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- 2026-03-14 21:15:19
- Policy
- 9 Atozet generic companies to join CKD via consignment
- by Lee, Tak-Sun Jan 12, 2021 06:22am
- A dyslipidemia treating combination drug ‘Atozet’ by MSD Nine pharmaceutical companies, initially preparing to launch a generic version of a dyslipidemia treatment Atozet (atorvastatin plus ezetimibe), joined a group of manufacturers to produce Chong Kun Dang’s evidence-submitting drug as CMO. Instead of generics applying for the health authority approval from this month, the companies seem to have chosen to manufacture the follow-on drug with evidence submission under the consignment contract. Apparently, some of them have already completed the bioequivalence test successfully. On Jan. 8, South Korea’s Ministry of Food and Drug Safety (MFDS) granted approval on 22 companies’ atorvastatin calcium plus ezetimibe combination drugs. Some of the companies are to sign consignment deal with Chong Kun Dang, who earned the approval for a same substance drug undergoing safety and efficacy evaluation in last October. With the deal, Chong Kun Dang has provided the data related to the government-approved same substance drug. The nine companies from the 22 companies are Dongkoo Bio & Pharma, Celltrion Pharm, Yuyu Pharma, Wooridul Pharmaceutical, Jinyang Pharm, Hana Pharm, Korea United Pharm, Korea Prime Pharm, and Hutecs Korea Pharmaceutical. Ultimately, the pricing and launching schedule have convinced the companies to take the consignment contract over the independent generic development. Drugs manufactured with Chong Kun Dang’s consignment would be counted as part of 20 same substance drugs, which means the contracted companies’ drugs would receive better pricing than the drugs launched after the 20th product. Moreover, the drugs sharing the Chong Kun Dang’s evidential material would be able to receive approval even before the original Atozet’s post-marketing surveillance expires. Accordingly, the generics that finished the bioequivalence test may apply for the approval from Jan. 23. For instance, Dongkoo Bio & Pharma was heavily criticized by other CMOs, as the company was originally calling for generic CMO after completing the bioequivalence test, but suddenly settled on an agreement with Chong Kun Dang. Other 13 companies that did not join Chong Kun Dang but received approval on the bioequivalence test would receive the lowest pricing according to the stepped pricing. Regardless, the companies like GC Pharma and Ildong Pharmaceutical would push on with the sales. The Atozet market is to face a drastic dynamic change with a group of follow-on drugs swarming in. The original Atozet is a star drug making 60 billion won a year. Understandably, the follow-on drugs would not miss the chance to absorb the market share. And it is still unknown if Chong Kun Dang would maintain the Atozet co-promotion contract with MSD Korea. The Korean company has been in charge of Atozet sales since it inked the deal in 2016. But the company’s same substance drug has been approved already based on its own clinical trial, and it is named ‘Lipilouzet,’ taking the motif from the main product’s name ‘Lipilou.’ Eventually, the company would highly likely to drop the co-promotion deal and focus on its product. MSD Korea would have to seek for a new partner for the Atozet co-promotion.
