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- 2025-12-25 17:28:51
- Policy
- We'll respond more aggressively through vaccines & tx
- by Kim, Jung-Ju Jan 08, 2021 06:19am
- President Moon Jae-in predicted that it will be able to respond more aggressively to COVID-19 as the commercialization and supply of vaccines and treatments will become reality next month. In particular, President Moon predicted that it would become a model country equipped with quarantine, vaccines, and treatments if commercialized, such as applying for conditional marketing authorization (CMA), for the development of domestic treatments. According to Cheongwadae, President Moon presided over the New Year's first cabinet meeting today (5th) and spoke about the early overcoming of Corona 19 and the stability of people's lives. President Moon said, "The Republic of Korea’s top priority this year is to get past the long tunnel of COVID-19 as quickly as possible." President Moon stressed, "Although the spread of COVID-19, after reaching a peak, has recently been contained little by little as evidenced by the fact that the basic reproduction number has been gradually dropping, overconfidence can be very dangerous. The government will respond more thoroughly to prevent COVID-19 so that the daily count of confirmed cases continues descent." President Moon said, "If we pass this hurdle well, we will be able to respond more aggressively through vaccines and treatments from next month. Development of domestic treatments is also becoming a reality, such as applying for CMA." President Moon said, "If treatments are commercialized, the Republic of Korea can become a model country for overcoming COVID-19 with all quarantine, vaccines, and treatments. President Moon said the government will do its best to speed up the daily recovery to make the greatest gift of the new year. Along with this, President Moon said, “Exports to the three new industries such as Bio Health have grown by double-digit, which is brightening the future, and by maximizing the positive changes in our economy, which became stronger amid the crisis, we will strive to foster companies to further increase the competitiveness and dynamics of our economy.”
- Policy
- The vaccination date of AZ’s vaccine will be advanced
- by Lee, Jeong-Hwan Jan 06, 2021 06:19am
- The MFDS announced that it will accelerate the marketing approval period as much as possible by approval/review process of AstraZeneca's COVID-19 vaccine, which was accepted for approval on the 4th, and the national lot release at same time. The approval/review system takes up to 40 days and lot release takes up to 20 days, but it is technically the intention to work together to shorten the time of inoculation by cooperating between the departments. On that day, Director of the MFDS Kim Sang-bong made this statement at the COVID-19 briefing at Central Disease Control Headquarters. AstraZeneca submitted an application for COVID-19 vaccine approval to the MFDS, and the MFDS were continuing a briefing on approval of the vaccine with the KCDA. Director Kim Sang-bong said some media reported that it took at least 60 days for AstraZeneca's vaccine to actually be marketed, but this was not true. It is true that the approval/review process takes up to 40 days and lot release takes up to 20 days, but this can be shortened as much as the maximum period of the administrative procedure. If the review of approval/review system data is completed within 20 days, it will be processed in 20 days instead of 40 days, and allow lot release as soon as it is confirmed. It is explained that a plan is being devised to advance the time of vaccination for the people by simultaneously conducting review and lot release. "The lot release usually takes 2-3 months, but we have built the infrastructure for the lot release of COVID-19 vaccine from last year. The principle is that approval/review and lot release are not carried out at the same time, but Pfizer, Janssen, Moderna and others are also sharing the application for approval." He said, "Clinical data and review results will be released through the media. However, at the time of completion of the approval, we will explain to the public in detail,and it was a measure to submit some of the experimental data." KDCA Commissioner Jung Eun Kyeong said that it has not been decided whether or not the overseas COVID-19 vaccine will be commissioned in Korea except for Astrazeneca’s vaccine. She said she is doing her best to prepare for safe distribution and vaccination after the vaccine is marketed. She advised not to use a combination of different types of COVID-19 vaccines. This means that the drug should be administered according to the efficacy and safety and vaccination cycle confirmed in clinical trials. She said, "Pfizer mRNA COVID-19 vaccine will be introduced in the third quarter. We are discussing for an early supply. It is difficult to say everything because there is confidential between institutions. We plan to explain it to the people once it is confirmed." She said, "We are preparing to discuss and simulate the distribution plan of COVID-19 vaccine with cold chain that can be distributed at –70°C and –20°C. It takes a lot of time to set up an inoculation center to prepare for vaccination. It is not a rule to mix different types of vaccines, and the relatively identical vaccines should be administered at the same time."
