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- 2026-03-14 21:27:04
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- Mavyret occupies 85% of HCV market...sales fall 36% in 3 yrs
- by Kim, Jin-Gu Feb 06, 2023 05:51am
- Pic of Abbvie Abbvie’s Mavyret has dominated the oral hepatitis C treatment market. Last year the drug increased its market share to 85%. Despite this increase in market share, the drug’s prescription performance fell 36% over the past 3 years. The analysis is that the absolute size of the Hepatitis C treatment market, which has a limited number of patients, has been decreasing due to the near-cure effect of the treatments in the market, which eventually led to a reduction in the overall market size. ◆Mavyret occupies 85% of the HCV market...prescription performance drops 36% in 3 years According to the market research institution UBIST on the 4th, Abbvie’s oral HCV treatment Maryret’s outpatient prescriptions recorded KRW 29 billion last year. This was a 10% increase compared to 2021 and is considered to be due to Maryret’s scope of reimbursement being expanded from adults to adolescents aged 12 years or older. With the reimbursement extension, its market share increased to 85%. Mavyret had quickly expanded its influence in the market since its release in September 2018, with its benefits of being pan-genotypic and short treatment period. In 2019, its market share increased to 70% and then to 75% in 2020 and 2021. However, in the long term, the reduction in prescription performance is clear. Outpatient prescriptions fell from KRW 45.6 billion in 2019 to KRW 35.7 billion in 2020, then to KRW 26.3 billion in 2021. This amounted to a 36% decrease in prescription performance compared to 2019. The reason for the decrease in prescription performance despite the increase in market share is because of the reduced overall market size. The size of the oral HCV treatment market has steadily decreased from KRW 135.3 billion in 2017 to KRW 73.7 billion in 2018, to KRW 65.1 billion in 2019, to KRW 47.4 billion in 2020, to KRW 35.1 billion in 2021, then to KRW 34.2 billion in 2022. Compared to 2017, when the market had expanded to its maximum, the market had shrunk to one-fourth its size in 5 years. ◆Increased cure rate had contracted market size...All HCV drugs other than Mavyret·Harvoni earn less than KRW 100 million In the pharmaceutical industry, the cause of market contraction is due to the characteristics held by HCV treatments. Before the introduction of direct-acting antivirals (DAAs) like Mavyret, HCV had been a very critical condition. However, the treatment effect of HCV drugs had increased dramatically with the introduction of BMS’s Daklinza and Sunvepra. Then, Gilead Sciences' Sovaldi and Harvoni. MSD’s Zepatier and Abbvie’s Mavyret followed, enhancing the treatment effect With the treatment effect high enough to be close to a complete cure, the market size quickly contracted with the number of patients being prescribed the drug increasing within the finite number of patients in the market. With the rapid contraction of the market, some drugs that once dominated the market decided to withdraw from the domestic market. In March 2021, BMS voluntarily withdrew the authorization for its for Daklinza and Sunvepra. In June, Roche also voluntarily withdrew its injectable HCV treatment Pegasys from the domestic market. The situation is also similar for drugs other than Mavyret. Prescription performance of drugs that had occupied the market after Daklinza and Sunvepra, such as Zepatier, Sovaldi, and Harvoni are converging to nearly 0. In the case of Zepatier, its prescription sales had recorded KRW 19.9 billion in 2018, but then fell rapidly to record less than KRW 50 million last year. Sovaldi’s sales had also fallen to less than KRW 10 million last year from the KRW 84.3 billion in 2017, and Harvoni’s sales had fell to KRW 5 billion from the 40.9 billion in 2016. ◆Gilead releases a new drug for the first time in 5 years...makes winning bid with low price Pic of Gilead ScienceThe market contraction is expected to continue in the market. The variable is the new HCV treatment released by Gilead Science. Gilead had released Epclusa and Vosevi, its next-generation HCV treatments in November last year. These were the first new drugs for HCV released by Gilead in 5 years after Sovaldi and Harvoni. Epclusa is a pan-genotypic treatment like Mavyret. Although its treatment period is 12 weeks, 1 month longer than Mavyret, it has a more convenient means of administration of one pill once daily compared to three pill once daily administration of Mayvert. Its price had been set lower than Mavyret. Epclusa is priced at KRW 117,030 per tablet and Vosevi at KRW 120,836 per tablet. In terms of total treatment cost, Epclusa costs KRW 9,830,520 and Vosevi 10,150,224. This is cheaper than the KRW 10,922,352 of Mavyret. Gilead plans to regain the glory it occupied in the past with treatments and Harvoni with its more competitive price than Mavyret.
