately KRW 80 billion in outpatient prescriptions last year. With the 2024 National Health Insurance reimbursement decided, it caused a storm in the prescription market. Despite its high price, nearing KRW 1 million per course, it achieved massive prescription volumes. Driven by fluctuations in COVID-19 patient numbers, Paxlovid showed an unusual prescription pattern, with monthly sales differing by as much as 50-fold.According to the pharmaceutical market research firm UBIST on the 20th, Paxlovid generated KRW 79.4 billion in outpatient prescription sales last year.Paxlovid is an oral antiviral that suppresses replication of the COVID-19 virus and is primarily prescribed to high-risk patients at risk of progression to severe disease. In the early phase of its introduction in Korea, the government directly procured and distributed the drug free of charge. However, in June last year, the government halted new supply purchases, transitioning Paxlovid to routine prescribing in medical institutions. Starting October 2024, Paxlovid formally entered the prescription market after its National Health Insurance coverage was finalized. The reimbursement ceiling price was set at KRW 941,940 per course, with a patient co-insurance of 5%.Monthly Paxlovid Outpatient Prescription Amount (Unit: million won, Source: UBIST)Paxlovid made its full-scale market debut in Q4 of last year with KRW 4.1 billion in prescriptions. In Q2 this year, prescriptions exceeded KRW 10 billion, reaching KRW 11.4 billion. In Q3, sales surged more than fourfold quarter-on-quarter, reaching KRW 47.7 billion. At that time, total influenza drug prescriptions accounted for only 0.4% of Paxlovid’s volume.Paxlovid showed fluctuating quarterly prescription sales last year. Sales rose 40% from KRW 8.2 billion in Q1 to KRW 11.4 billion in Q2, then soared to KRW 47.7 billion in Q3. However, Q4 sales plummeted to KRW 12.1 billion, just 25% of the previous quarter's level.The high cost of Paxlovid, coupled with the rapidly fluctuating number of COVID-19 patients, led to significant fluctuations in prescription performance.In the first half of last year, weekly COVID-19 hospitalizations remained relatively stable at around 100 patients per week. The peak was recorded in Week 13 (March 24–30) with 178 admissions, compared with a low of 56 patients in Week 5 (January 27–February 2).Weekly COVID-19 Hospitalization in 2025 (Unit: Persons, Source: Korea Disease Control and Prevention Agency)COVID-19 hospitalization counts are tallied based on patient numbers reported by 221 hospitals and higher-level medical institutions participating in the Acute Respiratory Infection Surveillance Program.Hospitalizations began rising sharply in Week 31 (July 28–August 3) with 220 patients, and peaked in Week 37 (September 8–14) at 459 patients, triggering concerns of another major outbreak. However, from October onward, case numbers declined steadily, returning to first-half levels by November and December.Monthly prescription data clearly reflects this trend. Paxlovid prescriptions rose from KRW 5.5 billion in July to KRW 17.4 billion in August, surpassing KRW 10 billion for the first time. In September, when COVID-19 hospitalizations peaked, monthly prescriptions reached KRW 24.9 billion, the highest among all pharmaceutical products. As hospitalizations declined, prescriptions dropped sharply to KRW 8.1 billion in October, followed by KRW 2.9 billion in November and just KRW 1.2 billion in December.
- Company
- Alteogen licenses out new drug tech to GSK subsidiary
- by Cha, Ji-Hyun Jan 21, 2026 09:07am
- Alteogen has signed a technology out-licensing agreement with a subsidiary of global big pharma, GlaxoSmithKline (GSK), based on its Hybrozyme platform.According to the Financial Supervisory Service on the 20th, Alteogen signed an exclusive license agreement with GSK subsidiary Tesaro for the development and commercialization of a subcutaneous (SC) formulation of the PD-1 immuno-oncology drug ‘Dostalimab’ utilizing the liver hyaluronidase-based SC formulation modification platform ‘ALT-B4’.Under the agreement, Tesaro obtains exclusive rights to develop and commercialize a subcutaneous formulation of dostarlimab using Alteogen’s Hybrozyme technology. Alteogen will be responsible for supplying ALT-B4 for both clinical and commercial products.The total contract value is up to USD 285 million (approximately KRW 421 billion). The deal includes a non-refundable upfront payment of USD 20 million (approximately KRW 29.5 billion) and development, regulatory, and sales-based milestone payments of up to USD 265 million (approximately KRW 391.4 billion). Alteogen will also receive additional royalties linked to product sales upon commercialization.Alteogen's ALT-B4 hydrolyzes hyaluronic acid in the subcutaneous tissue, enabling the conversion of intravenous (IV) formulations into SC formulations. Unlike IV formulations, which require patients to receive injections at the hospital for 4-5 hours, the SC formulation allows patients to self-administer the injection at home in less than 5 minutes.Alteogen's Hybrozyme platform has proven its competitiveness through multiple licensing agreements with global pharmaceutical companies, including MSD, GSK, AstraZeneca, Daiichi Sankyo, Sandoz, and Intas. Notably, MSD developed a subcutaneous formulation of Keytruda using ALT-B4, which received approval in the US and Europe last year and has since been launched commercially.
