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- 2025-12-23 20:00:40
- Policy
- AZ vaccine’s import authorization still under review
- by Lee, Tak-Sun Apr 21, 2021 05:50am
- Attention has been rising on the reason for the delayed approval of the imported AstraZeneca’s COVID-19 vaccine, which was the first vaccine to submit its application in Korea. Although the Ministry of Food and Drug Safety (MFDS) had shortened the review period to 40 days, 3 months have passed and no news on the approval of the imported product has been heard to date. This means that Korea’s procurement of AstraZeneca vaccines depends solely on the local supply produced by SK Bioscience. On January 4th, AstraZeneca had submitted two applications for its vaccine; one for the manufacture and marketing authorization of its products manufactured by its CMO SK Bioscience, and the other for the import authorization of products manufactured outside of Korea, including those from Italy. The ‘Korea AstraZeneca’s COVID-19 Vaccine Inj.’ which is manufactured under a CMO deal by SK Bioscience was been approved on February 10th and became the first COVID-19 vaccine to receive marketing authorization in Korea. The approval process took only 40 days through a rolling review by MFDS. However, the application for the imported product that was submitted the same day is still under review. Regarding the matter, an MFDS official explained, “The GMP site data is known to be insufficient. It seems that the submission of supplementary data by the company is being delayed due to the global use of the vaccine.” However, he added that the review process will not take long. Among the AstraZeneca vaccines in use, 1.57 million doses (for 780,000 people) that were secured via independent contracts were approved for national lot release on February 17th. However, due to the limited supply, authorities are having trouble speeding up the vaccination process. Fortunately, an additional 7 million doses are expected to be introduced from May to June to be used for vaccination of those aged 65 or older However, regrets remain as the approval of the imported vaccine would have made procurement much easier. 3 types of vaccines – Pfizer and Janssen’s vaccines in addition to the AstraZeneca vaccine produced by SK bioscience – are currently approved in Korea. On the 12th, GC Pharma, which is responsible for the domestic distribution of the Moderna vaccine, applied for approval. All vaccines other than the AstraZeneca vaccine are imported products. The prevailing opinion is that we need more locally manufactured vaccines for better procurement. In the same line, the possibility of Moderna establishing a subsidiary in Korea for local production of vaccines has been raised. In the ‘Moderna plans to establish a subsidiary in Korea’ report, Byung-Gook Park, a researcher at NH Investment & Securities stated that “Moderna had mentioned the possibility of establishing a subsidiary in Korea in its second Moderna Vaccines Day held on the 15th. It plans to strengthen its vaccine capability by establishing subsidiaries in Korea, Japan, and Australia this year.” For a locally manufactured Moderna vaccine to be introduced to the market, the company would need to submit an additional marketing authorization application for the drug to MFDS.
- Policy
- The domestic COVID-19 vaccine is still some way off
- by Lee, Jeong-Hwan Apr 21, 2021 05:49am
- It was pointed out that amid intensifying competition in countries around the world over the supply and demand of COVID-19 vaccine, there is a low possibility that a domestic vaccine will be marketed within this year, increasing public anxiety. Compared to the fact that about three domestic-made COVID-19 treatments are expected to be marketed within the year, domestic vaccines are planned to be used in a phase 3 clinical trial at the end of the year, so they can only be approved for use next year. This was revealed through the 'COVID-19 Treatment and Vaccine Domestic Clinical Support Status' data submitted by the KHIDI. It is estimated that the government is supporting ￦71 billion for R&D for the development of a domestic COVID-19 treatment and ￦34 billion for the vaccines. The domestic companies that are developing COVID-19 treatments that are receiving government support are 4 pharmaceutical companies including Celltrion, and 5 pharmaceutical companies including SK Bioscience for vaccines. In the case of COVID-19 treatment, Celltrion's Regkirona received CMA in February of this year and is using it, and the blood system treatment under development of GC Pharma is also scheduled to apply for CMA in April. Daewoong is receiving support for the development of two treatments, and CMA is expected in the second half of this year. As for the vaccine, SK Bioscience, Genexine, Geneone Life Science, CELLID, and EUBIOLOGICS are in clinical trials with government support. However, it is currently in the early stages of phase 1 or 2 clinical trials, and it is expected to enter phase 3 in the second half of this year, so it is unlikely that marketing approval will be possible within this year. Rep. Jeon Bongmin said, "Recently, people are feeling anxious about the supply and demand of COVID-19 vaccine. It is regrettable that the development of this year is difficult in the current situation." He added, "The government should prepare measures to relieve public anxiety related to the supply and demand of vaccines as soon as possible."
