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- 2025-12-19 17:27:21
- Policy
- SGLT2 Jardiance likely to receive expanded reimb for CKD
- by Lee, Tak-Sun Jun 20, 2025 06:06am
- Product photo of JardianceThe SGLT-2 inhibitor Jardiance (empagliflozin, Boehringer Ingelheim) is expected to be reimbursed for the treatment of chronic kidney disease (CKD). This drug is currently reimbursed for the treatment of diabetes and chronic heart failure. If expanded reimbursement is approved for CKD, the volume of usage is likely to be increased. Furthermore, its market presence is expected to be strengthened in the SGLT-2 inhibitors market. According to industry sources on June 19, the agenda related to Jardiance's expanded reimbursement to include CKD passed the Drug Reimbursement Evaluation Committee (DREC) held on the 12th. Once it undergoes the National Health Insurance Service's simplified negotiation process and reports to the Health Insurance Policy Deliberation Committee, Jardiance is anticipated to be reimbursed for treating CKD. Since the company already completed drug price estimation process, reimbursement may be approved as early as July 1. It has been reported that Jardiance's expanded reimbursement for CKD was approved for the pre-drug price reduction program for expanded usage scope drugs. This program is designed to quickly enhance patient access to treatments by omitting the cost-effectiveness evaluation and applying a pre-reduction rate table, with a maximum 5% reduction in the ceiling cap, considering the estimated additional claim amounts due to the expanded reimbursement criteria. If a drug's ceiling price is adjusted via this program, its company will only have to undergo negotiations related to supply requirements, such as those required for other reimbursed medicines. Jardiance's company applied to the Health Insurance Review & Assessment Service (HIRA) for expanded reimbursement for Jardiance's CKD indication in the first half of last year. Jardiance was the first SGLT-2 inhibitor to file. Jardiance Tab 10mg is currently indicated for the treatment of 1. Type 2 diabetes mellitus, 2. chronic heart failure, and 3. chronic kidney disease. Jardiance Tab, which was listed for reimbursement as a diabetes treatment in 2017, has also been reimbursed for chronic heart failure since February 2024. Since January this year, the reimbursement criteria have been expanded, allowing patients with heart failure with preserved ejection fraction (HFpEF) who have symptoms and signs of heart failure and a left ventricular ejection fraction exceeding 40% to receive national health insurance benefits. Currently, the only SGLT-2 drugs covered for diabetes and chronic heart failure patients, besides Jardiance, are Forxiga (dapagliflozin) and HK inno.N's DapaN Tab, which transferred Forxiga's indications. However, there is currently no drug reimbursable for CKD. If the reimbursement expansion procedure for Jardiance is completed, it is expected to be the only SGLT-2 inhibitor with coverage for CKD reimbursement. The efficacy of Jardiance has been demonstrated through clinical trials, showing a statistically significant 28% relative risk reduction in the progression of kidney disease or cardiovascular death compared to placebo. The clinical trials that Jardiance significantly reduced a relative risk in the progression of kidney disease or cardiovascular death compared to placebo by 28%. The expanded scope of use will provide advantage in competition with generic drugs. Jardiance's substance patent expires in October this year. Therefore, tens of domestic generic drugs are likely to enter the market. Jardiance, jointly sold by Boehringer Ingelheim and Yuhan, recorded outpatient prescription sales of KRW 66.3 billion last year, according to UBIST.
