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- 2025-12-20 12:40:27
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- More treatment options for PNH…entry of 'Piasky' imminent
- by Eo, Yun-Ho Jun 04, 2025 06:19am
- The entry 'Piasky,' a new PNH drug, into the Korean market is imminent. According to industry sources, Roche Korea's Piasky (crovalimab), a treatment for paroxysmal nocturnal hemoglobinuria (PNH), is undergoing final review for approval by the Ministry of Food and Drug Safety (MFDS). It is expected to be officially approved in the second half of this year. Piasky received the U.S. Food and Drug Administration (FDA) approval in June 2024. Then, it was commercialized in Europe in August of the same year. In February 2024, Piasky was designated as an orphan drug in South Korea. Discovered by Japan's Chugai Pharmaceutical and developed by Roche, crovalimab is a type of new anti-complement (C5) antibody. Low-dose subcutaneous administration every four weeks enables circulation of the drug in the blood, thereby repeatedly inhibiting the complement. Piasky's potential was confirmed based on the Phase 3 COMMODORE 2 study, which directly compared the drug to AstraZeneca's 'Soliris (eculizumab).' The study results showed that subcutaneously injected crovalimab provides disease control. The safety of the drug was non-inferior compared to Soliris, a standard therapy that is administered intravenously every two weeks. In the clinical study, adverse reactions occurred in 78% of the crovalimab group and 80% of the eculizumab group. The most common adverse reactions were infusion-related reactions. Based on the efficacy and the safety data secured from a separately conducted Phase 3 COMMODORE 1 study, patients with PNH who switched from complement C5 inhibitors that are approved and in use to crovalimab also showed a stable effectiveness profile. Meanwhile, competition in the market for PNH is expected to intensify. AstraZeneca has launched Ultomiris (ravulizumab) as a follow-up drug to Soliris. The European patent for Soliris expired in 2023, while the U.S. patents are set to expire in 207. Unlike Soliris, which is intravenously injected every two weeks, Ultomiris offers an expanded administration interval of once every eight weeks. Novartis obtained the U.S. approval of 'Fabhalta (iptacopan),' an orally administered treatment for PNH. Fabhalta is a Factor B inhibitor that acts proximally in the immune system's alternative complement pathway, providing comprehensive control of red blood cell (RBC) destruction. Fabhalta is currently undergoing drug price negotiations with the National Health Insurance Service (NHIS). Once an agreement is reached, this drug will be included in the national health insurance list. Additionally, 'Epysqli,' Samsung Biepis' biosimilar to Soliris, has been commercialized in South Korea. It was the first case of Soliris biosimilars to receive domestic approval, and Samsung Bioepis also obtained approval in Europe last year. Dr. Jang Jun Ho, professor at Samsung Medical Center Seoul, said, "When C5 inhibitors were introduced, experts viewed that it would bring a paradigm shift to the PNH treatment. However, C5 inhibitors are limited in controlling extravascular hemolysis (EVH). Thus, we have high hopes for new treatment options."
