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- 2026-05-09 13:16:36
- Policy
- Yuhan's Lazertinib was approved
- by Lee, Tak-Sun Jan 20, 2021 06:02am
- The new drug Lazertinib developed by Yuhan for the treatment of non-small cell lung cancer has obtained approval from the MFDS. The technology was transferred to the global pharmaceutical company Janssen and is currently undergoing licensing procedures in other countries such as the United States. It is the first country in the world to obtain approval from the FDA. The MFDS announced on the 18th that it has approved Yuhan's non-small cell lung cancer treatment Leclaza (Lazertinib mesylate) as the 31st new drug developed in Korea. Leclaza is used in patients with advanced lung cancer with specific gene mutations who have previously been treated for lung cancer. It is a target anticancer drug that inhibits the proliferation and growth of lung cancer cells by interfering with the signal transmission involved in lung cancer cell growth, and is less toxic to normal cells. The drug treats patients with EGFR T790M mutation-positive locally advanced or metastatic non-small cell lung cancer who have previously been treated with EGFR-TKI. It selectively inhibits the epithelial cell growth factor receptor Tyrosine Kinase, which is involved in the growth, differentiation, and survival of cancer cells, and prevents cancer cell survival, proliferation and metastasis. Yuhan applied to conduct a phase III clinical trial after marketing based on the results of a phase II clinical trial conducted in Korea. The MFDS explained that the quality, safety and effectiveness, and post-marketing safety management plans were scientifically reviewed and evaluated according to the review criteria of the Pharmaceutical Affairs Law. The Central Pharmaceutical Affairs Review Committee, which includes experts treating lung cancer in the medical field, gave the final approval after consulting on the completion of the license and conformity to the system. The MFDS said that the approval of the new drug is expected to expand the range of drug options for the treatment of patients with recurrent non-small cell lung cancer. It emphasized that it will continue to provide scientific and thorough approvals and reviews, and by securing objectivity and transparency through expert advice, to ensure that the safety and effectiveness of treatments are sufficiently verified.
- Policy
- COVID-19 vaccination to start in February
- by Lee, Jeong-Hwan Jan 20, 2021 06:01am
- “COVID-19 vaccination begins at the end of February and early March, and will form herd immunity in November at the latest. If side effects occur only after the vaccination, the government will be fully responsible. I am urged to inoculate, and if the national anxiety increases and the need to take an initiative, as the president, I will not avoid it.” President Moon Jae-in said that COVID-19 vaccination will begin in late next month (February) and early March, and that he will form Herd immunity by November at the latest. He promised that the government will take all responsibility from mild to severe side effects that can occur after free vaccinations for all citizens, and said that he would be the first to get the vaccine as a president to alleviate public anxiety. On that day, BBC Bureau chief Laura Bicker asked President Moon, "If Korea had secured the vaccine a little faster, wouldn't the point of returning to daily life have been accelerated?" President Moon said that the domestic COVID-19 vaccine introduction and vaccination plan were systematically established. He especially hoped that he could succeed in forming herd immunity faster than any other country. The vaccination will be from late February to early March, and herd immunity is expected to be formed in November at the latest. President Moon said, "COVID-19 vaccine is the first vaccine developed in the world. We evenly purchased various vaccines to distribute the risks and secured sufficient quantities. Because vaccination takes time and the expiration date is short, herd immunity will be formed by starting the vaccination in February and the end of the vaccination management of the people by September." President Moon said, "If the vaccination is completed in the fourth quarter, the formation of Herd immunity is expected in November at the latest. It will be rather faster compared to other countries." He said, "The start of vaccination is at the end of February or early March, and there is a possibility that the quantity of COVAX facility will be introduced first, and the possibility that the time of introduction will be accelerated is being reported." The authorities will report it to the public in detail.“ President Moon said not to worry about the public being anxious about the side effects of COVID-19 vaccine. He said that if it helps relieve anxiety, he will be the first to receive vaccination as the president. The government will take full responsibility for any personal damage. President Moon said, "The quarantine authorities were very cautious in the process of signing a vaccine introduction contract, including side effects. As a vaccine that took more than 10 years was developed in one year with a fast track, we carefully observed the results of phase II/III clinical trials. "The MFDS approves global vaccines according to domestic standards. We analyze enough side effects. The public can trust the safety of vaccinations in Korea." President Moon said, "However, all vaccines have some side effects. From mild pain to more serious side effects. In this case, the government will take full responsibility for the side effects. So please do not worry about personal damage without government protection." He said, “Today (18th), the number of confirmed cases is about 300. It is clear that the third COVID-19 epidemic is over. If less than 400 people are confirmed during this week, the level of quarantine can be lowered. Because vaccination and treatment will be available soon, we will be able to succeed in quarantine ahead of any other country in the world and return to our daily routine after overcoming the crisis.”
