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- 2025-12-22 02:59:45
- Policy
- "Will maintain stability of essential·short supply drugs"
- by Lee, Jeong-Hwan Mar 28, 2025 06:39am
- The government will reportedly provide necessary administrative support for a stable supply of essential drugs and medications and improve the system so that innovative new drugs and new medical devices can quickly introduced into medical practices. Preferential pricing for national essential drugs that use domestically sourced raw materials will be implemented in the first half of this year. In contrast, the government will continuously increase the prices of drugs that are in supply instability. For innovative new drugs, specific innovation criteria will be applied during cost-effectiveness evaluations, and the policy of offering preferential pricing for drugs developed by companies with a high proportion of R&D investment will be maintained. Additionally, detailed timelines have been established for initiatives aimed at ensuring fair compensation for essential medical services and for innovating non-reimbursable and private insurance to safeguard the sustainability of the National Health Insurance budget. On May 27, the Ministry of Health and Welfare (MOHW) convened the 6th Health Insurance Policy Review Committee for 2025. It reviewed and approved this year’s implementation plan under the '2nd National Health Insurance Comprehensive Plan (2024–2028).' Maintaining stability of essential drugs·providing preferential pricing of innovative new drugs The government will continue to ensure a stable supply of essential medicines and therapeutic materials while improving the regulatory system to enable the rapid market entry of innovative new drugs and medical devices. To secure supply stability, the government will implement preferential pricing to nationally essential drugs that use domestically sourced raw materials, and drugs with supply instability will have their prices promptly increased continuously. In addition, a system for monitoring, analyzing, and addressing shortages of therapeutic materials will be established. Establishment of monitoring·analyzing materials of supply instability and response measures For innovative new drugs, cost-effectiveness evaluations will incorporate specific innovation criteria (revised on August 2024). Drugs developed by pharmaceutical companies with a high R&D investment ratio will receive preferential pricing. Innovative medical devices that have undergone an extended deferment period and rigorous clinical evaluation and have subsequently received MFDS approval will be allowed immediate market entry. The government will also expand the access to and use of National Health Insurance data for public interest research, scientific studies, and self-directed health management while supporting international cooperation through organizations such as the WHO and OECD in matters related to health insurance systems and initiatives. Enhancing the Supply of Essential Medical Care·Ensuring Fair Compensation To eliminate low-reimbursement structures and address overall imbalances in health insurance fees, more than 1,000 fee items for surgeries, procedures, and anesthesia will receive targeted increases by the first half of this year. In particular, fees in high-difficulty areas and resource-intensive, such as pediatric and emergency services, will be significantly raised, with rapid adjustments planned for over 2,000 low-reimbursement items by 2027. Furthermore, the cost survey framework will be strengthened by establishing a fee-determination system linked to conversion indices and relative value scores, developing standardized cost-calculation guidelines, and expanding the panel hospital network. Reimbursement for high-difficulty medical procedures, such as additional age-based fees for pediatric surgery, will be reinforced, and public policy fee support for maintaining maternity care infrastructure will continue. The performance of pilot projects for alternative payment systems, which offer differential reimbursement based on the quality and outcomes of care rather than volume, will be evaluated, with ongoing efforts to sustain their implementation. Closing medical care access gaps and ensuring a healthy life To provide uninterrupted healthcare, long-term care, and support services across each region's acute, recovery, and chronic phases, the government will strengthen local medical institutions and expand integrated healthcare and care support. To establish a regionally comprehensive essential healthcare system, the government will provide support to key regional hospitals—such as national university hospitals and general hospitals—through funding for faculty salaries (KRW 26 billion) and for facilities and equipment (KRW 81.5 billion), as well as low-interest loans of KRW 120 billion for any additional necessary resources. These measures aim to enhance institutional capacity, expand the infrastructure for recovery-phase healthcare institutions, and reinforce long-term care support systems (including nursing and caregiving services) in preparation for an aging society. Efforts to promote routine health management to prevent complex and chronic diseases will be strengthened, with additional support provided in high-demand areas such as mental health, women's and pediatric care, and end-of-life care. Moreover, ongoing measures will continue to strengthen the healthcare safety net to address underserved areas. The government will strengthen the healthcare safety net to close access gaps. This includes the ongoing promotion of pilot projects for primary care for individuals with disabilities and in dental care, as well as the expansion of reimbursement for treatments targeting severe and rare diseases (with 20 new items expected to be added and the reimbursement scope broadened for 10 additional items), all designed to enhance access to healthcare for vulnerable populations and alleviate their financial burdens. Enhancing the financial sustainability of National Health Insurance The National Health Insurance system will be fostered sustainably by managing medical supply by ensuring adequate hospital beds, installing·operating high-quality medical equipment, and encouraging appropriate healthcare utilization through demand management. Non-reimbursable services and indemnity insurance management will also be strengthened to promote appropriate healthcare usage. For non-reimbursable services prone to overuse, measures such as applying managed reimbursement and requiring pre-service explanations and informed consent will be enforced. Reimbursement for non-reimbursable services related to cosmetic or plastic surgery will be limited, especially if provided alongside reimbursable services. Furthermore, to rationalize the co-payment coverage under private insurance and prevent distortions in the healthcare system, non-reimbursable services will be appropriately covered. At the same time, review processes are strengthened and transparency is enhanced. Moreover, financial management transparency will be boosted by expanding the disclosure of financial indicators, such as fund operation status (March) and financial settlement status (May), publishing annual five-year financial forecasts, and enhancing the accuracy of short-term forecasts, all aimed at improving the overall management framework. The MOHW stated, "Through the '2nd National Health Insurance Comprehensive Plan (2024–2028), we plan to reach a goal for strengthening essential medical care and establishing sustainable National Health Insurance," adding, "We will also integrate these initiatives with the '2nd Healthcare Reform Implementation Plan' and other reform projects and effectively implement."