- Company
- UCB Korea launches psoriasis drug Bimzelx with reimb
- by Whang, byung-woo Jun 04, 2025 06:18am
- Pic of Bimzelx On June 2, UCB Korea (CEO Sujin Hwang) announced that its psoriasis treatment Bimzelx (bimekizumab) was launched on June 1 with reimbursement coverage under the national health insurance system. In line with the Ministry of Health and Welfare (MOHW) notification, Bimzelx is reimbursed as a treatment for moderate-to-severe plaque psoriasis in adult patients who require phototherapy or systemic therapy. The treatment is indicated for adult patients aged 18 years or older with chronic moderate-to-severe plaque psoriasis that has persisted for 6 months or longer, meeting one of the following criteria: ▲ plaque psoriasis covering 10% or more of the total body surface area, or ▲ a Psoriasis Area and Severity Index (PASI) score of 10 or higher, despite 3 months of treatment with methotrexate or cyclosporine, or inability to continue treatment due to adverse effects, or ▲ PUVA or UVB therapy for at least 3 months with no response or side effects that prevent continued treatment. In addition, if PASI is reduced by 75% or more in the evaluation after 16 weeks of Bimzelx prescription, an additional 6 months of administration is granted reimbursement, and thereafter, if the initial evaluation results are maintained during evaluation every 6 months, continued administration with reimbursement is approved. In addition, in the case of switching, if the patient’s previous drug is ineffective or cannot be continued due to side effects, or if there is a need to improve medication compliance, the patient may substitute Bimzelx. Bimzelix is the first and only (as of May 2025) next-generation plaque psoriasis treatment that simultaneously and dually inhibits interleukin-17A and 17F. Last August, it was approved by the Ministry of Food and Drug Safety as a treatment for moderate-to-severe plaque psoriasis in adult patients who require phototherapy or systemic therapy. In particular, unlike existing interleukin inhibitors that target and block only one trigger, such as interleukin-17A or 23, Bimzelx has a mechanism of action that simultaneously and dually inhibits interleukin-17A and 17F. By blocking both interleukin-17A and 17F simultaneously, it has been confirmed that Bimzelx is more effective in suppressing inflammation than existing interleukin-17A inhibitors. The reimbursement of Bimzelx was based on BE VIVID14, BE SURE15, and BE RADIANT16, which are comparative clinical trials with other biological drugs whose safety and efficacy have been confirmed. In these studies, the percentage of patients who achieved completely clear skin (PASI 100) at Week 16 was 59% in the Bimzelx group and 21% in the ustekinumab group in BE VIVID; and 60.8% in the Bimzelx group and 23.9% in the BE SURE study. Yong-Beom Choi, President of the Korean Society for Psoriasis (Department of Dermatology, Konkuk University Medical Center), said, “Psoriasis is an intractable disease that recurs and improves repeatedly, and the quality of life of patients with severe psoriasis in particular tends to deteriorate significantly, affecting their mental health. Therefore, the reimbursement and launch of Bimzelx, which has been proven to be highly effective, is very meaningful for both medical professionals and patients.” He added, “Based on its next-generation mechanism of action, Bimzelx is expected to be an excellent treatment option for both new patients and those who have not seen sufficient results with existing treatments.”
- Company
- "U.S. MFN drug policy will impact KOR's new drug companies"
- by Kim, Jin-Gu Jun 04, 2025 06:17am
- Analysis suggests that the Korean pharmaceutical and biotech industry may be significantly impacted if the U.S. government institutes a 'most-favored-nation (MFN)' policy on drug prices. Sejin Lee, CEO of Acadia Pharmaceuticals, presented the potential impact of U.S. drug price policy changes on the Korean pharmaceutical industry during the 'U.S. Pharmaceutical and Biotech Market Entry Webinar' hosted by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) on May 30. Lee warned that "MFN policy may structurally impact sales, new drug value, and global entry strategies of Korean companies. PART II: U.S. Trump Administration revives "most-favored-nation (MFN)" drug price policy. The second Trump administration revived the MFN policy and announced that it would implement the lowest drug price after conducting a drug price comparison. Earlier this month, U.S. President Donald Trump signed an executive order reducing prescription drug prices within the U.S. to the lowest among advanced nations (MFN). The proposal is to compare drug prices with those of OECD countries where the GDP per capita is 60% or more of that of the United States and then lower U.S. drug prices to the lowest among these compared countries. The MFN policy will be applied to items without biosimilars and generics. The U.S. Department of Health and Human Services (HHS) aims to induce voluntary drug price reductions from pharmaceutical companies initially, then plans to mandatorily lower drug prices. If the MFN policy is fully implemented, the prices of new drugs launched in the U.S. are expected to be set lower than in other countries, such as the EU and Canada. This process raises concerns that U.S. drug prices for Korean pharmaceutical companies may decrease automatically. Lee anticipated that the MFN policy would significantly impact new drug development companies. It is predicted that if drug prices in the U.S. fall to European or Canadian levels, pharmaceutical companies' projected revenues will decrease, and the asset value of new drug licenses will decline. Companies that out-licensed might also receive less licensing revenue than initially expected. Furthermore, global big pharma companies could launch products only in the U.S. or delay launches in major countries to circumvent the MFN policy. However, biosimilar and generic drug companies are not expected to experience a direct impact, as the MFN policy targets items without generic and biosimilar alternatives. However, the profitability of these products could still come under pressure in the future. Specifically, if original drug prices decrease, the standard prices for biosimilar products could also be lowered, potentially reducing sales incentives. Lee explained, "For new drug development companies, U.S. sales are substantial, so a drop in drug prices directly translates to a decrease in corporate value," and added, "Considering patient access and distribution structures, Korean companies with high-cost, high-risk pipelines could be more significantly impacted." "If price distortions between countries intensify, pharmaceutical companies might choose specific countries as priority suppliers, leading to supply imbalances," Lee pointed out. "Ultimately, a global supply shortage phenomenon could become extended." "It is unlikely that the executive order issued by President Trump will be fully implemented as is due to legal issues within the U.S. However, there is a possibility that it could be enacted into law by the U.S. Congress. In that case, the impact would be immense," Lee emphasized. "The Korean government may need to conduct a preliminary scenario analysis and formulate a communication strategy with the U.S."