- Policy
- NMO drugs ready for Korean market release within this year
- by Lee, Tak-Sun Jan 19, 2021 06:02am
- Roche’s NMO treatment Enspryng with satralizumab. A group of rare disease neuromyelitis optica (NMO) treatments are preparing for the South Korean market. NMO is a chronic disease with a no specific treatment. Recently, however, a number of treatments for the disease have passed the U.S. Food and Drug Administration (FDA) and they are now readying for the South Korean health authority’s approval as well. According to the pharmaceutical industry on Jan. 18, Mitsubishi Tanabe Pharma’s inebilizumab and Roche’s satralizumab have reportedly submitted application to the Ministry of Food and Drug Safety (MFDS) for the approval review. Inebilizumab received the U.S. FDA approval in last June. The U.S. health authority also granted an approval on satralizumab in last August as well. The first NMO treatment is Alexion’s Soliris. Initially, the drug was cleared by the FDA in 2007, indicated to treat patients with paroxysmal nocturnal hemoglobinuria (PNH). The additional indication to treat neuromyelitis optica spectrum disorder (NMOSD) was approved in June 2019, making it the first drug to treat the disease. Regardless of the title, the additional indication is not yet expanded in South Korea. The industry expects that Soliris would also follow through with the MFDS indication expansion procedure. NMO is an extremely rare disease, also characterized as an inflammatory demyelination that attacks the eye nerves and the spinal cord. The symptoms include numbness, weakening muscles and rapid loss of vision. Apparently, the disease is more likely to be expressed in Asian females, and the symptoms tend to stay permanently, while it could result in death due to shortness of breath. As all three drugs have applied for the approval, the patients may expect to get access to the first NMO treatment in South Korea. But the last hurdle is the pricing. Administering satralizumab costs over 200 million won per year. Soliris is famous in South Korea as ultra expensive drug. The financial impact on the National Health Insurance would be inevitable. The key to South Korean market release would be the successful pricing negotiation. The industry is closely following the relevant news to see who would become the first NMO treatment in the country and for how much with the reimbursement.
- Policy
- 68% to “wait and see” before COVID-19 vaccination
- by Jan 18, 2021 06:14am
- Sandra Lindsay, a nurse in the U.S., is taking the COVDI-19 vaccine (Source: CNN). Apparently, six out of 10 people in South Korea are intending to ‘get inoculated after confirming the outcome’ of the COVID-19 vaccine. Only 28.6 percent answered they would ‘get inoculated as soon as possible.’ As requested by a public survey research firm KSTAT Research, Professor You Myung Soon at Seoul National University Graduate School of Public Health surveyed 1,094 adults around the country from Jan. 8 through 10 for the 11th survey on their perception of COVID-19. The study found 67.7 percent would wait until later to see the performance of the vaccine to take the vaccine. Regarding the timing of initiating the inoculation in South Korea, 59.9 percent said they should wait and see, while 37.8 percent said as soon as possible. On the questionnaire asking about the fear and anticipation of the vaccine, 40.4 percent said they have a same level of both fear and anticipation, when 28.1 percent have more fear and 25.6 percent have more anticipation. 42. percent expects the timing of the vaccine commercialization would be around the middle of the year, and 35.4 percent and 11.2 percent answered late this year and next year, respectively. The majority of the survey participants, or 80.3 percent of them said they intend to receive free safety-proven vaccine (53.2 percent maybe, 27.1 percent absolutely). Professor You Myung Soon noted, “The survey provided an insight into the people’s sense of threat by the COVID-19 pandemic, prudence in vaccine development and use, and a positive level of trust in the healthcare system and the government’s vaccination plan. The government would need to endeavor to reflect the people’s intention and experience from various angle based on the understanding that their final judgment would be comprehensively made.” The survey participants answered the South Korean society in last 12 months of COVID-19 was not safe (59.7 percent), average (29.2 percent), and safe (11.2 percent). The ratio of the participants answering ‘not safe’ peaked from the entire series of the COVID-19 surveys Professor You has done so far. Regarding the third wave of the pandemic, 51.9 percent said the worst has yet to come, whereas 23.8 percent said the worst has passed. The participants also scored average 40 assessing if the daily life has recovered from the changes COVID-19 brought, when 100 indicates ‘completely.’ However, the score was lower in different demographics, such as the low income community (35.4), unemployed (35.5) and women in 30s (35.3).