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- EXKIVITY, PO lung cancer treatment, is released
- by Jung, Sae-Im Feb 03, 2023 08:51am
- Differences between oral medication and long-lasting effects "Further study needed to find suitable patient population" The second new drug targeting EGFR mutations, which are rare in non-small cell lung cancer, has been released in Korea. Takeda Pharmaceutical's Exkivity is expected to compete with oral drugs and long reaction duration. Takeda Pharmaceutical Korea held a press conference at The Plaza Hotel in Jung-gu, Seoul on the 1st and officially announced the launch of the new non-small cell lung cancer drug 'Exkivity'. Exkivity is a targeted treatment for EGFR Exxon 20 inserted mutated non-small cell lung cancer and can be used as a secondary treatment in patients who have previously been treated with platinum-based chemotherapy. EGFR Exxon20 insertion mutation is rare enough to account for about 10% of EGFR-mutated non-small cell lung cancer and about 2% of all non-small cell lung cancer. The survival period is about twice as short as that of the Exxon19 defect and the Exxon21 (L858R) substitution mutation, which accounts for most of the EGFR mutations. It is known that the existing EGFR mutation target treatment does not work well with the Exxon 20 insertion mutation. Ahn Myung-joo, a professor of hemato-oncology at Samsung Medical Center, said, "Exon 20 mutant patients had a significantly lower prognosis and survival rate than common EGFR mutant patients," adding, "We knew the existence of Exxon 20 mutant for about 20 years, but the demand was high because there were no suitable drugs." Last year, two new drugs targeting this biomarker appeared. Janssen Rybrevant and TakedaIt's pharmaceutical Excitivity. Rybrevant is a dual antibody that targets both the EGFR Exxon20 insertion mutation and the MET mutation. On the other hand, Exkivity is the only oral drug that intensively targets the Exxon20 insertion mutation. It is expected to compete with Rybrevant with the launch of Exkivity in February. Exkivity recorded an objective response rate (ORR) of 28%, a median overall survival period (mOS) of 24.0 months, and a median progressive survival period (mPFS) of 7.3 months in clinical trials of 114 patients, respectively. The median reaction time after administration was 1.9 months, showing a rapid medicinal effect. The safety profile was also shown to be good. The most common adverse reactions were diarrhea, rash, and fatigue, which could be managed through dose reduction. In particular, Exkivity showed a long reaction duration of 17.5 months. Kim Tae-min, a professor of hematologic oncology at Seoul National University Hospital, said, "One of the important indicators when confirming the effectiveness of targeted anticancer drugs is the duration of the reaction from the first reaction to the time when the reaction lasts longer, which can ultimately lead to the patient's survival." It is expected that Exkivity will show its strength in that it has increased the convenience of taking oral drugs, unlike Rybrevant, an intravenous injection, along with a long duration of the reaction. Experts agreed that further research is needed to find a suitable patient group for each drug. Professor Kim said, "Each patient has different reactions to the drug. Some patients respond only to Exkivity or Rybrevant, and some respond to both. It is necessary to analyze it through additional data, he said. "In addition, the two drugs differ in formulation and adverse reactions, so we need to determine the appropriate drug through close communication with patients." Professor Ahn also said, "It is dangerous to compare and judge the two drugs based on this data because the number of patients currently participated in the clinical trial is only about 100," adding, "It is clear that it is more effective than conventional drugs, but more data should be accumulated."
