- LOGIN
- MemberShip
- 2026-05-07 16:19:10
- Company
- Mylotarg can be prescribed at general hospitals
- by Eo, Yun-Ho Jan 09, 2023 06:11am
- Mylotarg, a new drug for acute myelogenous leukemia, can be prescribed at general hospitals. According to related industries, Mylotarg, Pfizer's Acute myeloid leukemia (AML) treatment, passed the Drug Commission (DC) of medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Sinchon Severance Hospital. Mylotarg can be used in the primary treatment of adult AML patients who are CD33 positive, and newly diagnosed with Antibody-Drug Conjugate (ADC). Mylotarg has not yet been applied to insurance benefits. The drug was introduced to the HIRA in May last year, but it was judged that the benefit standard was not set. Mylotarg, approved in Korea in December 2021, is an ADC composed of CD33 target monoclonal antibodies and a cytotoxic drug Calicheamicin, which acts on cells expressing CD33 antigens that appear in 90% of all AML patients. This blocks cancer cell growth and induces apoptosis. The Mylotarg permit was based on a clinical study conducted on 271 newly diagnosed AML patients with no treatment experience before the age 50 to 70. The clinical trial was ALFA-0701 clinical trial, which was conducted with open-label, random assignment, and multi-organ phase 3. The existing chemotherapy, Downorubicin or Citarabin combination therapy, Mylotarg, Daunorubicin, and Cytarabine combination therapy were compared and evaluated. As a result, the Mylotarg+Daunorubicin+Cytarabine combination group showed an effect of extending about 7.8 months compared to 9.5 months of the Event-free survival median value of 17.3 months. The risk of induction failure, recurrence, or death was reduced by about 44%. The median value of Relapse-free survival was 28.0 months in the Mylotarg+Daunorubicin+Cytarabine bottle administration group and 11.4 months in the Daunorubicin+Cytarabine combination administration group, showing a significant difference of about 16.6 months. In the case of the median value of Overall survival, there was no statistically significant difference between the Mylotarg+Daunorubicin+Cytarabine combination administration group for 27.5 months and the Daunorubicin+Cytarabine combination administration group for 21.8 months.
- Company
- Reinforced drug regulations change generic drug approvals
- by Chon, Seung-Hyun Jan 09, 2023 06:10am
- The number of generic drugs approved per every bioequivalence test fell greatly. Affected by the reform made in Korea's drug pricing policy, the proportion of generic drugs approved per bioequivalence test dropped significantly. According to the Food & Drug Statistical Year Book published by the Ministry of Food and Drug Safety on the 6th, 648 items were approved after being recognized as bioequivalent to their alternative in 2021. This was a 58.8% decrease from the 1,573 approved in 2020. Compared to the 2,358 in 2019, this was a 72.5% decrease in 2 years. Drugs recognized as bioequivalent are products recognized as being equivalent to their original drug, and are mostly granted for newly approved generic drugs. No. of bioequivalent items (left) and No. of items approved per bioequivalence test (right) (Unit: items, Data: MFDS) The drastic reduction in the number of bioequivalent drugs in 2021 is considered to have been directly influenced by the reform of the drug pricing system. The main change that had been made with the reform of the drug pricing system that had been implemented in July 2020 was that only generic drugs that meet both requirements – those that directly perform bioequivalence tests and those that use registered APIs – are allowed to maintain a price level that is at 53.55% of the original drug price prior to patent expiry. The reformed system also contained a stepped drug pricing system that lowers the price ceiling of drugs by order of listing and reducing the price of those that are listed later. If 20 or more generic drugs are listed for a certain ingredient, the price ceiling set for the newly listed drugs afterward is set at 85% of the existing lowest price. As companies cannot receive a high drug price without directly performing bioequivalence tests, this reduced the companies’ attempts to receive approval for generic drugs after consigning the whole manufacturing process. Therefore, the number of