- Policy
- Celltrion announced results of external clinical trials
- by Lee, Tak-Sun Jan 18, 2021 06:13am
- The MFDS will hold a verification advisory group meeting on the 17th to evaluate the appropriateness of the clinical trial results for COVID-19 treatment Rekirona developed by Celltrion. And it plans to announce the results on the 18th. After the verification advisory group meeting, the Central Pharmaceutical Affairs Review Committee and the final review committee decide whether to grant CMA through internal and external verification. The MFDS is currently operating the Central Pharmacy Review Committee on matters related to the safety and effectiveness of new drugs in accordance with the Pharmaceutical Affairs Law and is undergoing a procedure to seek advice. Taking into account the severe situation of COVID-19 pandemic, COVID-19 Treatment/Vaccine Safety and Effectiveness Verification Advisory Group and the Final Inspection Committee were additionally formed to go through a triple consultation process. The verification advisory group, the Central Pharmaceutical Affairs Review Committee, and the final review committee are in order. The Verification Advisory Group is a procedure in which the MFDS collects advisory opinions such as clinical, non-clinical, and quality from various experts prior to consulting the Central Pharmaceutical Affairs Review Committee. It was composed of about 30 experts in statistics, etc. Depending on the agenda, an advisory group meeting will be held in which experts in the field participated. The Central Pharmaceutical Affairs Review Committee is an advisory body of the MFDS pursuant to Article 18 of the Pharmaceutical Affairs Law. The advisory committee consists of about 15 members, including standing members of the Biological Drug Subcommittee and related experts, and consults on matters discussed by the verification advisory group and clinical usefulness. The Biologics Subcommittee is a specialized subcommittee for deliberation on the safety and effectiveness of biopharmaceuticals such as vaccines and genetically modified drugs. Prior to the final approval decision, the MFDS plans to hold a'final inspection committee' in which internal and external experts (about 10 people) jointly participate, and conduct a final inspection based on the results of the verification advisory group and the'Central Pharmaceutical Affairs Review Committee . The Ministry of Food and Drug Safety will hold a verification advisory group meeting on the clinical trial data of Celltrion's Rekirona on the 17th, and the results will be released on the 18th. At the verification advisory group meeting, it plans to receive advice on whether the clinical results for the indicators for measuring the clinical effectiveness and the indicators for measuring the principle of operation of the drug used in clinical trial of Rekirona are appropriate to acknowledge the therapeutic effect of this drug. The clinical efficacy measurement index is to evaluate how quickly the administered patient recovers from the seven symptoms of COVID-19 (fever, cough, difficulty breathing, sore throat, muscle pain, fatigue, and headache). A measure of how the drug works is to evaluate how short the time between positive to negative virus test results is reduced. An official from the MFDS said, "We will try to collect various opinions from experts in the process of reviewing the approval of the treatment and vaccine for COVID-19 so that a thorough approval and review can be accomplished.
- Policy
- Will COVID-19 vaccine by SK be released first?
