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- 2026-05-11 13:38:11
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- SGLT-2 I is a great help in the treatment of heart failure
- by Kim, Jin-Gu Feb 06, 2023 05:51am
- SGLT-2 inhibitors developed for the purpose of treating diabetes are speeding up the expansion into the area due to heart failure. The use of SGLT-2 inhibitors targeting heart failure is expanding not only in university hospitals but also in the local area. This trend has been expanding since the revision of the domestic heart failure guidelines last year. Although benefits are still limited, expectations for the drug are said to be very high at the front-line prescription site. Jung Young-jin (37), head of the cardiovascular center at Yongin Myeongju Hospital, said, "SGLT-2 inhibitors are very helpful in treating heart failure. He said, "The effect of improving major symptoms of heart failure, including difficulty breathing, is visible," adding, "Personally, we are more actively prescribing SGLT-2 inhibitors to heart failure patients than in the past." ◆SGLT-2 Inhibitor, Improvement of Heart Failure Symptoms Visibly The Korean Heart Failure Association revised the guidelines for heart failure treatment in July last year. The revised guidelines recommended SGLT-2 inhibitors as the main treatment for heart failure treatment regardless of the presence or absence of diabetes. It was used limitedly only to reduce heart rate and mildness during heart failure, but the revision of the guidelines added an area to preserve heart rate. The pharmaceutical industry predicts that SGLT-2 inhibitors will become the basic treatment for heart failure. SGLT-2 inhibitors have previously been known to be diabetes treatments that benefit cardiovascular diseases. Still, their status has risen significantly as the results of solo clinical trials on heart failure patients were announced in 2019. Expectations for this drug are high even at the front-line prescription site. Jung Young-jin, head of the cardiovascular center at Yongin Myeongju Hospital, said, "It is prescribed a lot to patients with heart failure who do not have diabetes," adding, "Improvement of major heart failure symptoms, including difficulty breathing, is visible." Jung, head of the center, said, "It was often used in heart failure patients in the past, but I have been using it more actively since a paper was published last year that it is effective in heart failure patients whose heart function is preserved." He added, "We are seeking consent from patients and prescribing them because the salary has not yet been applied." The pharmaceutical industry also predicts that SGLT-2 inhibitors will be able to further expand their areas in the future. SGLT-2 inhibitors are mechanisms that selectively inhibit SGLT-2 transporters involved in the reabsorption of glucose. Through this, blood sugar is controlled by blocking the reabsorption of glucose discharged into the urine into the bloodstream. In this process, SGLT-2 inhibitors also inhibit the secretion of inflammatory cytokines, which has the effect of treating heart failure. Considering this mechanism alone, it is estimated to be effective not only for heart failure but also for cardiovascular disease as a whole. This means that SGLT-2 inhibitors can be used to treat heart failure and other cardiovascular diseases such as myocardial infarction. Already in the United States and Europe, a paper has been published on the effect of SGLT-2 inhibitors on the treatment of myocardial infarction. AstraZeneca and Beringer Ingelheim, which have major drugs, are undergoing phase 3 clinical trials for myocardial infarction. The two clinical results are scheduled to be released this year. He also agreed with the possibility. Since the most common cause of heart failure is ischemic heart failure, I think it will be effective in other cardiovascular areas, said he, head of the center. "There is a possibility in terms of the mechanism."
- Company
- 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.
- Company
- 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."