- Policy
- Growing role of the Korea Orphan & Essential Drug Center
- by Lee, Hye-Kyung Jun 19, 2025 06:03am
- "The emergency import of essential medicines through the Korea Orphan & Essential Drug Center (KOEDC) will be expanded, and support for pharmaceutical companies producing domestic products will be planned." President Lee Jae-myung made this pledge on his Facebook page on May 28, during his campaign for the presidency. President Lee emphasized the importance of the KOEDC, stating that he would strengthen national guarantees for the treatment of rare and intractable diseases. However, the KOEDC is a Ministry of Food and Drug Safety (MFDS)-affiliated organization with a fixed quota of only 30 personnel. KOEDC is responsible for the supply of rare and national essential medicines, establishing a stable supply base for national essential medicines, and supporting R&D. The center is currently understaffed. Kim Young-rim, CEO of Korea Orphan & Essential Drug Center (KOEDC)Kim Young-rim, CEO of KOEDC, stated at a briefing for journalists covering the MFDS on June 17, "The global supply chain has become increasingly important after COVID-19, and the role of the center is also growing." Kim added, "As a small organization with only 30 personnel, where individual roles and responsibilities are significant, it is necessary to devise ways to perform duties efficiently." In particular, the emergency import of essential medicines mentioned by President Lee is part of the national essential drug supply management plans implemented by the KOEDC. The KOEDC plays a crucial role in managing emergency imports of medicines that could be subject to potential supply shortages from overseas, domestically produced products under contract manufacturing, and emergency use authorizations for items deemed necessary to address public health crises. Kim stated, "The KOEDC is a specialized organization responsible for the stable supply of rare and essential medicines in Korea. This year, we plan to actively identify and promote tasks in line with the new government's initiatives to strengthen our role in ensuring a stable supply of rare and essential medicines." Regarding national essential medicines, strengthening on-site supply and demand monitoring, as well as emergency importation of drugs, is one of the main tasks for this year. The goal is to enhance management analysis of discontinued drugs, thereby shortening the designation period for emergency imported drugs and their subsequent domestic entry. Additionally, it aims to prioritize the classification of emergency imported drugs to facilitate appropriate inventory management. The KOEDC's role also includes planning the details for stable supply, such as identifying annual supply and demand plans for drugs requested by government ministries and expanding procurement sources. In addition to national essential medicines, the KOEDC also announced plans for rare diseases this year. Kim said, "For items that have been labeled as essential in areas where no existing treatments were available and have been designated as MFDS GIFT (Global Innovative products Fast Track) and approved, we will temporarily supply them during the domestic supply gap period before drug price negotiations, contributing to increased patient access." They are also planning expedited reimbursement applications for pediatric drugs such as 'Glucagen hypo kit,' 'Baqsimi Nasal Spray,' and 'Rapamune Syrup.' KOEDC is exploring ways to reduce patient burden by converting candidates to tax-exempt status after reviewing relevant provisions. The KOEDC has been conducting the "Research on Establishing a Domestic Stable Supply Base for National Essential Medicines" since 2022 to establish a domestic self-sufficiency base for national essential medicines in response to supply chain crises. Through Phase 1 of the project, conducted from 2022 to 2023, a domestic production base for two finished pharmaceutical products and three active pharmaceutical ingredients (APIs) has been established. Ahn Myung-soo, a division head at the KOEDC, stated, "Myung In Pharm used to import benserazide raw material from China, but we have developed it domestically and completed its DMF registration with MFDS." Ahn added, "While commercialization is a decision for the pharmaceutical company due to drug pricing issues, its significance lies in being registered in the DMF so that it can be used at any time." Furthermore, Korus Pharm's amiodarone injection received approval for export. With additional processing, a push for technology transfer, and further R&D investment, it could become commercialization-ready. Since last year, Phase 2 of the project has been underway, which includes the domestic development of both the API and finished drug for acetaminophen. Ahn added, "We have succeeded in achieving self-sufficiency through the domestic development of the API and finished pharmaceutical product for acetaminophen. A product approval application will soon be submitted to MFDS," and added, "This means that domestic self-sufficiency is possible if there are shortages, regardless of the global supply chain." In this regard, Kim stated, "There are limitations to securing a stable supply network through projects funded by the KOEDC." Kim added, "Budget and personnel support are necessary for these projects to be sustainable within the KOEDC's scope. To achieve this, we plan to work towards this continuously."
