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Company
Whether companies give up developing COVID-19 vaccines
by
Kim, Jin-Gu
Mar 16, 2022 05:57am
Domestic pharmaceutical companies are divided over the development of the COVID-19 vaccine. After the introduction of Pfizer, Moderna Vaccine, some companies stopped developing due to reduced commerciality and difficulties in recruiting clinical participants. Companies that are newly developing in preparation of the coronavirus are steadily appearing, creating conflicting scenes. ◆ Three new clinical trials after approval of Pfizer vaccine According to the pharmaceutical industry on the 14th, Genematrix applied for a patent for a candidate substance for the next-generation COVID-19 vaccine. The company confirmed its effectiveness on various mutations such as delta and omikron, and explained that it is expected to be used universally. In addition to Genematrix, at least three companies are believed to have challenged themselves to develop a new coronavirus vaccine in the past year. Quratis and HK inno.N were approved for phase I clinical trials in Korea in July last year. In August last year, Aijin was approved for the 1/2a clinical trial. They have entered clinical trials or began development in earnest since the domestic approval of the Pfizer vaccine (March 2021). ◆Genexine discontinued clinical trials, delaying Cellid's subsequent clinical approval Some of the companies that had previously conducted clinical trials stopped clinical trials. Genexine announced on the 11th that it will stop developing 'GX-19N'. Genexine plans to withdraw its Phase 2 and Phase 3 clinical trials approved in Indonesia. Genexine received approval for Phase 1/2a in Korea in June 2020 and began developing a coronavirus vaccine using a DNA platform. However, with the release of the Pfizer and Moderna vaccines first, the vaccination rate at home and abroad increased, and it was difficult to recruit patients and eventually gave up development. It is the same for other companies that have started to develop COVID-19 vaccines. In the case of Cellid, phase 1/2a, which began in December 2020, has been completed, but approval of phase 2b/3 is being delayed. Cellid applied to the Ministry of Food and Drug Safety for a phase 2b/3 in November last year. Geneone also went on phase 1/2a in December 2020, but it is confirmed that patients are still being recruited. ◆SK Bioscience and EuBiologics entered phase 3, and what they have in common is that they are synthetic antigen platforms It is understood that only SK Bioscience and EuBiologics are in progress among domestic coronavirus vaccine developers. SK Bioscience is conducting phase 3 of GBP510. SK Bioscience plans to commercialize its products within the first half of this year. EuBiologics also entered the final stage with the approval of Phase III clinical trials in January this year. SK Bioscience and EuBiologics have something in common that they have adopted a synthetic antigen platform. The pharmaceutical industry analyzes that synthetic antigen platforms, a traditional vaccine manufacturing method, have advantages in measuring safety and efficacy.
Policy
HPV vaccine, which costs 600,000 won, free of charge ?
by
Lee, Jeong-Hwan
Mar 16, 2022 05:57am
Human papilloma virus (HPV) vaccine, which costs about 200,000 won per inoculation and 600,000 won per inoculation, is expected to do well in the health insurance coverage of room 9. It is the gate that President-elect Yoon Seok-yeol promised to expand the insurance of Gadasil 9 as a life-friendly pledge. Looking at the 13th "59-second shorts" pledge posted on Yoon's YouTube channel on the 10th, the cost of vaccination for MSD Gadasil 9 in Korea, called cervical cancer vaccine, is expected to increase. Gadasil 9 currently has a much wider range of prevention of related diseases than Cervarix and Gardasil, the national HPV vaccines. This is because Cervarix is a divalent and Gardasil is a tetravalent vaccine, which has fewer target viruses than the 9-valent Gardasil 9. As Gardasil 9 targets a wider range of disease-causing viruses, inoculation costs are also high. Currently, the price of vaccinations for Gardasil 9 at front-line medical institutions is between 450,000 won and 600,000 won. In the 59-second shorts pledge, Yoon promised to apply insurance to both the recommended age and gender of Gardasil 9 licensed in Korea. Specifically, Gardasil 9 inoculation age is 9 to 45 years old for women and 9 to 26 years old for men, and Yoon pledged to pay all of them for inoculation. Women can prevent cervical cancer, vulva cancer, vaginal cancer, anal cancer, genital warts, etc. caused by HPV infection through Gardasil vaccination, and men can prevent anal cancer and genital warts caused by HPV infection. HPV is a virus that spreads to women through men and requires vaccination for both men and women, but the male vaccination rate has been significantly lower than that of women. Gardasil 9 is inoculated three times, and the price is known to be approximately 500,000 won to 700,000 won. As a result, the possibility of Gardasil9's health insurance benefits is expected to increase significantly after Yoon took office as president. It is explained that the People's Power Party fully considered the budget for Gardasil 9 health insurance benefits at the time of designing the pledge. "Gardasil 9 is inoculated to both women and men and must be inoculated three times in total," said an official at the People's Power Election Headquarters. "The pledge is to support the cost of inoculating 200,000 won per session three times."
