- LOGIN
- MemberShip
- 2026-05-01 23:17:59
- Policy
- Chinese pharma targeting KOR, BeiGene gets greenlight
- by Lee, Hye-Kyung Jan 10, 2025 05:52am
- Product photo of BrukinsaBeiGene Korea expands market dominance by conducting clinical trials to achieve competitiveness in the Korean market. Based on this year's Ministry of Food and Drug Safety (MFDS)'s clinical trial approval report, two out of ten approved clinical trial applications were BeiGene Korea's Phase 1 clinical trials. BeiGene has been strengthening its pipeline of solid cancers, focusing on the PD-1 inhibitor, 'Tevimbra (tislelizumab).' The company was approved to conduct Phase 1 clinical trials for its new drug candidates, 'BGB-58067' and 'BG-C137.' BGB-58067 is a new drug candidate designed to avoid the hematological toxicity typically associated with PRMT5 inhibitors. It is recognized for its high efficacy and brain-penetrating capability. Domestic clinical trials are conducted in 'Big 4' hospitals, Samsung Medical Center, Seoul National University Hospital, Seoul Asan Medical Center, and Severance Hospital, enrolling patients with advanced solid tumors patients. BG-C137 is an antibody-drug conjugate (ADC) targeting FGFR2b in patients with advanced solid tumors. A Phase 2 trial is conducted in Severance Hospital, Seoul National University Hospital, Seoul National University Bundang Hospital, and Seoul Asan Medical Center. Meanwhile, BeiGene had prepared to enter the Korean market early, establishing a Korean subsidiary in October 2019. The company began conducting clinical trials in 2022. A total of 17 clinical trials were approved in South Korea. The company has new anticancer drugs, such as 'Tevimbra' and 'Brukinsa,' that received approvals from global regulatory institutes, including the US FDA. The second-generation BTK inhibitor 'Brukinsa (zanubrutinib)' and an immunotherapy 'Tevimbra' are new drugs designated as Korea's No.1 and No.2 new drugs, respectively. Brukinsa was approved by the MFDS in 2022 for demonstrated efficacy·effectiveness in ▲Monotherapy in adult patients with mantle cell lymphoma (MCL) who had one or more prior therapy ▲Monotherapy in adult patients with Waldenstrom macroglobulinemia (WM) who have had one or more prior therapy. Tevimbra, a PD-1 inhibitor immunotherapy cancer, received domestic approval in 2023 as a monotherapy for the treatment of adult patients with unresectable, recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma who are unable to continue platinum-based chemotherapy or have experienced recurrence or progression following such treatment.
- Company
- Hexaxim may be administered in general hospitals in Korea
- by Eo, Yun-Ho Jan 10, 2025 05:52am
- Hexaxim, a hexavalent combination vaccine for infants that was included in the National Immunization Program, may now be administered in general hospitals. According to industry sources, Sanofi Korea's Hexaxim prefilled syringe has now passed the drug committees (DCs) of 17 medical institutions nationwide, including Seoul National University Hospital. With its inclusion in Korea’s NIP (National Immunization Program), the number of medical institutions that offer Hexaxim vaccinations is expected to continue to increase. As the first and only hexavalent combination vaccine in Korea (as of January 2025), Hexaxim can simultaneously protect against 6 infectious diseases, which includes hepatitis b in addition to the 5 infectious diseases (diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b) that can be prevented by existing pentavalent combination vaccines. Infants who received hepatitis B monovalent vaccines at birth are eligible for the vaccine, which is given in a series of 3 doses at 2, 4, and 6 months of age. However, infants born to hepatitis B-positive mothers will be vaccinated with the pentavalent combination vaccine and hepatitis B monovalent vaccine as before, as it is necessary to prevent vertical infection of hepatitis B. The designated medical institutions for the National Immunization Program can be found on the NIP KDCA website, and it is necessary to check the types of vaccines that can be administered at the designated medical institution before visiting, as the types of vaccines offered may differ depending on the medical institution. The hexavalent combination vaccine for infants has been already recommended as an essential vaccine in more than 40 countries, including Europe, Canada, and Australia. Hexaxim also reduces the total number of doses from 6 to 4 compared to the current schedule that requires separate doses of the pentavalent combination vaccine and hepatitis B monovalent vaccine, rendering it easier for parents and infants to get vaccinated and improving timely immunization rates by reducing delays and missed doses of recommended vaccines. In addition, Hexaxim is a ready-to-use formulation that maximizes convenience and efficiency of administration, requires no reconstitution, and is easy to use. This reduces vaccination preparation time and significantly reduces the risk of reconstitution errors, making the process more efficient for healthcare professionals and enabling them to provide safe and rapid immunization services to parents and infants. Sanofi has been working with SK Bioscience since the end of last year to ensure a steady and stable supply of Hexaxim to medical institutions designated for the National Immunization Program for children nationwide and will continue to work with SK Bioscience on the national distribution of infant and childhood combination vaccines including Hexaxim and conduct marketing activities.
