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- 2026-03-10 00:45:10
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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."
- Company
- 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."
- Policy
- Generic development for low-strength Rosuzet to begin soon
- by Lee, Tak-Sun Jan 20, 2026 07:54am
- Hanmi's Rosuzet TabDevelopment of generic versions of Hanmi Pharmaceutical’s low-strength combination lipid-lowering drug Rosuzet has begun, as its re-examination period is set to end in September next year.The low-strength Rosuzet formulation, which combines rosuvastatin 2.5 mg and ezetimibe 10 mg, was approved in September 2021 and designated as a re-examination drug for six years.The Ministry of Food and Drug Safety (MFDS) approved Shinil Pharma’s bioequivalence study for its generic candidate SIL1124 on the 13th. The reference drug is Rosuzet 10/2.5 mg, and the study will be conducted in 60 healthy adult volunteers.This marks the start of generic development for Rosuzet 10/2.5 mg. The product was approved on September 24, 2021, and its re-examination period will end on September 23, 2027.Generic applications may be submitted only after the re-examination period expires. The initiation of the bioequivalence study is therefore viewed as part of preparations to meet the regulatory filing timeline. In addition to Shinil Pharma, more companies will likely begin bioequivalence studies in the near future.More than 50 pharmaceutical companies have already expressed interest in developing their generic versions.In addition to the re-evaluation exclusivity period, patents listed in the Green List (specifically, an oral combination tablet containing ezetimibe and rosuvastatin, scheduled to expire on November 29, 2036) are also one hurdle for generic developers.As a result, many generic companies have launched patent challenges. To date, a total of 56 patent avoidance (non-infringement confirmation) trials, including one filed by Shinil Pharma, are currently pending before the Intellectual Property Trial and Appeal Board.If the Patent Trial and Appeal Board rules in favor of the generic companies, this will resolve their patent issues. They could then launch generic versions by September next year, upon expiry of the re-examination period.Low-strength Rosuzet gained rapid popularity following its launch, as it reduces the risk of adverse events such as diabetes and myopathy associated with high-dose statin therapy, while offering superior efficacy compared to statin monotherapy. The product is reported to generate annual sales exceeding KRW 20 billion.Hanmi Pharmaceutical demonstrated Rosuzet’s efficacy and safety through a Phase III clinical trial involving 279 Korean patients. The study was published in the online edition of the international journal Clinical Therapeutics.Currently, 12 products containing the same active ingredients as low-strength Rosuzet have already been approved. However, these products are not generics that completed bioequivalence studies using Rosuzet 10/2.5 mg as the reference drug; instead, they were approved as data-submission products based on independent clinical trials. Their re-examination periods are also identical to those of Rosuzet 10/2.5 mg.As the recent trend in new drug development shifts toward anticancer agents and orphan drugs, new drugs for chronic diseases like hypertension, hyperlipidemia, and diabetes have become scarce. As a result, domestic generic companies that rely on physician-centered marketing of generic chronic disease drugs are facing growing limitations in business development.In this environment, the upcoming expiration of exclusivity for a blockbuster drug like low-strength Rosuzet is expected to draw strong interest from generic manufacturers. Accordingly, generic activity is expected to accelerate ahead of the re-examination expiry in July next year.
- Company
- 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.
- InterView
- "Lilly's values in caring and discovery: social contrib."