- Opinion
- [Reporter's View]Unifying the price of pneumococcal vaccines
- by Eo, Yun-Ho Mar 28, 2025 06:38am
- The National Immunization Program (NIP) is the ideal “goal” for vaccine-holding pharmaceutical companies. This is because the government's policy of purchasing vaccines and providing them free of charge to the public, above all, ensures stable sales. Therefore, when the government announces that it has selected a preventive vaccine for a specific disease for NIP, companies with relevant vaccines begin to compete fiercely. Companies deploy various strategies to increase market share within the set market as well as to be selected for NIP. The National Immunization Program (NIP) of pneumococcal vaccines has recently been in the spotlight. The new addition of 'Prevnar 20' from Pfizer Korea, the original leader in the market, has stirred the battle between multinational pharmaceutical companies' premium vaccines. Pfizer’s pneumococcal vaccine pipeline, which ranges from Prevnar and Prevnar 13, has virtually dominated Korea’s market. In this market, a new 15-valent vaccine, MSD's Vaxneuvance, joined as a new player and driven change, so Pfizer is aiming for the throne again with its new 20-valent vaccine. At the core of the claim of the “superiority” of these new vaccines is serotype coverage. If 13 serotypes are covered, it is called a 13-valent vaccine; if it covers 15 it is a 15-valent, and 20 a 20-valent vaccine. The general perception is that a vaccine that covers more serotypes has a relatively higher level of preventive power. However, a higher serotype coverage does not necessarily mean better preventive power. However, the fact that a product “covers more serotypes” to prevent the same disease resonates with the consumers. In the NIP market, the vaccine with the highest price has always been the winner. However, there has been an interesting change in the stance of pharmaceutical companies entering the NIP with their pneumococcal vaccines. The companies have decided to supply their newly developed products at the same price as their existing vaccines. This is called price unification. The reason why the change is interesting is this: When Prevnar 13 was introduced to the NIP, Pfizer insisted on differentiating it from its strong competitor, GSK Korea's 10-valent vaccine ‘Synflorix,' and demanded a dual pricing system, which was implemented. The same goes for MSD. This company also requested a different price from GSK's 'Gardasil' and ‘Cervarix,' which are quadrivalent vaccines, when they entered the NIP for HPV vaccines. This is called the dualization of prices. The dualization of prices means the government's discrimination in the purchase price of NIP vaccines. If the prices of the 2 vaccines granted by the government are different even though they are free vaccines, the majority will choose to take the higher-priced option. The result was clear. However, for some reason, neither MSD, when it entered the market with its 15-valent vaccine, at a time when the 13-valent vaccine was the best, nor Pfizer, when it launched its 20-valent vaccine, demanded a price differentiation for their more serotype coverage. Both pharmaceutical companies chose to standardize their prices. Even though they have pride in their follow-up products. This is a reflection of the correct market logic. The situation in the pneumococcal vaccine market is different from the time when there was a price dualization. Rather than taking the time to raise the price of both the 15-valent and 20-valent vaccines, the companies decided to enter the market as quickly as possible. It is only natural for a company to pursue profit. The strategy may vary depending on the strategic decision to attract sales by competing with competing products. Before, the strategy was ‘dualization of price,' but now it is 'unification.' However, the message of 'for the health of the people' does not seem to be the reasoning behind the companies’ choice of unifying the price.