- Company
- Lilly Korea releases Ebglyss for atopic dermatitis in Korea
- by Whang, byung-woo Jan 10, 2025 05:52am
- Pic of Ebglyss Lilly Korea announced on the 9th that it had launched Ebglyss (lebrikizumab) in Korea for the treatment of moderate-to-severe atopic dermatitis. Ebglyss is a novel biologic agent that selectively blocks cytokine interleukin (IL)-13, a major cause of atopic dermatitis. It was approved by the Ministry of Food and Drug Safety in August 2024 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 treatments or for whom such treatments are not recommended. Ebglyss demonstrated its clinical efficacy and safety profile in a pivotal Phase III clinical trial. Patients who achieve a clinical response after 16 weeks of treatment can thereafter receive a maintenance dose (250 mg) every 4 weeks, making it a useful first-line treatment option for patients with atopic dermatitis in Korea. The clinical studies on which the license was based 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. “We are pleased to be able to quickly introduce Ebglyss, a novel biologic with a favorable clinical efficacy and safety profile, as well as improved dosing convenience, to patients with atopic dermatitis who require long-term treatment,” said Taehyun Kim, Immunization Business Unit Director at Lilly Korea. ”Lilly Korea will continue to actively engage with stakeholders, including healthcare professionals, to provide an improved treatment experience for patients with moderate-to-severe atopic dermatitis in Korea with Ebglyss.”
- Company
- Leclaza’s new trial data shows improved OS
- by Son, Hyung Min Jan 09, 2025 05:57am
- The Leclaza plus Rybrevant combination achieved statistically significant overall survival (OS) results. Johnson & Johnson expects Leclaza plus Rybrevant to extend OS by more than a year compared to Tagrisso monotherapy. The positive OS outcome for the combination strengthens its potential to become the first-line standard of care for EGFR-positive NSCLC. On the 7th, Johnson & Johnson announced top-line OS results from the Phase III MARIPOSA study, which evaluated the efficacy of the combination of Leclaza plus Rybrevant in patients with locally advanced or metastatic NSCLC. Leclaza is a third-generation tyrosine kinase inhibitor (TKI) targeting exon 19, and exon 21 (L858R) in EGFR-positive NSCLC that was developed by Yuhan Corp. Johnson & Johnson acquired global rights to Leclaza and is conducting clinical trials for the drug in combination with its targeted therapy option, Rybrevant, which targets exon 20 and the MET mutation. The recently published OS results showed that Leclaza plus Rybrevant was superior to Tagrisso monotherapy. Johnson & Johnson explained that Leclaza plus Rybrevant extended median OS by more than a year compared to Tagrisso alone, which was a statistically significant result. As Tagrisso achieved a median OS of 38.6 months in the FLAURA study that became the basis of its approval, the OS for Leclaza plus Rybrevant is expected to have exceeded 50 months. This is progress over previous clinical data, which demonstrated efficacy in the primary endpoint of PFS, but only a favorable trend over Tagrisso in the secondary endpoint of OS. OS is one of the most important indicators in determining the clinical value of an anticancer drug. OS is the overall survival period