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- 2025-12-17 22:15:39
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- 'Mounjaro' confirmed to have reimb appropriateness
- by Son, Hyung Min Dec 17, 2025 09:51am
- There are ongoing concerns that the treatment landscape for Type 2 Diabetes (T2D) in South Korea is facing limitations.While this issue persists, the GLP-1/GIP receptor dual agonist Mounjaro has passed the initial hurdle for national health insurance reimbursement coverage for diabetes, drawing significant attention to whether it will lead to a paradigm shift in domestic treatment.According to industry sources on December 17, Mounjaro (tirzepatide) passed the initial stage for national health insurance reimbursement earlier this month. Consequently, Mounjaro's developer, Eli Lilly, will now enter price negotiations with the National Health Insurance Service (NHIS). Lilly has been pursuing reimbursement for Mounjaro since early 2024, achieving the positive result after approximately two years.Lilly confirmed that Mounjaro demonstrated improved clinical utility compared to comparator drugs. Following discussions on cost-effectiveness based on economic evaluation with the Health Insurance Review and Assessment Service (HIRA), Mounjaro was considered for the final Drug Reimbursement Evaluation Committee (DREC) meeting of the year and was received reimbursement appropriateness decision. Experts anticipate that the remaining steps will proceed quickly, given Mounjaro’s acknowledged clinical value, economic feasibility, and necessity within the domestic treatment environment.Type 2 diabetes treatment 'Mounjaro'T2D diabetes management becomes harder over time...demands for new treatment option↑Given rising obesity rates and an aging population, there is a growing demand for treatment options that can manage not only blood glucose but also body weight and overall metabolism. T2D is a chronic condition where prolonged disease duration leads to cumulative decline in insulin secretion function and increased insulin resistance, resulting in a significant number of patients failing to reach target blood glucose levels with conventional strategies alone.According to the 2025 Factsheet by the Korean Diabetes Association, 6 out of 10 diabetes patients in South Korea are not achieving the treatment goal of a hemoglobin A1c (H1A1c) level of 6.5%. T2D is a progressive disease with difficulty achieving remission. With prolonged disease duration, pancreatic insulin secretion deteriorates, worsening insulin resistance and leading to difficulties in glucose regulation.The prevalence of obesity is also rising. Over half of diabetes patients (52.4%) are also obese, and 61.1% have abdominal obesity. Conversely, the prevalence of diabetes among the obese population is 17.6%, about twice as high as in the non-obese population. Among the obese population aged 65 and over, one in three (31.6%) has co-morbid diabetes.The problem is that, in patients with high Body Mass Index (BMI), visceral fat contributes to insulin resistance, and inflammatory responses in adipose tissue impair insulin action. This not only makes blood glucose management difficult but also reduces overall metabolic function. Consequently, blood glucose regulation can be challenging with conventional oral treatments or insulin alone. Failure to control blood glucose in T2D patients increases the risk of various complications, including retinopathy, neuropathy, stroke, angina, and myocardial infarction due to arteriosclerosis. One study showed that T2D patients who fail to control their blood glucose have a 2–3 times higher risk of cardiovascular disease in men and 3–5 times higher risk in women compared to the general population.Thus, there is high demand among healthcare providers and patients for GLP-1 class treatments that offer benefits not only in blood glucose control and weight loss but also in overall metabolic health. Mounjaro, which can be administered once weekly, is the first and only therapeutic agent designed to bind to and activate both GLP-1 and GIP receptors selectively.Mounjaro has mechanistic advantages that stimulate insulin secretion, improve insulin sensitivity, lower glucagon levels to lower blood glucose, and delay gastric emptying to reduce food intake, leading to weight loss.Mounjaro demonstrated superior HbA1c reduction across all doses compared to all comparator arms in the five Phase 3 clinical trials (SURPASS 1–5) involving T2D patients. The achievement rate of the T2D treatment goal, which is HbA1c level below 6.5%, in the Mounjaro group was up to 95% (SURPASS-5, 10mg), and the achievement rate of HbA1c < 5.7%, indicating a near-normal blood glucose level, reached up to 62% (SURPASS-5, 15mg). Furthermore, since a weight reduction of over 10% significantly improves blood glucose in T2D patients, up to 69% of patients in the Mounjaro group achieved this goal (SURPASS-3, 15mg).Notably, despite effective blood glucose reduction, the risk of clinically significant or severe hypoglycemia did not increase compared to the control groups. This means that even patients whose treatment options were limited by hypoglycemia risk can now expect to reach their target blood glucose (HbA1c < 6.5%) and