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- 2026-04-03 10:38:09
- Policy
- Partial reimb for anticancer drug combos to be postponed
- by Lee, Tak-Sun May 30, 2025 05:57am
- The announcement of drugs eligible for partial reimbursement as anticancer drug combination therapy, which is currently in effect as of this month, is expected to be delayed until after June 1. Initially, the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee (CDDC) which convened on the 14th, planned to announce 35 combination therapies on June 1, but due to delays in internal government discussions, the commitment could not be fulfilled. As of the 28th, HIRA had not conducted the “public opinion survey on the revised draft of the announcement on drugs prescribed and administered to cancer patients” that contained the partial reimbursement for anticancer drug combination therapies. With only three days remaining until June 1, and considering the usual opinion survey period, it is practically impossible to announce the list by June 1. The opinion survey period typically lasts around seven days, and even if the timeline is shortened, the prevailing view is that a June 1 announcement is unlikely. As a result, confusion in the field is unavoidable for the time being. Earlier, the MOHW established partial reimbursement for anticancer drug combination therapies by revising the “Details on the Application Standards and Methods for Medical Care Benefits (Drugs)” starting this month. Although this falls within the scope of the MFDS's approval, the MOHW intends to apply the existing coinsurance payment for existing anticancer therapies in cases where such anticancer therapies are reimbursed and used in combination with other anticancer drugs that are not included in the reimbursement standards. However, confusion arose in the medical field as it was unclear which drugs were eligible for reimbursement. This was because the MOHW did not provide detailed information on which drugs were eligible when it announced the revision. In response, HIRA hastily opened a CDDC meeting and decided to announce the 35 cases eligible for partial reimbursement as of June 1. At the time, HIRA stated, “In order to reduce confusion in practice and ensure predictability in the application of the detailed notification on existing reimbursed anticancer therapies used in combination with other anticancer drugs, we discussed the list of combination therapies, taking into consideration each indication and the opinions of academic societies. We decided to announce the list as soon as possible, to implement it on June 1.” “We also plan to review other combination therapy options that academic societies apply for after deliberation by the Cancer Disease Deliberation Committee.” However, it is now unlikely that the June 1 announcement committeemen will be kept. The MOHW has been showing a cautious stance, explaining that HIRA's partial reimbursement announcement was working against the original intent of the revision and included elements that would rather limit reimbursement. As a result, internal discussions have been prolonged, and it is believed that HIRA was unable to seek opinions on the revised announcement in time. However, HIRA has confirmed that it believes the announcement of the drugs eligible for partial reimbursement is necessary to reduce confusion in the field. Therefore, even if the announcement is delayed, it is expected that HIRA will seek opinions on the revised announcement soon.
- Opinion
- [Reporter's View] Addressing drug shortage, healthcare
- by Lee, Jeong-Hwan May 30, 2025 05:57am
- Ahead of Korea's early presidential election, scheduled for June 3, leading candidates have prioritized pledges to strengthen government support for essential medicines·address drug shortages. Lee Jae-myung, the candidate for the Democratic Party of Korea, included the resolution of a supply shortage of essential medicines in his top 10 pledges, suggesting the possibility of a partial introduction of generic name prescribing for drugs such as flu treatments and cold medicines. Kim Moon-soo, the candidate for the People Power Party, also promised to create a system for detecting drug supply shortages, establish a public electronic prescription system, and set up a drug supply management committee. Lee Jun-seok, the candidate for the Reform Party, also acknowledged that frequent drug shortages are a pressing concern for pharmacists, indicating his intention to establish an independent channel with the Korean Pharmaceutical Association (KPA) to discuss related solutions. Likewise, the inconvenience faced by pharmacies and patients due to shortages of frequently sought-after essential medicines has remained unresolved for several years, becoming a nationwide headache to the extent that presidential candidates have uniformly listed it as their top