generic drugs approved per bioequivalence tests has been reduced greatly. Among the 648 bioequivalent drug items approved in 2021, 75 performed a direct bioequivalence test. This roughly translates to 8.6 generics being approved for each test. In 2019 and 2020, the number has been 29 and 9.4 drugs per bioequivalent test each. The proportion of consigned generics among bioequivalent drug items reached 96.6% in 2019 but was reduced to 88.4% by 2021. By year, the number of bioequivalent drug items increased exceptionally in 2019 and 2020. The number, which had been 625 and 789, suddenly rose threefold in just a year to 2,358 in 2019. This explosive increase is analyzed to be caused by the government's move to tighten regulations on generic drugs. A total of 175 valsartan-containing hypertension drugs were suspended sales due to excess detection of impurities. At the time, the Ministry of Health and Welfare and the Ministry of Food and Drug Safety prepared measures to inhibit the flooding of generic drugs by organizing a ‘Consultative Body to Improve the Generic Drug System.’ In response to the government’s move to reinforce regulations, pharmaceutical companies have worked to receive approval for their generic drugs in advance, which greatly increased the number of generic approvals for a short period of time. In other words, the government’s work to reinforce regulations had caused an increase in generic approvals, and the level only returned to the previous level after the system reform. As the regulations for the approval of generics have also been strengthened, the proportion of approved consigned generics is expected to be further reduced. According to the amended Pharmaceutical Affairs Act, which took effect in July last year, the number of consigned generics that can be approved for each bioequivalence test has been limited to a maximum of three. Therefore, the proportion of consigned generics among generic approvals will not be able to exceed 75%.
- Company
- Sanofi consumer healthcare appoints Chung Kyung-hee as CEO
- by Eo, Yun-Ho Jan 09, 2023 06:10am
- Sanofi's Korean subsidiary Consumer Healthcare (Sanofi CHC) division announced on the 5th that it had appointed Chung Kyung-hee as its new CEO. Chung Kyung-hee, the new CEO, has been intensively building his capabilities in various global companies' marketing and digital fields over the past 26 years. From 2020 to May last year, he served as CEO of Pierre Fabre Dermocosmetics Korea, leading in-house cultural innovation to improve the group's overall performance and organizational efficiency. From 2015 to 2020, he led the successful sales growth of major brands such as Aveda, Clinique, and Lab series as a brand general at ELCA Korea. "Based on our past experience, we will do our best to bring out the potential and balanced growth of the CHC division," said new CEO Chung Kyung-hee.
- Company
- Diabetes combination benefits
- by Nho, Byung Chul Jan 06, 2023 05:57am
- SGLT-2 inhibitory diabetes medication (from left to right, Forxiga, Jardiance, Xigduo, Jardiance Duo)As health authorities officially announced the suspension of financial impact analysis on drugs subject to expanding the scope of use, discussions on expanding the benefit standard for diabetes solvents are likely to be postponed up to three years later. According to the industry, the HIRA recently stopped evaluating financial impact analysis reports submitted by individual pharmaceutical companies based on a request to temporarily suspend economic impact analysis on drugs subject to the expansion of the scope of use of insurance drugs by the Ministry of Health and Welfare. The plan to expand the salary standard has a structure in which the HIRA Drug Standards Department listens to related academic societies and internal opinions and confirms the contents. After that, the Ministry of Drug Safety and Standards reports this to the Ministry of Health and Welfare, and the Ministry of Health and Welfare will review whether to lower the drug price based on additional financial needs to the HIRA drug price calculation government. However, the expansion of the standard for diabetes solvents has been conducted by first requesting opinions from pharmaceutical companies and self-reviewing them over the past year, and notified of the request to temporarily revise the financial impact