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- Company
- Will the new GVHD drug Rezurock be reimbursed in 2H?
- by Eo, Yun-Ho Sep 16, 2025 06:10am
- Attention is growing over whether the graft-versus-host disease (GVHD) treatment Rezurock will be included in the national health insurance reimbursement list in the second half of this year. Sanofi Korea’s ROCK2 inhibitor Rezurock (belumosudil) recently passed the Health Insurance Review and Assessment Service (HIRA)’s Drug Reimbursement Evaluation Committee. Accordingly, the company is expected to soon enter pricing negotiations with the National Health Insurance Service. If the procedures proceed smoothly, reimbursement listing may be possible within the year. Rezurock, which received accelerated approval from the US FDA, was granted domestic approval in Korea in August last year, and was launched without reimbursement in November. It selectively inhibits ROCK2, a novel mechanism of action that targets inflammatory and fibrotic processes in chronic GVHD. Chronic GVHD is a complication that occurs in about half of patients who undergo allogeneic hematopoietic stem cell transplantation. Although the patient pool is relatively small, it affects about half of transplant patients and is a life-threatening condition that requires treatment. GVHD accounts for 37.8% of deaths in hematologic malignancy patients aside from relapse. With the number of hematopoietic stem cell transplants increasing every year (1,794 cases in 2023), the need for chronic GVHD treatment has also been on the rise. Within 3 years on average, 42% of transplant patients develop chronic GVHD, and 66% already are experiencing acute GVHD. However, a treatment gap exists in chronic GVHD. Both domestic and international treatment guidelines recommend steroids as first-line therapy, but it cannot be used in the long-term, as prolonged use can cause various systemic side effects of Cushing’s Syndrome, including osteoporosis, joint necrosis, organ failure, hyperlipidemia, gastrointestinal disorders, and growth retardation. While 96% of chronic GVHD patients receive steroids as first-line therapy, 70% move on to second-line treatment, and 50% eventually require third-line treatment. In cases where second-line treatment fails, there has been no effective third-line option, leaving patients to rely on combination therapy with steroids and immunomodulators. Also, 97% of chronic GVHD patients treated with steroids experience at least one complication, with infection being the most common (79.5%). Symptoms manifesting across multiple organs significantly lower quality of life, and host reactions in the lungs and liver can be particularly fatal. Against this backdrop, attention is on whether Rezurock will establish itself as a new treatment option through reimbursement coverage in Korea. Rezurock demonstrated a high overall response rate (ORR) of 75% in clinical trials targeting patients who failed two or more lines of systemic therapy, proving superior efficacy compared to existing treatments. In particular, it showed high response rates in previously hard-to-treat organs: 71% in joints, 39% in the liver, and 26% in the lungs. Professor Hee-Je Kim, Head of Hematology at Seoul St. Mary’s Hospital, said, “Forty-two percent of chronic GVHD patients develop symptoms across multiple organs, which significantly lowers their quality of life. Host reactions in the lungs and liver can have fatal consequences for hematologic cancer patients, so there has been an urgent need for a therapy that can effectively manage these.”
- Policy
- Spray formulation of 'nicotine' wins nod in KOR as OTC
- by Lee, Tak-Sun Sep 16, 2025 06:10am
- A spray formulation containing nicotine, which is used as a smoking cessation aid, received its first approval in Korea. The nicotine spray was previously discussed for classification as a prescription drug in 2019, but this time it obtained approval as an over-the-counter (OTC) drug that is exempt from safety and efficacy review. Spray formulations are widely used as OTC products overseas. On September 15, the Ministry of Food and Drug Safety (MFDS) approved Johnson & Johnson Korea's 'Nicorette QuickMist Mouthspray (nicotine).' This drug is an adjunct therapy for smoking cessation and is used to relieve nicotine cravings and withdrawal symptoms. As a nicotine replacement therapy (NRT), it reduces cravings and withdrawal symptoms by allowing nicotine to be absorbed through the oral mucosa. This drug is used in three stages: In Stage 1 (weeks 1-6), one spray is used when a craving to smoke arises. In Stage 2 (weeks 7-9), the daily usage is gradually reduced, with the goal of using half the average number of sprays used during Stage 1 by week 9. In Stage 3 (weeks 10-12), if the usage has been reduced to 2-4 times a day, the use of this drug should be discontinued. Complete smoking cessation is required while using the oral spray. The method of use is to open the mouth, bring the spray nozzle as close to the mouth as possible, and press firmly on the top of the spray to dispense it, avoiding the lips. J&J's Nicorette is a leading brand of smoking cessation aids sold in pharmacies. In Korea, three formulations are currently sold: Nicorette Gum, Nicorette Lozenges Coolmint, and Nicorette Invisi Patch. While the spray formulation is sold overseas, it had not been launched in Korea due to concerns over potential misuse and abuse. It has reportedly been sold as an OTC product in the UK for nearly 20 years. In 2019, the MFDS Central Pharmaceutical Affairs Advisory Committee (CPAC), while discussing approval for the nicotine spray formulation, had shared the opinion that classifying it as a prescription drug was appropriate. At that time, 5 out of 7 committee members favored a prescription drug classification due to concerns about misuse by adolescents. Subsequently, the nicotine spray formulation was not approved. Six years later, with MFDS granting approval for this drug as an OTC drug, which offers good consumer accessibility, it is gaining attention whether this market will become more active. The approval process also excluded a safety and efficacy review.