- by Son, Hyung Min Jan 19, 2026 09:02am
- "Lilly's core values have always been 'Caring' and 'Discovery'. GDOS demonstrates that these values are not merely slogans, but a platform where employees can personally practice them within the community and reaffirm the company's reason for existence."On September 25 last year, Eli Lilly Korea held a volunteer activity attended by all employees to celebrate the 'Global Day of Service (GDOS).' GDOS is a global volunteer program launched by Lilly in 2008, which has accumulated over 1.2 million volunteer hours across 65 countries to date. Eli Lilly Korea has participated since 2010, contributing more than 20,000 hours of service.The Global Day of Service is a day when organizations and individuals worldwide volunteer for local communities and global issues. Lilly operates this day annually as its own GDOS, effectively establishing it as "the volunteering day for Lilly employees worldwide."The theme for the 2025 Eli Lilly Korea GDOS was "A Better World Made Together," centered on two pillars: environmental improvement and support for underprivileged children. Approximately 250 employees were divided into groups to conduct plogging in Jung-gu and Seodaemun, and to create donation kits for child support. The donations were delivered through Save the Children, in cooperation with the Community Chest of Korea. They provided necessary items to children at the Manan District Social Welfare Center in Anyang.2025 Eli Lilly Korea GDOS TF Team. From left: Hyung-min Kim (Regulatory Affairs), Minju Kang (Medical), Yu Seok Kang (ENC), Joohee Lee (Medical)Notably, they introduced 'GDOS Night; for the first time last year, featuring a charity performance by the in-house band and a donation program. A new attempt was made to expand the post-volunteer interaction into another act of sharing by accumulating the entire proceeds from food and beverages purchased by employees as donation funds.GDOS aligns with Lilly's global sustainability strategy, which includes: ▲ expanding access to medicines ▲ improving environments with limited medical infrastructure ▲ strengthening community resilience ▲ minimizing environmental footprints ▲ fostering innovation grounded in inclusion and diversity.We met with Minju Kang, Medical Director of Eli Lilly Korea, who managed last year's GDOS, and the TF team (Joohee Lee, Yu Seok Kang , and Hyung-min Kim) to discuss preparations, operations, achievements, and future directions.Q. Please describe your roles in last year's GDOS.Minju Kang (Medical): I am Minju Kang, head of the Medical Department and the sponsor for GDOS. Each year, a different department takes turns sponsoring GDOS, and since the Medical Department was in charge last year, I took on the role of sponsor.Hyung-min Kim (Regulatory Affairs): I am Hyung-min Kim from the Regulatory Affairs team. For this GDOS, I established the overall program plan, selected volunteer activities, and managed group assignments.Joohee Lee (Medical): I am Joohee Lee from the Medical Department. This program was led by three 'Champion Leaders' centered around Vice President Minju Kang. My role involved planning the program, encouraging employee participation, and setting the direction for which values we should focus on.Yu Seok Kang (ENC): I am Yu Seok Kang from the ENC team. Since GDOS is a long-standing event, my primary role was to ensure that the company's regulations and procedures were strictly followed throughout the support process.Q. What kind of event is GDOS?Minju Kang (Medical)Minju Kang: GDOS is a global corporate social responsibility program in which all Lilly branches worldwide, including the U.S. headquarters and Korea, participate. It has continued for nearly 20 years since its 2008 launch, and Eli Lilly Korea has participated consistently since 2010.It is highly significant because it goes beyond a simple annual event; it is a time for us, as members of a pharmaceutical company, to reconnect with our fundamental purpose asking 'Why do we do this work?'GDOS is operated as a volunteer-based activity involving all employees, and each year the TF Champions plan the program. The format changes annually. In some years, we conduct plogging to improve community environmental health, and other years we assemble donation kits for the underprivileged.Last year, we conducted plogging and kit production simultaneously. Furthermore, we introduced GDOS Night, aiming to extend the lasting impact of volunteer work into a time for sharing and interaction.Q. Compared to other CSR activities, what makes Lilly's program special?Hyung-min Kim (Regulatory Affairs)Hyung-min Kim (Regulatory Affairs): Generally, many volunteer programs rely on external vendors to handle the event's composition and operation. However, at Lilly, employees form their own TF to take the lead in the entire process—from planning and execution to reporting results.Members experience creating the program as protagonists rather than mere participants, gaining a sense of belonging and achievement. I believe this is the fundamental differentiator of Lilly's CSR activities.Joohee Lee: Having worked at other pharmaceutical companies, I found it particularly impressive that Lilly employees worldwide participate in volunteer work on the same day.It is rare to find CSR activities in which employees from every country, including the U.S. headquarters, work toward a common goal with a consistent identity as 'Team Lilly.'Additionally, not only the domestic TF but also TF Champions from each country meet in advance to discuss the planning direction and implementation methods for the GDOS program, and share the results after the