- LOGIN
- MemberShip
- 2026-03-17 09:48:45
- Company
- Export of Celltrion/Samsung bioepis exceed ₩10trillion
- by Chon, Seung-Hyun Apr 03, 2022 04:18pm
- According to the Financial Supervisory Service on the 1st, four biosimilars, Celltrion Healthcare's Remsima, Truxima, Herzuma and Remsima SC, recorded a total of 1.5694 trillion won in exports last year. It fell 2.0% from 1.616 trillion won in 2020, but exceeded 1 trillion won for the third consecutive year from 2019. Celltrion Healthcare is an affiliate of Celltrion, and Celltrion Healthcare Holdings is the largest shareholder (24.3% stake). Celltrion Healthcare receives antibody biosimilar products from Celltrion and sells them to global retailers. Celltrion Healthcare sells four biosimilars, Remsima, Truxima, Herzuma and Remsima SC, in overseas markets. Remsima's original drug is Janssen's Remicade. Remsima SC is Remsima's injection formulation. Truxima and Herzuma are biosimilars from Mabthera and Herceptin, respectively. According to last year's export performance by item, Remsima recorded the largest export amount of 809.6 billion won. It recorded the highest export performance ever, up 31.1% from 617.4 billion won in 2020. Remsima SC exported 89.6 billion won last year, up 157.3% from the previous year. Remsima and Remsima SC collaborated on a total of 899.2 billion won in exports last year. Remsima is the first biosimilar product approved in 2012. Remsima recorded the largest export of Celltrion's biosimilars every year, with Truxima leading the way with 786.8 billion won in 2019. However, Remsima beat Truxima last year, re-establishing its lead in exports. Truxima's exports amounted to 459.1 billion won last year, down 41.6% from the previous year. The company explains that sales have decreased due to temporary supply schedule adjustments. Celltrion Healthcare started selling Truxima in the U.S. in 2020. At this time, Truxima's supply decreased relatively last year as U.S. sales partners supplied a large amount of Truxima's launch volume. It is analyzed that growth has slowed down somewhat as competition for biosimilars intensified. Truxima had a 25% prescription share of the U.S. market in the fourth quarter of last year. Truxima had a 34% share of the European market as of the third quarter of last year. Herzuma's exports amounted to 211 billion won last year, up 29.8% from the previous year. Herzuma took the lead in the Japanese market with a 51% share as of the third quarter of last year. However, the European market has slowed down recently. Herzuma had a 19% market share in Europe in the first quarter of 2020, but fell to 13% in the third quarter of last year. Celltrion Healthcare, which was listed on the KOSDAQ market in 2017, has listed its export performance in its business report since 2014. Remsima and Remsima SC recorded the largest export performance of 4.2742 trillion won since 2014. Truxima, which has had export performance since 2017, posted 2.1783 trillion won in cumulative exports, while Herzuma's cumulative exports amounted to 693.9 billion won. Celltrion Healthcare's export performance of four biosimilars recorded last year since 2014 totaled 7.16 trillion won. Samsung Bioepis has also set a new sales record every year since 2016. Samsung Bioepis posted 847 billion won in sales last year, up 9.0% from the previous year. It is the largest since the company was established in 2012. It has continued to grow recently, increasing 129.7% in three years from 368.7 billion won in 2018. Annual Celltrion Healthcare biosimilar exports (unit: 1 million won, data: Financial Supervisory Service) Most of Samsung Bioepis sales occur through overseas sales of its own biosimilar products. Samsung Bioepis succeeded in commercializing biosimilar products of six biopharmaceuticals, including Enbrel, Remicade, Herceptin, HUMIRA, Avastin, and Lucentis. In Europe, all six products have been licensed, and in the United States, five products have been approved for sale except Avastin. Since Samsung Bioepis recorded sales of 765.9 billion won in 2019, its growth rate was only 1.5 % the following year. In the early days of the COVID-19 crisis, the number of drug prescriptions decreased, resulting in a temporary market reduction. Quarterly performance fluctuated as pre-orders from hospitals and wholesalers in Europe occurred with the aim of securing inventory in preparation for the prolonged COVID-19. However, it recovered its growth last year due to the expansion of biosimilar sales in the U.S. and Europe. Samsung Bioepis' biosimilars are sold overseas by its partners Biogen and Organon. Biogen will sell three types of biosimilars for autoimmune disease treatments: Enbrel, Remicade, and Humira in Europe. Organon sells these three products in the rest of the world except Europe and South Korea. In the United