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- 2026-04-28 15:52:42
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- ALS drug Qalsody to be commercialized in Korea
- by Eo, Yun-Ho Jan 31, 2025 05:56am
- Commercialization of the new drug ‘Qalsody’ for amyotrophic lateral sclerosis is expected in Korea. According to industry sources, Qalsody (tofersen), Biogen’s drug indicated for the treatment of amyotrophic lateral sclerosis (ALS) associated with a mutation in the Superoxide Dismutase 1 (OD1) gene mutation, is undergoing a review for marketing authorization by the Ministry of Food and Drug Safety. The drug had been designated an orphan drug in August last year. Qalsody, which was developed by Biogen, is an ASO (antisense oligonucleotide) drug that blocks the messenger ribonucleic acid (mRNA) associated with the SOD1 gene mutation to prevent its expression. The drug was approved by the US FDA in June of last year and by the European EMA in May of the same year. In fact, the efficacy data for Qalsody is not well received. However, it is believed that the situation reflects the fact that there are very few treatment options for ALS. In the Phase III VALOR study, Qalsody did not meet the primary endpoint, the ‘ALS Functional Rating Scale.’ However, the secondary indicator, ‘increase in the level of SOD1 protein in cerebrospinal fluid,’ and ‘the concentration of neurofilament light chain (Nfl) measures’ were found to be reduced by 26-38% and 48-67%, respectively. The most common adverse reactions reported in clinical trials were pain (back pain, pain in arms or legs), feeling tired, muscle and joint pain, fever, and increased white blood cell count in the cerebrospinal fluid (CSF). Meanwhile, Lou Gehrig's disease is a rare neurological disorder that affects the nerve cells in the brain and spinal cord that are responsible for muscle movement, which can lead to progressive paralysis and death. Even though quite a lot of clinical trials are being conducted in comparison to its incidence, most of the available treatments only work to alleviate patient symptoms.
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- Epkinly may be prescribed in general hospitals in KOR
- by Eo, Yun-Ho Jan 31, 2025 05:56am
- Epkinly, an innovative bispecific antibody drug that binds to T cells, may now be prescribed in general hospitals in Korea. According to industry sources, AbbVie Korea’s Epstein-Barr virus (EBV)-associated diffuse large B-cell lymphoma (DLBCL) treatment Epkinly (epcoritamab) has recently passed the drug committee (DC) review of Asan Medical Center. In addition, prescription codes for the drug have been generated through emergency DCs at 4 to 5 other major medical institutions. Epkinly, which was approved last June in Korea, was also designated as an orphan drug by the Ministry of Food and Drug Safety. However, Epkinly remains non-reimbursed in Korea. The drug reimbursement application was submitted to the Health Insurance Review and Assessment Service's Cancer Disease Review Committee in December last year, but the committee was unable to set the reimbursement criteria. Epkinly is an immunoglobulin 1- bispecific antibody that simultaneously binds to CD3 of T cells and CD20 of B cells, inducing T cell-mediated killing of lymphoma B cells. Recently, the US FDA granted accelerated approval for the drug based on the results of the Phase I/II EPCORE NHL-1 study. The study enrolled 148 patients with CD20-positive diffuse large B-cell lymphoma, 86% of whom were patients with diffuse large B-cell lymphoma not otherwise classified. Of these, 27% were patients with DLBCL who had transformed indolent lymphoma. The remaining 14% were patients with high-grade B-cell lymphoma. As a result, Epkinly showed an objective response rate of 61%, a complete remission rate of 38%, and a median duration of response of 15.6 months in patients with relapsed or refractory DLBCL who had previously received an average of three treatments. “The bispecific antibody treatment Epkinly not only showed a complete remission rate similar to CAR-T treatment but can also be administered to patients immediately without a separate manufacturing period at medical institutions,” said Deok-hwan Yang, Professor of Hematology at Chonnam National University Hwasun Hospital. “It is encouraging that a new treatment option has emerged for patients who have failed CAR-T therapy, as Epkinly targets a different antigen than CAR-T therapies that target CD19.”
