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- 2026-04-11 19:53:32
- 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.
- Policy
- Drugs granted conditional approv to report clinical progress
- by Lee, Hye-Kyung Sep 05, 2022 05:55am
- Treatments for life-threatening serious and rare diseases are being granted conditional approval from July 21st this year. However, to inform the public of the conditions, items for which data on confirmatory clinical trials were not submitted should be specified in the label’s indication, and the clinical trial status of the subject drugs needs to be reported to the Minister of Food and Drug Safety by March 31 each year. At a trade journal correspondent briefing that was held on the 30th, Soo-Jeong Lee, Director for Approval Management of the Ministry of Food and Drug Safety, said, “With the amendment of the Pharmaceutical Affairs Act and the amendment of the Regulation on Safety of Medicinal Products, etc. that followed in July, the MFDS has been granting conditional approval to treatments for life-threatening diseases such as cancer or rare diseases based on Phase II trial data. We are preparing a guideline to inform the public about this conditional approval system.” In line with the act, the MFDS released the “Guidelines for Management of Drug Items granted Conditional Approval” on the 1st to reflect the amendments recently made to the law, including subjects for conditional approval, to improve the transparency and predictability in the operation of the conditional approval system. The conditional approval system allows for the MFDS to grant marketing authorization to drugs that are used for cancer, life-threatening rare diseases, and drugs used in emergency situations, to expand treatment opportunities for the patients under the condition that the Phase III trial (confirmatory trial) results are later submitted. When a pharmaceutical company applies for conditional approval for its product to the MFDS, the Central Pharmaceutical Affairs Council holds a meeting to assess the completeness and suitability of the conditional approval on the item. The approved drug's indication must specify that “no confirmatory trial data that demonstrates the efficacy of the drug exists, or “the efficacy of the drug is evidenced by its response rate and period, and there is no available data on its improvement of overall survival in a therapeutic confirmatory trial.” The approval is provided under the condition that clinical trial data on administered patients, etc. submitted within a separately stipulated period to confirm the drug’s safety and efficacy on the human body. The specified indication and condition are deleted when the conditions are fulfilled in the future. However, if a domestic or overseas clinical trial has not yet been approved for a therapeutic confirmatory trial, the clinical trial protocol must be submitted post-approval. Items that received conditional approval must report their clinical trial status on administered patients to the Minister of Food and Drug Safety by March 31st every year. If there is a separate regular reporting schedule set for the item, clinical data on the item may be reported on that reporting date. However, the conditional approval is revoked if ▲the approval was obtained by fraudulent or other illegal means, ▲if the company that has obtained the conditional approval for the item fails to comply with the conditions without justifiable reasons, or ▲the company that has obtained the conditional approval for the item fails to report under Article 35-2 (1) or does not fulfill the measure order under clause (2) of the same article. Lee said, “The conditional approval is granted under the condition that the Phase III trial results are submitted by a specified date. As the public and medical professionals may not be aware of the conditional approval that is granted, we have prepared a guideline to specify that the approval has been granted, and its Phase III trial is currently underway.”
- 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.
- Policy
- MFDS has launched permission review for Pfizer Comirnaty 2
- by Kim, Jung-Ju Sep 05, 2022 05:55am
- Pfizer's COVID-19 2-valent vaccine Comirnaty2 0.1mg/mL permission review has begun. The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced that Pfizer Korea has applied for permission today (29th) to import 0.1mg/mL of Comirnati 2, an mRNA-type bivalent vaccine that expresses the initial COVID-19 virus and mutant virus (Omicron periphery BA.1) antigens, respectively. Comirnaty 2 0.1 mg/mL shows the preventive efficacy of COVID-19 caused by the SARS-CoV-2 virus at the age of 12 and has been developed for use in additional vaccinations after basic vaccination. The authorities will quickly and closely review the clinical, nonclinical, quality, and GMP data submitted when applying for the item license, and consult vaccine experts, including infectious medicine experts, on the safety and effectiveness of the vaccine. The Ministry of Food and Drug Safety explained that Pfizer is conducting a review as it applied for a preliminary review of 0.1 mg/mL of Comirnaty 2 clinical data on the 5th. The Ministry of Food and Drug Safety said, "We will continue to do our best to supply safe and effective vaccines to our people."
