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- 2026-05-05 20:40:10
- Policy
- MOHW·MOTIE accelerates Global COVID-19 Vaccine Hub project
- by Kim, Jung-Ju Jan 14, 2022 05:50am
- The Ministry of Health and Welfare (MOHW) and the Ministry of Trade, Industry, and Energy (MOTIE) joined forces to come up with a plan to accelerate the government’s goal of Korea becoming a ‘Global Vaccine Hub’ that was set last year. On the morning of the 13th, Minister of Health and Welfare Kwon Deok-Chul and First Vice Minister of Trade, Industry, and Energy Park Jin-kyu co-hosted the ‘Meeting to promote investment in companies for vaccine and raw materials, followed by a ‘Cooperative meeting of the heads of Top 10 relevant agencies.' The events were held in the light of the new year for the government, companies, and related agencies to share their achievements and progress that were made to turn Korea into a global vaccine hub in 2021, as well as discuss policy vision and direction for this year. Officials from relevant ministries such as the Korea Disease Control and Prevention Agency (KDCA), Korean Intellectual Property Office (KIPO), MOTIE, Ministry of Food and Drug Safety and Korea Customs Service, as well as 10 heads of relevant institutions, and presidents from KoreaBio, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korea Biomedicine Industry Association, as well as CEOs from 14 vaccine and raw material companies, attended the meeting. In the first part of the event, the 'Meeting to promote investment in companies for vaccine and raw materials,’ ▲Presentation on the investment performance of 13 vaccine and raw material companies ▲Import/export trend of vaccines and measures to strengthen support for export ▲Business roundtable were held sequentially. Using the government’s ₩18 billion (last year's supplementary budget) to prime investment and ₩50.4 billion of their own investment fund, the 14 vaccine and raw material companies plan to complete their facility investments worth ₩68.4 billion by July this year. The 10 vaccine companies participating are ST Pharm (mRNA), Quratis (mRNA), BMI Korea (mRNA), Hanmi Pharmaceutical (mRNA/DNA), HK Bio Innovation (synthetic antigen), CdmoGen (mRNA), Humedix (vector type), Jetema (vector type), Boran Pharma (vector type), and CELLID (vector type), and 4 raw material companies are Hanmi Fine Chemical (mRNA), Amicogen (synthetic antigen/vector type), LMS (mRNA), and Ecell (mRNA) The investments are expected to expand the manufacturing capability of various vaccine platforms for mRNA, virus vector, and synthetic antigen vaccines in Korea's progress to becoming a global vaccine manufacturing hub. Also, 847 new employees will be hired in the vaccine and raw material manufacturing sector to help ease the youth unemployment issue and contribute to fostering high-quality personnel. In addition, over 34%, ₩23.8 billion of the ₩68.4 billion of the fund for purchasing facilities and equipment will be used to first purchase domestic equipment and provide market support for domestic equipment manufactures, and improve business conditions. In terms of vaccine import and exports, vaccine export last year reached a record-high amount of $520 million powered by the export of contracted COVID-19 vaccine products among others. This is a threefold increase from the previous year. In terms of vaccine API and raw materials, exports of ▲vaccine carriers and low-temperature storage boxes, ▲Sterol (raw material that makes up mRNA vaccines and LNP), and ▲syringes also increased with the expanded global vaccine market. Export of carriers and cold boxes also reached a record-high of $1.35 billion. The increase in manufacturing of mRNA vaccinees (Pfizer/Moderna) had increased the export of sterols by 72% to reach a record of $4.74 million this year. For syringes, the increased vaccination rate had made the largest ever exports, with a record-high growth rate of 87.9%. Meanwhile, the government announced it will be strengthening the corporate support services to expand exports of vaccines and raw materials, including corporate matching and marketing support. In the case of the corporate matching service, the government will actively support matching between domestic and global pharmaceutical companies and the companies’ market pioneering through the ‘Global Partnering (GP)’ business in linkage with the 3 major B2B export platforms in Korea, as well as through Bio Korea. For marketing support, the government will hold a global vaccine business forum tour in Korea and abroad and support customized overseas expansion services (local market research, roadshows, etc.) for individual companies. In the case of financing, the government will increase the trade insurance cap of vaccine exporters to twice the current amount, provide insurance premium discounts, and loan funds for building domestic facilities for vaccine export purposes. Also, the government will significantly strengthen export support using its trade networks such as the WTO and FTA to establish global vaccine partnerships that encompass advanced and developing countries alike. In particular, based on the Korea-US and Korea-EU