- Policy
- Donepezil patch has been applied for permission
- by Lee, Tak-Sun Apr 19, 2021 05:56am
- Donepezil patch (Source: Icure)While Icure applied for permission for the world's first dementia treatment Donepezil patch, it was found that domestic competitors are still in the Phase I stage. Icure is expected to preoccupy the domestic market if it obtains a license because it is faster to commercialize than its competitors. In particular, Donepezil is most often used for the treatment of dementia, and due to the characteristics of dementia patients, it is expected that it will become a competitive drug for the original Aricept because it is a patch formulation that is applied rather than an oral formulation. On the 13th, Icure and Celltrion announced that they applied for an item license for Donerion patch for Alzheimer's dementia treatment with the MFDS. The Donerion patch was developed by Icure, and after completing phase I clinical trials, a joint domestic copyright contract was signed with Celltrion. Icure conducted phase III clinical trials in about 400 patients with mild and severe dementia in four countries, including Korea, Taiwan, Australia, and Malaysia, proving non-inferiority compared to oral Donepezil. Donepezil patch is currently not commercialized worldwide. Icure will begin applying for permits in Korea and will proceed with worldwide development. In March, the US FDA applied for a phase I trial protocol. The sales volume of the domestic Donepezil market is about ₩230 billion, and the global market is known to be around ₩7 trillion. Because the patch has good patient compliance, it is expected to rapidly erode the market share of existing oral drugs. After launch, Icure aims to achieve 50% of the domestic market share of Donepezil. In particular, as it is ahead of competitors in terms of commercialization speed, Icure is expected to dominate the market through patch formulation. Domestic pharmaceutical companies that are currently developing the Donepezil patch are Dong-A ST, Daewoong, and Boryung. The three companies are currently in phase I. In the case of Dong-A ST, both clinical phase Ia to evaluate safety, tolerability, and pharmacokinetic characteristics when administered once and phase Ib to evaluate safety, pharmacokinetic and pharmacokinetic characteristics during repeated administration have been completed. Initially, Dong-A expected that it would be possible to apply for permission if it confirmed equivalence through Phase I clinical trials, but it is known that the MFDS is also requesting long-term safety data. In addition, since Icure applied for approval through phase III clinical trials, if the application for approval was accepted only in phase I clinical trials, it is expected to raise issues in terms of equity. Dong-a is also preparing for clinical trials in India. Boryung has completed Phase Ia clinical trials and is analyzing the results. Boryung has also conducted joint development with Icure in the past, but has now moved to Celltrion. Instead, Boryung is working with Raphas on commercialization development. In May of last year, it took its first clinical steps. Daewoong was approved for Phase I clinical trial in July 2019, but it is said that it has not been completed. If the MFDS demands them for phase III clinical trials, the completion of commercialization will be further delayed. Therefore, if Icure and Celltrion receive product approval, the possibility of preoccupying the market as the first product will increase. Since the patch is a product that competes with original Aricept, it is expected to lead the entire dementia treatment market.
- Policy
- Abbott Korea·Medtronic Korea caught subsidizing doctors
- by Lee, Tak-Sun Apr 19, 2021 05:56am
- Abbott Korea Co. and Medtronic Korea Co. were found to have unfairly supported doctors to participate in overseas seminars to encourage the use of their cardiovascular stents. As a result, the Korea Fair Trade Commission (KFTC) decided to impose a 16 million won fine on Abbott Korea. Both companies have kept a record of sales for each doctor and encouraged the use of their company's stent by providing unfair support to the doctors as an expense for overseas conferences. More specifically, sales representatives of both companies used this support for overseas academic conferences as a sales promotion strategy to increase the use of its products for doctors that show decrease usage or to manage sales. Overview of the support provided for attending overseas academic conferences (Before event) From May 2014 to April 2018, while providing support to a Korean medical society in accordance with the Fair Competition Code, Abbott Korea had violated the same Code that prohibits direct support to a specific doctor by notifying its Hong Kong branch and the overseas academic society in advance to issue invitations to 21 doctors in 21 hospitals. In the process, the company requested the Hong Kong branch make exemptions and issue invitations to doctors that submitted their case presentations after the deadline or pressed the branch and academic society to issue invitations in line with the registration period set in Korea. Also, 14 