- Policy
- Petition filed urging expedited reimbursement of Livmarli
- by Lee, Jeong-Hwan Jun 17, 2025 06:00am
- A national petition has been filed to urge for the health insurance reimbursement of Livmarli (maralixibat), which is used to treat pruritus (itching) in patients with Alagille syndrome. The petition period runs until the 12th of next month, with over 1,600 signatures signed as of the 16th. Alagille syndrome is a condition in which the intrahepatic bile duct becomes significantly reduced in number (bile duct paucity), preventing bile from being excreted from the liver. This leads to its accumulation in the liver and is often accompanied by complications affecting the cardiovascular system, skeletal system, eyes, and skin. The drug is indicated for “biliary pruritus in patients with Alagille syndrome aged 1 year or older,” in Korea, and is imported by GC Biopharma. Livmarli is the first treatment in Korea for pruritus in patients with Alagille syndrome and is expected to be of great help to patients suffering from itching skin and other symptoms. According to data from the Health Insurance Review and Assessment Service, as of 2021, there are 136 patients with Alagille syndrome in South Korea. Livmarli obtained domestic marketing approval in February 2023, but it is not yet covered by health insurance. A petitioner who identified herself as Kim, a mother of a child with Alagille syndrome, wrote that her child is receiving treatment at Severance Hospital but is facing difficulties in treatment due to the lack of health insurance coverage for Livmarli. Kim explained that medical staff suggested participating in a clinical trial for another treatment, Bylvay Cap (odevixibat), but that this was not possible due to the child's young age. She added that there is a medical necessity to prioritize the use of novel drugs over liver transplantation for infants who have passed their first birthday and that the medical staff recommended Livmarli as an effective treatment option for such. This is why Kim launched a petition calling for the immediate reimbursement of Livmarli. Kim said, “The itching and skin damage (caused by Alagille syndrome) are destroying my child's daily life,” adding, “Xanthomas are not merely a cosmetic issue, but a serious indicator of how much bile and fat are accumulating in the body.” “For such a young child like mine, the opportunity and choice to alleviate symptoms with medication rather than undergoing a major surgery like a liver transplant is desperately needed. Rare diseases are not something families can face alone. It's heartbreaking that treatments exist but must be given up simply because they are not covered by insurance.”
- Policy
- Atopic dermatitis drug Ebglyss reimbursed from next month
- by Lee, Tak-Sun Jun 16, 2025 06:03am
- With pricing negotiations between the National Health Insurance Service and the manufacturer of the new atopic dermatitis drug ‘Ebglyss Autoinjector (Lebrikizumab, Lilly Korea)’ complete, the drug is expected to be listed for reimbursement next month in Korea. Once listed, the number of biological agents available for atopic dermatitis will increase from two—Dupixent (dupilumab) and Adtralza (tralokinumab)—to three. According to industry sources on the 13th, the NHIS recently updated its website with news of the agreement made on Ebglyss Autoinjector. In August 2024, the Ministry of Food and Drug Safety approved this drug as a treatment for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years of age and older (weighing at least 40 kilograms) who are inadequately controlled by topical therapies or for whom such treatments are not recommended. In February, the drug’s reimbursement application was approved by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service. At the time, the condition was attached that the adequacy of its reimbursement would be recognized if the company accepted the price below the initially assessed value. Lilly Korea accepted such a price and began negotiations with the National Health Insurance Service in March." It is highly likely that Ebglyss waived drug price negotiations as it accepted a price below the weighted average price of existing atopic dermatitis