analysis review in mid-December 2022. The industry is taking this as an exception because a financial impact review is an essential administrative requirement for drugs that expand their salary standards. This is because some pharmaceutical companies' confirmation of the HIRA has been set to proceed with the voluntary cut conducted in November, not the financial impact analysis. The future outlook following the aftermath cannot rule out the possibility that the expansion of the combined benefit standard will go to a zero source base if sufficient financial savings due to voluntary cuts are not reflected. In addition, there seems to be room to review the combined benefits once again from 2025 when SGLT-2 and DPP-4 diabetes treatment generic enter in earnest. Considering that the additional finances required for this combined benefit are a banding width of 30 to 50 billion won, the most efficient way to realize this without any separate financial requirements may be to voluntarily cut 5% of the existing drug costs, mainly from the original company. It is not easy to enforce such a method in the face of the patent of the original diabetes treatment, and it is believed that few foreign subsidiaries have submitted such doctors to the Ministry of Health and Welfare so far. Therefore, it is analyzed that the health authorities are more likely to use the compensated amount by waiting for the expiration of the original drug patent within one to three years rather than spending additional finances to expand the combined benefits of diabetes drugs. If the original drug price is reduced by 30% due to ex officio adjustment, the budget will be reduced by about 30 billion to 50 billion, which is interpreted as an intention to turn it into a share of combined benefits. The expansion of salary standards for the combination of diabetes treatment SGLT-2 inhibitor drugs and DPP-4 inhibitor drugs was expected to be applied by the end of this year as it was discussed in 2022 after the diabetes association requested it to the health authorities in 2016. Since then, the HIRA has conducted a financial impact analysis in June by reviewing the pay standards for three-drug therapy such as metformin+SGLT-2+DPP-4, metformin+SGLT-2+TZD, and SGLT-2+sulfonylurea or insulin combination therapy.
- Company
- Rare RCC drug Welireg may be commercialized in Korea this yr
- by Eo, Yun-Ho Jan 06, 2023 05:57am
- The new rare anticancer drug ‘Welireg’ is expected to be commercialized in Korea within the year. According to industry sources, the Ministry of Food and Drug Safety is currently reviewing approval of MSD Korea’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, ‘Welireg (belzutifan).’ The drug had been designated as an orphan drug in January last year for the treatment of Von Hippel-Lindau disease, and the company applied to receive approval for the indication the same year. In the US, the drug was granted priority review in 2021 and approved. The indication the company applied for in Korea is also for the treatment of adult patients with VHL disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET) that do not require immediate surgery. As a HIF-2α inhibitor, Welireg reduces transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis, and tumor growth. The drug’s efficacy was demonstrated through the open-label Study 004 trial which investigated 61 patients with VHL-associated RCC that were diagnosed with at least one measurable solid tumor localized to the kidney. Patients enrolled in the trial had other VHL-associated tumors including CNS hemangioblastomas and pNET. The major efficacy endpoint of the clinical trial was the overall response rate (ORR) in patients with VHL-associated RCC as measured by radiology assessment using RECIST v1.1 as assessed by an independent review committee (IRC). Additional efficacy endpoints included duration of response (DoR) and time to response (TTR). In the study, Welireg showed an ORR of 49% in patients with VHL-associated RCC. All responses were partial responses. The median DoR had not yet been reached, and the DoR among responders that were still responding after at least 12 months was 56%. Median TTR was 8 months. In patients with VHL-associated CNS hemangioblastomas, Welireg showed an ORR of 63%, with a complete response rate of 4% and a partial response rate of 58%.
