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- 2025-12-19 23:23:08
- Policy
- Reimb listing a hurdle for Dutasteride + Tadalafil combos
- by Jung, Heung-Jun Sep 18, 2025 06:02am
- The dutasteride-tadalafil combination was approved in January for the treatment of benign prostatic hyperplasia (BPH), but has failed to clear the reimbursement hurdle, which is delaying the drug’s market launch. Four companies – Dongkook Pharmaceutical, Dong-A ST, DongKoo Bio&Pharma, and Shinpoong Pharm - are reportedly discussing a non-reimbursed launch, though some differences in opinion remain. According to industry sources on the 16th, the four companies are debating whether a non-reimbursed launch would have sufficient market potential or whether it would be better to attempt another reimbursement bid. If they proceed with a non-reimbursed launch, they must also decide on the appropriate timing. Dongkook Pharmaceutical (Uresco Tab), Dong-A ST (Dutana Tab), DongKoo Bio&Pharma (Uroguard Tab), and Shinpoong Pharm (Avocial Tab) drew attention in January for obtaining the world’s first approval of fixed-dose dutasteride-tadalafil combinations. Although the companies applied for reimbursement listing, concerns over potential misuse became an obstacle. In particular, the non-reimbursed component of tadalafil was said to have been the sticking point. An industry official commented, “If launched without reimbursement, we need to assess how much market potential it would really have. Some companies also favor making another reimbursement attempt, so consensus must be reached.” The companies are in a difficult position, as launching without reimbursement and then reapplying for listing is not an easy path. The dutasteride-tadalafil combination was first developed by Dongkook Pharmaceutical in 2012 and has come to fruition after 13 years of research. A Dongkook Pharmaceutical representative said, “No definite timeline has been set for a non-reimbursed launch yet, and discussions are still ongoing with the three partner companies.” The companies hold exclusive sales rights for 6 years following approval. The longer the launch is delayed, the shorter the effective exclusivity period becomes. According to IQVIA, the market for dutasteride has been steadily growing alongside the hair loss treatment market. Last year, sales of the original product Avodart reached KRW 42.9 billion, while generics totaled KRW 49.4 billion.
- Company
- Samjin Pharm and Sanofi collide in the influenza vaccine mkt
- by Hwang, byoung woo Sep 17, 2025 06:12am
- With the influenza (flu) vaccination season approaching, competition in the vaccine market for adults aged 65 and over is anticipated. The government has switched the National Immunization Program (NIP) vaccine to a three-valent vaccine and lowered the procurement price. The introduction of the four-valent vaccine in the non-reimbursed medicine market is likely to be a variable. (from left) product photo of Fluad Quad and Efluelda According to the Korea Disease Control and Prevention Agency (KDCA), the 2025-2026 seasonal influenza National Immunization Program (NIP) will begin on the 22nd of this month and run until April of next year. Free vaccinations will be provided to high-risk groups, including children aged 6 months to 13 years (born between January 1, 2012, and August 31, 2025), pregnant women, and individuals aged 65 and over (born before January 1, 1956). Considering that influenza vaccinations typically begin with the NIP, the competition between Samjin Pharm-CSL Seqirus and Sanofi is expected to heat up from October. Samjin Pharm-CSL Seqirus and Sanofi are aiming to expand their market influence by promoting an adjuvanted vaccine and a high-dose vaccine, respectively. First, Samjin Pharma, in cooperation with CSL Seqirus, is scheduled to supply 'Fluad Quad,' an adjuvanted vaccine for elderly individuals, and 