achieve higher levels of glycemic control with Mounjaro.Mounjaro recommended in major guidelines..."Effective strategy needed for long-term metabolic health"In October, the Korean Diabetes Association (KDA) issued a statement emphasizing the need to manage comorbid conditions in T2D. A key change in the KDA's newly proposed T2D management algorithm is the initial separate listing of the GIP/GLP-1 receptor dual agonist from existing GLP-1 receptor agonists. The KDA also specified the GIP/GLP-1 receptor dual agonist as a preferred medication for T2D patients with co-morbid obesity.Professor Byung-Wan Lee (Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University, Severance Hospital), who directed Guidelines for the KDA stressed, "T2D patients with co-morbid obesity require a more effective treatment strategy that includes weight loss and improved insulin sensitivity, in addition to overall and long-term metabolic health improvement."Professor Lee stated, "It is significant that, following the last guideline revision where Mounjaro was first listed as a distinct component name separate from existing GLP-1 receptor agonists to emphasize its efficacy in blood glucose and weight control, this algorithm update reconfirms the clinical utility of the GIP/GLP-1 receptor dual agonist in T2D patients with obesity."He added, "For T2D patients with obesity who failed to reach target blood glucose levels even with existing oral treatments or insulin, We hope access to Mounjaro is improved as quickly as possible so that these patients can benefit from Mounjaro's blood glucose and weight loss results."An algorithm for Type 2 diabetes management.Based on Mounjaro's clinical and practical value, domestic and international guidelines categorize it separately from existing GLP-1 receptor agonists. Furthermore, the World Health Organization (WHO) designated Mounjaro as an Essential Medicine in September for T2D patients with comorbid conditions such as obesity.This decision is significant as it officially recognizes Mounjaro as an essential, public-health-critical drug for T2D treatment with co-morbid obesity, underscoring the need to improve access through expanded insurance coverage.Professor Lee stated, "In a situation where the number of T2D patients with obesity is rising, ensuring accessibility to innovative treatments that can improve overall metabolic health beyond simple blood glucose reduction, regardless of economic status, is beneficial, both for individual patients and for long-term national health improvement," and added, "As Mounjaro has been recognized globally as an essential medicine for T2D patients with obesity, prompt policy action is needed so that it can be managed under the system and safely used by patients who critically need it."
- Company
- CKD and Bayer sign copromotion agreement for Eylea
- by Lee, Seok-Jun Dec 17, 2025 09:51am
- Chong Kun Dang Pharma (CEO Young-joo Kim) announced on the 16th that it has signed a domestic copromotion agreement with Bayer Korea (CEO JinA Lee) for the retinal disease treatment Eylea (aflibercept) at its headquarters in Chungjeong-ro, Seoul.Under the agreement, Chong Kun Dang will be responsible for sales, marketing, and distribution of both Eylea 2 mg and Eylea 8 mg, targeting clinic-level medical institutions.Bayer’s Eylea is an anti-vascular endothelial growth factor (anti-VEGF) therapy used to treat a range of retinal diseases, including wet age-related macular degeneration (AMD), diabetic macular edema, macular edema secondary to retinal vein occlusion, and vision impairment due to choroidal neovascularization associated with pathological myopia. Based on its innovative therapeutic efficacy and trust, Eylea has maintained its position as a standard of care for more than 10 years.In particular, Eylea 8 mg, the high-dose formulation that was launched last year, demonstrated comparable vision improvement and safety to Eylea 2 mg while allowing the dosing interval to be extended to up to 20 weeks, significantly improving treatment convenience for patients.Young-joo Kim, CEO of Chong Kun Dang Pharma, said, “Chong Kun Dang has already built extensive sales and marketing capabilities in the ophthalmology field through our diverse product lineup. Leveraging our expertise and sales strength in ophthalmic diseases, we will actively promote the excellence and stability of Eylea and further expand the market.”JinA Lee, CEO of Bayer Korea, stated, “Through our collaboration with Chong Kun Dang, we aim to further enhance patient access to Eylea, which has led the anti-VEGF market for over a decade. Building on our strong partnership, we will continue to provide reliable treatment options more smoothly to patients with retinal diseases and healthcare professionals in Korea, and contribute to improving patients' quality of life.”Chong Kun Dang and Bayer Korea have maintained a successful partnership, co-promoting the antibiotics Ciprobay and Avelox since 2005, and the type 2 diabetes-associated chronic kidney disease treatment Kerendia since 2024. In addition, Chong Kun Dang independently distributes Bayer Korea’s cardiovascular drugs Aspirin Protect and Adalat OROS, as well as the hepatocellular carcinoma treatments Nexavar and Stivarga.