- Company
- “I strongly recommend Retevmo as first-line treatment”
- by Jan 06, 2023 05:57am
- Reimbursement listing for Lilly’s ‘Retevmo(selpercatinib),’ which opened a new door to treating RET-targeted mutations, is gaining momentum in Korea. If approved for reimbursement, the scope of treatment for patients with RET mutations is expected to broaden significantly. In November this year, the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service set the reimbursement standards for Retevmo in non-small cell lung cancer (NSCLC) and thyroid cancer and is up for deliberation by the Drug Reimbursement Evaluation Committee (DREC). As HIRA announced it will reduce the reimbursement listing period by 30 days for drugs that treat life-threatening diseases like Retevmo, discussion on the drug’s reimbursement is expected to speed up further. Retevmo is the first targeted therapy that targets the RET mutation. The RET gene is in charge of the formation of normal organs as well as the maintenance of various tissues including neural, neuroendocrine, hematopoietic, and male reproductive cells. However, the abnormal activation of RET due to mutations in the RET gene, such as fusion or point mutation causes malignant tumors. The mutation is mostly found in NSCLC, thyroid cancer, and medullary thyroid cancer. In NSCLC, RET mutation occurs in 2 to 6 % of all cases. The drug is already being used actively in the field in Japan, where Retevmo was approved earlier and is being reimbursed. Dailypharm interviewed Professor Kaname Nosaki of the National Cancer Center Japan (Department of Thoracic Oncology) to seek insight into Japan’s treatment experience with Retevmo in RET fusion-positive NSCLC. Professor Kaname Nosaki, National Cancer Center Japan In the interview, Professor Nosaki stressed the need for Retevmo in patients with RET fusion-positive NSCLC. Prior to its introduction, patients had no other option but to use chemotherapy, which has high toxicity. Professor Nosaki said, “With no other targeted therapy available before Retevmo, patients who were identified with RET mutations had no other option but to receive chemotherapy. As expected, due to poor treatment prognosis and low rate of survival, a strong unmet need existed in the field. Retevmo is very necessary for these patients as it has demonstrated excellent clinical efficacy, duration in effect, and excellent safety.” The Japan Lung Cancer Society updated its clinical practice guidelines to strongly recommend the use of Retevmo in patients with RET fusion-positive NSCLC who have no prior treatment experience. The recommendation is based on the LIBRETTO-001 trial that was conducted on 702 patients with advanced or metastatic solid cancer with RET mutations. The objective response rate (ORR) of Retevmo was 85% in patients with no prior chemotherapy experience. Also, 79% of the Retevmo patients showed continued response during the follow-up period (median 7.4 months). The ORR was slightly lower in patients with previous treatment experience but was still 64%. The median duration of response (DoR) was 17.5 months. Professor Nosaki said, “The overall survival (OS) is yet to be reached in the Retevmo trial. We need to continue monitoring the data, but we are positive about the results as the 2-year survival rate of enrolled patients is near 70%. When the OS has not been reached, we evaluate results based on progression-free survival (PFS) or duration of response (DoR), and Retevmo showed good results in the criteria with an mPFS of 18.4 months and DoR of 20.4 months. He emphasized that the use of Retevmo in the first line should be considered after identifying RET mutations in the initial stages of diagnosis in patients with NSCLC. Due to differences in the diagnostic environment, the less common RET mutations are identified relatively later than other mutations. In other words, patients are first searched for major mutations such as EGFR·ALK·ROS1, and those without these mutations are prescribed cancer immunotherapies and then identified for minor mutations. Therefore, patients found with RET mutations at this time may only use Retevmo in the second line. On this, Professor Nosaki said, “Patients with a certain mutation may not respond well to immunotherapies, therefore, treatment sequence is all the more important in these patients. Unexpected toxicity problems may occur when using cancer immunotherapies first then using TKIs, which may lead to pneumonia or liver function deterioration.” He added, “Therefore, if available, it is more appropriate to use the targeted therapy first. Doctors should quickly identify major and minor mutations with next-generation sequencing (NGS) from the early stage of diagnosis to allow patients to be treated with good drugs early on."
