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- 2026-03-10 00:57:08
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- 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."
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- 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.
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- "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."
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- 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.
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- 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.
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- 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."
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- Once-monthly Elrexfio sets new standard for multiple myeloma
- by Son, Hyung Min Jan 20, 2026 07:55am
- Elrexfio, a treatment for relapsed or refractory multiple myeloma (RRMM), is emerging as a new option in the hematologic cancer landscape where long-term treatment is inevitable, by extending its dosing interval. This measure is evaluated as a strategic move that simultaneously considers treatment continuity and patient convenience for those who have maintained a response for a certain period.Pfizer’s ElrexfioAccording to industry sources on the 15th, Pfizer’s RRMM treatment 'Elrexfio (elranatamab)' recently extended its dosing interval from once every two weeks to once every four weeks.The Ministry of Food and Drug Safety revised the product label last October to permit once-every-four-weeks dosing, only for patients who achieved a response after at least 24 weeks of treatment and subsequently maintained that response with dosing at 2-week intervals for 24 weeks or longer.This change is significant not merely as a schedule adjustment but because it provides a sustainable treatment environment for multiple myeloma patients requiring long-term care. With the extended interval, patients can reduce their hospital visits by half, easing the physical and psychological burden accumulated during long-term treatment.Multiple myeloma is a representative hematologic cancer characterized by the abnormal proliferation of plasma cells in the bone marrow. Due to its inherent nature of recurrent relapse and resistance, long-term management is considered the cornerstone of treatment. In Korea, the number of patients is steadily increasing due to an aging population and advancements in diagnostic technology, with approximately 2,000 new cases reported annually as of 2022. Its age of onset is concentrated in the elderly population aged 60 and above, posing significant challenges for treatment continuity.While the treatment landscape for multiple myeloma has rapidly advanced with the introduction of various options such as proteasome inhibitors (PI), immunomodulatory drugs (IMiD), and anti-CD38 monoclonal antibodies, a significant limitation remains as a substantial number of patients eventually develop resistance to existing therapies or experience relapse. This has heightened the demand for new treatment strategies that can overcome drug resistance while maintaining long-term response.Elrexfio subcutaneous injection formulation offers a short administration time and greater convenience for both healthcare providers and patients compared to intravenous injections. This approval for once-every-four-weeks dosing maximizes these formulation advantages and represents an opportunity to strengthen the paradigm of patient-centered care.As a BCMA-targeted bispecific antibody, Elrexfio features a mechanism where one antibody simultaneously recognizes CD3 on T-cells and BCMA on tumor cells. By directly linking these two cells, it induces T-cells to selectively attack cancer cells. The formation of this immune synapse triggers T-cell activation and cytotoxic responses, promoting tumor cell death.Contrary to chimeric antigen receptor T-cell (CAR-T) therapies that require complex cell collection and manufacturing processes, Elrexfio can be administered immediately via subcutaneous injection and stably expresses both target specificity and immune activation. It is administered at a fixed dose regardless of body weight, and a stepwise dose escalation and pre-treatment protocol is applied to minimize the risk of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity (ICANS).Clinical evidence also supported the extended dosing interval. Long-term follow-up results from the global Phase II MagnetisMM-3 study showed an objective response rate (ORR) of 61.0% and a complete response (CR) or better rate of 37.4% in 123 patients with relapsed or refractory multiple myeloma who had failed triple therapy. The median progression-free survival (PFS) was 17.2 months, and the median overall survival (OS) was 24.6 months.Consistent efficacy was also confirmed in real-world data. The COTA study, which compared the MagnetisMM-3 clinical results to the real-world setting, found that the Elrexfio group showed a 43% lower risk of progression-free survival and a 47% reduction in the risk of death compared to the physician's choice of therapy. The most commonly used physician's choice of therapy in COTA was DPd (daratumumab-pomalidomide-dexamethasone), KPd (carfilzomib-pomalidomide-dexamethasone), and Kd-cyclophosphamide.A matched cohort analysis using the US Flatiron Health (FH) database also showed a 59% reduction in the risk of progression-free survival and a 40% reduction in the risk of death. The most frequently used treatment regimens in the FH cohort were Kd (carfilzomib-dexamethasone), DPd, and EPd (elotuzumab-pomalidomide-dexamethasone).Based on this clinical and real-world evidence, the U.S. Food and Drug Administration (FDA) and the Ministry of Food and Drug Safety (MFDS) officially approved Elrexfio’s once-every-four-weeks dosing regimen. As the focus of multiple myeloma treatment shifts from short-term response to how long and stable treatment can be sustained, Elrexfio’s dosing strategy could likely become a major turning point.Professor Ki-hyun Kim of the Hematology-Oncology Department at Samsung Medical Center stated, "Elrexfio’s bispecific antibody platform enhances both treatment accessibility and effectiveness by directly utilizing the patient’s T-cells without separate cell manipulation. This transition to once-monthly dosing is a meaningful step forward in alleviating the burden of long-term treatment and helping patients regain their daily lives."