event. This systematic approach, in which we learn from and spread the activities of different countries, sets GDOS apart as a sophisticated global volunteer program rather than a simple local activity.Q. We heard the 2025 theme was 'A Better World Made Together.' What were the central messages you focused on?Yu Seok Kang : The first pillar was 'Environmental Improvement.' To this end, we collaborated with the 1365 Volunteer Center to conduct plogging activities that could directly improve the local community's environment. The second pillar was 'Child Support.' In the past, we focused on visiting orphanages to improve their facilities. Last year, during discussions with the Community Chest of Korea, we explored ways to provide more practical help to children.As a result, we agreed that an approach of personally creating and delivering items that children need and would enjoy was more meaningful. By structuring the program around these two core pillars (environment and children), we prepared for the theme of "A Better World Made Together" to be portrayed through the activities.Q. Could you explain what "GDOS Night" was?Joohee Lee (Medical)Joohee Lee: In the past, after the volunteer work was completed, employees typically went their separate ways.Last year, we introduced GDOS Night to strengthen GDOS's communal values further.Many employees voluntarily attended the event even after the official activities ended, continuing the interaction and sharing. I believe this experience catalyzed GDOS to naturally expand its purpose.Minju Kang: GDOS Night was an event planned around the 'Lilly Band,' an in-house club.Employees who participate in the band as a hobby held a charity concert. We expanded the traditional 'one-day cafe' format by renting an external club space, selling food and drinks, and raising funds.It was meaningful because it provided a direct platform for employees to participate and spread a culture of donation beyond just a concert.Q. What is the meaning behind Lilly's core value, 'To unite caring with discovery to make life better for people'?Yu Seok Kang : We thought deeply about how to integrate caring and discovery into our activities harmoniously. In particular, introducing the unprecedented GDOS Night was meaningful because it expanded the event from a mere gathering of Lilly members into a festival where we could share and personally experience the values the company pursues.Furthermore, we interpreted the purpose of GDOS differently by introducing a structure that converted the program's proceeds into donations. I believe this series of processes was an attempt to meld the corporate purpose of caring and innovation into overall activities, and a case of seeking new ways through new methods.Minju Kang: Lilly holds 'Respect for People' as one of its core values, which is based on fundamental respect for human dignity and life. Caring, stemming from this value, has a practical meaning for a pharmaceutical company: providing patients with treatment opportunities and improving their quality of life. At the same time, for such caring to be realized in reality, innovative discovery and continuous R&D investment are essential.Therefore, Lilly simultaneously pursues a people-centered perspective and the discovery that realizes it. The discovery mentioned here refers to the development of new medicines, which directly links to our corporate purpose, as only innovative treatments can provide substantial benefits to patients. From this perspective, GDOS is not an event separate from the company's daily operations, but an extension of the process where caring and discovery for a better life are connected through activities.Q. Is there a message you would like to send to the TF preparing for this year's GDOS?Yu Seok Kang (ENC)Yu Seok Kang: Last year, we made various attempts based on collaborations with several volunteer organizations. However, since most volunteer groups operate with small numbers, there were constraints on schedules and operational methods during the coordination process for GDOS, which requires large-scale participation.In the future, we can enhance efficiency and meaning further if collaboration schedules are coordinated and prepared at an even earlier stage. Although there was some trial and error, the process itself, including discussing with TF members and brainstorming ways to maximize employee participation, was very valuable, and I am satisfied with the overall results.Joohee Lee: The feedback left by CEO after last year's GDOS was also memorable. The suggestion was to consider activities that can deliver hope to patients, caregivers, and the community, aligned with a pharmaceutical company's identity and role. From this perspective, I believe programs that create direct touchpoints with patients, such as the Lilly Band holding a concert for patients, are directions worth considering for the future.Kim Hyung-min: GDOS is not an activity directly linked to performance metrics, but it is an event we must participate in with a sense of mission, personally practicing the company's values as Lilly employees. Since it required preparation outside of working hours, personal motivation was necessary, and being able to provide momentum to each other while working as a team was a great help. I believe a TF involving members who can voluntarily offer opinions is a crucial element for the future success of GDOS.Minju Kang : The charity concert (GDOS Night), which was attempted for the first time last year, received a very positive response. If we consider how to further evolve this format for the charity concert next year, we can expand the meaning of GDOS even further.