partnerships, the government will specifically support the procurement of vaccines and raw materials, investment attraction, and mutual market entry with advanced countries. With the developing countries, the government will explore the possibility of cooperation, such as discovering domestic vaccine exporters and joint manufacturing of vaccines and raw materials, at various occasions of bilateral talks. In addition, the government held a business roundtable at the meeting in four separate sessions, ▲ clinical-related support ▲ R&D/patent/testing support ▲ raw material supply/demand support ▲ production/export/customs clearance support, to hold an ear out to the difficulties experienced by companies and derive results. For clinical-related support, the government will provide all-out support at the government level through various diplomatic channels to contact foreign governments and utilize international conferences such as WHO and CEPI in addition to reaching out to individual companies to secure comparator vaccines for the Phase III trials that are essential for the development of domestic vaccines. The licensing and authorization process will also be simplified. The MFDS will accelerate the review of clinical trial protocols and marketing authorization for COVID-19 vaccines and treatments through a rolling review that allows for prior review of company data (non-clinical, GMP, quality, clinical trial protocol, etc) upon their preparation before applications are filed. In the case of R&D/patent/testing support, the MOHW plans to organically link and support R&D projects distributed to each Ministry as the national vaccine R&D control tower while establishing an industry-academia-research-hospital cooperative model to secure domestic technology for mRNA platform development in Korea. Support measures for patent response were also prepared. KIPO plans to address the lack of patent information and actively support domestic vaccine and raw material companies' response to patents that may hinder the production of undiluted vaccine solutions and raw materials. KIPO will also expand its patent-R&D strategies to provide patent evasion and licensing strategies to the vaccine and raw material companies in the R&D stage and provide early diagnosis and support dispute response strategies for small-and-mid-sized companies in the product production and export stage. Also, measures to secure raw materials were prepared. MOTIE will request cooperation from major suppliers for the stable procurement of raw materials to resolve the difficulties in supply and demand of such materials and work with diplomatic offices overseas and KOTRA to support the discovery of alternative supply lines. In addition, the authorities will expand R&D support to secure technology for raw materials in Korea to prepare a basis for a stable supply of raw materials domestically. Also, MOTIE will regularly hold a ‘consultative body to seek cooperative co-growth for vaccines, raw materials, and equipment’ and devise diverse support measures such as an exchange between demand and supplier companies and promotion of best practices. MOTIE will encourage cooperation between the companies supplying and demanding the products to increase acceptance of domestic products. Furthermore, a measure will be prepared for developers to borrow raw materials from one other. MOTIE and MOHW plan to prepare a forum where the general measures for cooperation may be discussed from sharing inventory status among major vaccine companies, mutual rental of raw materials, and the possibility of joint purchases between major vaccine companies in Korea through the ‘consultative body to seek cooperative co-growth for vaccine, raw materials, and equipment.' Currently, Samsung Biologics, Celltrion, LG Chem, SK Bioscience, Hanmi Pharmaceutical, GC Pharma, ST Pharm, Ecell, Dongsin Tube Glass, Junghyun Plant, Wiatek are members of the consultative body, and the authorities are planning to increase participating companies in the coming future. The government will also support the localization of raw materials and equipment for vaccines. MOTIE plans to accelerate the technological development of key items by newly establishing a technology development project specializing in the production of raw materials for vaccines this year (₩30 billion by 2025). In particular, MOTIE plans to intensively support the development of raw materials for mRNA COVID-19 vaccines (core enzymes, resins, etc.), and the development of the mRNA vaccine manufacturing process and core equipment technology. Measures to support the production, export, and customs were also prepared. The MOHW is seeking measures to improve the system from various angles, such as sending an official letter to local governments to shorten the time required for the review of 'prior approval for research and production facility installation, which is required before registering plans within registration in the high-tech medical complex.’ MOTIE plans to also prepare a performance evaluation system for raw materials of vaccines at a global level this year, including various test and evaluation support measures necessary needed by companies, including leachable tests. In addition, the government plans to significantly strengthen export support for companies that produce vaccines, raw materials, and equipment. For this, the Korea SMEs and Startups Agency (KOSME) will award up to 5 additional points for vaccine and raw material companies that wish to participate in the export voucher business. Also, it will prioritize entrance of the companies’ vaccine and raw material products in the Top 3 B2B export platforms in Korea - BuyKOREA (KOTRA), GoBizKorea (KOSME), and TradeKorea (Korea International Trade Association) - and BioKorea (Korea Health Industry Development Institute), and expand the provision of customized support for the vaccine industry, such as support for major overseas market research, buyer matching, and certification support. MOTIE had previously only supported booth installation cost for overseas exhibitions, but will now support booth installations in academic conferences and forums in the future. In the second part of the event, ‘Cooperative meeting of the heads of Top 10 related organizations,’ ▲ Korea’s achievements in becoming a global vaccine hub and its future tasks, ▲ achievements and strategies for attracting foreign investment in vaccines and raw materials ▲ top 10 related organizations’ visions and focus plans for this year, were discussed. Looking at Korea’s achievements in becoming a global vaccine hub and its future tasks, SK Bioscience conducted Phase III clinical trials after receiving approval for its trial protocol (August last year) and plans to commercialize ‘the first homegrown COVID-19 vaccine’ in the first half of this year. In addition, the company plans to expand the domestic CMO production of COVID-19 vaccines (Moderna, Novavax, etc.) this year as well. On December 13th last year, Samsung Biologics had obtained marketing authorization for the Moderna vaccine it manufactured under a CMO agreement with Moderna. This is the first domestically manufactured mRNA vaccine approved for marketing authorization in Korea. Under the companies’ agreement, hundreds of million doses of Moderna vaccine will be produced and distributed within Korea and exported abroad. This marketing authorization obtained by Moderna Korea officially allows Moderna’s COVID-19 vaccine manufactured at Samsung Biologics’ local pharmaceutical production facilities to be distributed within Korea and exported to other countries. SK Bioscience had signed a CMO agreement to produce AstraZeneca’s vaccine from February of last year, however, the CMO agreement expired on December 31st of the same year. On the other hand, Novartis received marketing authorization for its vaccine from the MFDS on the 12th of this month and is expected to start manufacturing in earnest this year. The MOHW plans to raise a "K-Global Vaccine Fund" worth ₩500 billion this year for clinical support in the biopharmaceutical sector In terms of achievements and strategies for attracting foreign investment in vaccines and raw materials, foreign direct investment in vaccines and raw materials last year reached $1,007 million, up 58.7% from the $635 million in 2020. In particular, Sartorius plans to invest $300 million, around ₩350 billion in Korean won to build a manufacturing plant to produce various raw materials and manufacturing facilities for cell culture media, pharmaceutical filters, and membranes until 2025 in Songdo. The company completed reporting the investment in December last year and will start construction after the City of Incheon confirms its location within the Songdo Biocluster by June this year. Also, Cytiva will invest $52.5 million, around ₩62.8 billion in Korean won from this year to 2026 to build manufacturing facilities for its raw materials including its disposable cell culture bags. The City of Incheon confirmed its location in Songdo in December last year, and construction is scheduled to start in the second quarter of this year. The government will continue to look for global raw material and equipment companies to attract to Korea and promote the project in consideration of the export scale, the demand of domestic companies, the possibility of foreign-invested companies entering the country, and project progress. Due to heated efforts to attract vaccine and raw material companies globally, the government plan to strengthen activities to attract such by each stage of investment rather than employ short-term events. The government will expand cash support and prioritize the designation of high-tech investment districts. In line with the expansion of investment tax deductions for national strategic technologies that are implemented this month, the government will also promote expanding cash support under the Foreign Investment Promotion Act. Each of the top 10 related organizations also set up visions and focus plans for this year. The top 10 relevant agencies will provide concentrated support for vaccines, raw materials, and equipment companies by linking them with support programs needed in the field, from technology development, financial loans, industrial support, export support, export insurance, and guarantees.
