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- 2026-03-16 21:30:23
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- It has been a year since the release of Leclaza
- by Chon, Seung-Hyun Sep 05, 2022 05:55am
- Korea's first new anti-cancer drug is expected to generate 10 billion won in annual sales. Leclaza, a new anti-cancer drug developed by Yuhan Corporation, surpassed 10 billion won in cumulative sales within a year of its release in Korea. It showed a smooth move in the early stages of its release and predicted that it would surpass 10 billion won in annual sales for the first time among new anticancer drugs developed in Korea. According to IQVIA, Leclaza recorded 6.9 billion won in sales in the first half of last year. After recording 3.2 billion won in the first quarter, sales expanded to 3.7 billion won in the second quarter. Leclaza is a non-small cell lung cancer treatment approved as the 31st new drug developed in Korea in January last year. Patients with local progressive or metastatic non-small cell lung cancer who developed T790M resistance after administration of the first and second generation epithelial cell growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). It acts as a mechanism to suppress the growth and growth of lung cancer cells by interfering with signal transmission involved in lung cancer cell growth. Leclaza entered the prescription market in earnest with the listing of health insurance benefits in July last year. It earned 4.1 billion won in sales in the second half of last year alone. The first sales of 1.5 billion won occurred in the third quarter of last year, and 2.6 billion won worth of sales were sold in the fourth quarter. Until the second quarter of this year, Leclaza's cumulative sales amounted to 11 billion won. It surpassed 10 billion won in cumulative sales within a year of its release. If this trend continues, Leclaza is likely to surpass 10 billion won in annual sales in its second year of release. Leclaza's early performance in the release is considered a smooth start. Anti-cancer drugs, which are usually used in large medical institutions, can be prescribed after passing the drug commitee, so it takes a considerable amount of time for sales to occur in the early stages of release. Domestic developed anticancer drugs approved before Leclaza include Ilyang Pharmaceutical Supect, Donghwa Pharmaceutical Millican, Chong Kun Dang Camtobell, Samsung Pharmaceutical Riavax, and Hanmi Pharmaceutical Olita. None of these products exceed 10 billion won in annual sales. Leclaza passed the Pharmacist Committee of 80 medical institutions within a year of the launch of the salary, and it is expected to grow more steeply in the second half of the year. Leclaza's recent excellent clinical results are also the background of optimism about market settlement. Recently released clinical results of Leclaza showed a meaningful figure that the median overall survival period was 38.9 months. The overall survival rate of the Leclaza-administered group was confirmed to be ▲ 90% of12 months, ▲74% of 24 months, ▲53 % of 36 months. Yuhan Corporation has secured a total of $150 million in technology fees through Leclaza. In November 2018, Leclaza was technically exported to Janssen Biotech, Inc., and at that time, it received a down payment of $50 million, which was not obligated to return. Yuhan Corporation received $35 million in milestones from Janssen in April 2020. At the time, Janssen began clinical trials of Amivantamab and Leclaza combination therapy, and provided additional milestones to Yuhan Corporation. In November 2020, Janssen paid an additional $65 million in milestones to Yuhan Corporation when it began recruiting subjects for the clinical trial.