drugs covered by the national health insurance, and would only have negotiated the estimated claims amount with the NHIS. Ebglyss demonstrated its clinical efficacy and safety profile in a pivotal Phase III clinical trial and is expected to become a first-line treatment option for patients with atopic dermatitis in Korea. The clinical studies on which the approval was based on are the Phase III ADvocate-1, ADvocate-2 and ADhere trials. The trials evaluated the clinical efficacy and safety of Ebglyss in 1062 adults and adolescents with moderate-to-severe atopic dermatitis. In ADvocate-1 and ADvocate-2, which evaluated Ebglyss as a monotherapy, Ebglyss improved outcomes, with 58.8% and 52.1% (16.2% and 18.1%, respectively in the placebo arm) achieving Eczema Area and Severity Index (EASI) 75; and 38.3% and 30.7% (9% and 9.5%, respectively in the placebo arm) achieving EASI 90 during the induction period (weeks 0-16) compared to placebo. Also, after one year of maintenance therapy (Week 52), 81.7% of the Ebglyss arm achieved EASI 75 (vs. 66.4% in the placebo arm) and 66.4% achieved EASI 90 (vs. 41.9% in the placebo arm), demonstrating significant symptom improvement in the long term. The most commonly reported adverse events following treatment with Ebglyss were conjunctivitis (6.9%), injection site reactions (2.6%), allergic conjunctivitis (1.8%), and dry eye (1.4%), with the majority of adverse events being mild or moderate and not leading to treatment discontinuation. Recently, the government has applied reimbursement for cross-administration of biological agents and JAK inhibitors used to treat severe atopic dermatitis, and Ebglyss is expected to benefit from this as well. Patients are also expected to benefit from the increased biological agent options and lower drug prices.
- Policy
- Roche’s SMA drug Evrysdi Tab approved in Korea
- by Lee, Hye-Kyung Jun 16, 2025 06:03am
- The table formulation of Roche's blockbuster drug for spinal muscular atrophy (SMA), Evrysdi (risdiplam), has received marketing authorization in Korea. On the 13th, the Ministry of Food and Drug Safety approved Roche Korea's ‘Evrysdi 5 mg (risdiplam).’ With the approval, SMA patients in Korea may now be prescribed the 5 mg tablet formulation in addition to the existing liquid oral solution, enabling easier intake. Evrysdi is the first oral treatment for SMA and has the advantage of self-administering without location restrictions. In addition, the newly approved Evrysdi Tab is the first tablet formulation for SMA treatment. The 5mg tablets can be swallowed whole or dispersed in water and may be stored at room temperature. The existing liquid solution will continue to be available, and patients weighing 20 kg or more and aged 2 years or older are eligible to take the tablet formulation. Spinal Muscular Atrophy (SMA) is a systemic disorder caused by a deficiency of the Survival Motor Neuron (SMN) protein, which is essential for motor function. The disease affects not only neuromuscular systems but also respiratory muscles, cardiac rhythm, skeletal muscles, joints, and the autonomic nervous system. Evrysdi is a splicing modifier that binds to the immature pre-mRNA of the SMN2 gene, increasing and maintaining the levels of Survival Motor Neuron (SMN) protein throughout the patient's body. It can cross the blood-brain barrier, allowing for even distribution across the entire body, including the central nervous system. In February, the U.S. FDA approved Evrysdi based on the results of a bioequivalence study. In the trial, Evrysdi 5 mg Tab and the existing liquid formulation demonstrated equivalent absorption of the active ingredient risdiplam. Meanwhile, in Korea, Evrysdi Dry Syrup 0.75 mg/mL (risdiplam) was approved in 2020 and has been reimbursed since October 2023, three years later. Evrysdi is currently reimbursed for the treatment of 5q Spinal Muscular Atrophy in patients who received a genetic diagnosis of 5q SMN-1 deficiency or mutation that ▲ have 3 or fewer copies of SMN2 even before the onset of symptoms, and are less than 6 months old at the time of treatment initiation; or ▲ have SMA types 1-3 with clinical symptoms and signs related to SMA and are not on permanent ventilation.
