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- 2025-12-25 08:27:05
- Company
- Sales of AZ COVID vaccine increased 32% to 655.3 billion won
- by Apr 06, 2022 06:05am
- AstraZeneca Korea surpassed 600 billion won in sales last year by supplying the COVID-19 vaccine. According to an audit report by AstraZeneca Korea, the company recorded 655.3 billion won in sales last year. The figure is up 31.6 percent from the previous year's 498.1 billion won. Operating profit was 26 billion won, up 7.5% from 24.2 billion won a year earlier. It is analyzed that the increase in operating profit was relatively small because there was little difference between the purchase amount and domestic sales amount purchased globally. AstraZeneca Korea, which has improved its performance with anticancer drug Tagrisso, saw its performance jump significantly last year when it supplied the COVID-19 vaccine AZD1222 in Korea. After gradually increasing sales to 383.1 billion won in 2018, 438.9 billion won in 2019, and 498.1 billion won in 2020, sales jumped more than 100 billion won last year when the COVID-19 vaccine was introduced in earnest. AstraZeneca started researching vaccines with a research team at Oxford University in the UK as COVID-19 spread around the world. In particular, it received attention by signing a contract with SK Bioscience, a Korean company, to produce the COVID-19 vaccine on consignment. Last year, SK Bioscience commissioned the production of AstraZeneca vaccine extract and the complement and supplied them to the global and domestic markets. The Korean government signed a purchase contract with AstraZeneca early last year and introduced the vaccine in earnest. At the beginning of the inoculation, when the supply and demand of the Pfizer vaccine were not smooth, AstraZeneca supplied most of the supplies. Although it received the EUA around the same time as Pfizer, the increase in AstraZeneca sales is relatively small. In the case of Pfizer Pharmaceutical Korea, which supplied the COVID-19 vaccine, sales reached a record high of 1.69 trillion won last year. The figure increased by 332.3% from 391.9 billion won in the previous year. Pfizer Pharmaceutical Korea generated about 1.3 trillion won worth of vaccine sales. The difference in vaccine supply had a significant impact on the performance of the two companies. This is because the use of the Astrazeneca vaccine has gradually declined as the number of vaccinations in Korea has been limited due to rare side effects, and the volume of modern and Pfizer vaccines has increased. According to the Korea Centers for Disease Control and Prevention, the total amount of Astrazeneca vaccinations over the first to third rounds is 20.32 million doses, which is one-third of Pfizer's 74.23 million doses. In the first inoculation, about 25% of the total were vaccinated against Astrazeneca, but in the third inoculation, only 4% were vaccinated against Astrazeneca. Vaccine prices have also led to differences in sales. According to the company's stance that it will not make profits from the COVID-19 vaccine, the price of the AstraZeneca vaccine was set at $4 per dose, the cheapest. It is only one-sixth the price of a Pfizer vaccine ($24).
- Company
- Sales of MSD in Korea exceeded 500 billion won
- by Apr 05, 2022 09:32am
- MSD Korea surpassed 500 billion won in sales last year. Keytruda's effect increased 1% year-on-year. Analysts say that it will be able to quickly recover its past sales of 800 billion won before Organon's spin-off. According to MSD audit report, the company recorded 541.9 billion won in sales last year. The figure is up 11.8% from the previous year's 486.8 billion won. During the same period, operating profit shifted from a deficit of 5.8 billion won to a surplus of 58 billion won. Sales of Keytruda, an immuno-cancer drug of MSD Korea, are evaluated to have been good. Keytruda's sales were not specified, but according to pharmaceutical research firm IQVIA, Keytruda surpassed 200 billion won in annual sales for the first time last year. The figure rose 28.5% to 2.1 billion won from the previous year's 155.7 billion won. The growth of Gardasil 9 and others also contributed to the expansion of sales. Based on IQVIA, Gardasil 9 recorded 72.6 billion won last year, up 70.9% from 42.5 billion won a year earlier. Another representative item of MSD Korea, the Januvia, reached 171 billion won in outpatient prescriptions last year. The expansion of MSD's performance is expected to continue in the future. This is because Keytruda's indication continues to expand, and from this year, it will be paid in the primary treatment of non-small cell lung cancer and the secondary treatment of Hodgkin's lymphoma. In fact, even when it was first listed in August 2017, Keytruda's sales rose vertically from 10 billion won to 100 billion won. At this rate, it is expected that the scale before the organon spin-off will be restored within a few years. According to an audit report by MSD Korea two years ago, when the obligation to disclose audit reports of limited companies was implemented, the sales of all companies of Organon spin off are estimated to be about 800 billion won. In the calculation of discontinued business profit and loss due to the division, the sales of organon products in the sales of organon products amounted to 326.8 billion won as of 2019. As of 2019, product sales of MSD accounted for 98% of total sales, and product sales are total sales. At that time, MSD's total sales amounted to 471.6 billion won. Operating profit turned into a surplus last year as other sales increased and management costs due to spin-off decreased. MSD Korea lost 18.4 billion won in 2019 and 5.8 billion won in 2020. Last year, other sales rose 42.8% year-on-year to 15.8 billion won, while sales and administrative costs fell 2.9% to 97.2 billion won. MSD Korea said, "Representative items such as Keytruda, Gardasil 9, and Januvia have driven sales growth, and we invested about 74.6 billion won in clinical research last year, up 33% from the previous year, which accounts for 13% of total sales."