- Company
- Multiple myeloma drug Elrexfio seeks reimb again in KOR
- by Eo, Yun-Ho Jun 02, 2025 05:51am
- The new multiple myeloma drug Elrexfio is again seeking insurance reimbursement coverage in Korea. Pfizer Korea recently submitted a reimbursement application for Elrexfio (elranatamab) and is aiming to receive the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee review. Following its rejection by CDDC in February, the company swiftly regrouped and is now proceeding with the necessary procedures required for Elrexfio’s reimbursement. Elrexfio has been designated by the Ministry of Food and Drug Safety as a Global Innovative Products on Fast Track (GIFT) and received fast-track approval. Therefore, it remains to be seen whether the company’s second attempt will be successful. Elrexfio is a fourth-line immunotherapy composed of two monoclonal antibodies - one targeting the antigen specific to multiple myeloma and the other engaging T cells. Bispecific antibody therapies are a form of immunotherapy composed of two monoclonal antibodies—one that recognizes a target antigen of multiple myeloma and another that binds to T cells. Typically, they are structured as bispecific IgG2 kappa antibodies that recognize BCMA (B-cell maturation antigen), the primary target antigen in multiple myeloma, and CD3. These therapies represent a novel approach that directly targets cytotoxic T cells to multiple myeloma cells expressing BCMA. Multiple myeloma, a cancer of plasma cells in the bone marrow, is a type of hematologic malignancy that primarily affects older adults. It is a disease where prolonged treatment can bring extended survival. Although various new therapies are being developed for the disease, monoclonal antibodies and bispecific antibody therapies are currently typically used in practice. In particular, the bispecific antibody mechanism is regarded as a safe and effective treatment for relapsed and refractory multiple myeloma, in which resistance increases with each treatment cycle, shortening the remission period and reducing the available treatment options. Since multiple myeloma is a disease where extended survival is achievable through continuous treatment, it is essential to have various therapeutic options available at each stage of treatment. This is why extending reimbursement coverage to fourth-line and later therapies remains an urgent priority. Currently, bispecific antibody therapies such as Elrexfio, Tecvayli (teclistamab), and Talvey (talquetamab) are approved in Korea, but none are granted reimbursement. Amid the failed discussions over coverage of a series of bispecific antibody drugs in the early stages, whether any drug will be granted reimbursement and improve patient access is gaining attention. Meanwhile, Elrexfio was designated by the Ministry of Food and Drug Safety as a GIFT item and was approved as a monotherapy for adult patients who have received more than three lines of treatment, including proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibodies, in May last year. The US FDA has also designated it as an innovative drug and granted accelerated approval for the drug. Elrexfio’s efficacy was demonstrated through the Phase II MagnetisMM-3 trial, an open-label, multicenter, non-randomized study that was conducted on 123 who had not received prior BCMA-directed therapy (i.e., BCMA-naïve patients). Results of Cohort A showed that the drug recorded an objective response rate (ORR) of 61.0% and a complete response (CR) of 37.4%. The progression-free survival (PFS) period was 17.2 months, and the overall survival (OS) period was 24.6 months, demonstrating an unprecedented long-term treatment effect. The data demonstrated that Elrexfio provided long-term survival benefits and slowed down disease progression to improve the quality of life of patients who had no other treatment options.
