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- 2026-03-14 21:27:04
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- 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.
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- 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.
- Company
- Will Tagrisso finally be reimb in the 1st line after 4 yrs?
- by Eo, Yun-Ho Jan 04, 2023 05:32am
- Whether the third-generation targeted anticancer drug Tagrisso will be able to receive reimbursement expansions in 2023 is gaining attention According to industry sources, AstraZeneca Korea submitted additional supplementary data to extend reimbursement of its EGFR mutation-positive non-small cell lung cancer (NSCLC) treatment to the first line at the end of last year after submitting its application in October last year. Therefore, whether Tagrisso’s reimbursement application will pass the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review and be finally extended to the first line after 4 years remains to be seen. Tagrisso, which added its first-line indication in December 2018 in Korea, attempted to extend its reimbursement to the indication in 2019. However, upon review by the Cancer Disease Deliberation Committee in October, the committee decided to defer the decision until the full data from the Phase 3 FLAURA trial that studied the overall survival (OS) of Tagrisso in NSCLC patients in the first-line was disclosed. Although AstraZeneca submitted the full FLAURA data and expressed their will to accept most of the cost-sharing plan proposed by the government afterward, the reimbursement fell through due to opposition from committee members (specialists) that raised the issue of the drug’s clinical efficacy. The new item the company brought in to support Tagrisso’s effect in 2023 is the results from the FLAURA China study that confirmed improved OS in Asians. In the FLAURA China trial that studied a cohort of Chinese patients, 71 patients were randomly assigned to the Tagrisso-treated group and 65 patients to the control group. In particular, patients in the control group were switched to use Tagrisso in the second line if their condition progressed to T790m-positive NSCLC, and 22 of the 65 patients in the control group thus continued treatment with Tagrisso. Results showed that The median OS in the Tagrisso group was 33.1 months, 7.4 months longer than the 25.7 months in the control group. Also, the risk of death was reduced by 15.2%. Also, the company added the Japanese real-world data that it had presented at ‘ESMO Asia Congress 2022.’ The real-world study evaluated the effect of Tagrisso in the first-line in clinical practice in 660 NSCLC patients with EGFR mutations from 2018 to 2020. 583 of the patients received Tagrisso in the first line, and the other 76 received another EGFR-targeted cancer therapy. Actual measurement was taken every 6 months in the 583 patients that received Tagrisso. The median follow-up period was 24.6 months. The real-world study results showed that the median progression-free survival (mPFS) in patients that were administered Tagrisso was 20.0 months. This is even longer than the mPFS of 18.9 months that had been identified in the global Phase III trial of Tagrisso. By mutation, Tagrisso’s mPFS in patients with exon19 deletions was 23.5 months. In those with L858R mutations, the PFS was 17.0 months. In terms of overall survival, the median OS was 33.1 months in the Tagrisso arm, 7.4 months longer than the 25.7 months in the control group, and the risk of death was found to be reduced by 15.2%. Meanwhile, the largest obstacle that blocked Tagrisso from receiving reimbursement in the first line was the Asian subgroup analysis results of the FLAURA trial. Tagrisso’s Os in the trial was 38.6 months, a significant extension of 6.8 months over its first-generation comparators ‘Iressa (gefitinib)’ and ‘Tarceva (erlotinib)’. The results were encouraging, considering that Tagrisso was the first EGFR TKI to demonstrate efficacy in the first line and that cross-over prescription was allowed for research ethics in patients with confirmed T790 mutations while receiving treatment with its first-generation comparators. However, the issue lay in the hazard ratio (HR) of the Asian subgroup analysis. HR was 0.995 when separately analyzing the Asian that received Tagrisso. An HR of 0.995 means that the difference between Tagrisso and the control group is 0.005, which could be interpreted as that there is virtually no difference between Tagrisso and its comparator. This was why the academic society raised the opinion that ‘Tagrisso’s OS in Asians, including Koreans, cannot be trusted in the first line,’ and the opinion had a dominant influence on the results of the CDDC review.
- Company
- ablbio will receive 32 billion won in technical fee
- by Jan 04, 2023 05:32am
- 1 trillion won technology export contract in January last year...Get 150 billion won in total. ablbio announced on the 2nd that it will receive $25 million (31.7 billion won) in short-term stages following the first administration of the dual antibody "ABL301" from Sanofi. The milestone is 594.2% of ablbio's sales of 5.3 billion won as of the end of last year. According to the contract, ablbio will receive the milestone within February 14. ABL301 is a candidate substance for the treatment of degenerative brain diseases such as Parkinson's disease, which ablbio exported technology to Sanofi in January last year. According to the contract, when ablbio completes the preclinical and phase 1 clinical trial, Sanofi proceeds from the subsequent stages. Sanofi has the right to develop and commercialize in markets around the world. The total amount of contracts, including $75 million in down payment, amount to $1.06 billion. Among them, the short-term milestone is $45 million, which is received according to the progress of ABL301's preclinical and phase 1 clinical development. In September last year, it received $20 million (25.4 billion won) as it completed a non-clinical toxicity test. As a result, ablbio will receive all the short-term milestones. Currently, the amount that ablbio receives from Sanofi amounts to 120 million dollars (152.5 billion won), including the down payment. ABL301 is a new drug substance that inhibits the accumulation of alpha-synuclein, the cause of Parkinson's disease, and IGF1R target BBB shuttle platform Grabody-B technology developed by ablbio is applied. This increased the transmittance by binding the receptor IGF1R that can pass through the vascular barrier to the end of the antibody, proving the BBB transmittance was 13 times higher than that of the sole antibody in animal experiments. On top of that, Parkinson's disease is fundamentally treated by adding a receptor that inhibits the accumulation of alpha-synuclein, known as the cause of Parkinson's disease.
- Company
- CTLA-4 inhibitor Imjudo is expected to commercialize
- by Eo, Yun-Ho Jan 04, 2023 05:32am
- The second CTLA-4 inhibition mechanism is expected to be commercialized in Korea this year. According to related industries, the Ministry of Food and Drug Safety is reviewing for approval of CTLA-4 inhibitor Imjudo, a combination therapy partner of AstraZeneca Korea's PD-L1 inhibitor Imfinzi. The combination therapy of Impinzi and Imjudo was approved by the U.S. FDA in October last year as a treatment for unstoppable hepatocellular carcinoma. The combination therapy is the only double immuno-cancer treatment approved so far for the primary treatment of liver cancer. The drug was recently approved by Japan's Ministry of Health, Labor, and Welfare, and EMA CHMP also expressed its support for approval. Combination therapy is a single Tremelimumab Regular Interval Durvalumab (STRIDE) strategy in which Impinzi is administered once and then Impinzi is administered at regular intervals every four weeks. The combination therapy demonstrated OS benefits by reducing the risk of death by 22% compared to the control Nexavar monotherapy in phase 3 clinical HIMALAYA study. The overall survival rate in the third year was 31% in the Impinzi and Imjudo combination therapy group and 20% in the sorafenib monotherapy group. Imjudo combination therapy was recently added to lung cancer indications in the United States. In phase 3 clinical POSEIDON study, which was the basis for permission, the patient group who received a combination of Impinzi, Imjudo, and platinum-based chemotherapy had a 23% lower risk of death than various chemotherapy controls. The overall survival rate in the second year was 33% in the combined group and 22% in the control group. Meanwhile, Imjudo is conducting phase 3 studies on combination therapy with an impingement in several types of cancers, including topical liver cancer (EMERALD-3 study), small cell lung cancer (ADRIATIC study), and bladder cancer (VOLGA and NILE study).