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- Vyndamax is finally a step towards benefits
- by Eo, Yun-Ho Sep 02, 2022 06:03am
- Transthyretin cardiomyopathy new drug Vyndamax has finally made progress. According to related industries, Vyndamax, a treatment for ATTR-CM (ATTR amyloidosis with cardiomyopathy) caused by Transthyretin amyloidosis in Pfizer, recently passed the HIRA Pharmaceutical Benefit Standards Subcommittee. This is the result of his fourth attempt. As a result, attention is being paid to whether Vyndamax can succeed in registering insurance benefits beyond the remaining hurdles. Vyndamax failed to designate an essential drug in its first benefit challenge at the beginning of last year. After that, the second challenge was made through an economic evaluation in the first half of the same year and a risk sharing agreement (RSA), but the results were the same. And in April, it failed to pass the standard subcommittee again, and this time, it overcame a crisis. Vyndamax is virtually the only ATTR-CM treatment option. ATTR-CM has been mistaken for simple heart failure, even though its survival period is only 2-3 years if proper treatment is not received, or it has been considered a disease with poor treatment performance due to lack of any treatment. In this situation, Vyndamax is a drug that has reduced the occurrence of cardiovascular events in CM patients through phase 3 ATTR-ACT study and proved its improvement effectiveness in a six-minute walk test. In the ATTR-ACT study, 441 patients were randomly assigned to the Tafamidis 80 mg, Tafamidis 20 mg, and placebo-administered groups at a 2:1:2 ratio, respectively, and were hierarchically evaluated for all-cause deaths and cardiovascular-related hospitalization as primary evaluation variables in the study. The main secondary evaluation variables of the study were 6-minute walk test up to 30 months compared to the base point and changes in the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS) score, which means better health as the score is higher. As a result of the study, it was found that the Tafamidis-administered group had a statistically significantly lower risk of all-cause death and cardiovascular-related hospitalization compared to the placebo-administered group..
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- Q2 sales of Nexavar and Lenvima both sluggish
- by Kim, Jin-Gu Sep 02, 2022 06:03am
- Picture of Nexavar, Lenvima Sales of all major liver cancer treatments are on the decline. Sales of Nexavar (sorafenib), which had dominated the first-line treatment market for liver cancer for over a decade, is on a continuous decline since the entry of its generics, and sales of Nexavar’s main competitor Lenvima have also been shown to be slowing down recently. The industry expects the sales of Nexavar and Lenvima to fall further with the reimbursement applied to the Tecentriq+Avastin combination therapy as first-line treatment for liver cancer in Q2 this year. ◆Nexavar’s quarterly sales fall below ₩2 billion…affected by the entry of competitor drug and generics According to the market research institute IQVIA, Nexavar’s Q2 sales recorded ₩1.6 billion this year. This is a 31% drop from the ₩2.3 billion it had recorded in Q2 last year. Since its release in 2006 and reimbursement listing as a liver cancer treatment in 2008 in Korea, Nexavar had enjoyed its exclusive position in the market for nearly 10 years until the introduction of its competitor, Lenvima. However, Nexavar’s sales started to decline after Lenvima started to slowly exert its influence in the market. In terms of quarterly sales, Nexavar's sales had been on a steady decline since recording their peak at ₩7.1 billion in Q2 2018. Quarterly sales of Nexavar·Lenvima·Soranib (Unit: KRW 100 million, Data: IQVIA) In particular, sales had fallen to a greater extent with Hanmi Pharmaceutical’s release of its Nexavar generic Soranib in Q2 last year. The government had reduced Nexavar’s ceiling price by 30% ex officio from ₩18,560 to ₩12,992 last February. Due to this, Nexavar’s sales, which had recorded ₩5.2 billion in Q2 2020 dropped by over half, to ₩2.3 billion in just one year. Afterward, Nexavar’s quarterly sales continued its decline, falling below ₩2 billion in Q2 this year. ◆ Lenvima’s sales on the decline since Q4 last year... the aftermath of Tecentriq’s release Contrary to Nexavar’s sales, Lenvima’s sales continued to rise until Q4 last year. Lenvima’s sales, which stood at ₩0.9 billion in Q4 2018, had risen fivefold in three years to record ₩4.4 billion in Q4 2021. However, its sales have also been on the decline since Q4 last year. Its sales fell to ₩4 billion in Q1 this year, then to ₩3.7 billion in Q2 this year. Nexavar’s generic, Soranib, has also shown a similar trend. After recording sales of ₩160 million in Q2 with its release, Soranib’s sales increased to ₩580 million in Q3. However, its sales then fell to ₩450 million in Q4 last year, to ₩350 million in Q1 this year, then to ₩270 million in Q2 this year. Experts have pointed to the entry of Tecentriq as the reason why sales of Nexavar and its competitors have all fallen together. The indication of Roche’s immuno-oncology drug Tecentriq, in combination with Avastin, has been extended to first-line treatment of hepatocellular carcinoma in July 2020. In addition, the indication received reimbursement approval as a first-line treatment for hepatocellular carcinoma in May this year. In the industry, prospects that the sales of existing HCC treatments including Nexavar and Lenvima will continue to decline as the Tecentriq+Avastin combination demonstrated superior treatment effect over Nexavar. Although the combination’s lack of a second-line option remains unattended, the prevailing opinion is that the Tecentiq combination therapy will replace Nexavar or Lenvima in the frontline setting. At a clinical trial, the Tecentriq+Avastin combination had significantly improved overall survival (OS) and progression-free survival (PFS) and had shown a twice higher response rate when compared with Nexavar.