- Company
- Vocabria+Rekambys for HIV lands in more hospitals in KOR
- by Eo, Yun-Ho Jun 02, 2025 05:51am
- More general hospitals are securing prescriptions for the long-acting HIV treatment combination therapy Vocabria+Rekambys. According to industry sources, the combination therapy of GSK Korea’s Vocabria (cabotegravir) and Janssen Korea’s Rekambys (rilpivirine) has recently been approved by the drug committees (DCs) of several major hospitals, including the "Big 5" HIV treatment centers—National Medical Center, Seoul National University Hospital, and Kyungpook National University Hospital—as well as Korea University Anam Hospital and Chung-Ang University Hospital. The combination has been gradually expanding its prescription areas before and after the reimbursement listing last month. The upper insurance price ceiling for Vocabria 30mg is KRW 16,303 per tablet and KRW 991,882 per vial. The Vocabria+Rekambys combination was approved by the Ministry of Food and Drug Safety in February 2022 as a combination therapy for the treatment of HIV-1 infection in adult patients who are virologically suppressed, have no history of virological failure, and have no known or suspected resistance to cabotegravir or rilpivirine. The advantage of this combination therapy is undoubtedly its convenience in administration. While existing HIV treatments require patients to take a tablet formulation once a day, the two injectable drugs will reduce the frequency of administration to once a month or once every two months with intramuscular injections, increasing satisfaction and reducing the burden on patients. The two drugs were originally developed as oral medications and then were developed into injectable drugs. While this long-acting injectable drug cannot cure HIV infection, it is a treatment that targets white blood cells to help lower and maintain the level of the AIDS virus. The Vocabria+Rekambys combination demonstrated non-inferior viral suppression efficacy compared to the existing three-drug oral regimen (BIC/FTC/TAF) in the SOLAR Phase III clinical trial, with a treatment failure rate of 1% over 12 months. During the same period, the rate of maintaining HIV RNA levels below 50 copies/mL was 90% in the injection group and 93% in the oral medication group. In terms of safety, there were no significant differences between the two groups other than injection site reactions. According to a treatment satisfaction survey released by GSK, 90% of HIV-infected individuals who had been taking existing oral medications reported higher satisfaction after switching to the injection therapy, with 85% citing “convenience of not having to take medication daily” and 75% highlighting “reduced HIV exposure concerns” as key benefits. Meanwhile, the Vocabria+Rekambys regimen demonstrated efficacy and safety in clinical trials where it was administered every 4 weeks or every 8 weeks as combination therapy and received approval in Europe in December 2020. Recently, its treatment indication was expanded to include adolescent patients in Europe.
- Company
- Samsung Bioepis’ Xgeva biosimilar approved in KOR
- by Chon, Seung-Hyun Jun 02, 2025 05:50am
- Samsung Bioepis announced on the 30th that it has received approval from the Ministry of Food and Drug Safety for its biosimilar Xbryk, a bone disease treatment. Xbryk, which contains denosumab, is used to prevent skeletal complications in cancer patients and treat tumor diseases such as giant cell tumor of bone. Prolia, which contains the same ingredient, has been approved as a treatment for endocrine disorders such as postmenopausal osteoporosis. Last year, the combined global sales of Prolia and Xgeva reached USD 6.599 billion (approximately KRW 10 trillion). The domestic market prescription volume amounted to approximately KRW 187 billion. Samsung Bioepis has pursued separate product approvals for each indication, just like the original medications. In April, it received approval for the Prolia biosimilar Obodence, and this time, it has added approval for the Xgeva biosimilar. With the approval, Samsung Bioepis has received 11 product approvals in Korea. All of the company’s biosimilars in its pipeline that have completed global clinical trials have reached the commercialization stage in Korea. Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis, said, “The marketing authorization for both Obodence and Xbryk in the domestic market following global approval is significant as it enables us to broaden treatment opportunities for patients with bone diseases by offering more cost‑effective therapeutic options.”