- Policy
- Ruling party proposes bill for free HPV vaccination
- by Lee, Jeong-Hwan Jun 13, 2025 06:02am
- Rep Lee Su-Jin (Democratic Party of Korea) The Democratic Party of Korea has submitted a bill to the National Assembly to significantly expand the scope of Korea’s National Immunization Program for human papillomavirus (HPV) vaccines. The bill proposes to provide free HPV vaccinations to all males and females aged 12 to 26, regardless of gender or income level. This legislation is in line with President Lee Jae-myung's campaign pledge to expand the National Immunization Program (NIP) for HPV vaccines. On the 12th, Rep. Lee Su-Jin (Seongnam City) of the Democratic Party of Korea submitted a bill titled “Partial Amendment to the Infectious Disease Control and Prevention Act” as representative. The bill aims to expand HPV vaccination coverage to all men and women aged 12 to 26, regardless of income or gender, for the prevention of HPV infection. The current law stipulates that the government shall provide NIP for HPV prevention to “female adolescents aged 12 to 17” and “low-income women aged 18 to 26.” However, Rep. Lee pointed out that individuals who are not eligible for government support are equally exposed to the risk of HPV infection, yet receive no assistance at all. Depending on age, two to three doses may be required, and each dose costs over KRW 150,000, placing a financial burden on individuals who must cover the expense themselves. President Lee included the expansion of the HPV NIP support program in his campaign pledge for the 21st presidential election, and Rep. Lee has proposed a corresponding legislative bill. Rep. Lee stated, “By providing HPV vaccination to all individuals aged 12 to 26, regardless of income or gender, we can prevent HPV infection and cervical cancer. I pledge to spare no legislative support to ensure women's right to health through proactive prevention.”
- Policy
- Measures to reduce industry burden for stronger GMP
- by Lee, Hye-Kyung Jun 12, 2025 06:04am
- With the Ministry of Food and Drug Safety set to enforce the revised GMP standards for aseptic drugs reflecting the international Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards from December, measures are being prepared by the industry to reduce its burden. Ahead of its rejoin into PIC/S in 2023, the MFDS announced the “Regulations on Drug Manufacturing and Quality Control (MFDS Notice)” which outlines a risk-based, systematic contamination control strategy to enhance the quality assurance of aseptic pharmaceuticals. At the time, in consideration of the need for sufficient preparation time for all pharmaceutical companies to establish contamination management strategies, the government decided to implement the regulations first for aseptic finished pharmaceutical products until 2 years after the announcement, and then for aseptic active pharmaceutical ingredients until 3 years after the announcement. The implementation of measures such as PUPSIT (Pre-Use Post-Sterilization Integrity Testing) for verifying the integrity of sterilizing filters has been granted a uniform grace period—up to three years from the date of the revised GMP regulation—considering the need for additional preparation time for revalidation of aseptic processes and administrative procedures for GMP compliance determinations under the current guidelines. However, as the implementation of certain requirements for sterile finished pharmaceutical products approaches, including ▲the obligation to establish and implement a systematic contamination control strategy for the manufacture of aseptic drugs, ▲ the establishment of individual manufacturing and quality control standards (GMP) for advanced biopharmaceuticals, and ▲ the clarification of detailed specifications for the types of formulations subject to GMP compliance assessment, as well as the procedures and methods for such assessments, some pharmaceutical companies are halting or withdrawing their aseptic product manufacturing operations on itself. Particularly, following the announcement by Ildong Pharmaceutical that it would discontinue production and supply of its ‘Ativan Inj,’ which has experienced repeated supply instability over the past 3 years since 2022, speculation has emerged that the ripple effects of the strengthened GMP standards for aseptic drugs may have