'Flucelvax Quad,' the cell-based flu vaccine. Samjin Pharma offers a specialized line of prescription drugs for treating chronic diseases and product lines related to pediatrics, such as Trestan. The company anticipates synergy with its existing sales capabilities. A Samjin Pharma official said, "The company has long strived to provide good treatments for chronic disease patients, who are a high-risk group for influenza," and added, "As our product portfolio is focused on chronic disease treatments, we intend to ensure that Fluad Quad, an adjuvanted influenza vaccine, can be administered to the chronic disease patients we have been focusing on." Sanofi is expected to pursue a continuous market strategy, building on its efforts from last year. Sanofi has already been prepared for inclusion of its product in the NIP, including the publication of a cost-effectiveness analysis in the international journal 'Human Vaccines & Immunotherapeutics' in November 2023, which compares its high-dose vaccine with a standard-dose vaccine using national health insurance big data. A Sanofi official emphasized, "Efluelda is the only product among the high immunogenicity flu vaccines recommended by the Korean Society of Infectious Diseases that has proven preventive efficacy in a randomized clinical trial," and added, "Efluelda will contribute to reducing the socioeconomic burden caused by influenza and pneumonia in adults aged 65 and over." The premium vaccine market for adults aged 65 and over has been increasing. One of the variables is the shift of the NIP vaccine to a three-valent formulation. Previously, a four-valent vaccine containing antigens for four types of viruses, including influenza A virus (H1N1 and H3N2) and influenza B virus (Victoria and Yamagata), was used in the NIP. However, based on the World Health Organization's (WHO) recommendation earlier this year, this season's vaccine will be a three-valent vaccine that excludes the influenza B/Yamagata virus antigen. Consequently, the procurement price has been lowered compared to the previous four-valent vaccine, and the four-valent vaccine that was previously administered will now be a non-reimbursed vaccine. It means that the adjuvanted vaccine and high-dose vaccine, which previously competed with the NIP-included four-valent vaccine, will now have to compete for market share with both the NIP-included three-valent vaccine and the (non-reimbursed) four-valent vaccine. Both the adjuvanted vaccine and the high-dose vaccine claim to offer higher preventive efficacy in elderly individuals than the conventional influenza vaccine, but a price barrier could be an issue. However, a prediction also exists that, in the long run, as both vaccines aim to enter the NIP, they will focus on expanding the market for vaccines specifically designed for elderly individuals, rather than just competing with each other. In a previous press conference, Professor Choi Min-joo of the Department of Infectious Diseases at Korea University Guro Hospital said, "Research results indicate that the switch from a standard influenza vaccine to an adjuvanted vaccine is a rational choice not only in terms of medical benefits but also from an economic perspective," and added, "These results suggest that an adjuvanted vaccine like Fluad could be a worthy subject for policy consideration in future discussions for selecting NIP vaccines for the elderly." An individual from the vaccine industry said, "The promotions by Samjin Pharma-CSL Seqirus and Sanofi will likely involve considering various factors beyond simple market share competition, including their products' potential inclusion in the NIP and vaccination patterns." They added, "Since both companies are already emphasizing not only their vaccination efficacy but also their cost-effectiveness through research, We believe they will consider growing the overall market pie."