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- Japan first approved AZ Evusheld as Coronavirus tx
- by Sep 02, 2022 06:02am
- Japan approved AstraZeneca's long-lasting antibody complex Evusheld for the first time in the world for COVID-19 treatment. On the 30th (local time), Ministry of Health, Labour and Welfare of Japan approved the Evusheld as a prevention of symptomatic diseases caused by COVID-19 infection (pre-exposure prophylactic therapy) and a treatment for symptomatic diseases caused by COVID-19. Evusheld has been approved for COVID-19 prevention in Korea, the United States, and Europe and is being administered to high-risk groups. Furthermore, Japan allowed Evusheld to be used for treatment for the first time in the world. With the approval, the Japanese government purchased Evusheld for 300,000 people. For prevention, Japanese health authorities have allowed adults and adolescents aged 12 or older and weighing 40 kg or more to use the COVID-19 vaccine for immunodeficiency that does not show an appropriate immune response. For treatment, it has a risk factor for severe COVID-19 infection and can be used in adults and adolescents who do not need oxygen assistance. When used for treatment, twice the dose for prevention is administered. In the TACKLE phase 3 clinical trial conducted by AstraZeneca, Evusheld reduced the risk of severe progression or death of mild and moderate COVID-19 patients by 50%. Patients who received treatment within three days of symptom onset decreased their risk of developing severe disease or death by 88% compared to placebo. The risk reduction of administration within 5 days of symptom onset was 67%. Laboratory studies on major omicron mutations worldwide, including BA.5 and BA.2, have also shown that Evusheld maintains neutralization activity. Professor of Microbiological-Infectious Diseases at Toho University said, "COVID-19 continues to have a great influence on the daily lives of the Japanese people. There is still a high risk that the treatment results of severe COVID-19 can be bad in many people, including the elderly, patients with underlying diseases, and immunization degradation. He said, "Evusheld is a necessary new option, which will provide long-term preventive effects for people who do not have an appropriate immune response even after vaccination and help prevent seriousness and death in infected people."