from the time a patient starts treatment until death. OS also includes patients who die of non-cancer-related causes, such as side effects and other complications. In the case of PFS, PFS is the length of time that a patient survives with cancer that has not progressed, i.e., the tumor has not increased in size while receiving treatment. In other words, while PFS is a measure of how well a new treatment can slow the progression of cancer, OS is a measure of how well it can prolong survival. If the Leclaza plus Rybrevant is ultimately to have an effect in improving PFS and OS, it could become the standard of care for EGFR-positive non-small cell lung cancer. Johnson & Johnson succeeded in receiving FDA approval for Leclaza plus Rybrevant in August of last year based on the results of the MARIPOSA trial. In December last year, Johnson & Johnson received approval in Europe as well. The approval was based on clinical results that Johnson & Johnson presented at the European Society for Medical Oncology 2023 Annual Congress (ESMO 2023). The results showed a median progression-free survival (PFS) of 23.7 months in the Leclaza plus Rybrevant combination arm and 18.5 months in the Leclaza monotherapy arm, compared to 16.6 months in the Tagrisso monotherapy arm. “Achieved results with targeted therapy+ targeted therapy”...ignites competition between combination therapies” The competition between combination therapies has also started in earnest in the market for the first-line treatment of EGFR-positive NSCLC. Currently, AstraZeneca is defending the market with Tagrisso plus platinum-based chemotherapy, which is approved for the first-line treatment of EGFR-positive NSCLC. However, platinum-based chemotherapy is categorized as an option for use after a patient develops resistance to conventional targeted therapies. This is why some have argued that using platinum-based chemotherapy as a first-line option could lead to a shortage of later-line therapy options after developing resistance. The downside to the use of the Leclaza plus Rybrevant combination is that it may be less convenient to administer. All EGFR-positive targeted therapies, including Leclaza, Tagrisso (third generation), Boehringer Ingelheim’s Giotrif, Pfizer’s Vizimpro (second generation), Roche’s Tarceva, and AstraZeneca’s Iressa (first generation), are oral formulations. However, Rybrevant is an intravenous (IV) formulation that requires clinic visits every three weeks. This may not be convenient for patients with NSCLC. To address the issue, Johnson & Johnson has developed a subcutaneous (SC) formulation of Rybrevant and has been studying the formulation in combination with Leclaza. The subcutaneous formulation can be administered in as little as 10 minutes, significantly reducing dosing time for the patients. In recently published clinical trial results, the combination of the subcutaneous formulation of Rybrevant and Leclaza demonstrated similar outcomes to the intravenous (IV) formulation of Rybrevant plus Leclaza. Infusion-related adverse events were lower in the Rybrevant SC+ Leclaza arm. “Leclaza+Rybrevant delivered clinically significant results without chemotherapy,” said Yusri Elsayed, Global Head of Oncology at Johnson & Johnson. ”Extending median overall survival by more than a year can be a game-changer in the NSCLC treatment landscape.”