- Company
- Imbruvica fails CDDC twice and reattempts 1st-line reimb.
- by Eo, Yun-Ho Apr 05, 2022 05:59am
- Once again, the blood cancer drug ‘Imbruvica’ is attempting to expand reimbursement to first-line treatment. According to industry sources, Janssen Korea has applied for the reimbursement extension of its Imbruvica (ibrutinib) as a first-line treatment for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL) to once again attempt at deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee. Imbruvica’s first-line indication was unable to pass deliberation by the CDDC twice, one of which was held in October last year. The company was able to receive reimbursement extensions to the second line after being listed through the PE exemption pathway but is having trouble extending its indication further into the first line. Therefore, how Janssen will progress discussions on reimbursement based on what adjustments remain to be seen. Imbruvica is a first-in-class oral Bruton's Tyrosine Kinase (BTK) inhibitor that is taken once daily. With its oral formulation, the drug has the strength of being able to be administered in the outpatient setting. Since it was approved in April 2018, the drug is being used as ▲ a second-line treatment for adult patients with CLL, ▲monotherapy for the treatment of adult patients over the age of 65 with previously untreated CLL, ▲in combination with obinutuzumab for the treatment of adult CLL patients over the age of 65 or those who have comorbidities or at high-risk and those under the age of 65 with previously untreated CLL. Meanwhile, CLL is a type of blood cancer that occurs mainly in adults over the age of 60, characterized by increased production of mature but dysfunctional B lymphocytes Around 120 to 130 patients are newly diagnosed with CLL every year, and 60-70% of the CLL patients in Korea are discovered in a state that does not require treatment. Like its name, this “chronic” condition progresses slowly, sometimes insignificantly for several years.
- Company
- AZ starts next-gen ADC dev with confidence from Enhertu
- by Apr 04, 2022 06:07am
- AstraZeneca is leading the next-generation ADC development environment. The company, which has successfully commercialized ‘Enhertu’ in partnership with Daiichi Sankyo, is targeting areas slow in development such as triple-negative breast cancer. On the 31st, AstraZeneca received approval for its Phase III trial of a new ADC drug last month. The new ADC drug subject to the trial is ‘datopotamab deruxtecan (DS-1062, hereafter datopotamab),’ a TROP2 targeting ADC that is being co-developed by AstraZeneca and Daiichi Sankyo. The Phase III trial for datopotamab will be conducted on patients with unresectable locally advanced or metastatic triple-negative breast cancer. The trial will evaluate the drug’s efficacy as a first-line treatment in patients who are not eligible for treatment using PD-(L)1 immunotherapies in comparison to chemotherapy. MoA of datopotamab(Source: Daiichi Sankyo) ADC is a next-generation drug that is produced by coupling a potent cytotoxic agent to a monoclonal antibody that binds to a specific antigen on the surface of a tumor cell. It minimizes the side effects while increasing the treatment effect by selectively working on cancer cells. Although ‘Kadcyla’ marked the start of the commercialization of ADC drugs, the drugs were unable to make significant performance in the earlier stages due to technical limitations. Since then, the development of next-generation ADCs, such as linkers that control the drug-antibody ratio (DAR) or enhance blood stability, is being developed in earnest. AstraZeneca already has experience commercializing an HER-2 targeted ADC, ‘Enhertu’ after signing a joint development agreement with Daiichi Sankyo. Enhertu had demonstrated superior efficacy over the early-generation ADC drug ‘Kadcyla’ as a second-line treatment in HER2-positive breast cancer. According to results from the DESTINY-Breast03 that was presented last year, Enhertu reduced the risk of disease progression and deaths by 72% compared to Kadcyla in the head-to-head trial. Also, the objective response rate (ORR) was significantly higher, 80% in the Enhertu group as compared to 34% in the Kadcyla group. The new ADC therapy that will be presented by AstraZeneca will target the field of triple-negative breast cancer that has poor prognosis. In the Phase I trial, datopotamab showed positive results with an ORR of 43% and DCR of 95%. If significant