pharmacy-related pledge. While pharmacists review their drug shortage checklists every morning and respond to the chaos by exchanging drugs with nearby pharmacies through local communities and KakaoTalk, they are frustrated that the process remains haphazard. These are the reasons the KPA proposed to the presidential candidates the establishment of a government-level drug shortage management system. The aim is to advance beyond merely sharing information about some drug shortages through the Drug Utilization Review (DUR) service and for the government to establish a system that assumes social responsibility. The newly appointed president, following the election, and the new government need to design and implement policies with a mission to find fundamental solutions to drug shortage issues, thereby strengthening national health security and pharmaceutical sovereignty. The drug shortage problem arises due to the instability of active pharmaceutical ingredient (API) supply due to accelerating drug nationalism. To domestically produce APIs that have low profitability, the government must provide sufficient incentives. In other words, the government must exert its public role to the fullest, encouraging domestic approval and manufacturing of essential drugs by pharmaceutical companies to improve self-sufficiency rates and also advance the distribution lines of produced medicines. Suppose a system is also created that can quickly promote the supply of the relevant active ingredient/product or alternative drugs when sudden shortages occur in local pharmacies. In that case, the frequent occurrence of drug shortages being raised at the annual national audit will decrease. We anticipate the election of a president who will operate the existing public-private consultative body for drug shortages, thereby implementing policies and budgetary solutions into actual systems to ensure organic cooperation among the pharmaceutical industry, the pharmacy community, and drug distribution.
- Opinion
- [Reporter’s View] Reimbursing the only RET-targeted therapy
- by Eo, Yun-Ho May 29, 2025 05:52am
- News of a new drug failing to be listed for insurance reimbursement always upsets patients. The blow is even harder when it is the only treatment option available. Such was the case in 2023 when the National Health Insurance Service and Lilly failed to reach an agreement on the price of the RET-targeted anticancer drug Retevmo (selpercatinib). This was the only case of a drug price negotiation failure that year. This drug was the first treatment option for patients with RET fusion-positive non-small cell lung cancer and thyroid cancer, and the only drug that was being reviewed for reimbursement in Korea. With the reimbursement listing of Retevmo falling through, patients were left to endure an indefinite wait. Then, this year, the developer, Lilly Korea, finally reaffirmed its commitment. Lilly recently submitted a reimbursement application for non-small cell lung cancer along with an indication for thyroid cancer. This is the company’s third attempt. Prior to the approval of Retevmo, there were no targeted treatment options available for patients with RET-mutated NSCLC or thyroid cancer. Therefore, the Ministry of Food and Drug Safety approved Retevmo through a fast-track review for the treatment of:▲ adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); ▲adults and pediatric patients 12 years of age or older with advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; and ▲ adult patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or lenvatinib treatment, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy. Among the A7 countries that are used as Korea’s drug price reference countries, Retevmo is covered and used in 6 countries (US, Germany, Italy, UK, Switzerland, and Japan) other than France. However, despite the considerable time that has passed, it is still not reimbursed in South Korea. The MFDS has been operating an expedited review system to promptly launch and supply highly innovative drugs for life-threatening or serious conditions to the market and patients. However, only a handful of the 23 approved through the fast track is currently being reimbursed by insurance. This means that even after the drugs receive accelerated approval through fast-track review, it is difficult for cancer patients to receive treatment benefits without reimbursement. While regulatory authorities often determine that rapid introduction is necessary, it is frequently the case that insurance authorities remain cautious and conservative. When it comes to the introduction and improvement of systems, ‘effectiveness’ is always a top priority. This reporter hopes that policies aimed at improving patient access to innovative new drugs can achieve the intended effect.
- 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.