States, only Remicade biosimilars are sold. Organon is also responsible for overseas sales of two types of biosimilars, Herceptin and Avastin. The company's five biosimilars recorded a total of $1.255.1 billion (about 1.5 trillion won) in overseas markets last year. It achieved its highest sales, up 11% from $1.125.8 billion in 2020. Sales of biosimilars sold by Biogen reached 831.1 million dollars last year, up 4% from the previous year. Organon sales rose 28% year-on-year to 424 million dollars. Founded in 2012, Samsung Bioepis generated 43.7 billion won in sales for the first time in 2013. In 2016, sales recorded 147.5 billion won as the overseas expansion of biosimilars began in earnest, and has continued to grow every year since then. Samsung Bioepis has recorded cumulative sales of 3.3649 trillion won since its launch in 2012. Most of Samsung Bioepis' sales come from overseas sales of biosimilars or profits from technology fees. Domestic sales are insignificant. According to IQVIA, a pharmaceutical research firm, Samsung Bioepis' sales of five biosimilars totaled only 13.2 billion won last year. Celltrion and Samsung Bioepis biosimilars have collaborated on exports of a total of more than 10 trillion won.
- Company
- MS anticancer drug Revlimid, RVD combined therapy benefits
- by Nho, Byung Chul Apr 03, 2022 04:13pm
- BMS Pharmaceutical Korea announced on the 30th that Revlimid (Renalidomide) will be subject to benefits when administered in combination with Bortezomib/Dexamethasone, which is used to treat multiple myeloma patients, from the 1st of next month. The law has proven its superior effectiveness and tolerance compared to current standard treatment through several clinical studies. Random allocation, public labeling, and phase 3 clinical trials (SWOG0777) in newly diagnosed patients with multiple myeloma confirmed significant progression-free survival and overall survival improvement compared to conventional RD (Revlimid+dexamethasone) therapy. The median progression-free survival period of the RVD therapy group was 41.7 months, 12 months longer than the 29.7 months of the RD therapy group, and the overall OS median was also statistically significantly improved from 69 months of the RD therapy group. The objective response rate was also significantly higher in the RVD therapy group (82.9%) than in the RD therapy group (72.5%), confirming its clinical usefulness. Even in newly diagnosed patients with polymyeloma with transplantation, RVD therapy showed a higher response rate and deeper response with treatment progress than the current standard therapy VTD (Vortezomib+Thalidomide+Dexamethasone). According to an integrated analysis of four phase 3 randomized control clinical trials, RVD studies (GEM2012, IFM2009) and VTD studies (GEM2005, IFM 2013-04), in comparison between GEM studies, RVD induction therapy confirmed a very good Partial Remission adverse response rate compared to VTD induction therapy. The response rate of very good partial response (VGPR) abnormalities gradually increased, showing 54.5% after three-cycle induction therapy and 70.1% after six-cycle induction therapy, which was significantly higher than VTD therapy throughout the treatment. The results of comparison between GEM studies also showed a higher response rate of VGPR abnormalities and a higher negative rate of Minimal Residual Disease (MRD) after transplantation with higher RVD therapy. As a result of the RVD study (GEM2012), the complete response at the end of induction therapy was similar to 34.8% in all patients (458 and 33.4%) and in the cytogenetic high-risk group (92), proving that it can be used regardless of whether it is a cytogenetic risk group. RVD therapy is already the most recommended treatment abroad. The U.S. National Cancer Network (NCCN) Guidelines, released in 2022, recommends RVD therapy as "preferred regimen, category 1", the highest recommended level in both cases that can or cannot be transplanted when treating multiple myeloma. ESMO guidelines also recommend it as the first choice of therapy (1st option) in all patients with multiple myeloma that can or cannot autologous hematopoietic stem cell transplantation. In addition, Revlimid is subject to health insurance benefits when administered in combination with Rituximab in the treatment of previously treated follicular lymphoma (grade 1-3a). Expectations have been high for the application of RVD therapy benefits in the medical field. With the application of this benefits, RVD therapy is expected to become a standard treatment for primary treatment of multiple myeloma. Kim Jin-young, CEO of BMS Pharmaceutical Korea, said, "We are glad that Revlimid's coverage of insurance benefits allows patients with multiple myeloma and follicular lymph nodes to enjoy advanced treatment benefits as soon as possible."