- Company
- 'Latuda,' the new schizophrenia drug, can be prescribed
- by Eo, Yun-Ho Jan 31, 2025 05:56am
- Product photo of Latuda 'Latuda,' a treatment for schizophrenia, becomes available for prescription at general hospitals. According to industry sources, Bukwang Pharmaceutical's Latuda (lurasidone) has passed the drug committees of tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, and Severance Hospital in Sinchon, and major medical centers, including Kangbuk Samsung Hospital and Ajou University Hospital. After Latuda was added to the reimbursement list in August 2024 and officially launched in November, it became widely prescribed. Latuda is an atypical antipsychotic medication developed by Japan's Sumitomo Pharma. In April 2017, Bukwang Pharmaceutical acquired the exclusive license of Latuda for South Korea and has exclusive development and sales rights. This drug is orally administred once daily and works by binding to dopamine and serotonin receptors in the central nervous system, blocking the action of neurotransmitters in the brain. Bukwang Pharmaceutical appears to be focusing on strengthening business capacity in the CNS field through Latuda. The company newly established a CNS business division last year. The company projects that Latuda will become a blockbuster pharmaceutical within several years. Currently, the second-generation antipsychotics Otsuka's 'Abilify,' Boryung's 'Zyprexa,' and Janssen's 'Invega' are dominant in the Korean market. Meanwhile, the efficacy of Latuda has been confirmed in five short-term (6 weeks) placebo-controlled clinical trials for the treatment of schizophrenia in patients between the ages of 18 and 72 who have schizophrenia (average age of 38.4). An active control (olanzapine or quetiapine) was included in two clinical studies to assess the analysis sensitivity. The primary endpoints were the PANSS score, a multi-item inventory primarily focusing on positive symptoms of schizophrenia, the Brief Psychiatric Rating Scale derived (BPRSd), and the Clinical Global Impression Severity scale (CGI-S). In the clinical trials, all Latuda dosages (40mg, 80mg, 120mg) showed superior BPRSd total score and CGI-S score compared to the placebo group. The 40mg Latuda treatment group had an average BPRSd score of 54.2 points, different from 48.6 points of the placebo group. The 80mg Latuda treatment group had 55.1 points, higher than 50.4 points of the placebo group, and the 120mg Latuda treatment group had 52.7 points, an improved score than 46.0 points of the placebo group.
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- KDA ‘Concern on use of SGLT2 inhibitors for weight loss'
- by Whang, byung-woo Jan 31, 2025 05:56am
- As interest in weight loss has increased with the advent of new GLP-1 analogs, experts have warned of the risk of overuse of SGLT2 inhibitors for weight loss or cosmetic purposes. The Korean Diabetes Association has recently issued a series of statements on the safe use of SGLT2 inhibitors for both experts and the general public. As the number of prescriptions for SGLT2 inhibitors, which were initially developed as a treatment for type 2 diabetes, has recently increased rapidly in patients with renal or heart failure who are not diabetic, the KDA has issued a statement to clarify the characteristics of the drugs and their potential side effects and to emphasize the need for cautious use. The KDA explained, “SGLT2 inhibitors have recently been found to have beneficial effects on patients with heart failure and chronic kidney disease, which has expanded their use to patients without diabetes. These drugs reduce blood sugar and have a slight weight loss effect, but they come with the risk of side effects such as genital infections and diabetic ketoacidosis and require careful use.” With the weight loss effect of SGLT2 inhibitor obesity drugs drawing attention, the weight loss effect of SGLT2 inhibitors in general has recently been gaining the spotlight. If you search for 'SGLT2 inhibitors for weight loss' on an internet portal, you can easily find relevant information. The problem is an increasing number of patients without appropriate indications request prescriptions for weight loss. On this, Kyu Jeung Ahn, President of KDA (Professor of Endocrinology and Metabolism at Kang Dong Kyung Hee University Hospital), said, “With the recent approval and launch of obesity drugs and the increasing amount of related information being disseminated, unreasonable demand for the drugs has been growing recently. It is difficult to generate specific statistical data, but there are aspects that the KDA board members have felt, so we have decided to organize and present the previously discussed content again. #i The KDA explained that although SGLT2 inhibitors have some effect on weight loss, they should not be used indiscriminately for weight loss or cosmetic purposes. In particular, the KDA specified that both healthcare professionals and patients should be aware of the side effects of this drug and that it should be used strictly according to appropriate medical needs. The KDA also reiterated that the recent issue of indiscriminate non-face-to-face prescriptions without confirming the patient’s condition or sufficient consultation or using it for the simple purpose of weight loss, is clearly abuse. “Only the positive aspects of the treatment are being highlighted recently, but as there are potential side effects, patients should be fully informed about the treatment and their situation before using it,” said Ahn. Along with this, the KDA said that SGLT2 inhibitors should be used with caution in patients at high risk of dehydration because they promote the excretion of glucose and water from the body. In the case of elderly patients, muscle loss due to weight loss along with dehydration may occur, so it is recommended that patients aged 75 or older and who are frail should consult with a diabetes specialist before using this product with caution. “It is KDA’s role to ensure that more benefits are being provided to people with diabetes through the use of proper treatment,” said Ahn. ”In addition to our association, efforts are also needed across the policy and industry sectors to ensure that the treatment is used for its original intended purpose and not for other purposes.”