- Company
- Vabysmo approved for retinal vein occlusion macular edema
- by Whang, byung-woo Jan 09, 2025 05:56am
- Pic of Vabysmo Roche Korea announced on the 8th that Vabysmo has been approved by the Ministry of Food and Drug Safety (MFDS) for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion. With the approval, Vabysmo is now approved for 3 indications in Korea, including as a treatment for ▲neovascular (wet) age-related macular degeneration; ▲visual impairment due to diabetic macular edema; and ▲visual impairment due to macular edema secondary to retinal vein occlusion. Retinal vein occlusion is the second leading cause of blindness due to retinal vascular disease. It primarily affects people over the age of 60 and can cause sudden vision loss. Retinal vein occlusion is divided into two main types: branch retinal vein occlusion, which occurs when one of the four smaller branches of the main central retinal vein becomes blocked, and central retinal vein occlusion, which occurs when the central retinal vein in the eye becomes blocked. The approval of this indication expansion is based on results from the global Phase III BALATON and COMINO clinical trials, which included over 1,200 patients with macular edema secondary to retinal vein occlusion. In BALATON and COMINO trials, Vabysmo met the study's primary endpoint by demonstrating non-inferior visual acuity improvement compared to the control group as measured by best-corrected visual acuity (BCVA) at week 24 in patients with branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO). Additional long-term data from up to 72 weeks of follow-up showed that more than 57% of patients in the BALATON study and more than 45% of patients in the COMINO study were able to extend the treatment interval to three- or four-month intervals. In the BALATON and COMINO trials, Vabysmo was well tolerated, with a safety profile consistent with previous studies. The most common adverse event was conjunctival hemorrhage (3%), with a comparable safety profile across study arms. “This indication expansion is significant because it allows Vabysmo, the first bispecific antibody treatment for ophthalmic diseases, to contribute to the treatment of a broader spectrum of retinal diseases, in the current situation where it is becoming increasingly important to treat ophthalmic diseases due to the aging population and increase in chronic diseases,” said Ezat Azem, General Manager of Roche Korea. “We will continue to work with key stakeholders, including the government and academia, to support healthier lives for Korean patients with retinal diseases by providing treatments for conditions that can cause blindness.”
- GC Biophara to offset Lipidil supra loss with new drug?
- by Lee, Tak-Sun Jan 09, 2025 05:56am
- As GC Biopharma successfully obtains reimbursement listing of a new product containing fenofibrate for treating hypertriglyceridemia, the industry closely watches its impact on shifting the competitive structure in the market. Lipidil supra containing fenofibrate is a product that GC Biopharma generated as a blockbuster drug after introducing it to South Korea in 2003. However, an analysis suggests that new competition has been initiated following Abbott, the company with domestic sales rights for fenofibrate-containing products such as Lipidil supra and Lipidil-NT, changed the domestic distributor to Handok. According to industry sources on January 8, GC Biopharma obtained reimbursement listing of Neofeno Tab 145mg containing fenofibrate 145mg in January and initiated sales. Fenofibrate 145mg has the benefit of administration regardless of food intake. The existing 160mg requires immediate oral administration due to drug absorption in the stomach. Currently, the products containing fenofibrate 145mg are GC Biopharma's new product, Yuhan's 'Fenowell Tab 145mg,' and Abbott Korea's 'Lipidil-NT.' Yuhan's Fenowell was launched in July 2022, and Abbott's Lipidil-NT was launched in January 2023. Abbott initially signed sales contracts for Lipidil-NT with GC Biopharma, its partnering company for selling Lipidil supra. Because of the contract, GC Biopharma did not list Neofeno Tab on the reimbursement list after obtaining approval in November 2020. However, since Abbott signed a contract with Handok in January to distribute fenofibrate-containing products, GC Biopharma launched its new product. Handok announced that it will be responsible for exclusive marketing and sales of Lipidil supra and Lipidil-NT, drugs for which Abbott has sales rights in South Korea. Currently, the approved company for Lipidil supra has changed from GC Biopharma to Abbott Korea, and the pharmaceutical company registered for the reimbursement listed product is projected to change from GC Biopharma to Abbott. Lipidil supra is a blockbuster drug with outpatient prescription sales of KRW 16.3 billion, based on a UBIST report in 2023. For GC Biopharma, the termination of Lipidil supra sales will likely result in revenue reduction. However, the industry closely watches whether GC Biopharma will take over the current Lipidil supra customer after launching its new product, which offers easier administration. "A competition for securing accounts is expected as Handok has initiated selling fenofibrate-based original product and the previous seller GC Biopharma launches a new product," a pharmaceutical personnel comments. "Whether GC Biopharma would take over previous accounts will be a determining factor in the competition." Meanwhile, the number of similar active ingredients for Neofeno Tab 145mg is between 2 and 19, so the price has been set the same as Yuhan and Abbott's products. It is priced at KRW 339 per tablet.