- Company
- Revlimid's reimb extended…maintenance therapy remains
- by Eo, Yun-Ho Apr 01, 2022 06:04am
- The reimbursement standards for ‘Revlimid’ in combination with Velcade, and dexamethasone (RVD) for multiple myeloma have been extended. However, reimbursement for the drug as a maintenance therapy still remains unaddressed. Starting on April 1st, BMS Korea’s Revlimid (lenalidomide) will receive insurance benefits as part of RVd (lenalidomide+bortezomib+ dexamethasone) therapy. The approval was made 6 months after the agenda passed the meeting of the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service in September last year. However, the maintenance therapy agenda that was deliberated on the same day still remains non-reimbursed. BMS had started the listing process in 2019, but no progress has been made as of yet. Revlimid had been presented for deliberation at the Cancer Disease Deliberation Committee meeting in September that gained attention due to its deliberation of the CAR-T therapy ‘Kymriah (tisagenlecleucel),’ to no avail. From the government’s perspective, there exist concerns on whether they should allocate NHI finances on drugs taken as a sort of ‘preventive measure’ after a patient’s condition has improved. In some parts, the government’s concerns may seem just. Revlimid maintenance therapy is used in patients post-autologous hematopoietic stem cell transplantation However, the agenda still deserves consideration. The progression-free survival of the patients that was demonstrated with the use of Revlimid maintenance therapy was 52.8 months, compared to the 23.5 months of the placebo group. This is a twofold difference. Based on the study data, patients who do not receive maintenance therapy after transplantation are required to start second-line therapy much faster. The three-drug combinations used as second-line with Revlimid such as Kyprolis, Empliciti, Ninlaro, and Daralex are relatively high priced. Therefore, delaying the time to relapse through the use of Revlimid as monotherapy may have the effect of delaying the use of the high-priced three-drug combo. In addition, Revlimid’s price has been discounted after its patent expiry, and the price will be further reduced if the reimbursement is extended to maintenance therapy. Hyeon-Seok Eom, Head of the Center for Hematologic Malignancy at the National Cancer Center Korea, said, “It goes without saying that maintenance therapy is important as it prolongs survival and improves the patients’ quality of life. We need to reduce the burden of treatment costs for our patients in Korea as soon as possible by expanding coverage of Revlimid as maintenance therapy in multiple myeloma as it is a well-established option that demonstrated its efficacy through a large-scale clinical trial.”
- Company
- Roche joins in competition for RET-targeted therapies
- by Apr 01, 2022 06:03am
- Following Lilly, Roche has also received approval for its RET targeted anticancer therapy. The entrance of two drugs in a similar period is expected to spark new competition in the RET-targeted therapy market. On the 29th, Roche received marketing authorization for ‘Gavreto (pralsetinib) from the Ministry of Food and Drug Safety. Its first indications are for non-small cell lung cancer and thyroid cancer. More specifically, Gavreto was approved for the treatment of adult patients with RET fusion-positive locally advanced or metastatic NSCLC, and adult patients with RET-mutated locally advanced or metastatic medullary thyroid cancer that require systemic therapy. Gavreto is the second RET-targeted therapy to be introduced to Korea following Retevmo. Retevmo (selpercatinib), which was developed by Lilly, received MFDS approval on the 11th. The two drugs have virtually landed at the same time in Korea. By indication, Retevmo’s indication is a bit broader. Compared to Gavreto, whose prescription was limited to adult patients, Retevmo may be used in patients over 12 years of age with medullary thyroid cancer. Also, Retevmo has an additional indication for RET fusion-positive thyroid cancer. The two drugs also