- Policy
- Prostate cancer treatment Erleada by Janssen was approved
- by Lee, Tak-Sun Jan 06, 2021 06:19am
- Janssen Korea has received domestic approval for a new prostate cancer drug. The emergence of new options after Zytiga (Abiraterone acetate) is expected to expand its influence in the prostate cancer treatment market. The MFDS approved Janssen's Erleada (Apalutamide) in Korea on the 30th. It is approved as a combination therapy with androgen blockade (ADT) in the treatment of patients with hormone-responsive metastatic prostate cancer (mHSPC). The recommended dose is Erleada 240mg once a day (4 tablets of 60mg). Erleada proved its effectiveness through a phase III SPARTAN study. In the SPARTAN study, the Erleada-treated group had a 72% reduction in the incidence of distant metastasis (cancer cells traveled to distant sites through blood vessels and lymphatic vessels to proliferate) or death compared to the placebo group. Metastasis-free survival (MFS) was also 40.5 months, which was 2 years longer than that of the control group. Erleada was approved by the US FDA in February 2018. At the time, Janssen emphasized that Erleada would be an alternative option to delay metastasis in the treatment of prostate cancer. Janssen is already expanding its influence in the market with a prostate cancer treatment called Zytiga. As of last year's IQVIA, Zytiga's domestic sales amounted to ₩6.9 billion. Zytiga has been recognized as a first-line treatment for metastatic castration-resistant prostate cancer since last year. The sales have been steadily increasing. Sales of Zytiga/Erleada are growing in the prostate cancer treatment market, and Astellas' Xtandi (Enzalutamide) and Bayer's Nubeqa (Darolutamide) are expected to compete in earnest.
- Policy
- AZ has applied for domestic approval of COVID-19 vaccine
- by Lee, Tak-Sun Jan 05, 2021 05:18pm
- The MFDS announced today (4th) that AstraZeneca Korea's application for item approval for COVID-19 vaccine (code name: AZD1222) has been received. This vaccine is a 'viral vector vaccine' manufactured by putting COVID-19 surface antigen gene into a chimpanzee adenovirus vector. Viral vector vaccines are manufactured by inserting viral antigen genes that cause infectious diseases into other viral genes used as carriers and mass-producing them. AstraZeneca vaccine uses adenovirus, which only infects chimpanzees, as a carrier to deliver COVID-19 surface antigen gene into human cells, and the delivered COVID-19 antigen gene synthesizes antigen proteins in the body to induce the production of neutralizing antibodies. US Johnson & Johnson (Janssen) vaccine was developed using a viral vector method. The expected target of AstraZeneca’s vaccine is 18 years of age or older, and the expected dosage is administered twice 4 to 12 weeks after one vaccination. This is the same as indications and dosages approved for emergency use in the UK, and the storage conditions are 2-8℃. AstraZeneca is currently conducting phase III clinical trials in 10 countries including the UK, Brazil and the US. The clinical trial was discontinued (September 6, 2020) due to an unexpected AEFI (one case of transverse myelitis). As a result of safety review, clinical trials were resumed (October 23, 2020, USA, and September 12, 2020, UK) because there was no direct relationship with the vaccine. Transverse myelitis is an inflammatory syndrome that affects the spinal cord and can be caused by a viral infection. However, no direct association with the vaccine was found in this study. The UK confirmed the preventive effect of 11,636 people in the vaccine clinical trial of AstraZeneca and made an Emergency Use Authorization on December 30, and the European Medicines Agency (EMA) has been conducting a preliminary review since October last year. AstraZeneca Korea applied for the approval for products that are consigned to SK Bioscience, a domestic pharmaceutical company, and for products manufactured overseas such as Italy. Item approval/examination data include non-clinical trials, clinical trials, quality, risk management plans, and manufacturing/quality control data. Non-clinical data is a verification of toxicity and effectiveness through animal testing prior to administration of a drug to humans. Clinical trial data confirm the effectiveness and safety when administered to humans. Unlike the clinical evaluation of general medicines that show therapeutic effects, it is important to evaluate the effectiveness of vaccines to prevent infection after vaccination in healthy people. The prophylactic effect (%) in the clinical trial is calculated based on the proportion of infected people who developed each after vaccination in the vaccination group and placebo group. For example, in a phase III clinical trial in which 10,000 people each vaccinated and placebo vaccinated, 10 confirmed cases out of the vaccinated group and 100 confirmed cases out