begun. Jung-yeon Kim, director of the MFDS In response, Jung-yeon Kim, director of the MFDS's Pharmaceutical Quality Division, said at a briefing with reporters on the 10th, “There have been ongoing issues with the supply of Ativan, and we have been in constant communication with the manufacturer since the end of last year. The company did not decide to withdraw from the market due to the stricter GMP standards, rather, there were internal circumstances, such as product profitability and drug price issues.” It is known that a similar sentiment was conveyed at a meeting between the MFDS and the heads of aseptic drug manufacturers on April 30. Kim explained, “About 20 companies participated in a factory manager meeting last month. At the time, the MFDS conveyed its position that it had no choice but to apply the same standards used by the 52 PIC/S member countries. Manufacturers also expressed difficulties in the preparation process, and that the MFDS should prepare supporting data through a research platform to reduce the burden on the industry and provide technical and regulatory support.” Instead of implementing the PIC/S-level GMP strengthening measures for aseptic preparations as scheduled in December, the MFDS plans to establish guidelines for large-volume IV solutions, contamination control strategies (CCS), and PUPSIT, referring to the results of the “Study on the Harmonizing the GMP Regulations on Aseptic Drugs” currently being conducted by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) Kim added, “In the case of large-volume IV solutions, strengthening GMP standards to comply with EU Annex 1 would require establishing a contamination control strategy for each batch, which companies find most burdensome. We are conducting research with three companies— HK Inno.N, JW Pharmaceutical, and Dai Han Pharm— and KPBMA to establish grounds that show there will be no changes in GMP quality even with eased standards.” The three companies participating in this study account for 90% of the large-volume IV solution market, and since November last year, they have been meeting with the KPBMA and MFDS to develop a research protocol and have completed kick-off meetings and preliminary workshops. Cheon-Woon Cheon, a research committee member at the KPBMA Cheon-Woon Cheon, a research committee member at KPBMA who is leading the study, said, “We have held meetings with the MFDS and companies to clearly set the direction of the project, and our goal is to produce results by October so that they can be reflected in the policy.” Cheon added, “The revision of Annex 1 has placed a significant burden on manufacturers of sterile products. We are seeking ways to reduce this burden and are currently researching the appropriate level of validation required for processes such as formulation, filtration, filling, and sterilization.” In this regard, Kim said, “There is no single correct answer in GMP. What matters is having a technically and scientifically justified rationale that achieves the intended goal. I hope that the research findings will provide a sufficient basis to support the level of aseptic control expected by PIC/S.” Through this study, the MFDS expects not only to relax the standards for large-volume IV solutions but also to establish guidelines for CCS and PUPSIT. Cheon said, “Small companies lack experience and have difficulty just approaching CCS. Our goal is to establish guidelines by the end of the year that small companies can follow by conducting research through large companies.” In the case of PUPSIT, which is scheduled to be implemented in December next year, a separate project team has been formed to establish its guidelines. Kim said, “In principle, each company is responsible for implementing GMP issues per the system, but the MFDS has tried to provide assistance through industry communication. Since November last year, we have been meeting with associations and industry representatives to ask them to follow the international standards, and we have formed a consensus on common research tasks.” Kim added, “While direct financial support is difficult at this time, we are exploring ways to reduce industry burdens through regulatory or technical support. Once research results are available, we aim to establish GMP management measures with a clear direction, which should also lead to cost savings.”