show a difference in their form of administration. Retevmo is taken orally two times a day and may be taken with or without food as long as it is not co-administered with PPIs. If the drug needs to be taken with antacids such as PPI or H2 receptor antagonists, Retevmo should be taken after a certain period. On the other hand, Gavreto can be taken orally only once a day. However, food intake is prohibited 2 hours before administration and at least an hour after administration. In the LIBRETTO-001 that was the basis of Retevmo’s approval, the ORR of the Retevmo-treated group in patients with RET fusion-positive NSCLC without platinum-based treatment experience was 85%, and 79% showed a continued response. In patients with platinum-based treatment experience, the ORR was 64%, and the median DoR was 17.5 months. 10 of the 11 patients had shown objective CNS response for the brain metastasis that around half of the patients experience. Major adverse events included increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), increased blood sugar (glucose), decreased leukocytes, decreased albumin, and high blood pressure. In patients with medullary thyroid cancer, the treatment-naïve patients showed a response rate of 73%, and those with experience 69%. The response rate of Retevmo in RET fusion-positive thyroid cancer was 79%. In the ARROW trial, which became the basis of Gavreto’s approval, Gavreto showed an ORR of 70% in treatment-naïve NSCLC patients. Patients who have been previously treated with platinum-based chemotherapy and those who received systemic therapy showed a 58% response. In RET-mutated locally advanced or metastatic medullary thyroid cancer, treatment-naïve patients recorded a response rate of 71%, and those with experience 60%. The major adverse events reported included neutropenia, anemia, and high blood pressure. Until now, only chemotherapy was available as an option for cancer patients with RET gene mutations. The introduction of Retevmo and Gavreto in the area is expected to dramatically improve the treatment environment. The scope of application of the drug is also wide. Oncogenic RET gene mutation is found not just in non-small cell lung cancer and thyroid cancer, but also in colorectal cancer, breast cancer, and pancreatic cancer. With the two drugs entering in a similar timeframe, the companies are expected to race to occupy a larger share of the pie. Lilly, which first received approval, has been showing more progress. The company has applied for Retevmo’s reimbursement through the approval-reimbursement linkage system. Lilly is also conducting a Phase III trial on patients with early-stage NSCLC for the use of Retevmo as adjuvant therapy after curative treatment (surgery or radiotherapy).
- Company
- Sandoz, launched a muscle relaxation antagonist with Ilsung
- by Mar 31, 2022 04:27pm
- Sandoz Korea announced on the 29th that it signed an exclusive sales partnership with Ilsung on the 28th with muscle relaxation antagonist Sandoz Sugammedex Sodium. According to the agreement, the two companies will start supplying and selling Sandoz Sugamadex on the 13th of next month. The two companies expected that Ilsung's sales know-how, with its superior quality of Sandoz Sugarmadex Sodium, would create synergy. Sandoz Sugarmadex is a muscle relaxation antagonist that was approved by the MFDS in January. It exhibits a reversal effect of neuromuscular blocking induced by Rocuronium or Vecuronium, a systemic anesthetic ingredient. Sandoz carried out the entire production process in Europe, from raw materials to finished products of Sandoz Sugammedex Sodium. The goal is to provide cost-effective treatment options with differentiated quality. As of last year, sales of muscle relaxation antagonists in Sugammedex Sodium ingredients amounted to 46 billion won, an average growth rate of about 19% over the past five years from 2017. Ahn Hee-kyung, CEO of Sandoz Korea, said, "Starting with Sandoz Sugarmadex Sodium, we will build a solid position based on the differentiated quality of Sandoz Korea in the anesthetic field in the future."