of the placebo vaccinated group occurred, the probability of infection of the vaccinated group Is 1/10 compared to the placebo group, so the effect of preventing COVID-19 infection is calculated as 90%. Looking at the WHO's considerations for COVID-19 vaccine evaluation, it is recommended that the standard of preventive effect of COVID-19 vaccine be at least 50%. The safety is checked and evaluated whether abnormal cases occur after vaccination, and the safety of the vaccine is collected through long-term tracking such as serious abnormal cases. In the 'Guidelines on clinical evaluation of vaccines' by the WHO, it is recommended to follow up for at least 6 months for general vaccines and at least 12 months for vaccines containing immune boosters. It is recommended to perform follow-up observation for at least 1 year in the case of COVID-19. Quality data are data related to the manufacturing process control of the drug and'standards and test methods' for quality control. In addition, the risk management plan (RMP) is data on a comprehensive safety management plan that includes measures to minimize the occurrence of hazards for safety management after marketing. Risk Management Plan (RMP) refers to a comprehensive safety management activity plan that is carried out to collect, investigate, test, and minimize risk occurrence of information on safety and effectiveness over the entire cycle before and after drug approval and marketing. GMP implementation status evaluation data are 10 kinds of data, including facility·environmental management and quality assurance system related to the item for which the license is applied. Good Manufacturing Practice (GMP): Refers to the standards that pharmaceutical manufacturers must comply with throughout facilities, equipment and production processes in order to manufacture excellent pharmaceuticals with guaranteed quality. In addition to general GMP evaluation data, AstraZeneca’s vaccine will be evaluated according to the characteristics of the virus carrier vaccine, such as management of biological raw materials and genetically modified organisms used in manufacturing, and biological safety level (BSL), the MFDS explained. AstraZeneca’s vaccine is planned to be produced in the US, UK, and Italy, as well as SK Bioscience in Korea. As for the quality data, SK Bioscience is currently submitting additional quality data on the original vaccines and finished drugs produced in Korea under consignment from AstraZeneca Company to the AstraZeneca headquarters. AstraZeneca, the original developer, reviews the data to analyze and verify the quality equivalence between the vaccine used in the clinical trial and the vaccine consigned to SK Bioscience in Korea. AstraZeneca prepares data including the results of quality equivalence evaluation between manufacturing sites, and AstraZeneca Korea plans to quickly submit the data to the MFDS. Among the clinical trial data, additional data obtained by collecting and analyzing vaccine adverse events through a planned 12-month follow-up will be submitted, which is the same worldwide. The clinical trial data submitted by AstraZeneca are data from phase I to III being conducted in the UK and Brazil, and the trial is still ongoing for the safety evaluation of the vaccine and is expected to be completed in September 2021. The safety evaluation method of the vaccine is applied to other vaccine methods in the same way, and Pfizer’s vaccine and Moderna’s vaccine will be equipped with additional long-term safety data through follow-up. The MFDS has announced that it will thoroughly verify the safety and effectiveness through the screening of experts in each field and external experts of COVID-19 vaccine and treatment license examination team so that the public can receive a safe and effective COVID-19 vaccine. The MFDS aims to shorten the existing processing period (180 days or more) and process it within 40 days for the rapid approval and review of COVID-19 vaccine and treatment, including the product for this approval. The MFDS is conducting a preliminary review on non-clinical and quality data (non-clinical 10.6~, quality 12.18~) at the request of AstraZeneca Korea and requested data supplementation for nonclinical data. In addition, it is reported that the AstraZeneca vaccine, commissioned and manufactured by SK Bioscience, is preparing for the nation's lot release the fastest. It is explained that the manufacturer's detailed test method was obtained at the end of August last year, and the test method was established at the end of December after receiving reagents such as standard products in November. Vaccines used in the pandemic of infectious diseases are subject to rapid lot release and will be treated preferentially over lot release drugs in other countries, and they plan to quickly complete the national lot release within 20 days, which usually takes 2-3 months or more.