- Policy
- The aftermath of the COVID-19 Pandemic
- by Lee, Hye-Kyung Feb 03, 2023 05:54am
- There is a need to convert COVID-19 vaccines and treatments, which had been designated for rapid screening, to general screening to cope with the COVID-19 pandemic situation. This is because it is argued that screening personnel should not be wasted due to rapid screening of COVID-19 vaccines and treatments in a situation where the world is concerned about COVID-19. In addition, there are voices that COVID-19 vaccines and treatments should be excluded from the rapid screening in order to focus on the Global Innovation Product Rapid Review Support System (GIFT) prepared by the Ministry of Food and Drug Safety last year. In this regard, an official from the Ministry of Food and Drug Safety said, "The Ministry of Food and Drug Safety is keeping an eye on the COVID-19 pandemic discussion. As it has been taken based on laws to cope with the COVID-19 public health crisis, we will take measures related to the rapid screening process for COVID-19 vaccines and treatments. Since August 31, 2020, the Ministry of Food and Drug Safety has established a rapid screening department and is conducting rapid screening only for innovative products such as life-threatening diseases or treatments for rare and incurable diseases and drugs that respond to public health crises. From September 2020 to July 2022, 23 items were designated for rapid examination of medicines, and 17 items were designated and subject to rapid approval review. According to the items that have been approved, COVID-19 vaccines accounted for the largest number of items with 10, followed by five chemicals, one biopharmaceutical, and one biopharmaceutical. The rapid screening period aims to shorten the general screening period to 75% of the general screening period, and the number of working days required for the rapid screening of the COVID-19 vaccine was short, averaging 26 days. This is because the screening period was shortened by using preliminary reviews in consideration of urgency, and 5 out of 10 COVID-19 vaccines that were approved were pre-reviewed and frequently reviewed in areas such as clinical, non-clinical, and quality. However, while the workload has increased, some say that the structure of drug screening personnel's work should be reorganized due to the rapid screening system of COVID-19 vaccines and treatments in order to properly utilize the GIFT system in the future. An official from the pharmaceutical industry said, "The seriousness of COVID-19 has decreased to the extent that even the obligation to wear indoor masks is lifted," adding, "The Ministry of Food and Drug Safety should also consider ending the rapid screening system for COVID-19 vaccines and treatments." Some say that all permits and screening personnel have been put into a rapid screening of COVID-19 vaccines and treatments, and other tasks have been pushed back by nearly a year, he said. "To solve the problem, we need to think about completing the system that was applied to a crisis." The United States recently declared that it would end the COVID-19 public health emergency from May to November. Subsequently, there is an opinion that Korea will be able to completely lift its obligation to wear a mask in May.
- Policy
- CDDC sets reimb standards for Inrebic Capsule
- by Lee, Tak-Sun Feb 03, 2023 05:54am
- A green light has been turned on for the reimbursement of the myelofibrosis treatment Inrebic Cap. (fedratinib, BMS Pharmaceutical Korea) with the Cancer Disease Deliberation Committee setting reimbursement standards for the drug. Also, the reimbursement standards for the ovarian cancer treatment Zejula Cap (niraparib, Takeda Pharmaceutical) have been extended. The drugs will be approved and listed for reimbursement after passing review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee and drug pricing negotiations with the National Health Insurance Service. HIRA announced that it had held the 1st Cancer Disease Deliberation Committee (CDDC) meeting in 2023 on the 1st and announced it had deliberated as such. Inrebic is indicated as a treatment for enlarged spleen or other symptoms related to ▲ primary myelofibrosis ▲ post-polycythemia vera myelofibrosis, and ▲ post-essential thrombocythaemia myelofibrosis in adult patients that have been previously treated with ruxolitinib. The CDDC determined that setting the salary standard in line with the indication was appropriate. The 1st CDDC deliberation results in 2023 Also, the CDDC determined it appropriate to extend reimbursement and set additional reimbursement standards for Zejula Cap as ‘maintenance monotherapy in adult patients with HRD-positive ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who have shown response to first-line platinum-based chemotherapy (partial or complete response).’ On the other hand, no reimbursement standard had been set for the MET exon 14 skipping mutation treatments Tabrecta and Tepmetko. At the same meeting, the CDDC declined Kyowa Kirin Korea’s application to set reimbursement standards for ‘Poteligeo Inj’ to treat adult patients with mycosis fungoides (MF) or Sézary syndrome (SS).