- Policy
- Lee pledges ‘generic prescribing for essential medicines'
- by Lee, Jeong-Hwan May 29, 2025 05:51am
- The Democratic Party of Korea’s presidential candidate Jae-Myung Lee (No. 1) pledged to introduce a limited implementation of the generic (ingredient-based) prescription system for essential medicines with unstable supply. The pledge also included plans to institutionalize telemedicine (non-face-to-face treatment) and establish a public electronic prescription transmission system to enhance patient safety and convenience. Also, plans to establish a neighborhood-based primary healthcare system centered on the patients’ regular clinics and pharmacies, and strengthen interprofessional collaboration among healthcare professionals, and secure adequate personnel were included. To resolve the instability in the supply of essential medicines, the candidate promised to establish a public consignment manufacturing and distribution system. To lay the groundwork for this, the candidate plans to expand support for the production and stockpiling of essential and shortage prevention medicines, actively support the development of technologies for the localization and self-sufficiency of essential raw materials and vaccines, and expand incentives for finished drugs using domestically produced raw materials. Lee also revealed his intention to establish a system linking new drug R&D investment ratios with drug price compensation systems and to strengthen the social responsibility of pharmaceutical companies by improving the Korea Innovative Pharmaceutical Company certification system. Lee issued the Democratic Party of Korea’s Central Policy Pledge Book on the 28th and announced that he would “strengthen national investment and responsibility in the pharmaceutical and biotechnology industry and establish a stable supply system for essential medicines.” Will address drug shortages through ingredient name-based prescriptions... establish a public electronic prescription system The most notable part was the pledge to introduce ingredient name-based generic prescriptions for essential medicines to address the problem of unstable supply. In addition, Lee announced plans to promote substitute prescriptions to resolve drug shortages and establish a public manufacturing and distribution system to stabilize the supply of essential drugs. At the same time, the candidate promised expanded support and stockpiling for manufacturing facilities of essential and drug shortage prevention medications, and active support for the development of domestic manufacturing and self-sufficiency technologies for essential raw materials and vaccines. Incentives for finished drugs using domestically produced raw materials will also be expanded. Telemedicine will also be institutionalized with consideration for medical quality and safety. The plan aims to establish a legal basis for telemedicine as a complementary means to face-to-face medical care and halt indiscriminate pilot projects. Lee will ensure medical quality and safety by setting reasonable scope and standards for telemedicine, while announcing plans to prohibit dedicated medical institutions and strengthen the management system for platform operators. The construction and utilization of a public electronic prescription transmission system are also included in the policy pledge. The plan is to establish a public electronic prescription system to ensure patient safety and prevent prescription forgery and misuse. Patient safety will be strengthened by preventing prescription information input errors in advance. Introduction of a drug price linkage system for new drug R&D…Improvement of the Korea Innovative Pharmaceutical Company certification system For the pharmaceutical and biotechnology industry, Lee included the establishment of a support system for innovative pharmaceutical companies and the strengthening of social responsibility for pharmaceutical companies. Lee also pledged to establish a drug price compensation system linked to R&D investment ratios, whereby pharmaceutical companies that invest more in new drug R&D will be rewarded with higher drug prices. Also, the pledge included a proposal to improve the certification system for Korea Innovative Pharmaceutical Companies, taking into account continuous investment and innovation, and encouraging pharmaceutical companies to expand their social contributions and diversify their contribution methods. Notable proposals for expanding national investment and reforming the compensation system to foster a pharmaceutical and biotechnology powerhouse included strengthening the strategic R&D investment system and the performance-based public return support system, establishing an investment ecosystem such as a bio-specialized fund, and concentrating efforts to cultivate specialized human resources. To encourage R&D investment, Lee pledged to integrate drug price management reforms to ensure predictability and create an ecosystem that integrates new technologies such as AI and big data for global new drug development. To improve the accessibility and innovation of medicines, Lee will promote the expansion of risk-sharing agreements (RSA) and, as part of its commitment to preparing for the next pandemic, expand support for research and development of next-generation vaccine platforms such as mRNA and synthetic antigen technology. The candidate will establish a governance framework for responding to the next pandemic, advance the infectious disease response system, expand joint research on infectious diseases, and strengthen international cooperation in responding to public health crises. Additionally, he pledged to support sustainable and appropriate ODA cooperation in the health sector commensurate with the nation's standing.