- Company
- Janssen attempts Darzalex’s reimb for AL amyloidosis in KOR
- by Eo, Yun-Ho May 30, 2025 05:58am
- Darzalex, which has been expanding its insurance coverage to multiple myeloma, is now seeking to receive reimbursement for amyloidosis in Korea. According to Dailypharm coverage, Janssen Korea recently applied for reimbursement expansion of Darzalex SC (daratumumab) in combination with cyclophosphamide, bortezomib, and dexamethasone (CyBorD). The amyloidosis indication was approved by the US FDA in 2021 and the Ministry of Food and Drug Safety in 2024. In the indication, the Darzalex combination has shown a dramatic improvement, increasing the hematological response rate in patients with amyloidosis by nearly threefold. The efficacy of Darzalex in amyloidosis has been demonstrated in the Phase III ANDROMEDA study. Amyloidosis is a disease characterized by the accumulation of amyloid—a special type of fibrous glycoprotein—in various tissues throughout the body. The study primarily focused on patients newly diagnosed with AL (amyloid light-chain) amyloidosis. Darzalex is the first human monoclonal antibody approved for multiple myeloma. Its active ingredient, daratumumab, targets and binds directly to CD38, a surface glycoprotein overexpressed on multiple myeloma cells. The ANDROMEDA study evaluated the efficacy and safety of adding Darzalex SC to the existing CyBorD combination therapy in patients with AL amyloidosis in comparison with the CyBorD monotherapy group. In the study, 71% of patients had cardiac involvement and 59% had renal involvement, with 65% of patients having involvement in two or more organs. The primary endpoint, hematologic complete response rate, was 53% in the Darzalex combination group, nearly three times higher than the 18% in the CyBorD monotherapy group. In addition, the overall reported hematological response rate was 92% in the Darzalex combination group and 77% in the CyBorD monotherapy group. The very good partial response rate also showed a clear difference at 79% and 49%, respectively. The company has been continuing to expand Darzalex’s reimbursement coverage in Korea. In February, a four-drug combination therapy (DVTd therapy: Darzalex, bortezomib, thalidomide, and dexamethasone) was approved for reimbursement as a first-line treatment, and recently, the DVd therapy (Darzalex, bortezomib, and dexamethasone was approved by the Health Insurance Review and Assessment Service's Cancer Disease Review Committee as a second-line treatment.
- Company
- Galderma challenges the atopic dermatitis market in KOR
- by Whang, byung-woo May 29, 2025 05:52am
- Galderma is challenging the Korean market for atopic dermatitis treatment with its first biologic, 'Nemluvio (nemolizumab).' Given the market's already competitive nature, Galderma is likely to secure a market presence with the drug's mechanistic differentiation, convenient administration, and expanded indication. Product photo of NemluvioGalderma Korea submitted an application for Nemluvio's Korean marketing authorization to the Ministry of Food and Drug Safety (MFDS) in August of last year. The company expects to obtain approval by the end of the fourth quarter of this year. Nemluvio's indications submitted for marketing authorization in Korea are two types: atopic dermatitis and prurigo nodularis. Approval of Nemluvio gathers attention because it is the first biologic from Galderma Korea. While Galderma has supplied ethical-the-counter (ETC) drugs such as acne treatments and botulinum toxins to the Korean market, most of these have been topical agents or aesthetic products. In that context, approval of nemolizumab for the atopic dermatitis indication is significant in terms of portfolio expansion. However, the current situation for nemolizumab, as a latecomer, is not easy given that global big pharma companies are fiercely expanding their presence in the severe atopic dermatitis treatment market in Korea. Starting with Dupixent, a biologic like nemolizumab, and followed by JAK inhibitors, as well as LEO Pharma's Adtralza and Lilly's Ebglyss, these drugs are also expanding their influence in the market. In the market for atopic dermatitis, where strong early entrants have been introduced, the key competitive advantage for Galderma's nemolizumab is projected to be its 'mechanistic differentiation.' Nemluvio is the first drug to inhibit the IL-31 pathway, which is central to itching, rather than the IL-4/13 or IL-13 pathways targeted by existing biologics. By binding to the IL-31 receptor alpha (IL-31RA) and blocking the itching signal itself through neuronal transmission, it is expected to provide a rapid and robust improvement in pruritus compared to existing drugs. The efficacy of Nemluvio was demonstrated in the multi-national Phase 3 clinical trial, the ARCADIA program. In a comparison study against topical corticosteroid (TCS) combination therapy, involving a total of 1,728 patients with moderate to severe atopic dermatitis, both the EASI-75 achievement rate and the itch improvement index (NRS)showed significant improvement at 16 weeks, meeting the co-primary endpoints. Furthermore, the administration method was designed with patient convenience in consideration, involving subcutaneous injections every 4 weeks, and a pre-filled pen for