- Company
- 3 variables affecting the growth of 'Entresto'
- by Kim, Jin-Gu Jan 31, 2025 05:55am
- Product photo of Entresto Novartis' chronic heart failure treatment 'Entresto (sacubitril/valsartan)' has maintained high growth, with prescription sales exceeding KRW 70 billion last year. Analysis suggests that expanded indications in 2022 and 2023 have led to skyrocketed growth. However, it is unknown whether this growth rate will continue this year. Numerous patent disputes raised by generic companies are ending, and Entresto's competing drug, Verquvo (vericiguat), has started to generate prescription sales. Earlier this year, the drug price was reduced by 5% due to the price-volume agreement (PVA). According to the market research firm, UBIST, Entreso's prescription sales from last year amounted to KRW 71 billion, up 24% from the previous year. Entresto is the first-in-class dual blocker ARNI combining valsartan, an angiotensin II receptor blocker (ARB) inhibitor, and sacubitril, a neprilysin inhibitor. Although it was launched seven years ago, Entresto maintains a high growth rate. Novartis launched Entresto with reimbursement in October 2017. In 2019, its prescription sales exceeded KRW 10 billion. In 2020, it recorded KRW 22.4 billion, up 56% from the previous year. Following that, it repeatedly showed skyrocketed growth by generating KRW 32.4 billion in 2021, KRW 42.5 billion in 2022, and KRW 57.5 billion in 2023. Entresto It has been reported that obtaining expanded indications in 2022 and 2023 has contributed to the skyrocketed growth. At the time of launch in 2017, Entresto received reimbursement coverage as a 'therapy for patients with chronic heart failure with reduced ejection fraction (HFrEF).' This drug was reimbursed for cases where patients receive standard therapy in combination with an ACE inhibitor of ARB inhibitor for over four weeks. In March 2022, the use of Entresto was expanded to include first-line treatment. It can be used to treat patients who have not previously been treated with either an ACE inhibitor or an ARB inhibitor. By July of the following year, Entresto became available for prescription to both hospitalized patients and outpatients. However, it is uncertain whether such a growth rate will continue this year. The most significant variable is the patent dispute with generic companies. Numerous patent disputes that began in 2021 are nearing the end. After January 2021, genetic companies filed for trials against Entresto's crystalline form patent, salt·hydrate patent, two use patents, and two ingredient patents. Generic companies won the first trials. After losing the first trials, Novartis appeal against three cases: crystalline form patent, use patent, and salt·hydrate patent. However, generic companies won the second trial as well. They won a dispute against the crystalline form patent and use patent. For the use patent, Novartis filed for the Supreme Court but received a 'discontinuance of a trial' ruling. Two rulings remain. The crystalline form patent dispute awaits the Supreme Court ruling, while the salt·hydrate patent case at the Intellectual Property Court of Korea has concluded and is awaiting the final verdict. The pharmaceutical industry projects that two cases of patent disputes will receive the final ruling within this year. If patent-challenging companies also win the remaining trials after their victory in the first and second trials, generic drugs are expected to launch early. The other variable is the competing drug. Bayer received approval for Verquvo in November 2021 for the treatment of patients with chronically impaired left ventricular contractility and left ventricular ejection fraction (LVEF) of less than 45%. In September 2023, the drug was covered with reimbursement. Last year, the drug landed at major general hospitals and began generating prescription sales. Verquvo generated prescription sales of KRW 1.3 billion last year. Verquvo is a treatment for heart failure that obtained approval six years after Entresto. It draws attention to the mechanism different from Entresto. Entresto blocks the harmful effects of neurohormonal activation upon myocardial and vascular dysfunction. In contrast, Verquvo is a novel soluble sGC stimulator that promotes the synthesis of cGMP (cyclic guanosine monophosphate), which regulates heart contraction, vascular tension, and heart reformation. Additionally, the reduction in drug prices due to the PVA is considered another variable. As of January 1, the price of Entresto reduced from KRW 1,683 to KRW 1,599, down 5.0%. Novartis signed an agreement with the National Health Insurance Service (NHIS) in December 2024 regarding the type-NA PVA. The drug price of Entresto has been reduced eight times since it was added to the reimbursement list at KRW 2,243 in 2017 until January this year. This includes adjustments made through the PVA agreement and voluntary reductions. During the process, the total reduction in the drug price amounts to 32.8%.