- Company
- Dupixent reimb for asthma imminent beyond atopic dermatitis
- by Eo, Yun-Ho Dec 17, 2025 09:50am
- The reimbursement coverage of the dual interleukin inhibitor Dupixent is expected to expand further in Korea.According to industry sources, Sanofi Korea has recently concluded price negotiations with the National Health Insurance Service (NHIS) for Dupixent (dupilumab), a biologic that inhibits both interleukin-4 (IL-4) and interleukin-13 (IL-13), for the indication of moderate-to-severe type 2 inflammatory asthma in adults and adolescents.This achievement comes approximately three months after the drug passed the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee in September.As a result, starting in 2026, Dupixent is expected to become reimbursable for patients with type 2 inflammatory asthma.First approved in Korea in 2018, Dupixent was initially listed for reimbursement in 2020 for the treatment of atopic dermatitis, with its reimbursement criteria gradually expanded over time. With the latest expansion into asthma, including adolescent patients, attention is now turning to whether the company will apply for reimbursement listing of its additional indications, such as chronic rhinosinusitis with nasal polyps and chronic obstructive pulmonary disease (COPD).The efficacy of Dupixent for asthma, for which the drug price negotiation was concluded this time, was demonstrated through the Phase III TRAVERSE study. This study drew attention as it also released results from a Korean subgroup analysis.According to the study, Dupixent demonstrated long-term efficacy up to 96 weeks and a consistent safety profile in Korean adolescents aged 12 years and older and adults with moderate-to-severe asthma. This reaffirms that Dupixent is an important treatment option for Korean patients with moderate-to-severe asthma, for whom long-term treatment data are limited.The Phase III TRAVERSE Open-Label Extension (OLE) study enrolled 2,282 patients with uncontrolled moderate-to-severe asthma who had previously participated in a Dupixent clinical trial.Patients enrolled in the TRAVERSE study after completing either a Phase II clinical trial (DRI study, 24 weeks) or a Phase III clinical trial (QUEST study, 52 weeks) and received an additional 96 weeks of Dupixent 300mg every 2 weeks. A subgroup analysis was conducted on 74 adolescent and adult patients aged 12 years and older enrolled at domestic study sites.Results showed that the unadjusted annualized rate of severe exacerbations was low at 0.47 throughout the treatment period. As early as two weeks after treatment initiation, patients experienced a rapid improvement in lung function, with a mean increase of 0.42 L (SD 0.47) in pre-bronchodilator FEV₁, which was sustained through week 96. In addition, the five-item Asthma Control Questionnaire (ACQ-5) score improved by a mean of –1.32 (SD 0.76) from baseline at week 48, indicating better asthma control.
- Company
- Takhzyro enters pricing negotiations with NHIS for reimb
- by Eo, Yun-Ho Dec 16, 2025 08:36am
- The hereditary angioedema drug ‘Takhzyro’ has entered the final stage towards reimbursement listing in Korea.Takeda Pharmaceuticals Korea, in accordance with an order from the Ministry of Health and Welfare, has begun price negotiations with the National Health Insurance Service (NHIS) for Takhzyro (lanadelumab), a treatment for hereditary angioedema (HAE). This marks the first tangible step toward reimbursement nearly 5 years after the drug received approval from the Ministry of Food and Drug Safety (MFDS) in February 2021.Therefore, attention is now focused on whether the company will successfully conclude pricing negotiations for Takhzyro so that the drug could emerge as a new treatment option in the HAE, where therapeutic choices remain limited. The drug passed the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service (HIRA) in November.Hereditary angioedema is a rare disease characterized by recurrent, unpredictable episodes of acute swelling throughout the body caused by abnormalities in the C1 esterase inhibitor (C1-INH) protein.Respiratory swelling can lead to breathing difficulties or even asphyxiation, while gastrointestinal edema causes severe pain and emergency conditions such as bowel obstruction.Approximately 40% of patients experience their first attack before age 5, and 75% before age 15. However, the majority undergo a prolonged “diagnostic odyssey” and receive an accurate diagnosis only in adulthood. Despite an estimated 1,000 HAE patients in Korea, only 200–250 cases had been diagnosed as of last year.On average, it takes about 19 years for patients to receive a diagnosis, and even after diagnosis, they remain constantly exposed to unpredictable attacks and emergency situations.Until now, access to disease-modifying therapies in Korea has been limited, prompting repeated calls from the medical community for the reimbursement of Takhzyro.Whether Takhzyro will successfully complete price negotiations with the NHIS and establish itself as a new therapeutic option in the underserved HAE treatment landscape remains to be seen.Meanwhile, Takhzyro demonstrated its efficacy in the Phase III HELP study. According to the results, patients receiving Takhzyro every two weeks experienced an 87% reduction in the mean monthly number of HAE attacks compared with placebo, while those receiving the drug every four weeks showed a 74% reduction.