- by Lee, Tak-Sun Jan 15, 2021 06:11am
- Among AstraZeneca's COVID-19 vaccines that have been applied for approval from the MFDS, it is highly likely that the vaccine that SK Bioscience is consigning and producing will be distributed for the first time in Korea. Recently, the MFDS has reported that item approval and lot release can be reviewed in duplicate to speed up the market. The industry analyzes that it will be possible to review vaccines previously produced by SK Bioscience for approval. The health authorities said through a briefing that they are in consultation with AstraZeneca to ensure that the vaccine that is distributed for the first time in Korea will be produced by SK Bioscience. On the 14th, an official from the MFDS said, "There is an exaggerated part of the press report that item approval and lot release are reviewed. Some overlapping periods can occur." Item approval and lot release are different. In the case of vaccines, after item approval, a lot release review is conducted for the products sold in Korea. Therefore, in order for item approval review and national lot release review to overlap, a commercial vaccine must be secured first. The MFDS is required to produce three commercially available lot numbers in advance and submit them as item approval review data according to the regulations on drug safety. Items produced for approval can be used for lot release screening. It is more likely to proceed with lot release for domestically manufactured vaccines rather than imported vaccines that take time due to customs procedures. The MFDS explained in a press release on the 11th that it plans to conduct an on-site survey on SK Bioscience for manufacturing and quality control evaluation during this month. This survey also includes production data for three lots numbers produced in advance. If the GMP (manufacturing and quality control standard) investigation is completed and the feasibility of the clinical trial is secured, it will be possible to review the lot release of commercial vaccines even before approval. The MFDS plans to shorten the period of item approval to a maximum of 40 days (currently more than 180 days) and lot release within a maximum of 20 days (currently 2 to 3 months). In order to start vaccination at the end of February, as announced by the government, lot release must also be carried out during the permit review period. AstraZeneca's COVID-19 vaccine was applied to the MFDS on the 4th. If item approval and lot release are up to 60 days, lot release should also be made during the approval review period. It is said that the health authorities are discussing it, but the vaccine that will be distributed for the first time in Korea is most likely a vaccine produced by SK Bioscience. When asked if the vaccine to be applied for the initial lot release screening is from SK Bioscience, the MFDS responded that it cannot be informed because the item is under review. The imported vaccine that AstraZeneca applied is known to be a product produced in Italy.
- Policy
- Tamiflu for oral suspension has withdrawn
- by Lee, Tak-Sun Jan 15, 2021 06:10am
- Tamiflu for oral suspension sold overseas In KoreaRoche's original influenza treatment Tamiflu for oral suspension is withdrawn from the domestic market due to the expiration of the product license. Generics for Tamiflu for oral suspension occupied in advance. As of the 13th, the MFDS withdrew Tamiflu for oral suspension 6mg/ml (Oseltamivir) from Roche Korea due to the expiration of the product license. It was approved on January 13, 2016. The main formulation of Tamiflu is capsule type, and patients such as children and the elderly have difficulty swallowing, so the drug in the capsules were ground into powder at a pharmacy and sold for pediatric use. However, since Tamiflu for oral suspension is mixed with water and taken in a liquid form, it is convenient to dispense at a pharmacy, and it is easy for children to take. Roche imported this suspension in Korea and obtained approval for the first time. However, due to the disagreement between Roche headquarters and Roche Korea, it delayed applying for Tamiflu for oral suspension and lost the competition with generic drugs. Hanmi received approval for Hanmi Flu Suspension one month later than Tamiflu for oral suspension, but it was first launched on the market in May 2016 after receiving insurance benefits. Since then, 30 kinds of generic drugs have been launched in 2017. Tamiflu for oral suspension was first approved in Korea, but it missed the timing of its release and started to withdraw from the market. Roche did not even apply for renewal and eventually decided to withdraw the license. Accordingly, Roche is expected to focus more on Tamiflu capsule. It is interpreted that the number of flu patients is decreasing due to the recent COVID-19 epidemic, which also affected the sales of Tamiflu for oral suspension.
- Policy
- Indications for Forxiga include CHF
- by Kim, Jung-Ju Jan 15, 2021 06:10am
- As the indication for AstraZeneca’s SGLT-2 inhibitor Forxiga 10mg (Dapagliflozin) has been extended to chronic heart failure, it is clearly covered in the benefit. On the 12th, the MOHW announced a partial amendment to the 'Pharmaceutical Reimbursement Listing Standard and Method', which establishes the reimbursement standards for additional authorizations for Dapagliflozin. Forxiga 10mg is an SGLT-2 inhibitor administered as an adjunct to diet and exercise therapy to improve blood sugar control in type 2 diabetes patients. The reimbursed price of Forxiga 10mg is ₩784. As of the 22nd of last month, the MFDS expanded the indication to chronic heart failure, requiring management of insurance benefits. Accordingly, the MOHW plans to include it in the notice to clarify the coverage of this indication. The benefits are recognized when Forxiga is administered to type 2 diabetes (general principle). If Forxiga is administered for an indication of chronic heart failure, the patient pays for the drug. The MOHW is planning to inquire industry opinions by the 14th, and it will be implemented and applied from the 15th if there is no specific matter.