- Company
- Lotte Biologics’ CMO business makes smooth progress
- by Chon, Seung-Hyun Mar 28, 2025 06:38am
- Lotte Biologics has been making smooth progress, building a new plant since its launch. Three years after its launch, it has received a total of KRW 800 billion from its parent company and is speeding up the construction of its Songdo plant. The US plant, which was acquired 3 years ago, also generated more than KRW 200 billion in sales every year. On the 27th, according to the Financial Supervisory Service, Lotte Biologics decided on the 26th to issue KRW 210 billion in paid-in capital to its shareholders. The new shares will be issued to Lotte Biologics shareholders in the form of 3,231,000 shares. The new shares to be issued will account for 35.8% of the total number of shares issued before the capital increase, which is 9,017,500 shares. The issue price of new shares is KRW 65,000 per share. Lotte Biologics, which was launched in June 2022, is owned by Lotte Corporation and Lotte Holdings, which have 80% and 20% stakes, respectively. Lotte Corporation and Lotte Holdings are estimated to have invested KRW168 billion and KRW 42 billion, respectively, in this paid-in capital increase. Lotte Corporation said, “We will invest KRW 168 billion to maintain control over Lotte Biologics and enhance its business competitiveness.” Lotte Biologics Lotte Corporation entered the biopharmaceutical industry in May 2022 by acquiring the BMS plant in eastern New York for USD 160 million (about KRW 200 billion). The BMS plant is a production facility dedicated to biopharmaceuticals, with an annual production capacity of 35,000 liters. Lotte also signed a USD 220 million Contract Manufacturing Organization (CMO) contract with BMS for biopharmaceutical production. In June 2022, Lotte Holdings officially entered the biopharmaceutical business by launching Lotte Biologics. Lotte Biologics will use the funds it has raised this time to build a factory in the Songdo Bio Campus. Lotte Biologics signed a memorandum of understanding (MOU) with the Incheon Metropolitan City and the Incheon Free Economic Zone in June 2023 to build a mega plant in Songdo, Incheon. Lotte Biologics plans to build 3 mega plants with a total capacity of 360,000 liters by 2030. Lotte Biologics began construction of Plant 1 in the Bio Campus in Songdo, Incheon, in March last year, and aims to obtain GMP approval by the second half of 2026 and start operations in 2027. This is the fourth paid-in capital increase made since Lotte Biologics' launch. Lotte Biologics conducted a paid-in capital increase through allocation to shareholders of KRW 210.6 billion in December 2022. In March 2023, it raised KRW 212.5 billion through a paid-in capital increase. Lotte Biologics also decided to conduct a paid-in capital increase of KRW 150.1 billion in June last year. When this capital increase is completed, Lotte Biologics will have raised a total of KRW 783.2 billion from its parent company through 4 paid-in capital increases since its launch. Lotte Biologics was launched with a capital of KRW 13 billion and has received a total of KRW 796.2 billion in investment from its parent company. The company has been generating steady profits from the BMS plant it acquired at the time of its launch. Lotte Biologics inherited the existing CDMO contract when it acquired the BMS plant. The drugs that BMS was producing will continue to be produced for the next three years after Lotte acquired the plant. It is reported that the BMS's immuno-oncology drugs 'Opdivo' and 'Yervoy', the kidney transplant immunosuppressant ‘Nulojix,’ and the multiple myeloma treatment ‘Empliciti’ were produced at the Syracuse plant. Lotte Biologics has set a goal of achieving sales of KRW 1.5 trillion by 2030. Lotte Biologics recorded sales of KRW 234.4 billion and an operating loss of KRW 66.3 billion last year. Lotte Biologics generated its first sales of KRW 228.6 billion in 2023. The cumulative sales of Lotte Biologics since its launch have been tallied at KRW 463 billion. Lotte Biologics announced its CDMO business vision at the JP Morgan Healthcare Conference in January. CEO James Park presented the successful CDMO transformation of the Syracuse Bio Campus in New York and the blueprint for the Songdo Bio Campus. He expressed an ambition to accelerate Lotte Biologics’ leap into the global CDMO market, unveiling its innovative proprietary ADC platform SoluFlex Link, and announcing plans to provide an ADC one-stop service in collaboration with finished drug product partners in North America. SoluFlex Link is an ADC platform that uses a unique linker technology jointly developed by Lotte Biologics and Kanaph Therapeutics, a drug fusion technology bioventure. The company believes SoluFlex Link improves instability, which is a major drawback of antibody-drug conjugates (ADCs) and can be used with various antibodies and payloads. “New ADC drug developers can conduct various research and development with this technology,” said Lotte Biologics. “We believe that can offer an optimized solution for the development and production of next-generation ADCs because it can increase production yield and treatment efficiency.”
- Company
- Shaperon discusses licensing out Nugel technology to Europe
- by Lee, Seok-Jun Mar 28, 2025 06:38am
- On the 27th, Shaperon announced that it has recently entered into discussions with global pharmaceutical companies about licensing out its next-generation atopic dermatitis treatment, NuGel, at Bio Europe Spring 2025, which was held in Europe. The company emphasized that it is accelerating the process of securing the company’s fiscal soundness by generating revenue through the commercialization of its technology, especially since it has made considerable progress during discussions with some large pharmaceutical companies. Shaperon held partnering meetings with a total of 27 companies, including large global pharmaceutical companies and global leaders in the field of dermatology at Bio Europe. Discussions were made around Nugel, the company's core pipeline. The large European pharmaceutical companies that had first meetings at this event also showed interest in Nugel and Shaperon’s major pipelines, including its preclinical alopecia areata treatment and treatment for idiopathic pulmonary fibrosis. Through this conference, Shaperon received requests from a number of global pharmaceutical companies that it had previously been in contact with and received on-site inspection requests on Nugel’s technical data, moving past the confidentiality agreement stage. The company explained that its interest in Nugel has increased considerably since the results of Part 1 of the Phase IIb clinical trial, which was recently completed in the United States, were positively received by many pharmaceutical companies. Europe is a key market that accounts for about 28% of the global atopic dermatitis treatment market. Many of the companies leading the development of atopic dermatitis treatments are based in Europe. “As several companies have expressed interest and are actively discussing the matter, we expect to see tangible commercialization results in the near future,” said a Shapreon official. “We plan to further accelerate the commercialization of Nugel through follow-up discussions with the pharmaceutical companies that are currently in talks.” Nugel is a treatment for atopic dermatitis that targets the ‘GPCR19 receptor’. It is characterized by its superior efficacy and safety compared to existing treatments through the inflammatory complex modulating mechanism of action that encompasses innate and adaptive immunity. Shapreon has begun recruiting patients for Part 2 of the Phase IIb trial in the United States, which is currently being conducted on 177 atopic dermatitis patients and is expected to receive the final report on Phase IIb in the first half of next year.