- Policy
- Lee ‘promises support for essential medicine companies’
- by Kang, Shin-Kook May 29, 2025 05:50am
- Jae-Myung Lee, presidential candidate for the Democratic Party of Korea, promised to support pharmaceutical companies producing essential medicines. On the 28th, Lee posted on his social media, “The state will take responsibility for supporting the supply of essential medicines. Over the past 5 years, the supply of over 100 essential medicines has been discontinued due to poor sales and deteriorating profitability. If essential medicines are not supplied on time, the damage will ultimately fall on the people.” He also stated, “We will expand the emergency introduction of essential medicines through the Korea Orphan & Essential Drug Center and push for support for domestic pharmaceutical companies.” Additionally, Lee noted, “Last year, there were 370,000 patients with rare diseases and 750,000 patients with severe and intractable diseases. This represents a 27.4% increase over the past 5 years.” He emphasized, “For these patients, what’s even harder to bear than the disease itself is that there is either no treatment available or the existing one is too expensive to afford?” He added, “The state must stand close to the pain of its people. We will ensure that patients with rare and intractable diseases are diagnosed early and receive timely treatment. We will strengthen the medical safety net with broader and thicker coverage.” The candidate promised to reduce the burden of medical expenses for patients with rare and intractable diseases. Currently, the out-of-pocket maximum system reimburses medical expenses exceeding a certain annual threshold, but this remains a significant burden for patients and their families who must pay large sums upfront. The candidate emphasized, “We will gradually reduce the out-of-pocket coinsurance rate under the health insurance special calculation system for rare and severe intractable diseases from the current 10%. We will alleviate concerns about treatment costs.” He also stated, “We will expand health insurance coverage for treatments for severe and rare intractable diseases. Currently, only about half of rare drugs are covered by health insurance. We will expand coverage to improve access to treatment and reduce the economic burden.” Additionally, he declared, “The primary responsibility of the state is to protect the lives of its citizens. We will build a country that does not give up on rare diseases or turn away from intractable diseases.”
- 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.”
- Policy
- 'Cabometyx' for ncRCC, failed to nego for expanded reimb
- by Lee, Tak-Sun May 28, 2025 05:57am
- Product photo of Cabometyx The anticancer drug Cabometyx tab (cabozantinib, Ipsen Korea), a treatment of kidney cancer, did not pass the expanded reimbursement during negotiations with the National Health Insurance Service (NHIS). Cabometyx tab gatherered attention following reimbursement for the first-line treatment of patients with non-clear renal cell carcinoma (ncRCC), which account for 10-15% of all kidney cancer. However, it will take more time due to the current failed negotiation. On May 26, the National Health Insurance Service (NHIS) announced on its website that 'Cabometyx' had failed to negotiate. This drug was determined to have appropriateness for expanded reimbursement by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review & Assessment Service (HIRA) in February, provided that the company accepted a price below the evaluated amount. After that, the pharmaceutical company accepted a price below the evaluated amount, and drug price negotiations withthe NHIS have been ongoing since March. Cabometyx was initially listed for reimbursement in February 2019 as a monotherapy for patients with advanced renal cell carcinoma who had previously received VEGF-targeted therapy. As of March 2022, it was reimbursable in combination therapy with the immuno-oncology drug nivolumab (Opdivo) in patients with advanced renal cell carcinoma. The company continued to push for further expanded reimbursement. In August of last year, the Cancer Disease Review Committee (CDRC) reviewed its use as a 'monotherapy in patients with locally advanced or metastatic differentiated thyroid cancer (DTC) who have previously received VEGF-targeted therapy or whose disease has progressed during treatment, and who are ineligible for or refractory to radioactive iodine therapy (RAI)' and 'first-line monotherapy in patients with non-clear cell renal cell carcinoma.' However, reimbursement criteria were not established at that time. However, in February of this year, DREC approved the ncRCC indication. Clear cell renal cell carcinoma (ccRCC) accounts for 80-85% of kidney cancers, with the remaining 10-15% being ncRCC. Despite ncRCC having a poorer treatment response compared to clear cell, there are currently few drugs covered for reimbursement. However, Cabometyx has emerged as a targeted therapy, gaining attention as a next-generation treatment option. The problem is the lack of reimbursement. With the breakdown of these negotiations, it is expected to take more time for Cabometyx to obtain reimbursement for ncRCC. Meanwhile, the NHIS announced that it is in negotiations with Novartis for 'Leqvio pre-filled syringe.' This drug, intended for the treatment of primary hypercholesterolemia or mixed dyslipidemia, passed the DREC in April.
