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- 2025-12-24 21:46:20
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- Zolgensma, which is the same price as an apartment
- by Moon, sung-ho Sep 08, 2022 05:58am
- With ultra-high-priced treatments from global pharmaceutical companies newly entering the benefit range this year, human "risk management" is emerging as an issue at clinical sites. Since the treatment is so expensive, "risk" management issues such as damage and loss that may occur during administration are acting as a key issue. #Kymriah, the CAR-T treatment of Novartis Korea, which entered the benefit range this year, and Zolgensma, the treatment of Spinal Muscular Atrophy (SMA), are representative. According to the pharmaceutical industry and the medical community, Novartis Kymriah Korea has been applied as a health insurance benefit since April, and it has been confirmed that it has been administered not only at university hospitals in the Seoul metropolitan area but also at university hospitals in provincial areas. Zolgensma, who has newly entered the health insurance benefit zone since August, has passed the Drug Committee (DC) of major Big 5 hospitals, including Seoul National University Hospital and Seoul Asan Hospital, and is preparing to administer patients in earnest. As expensive treatments, which cost hundreds of millions of won alone, are administered in earnest at the clinical site, "risk management" that may occur is emerging as a key issue. For example, the question is who will be responsible for the damage or loss of the treatment in the process of handling patients with expensive treatments. This is because the price of the treatment is expensive, so both hospitals and pharmaceutical companies can be burdened depending on where they are responsible. Moreover, in Korea, it is recognized as a bigger problem because there is no insurance system that can be called a safety device in preparation for the human risk of such expensive treatments. However, there is a difference if Kymriah and Zolgensma are directly compared in terms of risk management. First of all, Kymriah, which entered the benefit range, is a pair due to the nature of the treatment, that is, a system that prepares two treatments in case of an emergency. An official from Novartis said, "In the case of Kymriah, due to the nature of the treatment, two treatments are prepared in case of an emergency." He explained the background, "As we make a treatment with T cells collected from the patient's blood, we can make two treatments with the same sauce." Kymriah reached up to 500 million won in the United States for a single administration, but in Korea, the patient's burden was lowered to up to 5.98 million won as it was set at 360.4 million won through drug price negotiations. Against this background, Um Ki-sung, a professor of blood medicine at Seoul St. Mary's Hospital, said, "In the process of introducing Kymriah, Novartis said that he would not receive drug costs if it was not actually administered, regardless of who did it wrong." Professor Um Ki-sung explained, "If a patient receives a lot of chemotherapy during the three-week administration, lymphocytes may not be extracted or cells may not come out." Professor Um said, "This means that pharmaceutical companies will not take issue with this and will only receive the drug price when the administration is completed." The problem is Zolgensma, which domestic drug price has been set at nearly 2 billion won. This is because the characteristics are different from Kymriah itself and there is no insurance system to prepare for risks that may occur during the administration process. In particular, in the case of Zolgensma, it is also worrisome that it differs from Kymriah in that the process is different, such as putting genes in vectors and transporting them so that they do not die. For this reason, there are opinions among large hospitals that are concerned about this. On top of that, Evrysdi, which is considering salaries as SMA treatments following Zolgensma, is also said to have to come up with a safety device for human risk. In this regard, the HIRA, which is considering benefits, reportedly asked pharmaceutical company Roche to come up with a plan. As Evrysdi is an oral drug, it means that safety devices should be prepared to prevent risk of patient loss. This is because Evrysdi will not have a high drug price compared to Zolgensma and Spinraza, but it is widely expected that it will be set as a burdensome drug price for patients. Novartis is in a position to discuss the plan with hospitals as it is scheduled to be administered in earnest according to the application of Zolgensma benefits. "Since it is an expensive treatment, it is not easy for hospitals and pharmaceutical companies to pay for it," a Novartis official said. "In the near future, Seoul National University Hospital is discussing how to manage risks and has been partially coordinated." "I think we will need to continue discussions in the future," he explained. He said, "I checked the insurance company in terms of human risk safety, but there is no insurance company that covers it." He added, "There is no internal determination of responsibility at the moment, but since it is the first time, we have to continue to discuss it in the future.".