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- Trelegy Ellipta lands in Big 5 tertiary hospitals in Korea
- by Eo, Yun-Ho Sep 01, 2022 05:56am
- The COPD treatment ‘Trelegy Ellipta’ has landed in general hospitals in Korea. The company has been making rapid entry into the market since its reimbursed release in June this year. According to industry sources, GSK Korea’s triple inhaled therapy for COPD (Chronic Obstructive Pulmonary Disease), “Trelegy Ellipta (fluticasone·umeclidinium·vilanterol)" has passed the review of drug committees (DCs) of 50 medical institutions nationwide, including the ‘Big-5’ general hospitals of Korea - Samsung Medical Center, Seoul National University Hospital, St. Mary’s Hospital, Severance Hospital, and Seoul Asan Medical Center. Trelegy Ellipta is the first triple combination therapy for COPD that was approved in Korea in May 2018. The drug can be prescribed as maintenance treatment for moderate-to-severe COPD in adult patients who are not adequately treated by a combination of a long-acting beta2- agonist (LABA) and inhaled corticosteroid (ICS) or a combination of a LABA and a long-acting muscarinic antagonist (LAMA). Its reimbursement is approved in Korea for the following three cases: ▲Patients whose FEV1
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- Imported shingles vaccine that has been suspended & delayed
- by Sep 01, 2022 05:56am
- The imported shingles vaccine is in short supply. This is because MSD's Zostavax has been out of stock for a while and the introduction of Shingrix, which was approved last year, continues to be delayed. According to the pharmaceutical industry on the 31st, Zostavax has been out of stock for about two months. MSD, which announced the news of its out of stock at the end of June, said it would resume supply at the end of July, but it is expected that it will not be able to supply again until September due to the postponement of the schedule. Zostavax was sold out in some regions due to a sudden increase in demand in 2020. In this regard, an MSD official said, "Zostavax is experiencing a short-term out of stock, and we are trying to speed up the lot release screening process as much as possible." "If we complete the process quickly, we expect to resume supply in early September," he explained. On top of that, GSK's new shingles vaccine Shingrix, which has been newly approved, has not been able to enter the domestic market for about a year due to continuous delay in its introduction schedule. Shingrix, which was approved by the Ministry of Food and Drug Safety in September last year, was originally scheduled to be released in February this year, but it continued to be delayed to the middle and second half of this year due to the delay in the introduction schedule. Shingrix was expected to rebound the size of the domestic shingles vaccine market. Recently, sales in the shingles vaccine market have been falling. According to IQVIA, a pharmaceutical market research firm, the size of the vaccine market for shingles prevention was KRW 45.1 billion last year, down 37.6% from KRW 72.3 billion a year earlier. In the first half of this year, it was also worth 20.4 billion won, almost no difference from the previous year. This is because many of the main target groups of shingles have been vaccinated, and in the case of shingles vaccines, they only need to be vaccinated once in their lives. After 8 years, the immune effect decreases, so additional vaccinations are recommended, but the additional vaccination rate is relatively low. The emergence of Shingrix is likely to increase the additional inoculation rate. Shingrix gained attention by demonstrating stronger shingles prevention effects than Zostavax. Clinical trials (ZOE-50) of adults aged 50 and older demonstrated a 97.2% ERA in 3.2 years of follow-up observation, and 3.7 years of follow-up observation (ZOE-70) showed 89.8% efficacy. Compared to Zostavax's 5% ERA in patients over the age of 50 and 41% over the age of 70. The industry predicts that Singrix will not be released this year at all. GSK is in a position that "no decision has been made on the schedule for introducing Singrix," which is bolstered by this prospect. GSK is also known to have decided on Singrix's domestic partner this year, but the release date is being delayed without any promise as the introduction in Korea is delayed. Some say that Singrix's global demand is increasing and it is not able to secure supplies to enter the country. This is because demand for Singrix, which had shrunk due to COVID-19, has risen significantly this year as it has been recovering since the second half of last year. In the first half of last year, Singrix's sales more than doubled from the same period last year to 1.429 billion pounds (2.26 trillion won). The industry this year, singgeuriksseu is looking to break sales a year.