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- Enhertu quickly lands at general hospitals in Korea
- by Eo, Yun-Ho Feb 03, 2023 05:53am
- Prescription of the next-generation new antibody-drug conjugate 'Enhertu' has started in earnest. According to industry sources, Enhertu (trastuzumab deruxtecan), AstraZeneca and Daiichi Sankyo Korea’s new antibody-drug conjugate drug for HER2-positive breast cancer have passed the drug committees (DCs) of 20 medical institutions in Korea, including Samsung Medical Center, Seoul National University Hospital, Sinchon Severance Hospital, Kangbuk Samsung Medical Center, and Chonnam National University Hwasun Hospital. Most hospitals held an emergency DC meeting to generate a prescription code for Enhertu, suggesting the healthcare professional’s high interest in the drug. The drug was approved by the Ministry of Food and Drug Safety in September last year based on the DESTINY-Breast01 and DESTINY-Gastric01 trials. In Korea, Enhertu is indicated to treat ▲ unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting’ and ▲ locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. Also, in December, based on the DESTINY-Breast03 trial, the drug’s indication was expanded to treat patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. Enhertu is an ADC that combines ‘trastuzumab,’ a monoclonal antibody that binds to specific target proteins, and ‘deruxtecan,’ a strong cytotoxic agent, by a linker. ADCs act selectivity on antibody targets and apoptosis of target tumor cells allows the drug to work selectively only on the tumor cells, increasing its therapeutic effect and minimizing side effects. However, Enhertu has not been reimbursed yet in Korea. AstraZeneca and Daiichi Sankyo applied for reimbursement listing in December last year and are awaiting review by the Health Insurance Review and Assessment Service. If listed, the drug’s prescriptions are expected to increase rapidly. Sun-Young Rha, Professor of Medical Oncology at Yonsei Cancer Center, said, “Enhertu is the first and only HER2-targeted therapy that demonstrated a survival period of over one year as a treatment for advanced gastric cancer after treatment with a trastuzumab-based regimen. We hope reimbursement will be applied as soon as possible in consideration of the small number of patients.” Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the head-to-head DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy. The interim analysis results that were updated in 2022 showed that Enhertu also continued to demonstrate a clinically meaningful improvement in progression-free survival (PFS) with a 22-month improvement in median PFS over T-DM1. The median PFS for patients in the Enhertu arm was 28.8 months compared to 6.8 months for T-DM1. Also, in terms of OS, the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1. Also, in the DESTINY-Breast01 trial, Enhertu demonstrated continued anticancer effect in patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens that include T-DM1, trastuzumab, and pertuzumab. Results showed that Enhertu met its main efficacy outcome with an objective response rate (ORR) of 60.9%. The median duration of response (DoR) was 14.8 months, and the drug showed a continued anticancer effect in severe patients with a median of 6 previous lines of treatment (range 2-27).
- Company
- Generic for Forxiga competition in the 90 Billion market
- by Kim, Jin-Gu Feb 03, 2023 05:53am
- Forxiga The patent for "Forxiga," a large diabetes treatment that produces more than 90 billion won a year, was completely lifted by the Supreme Court ruling. It is expected that patent challengers will release Forxiga generic in two months. Competition for generics is expected to intensify when the sales ban period ends in January next year due to the permission for priority sales items. ◆14 Generics are expected to be released in April this year, expanding to 90 in January next year On the 2nd, the Supreme Court ruled against 17 companies, including international drugs, in an appeal filed by AstraZeneca to side with generic companies. As a result, patent challengers will be able to release generics after Forxiga's first substance patent expires on April 7 this year. Patent challengers were qualified to release generics because they won the first and second trials. However, AstraZeneca's appeal did not rule out the possibility of a reversal decision by the Supreme Court, putting a lot of pressure on the release of Generic. The Supreme Court finally ruled in favor of patent challengers, and Generics succeeded in relieving the burden of patent infringement completely. It is expected that 14 companies that have acquired generic for exclusivity will release the product in April. Forxiga received generic for exclusivity use as 39 items of single and composite products. Generic for Exclusivity is until January 7 next year, when Forxiga's second substance patent expires. After that, more pharmaceutical companies are expected to enter the market. According to the Ministry of Food and Drug Safety, 89 pharmaceutical companies have been approved for 285 items as a single Forxiga drug and complex. This means that when the effect of generic for exclusive expires in January next year, more than 90 pharmaceutical companies will compete with the same ingredient. ◆Forxiga·Xigduo Last year's prescription amount of 91.4 billion won Drug price cuts are inevitable when General Electric is released. The reason why generics are paying keen attention to the market is that Forxiga is producing more than 90 billion won in prescriptions. According to UBIST, a pharmaceutical