self-administration has also been secured. This method offers the advantage of a lower medication burden compared to treatments that require administration once every two weeks or daily oral intake. Galderma is also accelerating the global launch of nemolizumab. Following obtaining initial approval in Japan at the end of 2023, nemolizumab was approved in Europe and the United States for the prurigo nodularis indication earlier this year. This strategy targets a niche market that shares a similar immunopathologic structure with atopic dermatitis but has had limited treatment options available. Indeed, Galderma is differentiating nemolizumab as a dual-indication product for treating both prurigo nodularis and atopic dermatitis, attempting to distinguish its marketing strategy in a market with high entry barriers. However, for Galderma Korea, as a latecomer, challenges remain, including initial price barriers and the uncertainty of reimbursement listing. That is, whether or not it achieves reimbursement is considered a crucial variable for its success or failure. This is a pattern that has been repeated with previous competitor drugs. Given that it is a latecomer compared to existing drugs, the drug pricing evaluation process is likely to be complicated. How Galderma designs its non-reimbursement marketing or specialized sales targeting healthcare professionals in preparation for this will be key. Additionally, nemolizumab is expected to test Galderma Korea's capabilities in building hospital and specialized channel networks in the Korean market. For Galderma, whose primary business has focused on aesthetics and general dermatology, this presents new challenges. How nemolizumab can quickly be established as an 'essential drug' among healthcare professionals and patients and gain market presence in Korea is expected to become clearer during the approval process in the second half of this year and the launch preparation in 2026.
- Company
- BeiGene announces name change to 'BeOne Medicines'
- by Whang, byung-woo May 29, 2025 05:51am
- BeiGene announced on May 28 that it has relaunched as BeOne Medicines Ltd., a company registered in Switzerland, along with its new name. This name change marks a significant milestone for the company and is part of a broader effort to strengthen its identity within the global biopharmaceutical industry. BeiGene Korea, the domestic entity, will also change its corporate name to 'BeOne Medicines Korea,' effective June 30. John V. Oyler, founder and CEO, stated, "BeOne is more than just a name change. It's a declaration of identity, signifying 'uniting to overcome cancer' alongside diverse stakeholders worldwide, including patients, caregivers, scientists, healthcare professionals, and governments." Oyler added, "We are already opening a new era through the remarkable growth of the hematologic cancer treatment Brukinsa, the expanding potential of the immuno-oncology drug Tevimbra, and over 50 oncology pipelines." This change was officially approved at a general shareholders' meeting held on April 28. The new 'BeOne' corporate brand will be progressively applied across all global business operations spanning six continents over the next few months. The relocation of corporate registration from the Cayman Islands to Switzerland will not affect the existing policy of operating flexibly, based on regional hubs, without a fixed headquarters organization. However, it will further strengthen the company's long-term growth foundation by reinforcing its strategic position in Switzerland, a global hub for pharmaceuticals and biotechnology. BeOne Medicines has consistently invested strategically across research and development (R&D), clinical trials, and manufacturing. The company has been building differentiated competitiveness and a sustainable growth foundation. This distinct business model not only enhances time and cost efficiency but also consistently maintains high-quality standards, thereby strengthening long-term operational resilience and contributing to the expansion of treatment access for more patients. Its flagship product, Brukinsa, has secured the broadest range of indications among treatments in the same class and currently holds the leading market share for new patients across all approved indications in the United States. Brukinsa, along with the BCL2 inhibitor (sonrotoclax) and the CDAC platform-based BTK protein degrader (BGB-16673), both in late-stage development, forms a core pillar of the company's hematologic cancer treatment portfolio. BeOne Medicines' research team advanced 13 new pipelines into the clinical stage in 2024 alone, a number that surpasses even those of major global pharmaceutical companies. Its current clinical development teams, comprising 3,700 people, are conducting or preparing clinical trials in over 45 countries, accelerating early clinical innovation through a 'Proof-of-Concept' strategy. To date, over 25,000 patients have participated in more than 170 clinical trials, and this execution speed and cost-efficiency ensure differentiated competitiveness within the industry. The company continues to expand its global manufacturing capabilities, centered around US$ 800 million in R&D and production base within the Princeton West Innovation Campus in Hopewell, New Jersey, USA.