- Policy
- "Regulatory hurdle eliminated to simply refund-type RSA"
- by Lee, Jeong-Hwan Mar 28, 2025 06:37am
- The government saw eliminating regulatory hurdle as a success in exempting the efficacy·cost-effectiveness evaluation procedure during the 'third-contract termination evaluation' for pharmaceuticals on the basic refund-type RSA for over 10 years. Even drugs that have been subject to fines or other administrative sanctions can still have their prices increased through negotiations with the National Health Insurance Service (NHIS) if supply shortages disrupt patient care. For example, if a pharmaceutical company that produces plasma fractionation products can prove production cost increases based on additional research into pricing models for raw plasma and related inputs, the government covers not only past losses but also future cost escalations, a policy to raise prices accordingly. This measure is regarded as a notable case of eliminating regulatory hurdle. On March 25, the government convened the 6th Bio-Health Innovation Commission at the ARPA-H Promotion Team conference room on the 16th floor of City Tower in Jung-gu, Seoul, chaired by Director Kim Young-tae, Vice Chairman from the private sector and Director of Seoul National University Hospital, to discuss improvements to so-called "killer regulations." The Ministry of Health and Welfare (MOHW) suggested several regulatory improvement initiatives, including enhancements to the repeated re-evaluation process for risk-sharing agreements, revisions to the evaluation criteria for drug price caps, and establishment of a cost-calculation methodology for plasma fractionation products. Under revised guidelines, drugs subject to a basic refund-type RSA contract that has been used for more than 10 years can exempted from the utility and cost-effectiveness assessment during the 'third-contract termination evaluation.' The MOHW believes these changes will help resolve issues such as the devaluation of new drugs due to repeated re-evaluation under risk-sharing agreements and the consequent delays in the domestic introduction of new therapies. As of January of this year, the MOHW improved the evaluation criteria so that even drugs facing administrative sanctions, such as fines, can be considered for ceiling price adjustments to enhance patient treatment access and ensure pharmaceutical access. In cases where drug supply shortages may disrupt patient care, it has become possible to negotiate with the NHIS to raise drug prices. Furthermore, the government implemented the regulatory revision to improve plasma fractionation products' stable supply and cost-effectiveness. After a decision by the Health Insurance Policy Deliberation Committee, a change has been made to the price ceiling for plasma fractionation products that are already listed. If a manufacturer can substantiate, based on additional research into pricing models for raw plasma and similar inputs, that cost-increasing factors exist, then prices may be raised not only to cover past losses but also to account for future cost escalations. The MOHW has also relaxed the criteria for accepting efficacy evidence in high-risk advanced regenerative medicine clinical trials. In order to alleviate the burden associated with such high-risk studies of advanced regenerative medicine, the 'Guidelines for Reviewing and Preparing Advanced Regenerative Medicine Clinical Trial Plans' have been revised to establish exception criteria for safety and efficacy evidence. Through these measures, institutions conducting regenerative medicine trials will be able to choose appropriate testing methods that can adequately demonstrate safety and efficacy, even if there are variations in administration routes or methods, provided that additional supporting data justifying changes in clinical design are submitted in line with the specific characteristics of each study. Monitoring implementation of Bio-Health Training Strategies An assessment of the progress of 81 bio-health training projects, managed by nine ministries in 2024, revealed that a total of 44,800 bio-health professionals have been trained. This figure far exceeds the target of 22,100 reported to the 2nd Bio-Health Innovation Commission last year. The government analyzed that this substantial increase is due to growing interest in the bio-health sector, which has led to the establishment of new courses, increased demand for education, and an expansion of educational institutions. In detail, in one of the four major areas of bio-health human resource development, such as "industry-based school education," enhanced practical training and strengthened industry-academia linkages have produced approximately 16,400 professionals. In addition, around 20,000 individuals have been trained in the area of production and regulatory science, including workforce development (through institutions like K-NIBRT), regulatory science, and continuing education for current employees. Furthermore, to support the NEXT semiconductor leap through core research human resource development, via initiatives in AI-driven drug development, specialized graduate schools, and programs for physician-scientists, about 8,000 professionals have been trained, and projects aimed at stimulating local employment and linking job creation with start-up support have also been successfully advanced. This year, in line with the plans of the various ministries, 10 of the original 81 projects that have either been completed or will not be pursued this year will be