- Company
- Ildong's market cap fivefold↑ over eight months
- by Chon, Seung-Hyun Dec 16, 2025 08:36am
- Ildong Pharmaceutical's stock price has surged significantly, setting continuous record highs on expectations for its obesity treatment development. The company's market capitalization has increased nearly fivefold over the past eight months. The oral obesity drug being developed by Ildong Pharmaceutical's subsidiary has demonstrated weight-loss effects in its Phase 1 clinical trial.According to the Korea Exchange on December 13, Ildong Pharmaceutical's stock closed at KRW 44,300 on the 12th, a 9.4% increase from the previous trading day. This continued the sharp rise following a 24.6% surge on the 11th.Ildong Pharmaceutical's stock price showed an increasing trend over five consecutive trading days since a 0.4% increase on the 8th. The stock jumped by 6.6% on the 9th and by 9.4% on the 10th. Compared with the closing price of KRW 27,750 on the 5th, the stock soared 59.6% over the five trading days.Based on the closing price on the 12th, Ildong Pharmaceutical's market capitalization reached KRW 1.4016 trillion, an increase of KRW 523.6 billion from KRW 878.0 billion just a week prior. Ildong Pharmaceutical surpassed the KRW 1 trillion mark again on the 10th, about two months after recording KRW 1.0725 trillion on September 29. The company's market capitalization increased from KRW 1 trillion on December 12 to KRW 1 trillion on December 27, 2022. The largest ever was KRW 1.5412 trillion recorded on July 18, 2022, when the stock surged on expectations for a COVID-19 treatment.The trend of Ildong Pharmaceutical's market capitalization (unit: KRW 100 million, source: Financial Supervisory Service)Ildong Pharmaceutical's stock price continued to soar with the attention to its new oral obesity drug candidate. The value of orally administered obesity treatments has increased significantly overseas.Pfizer recently acquired the rights to the small-molecule GLP-1 class obesity treatment 'YP05002' from China's Fosun Pharma subsidiary, Yao Pharma, for up to $1.93 billion (approximately KRW 3 trillion), including an upfront payment of $150 million (approximately KRW 220 billion).YP05002 is a new drug candidate currently undergoing Phase 1 clinical trials in Australia and is being developed as an oral obesity treatment. Pfizer will conduct the Phase 2 clinical trial after Yao Pharma completes the ongoing Phase 1 trial.This global trend is the background for the high interest in 'ID110521156', the oral obesity drug being developed by Ildong Pharmaceutical's new drug development subsidiary, Yunovia.ID110521156 is a GLP-1 receptor agonist that acts as an analogue of the GLP-1 hormone, which induces insulin secretion to regulate blood sugar levels in the body. The GLP-1 hormone is produced by the beta cells of the pancreas. It plays a role similar to that of GLP-1, which is involved in insulin synthesis and secretion, blood glucose reduction, regulation of gastrointestinal motility, and appetite suppression.While existing GLP-1 receptor agonists are primarily injectable formulations of biological agents such as peptides, ID110521156 is a small-molecule synthetic compound candidate. Ildong Pharmaceutical's strategy is to position the drug as a convenient oral treatment for patients, capitalizing on its structurally stable properties compared to peptide formulations, offering superior manufacturing efficiency and productivity.The weight loss effect of ID110521156 was confirmed in the Phase 1 topline data released in September. The study was conducted on 36 healthy adults admitted to a clinical facility. Participants were divided into three dosage groups ▲50mg ▲100mg ▲200mg, with 12 subjects assigned to each group. ID110521156 was administered once daily for 4 weeks (28 days).Results showed that the 50mg and 100mg groups achieved average weight-loss efficacy of 5.5% and 6.9%, respectively, over 4 weeks. The 200mg group showed excellent weight loss, with an average of 9.9% and a maximum of 13.8%. The company explained that it secured clinically significant data, as the percentage of subjects who achieved 5% or more weight loss after the four-week treatment was 0% in the placebo group, but 55.6% in the 50mg group, 66.7% in the 100mg group, and 87.5% in the 200mg group.Ildong Pharmaceutical's market capitalization was only KRW 294.7 billion on April 9 and remained in the KRW 300 billion range until July 4. The stock surged after hitting the upper limit on July 7 and continued its upward trend, leading to an approximate fivefold increase in market capitalization over eight months.