market research firm, Forxiga's outpatient prescription performance last year was 48.5 billion won. It increased by 14% from 42.6 billion won in 2021. Xigduo, a compound of dapaglyfluazine and metformin, recorded 42.9 billion won last year. It increased 16 percent from 36.9 billion won a year ago. Forxiga and Xigduo repeated rapid growth every year. The combined prescription amount, which was 33.3 billion won in 2017, increased 2.7 times to 91.4 billion won in five years. ▲ Forxiga and Xigduo prescription performance by year (unit: 100 million won, data UBIST) However, it is widely expected that the existing growth will be dampened if the generic is released after April this year. This is because a 30% reduction in drug prices is applied to the release of drugs with the same ingredient. Then, one year after the release of the Generic, the drug price will be further lowered to 53.55% of the existing upper limit. On top of that, AstraZeneca cannot avoid competition with Generic, which is newly entering the market. Dong-A ST released Dapflo in December last year with the same ingredients as Poshiga. Dapflo is a prodrug product with the same main ingredients but a different chemical structure from the original. When absorbed into the body, the structure changes and has the same effect as Forxiga. Dong-A ST alone challenged Forxiga's first substance patent for early release of generic. After succeeding in avoiding the first trial, Dong-A ST pushed ahead with the sale of Dapflo based on the victory of the first trial at a time when a patent dispute with AstraZeneca was underway. As a result, it released generic products about four months ahead of other companies that have acquired generic exclusivity. Dong-A ST believes that it will take risks and preoccupy the generic market, given that Forxiga generic competition is expected to be very fierce in the future. The key is how much Dong-A ST maximizes the effect of preoccupying the market for four months. Dong-A ST has its own developed Suganon as a DPP-4 inhibitor-based diabetes treatment. Dong-A ST plans to increase Dapflo's influence by linking with Suganon for the remaining two months until April when Forxiga generic is released. In this extension, Dong-A ST plans to maintain the sale of Dapflo regardless of the Supreme Court ruling. On the 2nd, the Supreme Court ruled in favor of AstraZeneca in an appeal filed by Dong-A ST against AstraZeneca on the avoidance of Forxiga's first substance patent. In response, an official from Dong-A ST said, "The first trial, which was the basis for the release of Tapflo, has nothing to do with the Supreme Court's ruling, and the second trial is currently underway due to AstraZeneca's appeal."
- Company
- Hanmi’s Rolontis makes USD 10 million in 3 mths
- by Kim, Jin-Gu Feb 02, 2023 05:48am
- Pic of Rolvedon Hanmi Pharmaceutical’s partner Spectrum Pharmaceuticals issued a press release announcing that “’Rovedon (Korean brand name: Rolontis)’ that the company had launched in October last year made an estimated sales of KRW 10 million in 3 months.” Spectrum plans to release details of the results on Rolvedon in its Fiscal Year 2022 Earnings Call that is scheduled for March. Spectrum received marketing authorization for Rolvedon from the US Food and Drug Administration in September last year, then released Rolvedon in the US in October last year. Rolontis is a new biodrug that Hanmi Pharmaceutical licensed out to Spectrum Pharmaceuticals in 2012. The drug is indicated for the treatment or prevention of neutropenia in cancer patients that receive myelosuppressive chemotherapy. As a granulocyte colony-stimulating factor (G-CSF) class that stimulates the granulocyte to increase neutrophil production, the drug has a similar mechanism of action with Amgen’s blockbuster drug ‘Neulasta (pegfilgrastim).’ In Korea, Rolontis was approved in March as the 33rd homegrown new drug.
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- Takeda's Exkivity launches as non-reimbursement
- by Eo, Yun-Ho Feb 01, 2023 05:52pm
- EGFR Exxon 20 insertion mutation target anticancer drug Exkivity, which is eaten by Takeda Pharmaceutical Korea, will be released as non-reimbursement in February. EGFR Exxon20 insertion mutation Non-small Cell Lung Cancer treatment Exkivity targets biomarkers such as Rybrevant of Janssen Korea, but there is a difference in that it is an oral drug. The EGFR Exon 20 insertion mutation is a biomarker that has recently attracted new attention in the field of non-small cell lung cancer. Currently, prescribed anticancer drugs are suitable for Exon19 deficiency or Exon21 L858R substitution mutation, which is commonly found in EGFR mutations, but EGFR Exon20 was still a blind spot. The benefit is still unknown. As Rybrevant failed to pass the HIRA, it remains to be seen whether Exkivity can succeed in registering. Takeda has yet to submit an application for Exkivity's benefit. Exkivity proved its effectiveness through phase 1/2 of 114 patients with EGFR Exxon20-inserted mutated non-small cell lung cancer who had previously undergone platinum-based chemotherapy. Clinical results showed that the ORR evaluated by IRC was 28% and the mDOR was 17.5 months in the group of patients taking Exkivity 160 mg. In particular, the median reaction time after administration of Exkivity was 1.9 months, and it was confirmed that the drug effect appeared rapidly from the beginning of treatment. The mPFS was 7.3 months and the mOS was 24.0 months. The safety profile was also shown to be good. The most common adverse reactions were diarrhea, rash, and fatigue, which can be managed by adjusting the dosage.