- Company
- Companies produced KRW 66.7B finished drugs a year
- by Chon, Seung-Hyun Jan 24, 2025 05:52am
- The average production performance of pharmaceutical companies has been gradually increasing. As the scale of the pharmaceutical industry grew, the average production value of both finished drugs and raw materials also continued to grow. For both finished drugs and raw materials, the share of small companies with annual production of less than KRW 10 billion was overwhelmingly large. According to the MFDS’s '2024 Food and Drug Statistical Yearbook,' 399 pharmaceutical companies produced a total of KRW 25.57 trillion worth of finished drugs in 2023. On average, each pharmaceutical company produced KRW 64.1 billion’s worth of finished drugs. Trends in average production value (left) and number of items (right) of finished drug companies by year (Unit: KRW million, % Source: MFDS) The average value of finished pharmaceutical products produced by pharmaceutical companies increased by 34.5% over 10 years from KRW 49.6 billion in 2013. As the pharmaceutical industry continues to grow, the average production value of pharmaceutical companies has also expanded. In 2023, the number of finished drug items produced by each pharmaceutical company was 53.4. This is the 8 less in nine years since 2014 when it reached 61.4. The production value per finished drug item in 2023 was KRW 1.249 billion, up 4.1% year-on-year from KRW 1.249 billion in 2022. The average production value of finished pharmaceutical products has increased by 60.6% over nine years, from KRW 777.93 million in 2014. This means that pharmaceutical companies are restructuring their products, reducing the number of finished drug items they own, and becoming larger companies with higher production values per item. However, the pharmaceutical industry as a whole was dominated by small companies. Of the 403 producers of finished pharmaceutical products in 2023, 204 companies with a production value of less than KRW 10 billion accounted for 50.6%. This means that more than one in two pharmaceutical companies are SMEs with annual production of less than KRW 10 billion. There were 126 manufacturers with less than KRW 1 billion in finished drug production. This means that one out of every three manufacturers is a small business with less than KRW 1 billion in annual production. The number of companies producing less than KRW 1 billion in finished pharmaceuticals has tripled in 10 years, from just 45 in 2013. In 2023, 73 companies produced more than KRW 100 billion in finished pharmaceutical products, an increase of 8 companies from the previous year. Compared to 38 companies in 2013, the number of companies with a production value of KRW 100 billion or more increased by 92.1%. The number of companies producing more than KRW 500 billion in finished pharmaceuticals has tripled in 10 years, from 4 in 2013 to 12 in 2023. Raw material drug companies are also scaling up their businesses, but the share of small companies is still large. In 2023, 296 raw material drug makers produced a total of KRW 3.768 trillion. Each raw material drug company produced an average of KRW 12.7 billion. The average production value of raw material drug companies has more than doubled in 10 years from KRW 5.9 billion in 2013. Trend of average production amount (left) and number of items (right) of raw material drug companies by year (Unit: KRW million, % Source: MFDS) The average number of items produced by raw material drug companies decreased by 6 over 10 years, from 27.1 items in 2013 to 21.1 items in 2023. Similar to finished pharmaceuticals, raw material drug manufacturers are also analyzed to improve their quality by reducing the number of products they handle while increasing the average production scale. In 2023, 239 of the 296 producers of raw material pharmaceuticals made under KRW 10 billion, accounting for 80.7%. The number of companies producing less than KRW 1 billion was 137, or 46.4%. Almost half of the companies produced less than KRW 1 billion in annual output. The number of companies producing less than KRW 1 billion in raw materials decreased by 106 over the 10 years from 243 in 2013. The number of companies producing more than KRW 100 billion in raw materials more than doubled in 10 years, from just three in 2013 to seven in 2023.