- Policy
- COVID-19 vaccine by NovaVax is approved in Korea
- by Lee, Tak-Sun Jan 14, 2022 05:50am
- COVID-19 vaccine by NovaVax was approved for domestic items on the 12th. At the final inspection committee held on the same day, experts judged that the Novavax vaccine had a sufficient effect on preventing COVID-19. The MFDS announced on the 12th that SK Bioscience has decided to approve the product on the condition that it submits a final report on the clinical trial results for the COVID-19 vaccine Nuvaxovid PFS, which has applied for approval for manufacturing and sales items. Nuvaxovid PFS is a gene recombinant COVID-19 vaccine developed by Novavax in the U.S. and manufactured by SK Bioscience in Korea from undiluted to complete. The main active ingredient is the same as a vaccine (10 vials packed with doses) conditionally licensed in EUA by 30 countries including Europe and WHO. The newly approved vaccine can be immediately inoculated with a single dose PFS injection that contains one dose per vaccine without dilution. Storage conditions are 5 months in refrigeration (2-8°C). The MFDS evaluated that the vaccine is meaningful in that it was manufactured in a gene recombination method with existing national vaccination experience, that it is convenient to store, transport, and inject, and that the types of vaccines that can be selected in the medical field have expanded. The MFDS began reviewing in advance from April 29 last year. A total of four data were submitted, including clinical trials conducted in Australia, the United States (clinical phase 1/2), South Africa (clinical phase 2), the United Kingdom (clinical phase 3), and the United States (clinical phase 3). As a result of analyzing the people who were confirmed with COVID-19 after 7 days of the second vaccination in clinical trials, about 89.7% of the preventive effect was found in British clinical trials, 10 in the vaccine group and 96 in the control group. In clinical trials in the United States, 14 vaccine groups and 63 control groups showed a preventive effect of about 90.4%. In addition, according to the evaluation of neutralizing antibodies that induce preventive effects by binding to the surface of the COVID-19 virus to neutralize the infectivity of the virus, compared to before vaccination, antibodies more than quadrupled from two weeks after vaccination. The final inspection committee for Novavax vaccine held on the 12th Abnormal cases predicted after vaccination (local, systemic) include tenderness, injection site pain, erythema, and swelling, most of which are mild to moderate, and were lost within one to three days of occurrence. The MFDS went through a triple advisory process consisting of experts to enhance the expertise and objectivity of the licensing process. Starting with the verification advisory group on the 29th of last month, the Central Pharmaceutical Review Committee on the 6th and the final inspection committee on the morning of the 12th were held. The final inspection committee judged that most of the reported abnormalities were generally good as predicted abnormalities related to vaccination. In addition, the review based on the submitted clinical trial data concluded that the preventive effect of the vaccine was sufficient.
- Policy
- The timing of approval for Novavax vaccine is unpredictable
- by Lee, Tak-Sun Jan 13, 2022 02:54pm
- The MFDS, which was active in disclosing information on COVID-19 vaccine screening, is suddenly not disclosing any information on the Novavax vaccine. There was no news of the expert advisory group, and 40 days have already passed the promised screening period. Some analysts say that this is because it is difficult for the MFDS to predict the timing of approval with "quality" data different from overseas. The Novavax vaccine was reviewed by the MFDS in November. It is the fifth COVID-19 vaccine to be officially reviewed. The previously approved vaccines of AstraZeneca, Pfizer, Janssen, and Moderna were approved 40 days after the screening. Considering the urgency of infectious diseases, the MFDS has established a policy to grant permission within 40 days by advancing the screening period for the COVID-19 vaccine as much as possible. However, the Novavax vaccine has not been approved for more than 60 days since the screening, let alone expert advice. The MFDS has set up a triple advisory group to speed up the screening of the COVID-19 vaccine as much as possible, but has finally approved it so that the public does not worry about safety and effectiveness. After the first COVID-19 vaccine safety and effectiveness verification advisory group, the second Central Pharmaceutical Review Committee and finally, the final inspection committee decided on the same day's approval. Whenever experts consulted, the MFDS distributed media data and held briefings. It was part of an attempt to increase transparency in public interest in screening. However, the Novavax vaccine seems to be an exception. According to some media reports, the first verification advisory group meeting among the triple advisory groups was passed. Now, the verification of the Central Pharmaceutical Review Committee and the Final Inspection Committee remains. However, unlike the previous vaccines, the MFDS has not actively disclosed information. Analysts say this is because there are other variables. The Novavax vaccine is a recombinant protein vaccine made by gene recombination technology that injects COVID-19 virus antigen proteins into the body to produce antibodies. Vaccines currently being reviewed by the MFDS are produced at SK Bioscience's Andong plant. However, the vaccines produced by SK Bioscience are different from those approved by the WHO and the EMA. Vaccines approved by the WHO and the EMA are multi-use vials, while domestic license applications are single-use PFS. Accordingly, the quality data submitted to the review authorities are also different. The MFDS is known to be cautious about this quality data. It is said that one or two supplementary orders have also been issued. The safety and effectiveness verification seen by the triple advisory group is not too unreasonable as it has been recognized overseas, but it seems that the MFDS is checking quality data that has never been verified abroad more meticulously as it is a sole review. Therefore, it is analyzed that the MFDS has been cautious about disclosing information so far because it is possible to predict the time of final approval when quality data are fully prepared than the triple advisory group. However, some insiders say that the Novavax vaccine is likely to be approved within this month. Analysts say that the expert verification plan will be disclosed and the final approval will be decided when the data submission is properly prepared. An official from the MFDS said, "Not only safety and effectiveness, but also quality data will be approved at the end of the review. We plan to proceed with expert advisory procedures soon."