excluded, while 7 new projects will be initiated. In total, 26,900 professionals are planned to be trained across 78 projects. Additionally, the government will focus on expanding interdisciplinary education, practical talent development programs, and initiatives for training professionals in new technology sectors within school curriculum. Furthermore, the Bio-Health Innovation Commission has reviewed research findings reflecting input from industry and academic experts on the persistent mismatch between the supply and demand of bio-health professionals, and is now discussing future strategies based on these insights. The research identified the primary factors contributing to the human resource mismatch as a lack of industry input in university curriculum, a skewed focus in human resource development that leaves a gap in understanding specialized fields such as new technologies, and a shortage of expert personnel (professors and instructors). In response, the Commission agreed on the importance of cultivating professionals tailored to corporate needs, training professionals to meet future demands in new technologies, and training globally competitive expert instructors. Going forward, the government plans to publish a '2025 Bio-Health Talent Development Business Guide' in May to boost awareness and participation among job seekers, schools, and educational institutions regarding these talent development initiatives. Going forward, the government plans to publish a '2025 Bio-Health Talent Development Business Guide' in May to boost awareness and participation among job seekers, schools, and educational institutions regarding these talent development initiatives. Director Kim stated, "At today’s meeting, we were able to discuss topics on a government-wide support plan to maximize industry capabilities by reviewing the implementation status of bio-health human resource development projects and improvements in regulatory issues," adding, "We will continue to monitor these issues regularly at the level of the Bio-Health Innovation Commission and strive to ensure that today’s discussions are reflected in government policies, aimed to achieve clear outcomes."
- Opinion
- [Reporter's View] Healthcare AI and diversity·expandability
- by Whang, byung-woo Mar 28, 2025 06:37am
- During the 'KIMES 2025,' held last week, artificial intelligence (AI) gained the most attention. The exhibition booths were filled with companies that showcased AI at the forefront, including hospital systems and diagnostic imaging to patient monitoring, chatbot consultations, and electronic medical records (EMR). Large booths prominently displayed slogans like 'AI-based' and 'AI solution,' drawing visitors’ attention to the cutting-edge AI technologies. With AI emerging as a spearhead of technological innovation, this emphasis was anticipated at the recent KIMES event. However, upon closer inspection, there were also elements of disappointment. Most of the AI technologies exhibited by these companies focused on aiding image interpretation and enhancing diagnostic accuracy. For instance, AI systems trained on existing medical imaging data from CT, MRI, and X-ray scans are being used to quickly and accurately identify specific diseases. Of course, in clinical settings, rapid and accurate diagnosis is critical, and a detailed review of each company’s AI innovations does reveal clear differentiators in their approaches. Although exhibition booths are limited in fully showcasing the company's strengths, one common question we encountered during our coverage was, "So, what's different?" This reaction suggests growing skepticism about whether the AI focus at this year's KIMES represents a departure from previous years. Recently, the government, industry, and the healthcare sector have all been touting the growth potential of digital healthcare and AI-driven medical innovation. Despite ongoing advancements, challenges remain with AI technology diversity. A conservative perspective still exists regarding their practical applications. As global medical device companies integrate AI into their products, domestic startups still face the challenge of overcoming capital gaps through technological advancement. Achieving diversity in AI technology is clearly a collective challenge that requires collaboration among companies, the government, and hospitals. A key hurdle is the limited accessibility of data. Due to privacy protections and legal constraints, medical data is confined mainly to major hospitals and select research institutions. To develop diverse AI solutions, diverse data from various medical institutions, patient populations, and lifestyle sources are essential. There is an urgent need to create an ecosystem that securely de-identifies such data for industrial use. It also includes accelerating the standardization of AI technologies. Differing computer systems, EMR formats, and data processing methods across hospitals impede the scalability of AI solutions. It is imperative to proactively establish related interfaces and data standards that facilitate seamless collaboration between AI companies and hospitals. Reflecting on KIMES 2025, it is clear that simply declaring 'we have adopted AI' is no longer enough to achieve differentiation. Instead, the focus must shift to 'diversity' so that AI is integrated throughout healthcare settings. Industry, policymakers, and the healthcare community must address this challenge together. We look forward to seeing even more diverse AI solutions at next year's KIMES event.