of the 21 doctors that received invitations used the invitations to attend the conferences and received financial support for their participation from the Korean medical society. During the period, Abbott Korea had supported a total of 16.99 million won as expenses to doctors that participated in 2 conferences. In addition, the company had proposed to provide the expense for a business class upgrade to doctors that participated in overseas education·training sessions in 2018 and provided local tours in China to 17 doctors in 2014. From August 2017 to June 2019, Medtronic Korea had internally selected doctors to attend overseas conferences and offered support for their participation. Then, the company sent the list and role of the 34 doctors in 36 hospitals that accepted the offer to the overseas conference organizers to issue invitations. Also, the company requested the conference organizers to issue the invitations to the company so they could personally hand over the invitations to the doctors. 23 of the doctors that received the invitations attended the conferences using the invitations and received financial support for their participation in an overseas conference. During the period, Medtronic Korea had supported a total of 27.72 million won as expenses to doctors that participated in 2 conferences. FTC explained that the acts by the two companies violate Article23(1)-3 of the Monopoly Regulation and Fair Trade Act in "unfairly soliciting customers." By providing unfair or excessive profits to doctors, the companies have induced doctors to do business with their companies rather than their competitors, which counts as an unfair trade act by unfairly soliciting customers. As a result, the government issued a fine (16 million won) and a corrective order (cease and desist order) to Abbott Korea and a corrective order (cease and desist order) to Medtronic Korea. The FTC said that the measure was meaningful in that they were able to expose a roundabout rebate act of supporting specific doctors that violates the Fair Competition Code, and that they will continue to take stronger measures to prevent companies from conducting acts that hinder competition under the pretense of supporting overseas conferences or education and training in the overall medical device market, including the stent market.
- Policy
- Leclaza’s clinical trial targeting Tagrisso is launched
- by Lee, Tak-Sun Apr 19, 2021 05:55am
- 'Leclaza (Lazertinib)', a Korean anticancer drug developed by Yuhan, is conducting a Sponsor Initiated Clinical Trial for patients with non-small cell lung cancer Leptomeningeal metastasis. Since the competitive drug Tagrisso (Osimertinib, AZ) has proven effective in metastasis to the central nervous system such as brain and soft meninges, if this test of Leclaza is successful, it is expected to be competitive in the 3rd generation EGFR-TKI market. The MFDS approved Leclaza's Sponsor Initiated Clinical Trial plan submitted by Seoul National University Hospital on the 5th. This trial is a phase II clinical trial in which Lazertinib and Pemetrexed Disodium Heptahydrate (Alimta) are used in combination in EGFR mutation-positive non-small cell lung cancer with leptomeningeal. Bum-seok Kim, a professor of hematology and oncology at Seoul National University Hospital, applied for approval for a clinical trial. Leclaza was approved as a treatment for patients with EGFR T790M mutation-positive local advanced or metastatic non-small cell lung cancer who had been treated with EGFR-TKI before last January, subject to the submission of Phase III clinical trial. On the 8th, it passed the HIRA's Pharmaceutical Benefits Advisory Committee, the first step in the reimbursement. The final drug price is announced after a drug price negotiation with the NHIS. When the drug price is announced, it is used in earnest for patients. Leclaza is expected to be Tagrisso's competitor. In particular, a fierce fight is expected to unfold in patients who are resistant to second-generation ERFR-TKI treatments such as Iressa, Tarceva, and Alimta. Tagrisso is expanding the market by advocating that it is effective for patients with central nervous system metastasis such as brain and leptomeningeal. As a result of confirming the status of cancer cells through MRI in the BLOOM phase I study, Tagrisso was found to reduce progressive lesions of the central nervous system regardless of the patient's T790M mutation. In particular, it was found to reduce the degree of EGFR mutations in the cerebrospinal fluid (leptomeningeal). In the AURA3 clinical trial using Tagrisso as a second-line treatment, the response rate to brain metastasis was 40%. Therefore, it is analyzed that Tagrisso lowered the risk of death due to metastasis to the central nervous system. In order for Leclaza to compete with Tagrisso, data showing that it is effective in patients with central nervous system metastasis is needed. Therefore, the results of this Sponsor Initiated Clinical Trial are drawing attention. This test was named LAZARUS. It also means 'Lazaros' resurrected by Jesus, and it is expected that Leclaza will become a valuable remedy that can restore life like this.