- 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.
- Opinion
- [Reporter’s View] Reform of reimb reevaluations
- by Jung, Heung-Jun Jan 19, 2026 09:02am
- While it is difficult to predict whether the revision of reimbursement reevaluation standards lead to an expansion or contraction of the list of targeted products, a transparent selection process appears necessary to prevent unnecessary controversy.Without proper discussion on the designation of active ingredients subject to re-evaluation, there is concern that wasteful debates will follow.Even before today's (15th) discussion on revising the reevaluation criteria at the Drug Reimbursement Evaluation Committee, the Pharmaceutical Society for a Healthy Society (PSHS) has voiced opposition, stating, “The direction is tilting solely toward the convenience of the pharmaceutical industry.”The group claims that the revised criteria lack clarity, particularly in cases where medicines are recommended by academic societies or experts, or where conflicting clinical data and efficacy evidence exist.Compared to the previous system, under which old drugs were filtered annually based on overseas reimbursement status and reimbursement claims, the new standards are seen as more ambiguous. As a result, critics fear that the reform may be aimed at shrinking the scope of products subject to re-evaluation.Conversely, however, this also means that any drug deemed necessary can be reevaluated, regardless of factors like listing countries or claim amounts.For instance, even drugs with claims under 0.1% (approximately KRW 20 billion) or listed in at least one foreign country (A8) would no longer be completely excluded from reevaluations.Last year, HIRA announced plans to revise the criteria, discussing expanding the scope to include items with claims under KRW 10 billion and fewer than three overseas countries listed.If that original direction is maintained, the revision of reimbursement reevaluation criteria could actually lead to an expansion of reevaluation targets, contrary to the concerns raised by the Pharmaceutical Society for a Healthy Society.Of course, industry backlash is expected even in this case. It will be difficult to accept the inclusion of ingredients that were not previously subject to reevaluation under the old criteria.Ultimately, regardless of where the impact of the standard revision lands, mechanisms are needed to minimize unnecessary controversy.At present, the revised criteria have not yet passed the Health Insurance Policy Deliberation Committee, nor has a concrete implementation plan been announced, making it too early to reach any firm conclusions. However, if a clear and broadly acceptable selection process is established, the reform could achieve meaningful progress in post-listing management of reimbursed drugs in Korea.
- 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.”