- Policy
- Qlaris starts Phase II trial for its glaucoma drug in KOR
- by Lee, Hye-Kyung Jun 12, 2025 06:03am
- Qlaris Bio, a US biotech company, is conducting a Phase II clinical trial in Korea for 'QLS-111,' a drug candidate for primary open-angle glaucoma (POAG) and ocular hypertension (OHT). On the 5th, the Ministry of Food and Drug Safety approved a randomized, active-controlled, multicenter, double-blind, preliminary study to evaluate the safety and tolerability of QLS-111 versus preservative-free 0.5% timolol maleate ophthalmic solution in subjects with normal-tension glaucoma (NTG). QLS-111 is a novel therapeutic agent that targets episcleral venous pressure (EVP), which reduces intraocular pressure by relaxing the vascular and vascular-like tissues in the trabecular meshwork to lower EVP. As there are currently no glaucoma treatments that reduce EVP (episcleral venous pressure), a successful clinical outcome would likely expand treatment options for patients. According to Qlaris, its two Phase II clinical trials conducted in the U.S. – the Osprey and Apteryx trials - met all primary and secondary endpoints. The Osprey study was a randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability, and intraocular pressure (IOP) lowering efficacy of QLS-111 compared to placebo in 62 adult patients with POAG or OHT across a range of doses. Study results showed that QLS-111 at a concentration of 0.015% administered once daily in the evening (QPM) resulted in the greatest reduction in intraocular pressure, with a mean reduction of 3.7 mmHg compared to the average intraday IOP of 23.0 mmHg. The Apteryx study was a randomized clinical trial evaluating the safety, tolerability, and additional IOP-lowering efficacy of QLS-111 when added to latanoprost in 32 patients aged 12 years or older with stable POAG or OHT using latanoprost monotherapy. When latanoprost monotherapy was administered, the mean intraday baseline IOP was 19.8 mmHg. QLS-111 0.015% administered in combination with latanoprost induced additional mean IOP reduction compared to latanoprost monotherapy, with a reduction of 3.2 mmHg with QLS-111 QPM administration and 3.6 mmHg with QLS-111 BID (twice daily) administration. Qlaris stated, “We are satisfied with the efficacy QLS-111 demonstrated in the Phase II Osprey and Apteryx trials. These results from our preservative-free new formulation reinforce our confidence that QLS-111 has the potential to become the first-in-class EVP selective targeted therapy.” Qlaris was founded in 2019 with a primary focus on the development of treatments for ophthalmic diseases. Last year, the company successfully secured $24 million in funding.
- Policy
- Speculation high over the new Minister of Health and Welfare
- by Lee, Jeong-Hwan Jun 10, 2025 06:05am
- (clockwise from the upper left) Former KDCA head Eun-kyung Jeong; former MOHW vice minister Sung-il Yang; Democratic Party of Korea’s Health and Medical Care Special Committee chair Cheong-hee Kang; lawmakers In-soon Nam, former lawmaker Hyun-young Shin, lawmaker Yoon Kim, lawmaker Hyun-hee Jeon Speculation is rife over who will become the first Minister of Health and Welfare in Lee Jae-myung's administration. Eun-kyeong Jeong, former Commissioner of the Korea Disease Control and Prevention Agency, who served as the chief campaign advisor for Democratic Party candidate Jae-myung Lee, is widely expected to be appointed as the next Minister of Health and Welfare. However, no official nomination has been confirmed as of yet. As a result, several names are being mentioned for the position of Minister of Health and Welfare, ranging from former public officials to former and current members of the Democratic Party of Korea. According to political circles on the 8th, the candidates for the position of MOHW include former KDCA head Eun-kyung Jeong; former MOHW vice minister Sung-il Yang; Democratic Party of Korea’s Health and Medical Care Special Committee chair Cheong-hee Kang; lawmakers In-soon Nam, Hyun-hee Jeon, and Yoon Kim, and former lawmaker Hyun-young Shin. Former KDCA head Jeong is credited with contributing to the Moon Jae-in administration's success in fighting COVID-19 on the front lines as well as to the election of Jae-myung Lee as president. Jeong, who has been consistently mentioned as the next MOHW minister before and after the presidential election, has stated that she will return to her position as a clinical professor of family medicine at Seoul National University College of Medicine after the election. During the presidential election period, Jeong herself repeatedly reaffirmed that her participation in the election was driven by the intention to contribute to the nation and its people amidst the turmoil caused by the declaration