- Company
- 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."
- Policy
- Introduction of online electronic sign-off from February
- by Lee, Tak-Sun Feb 02, 2023 05:48am
- NHIS Pharmaceutical Price Negotiation Introduces Online Electronic Signing from February Simplify operations to shorten the end of negotiations. The online electronic signing method will be introduced in next month's drug price negotiations. It is expected to simplify work and shorten the negotiation period by compensating for the shortcomings of the existing written agreement. The NHIS plans to introduce drugs subject to calculation and adjustment first, and next year, it plans to introduce an electronic signing method to negotiate new drugs and usage. NHIS (Chairman Kang Kyung-tae, hereinafter referred to as the Public Corporation) announced on the 30th that it will sign online electronic contracts for drugs subject to calculation and adjustment starting with drugs ordered by the Ministry of Health and Welfare. Since the electronic signing method is a method of signing in the form of an electronic (PDF file) through an authentication service company, it is evaluated that it has compensated for the shortcomings of the existing written agreement. The NHIS expects that related tasks will be greatly simplified, such as issuing and submitting seal certificates and eliminating the process of sending seal seals and mail in written agreements, which have been repeated every negotiation, and the end of the negotiations will be shortened by at least six days. In order to consider the preparation period of pharmaceutical companies and prevent confusion, the company will first apply it to the existing written agreement method and actively promote it by sending detailed notices to individual pharmaceutical companies and pharmaceutical associations and holding online briefing sessions for pharmaceutical companies. An NHIS official said, "We plan to expand the electronic contract method to new drug and usage negotiations next year and unify the agreement method to electronic signing method in the second half of this year. NHIS will continue to contribute to stabilizing the supply and quality of medicines and protecting public health by actively communicating and cooperating with pharmaceutical companies."
- Policy
- A year after Abilify 1mg was released,
- by Lee, Tak-Sun Feb 02, 2023 05:48am
- Competition is expected to intensify as generic companies gradually for Aripiprazole 1mg used for childhood autism hypersensitivity. The original product of this preparation is Otsuka's Aripiprazole 1mg. The drug was approved on December 3, 2021, and even generics appeared in more than a year. According to the industry on the 31st, 1mg of Aripiprazole from Whanin will be listed at 170 won per tab from the 1st of next month. This is the third time as an Aripiprazole 1 mg preparation. As for generic companies, Repizole was the first to register 1mg of Aripiprazole The first drug listed was the original Aripiprazole 1mg, which was listed at 595 won per tab in March last year. Myungin Repizole 1mg was then listed in November last year, becoming the first generic to enter the market. The upper limit of Myungin and Whanin is the same at 170 per tablet. It is about 71% cheaper than the original. Aripiprazole, which is used for schizophrenia and depression, had various doses such as 2 mg, 5 mg, 10 mg, and 15 mg, but there was no use for 1 mg until the 1 mg product was approved. The demand for 1mg was not small while prescribing first doses or combinations. However, as the 1mg product was approved, a new indication was created. 1 mg was recommended with 2 mg as the recommended initial dose of hypersensitivity related to autism disorder in children (6-17 years old). Previously, Otsuka was also licensed in Japan for 1 mg as an initial dose of childhood autism disorder hypersensitivity. As new products came out like this, generic companies responded quickly. Eight months after the original's salary was registered, a master entered the market, and Hwanin also joined the ranks this time. The two pharmaceutical companies also succeeded in paying 30mg of Aripiprazole, which is not even in the original. Last year, the original Aripiprazole was 31.9 billion won in outpatient prescriptions. Myungin Repizole and Whanin Aripizole are 400 million won and 1.2 billion won, respectively, which are wide apart from the original, but latecomers are expected to gradually increase their market share as they are strengthening sales and marketing activities. Accordingly, the movement of the two CNS-specialized pharmaceutical companies, including Myungin and Whanin which have received the 1mg market, is also expected to become active.
- 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.