- Policy
- Breaking down MOHW 2021 action plan for NHI Master Plan
- by Kim, Jung-Ju Jan 12, 2021 06:19am
- The drug reimbursement benefit would be improved throughout chronic disease treatment this year, centering hepatitis B and C virus treatment and antidiabetic combination drugs. The already listed drug reimbursement reevaluation would be enforced from the latter half of the year, when the subjects are decided in the first half of the year. Moreover, the external reference pricing criteria, generic substitution incentive, also known as Rewards for Saving Drug Expenditure (RSDE), would be amended within this year. South Korea’s Ministry of Health and Welfare (MOHW) is to unfold the ‘2021 Action Plan for the First National Health Insurance (NHI) Master Plan’ as scheduled. These plans would follow the yearly flow of innovative NHI coverage enhancement initiative and the reimbursement quality and finance management programs. Pharmaceutical coverage enhancement initiative—granting reimbursement on non-reimbursed drugs The ‘Reimbursement Provision on Non-reimbursed Drug’ program that enhances coverage while keeping the positive listing system, would expand on chronic disease treatment as it did on musculoskeletal and pain clinic medication and anticancer treatment (adjuvant drug) last year. So far, the government completed newly listing total 60 items (22 anticancer treatments and 38 general drugs) with high social and clinical demand, originally categorized as non-reimbursed drug. An immunotherapy Tecentriq (January 2018), a multiple myeloma treatment Kyprolis (February 2018), a renal cell carcinoma treatment Cabometyx (February 2019) and an immunotherapy Imfinzi (April 2020) are now all covered by NHI. General drugs, such as hepatitis C virus treatment Mavyret (June 2018), a new drug for spinal muscular atrophy (SMA) Spinraza (April 2019), a severe atopic dermatitis treatment Dupixent (January 2020), and a hemophilia treatment Hemlibra (May 2020), were also listed for reimbursement. With the initiative to cover the listed drugs in non-reimbursed criteria, the coverage was applied on total 124 items, consisting of 15 anticancer treatment and 109 general drugs. A chronic lymphocytic leukemia treatment Imbruvica (April 2018), a breast cancer treatment Perjeta (May 2019), a hepatocellular carcinoma treatment Nexavar (January 2020), an acute lymphoblastic leukemia treatment Blincyto (April 2020) and a parenteral iron therapy Venoferrum (May 2020) received the NHI benefit. The drug coverage expansion program is to continue this year as well, concentrating on non-reimbursed treatments for chronic disease, i.e. hepatitis B and C virus treatments and antidiabetic treatment. The government plans to revise the pharmacoeconomic evaluation guideline within the first quarter, and reflect the external reference pricing changes on regulation by the second half of the year. The government expects the patients’ treatment access would be improved and their financial burden would be lessened by the new coverage on drugs with high social and clinical demand. NHI sustainability—reevaluating listed drugs The government has been reassessing the reimbursement adequacy and feasibility on medical service, pharmaceutical, and medical treatment material, in the said sequential order. In November 2019, Drug Post-listing Evaluation Subcommittee under the Drug Reimbursement Evaluation Committee was formed and selected choline alfoscerate to reevaluate the reimbursement from February through July and changed the benefit to selective reimbursement (copayment rate 80 percent) for using the drug in treating conditions other than dementia. Also, the government is to initiate the reevaluation program this year after finalizing the process and revising the weighted drug pricing system since last February. In particular, by integrating the current weighted pricings—‘one year plus infinite (number of companies supplying same substance drug less than three)’ for synthetics, and ‘two years plus one year (number of same substance drug suppliers less than three)’ for biologics—the government is to apply ‘one year plus two years (number of same substance drug suppliers less than three)’ for both synthetics and biologics and to extend two years after deliberation. The weighted pricing reevaluation would be conducted within the first half of the year, and the actual full on reevaluation would start from the latter half of the year after selecting subject drugs with uncertainty. The government anticipates the reevaluation to create a foundation for essential drug-centered coverage expansion. NHI sustainability—improved management of pharmaceutical expense To better manage the pharmaceutical expense, the government has been compiling long and mid-term drug reimbursement strategy so far based on the revised volume-pricing linkage system. First, the RSDE program improvements would be established to control the drug use volume by referring to the previous researches. The government would review the plan in the first quarter, put together the improvements and finalize them by the end of the year. As for pharmaceutical expense control, the detailed drug reimbursement-deciding principles and listing prioritization would be reviewed by the third quarter and finalized within the fourth quarter. The final adjustment would be decided and finalized in the latter half of the year, after thoroughly analyzing the external reference pricing with the current pricing range for each chronic and senile disorder drugs in South Korea.