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- Will long-acting HIV treatment be included in the reimb list
- by Eo, Yun-Ho Jan 24, 2025 05:52am
- The long-acting HIV treatment 'vocabria+rekambys' gets attention whether it will be included in the National Health Insurance reimbursement list, two years after receiving approval in South Korea. According to industry sources, GSK Korea and Janssen Korea have recently entered drug price negotiations for their new HIV drugs, vocabria (cabotegravir) and rekambys (rilpivirine), respectively. GSK will be responsible for conducting negotiations. The combination therapy 'vocabria+rekambys' passed the Drug Reimbursement Evaluation Committee (DREC) review of the Health Insurance Review and Assessment Service (HIRA) in December last year. These two drugs were approved by the Ministry of Food and Drug Safety (MFDS) in February 2022 as the combination therapy for the treatment of HIV-1 infection in adult patients who are virologically suppressed, no prior virological failure with cabotegravir or rilpivirine, and without past and present evidence of viral resistance. In South Korea, the vocabria+rekambys therapy was approved as an injectable that can be administered monthly or twice monthly. The benefit of this combination therapy is reported to be convenience. Prior HIV treatment required once-daily administration of a tablet-type medication. These two injectables can be given once a month or bi-monthly as intramuscular injections, decreasing the administration frequency and increasing satisfaction. The marketing authorization of this therapy is projected to reduce the patient burden. These two drugs were initially developed as oral formulations, and subsequently, each was formulated as an injectable. Although it cannot cure the HIV infection, it is a long-acting injectable that can target white blood cells and help lower and maintain the amount of HIV. The efficacy and safety of the combination therapy were demonstrated in a group treated once every 4 weeks or once every 8 weeks, and the vocabria+rekambys therapy received approval in Europe in December 2020. In the clinical trial, the most adverse reactions observed in a group treated with vocabria+rekambys were injection site reactions, headache, fever, vomiting, fatigue, lack of strength, and muscle aches. It is to be closely watched whether this combination therapy will be recognized by the healthcare authority for its benefit of convenience and receive approval for inclusion in the reimbursement list.
- Company
- The era of compound management for obesity
- by Whang, byung-woo Jan 23, 2025 05:54am
- Wegovy (semaglutide), an obesity drug hailed as a game-changer, is seeking synergy with its cardiovascular benefits in addition to weight loss. Experts say that the obesity treatment paradigm is already evolving beyond weight loss to overall health care. In the future, it will be a challenge to improve access through expert review and reimbursement. (from the left) Soo Lim, Professor of endocrinology and metabolism at Seoul National University Bundang Hospital, Jong Chan Yoon, Professor of Cardiology at Seoul St. Mary Novo Nordisk held a media session on the 21st of this month to highlight the weight loss and cardiovascular disease risk reduction effects of Wegovy. Wegovy is an obesity treatment that is administered once a week. It is licensed in Korea as an adjunct to weight loss and weight management in patients with weight-related comorbidities. In July last year, the indication was expanded to include the risk reduction of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) in overweight and obese patients with established cardiovascular disease. “The 20% reduction in major adverse cardiovascular events (MACE) seen with semaglutide in adult obese patients with cardiovascular disease is a significant step forward in the treatment of obesity,” said Julie Broe Honore, Senior CMR (Clinical, Medical, and Regulatory) Director at Novo Nordisk Korea. “From a clinical perspective, semaglutide is a treatment option that can be used in conjunction with diet and increased physical activity to help manage weight and reduce the risk of major cardiovascular events.” Korean experts also emphasize the importance of active treatment interventions as obesity is a chronic disease that goes beyond simple weight gain and leads to multiple metabolic and cardiovascular complications. “The comorbidities of diabetic patients in Korea include hypertension (60%), kidney disease (40%), hyperlipidemia (70%), and obesity (50%),” said Dr. Soo Lim, Professor of endocrinology and metabolism at Seoul National University Bundang Hospital. ”It is time to control multiple diseases together, and I think GLP-1 will be the best medicine to manage them all at once.” Jong Chan Yoon, Professor of Cardiology at Seoul St. Mary Jong Chan Yoon, MD, Professor of Cardiology at Seoul St. Mary's Hospital, noted that obesity significantly increases the risk of cardiovascular disease. “Cardiovascular disease is one of the leading causes of death globally, and after analyzing data from 195 countries around the world from 1990 to 2015, we found that about two-thirds of obesity-related deaths were associated with cardiovascular disease,” said Professor Yoon. In the SELECT study, Wegovy demonstrated a significant 20% reduction in the risk of major cardiovascular events in the Wegovy arm compared to the placebo arm over a median follow-up of 39.8 months. “The results of the SELECT study demonstrate that the treatment goals for obesity can be expanded beyond