- Company
- JP’s Mitsubishi Tanabe Pharma name changes to 'Tanabe Pharma'
- by Eo, Yun-Ho Dec 15, 2025 09:16am
- Mitsubishi Tanabe Pharma has changed its company name to Tanabe Pharma.Accordingly, the Korean subsidiary was officially re-branded as Tanabe Pharma Korea (TPKR) as of the 1st of this month. This decision was made at the parent company's recent extraordinary general meeting of shareholders.Mitsubishi Chemical Group sold Mitsubishi Tanabe Pharma to the U.S. private equity firm Bain Capital earlier in February. Mitsubishi Chemical Group plans to withdraw from the pharmaceutical business, which requires massive R&D spending, and focus its management resources on its core businesses.Tanabe Pharma Korea plans to continue its activities to ensure a smooth supply of medicines to the Korean market, irrespective of the name change.Tanabe Pharma Korea recently secured market approval for Radicut Suspension, the oral formulation of the ALS (Amyotrophic Lateral Sclerosis) treatment Radicut. It is also proceeding with the reimbursement listing process for Uplizna (inebilizumab), a treatment for anti-aquaporin-4 (AQP4) antibody-positive adult patients with Neuromyelitis Optica Spectrum Disorder (NMOSD).Meanwhile, Tanabe Pharma was initially established in 1678. It reached its current form after merging with Mitsubishi Pharma, a subsidiary of Japan's largest chemical group, Mitsubishi Chemical Group, in 2007.
- Company
- "Securing global CDMO foundation in KOR"
- by Kim, Jin-Gu Dec 15, 2025 09:16am
- (from left) Yong Ki Park (Project Manager, Samsung Biologics), Yoon Hee Choi (Senior Research Fellow, KIET), Sun Hee Lee (Professor, Ewha Womans University), Tae-kyu Lee (CEO, Scale Up Partners), Tong Kook Lee (Attorney, Dongin Law Group Lawyer), Kang Seop Im (Head, Ministry of Health and Welfare's Division of Health Industry Promotion)The Korea Pharmaceutical and Bio-Pharma Healthcare Alliance, an assembly of organizations representing South Korea's domestic pharmaceutical, bio, and medical device sectors, held its second official Forum. At the event, the industry voiced for regulatory rationalization and expanded nation-level investment in manufacturing infrastructure to elevate domestic capabilities to a global standard.The Korea Pharmaceutical and Bio-Pharma Healthcare Alliance hosted its 2nd Forum on December 11 at the National Assembly Hall, focusing on the topic of 'manufacturing innovation strategy for the healthcare industry to enhance global competitiveness'.The Korea Pharmaceutical and Bio-Pharma Healthcare Alliance is a healthcare consultative body formed by key associations representing the South Korean healthcare industry, including pharmaceuticals, medical devices, regenerative medicine, and digital health. Nine organizations have joined the alliance, including the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), Korea Biomedicine Industry Association, Korea Pharmaceutical Traders Association(KPTA), Korea Drug Research Association (KDRA), Council for Advanced Regenerative Medicine (CARM), Korea Digital Health Industry Association(KoDHIA), Korea Medical Devices Industry Association (KMDIA), and Korea Biotech Industry Organization.The forum was attended by heads of alliance member institutions, including Yunhong Noh (President, KPBMA), Jung Jin Kim (Chairman, KDRA), Jeong Seok Lee (Chairman, KBMIA), Young Min Kim (Chairman, KMDIA), Byoung-jun Bae (Chairman, CARM), Ki-yoon Yoo (Executive Director, KoDHIA), and Dong Hee Lee (Vice President, KPTA).Panelists included Sun Hee Lee (Professor, Ewha Womans University), Yong Ki Park (Project Manager, Samsung Biologics), Tong Kook Lee (Attorney, Dongin Law Group Lawyer), Tae-kyu Lee (CEO, Scale Up Partners), Kang Seop Im (Head, Ministry of Health and Welfare's Division of Health Industry Promotion), and Yoon Hee Choi (Senior Research Fellow, KIET), discussing strategies for domestic healthcare manufacturing innovation and strengthening national Contract Development and Manufacturing Organization (CDMO) competitiveness. The Korea Pharmaceutical and Bio-Pharma Healthcare Alliance hosted its 2nd Forum on December 11 at the National Assembly Hall, focusing on the topic of 'manufacturing innovation strategy for the healthcare industry to enhance global competitiveness'.Jung Woon Chun, a researcher at the KPBMA, assessed that domestic pharmaceutical and bio manufacturing and quality competitiveness remain at an early stage, with distinct disparities by company size. Researcher Chun noted, "According to a survey conducted by the association involving 45 companies and 61 plants, the automation level of domestic companies remains at the MES/ERP implementation stage (Level 2), with only 18% reaching Level 3 or higher, which enables data linkage between processes or predictive analytics." He added that