- Company
- First-ever RET inhibitor 'Retevmo' attempts reimbursement
- by Eo, Yun-Ho Mar 31, 2022 05:58am
- The first RET-targeted anticancer therapy is attempting to receive insurance reimbursement in Korea. According to industry sources, Lilly Korea has recently submitted a reimbursement application for its ‘Retevmo (selpercatinib) that targets the RET (Rearranged during transfection)-gene fusions. After receiving approval from the Ministry of Food and Drug Safety through the fast track system, the company has been making progress through the approval-reimbursement linkage system. In 2020, Retevmo was approved as the first treatment option for cancer patients with RET gene alternations in the US after the FDA reviewed the drug through the Accelerated Approval and Priority Review pathway and granted the Breakthrough Therapy & Orphan Drug Designation. Retevmo is indicated for the treatment of:▲ adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); ▲adults and pediatric patients 12 years of age or older with advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; and ▲ adult patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or lenvatinib treatment, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy. Retevmo is expected to compete with Roche Korea’s ‘Gavreto (pralcetinib)’ in the future. Gavreto, which has the same mechanism of action as Retevmo, was approved in Korea on the 29th for the treatment of ▲ treat adult patients with RET fusion-positive locally advanced or metastatic NSCLC; and adult patients with RET-mutated locally advanced or metastatic medullary thyroid cancer that require systemic therapy. Professor Byoung Chul Cho of the Yonsei Cancer Hospital’s Lung Cancer Center said, “We had no choice but to conduct chemotherapy in cancer patients with RET gene mutations due to lack of other available treatment options. The approval of Retevmo will become a good alternative for patients who saw relatively low treatment effect from existing chemotherapies and had difficulties due to chemotoxicity.” Meanwhile, Retevmo demonstrated its efficacy through the LIBRETTO-001 trial that was conducted on 702 patients with advanced or metastatic solid cancer with RET mutations. Patients with RET fusion-positive NSCLC, RET-mutated medullary thyroid cancer, and RET fusion-positive thyroid cancer patients with or without prior treatment experience were enrolled in the LIBRETTO-001 trial. The primary endpoints of the trial were the objective response rate (ORR) and duration of response (DOR) as assessed by the independent review committee In patients with RET fusion-positive NSCLC without platinum-based treatment experience, the ORR in the Retevmo-treated group was 85%. Although the median DoR was not yet reached, 79% of the patients showed duration of response during the follow-up period (median 7.4 months). In patients with platinum-based treatment experience, the ORR was 64%, and the median DoR was 17.5 months.
- Company
- Kidney care is also important for diabetic patients
- by Eo, Yun-Ho Mar 30, 2022 06:09am
- SGLT-2 inhibitors, which have obtained indications for chronic kidney disease, are emerging as the mainstay of chronic disease management along with diabetes. According to data from the Korean Diabetes Association, the rate of kidney disease accompanied by type 2 diabetes patients in Korea was about 30%, and one in three diabetes patients in Korea had renal function abnormalities. Studies have also shown that diabetes (40%) is the most common cause of end-stage kidney disease. Diabetes patients have an average annual glomerular filtration rate (eGFR) decrease about twice as quickly as those without diabetes, and the 10-year neoplasia rate for diabetic patients is very low at 40%. Effectiveness of SGLT-2 inhibitors Forxiga, the first diabetic drug in the SGLT-2 inhibition mechanism to obtain an indication for chronic kidney disease, is also drawing attention from domestic medical staff. Forxiga confirmed the benefits of kidney disease in type 2 diabetic patients through a study of DECLARE-TIMI 58. In Forxiga of the DECLARE study, the secondary renal complex evaluation index (decreased by more than 40% eGFR, death from terminal kidney disease, kidney or cardiovascular disease) was 4.3% lower than placebo. The kidney subanalysis of the same clinical trial showed a continuous decrease in eGFR compared to placebo of less than 60 ml/min1.73 m2 by more than 40%, and a 47% reduction in the risk of death from terminal kidney disease or kidney disease. Forxiga confirmed benefits for patients with chronic kidney disease, regardless of diabetes. Jardiance is currently in the process of obtaining a kidney disease indication in the United States. This drug was confirmed to be effective through EMPA-KIDNEY research. The study will be discontinued early according to the recommendation of an independent data monitoring committee while meeting the criteria for positive efficacy. #Sb Society Guidelines also emphasize importance Several domestic and foreign societies first recommend SGLT-2 inhibitors to type 2 diabetes patients with chronic kidney disease in treatment guidelines, emphasizing the importance of integrated management of diabetes and kidney disease. The Korean Diabetes Association recommended that treatments including SGLT-2 inhibitors that have proven cardiovascular and kidney benefits should be considered first if albuminuria exists or the estimated glomerular filtration rate decreases in the 2021 Diabetes Care Guidelines. The American Diabetes Association recommended the use of SGLT-2 inhibitors that demonstrated benefits from heart failure or kidney disease in patients with heart failure or chronic kidney disease in the "2022 Diabetes Guidelines". The European Association for the Study of Diabetes and European Society of Cardiology also recommended SGLT-2 inhibitors as drugs to reduce the progression of diabetic nephropathy in the area of chronic kidney disease management in the "2019 Guidelines for Diabetes, Prediabetes and Cardiology". The KDIGO also recommended combination therapy with metformin and SGLT-2 inhibitors as the primary treatment along with lifestyle correction such as physical activity, diet, and weight loss in patients with chronic kidney disease with glomerular filtration rate of 30ml/min/1.73m2. Kim Dae Joong Professor of Endocrinology at Ajou University Hospital said, "In the long run, exposure to high blood sugar can cause glomerular damage, and proteinuria can occur from a relatively early stage in diabetic patients, so albumin excretion in urine should be measured annually. It is important to evaluate the glomerular filtration rate to determine the degree of abnormalities in new functions," he advised.