- Company
- Godex’s price to be cut further under PVA
- by Nho, Byung Chul Sep 07, 2022 05:52am
- Celltrion Pharm’s liver disease treatment Godex cap. is experiencing ‘double trouble,’ being subject to Price-Volume Agreement negotiations after reimbursement reevaluations. According to industry sources, Godex’s price will be cut by ₩15 per capsule (4% reduction) from ₩371 to ₩356 as of the 1st of this month. Until now, Godex’s price had been discounted 11 times, from ₩434 in 2009 to ₩433 in 2011, to ₩431 in March 2016, to ₩422 in December 2016, to ₩422 in February 2017, to ₩413 in November 2017, to ₩402 in 2018, to ₩388 in 2019, to ₩376 in 2020, to ₩371 in 2021, to finally reach ₩356 in September this year. Godex, which was approved in Korea in 2000, is a combination of Biphenyldimethyldicarboxylate (main ingredient), Cyanocobalamin, Adenine Hcl, Carnitine Orotate, Pyridoxine Hcl, and antitoxic liver extract. Although its patent had become expired due to difficulty demonstrating bioequivalence, no generics have been released as of yet. The drug, which had enjoyed exclusivity in the market over the past 23 years due to this reason, is under adjustments after filing an appeal after the Health Insurance Reimbursement and Assessment Service failed to recognize the adequacy of its reimbursement during reevaluations, and its course of direction will be decided upon soon. In addition to the rise of such situational variables, Godex also became subject to management under the Price-Volume Agreement system and was cut ₩15 per capsule, hampering the product’s external growth. Even excluding the potential threat of reimbursement reevaluations, Godex will incur a ₩2.4 (4%) drop in annual sales from its current ₩60 billion in annual sales. Meanwhile, the PVA system was implemented with the positive-listing system to improve drug price management and encourage appropriate use of NHI finances. The PVA system discounts a drug’s price by up to 10% through negotiations between the pharmaceutical company and NHIS for products whose use volume had exceeded a certain rate. The system is largely categorized into those applied to new drugs and generic drugs, as ▲Type A (new drug); ▲Type B (new drug); ▲Type C (drugs and generics listed without negotiations). Type A applies to cases where the volume of the estimated claims exceeds the volume negotiated with the NHIS by over 30%. Type B applies to claims volume increases by ① over 60% from the previous year, or by ② over 10% and exceeds ₩5 billion for drugs in the same therapeutic class for which the maximum volume had already been adjusted according to type A. Drugs fall under Type C when claims of products in the same therapeutic class ① increase by over 60% from the volume of claims filed in the previous year, or ② has increased over 10% but the increased volume exceeds ₩5 billion and does not fall under PVA Type A or Type B. However, drugs with an annual claims volume less than ₩1.5 billion, whose ceiling price is less than the arithmetic average of other same-ingredient drugs, and Drug Shortage Prevention Program drugs are not subject to PVA.
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- Poziotinib responds 100% to pts with lung cancer mutations
- by Sep 07, 2022 05:52am
- Poziotinib, a new lung cancer drug exported by Hanmi Pharmaceutical, was found to have a significant effect on the G778 mutation, which is common in patients with HER2 Exxon20 insertion mutation. As a result of ZENITH20 clinical subanalysis, 12 patients showed 100% response, and PFS was also longer than other HER2 Exxon20 mutants. In particular, when Poziotinib was first used, the PFS reached 9.8 months. ESMO pre-released a draft of clinical studies scheduled to be announced ahead of the opening of the academic conference on the 5th (local time). Further analysis results of ZENITH20 clinical trials conducted by Hanmi Pharmaceutical partner Spectrum Pharmaceuticals were also published. Poziotinib is a pan-HER2 anticancer drug that Hanmi Pharmaceutical transferred technology to the spectrum in 2015. Spectrum has taken over the right to develop and commercialize Poziotinib in countries around the world except Korea and China. At the end of last year, Spectrum filed an application for Poziotinib's permission with the U.S. Food and Drug Administration (FDA) based on the results of the cohort 2 study among the ZENITH20 Global Phase 2. The official review process will begin in February and an advisory committee will be held this month. The data released this time is the result of confirming the effect of Poziotinib in the patient group with the G778 mutation among subtypes of non-small cell lung cancer with HER2 Exxon20 insertion mutation. According to the spectrum, the G778 mutation is one of the most common submutants found in 9-19% of patients with HER2 Exxon20 insertion mutation. Of the 170 patients who participated in the ZENITH20 study, a total of 14 patients showed G778 mutations among non-small cell lung cancer patients with HER2 Exxon20 insertion mutations. They were included in cohort 2 and cohort 4, respectively. Cohort 2 is for patients with past treatment experience, and Poziotinib 16mg was administered (QD) per day. Cohort 4 administered one pill a day of Poziotinib 16mg or two tablets a day (BID) of 8mg to patients with no history of treatment. As a result of analyzing 12 people who can be evaluated out of 14, all of them (100%) showed PR, and the DoR median value was 5.5 months. The median PFS was 7.8 months. In particular, in the case of cohort 4 consisting of patients with no treatment experience, the median PFS value reached 9.8 months, which was superior to the group of patients without G778 mutation. The PFS of the patient group without G778 mutation was 5.5 months in cohort and 45.6 months in cohort. Side effect profiles were similar to existing TKI ratings. Spectrum commented, "No treatment experience or Poziotinib was effective in G778."