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- Next-gen Alzheimer's drug Kisunla to enter Korean market this year
- by Eo, Yun-Ho Jan 20, 2026 07:54am
- Another new treatment option for Alzheimer’s disease, Kisunla (donanemab), is expected to be commercialized in Korea later this year.According to industry sources, Lilly Korea submitted a marketing authorization application to the Ministry of Food and Drug Safety (MFDS) late last year for ‘Kisunla (donanemab)’, a targeted antibody therapy that removes beta-amyloid (β-amyloid, Aβ) protein, which is known to be a major cause of Alzheimer's disease.Kisunla, which is drawing attention as a next-generation Alzheimer's treatment, was approved in the United States and Japan in 2024 and in Europe in 2025.Specifically, Kisunla is indicated for the treatment of early symptomatic Alzheimer's disease in adults with confirmed amyloid pathology who are either heterozygous for the apolipoprotein E ε4 (ApoE4) or non-carriers.The efficacy of Kisunla was demonstrated through clinical trials, including the double-blind, placebo-controlled TRAILBLAZER-ALZ study.In the trial, 1,736 patients with amyloid pathology and either mild cognitive impairment or mild dementia due to Alzheimer’s disease received Kisunla at a dose of 700 mg every four weeks for the first three doses, followed by 1,400 mg every four weeks for up to 72 weeks.At weeks 24, 52, and 76, patients were switched to placebo based on whether they achieved a pre-specified reduction in amyloid measured by positron emission tomography (PET).Analysis showed that patients treated with Kisunla demonstrated a statistically significant reduction in decline on the Integrated Alzheimer’s Disease Rating Scale (iADRS) at Week 76 compared with placebo. Statistically significant improvements were also observed on the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog13) and the Alzheimer’s Disease Cooperative Study–Instrumental Activities of Daily Living (ADCS-iADL).The prescribing information includes a warning for amyloid-related imaging abnormalities (ARIA). ARIA generally presents as temporary brain swelling that resolves over time and may be accompanied by small hemorrhagic spots within or on the surface of the brain.Although serious and life-threatening ARIA events were rare and most cases were asymptomatic, patients who are ApoE4 homozygotes showed higher rates of symptomatic and severe ARIA. Therefore, ApoE4 genotyping is required prior to initiating treatment.Meanwhile, Alzheimer's disease is a representative degenerative brain disorder, accounting for approximately 70% of dementia cases worldwide. Its core pathology is known to involve the abnormal accumulation of beta-amyloid protein clumps in the brain, causing neuronal damage that progressively worsens memory and cognitive function.
- Company
- 16 Korean pharma win first appeal against 'Rinvoq' crystal-form patent
- by Kim, Jin-Gu Jan 19, 2026 09:02am
- Product photo of 'Rinvoq (upadacitinib)'Generic companies won the first trial against the crystal-form patent for 'Rinvoq (upadacitinib),' AbbVie's oral autoimmune disease treatment.According to the pharmaceutical industry on the 16th, the Intellectual Property Trial and Appeal Board (IPTAB) recently issued a favorable ruling in a passive scope-of-confirmation trial filed by 16 companies, including Chong Kun Dang, against AbbVie's crystal-form patent for Rinvoq (10-2753815).Chong Kun Dang initially filed for the trial against the Rinvoq crystal-form patent in August last year. Following Chong Kun Dang, 15 other companies, including Daewoong Pharmaceutical, Alico Pharm, Genuone Sciences, Genupharma, GC Biopharma, Samjin Pharm, Sama Pharm, Kolon Pharma, Whan In Pharm, Ildong Pharmaceutical, Pharmbio Korea, LitePharmTech, Hanlim Pharm, Dong-A ST, and Huons, joined the dispute by filing identical trials.With this ruling, the patent-challenging companies have moved a step closer to securing exclusivity for the first Rinvoq generic entrant. To qualify for the exclusivity, three conditions must be met: ▲first to file for trial ▲first to win the trial or subsequent litigation ▲first to apply for marketing authorization. Among these, the companies have now satisfied the requirements of being the first to file and winning the trial.The patent-challenging companies plan to launch generics prematurely following the expiration of the substance patent in May 2032. Currently, two Rinvoq patents are registered: a substance patent expiring in May 2032 and a crystal-form patent expiring in October 2036. The generic companies have successfully circumvented the latter.Rinvoq is a JAK inhibitor used for autoimmune diseases such as rheumatoid arthritis and atopic dermatitis. Its mechanism of action involves inhibiting inflammatory cytokines to block inflammation, pain, and cell activation.According to UBIST, a pharmaceutical market research firm, Rinvoq's outpatient prescription sales reached KRW 36.2 billion last year. This represents a 39% increase over the past year, up from KRW 26.1 billion in 2024. After claiming the top rank in the JAK inhibitor market in the fourth quarter of 2023, Rinvoq has steadily expanded its market share.