- Company
- Jemperli nears final hurdle for reimb in endometrial cancer
- by Eo, Yun-Ho Sep 17, 2025 06:11am
- The immunotherapy Jemperli is on the verge of securing expanded reimbursement coverage for endometrial cancer in Korea. According to industry sources, GSK Korea has recently finalized drug price negotiations with the National Health Insurance Service (NHIS) for the PD-1 inhibitor Jemperli (dostarlimab). The only step remaining is review by the Health Insurance Policy Deliberation Committee. Specifically, the indication for reimbursement is extended to the treatment of newly diagnosed recurrent or advanced high microsatellite instability (MSI-H)/mismatch repair-deficient (dMMR) endometrial cancer. Currently, the first-line standard of care for endometrial cancer is platinum-based chemotherapy combining paclitaxel and carboplatin. However, one in four patients relapses or progresses after this therapy. With the number of recurrent/advanced cases increasing but effective options lacking, the 5-year survival rate remains under 20%. Jemperli was first listed for reimbursement in December 2023 as a second-line treatment for recurrent/advanced (FIGO stage IIIB and above) endometrial cancer that had progressed during or after platinum-based chemotherapy. Since then, efforts have been made to add a first-line indication and expand reimbursement. The drug’s efficacy in the first-line setting was confirmed through the Phase III RUBY trial. The RUBY trial enrolled 494 patients with advanced or recurrent endometrial cancer, comparing Jemperli plus platinum-based chemotherapy (carboplatin + paclitaxel) against placebo plus chemotherapy. Designed with more than 3 years of treatment follow-up—given that the average survival under standard platinum therapy is less than 3 years—the primary endpoints were progression-free survival (PFS) and overall survival (OS) per RECIST (Response Evaluation Criteria in Solid Tumors). Results showed that the Jemperli combination reduced the risk of death by 31% versus the control group across the overall advanced/recurrent patient population. Over a median follow-up of 37 months, the median OS in the Jemperli arm was 44.6 months, compared to 28.2 months in the control arm, extending survival by 16.4 months and lowering the risk of death by 31%. Jae Kwan Lee from the Department of Obstetrics & Gynecology at Korea University Guro Hospital, said, “Endometrial cancer carries a high risk of recurrence even after initial treatment, so effective first-line options are crucial. The RUBY trial is recognized as a landmark study that demonstrated the long-term efficacy of immunotherapy in this setting.” He added, “Jemperli in combination with platinum chemotherapy is the only immunotherapy available in Korea to show an OS benefit in endometrial cancer. Importantly, the trial included high-risk groups, such as patients relapsing more than 6 months after chemotherapy and those with carcinosarcoma, yet still demonstrated significant clinical value.”
- Company
- Vivozon "Joint sales of Unafra with Daiichi Sankyo"
- by Kim, Jin-Gu Sep 17, 2025 06:10am
- Vivozon has chosen Daiichi Sankyo Korea as its co-promotion partner for Unafra Inj (opiranserin). The pharmaceutical industry points to two key reasons for this partnership: a synergy in sales and marketing for postoperative patient care, and the potential for Daiichi Sankyo Korea to play a positive role in Unafra's global market entry. Joint sales promotion of Unafra Inj: synergy between product·sales expected in 'postoperative patient care.' On September 16, Vivozon announced that it had signed a co-promotion and sales agreement with Daiichi Sankyo Korea for the distribution, marketing, and sales of Unafra in Korea. Under the terms of the agreement, Vivozon will supply the finished product, and the two companies will share the responsibilities of distribution, sales, and marketing. Vivozon announces signing a co-promotion and sales agreement with Daiichi Sankyo Korea for its Unafra. Unafra received the marketing authorization as the 38th new Korean drug in December of last year. Around the time of the product's approval, Vivozon began searching for a co-promotion partner. For Vivozon, securing a domestic sales partner was crucial. Its existing sales team of about 30 people handled promotion and sales for regional hub hospitals, but this was insufficient for a stable landing of the new drug. To effectively sell Unafra, which is approved for postoperative pain management, a sales team specializing in large hospitals was needed. Consequently, the company focused on securing a partner while also expanding its own sales force. It is reported that several other pharmaceutical and biotech companies showed interest, but Vivozon ultimately chose Astellas Pharma Korea. A Vivozon official stated, "With the Unafra's approval set, we added about 10 sales representatives dedicated to the product. With this partnership, we will now begin full-scale sales of Unafra," and added, "Daiichi Sankyo Korea will be responsible for sales and marketing at general hospitals with over 300 beds, while both companies will jointly handle sales and marketing for hospitals and clinics with fewer than 300 beds." Daiichi Sankyo Korea's product portfolio, which targets postoperative patients, is also considered a background to the partnership. Daiichi Sankyo Korea holds 'Nasea (ramosetron),' a preventive medication for nausea and vomiting, and 'Taleaje (mirogabalin),' a treatment for neuropathic pain. Both products are primarily used for