- Company
- LigaChem Biosciences invests ₩36.6B in its UK partner
- by Cha, Jihyun Mar 27, 2025 05:54am
- LigaChem Biosciences announced on the 21st that it will invest USD 25 million (about KRW 36.6 billion) in its partner, UK-based Iksuda Therapeutics, to participate in management. The first USD 15 million was invested in the fourth quarter of last year. The additional USD 10 million will be invested in the middle of this year. After the investment is completed, LigaChem Biosciences will secure a 26.6% stake in Iksuda. In addition to this equity investment, LigaChem Biosciences has also secured the right to purchase the shares of Iksuda’s existing major investors and the actual rights to the Iksuda pipeline. LigaChem Biosciences has signed an agreement with existing major investors so that the company can purchase the investors’ shares within 3 years at the investment principal. This will enable LigaChem Biosciences to secure up to 73.9% of Iksuda’s shares. This means that LigaChem Biosciences will be able to substantially lead the management of Iksuda and the development of its pipeline. Based on this investment, LigaChem Biosciences plans to accelerate the clinical development of Iksuda's ADC pipeline to bring it to the global market sooner. In particular, the company plans to speed up the technology transfer of HER2-ADC and expand and conduct additional multinational clinical trials targeting patients resistant to existing ADC competitors in the market to increase the value of the pipeline. Iksuda has introduced technologies for multiple substances from LigaChem Biosciences. It has a number of pipelines, including LCB14 (HER2-ADC), LCB73 (CD19-ADC), and IKS04 (CanAg-ADC) and IKS012 (FRα-ADC) acquired through platform technology transfers. Iksuda is working to license out a number of programs in their clinical stages, including LCB14 and LCB73, which were developed by LigaChem Biosciences, to global pharmaceutical companies. “Through this investment, we plan to focus on early clinical development and commercialization of the pipelines of both companies by utilizing the abundant clinical development capabilities of Iksuda with its specialty in the ADC field,” said Yong-Zu Kim, CEO of LigaChem Biosciences. “In addition to this investment, we plan to further strengthen open innovation to secure future growth engines to achieve VISION 2030 sooner.”
- Company
- ADC mkt leader Daiichi-Sankyo's R&D drive
- by Whang, byung-woo Mar 27, 2025 05:54am
- Daiichi-Sankyo, a company leading the antibody-drug conjugate (ADC) market, is expanding its R&D capacity through the 'Expand & Extend'-based strategy. Daiichi-Sankyo plans to focus on expanding and strengthening access through the DXd-ADC platform, which is a basis for the company's chief pipeline. Daiichi-Sankyo's chief ADC drug is Enhertu (ingredient: trastuzumab deruxtecan). Currently, Enhertu is approved in most countries for the treatment of HER2-positive breast cancer, gastric cancer, and non-small cell lung cancer (NSCLC). Recently, Enhertu received an expanded indication from the U.S. Food and Drug Administration (FDA) for the treatment of patients with 'HER2-low metastatic breast cancer who have been treated with one or more endocrine therapy sessions' and expanded its market impact. The DXd-ADC platform has been the basis of this achievement. Daiichi-Sankyo, launched after a merger between Daiichi and Sankyo, strengthened ADC technology based on a synergy between Sankyo's monoclonal antibody (mAb) technology and Daiichi's anticancer agent payload and linker technology. Previously, conventional ADCs have been limited in therapeutic effects due to ▲Lack of payload diversity ▲Heterogeneity in drug conjugation sites ▲Linker instability ▲Restrictions on the number of drugs that can be conjugated. The DXd-ADC platform gained attention because it offered improved anticancer effects and overcame existing ADC limitations. The DXd-ADC platform has been used to expand the pipeline in addition to Enhertu based on seven technological strengths, including ▲High-potency payloads ▲High drug-to-antibody conjugation ratios ▲Uniform binding between the drug and antibody. Enhertu, jointly-developed by Daiichi-Sankyo and AstraZeneca, secured the most indications and ranked the top among new ADC drugs. Enhertu recorded the highest sales in the U.S. market last year, with U.S. sales reaching 282.4 billion yen, a 36.0% increase year-over-year, and the U.S. market is expected to account for 49.0% of Enhertu's total sales in 2024. In South Korea, Daiichi-Sankyo Korea recorded sales of KRW 274 billion in 2023, the highest among Japanese pharmaceutical companies operating in South Korea. Given Enhertu's growth, its overall sales are projected to exceed KRW 300 billion in 2024. Global Sales of Major ADCs in 2023 and 2024 (unit: KRW 100 million) Daiichi-Sankyo is preparing for a new drug that is Enhertu's follow-up…focusing on expanding the pipeline Daiichi-Sankyo has been employing a '5 DXd-ADC & Next Wave' strategy, focusing its R&D capacity on five ADCs in the oncology sector and the 'Next Wave' pipeline, including products for rare diseases and vaccines. Daiichi-Sankyo's chief pipeline includes ▲TROP2-directed Dato-DXd (datopotamab deruxtecan) ▲HER3-directed HER3-DXd (patritumab deruxtecan) ▲B7-H3-directed I-DXd (ifinatamab deruxtecan) ▲CDH6-directed R-DXd (raludotatug deruxtecan). A Trop-2-directed antibody drug, Datroway, is Enhertu's follow-up drug, and it was approved by the Food and Drug Administration (FDA) in January as a breast cancer medication. Datroway is soon to be launched. Datroway can be used as a treatment for hormone receptor (HR)-positive and human epidermal growth factor 2 (HER)-negative breast cancer. Furthermore, patritumab deruxtecan is a drug candidate that is expected to receive approval this year. Clinical trials of patritumab and ifinatamab are being conducted involving patients with lung cancer and ovarian cancer, respectively. In addition, Daiichi-Sankyo is focusing on securing next-generation growth drivers by developing innovative therapies in the specialty drug and vaccine sectors, leveraging its proprietary modality technology. Jeong-tae Kim, CEO of Daiichi-Sankyo KoreaDaiichi-Sankyo has unveiled its 'Expand & Extend' strategy to provide the DXd-ADC pipeline to patients quickly. The 'Expand' strategy aims to establish a DXd-ADC treatment approach for breast and lung cancers and subsequently expand its indications to earlier treatment stages and a broader range of cancer types. Meanwhile, the 'Extend' strategy encompasses the development of next-generation ADCs and new modalities that maximize platform effects through combination therapies and formulation changes. Thus ultimately providing additional treatment options beyond DXd-ADC therapy. Jeong-tae Kim, CEO of Daiichi-Sankyo Korea, stated, "As of 2024, over 40 of our global clinical studies have been conducted in South Korea, and two Korean medical institutions have been selected among 15 Phase 1 clinical sites across eight countries, contributing from the earliest stages of clinical research." "We plan to launch four ADCs and targeted cancer agents and have substantially prepared and put efforts into leaping as a leader in the oncology sector. For instance, providing treatment options to more patients," Kim added, "In addition to distributing pharmaceuticals, we will provide pragmatic hope by leading innovations in collaboration with Korean medical communities and acting as a bridge with the headquarters."