- Policy
- NHRC issues ‘expedited listing of Kymriah’ opinion to MOHW
- by Lee, Jeong-Hwan Jan 13, 2022 06:05am
- The National Human Rights Commission of Korea urged the Ministry of Health and Welfare on the need to expedite insurance listing of the CAR-T therapy ‘Kymriah’ that is used to treat leukemia and lymphoma. The NHRC’s position is that the government should set a temporary drug price with NHI coverage for drugs that are directly related to life immediately upon its sale for the patients’ benefit. In this case, Kymriah will be again put on the agenda and discussed by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee on the 13th. On the 12th, the NHRC turned down the complaint filed by leukemia patients and patients preparing to use Kymriah against the Minister of Health and Welfare, and issue an opinion to the MOHW to expedite insurance listing of the drug. Kymriah is awaiting deliberation by DREC on the 13th. The petition was filed by KLPO last year to the NHRC to urge for the expedited reimbursement listing of Kymriah, and NHRC turned down the petition but issued its opinion on the need for an expedited listing of the drug to the Minister of Health and Welfare. For the reason why the NHRC rejected the petition, the NHRC pointed to the fact that the reimbursement standards that are set for specific treatments are an area that requires high-level expertise, and that NHRC is not capable of comprehensively considering and making a decision on Kymriah based on approval cases in Korea and abroad, clinical trial results, and academic and expert opinions. In addition, the NHRC said it is difficult to say that the ‘petitionee’ MOHW had made no effort for the prompt insurance listing of Kymirah. In addition, the NHRC told the Minister of Health and Welfare that it is necessary to allow patients to first receive treatment at a temporary drug price that is covered by health insurance as soon as Kymriah is sold post-MFDS approval. NHRC’s request is that a system needs to be prepared to expedite insurance listing of new drugs directly related to life. The KLPO agreed to the opinion issued by NHRC, criticizing Korea’s reality in which no system is available for prior use of NHI finances even for new drugs that are directly related to life. In other words, the KLPO also pointed to the need for an added expediated NHI listing system for new drugs that are directly related to life. Also, the KLPO pointed to Novartis Korea’s high-price request as the cause of the delay in Kymriah’s CDDC and DREC review. According to KLPO, a non-reimbursed patient should pay around ₩460 million to be treated with Kymirah. Therefore, KLPO believes that the company should prepare a reasonable fiscal sharing plan while the health authorities make efforts to promptly introduce an expedited listing system. KLPO said, “The unceasing tug-of-war between Novartis, which is trying get a high price, and the government, which is trying to save NHI finances, is hurting the patients who cannot bear the high cost of the drug. The due procedures for Kymriah’s listing, including deliberation and vote by DREC, the drug pricing negotiations between NHIS and the Novartis, as well as deliberation by HIPDC, should be proceeded in a prompt manner.”
- Policy
- Lee wants to cover infertility, contraception, HPV vaccines
- by Lee, Jeong-Hwan Jan 11, 2022 06:29am
- With the rising heat over the insurance coverage of hair loss treatments that was mentioned by presidential candidate Jae-Myn Lee, other healthcare-related election pledges made by the presidential candidates are also being reilluminated. Lee, who is planning to publically announce his pledge promising the insurance coverage of hair loss treatments, had previously already pledged to expand insurance coverage for infertility couples, contraception and abortion, and HPV vaccines. On the 7th, Lee’s camp announced that its policy team was reviewing the hair loss treatment coverage plan to set a specific pledge. Lee said that hair loss is not a cosmetic issue but a disease, therefore, his camp is seriously reviewing its details such as health insurance coverage targets, proportion, and required finances. In particular, he said that covering hair loss treatments should be positively considered because the coverage could be provided at an annual cost of 100 billion won. In addition, Lee is also known to be considering applying health insurance to wigs and hair transplants. In addition to the pledge for hair loss treatments, Lee had also made a number of pledges to expand health insurance coverage to various other areas. More specifically, Lee had announced the reimbursement of infertility-related treatment cost, contraception and abortion, and HPV vaccination for adolescents as part of his ‘small but definite happiness pledges.’ In covering infertility treatments, Lee said he will simplify the complicated number and support amount set for various parts of the in-vitro fertilization procedure and expand insurance coverage to necessary pharmaceuticals including ovulation inducers. Also, basic tests to identify infertility status will be added to the regular health examination items and promised emotional and psychological support through the provision of counseling vouchers, etc. to infertility couples. The contraception and abortion pledge promises insurance coverage for modern contraceptive procedures and well medical practice for the termination of pregnancies. This pledge may not only benefit contraception and abortion treatment but lead to the reimbursement of the abortion pill ‘Mifegymiso’ that may soon be granted marketing authorization in Korea. Lee also pledged to expand the subject for free HPV vaccinations to all adolescents between the ages of 12 and 17, male and female. In addition, he said he will change the name of the vaccination project from ‘First step for women’s health clinic project’ that is currently being used to ‘HPV vaccine national inoculation project.’ HPV, which causes cervical cancer in women and anal cancer in both men and women, is infectious regardless of gender, so Lee believes that the government should bear the cost of its vaccination so that both men and women can get vaccinated in a timely manner. In addition, Lee is known to be reviewing covering dental implants in addition to hair loss treatments as his insurance coverage expansion pledge. Currently, people aged over 65 are applied insurance for dental implants, and the number of teeth covered is limited to 2 for each person. Lee is reviewing extending the coverage to 4 teeth per person. Lee had mentioned his position on MBC’s 100 Minute Debate on the 6th. Lee said, “ Implants are also one of the NHI coverage agendas I am considering. 2 are not enough to chew. We need to cover at least 4 teeth implants.” The ruling party's leading candidate’s series of health insurance benefit expansion pledges have led the presidential election stage to focus on each candidate’s healthcare pledges. In response to Lee’s hair loss treatment pledge, Cheol-soo Ahn, presidential candidate of the minor opposition People's Party, pledged to reduce the price of hair loss drug generics and said that Lee’s pledge would worsen the financial status of the current national health insurance. Members of the leading opposition party had also set out to criticize Lee’s pledge as populism that undermines the domestic health insurance application procedures and standards that were just made to attract votes. In response to the populism criticism, the Democratic Party plans to hold a meeting to comprehensively review the coverage of hair loss treatments including the possibility of expanding NHI finances and the establishment of medical standards, then announce it as an election pledge.
- Policy
- Alopecia belongs to the health sector, benefits are possible
- by Lee, Jeong-Hwan Jan 11, 2022 06:29am
- Democratic Party of Korea's presidential candidate Lee Jae-myung claimed that the application of health insurance for hair loss treatments is a health pledge to alleviate public pain, and said he is reviewing the targets, ratios, and amounts through experts in the camp. He said that if pain relief is possible at an annual cost of around 100 billion won, we should think positively, but that it is necessary to discuss to what extent we will apply health insurance and to what extent. He said in MBC's current affairs program "100 Minute Discussion" on the 6th, "It is said that health insurance finances will collapse over the application of hair loss health insurance, and if an additional 100 billion won is paid annually, the drug price will be cheaper." He said that people who do not suffer from hair loss can never understand the pain caused by hair loss, adding that the application of health insurance related to hair loss belongs to the health field related to diseases, not welfare at the beauty level. He also said that the application of health insurance for hair loss should be viewed positively. However, he expressed his position that analysis and discussion are needed to determine to what extent insurance should be applied. He said, "People who are worried about hair loss are really in pain and the cost of medicine is quite burdensome. If there is anything that the people are in pain, it is the role of the government to alleviate and resolve it." He said, "If health insurance coverage for hair loss belongs to beauty, it is close to welfare, but it is a health area because it relieves pain. In the past, the Park Geun Hye government covered scaling. "At that time, it is not understandable to say that it distributes health insurance for hair loss, which costs about 100 billion won a year, rather than distributing it recklessly," he stressed. Candidate Lee said, "We need to think positively about the application of hair loss health insurance. However, it is necessary to discuss to what extent and to what extent it will be done. Experts are reviewing health insurance targets, support, ratio, and amount. The policy is to find a compromise. We will try to adjust it appropriately so that the majority opinion is not excluded."