- Company
- KDDF successfully holds 2025 KDDF Global Biotech Showcase
- by Whang, byung-woo May 28, 2025 05:55am
- 2025 KDDF Global Biotech Showcase Group Photo [The Korea Drug Development Fund (KDDF, CEO Yeong-Min Park) announced on the 27th that it will hold the '2025 KDDF Global Biotech Showcase' to attract overseas investment for excellent new drug candidates developed in Korea. The showcase, which will be held over two days from May 27 to 28 at the Fairmont Ambassador Seoul Hotel, will focus on 1:1 partnering meetings with venture capitalists (VCs), where companies and investors will meet directly to discuss specific cooperation plans, to inject practical vitality into the domestic new drug development ecosystem. Additionally, the event will focus on strengthening domestic pharmaceutical and biotech companies’ presence in the global market and accelerate new drug development through collaboration with investors. Even in the current contracted global investment environment, it is crucial to provide domestic pharmaceutical and biotech companies with opportunities to connect with global investors and pharmaceutical firms through trusted platforms. This approach lays the groundwork for overseas expansion and technology transfer while building trust through ongoing communication with investors. The opening ceremony was attended by Chang-Yune Lee, 1st Vice Minister of Science and ICT, who expressed the government's high level of interest and support. In his congratulatory address, Deputy Minister Lee said, “The Korean government recognizes the pharmaceutical and biotechnology industry as a core industry that will determine the future competitiveness of the country. I expect today's event will serve as an important catalyst for the development of the industry.” Now in its third year, the event has seen a significant increase in participation from global VCs as well as domestic VCs and CVCs (corporate venture capital). The event strategically expanded the investment value chain by structuring it to enable follow-on investment discussions that connect early-stage funding, commercialization, and entry into domestic and global markets. A total of 67 investors, including global and domestic VCs and CVCs, will participate in various programs such as panel discussions, special lectures, roundtable meetings, and one-on-one partnering meetings. Park said, “We anticipate that this event, where domestic and international investors gather in one place, will serve as a turning point for domestic new drug development companies and institutions to secure substantial investments.” He emphasized, “The KDDF will further strengthen its role as an industrial ecosystem platform that accelerates the Korean companies’ entry into the global market.” The participating global VC and CVC institutions are as follows: ▲AbbVie Inc. ▲Johnson & Johnson Innovation ▲Boehringer Ingelheim ▲Boehringer Ingelheim Venture Fund ▲Novo Holdings ▲ARCH Venture Partners ▲L illy Ventures) ▲Roche ▲Roche Accelerator ▲Solasta Ventures ▲YAFO Capital ▲Playground ▲Panacea Venture ▲Pivotal BioVenture Partners ▲Avidity Partners ▲DCI Partners (DCI Partners Co., Ltd.) ▲Mass General Brigham Innovation ▲Qiming Venture Partners ▲Humboldt fund ▲JLABS ▲Ascenta Capital ▲Astellas Venture ▲Lexington Partners. Domestic VC/CVC participating institutions are as follows. ▲IMM Investment ▲Mirae Asset Capital ▲Partners Investment ▲Woori Venture Partners ▲Intervest ▲ Widwin Investment ▲KB Investment ▲CKD Venture Capital Inc ▲HLB Investment ▲Daewoong Investment ▲Scale Up Partners ▲LSK Investment Co., Ltd ▲Stonebridge Ventures ▲KB Securities ▲Kakao Ventures ▲ Korea Technology Finance Corporation ▲Samil PwC ▲Celltrion ▲SK Biopharm ▲LG Chem ▲Huons ▲Huons Global ▲GC Cell (Green Cross).