- Company
- Global expansion in sight for organoid leader CellArtgen
- by Whang, byung-woo May 28, 2025 05:58am
- Organoids, miniature organs composed of cells, are emerging as a technology to replace animal testing in the pharmaceutical and biotechnology industry. With the field of organoids gaining attention, the activities of CellArtgen, which was founded by Cho Seung-woo, a leading expert in the field and professor at Yonsei University's Department of Biotechnology, have also been drawing attention. Based on its core platform technology patents, the company has been expanding its presence by building advanced drug evaluation platforms, including the organoid disease platform 'ORANOSCREEN.’ Seung-Woo Cho. CEO of CellArtgen (Professor of Biotechnology, Yonsei University) CellArtgen was founded by Seung-Woo Cho, one of the world's leading experts in advanced biomaterials and organoid technology. As the company was established with an academic foundation, the company's strong point lies in its extensive portfolio of proprietary technologies. Dailypharm met with CellArtgen (a member of the KoreaBIO) to discuss the company's vision and strategy. The technical strengths of the CellArtgen organoid platform lie in the integration of “extracellular matrix (ECM)-based microenvironment creation technology” and “microfluidics chip technology.” Cho explained, “We remove cells from tissues or organs and introduce the remaining ECM into organoid culture. By using organ-specific ECM, we create an environment similar to actual organs, thereby enhancing the performance of organoids.” For example, to create heart organoids, the ECM matrix obtained from decellularized hearts is used to produce organoid models that not only include tissue-specific cellular components but also recapitulate the inherent microenvironment, including immune cells and vascular cells, on a standardized platform with high efficiency. In particular, CellArtgen highlights its “multi-organoids-on-a-chip” technology, which connects organoids from multiple organs onto a single chip to mimic the human body's digestive, respiratory, and nervous systems. Cho stated, “When direct interaction between organoids is required, we apply ‘assembloids,’ which combine different organoids. The fact that we have independently secured ECM materials, organ chips, and multi-organ integration technology and integrated them into a single platform is the differentiating factor of CellArtgen’s technology.” FDA regulatory changes… organoid technology gains attention The company has been gradually increasing sales and expanding its customer portfolio based on its proprietary technology. Last year, the first year of commercializing its technology, CellArtgen achieved sales of KRW 200 million, and this year, it expects sales of approximately KRW 3 billion by combining ECM products and organoid-based drug evaluation services. The market environment is also becoming more favorable for CellArtgen. The U.S. Food and Drug Administration (FDA) removed the mandatory animal testing requirement for new drug approvals at the end of 2022 and officially announced its plan to phase out animal testing last month, signaling changes in the new drug evaluation system. According to Cho, in addition to the long-term regulatory changes, the overall sentiment of pharmaceutical companies is also changing. He mentioned, “Pharmaceutical companies are showing more interest in organoid technology than before, and there is a growing movement on its practical use in the industry. The change in the atmosphere is palpable.” Cho believes that changes may occur faster than expected, particularly because global pharmaceutical companies are taking more proactive steps than large Korean pharmaceutical companies. Cho added, “Major pharmaceutical companies in the US and Europe have already made significant preparations, such as acquiring organoid companies and recruiting experts to form dedicated teams. While domestic pharmaceutical companies are still observing the situation, CellArtgen is striving to secure a leading position in line with global trends.” He also noted that the extent to which CellArtgen, which is still a bioventure, can accumulate successful cases will serve as a benchmark for its strategy to survive the global competition. In this regard, CellArtgen has already begun providing organoid model services for difficult-to-treat