- Company
- Sanofi-MTPK sign exclusive sales agreement for Aubagio
- by Son, Hyung Min Sep 16, 2025 06:09am
- Mitsubishi Tanabe Pharma Korea (CEO Wonkyu Lee, MTPK) announced that it has entered into an exclusive domestic promotion and distribution agreement with the global biopharmaceutical company Sanofi Korea (General Manager Kyung Eun Bae), for the multiple sclerosis (MS) treatment Aubagio. The agreement officially took effect on September 1, 2025. Both companies aim to ensure stable product supply and patient-focused service through close collaboration. Through this partnership, MTPK has secured exclusive sales rights for Aubagio in Korea and will be responsible for local sales and marketing activities. Sanofi will continue to handle product importation, supply, regulatory affairs, and overall product management. Aubagio has demonstrated efficacy in reducing relapses and slowing disease progression in patients with relapsing multiple sclerosis. It is a once-daily oral therapy, offering convenience that is being used widely both in Korea and abroad. MI Youn Lee, Head of EP & Portfolio at Sanofi Korea and Australia/New Zealand, stated, “With this agreement, we expect that more Korean MS patients will gain stable access to the therapeutic benefits of Aubagio. Sanofi will continue to strive to build a sustainable treatment environment that allows patients to maintain better treatment and improve their quality of life.” Won Kyu Lee, CEO of MTBK also said, “Drawing on our extensive experience in the field of neurological diseases, we will do our utmost to ensure Aubagio reaches Korean MS patients more effectively. In line with our corporate philosophy, we will continue to enhance corporate value through the introduction of innovative new drugs and contribute to patients and society through ongoing activities.”
- Policy
- "Gov't actively supports the development of new drugs"
- by Lee, Jeong-Hwan Sep 16, 2025 06:08am
- The Ministry of Health and Welfare (MOHW) explained that its establishment of a first-ever 'Phase 3 Specialized Fund' as one of its budget projects for next year is the result of government's commitment to creating innovative new drugs in Korea. The MOHW also announced that it would first design a specific business model for the 'Loan System for New Drugs Based on Success' by next year through a research project, and then begin selecting pharmaceutical and bio companies to receive benefits from 2027. A MOHW official, in a recent meeting with the Korea Special Press Association, explained, "The establishment of a specialized fund by the government to support pharmaceutical companies with the will and capability to develop new drugs in Phase 3 is the first of its kind, and it holds significant meaning." The MOHW has allocated KRW 60 billion in new costs for the establishment of the Phase 3 specialized fund next year. The goal is to establish a total fund of KRW 150 billion by combining the MOHW's contribution and investment from a fund of funds. This fund will then be used to select and support pharmaceutical and bio companies that have innovative new drug and Bio-Better pipelines and the intention to pursue Phase 3 clinical trials. Once the fund is established, the MOHW will not be directly involved in the selection of pharmaceutical companies or new drug candidates, entrusting that responsibility to investment firms. The MOHW also allocated KRW 500 million for a research service budget to design a Korea model for the 'Loan System for New Drugs Based on Success.' Given that it is rare to invest such a large amount, such as millions of KRW, into a research budget, it demonstrates a strong will to design a proper loan model for Korea. The Loan System is a policy that exempts or partially reduces the loan repayment responsibility for pharmaceutical companies that receive government investment and support for new drug development, even if the new drug ultimately fails to be created. If next year's budget is approved by the National Assembly, the MOHW plans to do its utmost to ensure that domestically developed new drug and bio companies can receive tangible benefits. A MOHW official said, "The Phase 3 specialized fund requires consultation with policy banks and other institutions. It's difficult to proceed with just government contributions, so we need to raise external investment." He stressed that, "While a KRW 150 billion fund may not be large when you consider the costs required for Phase 3, the fact that this is the first time the government is establishing a specialized fund to provide customized support for Phase 3 clinical trials is what makes it meaningful." The official added, "This is a demonstration of the government's strong will to discover new drugs." He continued, "The fact that this is the first time we are providing such support is impressive, and if the project is successful, we can increase its size, which makes it a crucial budget." And added, "For the Loan System, we will only be conducting research next year. We've allocated KRW 500 million, which is a significant amount for a research budget." He added, "We will design a specific implementation plan and a practical loan model for new drugs. After completing the research next year, we plan to reflect the actual project support budget in the 2027 budget plan." Finally, He said, "The Loan System requires collecting many opinions from the pharmaceutical and biotech industry during the research process," and added, "We need to discuss details, including pharmaceutical companies willing to support, the number of new drugs, and the criteria for success. We decided that we need such a system to encourage challenging investments in new drug development, which has a high probability of failure, and the Ministry of Economy and Finance agreed to include it in the budget plan."