- Policy
- ‘Will create first FDA-approved Korean drug by 2030’
- by Lee, Jeong-Hwan Jan 19, 2026 09:02am
- Amid the Ministry of Health and Welfare's ambition to foster Korea’s pharmaceutical industry by establishing a new dedicated “Division of Pharmaceutical and Bio Industry,” Kang-Seop Lim, its first director, expressed his ambition. He said, “We will create cases where domestically developed new drugs independently obtain approval from the U.S. Food and Drug Administration (FDA).”Rather than relying on licensing-out deals to global pharmaceutical companies for overseas market entry, what the government wants to do is support Korean pharmaceutical firms in completing Phase III clinical trials and securing FDA approval on their own, paving the way for direct global commercialization of Korean blockbuster drugs.On the 18th, Director Lim met with the Ministry of Health and Welfare's press corps and stated, “Our goal is to create a successful case of a fully developed Korean drug completing Phase III trials, securing FDA approval, and being sold directly in the U.S. market within five years. We will make this year the starting point, with the aim of achieving this milestone by 2030.”When asked what administrative priorities he would focus on this year as the inaugural head of the new division, Director Lim cited “developing a finished new drug that successfully completes Phase III clinical trials, secures FDA approval, and achieves direct sales” as the top priority.While the ministry will continue to support technology licensing deals, Lim emphasized that the new policy direction is focused on enabling Korean-developed drugs to enter global markets independently, without relying on multinational pharmaceutical companies.To this end, MOHW will operate a dedicated fund specifically supporting Phase III clinical trials for new drug candidates showing potential for final regulatory approval.The Ministry has already allocated KRW 60 billion in government capital in this year's budget proposal for this purpose. Combined with matching funds from the Fund of Funds, it plans to establish a ‘Phase III Clinical Trial Specialized Fund’ totaling KRW 150 billion.Lim said, “Last year, Korea recorded its highest-ever technology licensing exports, yet there are still very few cases of fully developed Korean drugs being launched overseas. Now is the time for Korea to take the lead in completing Phase III clinical trials and securing FDA approval.”“Looking at the K-Bio Vaccine Fund, roughly 50% went to preclinical research and 50% to Phase I–II trials, but there were virtually no Phase III investments. That gap is something we are now determined to fill, which is why we decided to establish a Phase III specialized fund based on this year's budget.”He added, “Of the KRW 150 trillion National Growth Fund, KRW 11.6 trillion will be allocated to the pharmaceutical, bio, and vaccine sectors over five years. We are also considering connecting this funding to late-stage clinical investments. We will signal that pharmaceutical and biotech companies can secure funding even in late-stage clinical trials, enabling them to plan their clinical and business strategies.”Lim added that the Ministry of Health and Welfare also plans to continue supporting technology licensing.This means the Ministry will assist pharmaceutical and biotech ventures and startups in growing from small and medium-sized enterprises (SMEs) to mid-sized companies, and their search for opportunities for further expansion, using technology exports as a starting point.The Ministry has allocated KRW 10.4 billion for its global open innovation budget and is developing collaboration plans to combine this with the Ministry of SMEs and Startups' budget to further expand the scale of the program.In the first half of the year, MOHW will establish a consultative body with biotech venture companies to gather feedback on regulatory reform and policy support. These discussions will feed into regulatory modernization initiatives and next year’s budget planning.Lim stated, “The number of companies to be supported through the global open innovation budget is around 32. For platform technology development R&D, we are considering planning it this year and including it in next year's budget. While existing R&D has primarily focused on candidate substances, preclinical studies, and clinical trials, we now intend to support investment in the platform technology itself.”He further noted, “The establishment of a dedicated department under the name ‘Division of Pharmaceutical and Bio Industry’ carries significant symbolic meaning. I feel a sense of responsibility. The follow-up budget and administrative measures for the Pharmaceutical and Bio-Health Leap Strategy unveiled last September will be fully implemented starting this year. We will present a changed approach to the industry, and the first message will be the announcement of the revised Innovative Pharmaceutical Company Certification System.”
