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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.