- Policy
- Korean CMO will produce MNC's COVID-19 vaccine from August
- by Kim, Jung-Ju Apr 16, 2021 06:03am
- A COVID-19 vaccine developed by a multinational pharmaceutical company will be produced by a Korean pharmaceutical company under a CMO deal. The government plans to officially announce the specific company and manufacturing plan in the near future. Young-Ha Baek, head of vaccine procurement at the pan-government vaccine procurement task force, announced the news today (15th) during the morning briefing. In a press gaggle, Baek said, “A Korean pharmaceutical company is currently working out the details on a contract manufacturing organization (CMO) deal to produce a COVID-19 vaccine that has been developed abroad. Under the CMO deal, the vaccine will be manufactured in Korea from August.” However, Baek did not disclose specifics on which company will manufacture how much for distribution, as the talks between the two companies are still in progress. Emphasizing how the deal will increase Korea’s manufacturing capacity, Baek added, “We will promptly organize the details in writing for an official announcement. Also, we will continue to promptly inform the public on matters related to vaccine procurement whenever they arise.”
- Policy
- Nicobreak ODF was approved for the first time in Korea
- by Lee, Tak-Sun Apr 16, 2021 06:02am
- CTC Bio's'Nicobreak ODF', a smoking cessation treatment that melts and eats, was approved for the first time in Korea. this. This product has been confirmed to be equivalent to the existing Champix (Varenicline, Pfizer), which is the same ingredient product. The Ministry of Food and Drug Safety approved two items of Nicobreak ODF1mg/0.5mg of CTCBIO on the 13th. This product is a varenicline, such as Pfizer's Champix, and is used as an adjuvant therapy for smoking cessation. In particular, this drug is the first ODF formulation in Korea that can be dissolved with the tongue without water. Conventional Varenicline tablets should be swallowed with water. Patients with difficulty swallowing or refusal to rehydration feel uncomfortable with the tablets. ODF formulations are expected to increase ease of use by covering the disadvantages of these tablets. After a smoking cessation date is set, this drug should be administered one week before the designated date. Smoking can be started within 35 days from the 8th day after the drug administration. For 1~3 days, 0.5mg once a day, 4~7 days 0.5mg twice a day, 1mg twice a day until the end of the administration after the 8th day. Champix ▲ Pfizer's anti-smoking treatment This drug has been compared to Champix to confirm its equivalence. As a result of measuring the plasma concentration of varenicline in 28 healthy adults taking THIS DRUG and Champix, it was demonstrated that the 90% confidence interval of the mean difference was bioequivalent from log 0.8 to log 1.25. Nicobrec's oral melting film is also different from Champix' salt. This drug differs from Champix's tartrate because it has salicylate. Champix's sales based on IQVIA last year were 20.7 billion won, and it is 10 billion blockbuster drugs despite the decrease in the number of nationally supported smoking cessation. Equivalence check with Champix CTCBIO Nicobreak ODF, a dissolving smoking cessation treatment, succeeded in obtaining approval for the first time in Korea. This product has been confirmed to be equivalent to the existing Champix (Varenicline, Pfizer), which is the same ingredient product. On the 13th, the Ministry of Food and Drug Safety approved two items of Nicobreak ODF 1mg/0.5mg of CTCBIO. This product is a varenicline, such as Pfizer's Champix, and is used as an adjuvant therapy for smoking cessation. In particular, this drug is the first ODF formulation in Korea that can be dissolved with the tongue without water. Conventional Varenicline tablets should be swallowed with water. Patients with difficulty swallowing or refusal to rehydration feel uncomfortable with the tablets. ODF formulations are expected to increase ease of use by covering the disadvantages of these tablets. After a smoking cessation date is set, this drug should be administered one week before the designated date. Smoking can be started within 35 days from the 8th day after the drug administration. For 1~3 days, 0.5mg once a day, 4~7 days 0.5mg twice a day, 1mg twice a day until the end of the administration after the 8th day. This drug has been compared to Champix to confirm its equivalence. As a result of measuring the plasma varenicline concentration of 28 healthy adults taking THIS DRUG and Champix, a 90% confidence interval of the mean difference was within log 0.8 to log 1.25, demonstrating bioequivalence. Nicobreak ODF is also different from Champix' salt. This drug differs from Champix's tartrate because it has salicylate. Champix's sales based on IQVIA last year was 20.7 billion won, which is a 10 billion blockbuster drug despite the decrease in the number of nationally supported cessation cessation applicants.