- Company
- Alopecia areata drug Litfulo may be prescribed hospitals
- by Eo, Yun-Ho Mar 27, 2025 05:54am
- The new drug for alopecia areata, Litfulo, has landed in general hospitals in Korea. According to industry sources, Pfizer Korea's new Janus kinase (JAK) inhibitor Litfulo (ritlecitinib) has passed the drug committees (DCs) of medical institutions such as Severance Hospital, Jeonbuk National University Hospital, and Chungnam National University Hospital. The company seems to be gradually expanding its prescription area upon the drug’s official launch earlier this month. As the first drug approved for the treatment of alopecia areata in Korea for adolescent patients, Litfulo was approved by the Ministry of Food and Drug Safety in September last year. Alopecia areata is an autoimmune disease that causes patchy or complete hair loss on the scalp, face, or body. It has underlying immune-inflammatory pathogenesis and occurs when the immune system attacks the body's hair follicles, causing hair loss. An increasing number of patients have been treated for alopecia areata over the past decade, from 154,380 in 2013 to 178,009 in 2023. In general, most patients with mild cases of alopecia areata recover naturally or respond well to treatment, but commonly recur, with about 40-80% of patients experiencing recurrence within one year. “The launch of a new treatment option has brought hope to patients who have been suffering from alopecia areata for a long time and have had an unmet need. For us as healthcare professionals, the fact that a new, safe option has emerged holds significance,” said Chong-Hyun Won, a professor of dermatology at Asan Medical Center in Seoul. Meanwhile, Litfulo was approved based on the global Phase IIb/III ALLEGRO trial. The proportion of patients with a score of 20 or less on the Severity of Alopecia Tool (SALT), the primary endpoint, at Week 24, was 23% for the treatment group, which was statistically significant compared to the 2% for the placebo group.
- Company
- Ja Q Bo ₩9B, K-CAB ₩8.2B, Fexuclue ₩4.7B
- by Chon, Seung-Hyun Mar 27, 2025 05:54am
- Homegrown P-CAB class new drugs for gastroesophageal reflux disease (GERD) have begun to generate export sales. Onconic Therapeutics’ Ja Q Bo generated significantly more overseas sales than domestic sales due to the effect of its licensing out deals. HK Inno.N's K-CAB and Daewoong Pharmaceutical's Fexuclue have begun to generate export sales in earnest with their overseas launch. As P-CAB class new drugs demonstrated their marketability in the domestic market through commercial success, overseas sales are expected to grow with the increase in the number of export countries. According to the Financial Supervisory Service on the 25th, Onconic Therapeutics' Ja Q Bo generated KRW 14.8 billion in sales last year. Onconic Therapeutics, which was established in May 2020, is a new drug developer subsidiary of Jeil Pharmaceutical. Onconic Therapeutics was launched after receiving technology transfer of new drug candidates for gastroesophageal diseases and a new drug candidate for anticancer drugs from Jeil Pharmaceutical. As of the end of last year, Jeil Pharmaceutical holds a 46.28% stake in Onconic Therapeutics. Onconic Therapeutics was listed on the KOSDAQ market in December last year. Onconic Therapeutics completed clinical trials for Ja Q Bo, a P-CAB (potassium-competitive acid blocker) class new drug, and received approval for the drug as the 37th homegrown new drug in April last year. Antiulcer drugs in the P-CAB class inhibit gastric acid secretion by competitively binding to proton pumps and potassium ions located at the final stage of acid secretion in gastric parietal cells. Annual export sales of homegrown P-CAB class new drugs Last year, exports accounted for 60.8% of Ja Q Bo's sales, amounting to KRW 9 billion. Ja Q Bo began domestic sales in October last year after being listed for reimbursement in the National Health Insurance, recording KRW 5.8 billion in domestic sales. Ja Q Bo's export performance last year was due to the inflow of milestone payments from the results of the licensing-out agreement. Onconic Therapeutics has signed licensing out deals for Ja Q Bo in 21 countries. Onconic Therapeutics signed a licensing out deal with the Mexican pharmaceutical company Laboratorios Sanfer in September last year. The contract is worth up to USD 127.5 million. Onconic Therapeutics will receive an initial non-refundable upfront payment of USD 15 million and up to USD 112.5 million in milestone payments for development, licensing, and commercialization milestones. Onconic Therapeutics transferred Ja Q Bo to an Indian company in May last year. The Indian company has secured exclusive