- Policy
- 22 generics for Atozet by Chong Kun Dang were approved
- by Lee, Tak-Sun Jan 11, 2021 06:10am
- MSD’s Atozet, generics of 22 companies were approved following Chong Kun DangThe products of 22 companies for hyperlipidemia (Ezetimibe/Atorvastatin) consigned by Chong Kun Dang were approved on the 8th. As a result, 20 generisc within the same ingredient were approved, and the next drug price application for the same drug product was reduced to the lowest price. This is because of the stepped drug price system that has been in effect since July of last year. On the 8th, the MFDS approved 22 companies' Ezetimibe/Atorvastatin combination. The companies are Kyongbo, Dongkoo Bio, Celltrion, Yooyoung, YuYu, Kukje, DongKook, Boryung, Samjin, SCD, Ahn-gook, Arlico, Alvogen Korea, SK Chemicals, HK inno.N, Wooridul, Reyon, Jinyang, Hana, Korea United, Korea Prime, and Hutecs. It also includes Dongkoo Bio, which has completed the development of generic and recruited contractors. Chong Kun Dang was approved in October as a drug for data-based re-evaluation through its own development of Ezetimibe/Atorvastatin. MSD Korea's original Atozet was approved before the expiration of PMS. Atozet's PMS will end on the 22nd of this month. Chong Kun Dang also recruited a commissioned generic company. Considering the drug price, more than 20 companies were recruited. This is because if it is less than 20, the next licensed generic drug can also receive the highest price within 20. Chong Kun Dang and consigned pharmaceutical companies promised that Chong Kun Dang would recruit 20 generic companies. In the current drug price system, if more than 20 active ingredients are listed, the upper limit of the newly listed item will drop to 85% of the existing lowest price. Some generic companies said they would file a complaint with the Fair Trade Commission, claiming that Chong Kun Dang and consignment manufacturers are fixing drug prices. They said that if the related companies voluntarily report, they will be excluded from the complaint. However, there was no company that voluntarily reported. The issue of preemption of drug prices through consignment of a drug for data-based re-evaluation led to controversy over revision of the law. Some lawmakers argued that there is a need to limit the number of drugs for data-based re-evaluation as well as generics. Jeong-sook Seo, a member of People Power Party Rep also proposed a related bill. However, small and medium-sized pharmaceutical companies strongly oppose it, and the MFDS, the ministry in charge, is also cautious about this. Therefore, the revision of the law is not expected to be easy. Chong Kun Dang changed the name of the previously approved product. The first licensed product name is used by Kyongbo. Lipilou is a blockbuster hyperlipidemia treatment sold by Chong Kun Dang. The use of the company's product name is a strategy to increase the awareness of the new product to existing customers. Chong Kun Dang's active marketing is expected. Chong Kun Dang is also jointly selling the original Atozet, and it is noteworthy whether there will be any changes due to the release of Chong Kun Dang's new product name.
- Policy
- Plasma treatment was completed in Phase II clinical trial
- by Lee, Tak-Sun Jan 11, 2021 06:10am
- Kwon Jun-wook, the 2nd vice-president of the Central Disease Control HeadquartersThe government confirmed that the patient administration of the clinical II trial of a domestically developed blood system drug has been completed. As in the case of Celltrion's antibody treatment, the application for Conditional Marketing Authorization (CMA) is imminent. Kwon Jun-wook, the 2nd vice-president of the Central Disease Control Headquarters said at a briefing on the current status of COVID-19 in Korea on the 7th, "Phase II clinical trials have been conducted at 13 medical institutions in relation to the clinical trials of blood system drugs currently being developed in Korea. In the situation where the medication was completed to 64 patients.” In this regard, a total of 6,554 people have registered plasma donation, and 4,139 people have actually completed plasma donation. He emphasized that on December 24 of last year, in the update of the COVID-19 treatment guidelines, he recommended the use of Remdesivir among antiviral drugs and Dexamethasone among immunomodulators as a treatment for the elderly, underlying disease and severe patients. He added, "In the case of malaria treatments such as Chloroquine single or combined therapy, it is not recommended because it does not appear to be effective against COVID-19, and HIV protease inhibitors such as Kaletra are also not recommended." Recently, treatments such as Chloroquine seem to have been mentioned to correct this as fake news about the effect of COVID-19 spread through SNS. Meanwhile, Remdesivir has been prescribed to 3,108 confirmed patients in 105 hospitals.