results continue on in the follow-up trials, AstraZeneca’s new ADC will likely compete with Gilead’s ADC therapy. Like datopotamab, Gilead’s ADC drug ‘Trodelvy’ also targets TROP2. Trodelvy was approved by the US FDA as a treatment for triple-negative breast cancer last April. AstraZeneca paid Daiichi Sankyo $1 billion (₩1.22 trillion) in upfront payment for the development rights of datopotamab. AstraZeneca will pay additional conditional amounts up to $6 billion according to the company’s achievement of development and commercialization milestones. In the past, AstraZeneca had signed a $6.9 billion (₩8.41 trillion) agreement with Daiichi Sankyo for the development rights of Enhertu. The company is also investigating using datopotamab in combination with its immunotherapy ‘Imfinzi’ in addition to another trial that assesses the effect of datopotamab in NSCLC. In addition to the ADC technology the company had bought from other companies, AstraZeneca is also developing a next-generation ADC using its linker technology, 'AZD8205.’ 'AZD8205 is a new drug candidate that targets overexpression of B7-H4 found in various solid cancers. The company plans to first disclose study results for AZD8205 at the ‘AACR 2022’ that will be held from the 8th.
- Company
- Keytruda, the primary treatment for esophageal cancer
- by Apr 04, 2022 06:07am
- Keytruda, an immuno-cancer drug of MSD, has become the primary option in esophageal cancer, where treatments have been limited. The medical team predicted that an immuno-cancer drug-oriented treatment strategy using Keytruda or Opdivo will be established depending on the PD-L1 expression rate. At a seminar to commemorate the expansion of Keytruda indications held online by MSD Korea on the 31st, Sun Jong-moo, a professor of hematological oncology at Samsung Medical Center, pointed out the meaning of the launch of Keytruda in esophageal cancer. He said, "As immuno-cancer drugs appear in esophageal cancer, treatment strategies are changing in the direction of considering using immuno-cancer drugs from the earliest stage possible depending on the PD-L1 expression rate of patients." Professor Sun Jong-moo of the Dept. of Hematology at SMC, who is presenting at the MSD Online Seminar in KoreaOn the 7th, the MFDS expanded indications for Keytruda in combination with chemotherapy in metastatic esophageal cancer and gastroesophageal junction cancer, which cannot be operated. Keytruda is the first immuno-cancer drug to be released in the primary treatment. Keytruda targets patients with positive PD-L1 expression. Esophageal cancer is largely divided into squamous epithelial cell cancer and adenocarcinoma, of which squamous epithelial cell cancer accounts for 90%. According to Professor Sun, esophageal cancer is considered a very difficult cancer, and if surgery is impossible, it should be treated with chemotherapy. However, when chemotherapy is used, mOS is only about 10 months. Although treatments have developed dramatically in various cancers over the past decade, esophageal cancer has continued for nearly 40 years. Keytruda significantly improved the therapeutic effect through a study on KEYNOTE-590, a licensed clinical trial. The mOS of Keytruda+anti-cancer chemotherapy group was 13.5 months, which was significantly longer than the control group (anti-cancer chemotherapy alone) of 5.5 months. Keytruda reduced the risk of death by 38%. mPFS also reduced the risk of disease progression or death by 49% compared to 5.5 months in the control group to 7.5 months in the Keytruda group. Keytruda previously put forward a distinctly different strategy from BMS's immuno-cancer drug Opdivo, which entered esophageal cancer. Opdivo can be used regardless of the PD-L1 expression rate, but can be used as a secondary treatment in patients who first used chemotherapy. Conversely, Keytruda was limited to PD-L1 positive patients, but acquired the status of primary treatment. Professor Sun said, "The current treatment that can be used in the primary esophageal cancer is a drug that has been used since the early 80s, and the demand for unmet was high." Professor Sun said, "Now that immuno-cancer drugs can be used in the first round, the treatment effect is expected to increase significantly," adding, "Medical staff also experienced that adding immuno-cancer drugs to chemotherapy does not significantly increase side effects, and the experience has been proven by clinical data."
- 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."