- Company
- Krazati receives orphan drug designation in Korea
- by Eo, Yun-Ho Jan 09, 2025 05:56am
- The second KRAS inhibitor 'Krazati' has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety (MFDS) recently announced the news through the first orphan drug designation announcement of the new year. Specifically, Krazati is indicated for 'locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation who have received at least one prior therapy. BMS's Krazati (adagrasib) received accelerated approval from the U.S. FDA in December 2022. It is the second KRAS inhibitor to be approved, following Amgen's Lumakras (sotorasib), which was approved in 2021. The development of KRAS-targeted anticancer drugs comes nearly 40 years after the oncogene KRAS was first discovered. Amgen and BMS are in a fierce race to capture the new market. Lumakras and Krazati have many similarities in terms of target mutation and indication. Both target the G12C variant of KRAS, and were first approved for non-small cell lung cancer. The companies are also conducting combination trials with drugs that have different mechanisms of action, either developed in-house or acquired through collaborative research. Krazati's first approval was based on results from the enrollable cohort from the Phase II KRYSTAL-1 study, and the company disclosed top-line results from a confirmatory Phase III study last year. The study evaluated Krazati versus docetaxel in 301 previously treated patients with KRAS G12C mutated locally advanced or metastatic NSCLC. The study enrolled patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who had been previously treated with platinum-based chemotherapy and anti-PD-1/PD-L1 immunosuppressive agents. Patients were randomized in a 1:1 ratio to receive Krazati or docetaxel. The primary endpoint was progression-free survival (PFS) as assessed by BICR. At 9.4 months of follow-up, the primary endpoint was met with a median PFS of 5.49 months for Krazati compared to 3.84 months for docetaxel, a 42% reduction in the risk of disease progression or death.
- Policy
- AML treatment Mylotarg stalled at the DREC review
- by Lee, Tak-Sun Jan 09, 2025 05:56am
- Product photo of MylotargThe high price was found to be the reason Pfizer Korea's new drug Mylotarg (gemtuzumab ozogamicin), a treatment for acute myeloid leukemia (AML), did not pass the Health Insurance Review and Assessment Service (HIRA) stage. HIRA acknowledged the drug's improvement in clinical utility but did not approve its cost-effectiveness. According to industry sources on January 7, HIRA recently disclosed a report from the Drug Reimbursement Evaluation Committee (DREC) held in November 2024 on the non-reimbursement assessment review for Mylotarg inj 4.5mg. Mylotarg is an antibody-drug conjugate (ADC) that can be used for the first-line treatment of newly diagnosed adult patients with CD33-positive AML. It binds to cells involved in leukemia and releases calicheamicin upon internalization, causing DNA double helix breaks and inducing cell death. It was approved on November 18, 2021, in South Korea and has been considered for national health insurance reimbursement listing. In May 2022, it was considered for the Cancer Disease Review Committee (CDRC) of the HIRA review but failed to establish reimbursement criteria. In October 2023, its reimbursement criteria were successfully established at the CDRC. Then, it was considered for the DREC review, the final stage for determining reimbursement appropriateness; however, it was acknowledged for reimbursement appropriateness. According to the DREC assessment report, Mylotarg is an anticancer drug approved for the 'treatment of patients with newly diagnosed CD33-positive AML.' It was acknowledged for improving clinical utility, including event-free survival (EFS), compared to an alternative drug. However, the DREC determined to maintain non-reimbursement status due to not having cost-effectiveness based on the economic assessment. In the cost-effectiveness assessment, Mylotarg's price was found to be higher than that of alternative drugs, 'cytarabine + daunorubicin, cytarabine + idarubicin combination therapies.' Additionally, the economic assessment result did not sufficiently persuade DREC committee members. Meanwhile, its clinical utility was acknowledged. The Korean Society of Hematology showed that Mylotarg improved the EFS than the standard therapy (7+3). Regarding the safety profile, bleeding and veno-occlusive disease (VOD) occurrence slightly increased, but it was determined safe because it was not significantly different from the side effect frequencies. Since Mylotarg is a standard therapy for cytogenetically favorable-intermediate patient groups based on treatment guidelines of the United States and Europe, the assessment suggested it should be provided to patients in South Korea. In the ALFA-0701 Phase 3 trial, the drug significantly improved the primary endpoint, demonstrating a median EFS of 17.3 months compared to 9.5 months in the control group. Currently, this drug is listed in the prescription price list of the US, UK, Germany, Italy, and Japan. Meanwhile, the prevalence of domestic AML is 2.5 cases per 100,000 population annually. The prevalence of the disease increases with age, and the median age of AML patients is between 65 and 69. As life expectancy increases, more AML patients are older. Patients with AML experience fatigue, weakness, loss of appetite, anemia, and thrombocytopenia due to bone marrow failure and extended infiltration of leukemia cells. It has been reported that young patient survival rate is below 20% with poor prognosis.