- Company
- Entresto patent dispute comes to an end after 5yrs
- by Kim, Jin-Gu Jan 19, 2026 09:02am
- The long-running patent dispute over Novartis’ heart failure drug Entresto (sacubitril/valsartan) has effectively come to an end, with Korean generic manufacturers securing decisive victories at the Supreme Court.The Supreme Court ruled in favor of the generic companies in all three appeals related to Entresto: ▲ the polymorph patent ▲ the salt/hydrate patent ▲ and the use-of-product patent lawsuits.The assessment is that the domestic generic companies' consecutive victories in this dispute stemmed from a strategic approach that went beyond simple ‘patent invalidation or avoidance’ arguments, instead precisely identifying and countering the structural vulnerabilities of each individual patent.Entresto patent dispute concludes with generic companies' victory after over 5 yearsAccording to industry sources on the 16th, the Supreme Court on the 15th dismissed Novartis’ appeal in its scope confirmation lawsuit against 10 companies, including Elyson Pharmaceutical, concerning Entresto’s polymorph patent.On the same day, the Court also ruled in favor of generic companies in Novartis’ appeal against Hanmi Pharmaceutical regarding the Entresto salt and hydrate patent. The dispute over the validity of the salt and hydrate patents between Novartis and Daewoong Pharmaceutical/ Elyson Pharm is awaiting a ruling at the Patent Court (second instance).Earlier, in April 2024, the Supreme Court had already dismissed Novartis’ appeal in its use-patent lawsuit against 11 companies, thereby affirming the generics’ victory.This effectively concludes the nearly 5-year-long Entresto patent dispute, according to analysis. Although an appeal remains pending in the salt/hydrate patent dispute between Novartis and Daewoong Pharmaceutical/ Elyson Pharm, the prevailing view is that a similar ruling will be issued, given the Supreme Court's precedent on identical patent issues.The Entresto patent dispute intensified after 2021. Generic companies filed comprehensive patent invalidation petitions targeting Entresto's crystal form patent, salt/hydrate patents, two use patents, and two formulation patents. The generics won all cases at the first instance. After losing the first instance, Novartis selected three patents for appeal: ▲the polymorph (crystal form) patent, ▲the salt/hydrate patents, and ▲the use patent. Ultimately, these three appeals became the focal point of the litigation. For each issue, the patent challengers presented different arguments.Polymorph patent dispute: scope of rights for ‘broad claims’ without experimentationThe starting point and most critical battle in this dispute was the validity of the Entresto polymorph patent. The patent covered a specific crystalline form of the supramolecular complex formed by sacubitril and valsartan.The core issue was whether the patent satisfied the written description and enablement requirements. Under established precedent, polymorph inventions in chemistry are considered highly unpredictable and therefore require detailed experimental disclosure and reproducibility.While Novartis’ specification disclosed experimental data for a specific 2.5-hydrate supramolecular complex, it failed to provide manufacturing methods, reproducibility principles, or experimental support for other solid forms of the supramolecular complex included in the claims. The patent challengers focused on this aspect.The Supreme Court ultimately held that a patent asserting a broad claim scope without experimental support constitutes insufficient disclosure. The rulings of the Intellectual Property Trial and Appeal Board and the Patent Court were therefore upheld.Salt/Hydrate patent dispute: doctrine of equivalents infringementIn the salt/hydrate patent case, the key issue was whether the scope of rights was infringed, particularly whether the generics’ products infringed Novartis’ patent under the doctrine of equivalents.Novartis's patent was based on Entresto's 2.5-hydrate supramolecular complex. In contrast, the domestic pharmaceutical company's product possesses a trihydrate structure with a different number of water molecules. Novartis argued that since the two hydrates represent substantially equivalent technology, they constitute equivalent infringement.The generics countered that the difference was not a mere numerical change, but reflected a fundamentally different problem-solving principle for achieving supramolecular complex stability.The Supreme Court accepted this argument. It ruled that the technical core of Novartis’ invention lay in achieving a specific stoichiometric structure. A hydrate with a different number of water molecules could not be regarded as using the same technical solution.Use patent dispute: judgment of novelty in the heart failure treatment effectIn the Entresto use patent case, the issue was whether the patent possessed novelty. The key question was whether the heart failure treatment effect from the combination of sacubitril and valsartan could be evaluated as a new medical effect compared to prior art.The Patent Court ruled that, in light of existing pharmacological mechanisms and prior technologies, the claimed therapeutic effect could not be regarded as an unpredictable or novel medical outcome. The Supreme Court upheld this reasoning, dismissing Novartis’ appeal without a full hearing.Attorney Dong-joo Kwon of Yoon & Yang, who represented the client in this case, commented, “This Supreme Court ruling is significant not merely as a victory in an individual dispute, but because it provides clear guidance on the boundaries of written description requirements and on how far the doctrine of equivalents can be stretched, which is central to determining the scope of rights.”Kwon added, “Even a global pharmaceutical company’s robust patent portfolio cannot survive if it attempts to claim excessive scope without experimental backing or relies on overly broad doctrine of equivalents arguments that deviate from the technical essence.”“This case demonstrates that rational patent challenges by domestic pharmaceutical companies can strike a balance between market competition and patient access. This ruling will serve as an important precedent for future similar patent disputes.”