pre- and postoperative patient management, creating a potential synergy with Unafra, which targets postoperative pain management. The global pharma Daiichi Sankyo Korea's support is expected for global expansion From the development stage, Vivozon set its goal on the global market for Unafra. The decision to choose Daiichi Sankyo Korea as a partner is interpreted as a move that extends beyond mere domestic sales and marketing collaboration, with the company also seeking practical and strategic support for its global expansion. Vivozon has established a two-track global entry strategy. For the U.S., Europe, and China, the goal is to enter the market through technology transfer. The company plans to out-license the drug to companies with local clinical and new drug approval experience. In the U.S. market, the largest, a local Phase 3 clinical trial for the injectable formulation is underway, and U.S. Food and Drug Administration (FDA) product approval remains a key hurdle. For Southeast Asia, the Middle East, North Africa, Latin America, and Russia/Eurasia, the company's policy is to secure regional export partners. It is reported that specific discussions are underway with several companies. During this full-scale global expansion, Daiichi Sankyo Korea's expertise in global clinical trials, approvals, and supply chain management can enhance the company's business credibility in negotiations for technology transfer to the U.S. and Europe, local clinical trial design and operation, and large-scale production and supply planning. Daiichi Sankyo Korea also has a global network, regional subsidiaries, and distribution channels, which could be instrumental in connecting with local partners and verifying distribution networks. It is expected that the company's network will play a crucial role in facilitating communication with local pharmaceutical companies and distributors when searching for regional export partners in areas such as Southeast Asia, the Middle East, and Latin America. A Vivozon official stated, "We expect this partnership with Daiichi Sankyo Korea, a global pharmaceutical company, to have a positive impact on Unafra's overseas expansion."
- Company
- Did companies pre-stock inventories in the U.S.?
- by Kim, Jin-Gu Sep 17, 2025 06:10am
- The surge in Korean pharmaceutical exports to the United States—driven by concerns over possible tariffs—returned to normal levels within 2 months. Industry observers suggest that companies may have frontloaded shipments to secure inventories in the U.S. market. While exports have declined, some note that since tariff risks remain unresolved, shipments to the U.S. could spike again at any time. August U.S. exports total USD 95.43 million…79% drop in just 2 months According to Korea Customs Service data released on the 16th, exports of Korean pharmaceuticals to the US in August reached USD 95.43 million (approx. KRW 130 billion). This represents a 4% increase compared to August 2024 (USD 91.75 million). This trend sharply contrasts with the previous 3 months, during which exports surged. Monthly pharmaceutical exports to the US in the past 2 years In May, exports rose 35% year-on-year to USD 184.35 million (KRW 260 billion). In June, exports hit a record USD 458.38 million, nearly equal to the previous 4 months combined. In July, exports more than doubled year-on-year (+120%), reaching USD 136.21 million. However, by August, exports increased only 4% year-on-year, effectively returning to typical levels. Compared with June, exports fell 79%, shrinking to one-fifth in just 2 months. The share of US exports in Korea’s overall pharmaceutical exports also fell—from 49% in June to 15% in August, returning to a level similar to the 2024 annual average of 18%. Did companies sufficiently secure local inventory...levels return to previous years' levels Analysts attribute the decline to companies having already secured sufficient inventories in the U.S. in response to tariff risks. Amid fears of potential US tariffs on pharmaceuticals, Korean companies boosted shipments to build local stockpiles. Once inventories were secured, exports normalized in August. In April, US President Donald Trump announced reciprocal tariffs globally, though pharmaceuticals were initially exempt. On July 30, the US and EU agreed to impose a 15% tariff on pharmaceuticals. However, tariff rates on Korean medicines remain undecided. With risks ongoing, Korean pharmaceutical and biotech firms have taken proactive measures. For example, Celltrion reportedly secured a 2-year supply of inventory in the US and is investing KRW 700 billion to acquire a local biopharmaceutical manufacturing facility. Companies with significant U.S. export shares, including Celltrion, are known to have employed similar strategies. As inventory levels in the U.S. were sufficiently secured during this process, it is suggested that export volumes likely returned to normal levels in August. However, some observers note that since tariff risks have not been fully resolved, pharmaceutical exports to the U.S. could increase again after September. A pharmaceutical industry insider stated, “The large volume exported in June and July may have accumulated as inventory within the U.S. Consequently, the need for additional procurement decreased in August, and export performance may have been adjusted. However, as the tariff risk has not yet been fully resolved, exports of domestic pharmaceuticals to the U.S. could fluctuate again around the time of the U.S. government's official announcement.”