the adoption of smart manufacturing and AI-based process technology is generally slow due to regulatory uncertainty and a lack of specialized personnel.To reduce the gap with global standards, Chun proposed establishing a national manufacturing and quality innovation roadmap and providing institutional support. He proposed several measures, including ▲Introducing manufacturing innovation incentives (tax benefits, subsidies, drug price preference) ▲Expanding field-based specialized workforce training programs ▲Establishing smart factory guidelines ▲Expanding public-private cooperation and sharing successful cases ▲Improving regulations for continuous manufacturing and Quality by Design (QbD).Chun added, "Securing global-level manufacturing competitiveness cannot be achieved solely through the efforts of individual companies." He emphasized, "As the industry aims to invest in AI and digital-based quality management, the government must promptly establish regulatory guidance and eliminate investment uncertainty for manufacturing innovation to realize."Hyun Soo Cho, a Manager at the Korea Biomedicine Industry Association, said that the CDMO industry needs to be developed by the government as a strategic industry. Cho noted, "The global biopharmaceutical market is being reshaped around manufacturing and quality capability, granting strategic advantage to countries that secure production infrastructure," and asserted, "Since South Korea already possesses the foundation for becoming a global CDMO hub, with the world's largest single production cluster (2.14 million liters) and large-scale facility capacity projected by 2030."Cho projected that the recently enacted 'Special Act on Regulatory Support for Biopharmaceutical Contract Development and Manufacturing Organizations (CDMO Special Act)' will be a turning point for the Korean CDMO industry. The CDMO Special Act, passed by the National Assembly on December 2, is a state-level industrial promotion law designed to help biopharmaceutical CDMOs meet global manufacturing/quality requirements and support exports/regulatory responses. Cho explained that institutional mechanisms such as the introduction of an export manufacturing registration system, quality management conformity certification, and raw material certification will further enhance the competitiveness of the domestic CDMO industry.Additionally, Cho emphasized the need to expand large-scale production bases, secure specialized personnel, and foster technology-focused CDMOs focused on next-generation modalities such as mRNA, cell/gene therapies, and ADCs. He stated, "It is urgent to expand the ecosystem to support successful companies and cultivate mid-sized and venture CDMOs as growth engines," and concluded, "For Korea to become a global production hub, support for process development, financial/tax incentives, and strengthening global certification capabilities must be pursued simultaneously."At the forum, policy directions for manufacturing, quality innovation, and enhancing global competitiveness were also discussed. In particular, the industry called for expanding the ecosystem, including the regular sharing of best practices in manufacturing/quality, customized professional workforce training, and matching support for joint development and process development between mid-sized/venture CDMOs and global companies.Yong Ki Park pointed out, "If the CDMO Special Act is the starting point for institutional foundation, then effective tax support and reform of the liability structure must follow in the subsidiary regulations," and criticized the current structure, which unilaterally transfers domestic liability to the manufacturer, saying it "does not align with global standards and could weaken competitiveness." Park stressed, "The establishment of a dedicated center for CDMO workforce training is urgent." He emphasized, "A national infrastructure must be established to systematically cultivate experts in GMP, process engineering, and quality who can be immediately deployed in the field, enabling the country to maintain its status as a global production hub."Yoon Hee Choi also argued that policy establishment is essential to strengthen R&D capabilities and transition to smart manufacturing. Choi advised, "A bold national strategy is required, including support for digital and AI-based process innovation in mid-sized and small companies, expansion of tax/subsidy incentives for nurturing technology-specialized CDMOs, and investment in professional infrastructure." Cho recommended, "It is necessary to support the growth of mid-sized and small CDMOs capable of customized biomanufacturing, such as cell and gene therapies, and establish collaboration platforms for process development and building track records between large corporations and ventures."