- Company
- Dupixent shows marked effect in Korean severe asthma patient
- by Mar 30, 2022 06:09am
- Study analysis results on Sanofi’s allergic disease treatment ‘Dupixent (dupilumab)’ have shown that the drug has a superior effect on severe asthma patients in Korea. Based on the sub-analysis results, Sanofi is pursuing a reimbursement extension for Dupixent in asthma in Korea. At the webinar on the ‘Present state of severe asthma treatment in Korea’ that was held by Sanofi on the 29th, Professor You-Sook Cho, Division of Allergy and Clinical Immunology at Asan Medical Center, disclosed the first-ever Korean sub-analysis data from the global Phase III QUEST trial on Dupixent that was conducted on asthma patients. The QUEST trial compared the efficacy and safety of Dupixent and placebo in 1,902 patients with moderate-to-severe type 2 asthma. Its primary efficacy endpoint was were annualized rate of severe exacerbation events during the 52-week study period and changes from baseline in pre-bronchodilator FEV1 which is commonly used to test liver functions. Of the enrolled patients, 74 were Korean, and most were severe asthma patients who have experienced severe asthma exacerbation twice. 사노피 듀피젠트 온라인 미디어 세미나 캡처 The Korean subanalysis results showed that annualized severe exacerbation rates were significantly reduced with Dupixent compared to placebo (0.259 vs 1.942). Also, in patients with baseline blood eosinophil count of ≥150 cells/μL and baseline FeNO ≥ 25 ppb, the severe exacerbation rates fell 94% and 92%, respectively, compared to placebo with the use of Dupixent. Cho said, “I could feel the reduction in asthma exacerbations in the field while treating patients with Dupxient for the trial” In terms of Pre-bronchodilator FEV1, the Dupixent-treated group showed significant improvement from week 2, the effects of which lasted during the treatment period. At week 12, the Dupixent-treated group showed a mean improvement of 560mL, and a significant improvement of up to 380mL compared to placebo at week 52. Cho said, “We obtained very encouraging results that Dupixent can maintain lung function through the FEV1 test. Usually, patients feel an improvement from 120mL, and therefore the 560 mL improvement in the Dupixent group is very significant.” The incidence of treatment-related adverse events and serious adverse events in the Korean sub-analysis was comparable in the Dupixent group and the placebo group. Comparing the Korean sub-analysis results with the total clinical trial results, Dupixent showed a higher effect on Koreans. Cho said, “Korean asthma patients had shown less symptom control than in Western countries before Dupxient, I believe that’s why Koreans were able to get a greater effect using a good drug. Study results showed a very significant effect in Korean patients with severe asthma, and even compared to the results of the entire study, the severity of asthma exacerbation rate and FEV1 were more significantly improved in Korean patients.” Cho added, “Before the introduction of new biologics, we could only prescribe steroids to severe asthma patients. After using Dupixent for 3 years, not only did I experience a reduction in the use of steroids in my patients, but their lung function had also improved, with less symptom exacerbation. However, it is a shame that we cannot easily prescribe the drug due to limited reimbursement standards,” Currently, Dupixent is not reimbursed for severe asthma. Cho said, “I wish we could use this strong and effective weapon, Dupixent, in a more broad range of patients.” Sanofi said, “We have applied for the reimbursement expansion in March last year, and will make our best efforts to bring good news to our patients in Korea."