- Policy
- Bill bans remote narcotics and hair loss drug prescriptions
- by Lee, Jeong-Hwan Sep 17, 2025 06:10am
- A partial amendment to the Medical Service Act was introduced in the National Assembly on the 16th, mandating that physicians check the Drug Utilization Review (DUR) system when prescribing via telemedicine. The rule applies to high-risk drugs such as narcotics, psychotropics, anti-obesity drugs like Wegovy, hair loss treatments, and isotretinoin acne drugs that are prone to misuse. The bill stipulates that physicians must confirm the DUR system when prescribing any drugs designated by the Ministry of Health and Welfare as prohibited for telemedicine. Violations will result in administrative fines of up to KRW 3 million. Rep. Sunmin Kim (Rebuilding Korea Party), who proposed the bill as representative, explained, “In telemedicine, physicians cannot prescribe government-banned drugs once they check DUR at the time of prescription. This legislation codifies the existing safeguard into law.” If enacted, the bill is expected to close loopholes where telemedicine could otherwise be exploited as a channel for prescribing high-risk, non-reimbursed drugs. The bill amends Article 18-2 (“Confirmation of Drug Information”) of the Medical Service Act, adding a clause requiring physicians and dentists providing telemedicine to check DUR before issuing prescriptions or dispensing medicines themselves. Terminology adjustments include renaming “telemedicine” (Article 34) to “non-face-to-face cooperative care,” while defining “telemedicine” in a new Article 34-2. The definition covers patient monitoring, consultation, education, diagnosis, and prescribing using computers, laptop computers, video conferencing, outside of medical institutions. Also, the bill limited telemedicine subjects to returning patients, residents in medically underserved regions (islands, remote areas), inmates in correctional facilities and military personnel, and patients eligible for proxy prescription pickup. Effectively, first-time patients cannot use telemedicine unless under special circumstances, being restricted access to telemedicine. Specifically, for patients eligible for limited initial telemedicine, the Minister of Health and Welfare can now legally prescribe the types of medications that cannot be prescribed and set appropriate prescription durations, thereby establishing legal safeguards to prevent adverse effects from initial remote consultations. Also. the MOHW minister may designate specific disease groups requiring non-face-to-face telemedicine consultations via video communication for clear diagnosis. Patients with burns are expected to fall under this category. The bill also newly establishes provisions for telemedicine platforms, specifying the authority and responsibilities of the platform industry within the Medical Service Act. To provide or operate a non-face-to-face medical care intermediary platform, one must report to the Minister of Health and Welfare according to standards set by the Minister of Health and Welfare. Compliance requirements for telemedicine platforms are also newly established as separate provisions, and platform management and supervision standards are included in the law. The bill prohibits platforms from interfering with a physician's medical judgment, encouraging the misuse or abuse of medical services or pharmaceuticals, or engaging in acts that undermine healthcare order or harm patient health. Specifically, telemedicine platforms shall not arrange, induce, or instigate collusive acts as defined by the Pharmaceutical Affairs Act. Platforms must not, either directly or through third parties, introduce, arrange, or lure patients or individuals holding prescriptions to specific medical institutions, medical practitioners, pharmacies, or pharmacy owners/employees, and in return, provide, demand, or promise money, goods, benefits, labor, entertainment, or other economic advantages, nor receive such from medical institutions or similar entities. Platforms are also prohibited from inducing users to recommend or select specific medical institutions or pharmacies. Platforms are required to report quarterly to the Minister of Health and Welfare on the number of users of telemedicine platforms and the medical specialties involved, for the purpose of surveying the status of such telemedicine intermediaries. The Minister of Health and Welfare may order platforms to provide necessary data for this purpose. Additionally, platforms must submit quarterly reports to the MoHW on telemedicine use, including number of users and medical departments involved. The Minister may also request further data as needed. If platforms violate service standards or fail to comply with corrective orders, the Minister may restrict or suspend facility or equipment use. Non-compliance with such orders can result in license cancellation or suspension of business operations for up to one year. These provisions establish legal grounds for cancellation of platform registrations and suspension of operations in cases of regulatory breaches.