- Company
- Kisqali’s sales surge, Ibrance’s sales falter
- by Sep 06, 2022 05:51am
- Competition for breast cancer-treating cyclin-dependent kinases (CDK) 4/6 inhibitors in the market are heating up. Kisqali, which was the last to enter the market, has grown rapidly in the first half of this year and exceeded sales of the runner-up product in the market, Verzenio. Ibrance, the sole leader in the market, has also seen a downfall in semiannual sales for the first time this year. According to the market research institution IQVIA, the domestic market size for CDK 4/6 inhibitors in 1H this year was ₩44.5 billion, an 8.4% increase from the ₩41.1 billion of the previous year. CDK 4/6 inhibitors control cell division and growth and selectively inhibit the proliferation of cancer cells. The drugs are mainly used to treat hormone receptor (HR)-positive or human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, which accounts for 60% of all breast cancers. Since the entry of the first CDK 4/6 inhibitor, Pfizer’s Ibrance (palbociclib) 6 years ago, Lilly’s Verzenio (abemaciclib), and Novartis’s Kisqali (ribociclib) followed, totaling the number of CDK 4/6 inhibitors in the market to 3. Ibrance, which overtook the market as a 'first-in-class' drug, experienced its first decrease in sales, recording ₩28.9 billion, down 11.3% from the ₩32.6 billion of the previous year. Ibrance, which had entered the market 3 years ahead of the other two products, has been leading the CDK4/6 inhibitor market emerging as a new treatment option for breast cancer patients who had to use chemotherapy, which had many systemic side effects. Its sales also grew every year and recorded ₩40 billion in annual sales during its unrivaled 3 years in the market. Last year, the drug saw sales of ₩65.6 billion. However, with the first-ever reduction in sales shown in the first half of this year, it is highly likely that its annual sales will also fall for this year. On the other hand, Kisqali, which was the last to enter the market, has shown marked growth during the same period. Kisqali sold ₩9.7 billion in the first half of the year, a 236.6% increase from the ₩2.9 billion it had made the previous year. Such an increase in Kisqali’s sales is expected to hurt Ibrance’s sales. Kisqali’s sales had first exceeded ₩1 billion in quarterly sales in Q4 2020 when it first started receiving insurance reimbursement. Since then, its sales had risen continuously to surpass that of Verzenio for the first time in Q3 last year. This year, the drug continued to make sales far exceeding that of Verzenio, making ₩4.4. billion in Q1 and ₩5.3 billion in Q2 this year. The analysis is that the rise in Kisqali‘s sales is attributable to the fact that it is the only first-line treatment option among CDK4/6 inhibitors that can be used in premenopausal breast cancer patients. Reimbursement for the drug had been extended to premenopausal breast cancer patients who had failed ‘adjuvant chemotherapy’ since Q3 last year, further accelerating sales of the drug. Although it is the only drug among CDK4/6 inhibitors that require ECG monitoring before initiating treatment, it had improved reliability by demonstrating consistent overall survival (OS) improvement in premenopausal, perimenopausal, and postmenopausal patients. Verzenio’s sales rose 5% YoY to record ₩5.9 billion in 1H this year. Verzenio’s sales have also been steadily increasing, but at a rate slower than that of Kisqali, and has been recording quarterly sales in the ₩2 billion range for 5 consecutive quarters.