- Company
- Active treatment needed for childhood·adolescent obesity
- by Eo, Yun-Ho Sep 15, 2025 06:03am
- With interest in obesity management becoming higher than ever with the introduction of Mounjaro and Wegovy, attention is also gathering to neglected areas. In particular, the rising prevalence of childhood obesity and the limited treatment options have raised the need for improved treatment environments. Globally, obesity has become the most common nutritional disorder among children, leading to physical problems such as growth hormone deficiency, precocious puberty, and polycystic ovary syndrome, as well as psychosocial issues including low self-esteem, depression, and anxiety. Since children and adolescents are continuously growing in height and weight, obesity is diagnosed using body mass index (BMI) percentiles based on sex and age. According to the Korean Society for the Study of Obesity’s Clinical Practice Guidelines (2022, 8th edition), children aged two years and older should be assessed using the 2017 growth chart: BMI at or above the 85th percentile is considered overweight, and at or above the 95th percentile is considered obese. ◆Childhood and adolescent obesity is on a continuous rise...Korea is also at risk The problem is the sharp increase in the childhood and adolescent obesity population. According to a pooled analysis by the World Health Organization (WHO) and Imperial College London, the number of obese children and adolescents has increased by more than tenfold over the past 40 years. By analyzing BMI and obesity prevalence trends from height and weight measurements in populations aged 5 and older across 200 countries between 1975 and 2016, the prevalence of childhood obesity rose from less than 1% in 1975 to 6% among girls and 8% among boys in 2016. This indicates a steady global rise in both the number and proportion of children affected by obesity, with particularly sharp increases in regions such as the Middle East and North Africa, South Asia, East Asia, and high-income English-speaking countries. In line with global trends, obesity prevalence among Korean children and adolescents has also been on the rise. According to the “2021 National Health Statistics” published by the Korea Disease Control and Prevention Agency, obesity prevalence among boys aged 6&8211;18 increased to 19.5% in the 8th survey period from 11.1% in the 5th (a 1.76-fold increase), while among girls it rose to 12.7% from 9.2%, which is a 1.38-fold increase. Also, a sample survey of elementary, middle, and high school students released by the Ministry of Education in April showed that 29.3% of students fell into the overweight or obese category last year&8212;which is roughly one in three. ◆Academic community aligns with clinical guidelines...recommends drug therapy Given this situation, clinical guidelines for childhood and adolescent obesity are also evolving. Notably, the necessity for more direct treatment approaches, including previously conservative drug therapy, is increasingly being raised. According to the guidelines released on January 9, 2023, by the American Academy of Pediatrics (AAP) for the evaluation and treatment of childhood obesity, pharmacological therapy is recommended for children aged two and older, and surgical interventions are permitted from age 13 onward&8212;emphasizing active intervention from the early stages of diagnosis. The recommended medications include Saxenda (liraglutide), Wegovy (semaglutide), Xenical (orlistat), and Qsymia (phentermine/topiramate). This has sparked debate by overturning the tendency to prioritize traditional dietary and behavioral therapies in children and adolescents, but it also underscores the urgent need for obesity management in severely obese children and adolescents. Korea has also recognized the need for pharmacotherapy. In 2022, the Korean Society for the Study of Obesity recommended considering drug therapy under the supervision of experienced specialists if intensive diet, exercise, and behavioral therapy fail to control ongoing weight gain and obesity-related comorbidities in children Furthermore, the first guidelines on childhood obesity that was published in Asia, which was in 2019, covered the ▲definition and diagnosis of overweight and obesity in children, ▲treatment principles of pediatric obesity, ▲behavioral therapy (including diet, exercise, lifestyle, and mental health), ▲pharmacological treatment, and ▲surgical treatment. For each area, they established recommendations and their respective levels of evidence (Level A&8211;D). Professor Hye-Woon Jung of Kyung Hee University Hospital’s Department of Pediatrics said, “Lifestyle intervention is important for severely obese children and adolescents, but it may not be enough. In such cases, active pharmacological treatment should be considered. Although some medications are approved for severe pediatric obesity, treatment options remain limited in Korea.”
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