- Company
- Wegovy vs Mounjaro in KOR…who's the winner?
- by Moon, sung-ho Jan 09, 2025 05:56am
- As more people are living with obesity in the world, obesity treatment is gaining popularity. According to the World Obesity Federation report, more than half of the world's population in 2035, 10 years from now, will be categorized as overweight or obese. South Korea is projected to have a similar rate. At the end of last year, Novo Nordisk's obesity drug 'Wegovy (semaglutide),' which gained popularity and was in short supply in the global market, was finally introduced to clinical practices in South Korea. After that, new drugs with significant weight-loss effects are being introduced into South Korea, indicating a shift in the paradigm of obesity treatment. The companies have applied for expanded indications for these drugs, influencing clinical areas. Prodouct photo of According to pharmaceutical industry sources on January 6, Novo Nordisk Korea has been supplying 'Wegovy Prefilled Pen Inj' to clinical practices since mid-October last year. Wegovy received domestic marketing authorization in April with indications to aid weight-loss overweight patients who have a Body Mass Index (hereafter referred to as BMI) of 30kg/m2 or higher or those who are overweight with early BMI of 27kg/m2 or higher and below 30kg/m2 and having one or more weight-related accompanying diseases. Additionally, in July 2024, Wegovy also receive approval for the indication to reduce risks of major cardiovascular events (death from cardiovascular diseses, non-fatal cardial infarction, or non-fatal cerebral strok) in overweight or obese patients with early BMI of 27 kg/m² or higher with cardiovascular diseases. Upon the launch of Wegovy, Novo Nordisk Korea actively worked to secure market dominance in the Korean obesity treatment market, using about 80 sales and marketing employees. As a result, Wegovy is currently being used in medical clinics as a non-reimbursable drug. Patients pay an average cost of KRW 700,000-800,000 per month for treatment. "Japan's drug price seems to be the world's lowest, but it is covered by insurance. It has been launched as the lowest price globally among non-reimbursed drugs," Chul Jin Lee, President of the Korean Society for the Study of Obesity (Joeun Family Health Clinic), said. "It is likely that the company has considered the potential launch of Mounjaro (tirzepatide) in Korean clinical practices." Wegovy's company seems to be attempting to dominate the market by entering the domestic clinical field ahead of Mounjaro. The industry's interest is now on the launching date of 'Mounjaro,' known as Wegovy's rival. Lily Korea plans to introduce the drug to clinical practices in South Korea this year. In addition to Mounjaro's approval for type 2 diabetes, Lily Korea received extended approval for the drug as an adjuvant therapy for chronic weight control, which is similar to Wegovy. Although it is being sold in the market for obesity treatment as the product name 'Zepbound,' Mounjaro will be used for treating diabetes and obesity in South Korea. Regarding this, Lily's recent announcement of the top-line results of the open-label SURMOUNT-5 Phase 3 clinical trial draws attention. This study directly compared the effects of Mounjaro to Wegovy. According to the results presented, patients treated with Mounjaro had greater weight loss effects compared to those treated with Wegovy. This finding indicates that Mounjaro is superior in a one-on-one comparison to Wegovy. In the clinical study involving 751 patients who are obese or overweight without diabetes, patients treated with Mounjaro for 72 weeks had a weight loss of 22.67kg, which is an average loss of 20.2% of the body weight. During the same period, patients treated with Wegovy had a weight loss of 13.7% (14.96kg). When the weight loss range was compared, Zepbound showed about 47% superior effects than Wegovy. Consequently, when Mounjaro becomes available in the Korean market, Wegovy will likely face a short-lived 'popularity.' "Mounjaro