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- JW Pharma develops new drugs with Merck Life Science
- by Lee, Seok-Jun Feb 01, 2023 05:55am
- JW Pharma is expanding AI technology from new drugs to raw drug research fields to increase R&D efficiency. JW Pharma announced on the 30th that it recently signed a business agreement with Merck Life Science in Germany to research and develop raw materials for new drugs using AI. Merck offers its AI software Synthia to JW Pharma. Synthia is a program that quickly analyzes and provides the synthesis route of raw drugs in the new drug development stage. Merck's Custom Synthesis Lab's know-how in synthesizing new materials is also consulted with JW Pharma. JW Pharma's raw material research center plans to actively utilize Synthia for research on the synthesis of its new drug candidates. It is expected to reduce research time and cost on the method of preparing compounds to be used in non-clinical and clinical trials. Based on the synthesis conditions proposed by Synthia, it also plans to establish an unmanned automated laboratory environment in which robots synthesize raw materials 24 hours a day on behalf of researchers. Lee Nam-gu, CEO of Merck Science and Lab Solutions Business, emphasized, "Synthia can derive solutions with more than 100,000 rules and sophisticated algorithms and use them for patent applications and papers as well as developing new drugs." Shin Young-seop, CEO of JW Pharma, said, "The company is conducting various open innovation activities with bio companies with innovative AI technologies to strengthen the pipeline of new drugs discovered through its own R&D platform. "The cooperation with Merck in automated synthetic research will serve as a cornerstone for efficiently conducting JW's various new drug studies," he said.
- Company
- Clotinab, exclusive in the bio-anti-hemolysis market
- by Nho, Byung Chul Feb 01, 2023 05:54am
- In the anti-hemorrhagic biopharmaceutical market, Korean biosimilar Clotinab is dominating the market. According to data on drug distribution performance, ISU ABXIS Clotinab's 2021 performance was 2.8 billion won, dominating the Abciximab biosimilar market. The sales of the product in 2018, 2019, and 2020 are 3,048 million won, 2,920 million won, and 2.94 billion won, and the cumulative performance of 3Q in 2022 is about 1,88 billion won. Clotinab's dominance is attributed to the withdrawal of the original biopharmaceutical Lilly Reopro from the market. Clotinab, the first antibody biosimilar title in Korea, challenged Reopro, which boasts 400 billion won in global sales in 2007. In the early days of its launch, it recorded around 400 million won in performance, but gradually expanded its scope by passing the so-called "Big 5" hospitals DC such as Seoul National University Hospital, Asan Hospital, Severance Hospital, St. Mary's Hospital, and Samsung Seoul Hospital. It is understood that the decisive cause of crossing the barrier to entry into the original drug lies in securing drug equivalence with relatively low drug prices. The drug price of Clotinab 2.5ml·5ml is listed at 315,084 won and 378,102 won, while Reopro's insurance price was 472,627 won, about 100,000 won higher. Reopro was completely withdrawn from the domestic market in 2017, with the appearance of around 10 million won. This drug is used as an auxiliary treatment for Heparin and Aspirin to prevent ischemic heart complications in high-risk patients during PTCA procedures. As a medication guide be careful of antithrombotic drugs, bleeding can be suspected if symptoms such as brown urine, dizziness, and headache appear during administration. In addition, patients who are about to undergo procedures and surgeries that are expected to bleed should stop administering drugs for a certain period of time because they may have difficulty stopping bleeding.