- 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..
- Policy
- Will Migraine drug Ajovy be reimbursed following Emgality?
- by Lee, Tak-Sun Sep 02, 2022 06:03am
- With the new migraine drug Emgality (galcanezumab, Lilly) being applied reimbursement in Korea starting this month, a green light has been given to Teva-Handok’s new migraine drug as well. The new drug has passed the reimbursement adequacy assessment of the Health Insurance Review and Assessment Service, after which the company will be entering pricing negotiations with the National Health Insurance Service. The NHIS announced on the 1st that it decided that Teva’s Ajovy prefilled syringe and autoinjector (fremanezumab) were adequate for insurance reimbursement at the 9th Drug Reimbursement Evaluation Committee (DREC) meeting. The drug, which is used for migraine prevention, is also a gene-related peptide (CGRP) targeting drug like Emgality, which was listed for reimbursement at ₩295,250 this month. Emgality’s price is expected to be used as a reference in reimbursement negotiations for Ajovy in the future. Meanwhile, the tuberculosis treatment ‘Dovprela Tab 200mg (fremanezumab, Viatris Korea)’ that was reviewed at the same meeting received a conditional nod and was assessed as adequate for reimbursement if the company accepts a price lower than the assessed price. The drug is used to treat adult patients with pulmonary extensively drug-resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).
- Policy
- The MFDS reviews Pfizer's vaccine permission for infants
- by Lee, Hye-Kyung Sep 02, 2022 06:03am
- The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced on the 1st that Pfizer Korea has begun reviewing the item as it applied for permission for imported items of the early COVID-19 vaccine for infants (6 months to 4 years old). The efficacy of "Comirnati 0.1mg/mL (for ages 6 months to 4 years)" applied this time is "Prevention of COVID-19 by the SARS-CoV-2 virus at ages 6 months to 4 years old," and the active ingredients are the same as "Comirnati 0.1mg/mL" (5 to 11 years old) approved by the MFDS. It plans to quickly and closely review clinical, nonclinical, quality, and GMP data submitted when applying for the item license, and consult vaccine experts, including infectious medicine experts, on the safety and effectiveness of the vaccine. Moderna applied for permission for early COVID-19 vaccine items that can be inoculated from more than six months on June 3 and is currently under review.
- 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.
- Policy
- Tylenol ER, voluntarily withdrawn, will be maintained
- by Kim, Jung-Ju Sep 02, 2022 06:03am
- Along with the withdrawal of Janssen Korea's Hyangnam plant, the suspension for Tylenol ER 8 hrs and children's Tylenol suspension, which were voluntarily withdrawn due to item maintenance, will be maintained until this year. The insurance drug product code of nursing institutions will continue to be maintained until the end of the year and can be sold. On the 31st, the MOHW issued a notice of extension of the grace period for the "drug benefit list and upper limit price table" and decided to extend the grace period for these drugs, which had been maintained as an August deadline, until December 31. Earlier last year, Janssen Korea decided to withdraw its Hyangnam plant, and maintained some of its drugs by withdrawing permission or converting them to export. Among them, the Tylenol series was also included in the maintenance, and the product license for these two drugs was voluntarily withdrawn. Under the Health Insurance Act, the MOHW decided to delete voluntary withdrawal benefits as of February 21 this year as a follow-up measure, as the basic premise is to obtain a license for items from the MFDS. The MOHW usually gives a grace period of three to six months for pay drugs that withdraw from the market, unless they are drugs that have safety problems. This is because the deadline for drug exhaustion, which is already distributed in the market, is expected to be 2-3 months at the shortest and 6 months at the longest. Considering the measures decided at the end of February this year, the deadline for payment of the drugs distributed so far is the end of August. However, it is necessary to extend the grace period for Tylenol 8hrs ER and Children's Tylenol suspension, considering the situation such as the shortage of cold medicines and the imbalance in supply and demand as much as possible. As a result, the Ministry of Health and Welfare changed the insurance benefit deadline for these two drugs and decided to allow them to be paid by December 31.