- Policy
- Generics for Arcoxia are coming soon
- by Lee, Tak-Sun Jan 04, 2021 05:58am
- Generic for Arcoxia, COX-2 anti-inflammatory analgesic is expected to be released soon. As the PMS ended on the 22nd of last month, it was confirmed that the generic company received the application on the 23rd, the next day. Since generic companies have already confirmed patent avoidance, they are expected to market their products as soon as they go through approval and reimbursed procedures. According to the MFDS on the 3rd, generic companies for Arcoxia (Etoricoxib) received applications on the 23rd. This drug is used to relieve symptoms or signs of osteoarthritis (degenerative arthritis). MSD Korea's Arcoxia obtained a domestic approval on December 23, 2014. The MFDS ordered a re-examination (PMS) for 6 years, and the end of the re-examination was on the 22nd of last month. Generic companies have been preparing for the market step by step. It succeeded in evading the patent with the remaining term. A trial was filed to confirm the scope of passive rights to evade crystalline patent of Arcoxia, and the claim was finalized in May last year. Participating pharmaceutical companies were Theragen Etex, Hana Pharm, Union Korea, Aju, Arlico, Reyon, Daewoopharm, Boryung Pharmaceutical, Hutecs, and Guju. A bioequivalence test was also conducted for product approval. Three companies of Theragen Etex, Aju, and Arlico conducted a bioequivalence test using Arcoxia as a reference drug. Accordingly, it seems that it succeeded in demonstrating the equivalent of the original drug and applied for permission immediately after the end of PMS. Arcoxia(Etoricoxib) is a nonsteroidal anti-inflammatory analgesic (NSAID) family of selective COX-2 inhibitors. In particular, it attracted attention that it is a follow-up item made by MSD of Vioxx (Rofecoxib), which was removed from the market due to cardiovascular risk as a COX-2 inhibitor. Arcoxia directly conducted clinical trials in Korea to resolve the safety controversy. However, there were fewer recognized indications than the competitive product Celebrex (Celecoxib). Arcoxia is only approved for osteoarthritis, whereas Celebrex has five indications, including ankylosing spondylitis, rheumatoid arthritis, and primary menstrual pain, as well as osteoarthritis. This leads to differences in performance in the market. Looking at the amount of outpatient prescriptions based on UBIST in the first half of last year, sales of Celebrex was ₩20.1 billion, whereas sales of Arcoxia were ₩1.7 billion. Large pharmaceutical companies except for Boryung analyzed that generics for Arcoxia were not very attractive in that they had limited indications for Arcoxia and generics for Celebrex were released after 2015. However, it is expected that the generics applied for approval this time will be able to produce new product effectiveness as they are the first generics that have successfully evaded patents.
- Policy
- Contract for 20 million people with Moderna was completed
- by Lee, Jeong-Hwan Jan 04, 2021 05:55am
- The government officially announced today (31) that it has signed a contract to purchase 20 million COVID-19 vaccines with Moderna, a US pharmaceutical company. As a result, Korea has secured the quantity of Moderna vaccines before the end of this year. This amount exceeds 100% of the population of Korea, and it is evaluated that it is sufficient for the formation of domestic collective immunity. On this afternoon, KDCA Commissioner Jung Eun Kyeong said at a briefing held at the KDCA located in Cheongju, North Chungcheong Province, "We have signed a contract to purchase COVID-19 vaccine for 20 million people with Moderna, and will be supplied to Korea from the second quarter." The government has been negotiating with Moderna for vaccine supply since July. In particular, on the night of the 28th, President Moon Jae-in and Moderna's CEO, Stéphane Bancel agreed on the timing and expansion of the vaccine supply through video calls. At the time, President Moon reached an agreement to supply 20 million people in the second quarter of next year, twice the amount of 10 million people originally secured by the government. Since then, the vaccine purchase contract between the health authority (the KCDA) and Moderna is proceeding smoothly. She said, "This contract was concluded through follow-up negotiations after the agreement to supply a vaccine for COVID-19 in a video call between President Moon and CEO Bancel for 20 million people. The vaccine purchased by the government is for a total of 56 million people, It exceeds 100% of the population. Enough to secure normal population immunity.” She said, "Because there are 30 million people who are eligible for the first vaccination, they must be vaccinated sequentially. In addition, (per person) they need to be vaccinated twice. Therefore, the vaccination starts from the first quarter, but the first vaccination is completed at the end of the third quarter," "We are preparing a plan to finish the second vaccination over a certain period of time." Currently, the MFDS is working on a preliminary review of the Moderna vaccine. The KCDA is planning to announce the current vaccination plan in the next month. The MFDS plans to complete the license/national lot release within 60 days when a pharmaceutical company applies for a license. Vaccination has already begun in the United States and the United Kingdom, and US Armed Forces in Korea has also begun vaccinating Moderna from the 29th. The government secured AstraZeneca’s vaccine for 10 million people, Pfizer for 10 million people, Janssen for 6 million people, COVAX Facility for 10 million people and Modena for 20 million people. With this, Korea will have a total of 56 million COVID-19 vaccines.