simple weight loss to include reducing the risk of major cardiovascular events,” said Professor Yoon. In particular, Professor Lim emphasized that the results of the study showed that GLP-1 class drugs have greater cardiovascular benefits than other diabetes medications. “When we directly compared the cardiovascular disease reduction effects of GLP-1 and SGLT2, GLP-1 showed better benefits, and in stroke, SGLT2 had no effect, but GLP-1 showed good effect,” Lim analyzed. However, Wegovy, which was launched in Korea in October last year, is currently non-reimbursed and has a cost hurdle. Apart from its clinical benefits, it is unclear how much it can be utilized in practice considering its cost-effectiveness. Soo Lim, Professor of endocrinology and metabolism at Seoul National University Bundang Hospital. In response to this, Professor Lim said, “It is good to use a lot of good drugs, but there is a limit to their use because they are not reimbursed. The government needs to also take the view that severe obesity is a disease,” adding, ”If a person with a BMI of 35 or 40 or more is socially disadvantaged due to obesity, it is necessary to consider providing some support through insurance.” “Although the treatments are also expensive in the U.S., if you consider the cost of procedures and hospitalization due to cardiovascular diseases, papers that show that treatments like Wegovy are rather cost-effective,” said Professor Yoon. ”I expect prescriptions to gradually increase in Korea, and if there is no cost hurdle, it will likely be used without limitation within the given indications.” In the end, the will of pharmaceutical companies in attempting reimbursement will be important to resolve the cost issue. In this regard, Novo Nordisk is considering mid- to long-term plans to strengthen access. “We understand that it is necessary to expand access to therapeutics, but this is something that needs to be discussed extensively,” said Ju Ok Lim, head of Medical Affairs at Novo Nordisk. ”It requires mid- to long-term discussion, but we are in the beginning stages of the process and are exploring various ways to expand access.”
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- MET inhibitor Tepmetko enters last stage to reimb in KOR
- by Eo, Yun-Ho Jan 23, 2025 05:54am
- MET-targeted anticancer drug ‘Tepmetko’ has entered the final gateway to insurance reimbursement nearly 3 years after its domestic approval. According to industry sources, Merck Korea has recently started negotiating drug prices with the National Health Insurance Service for its Tepmetko (tepotinib), a treatment for locally advanced or metastatic non-small cell lung cancer with a confirmed MET exon 14 skipping mutation. The drug passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review in December last year. Tepmetko obtained domestic approval and went through the reimbursement process in 2021 at the same time as the same mechanism drug Tabrecta (capmatinib). However, no MET cancer drug has been listed for reimbursement in Korea yet. Therefore, it remains to be seen whether Tepmetko will complete the reimbursement process. The drug has failed to meet the criteria for insurance reimbursement twice, including failing review by the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee in March. It then voluntarily suspended the coverage process and submitted another application for coverage in July, and this time, it passed the committee. This achievement was made 3 years after its domestic approval. Non-small cell lung cancer accounts for 80% of all lung cancer diagnoses. MET exon 14 skipping mutation is a rare type of cancer that is present in approximately 3-4% of these patients. In Korea, of the 1,020 NSCLC patients in Korea, 1.9% of the NSCLC patients were confirmed to have MET exon 14 deletion. Tepmetko’s efficacy was demonstrated through the VISION study, which enrolled the largest number of NSCLC patients with MET exon 14 skipping mutations. The results showed a significant life extension effect, with a median progression-free survival (PFS) of 15.3 months and an objective response rate (ORR) of 56.8 percent. The median duration of response (DoR) was 46.4 months, and the median overall survival (OS) was 25.9 months, showing continuous antitumor activity in the long term. Also, according to a presentation by Ji-Youn Han, Professor of Oncology at the Center for Lung Cancer at the National Cancer Center, which was at the Korean Association for Lung Cancer International Conference last year after analyzing 79 Asian patients that participated in the VISION study, the ORR was quite high at 66.7%, and 48.1% in the second-line treatment group. Meanwhile, Tepmetko also showed significant results in a follow-up analysis of Asian patients enrolled in the pivotal Phase III VISION study. In this analysis, Tepmetko demonstrated an objective response rate of 56.6%, a median duration of response of 18.5 months, a median progression-free survival of 13.8 months, and a median overall survival of 25.5 months. The objective response rate was 64.0% in treatment-naïve Asian patients, confirming previous findings that the first dose was more effective. No new safety information was identified, with 39.6% of patients experiencing grade 3 or higher adverse events. In addition, Tepmetko has now passed the Drug Committees (DCs) of more than 30 medical institutions nationwide, including the Big 5 tertiary hospitals - Samsung Medical Center, Seoul National University Hospital, and Seoul St. Mary's Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital.