- Company
- Cardiomyopathy indication added to Amvuttra
- by Eo, Yun-Ho Dec 12, 2025 07:54am
- The RNAi therapy Amvuttra may be additionally approved to be used for ATTR-CM.The Ministry of Food and Drug Safety (MFDS) is currently reviewing expanding the indication for Amvuttra (vutirisiran), developed by Alnylam and introduced by Medison Pharma Korea, to treat transthyretin amyloid cardiomyopathy (ATTR-CM).Amvuttra was first approved in Korea in November 2023 as a treatment for transthyretin familial amyloid polyneuropathy (hATTR-PN).Administered as a single subcutaneous injection every 3 months, Amvuttra targets and silences specific messenger RNA, blocking the production of both wild-type and hereditary transthyretin (TTR).The drug’s efficacy in ATTR-CM was demonstrated through the Phase III HELIOS-B study.Designed as a randomized, double-blind, placebo-controlled, multicenter, global clinical trial, the study included diverse patients, including those previously treated with standard therapies such as Vyndaqel (tafamidis) and sodium-glucose cotransporter-2 (SGLT-2) inhibitors.Study results showed that Amvuttra significantly reduced the risk of all-cause mortality or recurrent cardiovascular events by 28% compared to placebo in patients with ATTR-CM. Furthermore, the risk of all-cause mortality or recurrent cardiovascular events was reduced by 33% in the group receiving only Amvuttra without Vyndaqel.ATTR-CM is a systemic protein deposition disorder caused by structural instability of transthyretin (TTR).TTR is a tetrameric transport protein primarily synthesized in the liver, responsible for stabilizing and transporting thyroid hormones and vitamin A. However, when genetic mutations or age-related changes destabilize the protein, the tetramer dissociates into monomers. These monomers then misfold and convert into insoluble amyloid fibers with a β-sheet structure. The accumulated amyloid fibers deposit in various organs, causing structural damage and functional decline.Meanwhile, Medison Pharma is currently working toward reimbursement listing for Amvuttra’s hATTR-PN indication. The drug recently passed the Drug Reimbursement Evaluation Committee review on December 4 and is now set to enter pricing negotiations with the National Health Insurance Service.
- Company
- AZ "Expanding Asia-based evidence…solid cancer trt options"
- by Son, Hyung Min Dec 11, 2025 08:40am
- AstraZeneca (AZ) highlighted the importance of building clinical evidence and a research network in Asia while presenting new therapeutic options across major solid tumor area.The company announced that it aims to have its treatments administered to one in three liver cancer patients, one in three bile duct cancer patients, and one in seven gastric cancer patients by 2030, emphasizing that Asia is the core driver of this vision. AstraZeneca explained that 60–70% of patients participating in its gastrointestinal (GI) cancer clinical trials are recruited from Asia, and with approximately 50 research sites operating across the region, Asia is playing a central role in global development.명이다. Key data unveiled for breast, lung, and GI cancers..."Survival improvement consistent in Asian patients"According to industry sources on December 10, AstraZeneca held a media briefing at the recent European Society for Medical Oncology Asia (ESMO Asia 2025) annual meeting in Singapore. Senior global executives from AZ uniformly stated that Asia is emerging as the central axis for new drug development, clinical evidence generation, and early diagnostic technology, moving beyond being just a participating region.From left, Eldana Sauran, Asia Oncology Director, Sylvia Varela, Vice President for AstraZeneca, Mark Sims, Vice President for AstraZeneca, Katy Miller, Vice President for AstraZeneca, Osama Rahma, Vice President for AstraZenecaThe executives particularly emphasized that the research disclosed at the conference, focusing on cancers with high incidence and unmet clinical needs in Asia, including lung, breast, and gastrointestinal cancers, will become "the evidence driving future changes to the global standard of care."AstraZeneca summarized and shared the latest data presented at the conference across major cancer types, including HER2-positive breast cancer, triple-negative breast cancer (TNBC), EGFR-mutated lung cancer, and early-stage gastric, liver, and bile duct cancers.First, in breast cancer, the key updates included ▲the potential of 'Enhertu (trastuzumab deruxtecan) + Perjeta (pertuzumab)' as a first-line therapy for HER2-positive metastatic breast cancer ▲Enhertu's role in the neoadjuvant preoperative setting ▲survival improvements demonstrated by 'Datroway (datopotamab deruxtecan)' in PD-L1-negative TNBC patients. It was strongly highlighted that the effects observed in the Asian patients were consistent with global findings.Sylvia Varela, Vice President for AstraZeneca, explained, "The Enhertu-based combination therapy in HER2-positive metastatic breast cancer showed the potential to surpass the limitations of the existing standard of care, and Datroway showed survival improvement in first-line triple-negative breast cancer, where immunotherapy is challenging. The shift towards ADC-centric treatment in breast cancer is fully underway."For lung cancer, clinical data were released concerning Asian patient characteristics, where EGFR mutations are particularly prevalent.Mark Sims, Vice President for AstraZeneca, noted that the 'Phase 3 NeoADAURA' study of neoadjuvant Tagrisso confirmed maintenance of patient quality of life and the Phase 3 'FLAURA2' study (Tagrisso + chemotherapy) achieved a median Overall Survival (OS) of nearly 4 years.Sims