in the form of vial is under consideration of domestic approval," Lee said. "Mounjaro's yearly cost is about KRW 3 million less than what Wegovy costs. Moreover, the drug price of vial formation saw a 50% reduction in the United States. When it launches in South Korea after obtaining approval, Mounjaro will likely priced significantly less. For this reason, clinical practices are closely watching Mounjaro." "When vial formation becomes available, doctors prefer using those than pen types," Lee added. "A weekly vial package treatment regimen would be optimal." Due to Wegovy and Mounjaro's success, GLP-1 emerged as the R&D trend in the domestic and foreign pharmaceutical and biotech industries. Recently, the FDA granted approval for Zepbound, containing a similar active ingredient to Mounjaro, for sleep apnea. In addition to its diabetes and obesity indications, the extended indication of sleep apnea suggests an increased volume of usage. Also, an extended indication is likely approved in South Korea. Companies witnessing these successes are evaluating the possibility of metabolic dysfunction-associated steatohepatitis (MASH) treatment since GLP-1 improves insulin secretion and sensitivity, improving blood glucose control. Because MASH is caused by fat buildup in the liver of people who consume little or no alcohol, weight loss can have a positive effect on patients. For this reason, pharmaceutical companies have determined that GLP-1 can be a treatment for MASH, alongside diabetes and obesity, and are currently conducting clinical trials. The same goes for Wegovy and Mounjaro's active ingredients, semaglutide and tirzepatide. Novo Nordisk and Lily are assessing the clinical utility of those drugs in patients with MASH, conducting phase 2 and phase 3 clinical trials, respectively. The industry is anticipating potential extended indications. Additionally, survodutide, under development by Boehringer Ingelheim, demonstrated clinical utility in a phase 2 trial, emerging as a new drug candidate for MASH. The biotech industry in South Korea is also considering the possibility of new GLP-1 drugs. Many companies have begun clinical studies. The outstanding companies are ProGen and D&D Pharmatech. ProGen is gaining attention for its new drug development in diabetes and obesity fields. The company is developing 'PG-102,' which works bi-specifically by binding GLP-1·GLP-2. ProGen's new drug candidate received approval from the Ministry of Food and Drug Safety (MFDS) for conducting a domestic phase 2 trial. ProGen aims to maximize the effects, such as improving intestine function, glucose uptake in adipose tissue, and alleviating chronic inflammation by targeting both GLP-1 and GLP-2. Kun-Ho Yoon, Chief Medical Officer of Progen (Endocrinology Specialist), says the significance of the study is that "Since there have been no new drug candidates that simultaneously target both GLP-1 and GLP-2, ProGen's 'PG-102' can be a first-in-class candidate treatment." D&D Pharmatech is conducting clinical trials for its GLP-1 agent for various fields, including MASH, Parkinson's disease, and dementia. Last year, the company initiated a Phase 2 trial after receiving the FDA approval of its Phase 2 trial Investigational New Drug (IND) application. The Phase 2 trial is being conducted in 10 clinical trial centers, and the trial involves 68 patients who are overweight or obese with accompanying MASH. The Korean clinical practices are closely watching the D&D Pharmatech's achievements. "D&D Pharmatech has GLP-1 and GLP-2 bi-specific agents and amylin-based products," Lee said. "The company has a competitive edge, especially having a proprietary platform for switching an agent to oral formation alongside having injectable." "Regarding developing a GLP-1 formation, the key to success is which company could diversify with lesser cost," Lee remarked. "The success in the market competition will be determined by providing various clinical benefits at lower prices for injectable, vial, and oral formations," Lee projected.