- Policy
- 22 companies' Dapagliflozin+Sitaglipin were approved
- by Lee, Tak-Sun Jan 11, 2022 06:28am
- DongKoo Bio has obtained a number of drugs that are the same as the new diabetes drug "Dapagliflozin+Sitagliptin" approved on the 23rd of last month. A large number of consignment items produced by Dongkoo Bio have entered. Dapagliflozin+Sitaglipin is a new combination complex that has never been released before, but competition has become inevitable as many pharmaceutical companies have secured it even before its launch. On the 4th, the MFDS approved 22 items combined with Dapagliflozin+Sitaglipin. Licensed pharmaceutical companies are Aprogen, Aju, PharmGen Science , NBK Pharm, Jin Yang, Dae Hwa, Myung Moon, GC Pharma, Dongkwang, Lite pharm tech, Binex, SCD Pharm, Daewoo, Kukje, Shinpoong, Ilyang, Reyonpharm, Ildong, Yungjin Pharm, Hana, Guju, and Sinil. All of these items are commissioned and produced by DongKoo Bio. DongKoo Bio is said to have shared the permit data with them. DongKoo and consignment companies signed contracts before July when the so-called "consignment biological equivalence limitation 1+3" system was implemented, so 22 companies were able to obtain permission this time. If the contract was made after the system was implemented, DongKoo could share product data with only three companies and produce consignment. Dapagliflozin (Forxiga) is an SGLT-2 inhibitory diabetes treatment and has recently grown rapidly in the diabetes treatment market. AZ's Forxiga, the original drug, recorded 18.3 billion won in outpatient prescriptions (based on UBIST) in the first half of last year. Sitagliptin (Januvia) is a DPP-4 inhibitory drug that has long been leading the market. MSD's Januvia recorded 21.2 billion won in outpatient prescriptions in the first half of the year. The domestic pharmaceutical industry expects that both ingredients will generate a lot of sales if they are developed as a complex because they are widely used in medical sites and frequently combined prescriptions. Both ingredients cannot be sold to the market before September 2023 because their material patents have not expired. In addition, domestic insurance authorities have not yet established a salary standard for a combination of SGLT-2 and DPP-4 components. However, it seems that many consignment companies have participated in the approval in advance because it is difficult to hold new products if there are expectations for success and the consignment biological equivalence restriction system is implemented. Two days before Dongkoo Bio's product was approved, Daewon Pharmaceutical received its first approval for Dapacombi (Dapagliflozin+Sitagliptin). It is said that Daewon is considering the exclusive launch.
- Policy
- Chong Kun Dang applied for combination of Januvia+Forxiga
- by Lee, Tak-Sun Jan 10, 2022 11:40am
- Chungjeong-ro Headquarters of Chong Kun DangA combination of diabetes treatments Januvia (Sitagliptin) and Forxiga (Dapagliflozin) is gaining popularity among domestic pharmaceutical companies. Although it can only be released after September next year due to patent rights issues, many domestic pharmaceutical companies are developing products. According to the pharmaceutical industry on the 6th, Chong Kun Dang recently applied for permission from the MFDS for a combination of Sitagliptin+Dapagliflozin. Combination of Sitagliptin+Dapagliflozin succeeded in commercialization for the first time in Korea on the 21st of last month when Dapacombi of Daewon Pharmaceutical obtained permission. Two days later, Dongkoo Bio's Sitaflozin, the same ingredient as Dapacombi, was approved. On the 4th, 22 items from other pharmaceutical companies entrusted by Dongkoo Bio were approved and the number of related items increased to 24. Pharmaceutical companies that started developing products for the purpose of product approval include Alvogen Korea, GL Pharm Tech, SK Chemical, and Theagen Etex. Alvogen was approved by the MFDS in October 2020, GL Pharm Tech in March last year, SK Chemical in September last year, and Theagen Etex in December last year. Chong Kun Dang seems to have applied for permission by completing the development ahead of them. However, even if commercialization is successful, it is expected to be after September 2023, when Januvia's material patent ends. The reason why many domestic companies are developing products is that commercial expectations are high. This is because the two components are the flagship items of SGLT-2 and DPP-4 inhibitors, which are currently leading the diabetes treatment market, and the proportion of prescriptions using both drugs in combination at the treatment site is high. Based on UBIST, Januvia's outpatient prescription amount in the first half of last year was 21.2 billion won, and Forxiga's outpatient prescription amount was 18.3 billion won, ranking at the top of the market. Combination of Januvia+Forxiga is the first product introduced by a domestic pharmaceutical company without an overseas original product, so expectations are high for market creation by domestic pharmaceutical company sales. However, more than 20 pharmaceutical companies have already been approved, so it is difficult for any one company to be exclusive, which is considered a limitation in generating profits. There are no overseas products with the same ingredients, but there are three overseas original products of the same category (DPP-4+SGLT-2) combination, so if they are reimbursed, there will be little market preoccupation effect. In the industry, it is highly observed that top companies with large-scale customers such as Chong Kun Dang will eventually take the lead over other companies in terms of market share.
- Policy
- Will companies be able to apply for EUA for COVID-19 tx?