- Policy
- GBP510 by SK Bioscience has been clinically approved
- by Lee, Tak-Sun Jan 04, 2021 05:55am
- Another COVID-19 vaccine developed by SK Bioscience has been approved for clinical trials in Korea. The MFDS announced on the 31st that it has approved the clinical trial of the domestically developed COVID-19 vaccine GBP510. GBP510 is a vaccine candidate being developed by SK Bioscience and is different from NBP2001, which was clinically approved in November. This clinical trial is to evaluate the safety and immunogenicity of GBP510 in healthy adults, and phase II will be sequentially conducted after phase I. Immunogenicity refers to the rate of increase in neutralizing antibody that eliminates or lowers viral infectivity. GBP510 is a recombinant vaccine made using gene recombination technology of surface antigen protein of COVID-19. The preventive principle is that the surface antigen protein of the vaccine stimulates immune cells to form neutralizing antibodies to induce an immune response, and when COVID-19 invades, the antibody removes COVID-19. SK Bioscience's recombinant vaccine NBP2001, which was approved clinically on the 23rd of last month (Phase I), induces an immune response with the surface antigen protein of COVID-19, and GBP510 is a surface antigen protein that has a nanostructure (icosahedral particle). There is a difference in inducing an immune response by binding to a specific protein that forms. Novavax in USA is conducting phase III clinical trials of a COVID-19 vaccine using genetically modified technology. The MFDS said, "We plan to do our best to ensure that our people can receive treatment opportunities by supporting necessary matters so that a safe and effective COVID-19 treatment and vaccine can be developed quickly."
- Policy
- Review of new evaluation index for innovative certification
- by Lee, Jeong-Hwan Dec 31, 2020 06:20am
- When the MOHW is certified as an Innovative Pharmaceutical Company, it is expected to initiate a reorganization of the system to create new evaluation indicators that take into account the characteristics of overseas pharmaceutical companies. The goal is to establish a pharmaceutical and bio environment that provides a basis for domestic investment through certification as an innovative pharmaceutical company by a multinational pharmaceutical company. On the 30th, Minister Kwon Deok-chul responded to the written inquiry of Miae Kim, a member of People Power Party of the National Assembly Health and Welfare Committee. The information was answered just before Kwon was appointed, and it shows the direction of policy improvement in the future. Miae Kim inquired to Kwon Deok-chul to "tell your opinoin on the need to provide a basis for domestic investment as an Innovative Pharmaceutical Company certification of a foreign pharmaceutical company." Her inquiry seems to be based on criticism that the Korean government's certification of Innovative Pharmaceutical Company has focused on domestic pharmaceutical companies relatively compared to overseas pharmaceutical companies. The Innovative Pharmaceutical Company certification system has been operated since 2012 as a system to certify and support companies with high R&D proportions and excellent performance. Minister Kwon explained that the system certifies not only domestic pharmaceutical companies, but also multinational pharmaceutical companies that have contributed to the development of the domestic pharmaceutical industry, thereby activating open innovation and technology exchange and cooperation within the industry. It is said that three companies, Janssen Korea, AstraZeneca Korea, and Otsuka, have obtained certification and are applying a fair evaluation method without discrimination between domestic and foreign companies. Minister Kwon said that he would prepare for reorganization, including the establishment of new evaluation indicators that take into account the characteristics of multinational pharmaceutical companies. Minister Kwon said, "The environment of the domestic and foreign pharmaceutical industry is changing and domestic investment by foreign companies is expanding." He replied, "We are reviewing the reorganization of the direction of establishing a new evaluation index considering the characteristics of foreign companies."