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- Piqray can be prescribed in 18 hospitals
- by Eo, Yun-Ho Aug 30, 2022 05:54am
- Piqray, an anticancer drug targeting the PIK3CA gene, can be prescribed at a general hospital. According to related industries, Novartis' Piqray passed the Drug Committee of 18 medical institutions nationwide, including Samsung Medical Center, Seoul St. Mary's Hospital, and Seoul Asan Medical Center, as well as Bundang Medical Center and Korea University Anam Hospital. Piqray, approved in Korea in May last year, is a PIK3CAα inhibitor that blocks excessive activity of the PI3K pathway by inhibiting overactivation of PI3K-α due to PI3CA gene mutation, and is a target anticancer drug prescribed in combination with Faslodex in previously failed HR+/HER2-transitive and progressive breast cancer patients. However, Piqray is still a non-reimbursed drug. It submitted an application for benefits at the end of last year, but failed to pass at the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service in February. Novartis is currently working on a re-challenge to register insurance benefits. Piqray demonstrated efficacy through SOLAR-1 studies conducted on 572 menopause women and patients with advanced or metastatic breast cancer after receiving or receiving HR-positive, HER2 negative, and aromatase inhibitor (AI). Clinical results showed that when Faslodex and Piqray were used in tumor patients with PIK3CA mutations, the median value of PFS (Progress-Free Survival) in patients with PIK3 tumors improved by 5.7 months to 11 months. ORR, which represents the proportion of patients whose tumor size has decreased by at least 30%, also showed a combined therapy group of 35.7%, more than double the difference from the monotherapy group of 16.2%. The OS in PIK3CA mutant patients, a secondary evaluation variable, was 39.3 months in the combined therapy group, about 8 months longer than 31.4 months in the monotherapy group, but was not statistically significant. Sohn Joo-hyuk, a professor of oncology at Sinchon Severance Hospital, said, "we recommends a combination of Piqray and Fulvestrant therapy in category 1 for breast cancer patients with PIK3CA gene mutations in the NCCN guidelines. With the introduction in Korea, we can expect to overcome resistance to endocrine therapy."
- Company
- HIV tx Delstrigo is available in major national hospitals
- by Eo, Yun-Ho Aug 29, 2022 06:03am
- The HIV complex Delstrigo is available in general hospitals. According to related industries, Delstrigo, a fixed-dose HIV tx taken once a day by MSD Korea, has passed the D.C. of medical institutions such as Sinchon Severance Hospital, National Medical Center, Pusan National University, Kyungpook National University, Chonnam National University, and Seoul Medical Center. Due to the nature of HIV drugs, as prescriptions are mainly made at national hospitals, landing was conducted mainly at major national hospitals. The drug was approved in Korea in January 2020 and has been on the list since January last year. Delstrigo's indication is "treatment of human immunodeficiency virus (HIV-1) infection in adults who have no previous experience in antiretroviral treatment." As of November 22, 2019, 100 mg of Doravirine was approved by the Ministry of Food and Drug Safety under the product name Pifeltro, and is required to be administered in combination with other antiretroviral drugs. Both Pifeltro and Delstrigo received indications for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients with no previous antiretroviral treatment. Delstrigo confirmed its validity through DRIVE-AHEAD clinical trials. In the clinical trial, Delstrigo demonstrated non-inferiority compared to Efavirenz, Emtricitabine, and Tenofovir therapy. The proportion of patients who reached viral inhibition (less than HIV-1 RNA 40copies/mL) at 48 weeks was 84% in the Delstrigo treatment group and 80% in the EFV/FTC/TDF treatment group. The treatment discontinuation rates due to abnormal reactions were 3% and 6.6%, respectively, which were lower in the Delstrigo treatment group. Meanwhile, in the domestic market, Gilead, GSK, MSD, Janssen, Abbvie, and BMS are competing in the HIV field, of which Gilead and GSK account for about 90% of the market.