- Policy
- Adenovirus for AZ vaccine, Sinopharm uses inactivated virus
- by Lee, Tak-Sun Jan 11, 2021 06:10am
- Diverse types of COVID-19 vaccines are currently in development. Pfizer and Moderna’s vaccine candidates are based on RNA, when AstraZeneca’s is a virus vector and Korean-based SK Bioscience’ is a recombinant vaccine. These types of vaccine have their respective strengths and weaknesses. Some types have been commercialized already, but mRNA vaccine has never been commercialized, making the COVID-19 vaccine the first product. On Jan. 7, South Korea’s Ministry of Food and Drug Safety (MFDS) explained about the different types of COVID-19 in development and their mechanisms. The international effort to promptly seek COVID-19 vaccine has pushed pharmaceutical companies to explore a variety of vaccine platform technologies, including virus vector vaccine, mRNA vaccine, recombinant DNA vaccine and inactivated vaccine. #AstraZeneca and Janssen take virus vector vaccine, when Pfizer and Moderna take mRNA vaccine A virus vector vaccine injects adenovirus harmless via virus vector to human body to generate the antigen in the body inducing the adequate immune response. AstraZeneca and Janssen, already signed the procurement deal with South Korea, use the mechanism for their vaccines. The AstraZeneca’s vaccine uses adenovirus that only infects chimpanzees. Compared to mRNA vaccine, the virus vector vaccine is considered to be more stable around heat. But the vaccine type requires cold chain maintained at 4 degrees Celsius as it uses a live adenovirus. So far, Janssen’s Ebola vaccine using the mechanism was the only vaccine approved to market. The U.K. health authority has approved AstraZeneca’s vaccine as of Dec. 30, 2020 for an emergency use, whereas European Medicines Agency (EMA) is reportedly conducting an evaluation from October last year. In South Korea, MFDS is currently reviewing the vaccine applied for approval on Jan. 4, 2021. Janssen’s (Johnson and Johnson) investigational vaccine is conducting a Phase III clinical trial since September 2020. The vaccine has already requested for evaluation in South Korea (Dec. 22, 2020) with the non-clinical and quality relevant evidences. A Korean company Cellid’s candidate vaccine is in process of Phase 1/2 clinical study. In development by Pfizer and Moderna, mRNA vaccine injects antigen gene as a messenger RNA form to generate antigen protein that instigates immune response. The type of vaccine is to be introduced to South Korea later this year. Although the particular vaccine type can be mass produced with fast manufacturing speed, maintaining the stability is extremely difficult with the RNA easily broken down by ribonuclease. Accordingly, the vaccine requires cold chain with temperature kept at around minus 20 degrees Celsius or minus 75 degrees Celsius. And it would be the first time for the type of vaccine to be commercialized. RNA, or ribonucleic acid, is one of two nucleic acids in a cell, which carries genetic information and adjusts genetic expression. Currently, the U.K (Dec. 2, 2020), the U.S. (Dec. 11, 2020) and Canada (Dec. 9, 2020) have granted an emergency approval on Pfizer’s vaccine, whereas Switzerland (Dec. 19, 2020) and EU (Dec. 21, 2020) have conditionally approved the vaccine use. MFDS elaborated the ministry is positive about the use of Pfizer’s vaccine as it is widely used all around the world, and even the World Health Organization (WHO) also granted approval on the emergency use (Dec. 31, 2020). The vaccine has applied for evaluation on its non-clinical and clinical data on Dec. 18 last year. Moderna’s vaccine has been approved for emergency use in the U.S. (Dec. 18, 2020) and conditionally cleared by EU (Jan. 6, 2021). The vaccine has not started the review and approval process in South Korea. From South Korea, Genexine and Gene One Life Science are respectively developing DNA vaccine, similar to the mRNA vaccine. DNA, or deoxyribonucleic acid, is one of two nucleic acids in a cell, which archives and conserves genetic information. Novavax and SK working on recombinant vaccine already used for HBV and HPV vaccine Recombinant vaccine directly injects antigen protein