assessed, "The strategy of moving therapeutic intervention to an earlier stage, from early-stage disease to metastatic disease, is yielding definitive results in Asian patients as well. Furthermore, consistent PFS improvement was reported in the Asian subgroup analysis for the savolitinib combination strategy targeting MET resistance mechanisms."For major GI cancers, including gastric, liver, and bile duct cancers, positive data for the immune checkpoint inhibitor 'Imfinzi (durvalumab)' were also presented across. Key studies included ▲MATTERHORN study, which demonstrated a new treatment axis in early-stage gastric cancer ▲SIERRA study, which confirmed therapeutic benefit for patients with hepatocellular carcinoma (liver cancer) with high unmet needs ▲TOURMALINE study, which demonstrated additional potential for the Imfinzi + gemcitabine combination.Katy Miller, Vice President for AstraZeneca, stressed, "A total of four GI-related studies were selected for oral presentation at ESMO Asia. This clearly demonstrates the high level of interest the oncology community has in these disease groups, and how critical these diseases are in the Asian region."Strengthening next-generation platform, precision medicine, and combination strategiesGiven the high cancer burden in Asia, AstraZeneca stated that the region will also be the center of development for next-generation oncology platforms.AstraZeneca presented its multi-mechanistic pipeline, including ▲next-generation ADCs (HER2, CLDN18.2) ▲the TIGIT-based bispecific antibody rilvegostemab ▲GPC3 CAR-T and T-cell engagers ▲next-generation PARP and PRMT5 inhibitors, and EGFR/MET-targeted radioconjugates. The core strategic directions presented were 'early stage intervention, precision targeting strategies, and presenting new combination possibilities to overcome resistance.AstraZeneca hosted a media briefing at the ESMO Asia 2025 event in Singapore to share its vision.Through this presentation, AstraZeneca clearly affirmed that Asia will play a decisive role in the future global oncology ecosystem.Since 60–70% of clinical trial participants are recruited from Asia and the majority of research is based on Asian data, evidence from Asia is expected to become even more important in future drug approval and reimbursement discussions.Osama Rahma, Vice President for AstraZeneca, stated, "We aim to move effective treatments to the earlier stages of the disease, because the earlier we intervene, the closer we can lead more patients to a cure," and added, "60–70% of patients participating in GI cancer clinical trials are recruited from Asia, and approximately 50 active clinical trial sites are operating across the region. We will continue our close collaboration with researchers and clinicians throughout Asia."VP Varela stated, "The proportion of cancer patients in Asia is continuously increasing. Cancer burden in Asia is expected to grow further due to population growth, aging, industrialization, increased exposure to environmental and occupational carcinogens, and lifestyle changes," and emphasized, "AstraZeneca aims to launch 20 new medicines by 2030, half of which are in oncology. Our vision is to eliminate cancer as a cause of death through therapeutic innovation and achieve health equity by improving access to diagnosis, treatment, and early detection."
- Company
- Oral ALS drug 'Radicut Suspension' wins nod in KOR
- by Eo, Yun-Ho Dec 11, 2025 08:39am
- The oral formulation of the Amyotrophic Lateral Sclerosis (ALS) treatment, 'Radicut', has been commercialized in South Korea.The Ministry of Food and Drug Safety (MFDS) granted final marketing approval on December 10 for Tanabe Pharma Korea's Radicut (edaravone) Oral Suspension, an ALS treatment.The advantage of the Radicut oral suspension is that it reduces the burden on patients by decreasing the number of required hospital visits and minimizing discomfort compared to the existing intravenous (IV) formulation.This drug was designated for Accelerated Approval by the U.S. FDA in October 2019 and was subsequently approved in May 2022. In countries like the U.S., the Radicut oral suspension is marketed under the product name 'Radicava'.The suspension formulation of Radicut significantly shortens the administration time compared to the IV injection. While the IV formulation requires the infusion of two ampules (60 mg edaravone) diluted in normal saline over 60 minutes once daily, Radicava ORS takes only a few minutes to administer.Tanabe Pharma conducted a comprehensive clinical development program for both the intravenous and oral formulations of edaravone over more than 10 years. The approval of Radicut oral suspension was based on data from multiple studies, including the Phase 3 clinical trial MCI186-19, which evaluated 137 patients with ALS.Notably, the MCI186-19 study measured the ALS Functional Rating Scale-Revised (ALSFRS-R), a validated assessment tool for monitoring disease progression, at Week 24. The oral suspension group showed a 33% slower decline in physical function compared to the placebo group.In addition, Tanabe Pharma conducted seven Phase 1 clinical pharmacology studies to investigate the pharmacokinetics, safety, drug interactions, dosage, bioavailability, and bioequivalence of Radicava ORS in healthy subjects and in ALS patients with or without a Percutaneous Endoscopic Gastrostomy (PEG) tube or a Nasogastric (NG) tube.Furthermore, a 24-week global Phase 3 clinical trial demonstrating the safety and tolerability profile of 'Radicava ORS' treatment in 185 ALS patients was also conducted. A Phase 3 clinical study evaluating the long-term safety and tolerability for up to 96 weeks is currently ongoing.