of martial law. In addition, Sung-il Yang, who entered public service after graduating from Seoul National University with a degree in social welfare and passing the 35th civil service examination, is also mentioned as a candidate. During the recent presidential election, he was active in Lee Jae-myung's think tank and, and served as the co-chair of the welfare policy subcommittee, devising strategies for the health insurance system reform and promoting the health industry. Specifically, Yang is considered to have played a key role in Lee’s campaign as chair of the Economic Growth Committee's Pharmaceutical and Bio Health Committee, chair of the Basic Social Policy Committee's Basic Care Subcommittee, and head of the Special Committee on Citizens with Disabilities. Cheong-hee Kang, Chair of the Democratic Party of Korea’s Health and Medical Care Special Committee who has practical experience as an insurance reimbursement director at the National Health Insurance Service and president of the Korea Public Tissue Bank, was also actively involved in Lee’s presidential campaign. Kang, who is a doctor by profession, ran for office in the 22nd general election in the Gangnam district of Seoul. Among the current members of the National Assembly, In-soon Nam, a four-term Democratic Party lawmaker; Hyun-hee Jeon, a three-term lawmaker; and Yoon Kim, a first-term lawmaker and medical doctor, have been mentioned as potential candidates for Minister of Health and Welfare. Nam served as the head of the functional headquarters in Lee Jae-myung’s presidential campaign, Jeon as a co-chair of the campaign committee, and Kim as the deputy head of the policy headquarters, all contributing significantly to the campaign’s victory. Hyun-young Shin, a former lawmaker who was elected as the Democratic Party of Korea’s No.1 proportional representative in the 21st National Assembly, is also being mentioned as a potential candidate. Shin, a former doctor who served on the NA Health and Welfare Committee, served as the spokesperson for the General Election Headquarters during the presidential election.
- Policy
- BMS’s next-gen targeted drug repotrectinib approved in KOR
- by Lee, Hye-Kyung Jun 09, 2025 05:51am
- BMS Pharmaceuticals' ‘Augtyro Cap (repotrectinib),' which is regarded a next-generation targeted therapy for lung cancer, has been approved in Korea. On the 5th, the Ministry of Food and Drug Safety granted marketing authorization for 2 items - Augtyro Cap 40 mg and 160 mg. Specifically, repotrectinib is indicated as: ▲treatment for patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) ▲ treatment for pediatric patients 12 years and older and adult patients with locally advanced or metastatic solid tumors that are unsuitable for surgical resection due to high risk of severe complications and harbor an Neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Augtyro was first approved by the US FDA in November 2023 as a treatment for non-small cell lung cancer and was designated as an orphan drug in Korea last May. Since August last year, it has been prescribed to patients after receiving initial approval for its use in Korea for therapeutic purposes. The drug’s efficacy was confirmed through the multinational Phase I/II TRIDENT-1 trial. The trial results showed that the primary endpoint, the objective response rate (ORR), was 79% for repotrectinib in 71 TKI treatment-naïve patients. Progression-free survival (PFS) was nearly double that of previous targeted therapies. The ORR was defined as the proportion of patients treated within a specific time frame who either had a decrease in tumor size (partial response) or no further signs of cancer (complete response). The median duration of response was 34.1 months. In 56 ROS1 TKI–naïve and chemotherapy-naïve patients, the objective response rate was 38%, and the median duration of response was 14.8 months. The trial also examined the drug’s efficacy in treating patients with resistance to existing targeted therapies. In the 56 patients with resistance to existing therapies, repotrectinib showed an ORR of 38% and a PFS of 9 months, and 17 patients who had acquired a baseline G2032R resistance mutation showed an ORR of 59% and a PFS of 9.2 months. The results of the TRIDENT-1 trial were published in the New England Journal of Medicine (NEJM) (IF 176.082), with Byoung-Chul Cho, Director of the Lung Cancer Center at Yonsei Cancer Hospital in Korea, participating as a corresponding author. ROS1-positive NSCLC accounts for 2% of all lung cancers. The standard of care is to use targeted anti-cancer therapies that target the mutated gene. Commonly used drugs include ‘crizotinib’ and ‘entrectinib,’ and repotrectinib is gaining attention as a next-generation drug.