- Company
- "PSA test determines prostate cancer survival rate"
- by Son, Hyung Min Sep 17, 2025 06:09am
- There is a growing need to introduce prostate-specific antigen (PSA) test for the early diagnosis of prostate cancer. On September 16, the Korean Urological Oncology Society held a press conference at the Press Center, highlighting current updates on prostate cancer and emphasizing the importance of early diagnosis through PSA testing. Professor Byong Chang Jeong, President of the Korean Urological Oncology Society (Samsung Medical CenterAccording to the National Cancer Registration Program's announcement last year, there were 20,754 new prostate cancer patients in 2022, accounting for 7.4% of all cancer cases. In particular, the incidence of prostate cancer in individuals aged 65 and over reached 416.1 per 100,000 people, and this burden is expected to grow as Korea approaches a super-aged society. Professor Byong Chang Jeong, President of the Korean Urological Oncology Society (Samsung Medical Center's Department of Urology), said, "The Society has designated the third week of September as 'Prostate Cancer Awareness Week' and has been conducting various campaigns to spread correct awareness of prostate cancer and establish early screening as a part of daily life." Professor Jeong stressed, "We are raising awareness about the importance of early diagnosis, such as with PSA testing." A variety of treatments for prostate cancer have been introduced, leading to improvements in patient survival rates. Androgen receptor inhibitors, such as Janssen's Zytiga, Erleada, and Akeega, Astellas' Xtandi, and Bayer's Nubeqa, are being used. Recently, radiopharmaceuticals have also emerged. Novartis' Pluvicto received domestic approval in Korea last May and is now available for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have previously received an androgen receptor pathway inhibitor and a taxane-based chemotherapy. PSMA is a proteolytic enzyme synthesized in the epithelial cells of the prostate. Its expression is typically high in high-grade, metastatic, and castration-resistant prostate cancer. Compounds that combine a ligand binding to PSMA with a radioisotope that emits relatively low energy (Gallium-68) are used for PET/CT diagnosis. In contrast, compounds combined with a high-energy emitting radioisotope (Lutetium-177) can be used as a treatment. Additionally, several Korean biopharmaceutical companies, including FutureChem and Celltrion, are also developing radiopharmaceuticals for prostate cancer. Professor Park Sung-woo, Vice President of the Korean Urological Oncology Society (Pusan National University Yangsan HospitalProfessor Park Sung-woo, Vice President of the Korean Urological Oncology Society (Pusan National University Yangsan Hospital's Department of Urology), assessed, "When prostate cancer is detected early, the treatment outcomes are so good that it is often curable. However, if it metastasizes, the treatment outcomes rapidly worsen." He stated, "Early diagnosis is a key variable that determines a patient's survival rate and quality of life." Park added, "Various treatments have been included in the reimbursement list, contributing to improved survival rates. However, the speed of listing is slow compared to the pace of new drug launches. If new drugs that emerge in the future are quickly covered by reimbursement, it will help improve the survival rates of prostate cancer patients." PSA testing plays critical role in the early diagnosis of prostate cancer Prostate cancer, like other cancer types, often has few early symptoms, making it difficult for patients to be aware of the disease and leading to delayed diagnoses. Because of this, PSA testing plays a critical role in the early diagnosis of prostate cancer. PSA is a protein produced by the prostate, and its levels increase when cancer cells multiply. The PSA test, a simple blood test, has a low patient burden and high accessibility. If included in regular health check-ups, it could significantly enhance the effectiveness of prostate cancer management. Professor Young Hwii Ko, Editor-in-Chief of the Korean Urological Oncology Society (Ewha Womans University Medical CenterBased on PSA levels, Gleason score, and stage, prostate cancer is classified into risk groups: ▲low-risk (PSA ≤10, Gleason score ≤6, stage