- Company
- "C-Trelin proven effective for SCD treatment…reimb needed"
- by Lee, Seok-Jun Jan 22, 2025 05:55am
- Product photo of There is currently no standard therapy available for 'spinocerebellar degeneration (SCD).' Doctors write prescriptions based on a patient's condition, but there are still unmet needs in 'SCD treatment.' Patients affected by disease likewise. SCD is a degenerative disease affecting the cerebellum or spinal cord due to various underlying causes. Ataxia and dysarthria commonly occur at an early stage, but the disease progression accompanies complications, including dysfunction of the heart, lungs, spine, and bones, causing the risk of death. Other diseases have specific medications; for instance, 'Levodopa' is used for Parkinson's disease and 'aspirin' is used for cerebral thrombosis. However, there is currently no major medication available for SCD. This is because no medication has been proven to improve symptoms or slow down disease progression. The efficacy and safety of C-Trelin Orally Disintegrated Tab (taltirelin hydrate) was demonstrated in large-scale Phase 4 clinical trials in patients with SCD. Dr. Seong Beom Koh, Professor at the Korea University Guro Hospital's Department of Neurology who led the Phase 4 clinical trial, stated, "None of the medications used in patients with SCD are better than C-Trelin Orally Disintegrated Tab." "C-Trelin Orally Disintegrated Tab has proven effective and safe in patients with SCD. Its oral formulation also yields favorable patient compliance. It means that it is a valuable treatment for patients. We should widely use this medication through reimbursement." The efficacy and safety of the drug has been demonstrated in the large-scale Phase 4 trial The clinical trial was published in the Journal of Movement Disorder under the title, 'The Efficacy and Safety of C-Trelin Orally Disintegrated Tab in Patients with ataxia induced by SCD.' The clinical trial involved 160 study participants, including randomly assigned 79 experimental group and 81 control group, and the results showed a significant reduction in the K-SARA (Korean version of Scale for the Assessment and Rating of Ataxia), objective evaluation index for ataxia at 24 weeks treatment, thus confirming the statistical significance of the drug. The standing up and impairment in language entries showed that the average difference in K-SARA of the experimental group was statistically lower than that of the control group. While no suitable medication is available for ataxia in SCD, publication of the Phase 4 trial results in the international journal is significant. Doctors are stating the importance of providing reimbursement for C-Trelin Orally Disintegrated Tab. "C-Trelin Orally Disintegrated Tab is an oral tablet required twice daily. This drug had no significant issue based on the clinical trial evaluating the efficacy and safety. Patient tolerance was favorable, and there were no side effects after administration. To date, no other treatments administered to patients with SCD are said to be efficacious than this drug. Therefore, this drug provides a valuable treatment option for patients with SCD," Dr. Koh remarked. "C-Trelin Orally Disintegrated Tab may require long-term use, which can be costly. This drug should be considered for patients with good mobility and could benefit from it. If a drug is as effective as this, we should pursue active treatment options through reimbursement," Koh added. 'C-Trelin Orally Disintegrated Tab 5 mg' obtained the Ministry of Food and Drug Safety (MFDS) approval in 2015. It costs KRW 4,900 per tablet as a non-reimbursable drug. Two tablets per day cost KRW 9,800 daily and cost KRW 3.5 million yearly. Doctors say that without National Health Insurance reimbursement coverage, it is practically impossible for patients, about 80% of those who do not have jobs, to continue taking the drug that requires long-term administration. Based on these clinical trial results, HLB Pharmaceutical has recently applied for reimbursement again.