made from recombinant DNA technology to induce immune response, which is one of the most commonly used vaccine platforms. Because the recombinant antigen protein could be insufficient for the full immune response, generally an administration route with vaccine adjuvant is needed. But it is known to be the highly safe vaccine for it has been used throughout the time. Hepatitis B virus vaccine and HPV vaccine use the platform, for instance. Novavax is using the platform for a COVID-19 vaccine with an ongoing Phase III clinical trial started from September last year. Regardless, it has not been approved by any foreign health authority. In South Korea, SK Bioscience is running a Phase 1/2 trial for the vaccine candidate. Inactivated vaccine is a traditional platform of vaccine that triggers immune response by injecting antigen made of killed virus. A number of vaccines are made with the technology. It can be rapidly developed when the infectious virus is collected, and the manufacturing process is comparatively simple and it has an advantage of having outstanding neutralizing antibody. However, for the COVID-19, the vaccine would require a manufacturing facility certified over Biosafety Level 3 (BL3). Biosafety level indicates the level of a facility to safely handle potentially lethal infectious pathogen and depending on the level of the lethal disease, the facility is given a level ranging from BL1 to BL4. Hepatitis A vaccine, injected polio vaccine and Japanese encephalitis vaccine use the inactivated virus platform. A Chinese-based Sinopharm has developed COVID-19 vaccine with the technology green lit for use on July 22, 2020 in China. And according to WHO’s COVID-19 vaccine candidate update report, CanSino Bio (virus vector vaccine) and Gamaleya (virus vector vaccine) are also working on other types of COVID-19 vaccines as well. Considering the public’s heightened interest on COVID-19 vaccine, MFDS stated it would constantly update the vaccine’s efficacy and safety information, and focus on creating an environment for the people to get inoculated with no concern. Moreover, the ministry official added they would do their best for the people to use the safe vaccine by strictly reviewing and managing safety and efficacy of the approved vaccine.
- Policy
- Boehringer's new obesity drug is conducting clinical trial
- by Lee, Tak-Sun Jan 08, 2021 06:19am
- Boehringer Ingelheim is conducting a clinical trial of a new obesity treatment in Korea. It is noteworthy whether it will exceed the sales of Saxenda (Liraglutide·NovoNordisk), which is currently leading in the Korean market. The MFDS approved the Phase II clinical trial protocol of BI 456906, a candidate for the new obesity drug of Boehringer Ingelheim on the 4th. This clinical trial is a 46-week trial that is administered subcutaneously once a week compared to placebo in obese or overweight patients. As a multinational clinical trial, 16 patients participate in Korea. The total number of subjects is 350. This drug is known as a candidate for a new drug obtained by Boehringer Ingelheim in partnership with the Danish pharmaceutical company Zealand Pharma A/S. It has a mechanism of dual action on glucagon-like peptide-1 (GLP-1) and glucagon receptors. GLP-1 and glucagon receptors play a role in regulating metabolic function. These substances reduce glucose synthesis in the liver and reduce blood sugar by increasing glucose absorption in the muscles. Saxenda Saxenda is also a GLP-1 analog, which induces weight loss by prolonging the action time of GLP-1. Saxenda ranks first in the domestic obesity treatment market. Cumulative sales in the third quarter of last year (based on IQVIA) were ₩28 billion, far ahead of Qsymia (Phentermine and Topiramate, Alvogen Korea), which recorded ₩16.7 billion. Saxenda is sold as a once-a-day formulation, but NovoNordisk is planning to market it as a once-a-week formulation with improved method. Boehringer's drug, which has been approved for clinical trials this time, is also a subcutaneous injection once a week. If commercialization is successful, it is expected to be a strong candidate against Saxenda.
- 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.