- Company
- Sales of Flu drug Tamiflu did not fare so well last year
- by Nho, Byung Chul Jan 08, 2025 05:53am
- The oseltamivir-based flu treatment market, commonly represented by Tamiflu, is on a vertical decline after peaking in sales in 2023. The market for related preparations was valued at KRW 35.6 billion in 2023, the largest in 5 years. By 3Q 2024, the oseltamivir market posted sales of KRW 6.2 billion; even when the sales of the fourth quarter are combined, it will be difficult to realize the KRW 10 billion mark. However, given how flu alerts were issued from December last year to January this year, a spike in the drug’s sales is expected during the period. The overall market for related ingredients has remained at the level of KRW 23.1 billion in 2019, and after reaching a low of KRW 10.5 billion in 2020 and KRW 339 million in 2021. The market recovered to KRW 20.9 billion in 2022 and reached KRW 35.6 billion in 2023. The market for related therapeutics shrank significantly during the peak of the pandemic due to the impact of COVID-19 vaccination and strict personal hygiene such as wearing masks and disinfecting hands. Oseltamivir is one of more than 20 products competing in the market for the treatment of influenza A-B virus infections. Roche's Tamiflu is the undisputed leader in the market, with sales of about KRW 2.6 billion through the third quarter of last year. That's down sharply from 2023 when it generated KRW 15.3 billion in sales. Tamiflu's performance in 2019-2020-2021-2022 had been KRW 7.4 billion-4 billion-137 million-14.1 billion, respectively. In second place is Hanmiflu Cap, which sold KRW 1.6 billion by the third quarter of 2024, a sharp drop from KRW 7.7 billion in 2023. Hanmiflu's performance in 2019-2020-2021-2022 is in the range of KRW 4.8 billion-KRW 1.7 billion-KRW 29 million-KRW 2.4 billion. Yuhan Corp’s Yuhan N-flu and Chong Kun Dang’s Tamivir ranked third and fourth with sales of KRW 490 million to KRW 470 million through the third quarter of 2024, respectively. Comyflu (Kolon Pharmaceutical), Seltaflu (Vivozon Pharm), and Oseltawon Cap (Daewon Pharmaceutical) followed, with sales in the range of KRW 100-400 million in the same period, down sharply from the KRW 1.2-1.8 billion in 2023. Kuhnflu (Kuhnil Biophamr), Hanaflu Cap (Hana Pharm), and Shinpoong Flu (Shin Poong Pharm) have been generating sales between KRW 30 million and KRW 80 million until the third quarter of last year. Oseltamivir is taken twice a day for five days within two days of symptom onset, regardless of food intake. The treatment is available for newborns starting at 2 weeks of age, with a recommended dose of 3 mg per kg for children under 1 year of age. Prophylaxis is approved for persons 1 year of age and older and is taken once daily for 10 days at a dose as directed by a physician within 2 days of contact with an infected person. Common adverse reactions include nausea, vomiting, and headache (>10%); if a gastrointestinal disorder occurs, taking it with food could be helpful. Patients should not discontinue the medication at their discretion and should receive guidance to fully take the medication as prescribed. NSAIDs and acetaminophen do not affect the effectiveness of anti-influenza antivirals and may be taken together. However, aspirin should be avoided if a child is infected with influenza and has a fever. Aspirin can cause Reye's Syndrome, a condition that can cause severe vomiting, convulsions, acute encephalopathy, fatty degeneration, and death in children with the virus.