diseases such as MASH (metabolic dysfunction-associated steatohepatitis) and IPF (idiopathic pulmonary fibrosis) to domestic pharmaceutical companies, accumulating initial results. Cho emphasized, “Some of the major domestic pharmaceutical companies that have utilized our services have expressed satisfaction to the extent that they have requested CellArtgen’s organoid experiment services again, and are currently preparing to forge long-term partnerships. Since the service was launched less than a year ago, we have not yet accumulated many cases, but we plan to thoroughly accumulate domestic cases by the first half of next year and then begin full-scale cooperation with overseas big pharmas.” Two-track strategy of diversifying business for revenue while targeting IPO by 2027 However, while organoid services for new drug development have significant long-term potential, the company also faces the limitation of being difficult to generate substantial revenue in the short term. In response, CellArtgen has adopted a realistic strategy. The company has chosen to commercialize ECM materials, with a particular focus on expanding into the cosmetics and medical device sectors. Cho explained, “While the company's ECM technology was originally developed for organoid culture, we identified its potential to achieve a certain level of regenerative therapy effects without cells and applied it to products for wound treatment and cosmetic purposes. For example, skin ECM can be used as a wound treatment agent or in cosmetics or as skin boosters, while cartilage ECM can be utilized as a cartilage filler or a treatment material for osteoarthritis.” In other words, the company is pursuing a two-track strategy to simultaneously achieve short-term revenue and technological validation by applying ECM-based materials developed for organoid culture to wound dressings (wound treatments) and skin beauty injections. While CellArtgen’s moves might seem like a bio-venture's foray into unfamiliar territory, the company is attracting attention for its technology, as evidenced by active discussions on development partnerships with major and mid-sized domestic pharmaceutical and biotech companies. First, the company launched its ECM-based cosmetic brand, Cellumé, in the first half of the year and is currently collaborating with the cosmetics industry. Cho stated, “A major domestic cosmetics ODM company has also taken notice of CellArtgen’s ECM raw material technology, conducted sample tests, and is currently requesting product supply. Additionally, we have been selected as the finalist in an open innovation competition hosted by a top-tier domestic medical device company and have begun discussions on joint development of next-generation medical devices utilizing ECM.” CellArtgen is pursuing a business strategy centered on collaboration. After demonstrating potential through the launch of its own brand, the company is placing emphasis on open innovation by partnering with capable companies. In the medical device sector, the company is actively utilizing external projects while continuing its development. CellArtgen aims to commercialize an ECM-based Class 2 wound dressing by the end of this year and then a Class 4 cartilage regeneration filler through government projects to launch it in 2027 after clinical trials. With its dual focus on organoid services and ECM-applied products, CellArtgen plans to pursue an IPO on the KOSDAQ market around 2027. The company aims to achieve sales of approximately KRW 3 billion this year, followed by KRW 5 billion in 2026, KRW 11 billion in 2027, and then KRW 50 billion by 2030. More than half of this is expected to come from sales of the aforementioned ECM cosmetics and wound dressings. However, while securing short-term sales and attracting investment is important, the company plans to maintain its identity as a regenerative therapy company based on its organoid platform technology, which is the company’s foundational technology that could revolutionize the paradigm of new drug development. Cho added, “We believe that CellArtgen’s organoid model has global competitiveness in areas such as antifibrotic therapy and metabolic diseases, and our goal is to replace animal testing and become a game-changer in the regenerative medicine field. We have a roadmap aimed at developing regenerative therapies for intractable liver diseases.”