- Company
- Daewoong’s ‘Fexclu’ speeds up overseas market penetration
- by Kim, Jin-Gu Mar 29, 2022 05:54am
- Daewoong Pharmaceutical is working to target the global market with ‘Fexclu tab (fexuprazan),’ its new drug for P-CAB gastroesophageal reflux disease (GERD).’ The company had signed 6 export agreements with 15 countries in North America, Latin America, China, and the Middle East, which amounts to ₩1.2 trillion. In the case of the Southeast Asian market, the company plans to export directly through its own local subsidiary. On the 28th, Daewoong Pharmaceutical announced that it has applied for the marketing authorization of Fexclu through its local subsidiaries in the Philippines, Indonesia, and Thailand. As its local corporation in Southeast Asia is classified as a subsidiary of Daewoong Pharmaceutical, their sales are expected to be counted as Daewoong Pharmaceutical's exports. Daewoong Pharmaceutical expects its exports for Fexclu to amount to ₩520 billion in the 3 Southeast Asian countries and will be applying for its authorization in other Southeast Asian countries soon. Analysts believe Fexclu’s penetration into the global market will accelerate with its entrance into the Southeast Asian market. Since 2020, Daewoong Pharmaceutical has signed a series of contracts with North America, Latin America, China, and the Middle East to export its Fexclu technology or its finished drug. According to Daewoong Pharmaceutical, the company has 6 Fexclu export agreements in place, which amounts to ₩1.2 trillion. In January 2020, it signed a contract with the Mexican company Moksha8 for the technology exports of its finished exports worth $44.42 million (about ₩54 billion), followed by a series of contracts worth $72.58 million (about ₩89 billion) with Brazil's EMS in August. In March last year, it signed a $339.55 million (about ₩420 billion) contract with China's Shanghai Haini Pharmaceutical and a $430 million (about ₩530 billion) technology export contract with the U.S. and Canada's Neurogastrx in June. Separate from the technology export, Daewoong Pharmaceutical was able to secure a 13.5% stake in Neurogastrx. In the same month, Daewoong Pharmaceutical had signed a contract to transfer the local licenses and sales rights in four countries, Colombia, Ecuador, Peru, and Chile to 'Pharma Consulting Group (BIOPAS)’ in South America. Its figure amounts to $29.26 million (₩36 billion). In October, it then signed a contract with ‘Aghras Healthcare Limited’ in the Middle East to supply Fexclu to Saudi Arabia, the United Arab Emirates, Kuwait, Bahrain, Oman, and Qatar for the next 10 years. The 10-year sales volume as expected by the two companies is $82.97 million (about ₩100 billion). Through the exports agreement, the company expects it can earn up to ₩1.2 trillion with the agreements signed in 15 countries in North America, Latin America, China, and the Middle East. Seng-Ho Jeon, CEO of Daewoong Pharmaceutical, said, "We will submit an application for the marketing authorization of our product to another overseas country within this year. We will make efforts to accelerate Fexclu's entry into the global market in earnest." Fexclu is Daewoong Pharmaceutical’s new drug for P-CAB gastroesophageal reflux disease (GERD)’ that reversibly blocks the proton pump that secretes gastric acid from the stomach wall.
- Company
- Wakix, a narcolepsy tx, can be prescribed at hospitals
- by Eo, Yun-Ho Mar 29, 2022 05:53am
- Wakix, a narcolepsy treatment, can be prescribed at general hospitals. According to related industries, Mitsubishi Tanabe Pharma's Wakix passed the Drug Committee of Seoul National University Hospital and other medical institutions. Wakix has been competing with Handok Teva's Nuvigil since last month as insurance benefits have been available. This drug is a new mechanism for increasing histamine concentration in the brain as a counteractive and antagonist that selectively binds to histamine H3 receptors. Nuvigil, an active isomer of sleep seizure treatment Provigil, is a drug that promotes awakening by activating dopamine in the brain and improves the duration of existing drugs. Hypnosis, a rare and intractable disease, has limited treatment options in Korea. In the United States and Europe, Modafinil, Sodium oxybate, Solriamfetol, and Pitolisant are used as narcolepsy treatments, but only Modafinil and isomeric Armodafinil are licensed in Korea. Narcolepsy is a sleep disorder disease characterized by confusion in the sleep awakening cycle and abnormal expression of REM sleep due to the loss of neurons that produce a neurotransmitter called Hypocretin in the brain. Symptoms include EDS (Excessive Daytime Sleepiness) and cataplexy, where REM sleep is expressed in awakening. Cataplexy is known to occur in 70% of narcolepsy patients. Wakix is the first drug approved in Korea to prove its clinical efficacy and safety. Wakix, a new drug developed by French pharmaceutical company Bioprojet Pharma, has been prescribed to narcolepsy patients in European countries such as the UK, France, and Germany since it was first approved as a rare drug by the EMA in March 2016. In August 2019, it was approved by the FDA.