- Policy
- "2030년까지 FDA 직접 허가 국산신약 사례 창출"
- by Lee, Jeong-Hwan Jan 19, 2026 09:02am
- [데일리팜=이정환 기자]보건복지부가 '제약바이오산업과'를 신설, 국내 제약산업 집중 육성 의지를 드러낸 가운데 임강섭 초대 과장은 "국산 신약이 자력으로 미국 식품의약국(FDA) 허가를 획득하는 사례를 만들겠다"는 포부를 내놨다.국내 제약사가 글로벌 빅파마에 신약 기술수출을 통해 미국, 유럽 등 해외 시장에 진출하는 현실을 뛰어 넘어 임상3상까지 오롯이 끝마친 뒤 블록버스터 신약으로서 직접 해외 허가를 따내는 원년으로 삼겠다는 의지다.18일 임강섭 과장은 복지부 전문기자협의회와 만나 "임상3상까지 끝낸 완제 신약을 개발해 FDA 허가까지 받아 직접 판매하는 사례를 5년 안에 만드는 게 목표고, 올해를 원년으로 삼아 2030년까지는 사례를 만들 것"이라고 피력했다.임 과장은 초대 제약산업과장으로 임명된 올해 무게중심을 둘 행정이 무엇이냐는 질문에 "임상3상 완료, FDA허가, 직접 판매에 성공하는 완제품 신약 개발"을 최우선 과제로 꼽았다.기술수출 지원도 지금보다 늘리겠지만, 우리나라 손으로 만든 신약이 빅파마 손을 빌리지 않고 해외 시장 문을 직접 두드릴 수 있게 돕는 복지부 지원에 방점을 찍겠다는 취지다.이를 위해 복지부는 최종 허가 가능성이 엿보이는 신약물질의 임상3상을 타깃으로 지원하는 전용 펀드를 운영한다.실제 복지부는 이를 위해 올해 예산안에 600억원 규모 정부 출자금을 편성한 상태로, 모태펀드 매칭을 합쳐 총 1500억원 규모의 '임상3상 특화 펀드'를 조성할 방침이다.임 과장은 "지난해 기술수출은 역대 최고치였는데 여전히 완제품 신약 해외 출시까지 가는 사례는 거의 없다"면서 "이젠 우리나라가 주체로서 임상3상까지 완료하고 FDA 승인을 받는 사례를 만들겠다"고 힘 줘 말했다.그러면서 "K-바이오 백신 펀드 집행 내역을 보면 전임상(동물실험)에 약 50%, 임상1상~2상에 약 50%가 쓰였는데 임상3상 투자 사례가 없어 아쉽다"며 "임상3상 투자 공백을 어떻게 메울지 방법을 고민했고, 올해 예산을 토대로 임상3상 특화펀드를 만들 것"이라고 설명했다.또 "국민성장펀드 150조원 중 제약·바이오·백신 분야에 11조6000억원을 5년간 활용한다고 하니, 이 자금을 후기 임상 투자로 연결하는 구상도 하고 있다"며 "제약바이오 기업들이 후기 임상 단계에서도 펀딩을 받을 수 있다는 신호를 전달해 임상·사업 계획을 세울 수 있게 하겠다"고 부연했다.임 과장은 복지부의 기술수출 지원 역시 계속 지원할 계획이라고 했다.제약바이오 벤처·스타트업 기업이 기술수출을 기점으로 중소기업, 중견기업으로 성장하고 또 더 큰 단계로 활로를 모색하는 경로를 복지부가 돕겠다는 얘기다.복지부는 글로벌 오픈이노베이션 예산으로 104억원을 편성한 상태로 중소기업벤처부 예산과 합쳐 규모를 더 키울 수 있도록 협업 방안을 만들고 있다.아울러 복지부는 중기부와 협력해 상반기 중 제약바이오 벤처와 협의체를 만들어 의견을 수렴하고 규제 완화 요구안과 지원안 등을 정리하는 작업도 추진한다. 이를 근거로 하반기부터 규제 선진화 작업과 내년도 예산 작업에 나선다는 게 임 과장 계획이다.임 과장은 "글로벌 오픈이노베이션 예산으로 지원하게 될 대상 기업 수는 32개사 정도다. 플랫폼 기술개발 R&D의 경우 올해 기획해서 내년 예산에 담는 방안을 검토 중"이라며 "기존 R&D가 주로 후보물질-전임상-임상에 집중됐다면 앞으로는 플랫폼 기술 자체에 대한 투자도 지원하려 한다"고 말했다.이어 "제약바이오 산업과란 명칭으로 전담과가 새로 생긴 건 상징적 의미가 크다. 책임감을 느낀다"며 "지난해 9월 발표된 제약바이오 대도약 전략의 후속 예산과 행정 조치가 올해부터 본격적으로 실행된다. 산업계에 변화된 모습을 제시할 것이고 첫 메세지가 혁신형 제약사 인증제 개편안 발표가 될 것"이라고 덧붙였다.