- Company
- Prevenar 13 set to make ₩40B this year
- by Nho, Byung Chul Sep 05, 2022 05:55am
- Pfizer’s Prevenar 13 was found to be maintaining its overwhelming 70% share in the pneumococcal vaccine market. According to its distribution & shipment performance data, sales of Prevenar 13 in 1H this year reached ₩19.4 billion, and its annual sales are expected to exceed that of the ₩38.1 made last year. In terms of growth, the growth of its competitor, MSD’s Prodiax 23, is slightly ahead. The product’s 1H sales were ₩8.5 billion, and if it maintains the status quo, its gross sales will exceed that of the ₩14.8 billion it had made in 2021. To strengthen its capabilities, Pfizer joined forces with Chong Kun Dang, one of the strongest players in sales & marketing at general hospitals and clinics in Korea. Since then, sales of Prevenar 13 have been slowly recovering after dipping downward due to the aftermath of the COVID-19 pandemic. Prevenar 13 had made a record performance in 2020, grossing ₩81.3 billion, a quantum leap from the ₩50 billion it had made in 2018 and 2019. The analysis is that such a rise in sales of Prevenar 13 in 2020 was due to a temporary surge in demand caused by concerns about worsening pneumonia symptoms caused by COVID-19 acute respiratory syndrome. After the supply and demand for COVID-19 vaccines and treatments, such as Paxlovid, became stabilized and the situation is nearing an endemic, sales are returning to place. In terms of maximum performance, Prevenar 13 had sold 5.5 times more products than Prodiax 23. However, in terms of market penetration, Prodiax 23 has better penetrated the market, drawing a steady upward curve in its share without ups and downs. Prodiax 23’s gross sales have drawn an upward S curve from 2018 to 2021, rising from ₩0.34 billion in 2018 to ₩0.5 billion in 2019 to ₩14.7 billion in 2020, then to ₩14.8 billion in 2021, the growth is evaluated as an encouraging phenomenon in terms of marketing growth potential. Meanwhile, Prevenar 13 prefilled syringe inj. was approved in 2010 for the “prevention of invasive pneumococcal disease caused by streptococcus pneumoniae (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F).” Prodiax 23 and Prodiax 23 prefilled syringe, approved in 2000 and 2016 respectively, are indicated for the “prevention of pneumococcal disease caused by vaccine-containing streptococcus pneumoniae capsule,” and their efficacy in preventing pneumococcal pneumonia and bacteremia has been demonstrated in controlled clinical trials and case-control studies that were conducted in South Africa and France.
- Company
- What are the chances of Dovprela's successful benefits?
- by Eo, Yun-Ho Sep 05, 2022 05:55am
- Attention is focusing on whether the new tuberculosis drug Dovprela, which appeared in 50 years, can be listed on the insurance benefit list. According to related industries, Viatris Korea's Dovprela passed the HIRA Pharmaceutical Benefit Evaluation Committee on the 1st. Dovprela, which was approved in Korea in October last year after U.S. approval in September 2019, can be used as a combination of three types of therapy with Bedaquiline and Linezolid in adult patients with extensive drug-resistant pulmonary tuberculosis, treatment-resistant or non-reactive multidrug-resistant tuberculosis. This drug is the first new treatment in more than 50 years. The TB treatment market has been shunned by front-line pharmaceutical companies for its poor drug economy. Dovprela is a drug created through collaboration with a non-profit organization called "TB Alliance" with Viatis. Multidrug-resistant tuberculosis is resistant to two or more tuberculosis treatments, including Isoniazid and Rifampicin, which are the two most effective anti-tuberculosis drugs for tuberculosis treatment, and is not treated with the treatment. The causes of the outbreak are divided into primary resistance and acquisition resistance, which are infections with resistant tuberculosis bacteria from the beginning, and acquisition resistance is when resistance is acquired during treatment due to arbitrary discontinuation of drug use and irregular administration. Multidrug-resistant tuberculosis has a treatment success rate of only about 50%, so the treatment efficiency is low, and secondary drugs used for treatment have more side effects than primary drugs. Since the treatment period is also long, 18 to 24 months, the cost burden is high, and in some cases, lesions must be removed through surgery. The combined treatment of seven drugs, including Bdq, which are currently used in the standard treatment of multidrug-resistant tuberculosis, is not well used in Korea due to its high drug resistance rate, and the treatment period is still 9-12 months, making it difficult for patients to manage medication and the treatment failure rate high. Dovprela demonstrated its efficacy through a phase 3 clinical Nix-TB study. Dovprela is a combination of three treatments (BPaL) with Bedaquiline and Linezolid, showing a successful treatment effect of 92% in the multidrug-resistant tuberculosis group and 89% in the broad drug-resistant pulmonary tuberculosis group in six months, confirming its potential as a new short-term combination therapy. The existing treatment period of 18 to 24 months was shortened to 6 months, and within 16 weeks, almost all patients with drug-resistant pulmonary tuberculosis and multidrug-resistant tuberculosis were confirmed to have sputum culture negative. BPaL therapy is a combination of ready-to-use therapy consisting only of oral drugs, with fewer drugs than the treatment guidelines recommended to administer at least four drugs to intensive care units, and showed complete data in about 90% of patients with extensive drug-resistant tuberculosis during 6-month treatment.
- Company
- 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.
- Company
- 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..
- Company
- 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.
- Company
- 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."