T1-T2a) ▲intermediate-risk (PSA >10 to ≤20, Gleason score 7, stage T2b) ▲high-risk (PSA >20, Gleason score 8-10, stage T2c or higher). Since the treatment strategy varies depending on the stage, PSA testing has the advantage of quickly identifying which risk group a patient belongs to, going beyond just early diagnosis. Professor Young Hwii Ko, Editor-in-Chief of the Korean Urological Oncology Society (Ewha Womans University Medical Center's Department of Urology), said, "The treatment outcomes and survival rates for prostate cancer are dramatically different depending on whether it's diagnosed early." He added, "The PSA test is both simple and highly accurate. If the PSA test were included in the NIP, it could help increase patient survival rates and reduce socioeconomic costs."
- 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
- Product photo of Nicorette QuickMist sold overseasA 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.
- Policy
- US pressures MFNs to cut drug prices
- by Lee, Jeong-Hwan Sep 16, 2025 06:09am
- As the US Trump administration pushes hard for Most Favored Nation (MFN) drug pricing policies, voices are growing within the industry that Korea should mitigate trade pressure by expanding the “risk-sharing agreement (RSA),” the key tool used during drug pricing negotiations in the reimbursement process. Industry representatives are arguing that non-innovative pharmaceutical companies’ new drugs developed for export, as well as anticancer and orphan drugs introduced through open innovation, should also be included in the refund-type RSA scheme. The industry insisted that the dual pricing system—currently applied only to exported drugs to allow higher external list prices—should also be extended to imported drugs. This would increase Korea’s freedom from U.S. pharmaceutical trade pressure while improving patient access. The Ministry of Health and Welfare acknowledged that Korea’s current drug price disclosure system is excessively transparent, creating disadvantages in international trade and exports, and promised to actively consider reforms such as refund-type RSAs and the dual pricing system. This signals a green light for system improvements in line with industry demands. On the 15th, Democratic Party of Korea lawmakers Yoon Kim and Youngseok Seo co-hosted a National Assembly debate on “Future Directions for the RSA System.” Professor Jeonghoon Ahn (Ewha Womans University, Department of Convergence Health Policy) who presented at the debate, explained that Korea’s drug prices significantly affect global markets. Initially, Korean drug prices were unofficially referenced by Asian countries. In 2013, Saudi Arabia formally included Korea as a reference country, followed by Canada in 2019, which greatly expanded Korea’s global pricing influence. Given that the US. MFN drug pricing policy under the Trump administration undermines the profitability of Korean drug exports, Prof. Ahn stressed that RSA expansion is necessary to address the issue. Ahn said, “Limiting RSAs only to anticancer and orphan drugs is far too restrictive compared to many advanced countries. If export-bound Korean drugs were also eligible for RSA, they could benefit when entering the US market. It is time to consider RSA expansion given the changing external environment.” “Refund-type RSA should also be applied to non-innovative pharmaceutical company’s anticancer drugs and rare disease drugs” Hee-Sung Kang, Head of the External Affairs Team at Daewoong Pharmaceutical, who participated as a panelist, expressed the opinion that expanding the scope of drugs eligible for the refund-type RSA would benefit domestic pharmaceutical companies pursuing export-focused strategies. When included as price reference countries in China, Southeast Asia, and BRICS nations, refund-type RSAs would allow higher list prices to be maintained while controlling domestic budget impact. This strategy would improve both domestic and global access to new medicines. “The March 2023 revision of the Drug Decision and Adjustment Criteria limited refund-type RSAs to innovative drugs developed by innovative pharmaceutical companies. But considering the reality of Korea’s pharmaceutical industry, new drugs from non-innovative pharmaceutical companies developed for export, as well as anticancer and orphan drugs