- Company
- Imfinzi expands biliary cancer indication
- by Feb 01, 2023 05:54am
- AstraZeneca Korea held a press conference on the 31st to commemorate the approval of its immuno-cancer drug Impinzi"Although there are few clinical patients, effectiveness improvement and safety performance" A new option for immuno-cancer drugs has been born in biliary tract cancer, where chemotherapy has long been the standard treatment. The medical staff said, "We improved the treatment of biliary tract cancer, which has not progressed for more than 10 years." Imfinzi's biliary tract cancer indication is the first immuno-cancer drug. In particular, it is significant in that the beginning of the clinical trial of researchers, which became the basis for permission for biliary tract cancer indications, is Korea. The study could begin after Oh Do-yeon, a professor of oncology at Seoul National University Hospital, actively persuaded pharmaceutical companies. Biliary tract cancer is a rare and aggressive gastrointestinal cancer consisting of cancer cells from the bile duct, gallbladder, or papilla. Early biliary tract cancer has no clear symptoms, and it is not well established who has a high risk of biliary tract cancer. Early diagnosis is difficult due to the lack of effective screening programs. When diagnosed with biliary tract cancer, most of them have limited treatment options and poor prognoses. Biliary tract cancer does not have a high prevalence like lung cancer or stomach cancer, and the incidence is lower in the West, so there have been relatively few new drug studies. There have been attempts to combine some targeted anticancer drugs, but clinical trials have repeatedly failed. This is why Gemcitabine + Cisplatin, chemotherapy, has still existed as a standard therapy for more than a decade. Professor Oh found out that immuno-cancer drugs responded relatively high in biliary tract cancer about 10 years ago, and persuaded AstraZeneca to conduct a researcher clinical trial. The possibility was confirmed here, leading to the third phase of the global market. Professor Oh designed the clinical design after a long discussion as a PI. The TOPAZ-1 study results were successful. The Impinzi group improved the overall survival rate (OS) by 20% compared to the placebo group (placebo+ Gemcitabine + Cisplatin). At the time of 2 years, the OS of the Impinzi group was 25%, which was more than twice that of the placebo group. mPFS was 7.2 months in the Impinzi group, an improvement of 25% compared to 5.7 months in the placebo group. In terms of safety, the safety profile was similar to that of the placebo group. Professor Oh, who attended the meeting, said, "I was very happy to see the safety profile as well as the effectiveness of phase 3 clinical results." "Even though we added Impinzi, the adverse reaction was similar to that of the placebo group," he said. "The rate of discontinuing treatment with drugs was rather less than that of the placebo group." The U.S. Food and Drug Administration (FDA) approved Imfinzi biliary tract cancer indications based on Professor Oh's clinical and TOPAZ-1 results. Furthermore, NCCN recommended Impinzi as the standard treatment (Category 1) in the primary treatment of progressive and metastatic biliary tract cancer. For the first time, immuno-cancer drugs were listed as the first standard treatment option, which had only chemotherapy. It is a very unusual case that the clinical trial of researchers initiated by Korean medical staff led to global approval and standard treatment. Professor Oh said, "The TOPAZ-1 clinical trial is drawing attention in that it has proven improved results in efficacy and safety despite the relatively small number of participating patients at 685, and its interest has been confirmed at a recent academic conference."
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- Sales of statin-ezetimibe combo rise threefold in 3 yrs
- by Chon, Seung-Hyun Feb 01, 2023 05:54am
- Statin-ezetimibe combination drugs greatly expanded their influence in Korea’s dyslipidemia treatment market. Their total prescription amount increased by over threefold in the past 5 years, and its annual market size exceeds KRW 750 billion. In the market, rosuvastatin-ezetimibe combinations drove market growth, and the bulk of generic atorvastatin-ezetimibe combination drugs that were recently released also supported the strong growth. ◆Sales of statin-ezetimibe combos rise from KRW 228.4 billion to KRW 750.4 billion in 5 yrs According to the market research institution UBIST on the 31st, outpatient prescriptions of statin-ezetimibe combination drugs reached KRW 750.4 billion last year, recording a 23.0% YoY increase. Its market size had increased 51.5% in two years from KRW 495.3 billion in 2020. The prescription market for statin-ezetimibe combination drugs had recorded KRW 228.4 billion in 2017 and then expanded over threefold