- Company
- 2 CGRP Migraine New Drugs
- by Eo, Yun-Ho Jan 06, 2023 05:57am
- Teva-Handok's Calcitoninene-related peptide (CGRP) targeted migraine treatment Ajovy has been covered by insurance benefits since January, and it will fight for prescription leadership with Emgality of Lily Korea, which was listed in September last year. The two drugs are in the same family, but there are differences in usage dosage, so choices are being made according to the characteristics of patients with severe migraines. Emgality is a method of administering 240 mg (two consecutive subcutaneous injections of 120 mg each) once, and subcutaneous injections of 120 mg once a month after that. In the case of Ajovy, 225 mg once a month or 675 mg (3 consecutive 225 mg) once every three months is used by subcutaneous injection. The domestic migraine treatment market is smaller than that of patients. The annual prescription amount of Tryptane-based drugs remains at 15.5 billion won as of 2020. However, the prevalence of migraines in Korea is not small at around 6%. According to the 2020 HIRA statistics, 550,000 patients have been treated for migraine headaches, but it is estimated that about 2 million patients have not visited the hospital. As Ajovy and Emgality have been registered as salaries, the market size is expected to expand in the future. Much of the prescription environment has already been created. Currently, Emgality can be prescribed at Big 5 general hospitals such as Seoul National University Hospital and Sinchon Severance Hospital, as well as medical institutions nationwide such as Gangbuk Samsung Hospital, Dongtan Sacred Heart Hospital, and Nowon Eulji University Hospital. Ajovy is also settled in general hospitals such as Asan Medical Center in Seoul and Severance Hospital in Sinchon. Both drugs are carrying out promotional activities through partnerships with domestic pharmaceutical companies. Teva-Handok has signed a joint sales contract with Chong Kun Dang and Lilly with SK Chemicals.
- Company
- Phase 1 of HLB Apixaban was approved
- by Lee, Seok-Jun Jan 06, 2023 05:56am
- HLB Pharmaceutical has received approval from the Ministry of Food and Drug Safety for phase 1 in Korea, which develops the oral thrombosis treatment Eliquis in the form of a long-term continuous injection (HLBP-024). According to the company on the 4th, HLBP-024 is a treatment developed independently based on HLB Pharmaceutical's long-term continuous injection platform (SMEBR). The company expects that it will be possible to develop various pipelines applying uniform particulate manufacturing technology in the future. The company has already succeeded in transferring long-term continuous injection technology for obesity treatment to the platform. This clinical trial is the first clinical trial in Korea to be applied with SMEBR developed by HLB Pharmaceutical in 2019. Safety and pharmacokinetic characteristics are compared after the administration of HLBP-024 and Eliquis to healthy subjects, respectively. Here, the effect and safety of inhibiting blood coagulation are investigated. Equis is a blockbuster drug (3rd in global sales) that sold about 20 trillion won last year. However, the hassle of taking it twice a day, gastrointestinal bleeding, which is a representative side effect of oral thrombosis treatment, and blood clots due to short-term suspension of administration were pointed out. This raised the need to develop long-term continuous injections. Han Yong-hae, CEO of HLB Life Sciences, said, "The long-term continuous injection of Apixaban ingredients has been quickly developed by HLB Pharmaceutical and patented, and it is the only technology in the world that can be developed only by HLB Pharmaceutical." "If clinical trials improve the convenience of taking drugs while having the same effect as existing oral thrombosis treatments, it will grow into a global blockbuster," he said. HLB Pharmaceutical plans to expand to the third phase of globalization in the future based on domestic clinical results. As the technology of the long-term continuous injection platform has been verified, the pipeline will be expanded to various incurable diseases such as obesity, diabetes, and dementia.