introduced through open innovation, should also be eligible.” He added: “This would help maintain high list prices at the time of local reimbursement, reduce concerns about reference pricing by overseas developers, and ultimately expand treatment options for domestic patients. Even in cases of post-marketing price cuts, if companies can choose refund-type RSAs, companies can preserve list prices while securing market trust.” “Applying dual pricing system to imported drugs could resolve U.S. trade issues” In-Hwa Choi, Director of the Korean Research-based Pharmaceutical Industry Association (KRPIA), stated that the Trump administration's push for MFN drug pricing and the increased likelihood of high tariffs should not be viewed merely as external pressure. Instead, she urged using this as an opportunity to supplement and innovate the structural weaknesses of the domestic drug pricing system. Most importantly, Choi called for revising the refund-type RSA system, which distinguishes between list price and actual price. She noted that Korea’s drug price disclosure system is highly transparent, which is advantageous in some respects but creates structural disadvantages in international negotiations. As a solution, she proposed extending the dual pricing system—currently applied only to exported drugs—to imported drugs as well. “Korea introduced the dual pricing system in March to allow higher list prices for exported drugs to prevent the risk of unfavorable, low drug pricing abroad. If we extend this system to imported drugs as well, we can partially resolve supply stability risks that may arise under the MFN trade environment.” Choi also suggested rebranding the dual pricing scheme under a new name, such as “Korean-style refund system,” to avoid misunderstandings associated with the term. “Other countries also use alternative terms like MEA or claw-back system,” she said. She concluded: “The K-refund system could become a strategic innovation model that helps Korea manage trade uncertainties while improving both patient access and industrial competitiveness. Patients would benefit from timely and stable treatment; the government would gain fiscal efficiency; and the industry would strengthen global competitiveness—a true win-win solution.” MOHW “RSA, U.S. MFN, and other external changes in addition to industry demands necessitate improvements and development” Yeon-Sook Kim, Director of the Division of Pharmaceutical Benefits at MOHW, emphasized that the ministry's principle for national health insurance reimbursement of pharmaceuticals is ‘timely reimbursement of effective drugs’. Kim acknowledged that the RSA system is at a point where development is needed in response to changes in the external environment and the pharmaceutical industry's demands. She also agreed on the need to closely monitor and respond swiftly to the significant domestic impact of the Trump administration's trade pressure regarding most-favored-nation (MFN) drug pricing. Yeon-Sook Kim, Director of the Division of Pharmaceutical Benefits at MOHW She admitted that Korea’s single-payer national insurance system, with its fixed patient co-payment model, has limited flexibility. This, combined with high transparency in drug pricing, has sometimes caused “unintended disadvantages” for pharmaceutical companies. Regarding whether South Korea's new drug prices are truly low, Kim mentioned there is much debate among experts and responded with the intention to partially improve the transparent drug price disclosure system. Kim said, “Operating within a robust public health insurance system inevitably leads to a lack of flexibility. Consequently, while a highly transparent system has been established, we understand that pharmaceutical companies experience unintended harm and unfairness. AS a result, the current drug price disclosure system is transparent, but it must be improved to address the inherent risk of being unreasonably disadvantaged.” Kim added, “While there was much initial debate about RSA, it is now making a significant contribution to Korea’s national health insurance. However, it is time for it to evolve in response to changes in the external environment. Various terms like RSA or dual drug pricing systems are being discussed, and the government will actively and promptly review the drug pricing system.”