in just 5 years. This analysis is that the increased preference for statin-ezetimibe combinations due to its excellent effect in lowering LDL-C and cost, which is not greater than taking the two drugs separately, has attributed to market growth. Currently, four types of statin-ezetimibe combinations that combine four types of statin - simvastatin, rosuvastatin, atorvastatin, and pitavastatin - with ezetimibe have been introduced to the market. ◆Rosuvastatin·ezetimibe combo occupies 65% of market...atorvastatin·ezetimibe combo expands market In the statin-ezetimibe combination market, rosuvastatin·ezetimibe combinations occupy the greatest share of the market. Last year, rosuvastatin·ezetimibe combination drugs raised KRW 488.5 billion last year, recording a 12.0% YoY increase. This is a 33.1% increase in 2 years from KRW 367.1 billion in 2020. Compared to the KRW 136.6 billion the combination had made in 2017, its market size has increased 257.8% in 5 years. Last year, the rosuvastatin·ezetimibe combination occupied 65.1% of the statin-ezetimibe combination market. Hanmi Pharmaceutical’s Rosuzet was the first product to enter the rosuvastatin·ezetimibe combination market. Hanmi Pharmaceutical entered the market earlier than its competitors by securing the right to use ezetimibe from its patent holder, MSD. Prescription sales of Rosuzet last year recorded KRW 123.2 billion, a 17.4 increase YoY. Among all combinations, the product made the second-most sales for two consecutive years, led only by Lipitor. Rosuzet’s prescriptions rose over threefold in 5 years from KRW 41.5 billion in 2017. Since 2020, sales exceeded KRW 100 billion for 3 consecutive years and showed off its status as the flagship statin-ezetimibe combination drug product. Yuhan Corp’s Rosuvamibe had shown prominence in the rosuvastatin-ezetimibe combination market. Rosuvamibe’s sales recorded KRW 66.8 billion last year, showing a 7.7% YoY increase. Rosuvamibe’s sales rose over twofold in 5 years from the KRW 23.7 billion it had made in 2017. Recently, atorvastatin·ezetimibe combination drugs have shown explosive growth in the market. Prescription of atorvastatin·ezetimibe combination drugs had recorded KRW 197.5 billion last year, which is a 53.4% YoY increase. Also, its market size expanded over fourfold in only 5 years from the KRW 44.2 billion it had made in 2017. The bulk of Atozet generics that entered the market rapidly expanded the market in a short period of time. Until 2020, the only atorvastatin-ezetimibe combination drug available was Organon Korea's Atozet. Then, the market size started to increase with around 100 companies in Korea simultaneously entering the atorvastatin-ezetimibe combination market with their generic versions in 2021. In October 2020, Chong Kun Dang received approval for ‘Lipilouzet’, a combination drug that contains the same ingredients as Atozet. During the same period, 22 companies received approval for their authorized generics of Lipilouzet and were listed for reimbursement from April 2021. Then, 88 more pharmaceutical companies received approvals for their Atozet generics from February 2021 and were reimbursed in May, one month after the reimbursement listing of authorized generics of Lipilouzet. In June 2021, 2 more companies have additionally received approval for their Atozet generics, raising the count of Korean companies that entered the Atozet market to 113. The atorvastatin-ezetimibe combination market had recorded KRW 82.8 billion in 2020 with only Atozet in the market, then grew 138.6% in 2 years after a load of generic drugs entered the market. Atorvastatin-ezetimibe combinations, which had only occupied 19.3% of the total statin-ezetimibe combination market in 2017, rose to 26.3% last year. On the other hand, sales of simvastatin-ezetimibe combinations have somewhat slowed down. Prescription sales of simvastatin-ezetimibe combinations had recorded KRW 35.9 billion last year, which is a 16.6% YoY decrease. Its sales fell for two consecutive years after recording KRW 45.4 billion in 2020. Prescription of simvastatin-ezetimibe combinations last year had decreased 21.0% compared with 2 years ago. Organon Korea’s Vytorin was the original drug to entered the simvastatin-ezetimibe combination market. However, the prescription market gradually shrunk compared to other combinations. In the statin-ezetimibe combination market, the share of the simvastatin-ezetimibe combination had shrunk to 4.8% last year from the 20.9% in 2017. In 2021, JW Pharmaceutical's first pitavastatin and ezetimibe combination, Livalozet, has recently shown good momentum. Pitavastatin is the main active pharmaceutical ingredient used in JW Pharmaceutical's flagship hyperlipidemia treatment, Livalo. Livaloaet was released in October 2021, and the drug made a successful debut raising prescriptions to KRW 28.5 billion last year in the first year of its release.