- Policy
- COVID-19 vaccine budget KRW 857.1 Bln received
- by Kim, Jung-Ju Jan 14, 2021 06:15am
- The South Korean health authority is fully readying for COVID-19 vaccination starting off from February as they have first secured the budget for the vaccine purchase and expenditure for inoculation. The Korea Disease Control and Prevention Agency (KDCA) announced on Jan. 12 the vaccine purchasing budget and inoculation expense budget of 857.1 billion won and 38 billion won have been allocated, respectively, through first and second budget request. KDCA first received 857.1 billion won to purchase globally developed vaccine, which would sequentially cover the upfront payment for Moderna vaccine and payments for the other vaccine supply deals. The health authority plans to continue seeking for finance from the financial authority for additional payments to procure vaccines for 56 million people. And approximately 35.6 billion won would be requested for preparing vaccine freezer for storing and inoculation, syringe and other equipments and establishing an integrated management system for vaccine distribution and inoculation. KDCA would also set up vaccine distribution, storage and management system before the first inoculation begins. Currently, KDCA is in process of purchasing mRNA vaccine freezer for Pfizer (-75℃±15℃) and Moderna (-20℃) and required syringe via the Public Procurement Service. Bidding for the freezer is ongoing since from Jan. 7, which would procure 100 units within this month and complete installing 250 units within the first quarter. Moreover, KDCA is to ink contracts with distributors within this month to safely ship vaccine to the inoculation centers. The agency official noted it is setting up a tight cold chain management system, as well as an integrated management system to inform the public of the COVID-19 vaccine and book timeslots for inoculation recipient. The budget of approximately 2.4 billion won is allocated for raising public awareness of inoculation, educating about the inoculation, and operating a call center. The training for human resources would be conducted for streamlined inoculation process, while the government would provide accurate information about the process and call center service for better communication and fact checking. Director Jeong Eun-kyeong stated, “The vaccine doses the government has signed the deal for 56 million people would be introduced in phases, and they would be prepared as soon as feasible. When the COVID-19 vaccine inoculation plan is finalized, the government would pay particular attention to the preparation to immediately and promptly conduct the inoculation.”
- Policy
- There is progress in introducing additional COVID-19 vaccine
- by Lee, Jeong-Hwan Jan 14, 2021 06:15am
- Prime Minister Chung Sye-kyun announced that significant progress has been made in introducing additional vaccines from other platforms, including Pfizer, Moderna, AstraZeneca, Janssen, and others regarding the COVID-19 vaccine. Although the spread of COVID-19 has recently slowed, he has been wary of hasty measures to mitigate quarantine. On the 12th, Prime Minister Chung held the Central Disaster and Safety At the Countermeasure Headquarters meeting, he said, "The government has been making efforts to introduce additional vaccines for another platform, and there has been considerable progress recently. Details will be reported to the public after the contract is finalized." Prime Minister Chung Sye-kyun said, "The government has signed a contract for a vaccine for 56 million people, enough to form collective immunity, and is preparing with all its might to start vaccination next month. Even with the vaccine, it is not yet known how long the immunity will last, and there is a possibility of safety issues. If the vaccination is not done within the expiration date, the vaccine may have to be discarded as it is due to the short expiration date." Regarding the recent COVID-19 situation, Prime Minister Chung said, "The spread has slowed since last weekend, and it can be confirmed as an objective indicator." "Danger comes soonest when it is despised," he stressed. He said, "The number of new outbreaks in the last week has decreased to less than a quarter compared to the previous week, and the infection reproductive index has also fallen to less than 1. The metropolitan area's medical response capacity has also recovered a lot." "It will be decided this week whether it will go to a certain level of stability, or if it will re-proliferate after being distracted," he said. "We have experienced what happens when social awareness is weakened, and we have seen the consequences of premature quarantine mitigation measures in the world case." He said, "A number of European countries have entered social blockade again, and Japan has declared an emergency with more than 100,000 confirmed cases in a month. K-quarantine should never commit the same mistake."