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- Pfizer Korea receives tax audit...files tax appeal
- by Aug 29, 2022 06:03am
- On why Pfizer Korea filed a “tax appeal” against the National Tax Service, the company said it had “duly instituted administrative procedures, judging that some of the imposed taxation standards were unreasonable,” refuting the allegations that the company was fined due to ‘cost overstatements.’ According to the pharmaceutical industry on the 26th, the National Tax Service levied fines on some Korean subsidiaries of multinational pharmaceutical companies including Pfizer Korea after tax audits. Pfizer Korea did not disclose the specifics on its amount, but the amount is estimated to be in the tens of billion won range. Pfizer Korea filed a tax appeal regarding the additional fine levied by the NTS on the company, claiming that the tax levied by the NTS was excessive. Pfizer Korea said, “A tax appeal can be filed based on the reasonability of the taxation standards, regardless of the amount. Judging that there were some unreasonable parts in the taxation standards, the company has been taking due process for the tax appeal.” The company stressed, “We have no intention to avoid taxes or exaggerate costs.” Pfizer Korea also drew the line on the so-called ‘cost overstatement’ allegations that were made, on the claim that the company had been writing the product's price higher than the existing price when importing products to increase profits for its headquarters. The company stressed that the imposed fines were irrelevant to sales of the company’s COVID-19 vaccine or oral treatment. The company explained, “the import price is set in consideration of various factors including the product’s cost and terms of transactions, etc.” The fines were imposed not due to cost exaggerations but as part of regular tax audits. In particular, the company added that “the fine was imposed on taxes paid in 2015-2020, at a time unrelated to COVID-19. The fines were levied as a result of a regular tax audit made every 5 years, regarding the taxes paid in 2015-2020, and has no relation to the company’s sales made related to COVID-19.” Pfizer Korea made nearly ₩1.7 trillion last year, ₩1.3 trillion of which is estimated to be from COVID-19 vaccines. In 2020, before COVID-19 vaccines were imported, Pfizer Korea’s sales had been in the ₩300 billion range. When adding the sales of its spin-off company, Viatris, the combined sales had been in the ₩600 billion to ₩700 billion range. Pfizer Korea said, “The company has been faithfully filing its tax returns and payments so far, and will be judged through due process of the taxation standards that are deemed unreasonable on the company’s part."
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- South Korea is looking forward to Xpovio's benefit
- by Aug 29, 2022 06:02am
- Xpovio, a treatment for multiple myeloma, succeeded in entering the benefit one after another overseas. Expectations are growing that the registration of overseas lists will have a positive effect on Korea, given that there has been no country to refer to drug prices. According to the pharmaceutical industry on the 25th, Canadian health authorities recently decided to reimburse for Antigen Pharmaceutical's new drug Xpovio, a multiple myeloma drug. Prior to this, it passed in Australia in March. Canada and Australia are not included in the A7 countries (US, UK, Germany, France, Italy, Switzerland, and Japan), which are drug reference countries. However, the domestic outlook is also bright as two countries with insurance registration systems similar to Korea have succeeded in registering insurance one after another. On top of that, last month, the European Commission (EC) approved Xpovio as a treatment for multiple myeloma. In the pharmaceutical industry, it is observed that benefits will be made in each country in Europe, starting with Germany and Switzerland. Xpovio received an item license from the Ministry of Food and Drug Safety in July last year. However, it has not passed the cancer disease review committee under the HIRA for a year. A review process, but was rejected. Because there is no suitable overseas country to refer to the drug price, Korea calculates the appropriate domestic drug price by referring to the drug price of seven overseas countries. Previously, xpovio was entered by permit only in the country, Medicaid and other benefits. But the drug price of the United States only appropriate that hard to calculate for the price of a position of the health authorities. That is currently released in January, the deliberative committee for the amjilhwan a xpovio, after failing to set wage did not meet the criteria number of benefits seven countries listed is sitting at a standstill, all the way. Multiple myeloma patients are asking for its speed in Australia and Canada for the price of a reference to benefits. Minhwan Back, the chairman of the KMPG said, "a third round of multiple myeloma after then developed an immunity to period is very quickly relapse. Xpovio is the only drug that can be used in the fifth round, but it is very economical because it can only be treated with non-reimbursement." He said, "Patients who failed the fourth treatment are waiting for the news of their benefits with the feeling of grasping at straws, Xpovio will be listed as soon as possible and give hope to patients who are in a difficult situation." The company position is to speed to the benefit is granted a measure of the station. The gimminyeong of Tianjin, the pharmaceutical representative said, "I am happy, and the results of a good rating agencies and other countries, waiting for a drug the molting season early to think I will try to local benefits can be made as soon as possible"