- Company
- Celltrion Remsima is licensed in 100 countries
- by Kim, Jin-Gu Jan 06, 2023 05:56am
- Celltrion announced on the 3rd that Remicade biosimilar Remsima has been licensed in 100 global countries 10 years after its domestic approval in 2012. Remsima is a biosimilar of TNF-억제 inhibitors used to treat autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, Crohn's disease, psoriasis. It started developing materials in 2006 and obtained permission from the Ministry of Food and Drug Safety for the first time in the world in July 2012. It was licensed in Europe in September 2013 and in the United States in April 2016. It then steadily obtained permits in Canada, Japan, Brazil, Australia, Egypt, and South Africa, and at the end of last year, the number of licensed countries surpassed 100. Remsima is expanding its global territory by expanding licensed countries while securing a stable share in the United States and Europe. According to Celltrion Healthcare, which is in charge of the global supply of Remsima, Remsima has a 53.6% share in the European market in the second quarter of last year. The U.S. market, which is being sold through Pfizer, has a 31.7% market share as of the third quarter of last year. Celltrion is making all-out efforts to expand the global approval and release of Remsima SC with the existing intravenous injection formulation as a subcutaneous injection formulation. Celltrion expects that if Remsima SC settles in the market, its competitiveness will be further strengthened along with the existing Remsima. The Remsima SC currently has licenses in 46 countries. In the U.S., which is considered the world's largest market, the U.S. is undergoing a licensing process to release Remsima SC as a new drug. Subsequent antibody biosimilars such as Herzuma and Truxima are also expanding their scope in licensed countries. As of December last year, including major markets such as the United States and Europe, Herzuma has obtained permits in 92 countries and Truxima in 88 countries. A Celltrion official said, "Remsima is a representative Korean biopharmaceutical that has successfully settled in the global market after overcoming a poor development environment at a time when the concept of biosimilars was unfamiliar. Celltrion will continue to expand its new pipeline of approval for follow-up antibody treatments such as Herzuma, Truxima, Yuflyma, and Vegzelma."
- Company
- Bayer and Boryung are competing in the aspirin market
- by Nho, Byung Chul Jan 04, 2023 05:32am
- In the market for aspirin-based cardiovascular treatments, Bayer Aspirin Protect 100 mg was found to be the undisputed No. 1. According to medical distribution performance data, Aspirin Protect recorded 18.8 billion won last year and is leading the market while maintaining the appearance of banding worth 20 billion won. Aspirin Protect's sales in 2018, 2019, and 2020 are 22.5 billion, 19.1 billion, and 17.1 billion won and cumulative sales by 3Q in 2022 are 15 billion won, which is likely to surpass 20 billion won this year. The second place was Boryung Biopharma's Astrix, which recorded 12.8 billion won in performance last year. During the same period, Astrix's appearance is 15.4 billion won, 14.6 billion won, and 13.4 billion won, and the cumulative total until 3Q is 9.2 billion won, which is expected to generate similar sales to the previous year. The market share of the two products was 45,31%, which dominated 76% of the market. The third and fourth places are Hanmi Pharmaceutical and Yuhan Corporation aspirin, which recorded sales of 3.3 billion won and 1.7 billion won last year. The market share of Hanmi and Yuhan is formed at about 8/4%. Products ranked 5th to 10th show performance of around 100 million to 300 million, and the fact that they are virtually meaningless competition is another characteristic of the aspirin cardiovascular treatment market. The drug prices of Aspirin Protect and Astrix, which were approved by the Ministry of Food and Drug Safety in 2001 and 2009, are 77 won each, the highest registered price among the same-component drugs, and the insurance price of Aspirin of Hanmi and Yuhan is 61 won per person. Aspirin, a representative antiplatelet drug, prevents coronary artery occlusion by inhibiting cyclooxygenase in the arachidonic acid pathway and inhibiting the production of thromboxane A2, a thrombus-causing substance. It lowers the morbidity and mortality of angina at a dose of 75 mg to 325 mg per day and is also used for other myocardial infarctions and strokes. In the case of secondary prevention of ischemic stroke, aspirin and clopidogrel are used, and aspirin and warfarin are prescribed to prevent stroke by atrial fibrillation. According to the CHEST guidelines, appropriate preventive drugs can be administered depending on the presence or absence of a history of stroke, transient ischemia, and the number of risk factors. For aspirin allergy patients, Clopidogrel, Ticagrelor, Prasugrel, etc. can be used. Meanwhile, aspirin is used as a fever and anti-inflammatory painkiller for high doses (250 mg, 300 mg, 500 mg), and low doses (75 mg, 81 mg, 100 mg) are used to prevent blood clots.