- Policy
- Item management of accelerated approval is strengthened
- by Lee, Tak-Sun Dec 31, 2020 06:20am
- The MFDS has established a policy that it will not approve the extension of the deadline if the clinical trial is unsatisfactory for phase III accelerated approval item. Periodic reports should be submitted in the middle of Phase III, and surveys will be conducted if necessary for items with no results. It was to supplement this by creating an internal management guideline for the MFDS in response to the fact that the management of items was insufficient during the last National Assembly audit. According to industry sources on the 29th, the MFDS recently prepared an amendment to the 'Guidelines for approval and management of drugs with conditions related to clinical trials' and began to collect industry opinions. Items subject to phase III accelerated approval are applied to ▲life-threatening or serious serious diseases, ▲no alternative drugs, or products with significant clinical benefit compared to existing drugs. This guideline focuses specifically on the management of accelerated approval items. In particular, detailed information on post-licensing management such as changes in conditions such as clinical trials and submission of periodic reports were included. Although it is possible to change the conditions of approval given earlier, for example, the deadline for submitting the final clinical trial or the number of patients to be tested, it has been decided not to approve the extension of the deadline for submitting items that are unfaithful to the clinical trial. Phase III conditional permit items are notified of the necessity of fulfilling the conditions and actions taken in case of non-compliance 1 month before the approval of the plan and 1 year before the submission of the result report. It monitors the clinical trial progress and distribution status of the item within the deadline of the license conditions, and if there is no performance, the measures taken if the license conditions are not fulfilled. If the Accelerated Approval item does not submit the final clinical trial results or periodic report data, we plan to cancel the item or delete the indication according to the Pharmaceutical Affairs Act. According to this guideline, the management of phase III conditional licensed items after approval is expected to be strict. In particular, it is expected that the Ministry of Food and Drug Safety can actively intervene and take action in the process of clinical trials through regular reports. On the other hand, at the National Assembly audit held in October, it was pointed out that the management of Accelerated Approval items was insufficient. In particular, it was pointed out that the MFDS was passive about the situation in which Accelerated Approved Riavax was revoked due to failure to complete the phase III conditions. Baek Jong-heon, a member of the People Power Party, said that eight out of 32 clinically accelerated applications in Phase III over the past five years have no production performance. This guideline seems to accept these comments and clarify the conditional implementation process. Currently, it is known that Baek Jong-heon plans to initiate a bill to legislate accelerated approval.
- Policy
- Benlysta is about to be listed as RSA (Refund·Expenditure)
- by Kim, Jung-Ju Dec 31, 2020 06:19am
- Benlysta (Belimumab), a new treatment for systemic lupus erythematosus by GSK, can be listed on the ‘Pharmaceutical Benefit List and Upper Limit Price List’ in February next year as soon as the administrative procedures are carried out sequentially. According to the pharmaceutical industry on the 28th, the government will promote insurance benefits for Benlysta 120mg and Benlysta 400mg. Benlysta is an injection approved by the MFDS for “the treatment of adult patients with autoantibody-positive active systemic lupus erythematosus being treated with standard therapy.” The number of domestic patients subject is about 835. In June 2013, after obtaining the approval of the MFDS, discussions took place in earnest at the Pharmaceutical Benefit Evaluation Committee following the application for insurance registration in May this year. As a result of negotiating drug prices with the NHIS in September, the pharmaceutical company agreed to refund a certain percentage of the initial amount of treatment and drug charges and the excess of the estimated cap to the NHIS during the RSA. According to the industry, Benlysta 120mg will be set at ₩182,696 and Benlysta 400mg will be set at ₩608,988. If applied, it is expected that the listing will be possible as early as February.