- Policy
- SK's Cosca 25mg was first approved
- by Lee, Tak-Sun Apr 15, 2021 05:56am
- SK Chemical introduces generic for Losartan 25mg earlier than the original. At one time, SK Chemicals had the experience of selling delegated generics of the original Cozaar, so it is drawing attention. On the 14th, the MFDS approved SK Chemical's Cosca25mg (Losartan potassium). Losartan potassium 25mg has been widely used, but it has not been approved so far. Originally, only Cozaar (MSD) 50mg and Cozaar (MSD) 100mg, which are representative products, are available. However, Cozaar (MSD) 25mg is used a lot in certain age groups as an initial dose. For example, Cozaar 25mg is recommended as an initial dose for the elderly over 75 years, dialysis patients, children and adolescents over 6 years old, and patients with excessive blood pressure reduction. Until now, Cozaar 25mg was not available, so Cozaar 50mg had to be split in half for the first dose prescription for that age group. This is uncomfortable for pharmacists when dispensing them, and there is a risk of contamination. The reason why this product is attracting attention is also that SK Chemicals sold entrusted generics through co-marketing with MSD in the past. SK chemicals received products from MSD Korea from 2008 to 2012 and sold them under Cosca. It was delegated generic for Cozaar. However, the partnership was ended in 2012, and after that, through a change of license, the company's factory is producing generics that have been verified to be equivalent to the original. It became a competitor to MSD. Cozaar and Cosca are long-established drugs among ARB-based hypertension drugs. Since many new drugs of the same series have been released so far, sales have decreased significantly compared to the initial release. Based on UBIST last year, Cozaar recorded ₩27.9 billion and Cosca recorded ₩3.4 billion. Before the release of generics, Cozaar exceeded ₩70 billion, and Cosca was the only generic over ₩10 billion. It is noteworthy whether SK Chemicals will recover Losartan's past sales through this product.
- Policy
- Moderna's COVID-19 vaccine has been applied for approval
- by Lee, Tak-Sun Apr 15, 2021 05:56am
- Moderna's COVID-19 vaccine has begun to be approved in Korea. If Moderna vaccine is approved, it will be the fourth vaccine after AstraZeneca, Pfizer and Janssen vaccines. The MFDS announced on the 12th that GC Pharma has applied for approval as an import item for COVID-19 vaccine from Moderna in the US. Moderna vaccine is one of the vaccines announced by the government and was developed in a two-doses (28 days apart). It is the same platform as Pfizer’s Comirnaty, which is approved in Korea as a 'mRNA vaccine' that induces an immune response by injecting the antigenic gene of COVID-19 in the form of mRNA to generate antigenic protein in the body. The government announced that it signed a supply contract for 20 million people with Moderna in January. The MFDS carefully reviews the submitted quality, non-clinical, clinical, and GMP data, and undergoes triple consultation from the COVID-19 vaccine safety and effectiveness verification advisory group, the Central Pharmaceutical Affairs Review Committee, and the final inspection committee to ensure the safety and effectiveness of the product. It said that it was going to check whether or not to grant permission. Meanwhile, Moderna vaccine has been Emergency Use Authorization in the United States and the United Kingdom, and CMA has been required to submit additional data after approval in the European Union (EU), Canada, and Switzerland. An official from the MFDS said, "We will do our best to ensure that safe and effective vaccines are quickly supplied to our people in the future."
- Policy
- NHIS and choline alfoscerate makers fail to reach agreement
- by Kim, Jung-Ju Apr 14, 2021 06:06am
- Negotiations on the retrieval of health insurance benefits paid for 60 choline alfoscerate products have all fell through despite the series of extensions made on its negotiation period. The key cause of the negotiation breakddown was that the payer, National Health Insurance Service (NHIS), and the pharmaceutical companies were unable to reach an agreement on the collection rate. As a result, the government is now at a crossroads. It may either order deletion of the 60 products from the benefits list or order renegotiations. According to industry officials on the 12th, NHIS reported to the Ministry of Health and Welfare that the negotiation between NHIS and relevant pharmaceutical companies on the retrieval of insurance benefits paid for the 60 drug products ended in a breakdown, The three main items for negotiation were: ▲recollection amount ▲recollection period ▲recollection rate. NHIS and the companies had reached some level of consensus on the first two items, as they agreed to cover the claims including the patient's copayment amount and to pay back the benefits received in the clinical re-evaluation period. Therefore, the key issue that could make or break the negotiation was the recollection rate. NHIS had originally set the rate at 100%. However, to close the gap in the negotiation process, NHIS had reduced the rate by half to 50% as an acceptable rate. However, the rate proposed by companies was around 10%, in the 6%-10% range. As the gap between the two rates was too large to close in the limited time period, the industry predominantly expected the negotiation to fall through. It is now up to the government to make the final decision. The government, which has extended the negotiation period and awaited its results, may now decide to the products from the benefits list or order renegotiations. At this point, the only hope left for the companies is to count on the renegotiation order that is generally made by the government for negotiations on drug prices.