- by Lee, Tak-Sun Jan 10, 2022 05:55am
- PfizerThe development of COVID-19 treatments is actively progressing at home and abroad. Pfizer's oral treatment Paxlovid received EUA from the MFDS in December last year and is expected to be used in Korea soon. Currently, pharmaceutical companies that develop COVID-19 treatments are in a position to introduce them quickly in Korea through EUA like Paxlovid. By the way, is EUA possible only with the will of pharmaceutical companies? Companies can apply for the EUA. However, the MFDS must first announce the scope of medical products subject to emergency. The EUA is a system introduced under the "Special Act for Promotion of Development and Emergency Supply of Medical Products Responding to Public Health Crisis" enacted in March last year. The EUA refers to the urgent introduction of drugs that have not been approved for domestic items. Even before this law, it was possible to introduce unlicensed imported items in Korea through special import system. In February last year, it was decided to introduce the Pfizer COVID-19 vaccine through special import. However, special import was only possible if the head of related organizations, such as the head of the KDCA, requested special cases. In other words, as a special import procedure, the developer could not request approval for the item. The newly established EUA system can introduce drugs not only at the request of the heads of related agencies, but also when the MFDS deems it necessary to adequately cope with public health crises. At this time, the MFDS must announce ▲ the scope of medical products subject to EUA, and ▲other matters determined by the Minister of Food and Drug Safety as necessary, such as EUA requirements and approval period, etc. Based on this announcement, pharmaceutical companies can apply for the EUA. The application documents include data that can prove the safety and effectiveness of medical products. Evidence such as▲ Clinical trial results of medical products studied until the date of announcement, ▲ current status of domestic and foreign permits, etc., ▲reason for applying for the EUA, ▲ the instructions for the medical product, ▲ Quality inspection results of overseas manufacturing plants, etc. should be submitted. The MFDS is in a position that at least a clinical second-phase report that can prove its validity should be secured. Under this EUA system, pharmaceutical companies that develop COVID-19 treatments have completed phase 2 clinical trials and quickly introduced products into Korea. However, It does not mean that the EUA system can be used according to the will of pharmaceutical companies. Only when the MFDS announces it first can it be applied to pharmaceutical companies. In the current COVID-19 situation, it is not easy for the MFDS to announce alone because the state oversees the purchase of vaccines and treatments. Therefore, like the existing special import system, it is highly likely that the MFDS will review EUA products by applying for KDCA. Pfizer's Paxlovid is also a case in which the EUA was decided by KDCA application. An official from the MFDS explained, "If EUA is needed, corporate applications can be received, but since COVID-19 tx and vaccines are purchased and managed under state control, it will be difficult to do EUA without KDCA applications." The recent plan that pharmaceutical companies that develop COVID-19 treatments will apply for EUA to the MFDS cannot be considered feasible. This is because the state must purchase the treatment.
- Policy
- Remdesivir has been officially granted over the age of 12
- by Lee, Tak-Sun Jan 10, 2022 05:55am
- The MFDS has approved the change to use Remdesivir, which was first approved as a treatment for COVID-19, only for those aged 12 or older. However, the EUA was decided for this age group to prevent gaps in pediatric treatment under the age of 12. This is the same as when the U.S. FDA officially approved Remdesivir in October 2020. The MFDS announced on the 7th that it has allowed administration range of Veklury, a treatment for COVID-19, to be changed to "inpatients with severe or pneumonia who are adults and 12 years old and need adjuvant oxygen treatment for children over 40kg." In July 2020, Veklury was conditionally approved to use the results of phase 3 clinical trials on the market for "severe inpatients who need 3.5kg or more of auxiliary oxygen treatment confirmed with COVID-19." As Gilead submitted the results of the global phase 3 clinical trial to implement the permit conditions this time, the results report was reviewed and the scope of administration was allowed to be changed. The MFDS decided to use Veklury for "inpatients with severe or pneumonia who need adjuvant oxygen treatment under the age of 12 or under 40kg (3.5kg or more) considering that there is no COVID-19 treatment available in Korea. Pfizer's oral treatment Paxlovid, which will be introduced soon, is also used only for those aged 12 or older. This measure reflects a comprehensive review of domestic and foreign cases for children and overseas approval cases such as the United States and Japan. When officially approved in October 2020, the United States took the same measures as in Korea, fearing a gap in pediatric treatment. In Japan, it has been used for children since approval. The EUA is a system that allows manufacturers and importers to manufacture and import medicines that have not been licensed in Korea or to supply them with different uses and capacities than those that have already been licensed.