- Company
- High expectations for new 'hair-loss' drugs
- by Choi Da Eun Jan 20, 2026 07:55am
- The technological competition within the pharmaceutical industry surrounding the hair loss treatment market is intensifying. Next-generation technologies that directly target hair follicle stem cell activation and immune·signaling pathways are emerging, overcoming the limitations of conventional treatments focused on male hormone suppression or vasodilation.According to industry sources, pharmaceutical and biotech companies are strengthening efforts to develop mid- to long-term growth strategies based on their hair loss treatment pipelines. In particular, as President Lee Jae Myung mentioned the need to support the costs of hair loss treatment and hinted at the possibility of National Health Insurance coverage, expectations for the development of new treatments are increasing across the pharmaceutical and biotech markets.Hair-loss treatments being developed by domestic pharmaceutical companies in Korea. JW Pharmaceutical's 'JW0061,' Hyundai Pharm's 'clascoterone' 5% solution, Chong Kun Dang's 'CKD-843,' Daewoong Pharmaceutical's 'IVL3001,' OliX Pharmaceuticals' 'OLX104C.'Among these are companies developing new hair loss drugs, including Hyundai Pharm and JW Pharmaceutical.Hyundai Pharm announced this month that its partner, an Italian pharmaceutical company, proved the meaningful efficacy of 'clascoterone' 5% solution for the treatment of male androgenetic alopecia in a Phase 3 clinical trial. Cosmo Pharmaceuticals had previously developed 'Winlevi Cream,' a 1% clascoterone cream for acne, through its subsidiary Cassiopea.JW Pharmaceutical is preparing to enter the market with 'JW0061,' a new drug candidate targeting the GFRA1 receptor. JW0061 is a topical candidate that promotes hair follicle generation and hair growth by directly activating GFRA1, a receptor expressed in hair follicle stem cells. Following U.S. patent registration, preclinical studies confirmed superior efficacy in hair follicle generation and hair growth compared to existing standard treatments.Based on these results, JW Pharmaceutical is preparing to enter Phase 1 clinical trials. Expectations are high as it is being developed as a treatment option applicable to both men and women.Chong Kun Dang and Daewoong Pharmaceutical are leading the development of incrementally modified drugs (IMDs) for hair loss.Chong Kun Dang is developing 'CKD-843,' an IMD that converts existing oral dutasteride medicine into a long-acting injectable administered once every 3 months. It is currently in Phase 3 clinical trials, with research aimed at reducing the medication burden and minimizing systemic side effects.Daewoong Pharmaceutical and Inventage Lab are also developing an IMD of 'IVL3001,' a hair-loss treatment candidate being co-developed by these companies. They have modified oral finasteride into a long-acting injectable administered once a month (up to every 3 months). They recently submitted a Global Phase 2 clinical trial plan to enter Phase 3.Cell- and regeneration-based approaches, primarily led by biotech ventures, are also active. Technologies that improve the hair follicle environment using stem cell-derived substances have drawn attention, with promising results at the research stage.FromBIO announced this month that it completed toxicity tests reflecting the administration route and dosage for its hair loss treatment candidate using adipose-derived stem cells, confirming no significant toxic effects. Based on this, Frombio aims to enter clinical trials by the first quarter of 2027.OliX Pharmaceuticals completed the first patient administration in a Phase 1b/2a clinical trial for its hair loss candidate 'OLX104C.' The company plans to accelerate development to finish Phase 1b this year and Phase 2a by next year. OLX104C works by reducing the expression of the androgen receptor, a key cause of androgenetic alopecia, thereby blocking the hormonal response that triggers hair loss.Additionally, ROKIT Healthcare has applied for the world's first 'Natural Substance PBM Epigenetics' patent for a reverse-aging technology that confirmed full hair regrowth within four weeks of administration and will officially start human clinical trials in March. Beyond simple symptom improvement, it contains epigenetic reverse-aging technology that returns the microenvironment of aged hair follicles to a youthful state.The global hair loss treatment market continues to grow due to aging populations, increased stress, and rising demand for beauty and wellness. Expectations are growing that these treatments will expand beyond the beauty sector into the chronic disease management market. Currently, minoxidil and finasteride-based treatments dominate the commercial market. They have been noted for structural limitations, such as side-effect concerns with long-term use and limited efficacy.However, the hurdles for hair loss research are high. Due to the nature of the treatment, which requires long-term administration, rigorous safety verification is needed, and proving actual hair growth through objective indicators is also difficult. Furthermore, securing price competitiveness and whether health insurance will be applied are considered key variables for market settlement.An industry official stated, "Since hair loss treatments require long-term administration, there is still a large unmet need for new drugs that improve upon the side effects seen in existing male hormone suppression or vasodilation mechanisms," adding, "If a treatment with an innovative mechanism appears, its market impact could be significant."And added, "However, medicines with next-generation mechanisms have a greater burden of proving hair growth with objective indicators as well as verifying long-term safety."