rights to the development, licensing, production, and post-launch commercialization of Ja Q Bo. The terms of the contract with the other party have not been disclosed. Ja Q Bo generated KRW 21.1 billion in exports in 2023. Onconic Therapeutics signed a licensing-out agreement for Ja Q Bo with Livzon Pharmaceutical Group, a Chinese pharmaceutical company, in March 2023. The contract size is up to USD 127.5 million. Onconic Therapeutics will receive a USD 15 million non-refundable upfront payment and up to USD 112.5 million in milestone payments for development, licensing, and commercialization. Onconic Therapeutics generated KRW 19.7 billion in sales in the first quarter of 2023. Sales of K-CAB, a new P-CAB class drug that first entered the domestic market, and Fexuclue have also been increasing gradually overseas. HK Inno.N’s K-CAB recorded KRW 8.2 billion in exports last year. This is the overseas sales of the finished drug, excluding technology fees and milestone payments. Although the overseas sales share in K-CAB's total sales of KRW 168.9 billion is negligible, the export value is continuously increasing. K-CAB recorded its first export performance of KRW 900 million in 2022 and KRW 5.5 billion in overseas sales in 2023. K-CAB was approved as the 30th homegrown new drug in 2018. HK Inno.N signed a technology export agreement with the Chinese pharmaceutical company Luoxin in 2015 and has been pushing K-CAB's overseas expansion in earnest. The contract with Luoxin is conditional on receiving a total of USD 18.5 million in technology fees upon achievement of each stage specified in the contract, including the down payment, clinical development, licensing, and commercialization. HK Inno.N In February 2019, the company signed an agreement with the Mexican pharmaceutical company Carnot to export the finished K-CAB drug to 17 Latin American countries. The contract is worth USD 84 million over 10 years, including the product supply price. HK Inno.N has since signed export contracts for K-CAB with Indonesia, Thailand, the Philippines, Mongolia, Singapore, Vietnam, Malaysia, the United States, and Canada. In January of last year, it signed a contract with Australian pharmaceutical company Southern XP to export K-CAB to Australia and New Zealand. K-CAB has been launched in 15 countries. The countries where K-CAB has been launched include China, the Philippines, Mongolia, Mexico, Indonesia, Singapore, Peru, Chile, the Dominican Republic, Nicaragua, Honduras, Guatemala, El Salvador, and Colombia. K-CAB's export performance has been boosted by its start of sales in Mongolia, China, the Philippines, and other countries starting in 2022. K-CAB set new export records in the third and fourth quarters of last year, with exports of KRW 2.5 billion and KRW 3.8 billion, respectively. K-CAB's cumulative export performance from 2022 is estimated to total at KRW 13.9 billion. This is the sales volume of K-CAB supplied by HK Inno.N. Therefore, the company estimates that the sales generated from local prescriptions on-site would be much higher. K-CAB is considered to be making a smooth start in the overseas market based on its marketability recognized in Korea. K-CAB's domestic sales last year reached KRW 160.7 billion. Daewoong Pharmaceutical's Fexuclue recorded KRW 4.7 billion in exports last year. In 2023, the company recorded its first export value of KRW 400 million, which increased more than tenfold last year. Fexuclue is the second domestically developed P-CAB class drug introduced, following K-CAB. Fexuclue is a homegrown new drug that Daewoong Pharmaceutical has successfully developed with its proprietary technology for 13 years since 2008. Daewoong Pharmaceutical Fexuclue first went on sale overseas in the Philippines in August 2023 and has begun generating export sales. Fexuclue has also been launched in Mexico, Ecuador, and Chile. Fexuclue has entered the market in 30 countries, including South Korea, or is about to enter the market. The countries that have applied for product licenses are 11 countries, including China, Brazil, and Saudi Arabia. Daewoong Pharmaceutical has signed export contracts for Fexuclue in 14 countries, including India and the United Arab Emirates. Fexuclue also made a smooth start in the domestic market. Fexuclue obtained approval from the Ministry of Food and Drug Safety in December 2021 and began full-scale sales after being listed for reimbursement with the National Health Insurance in July 2022. Fexuclue posted KRW 97.2 billion in domestic sales last year. Combined with its export performance, the company posted a total sales of KRW 102 billion, exceeding KRW 100 billion in sales for the first time in 3 years since its launch.