Company
Exon 20 insertion targeting Exkivity comes to Korea
by
Eo, Yun-Ho
Mar 15, 2022 05:58am
Takeda’s new lung cancer drug ‘Exkivity’ is coming to Korea. According to industry sources, Takeda Pharmaceuticals Korea recently submitted an application for the marketing authorization of ‘Exkivity (mobocertinib).’ The drug is expected to be approved within the year at the earliest. Exkivity was approved in the US in September last year as a non-small cell lung cancer (NSCLC) treatment that targets EGFR Exon20 insertion mutations like Janssen’s ‘Ryvrevant (amivantamab)’ that was approved last month. Unlike Exkivity, Ryvrevant has the strength of being an oral tablet. Exkivity was granted priority review and received Breakthrough Therapy Designation, Fast Track Designation, and Orphan Drug Designation by the FDA. EGFR Exon20 insertion mutation is a new biomarker that is newly receiving attention in the field of NSCLC. Targeted anticancer therapies that are currently available for prescriptions include those that target the Exon19 deletion or Exon21 L858R substitution mutations that are commonly found in EGFR mutations, but an unmet need existed for EGFR Exon20 insertion mutations. In this context, the introduction of targeted therapies like Exkivity is expected to play an important role in managing NSCLC in the future. Meanwhile, Exkivity demonstrated its efficacy through the Phase I/II trial. In the study, Exkivity demonstrated an ORR of 35% as well as a median progression-free survival (PFS) of 7.3 months. The Phase 1/2 trial of EXKIVITY consisted of 114 patients with EGFR Exon20 insertion-positive NSCLC who received prior platinum-based therapy and were treated with a 160 mg dose of Exkivity. The most common adverse reactions were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain.
Policy
The government will begin to establish an Asian vaccine fund
by
Lee, Jeong-Hwan
Mar 15, 2022 05:58am
The government will review the need for joint vaccine purchase funds in Asia and start working on creating grounds for establishment. The move is aimed at preventing repeated cases of global difficulties in supplying vaccines with COVID-19 Pandemic and bridging the gap in accessibility to public vaccines and biopharmaceuticals by country. On the 14th, the Ministry of Health and Welfare's Global Vaccine Hub Promotion Team announced that it will start researching a joint vaccine purchase fund to ensure access to vaccines in mid- to low-income countries in Asia. According to the MOHW, GAVI had difficulty in supplying vaccines in Asia as it implemented a vaccine supply policy that utilizes a differentiated pricing system according to income by country. Accordingly, the background of this study is that it is necessary to prepare to become a global vaccine hub by promoting vaccine cooperation in Asia. The Ministry of Health and Welfare predicted that through research, large-scale vaccine demand will be discovered, Korean vaccine production companies will pioneer markets and lay the foundation for vaccine exports by the authority to adjust the fund's contribution. It also analyzed that it will secure equity by bridging the gap in accessibility between countries to global health crisis management such as Pandemic and essential public vaccines and biopharmaceuticals. The Ministry of Health and Welfare will review the need for a joint Asian vaccine purchase fund and conduct literature surveys and interviews to lay the groundwork for its establishment. Considering the national mandatory vaccination by country and the status of infectious diseases, the status and demand of inconsistency in supply and demand of vaccines will be identified. Specifically, the current system to strengthen vaccine accessibility in middle and low-income countries is analyzed, and the necessity of introducing a vaccine accessibility enhancement program for countries excluding GAVI is reviewed. It will also come up with a plan to establish a vaccine joint purchase fund. Starting with the analysis of the impact of GAVI vaccine supply mechanisms and changes in target countries on vaccination by country, the need for Asian vaccine accessibility programs such as joint Asian vaccine purchase funds will also be reviewed. Along with basic designs such as vaccine joint purchase fund operators, joint purchase items, and operating systems, it will also investigate whether it can function as a basis for Korean vaccine exports by utilizing coordination rights based on fund establishment such as specific company priorities. The MOHW said, "It takes time to establish a vaccine joint purchase fund and it will estimate the budget and set the scope of participating countries, regions, and private foundations. The MOHW will visit the SAEAN to exchange information and ask for cooperation." The MOHW said, "We will be able to establish policies based on empirical data through accurate diagnosis and analysis related to the establishment of the Asian Vaccine Joint Fund." The Ministry of Health and Welfare added, "We will present the direction of fund establishment according to the demand and supply of vaccines for major infectious diseases by country and design effective operation plans."
Company
Samsung·Celltrion speeds up dev of follow-on similars
by
Ji Yong Jun
Mar 15, 2022 05:58am
(Pic of Samsung Bioepis and Celltrion) Celltrion and Samsung Bioepis’s follow-on biosimilars are gaining momentum in the global market. A total of 11 biosimilars from the two companies are being prepared for their launch into the global market. According to the industry on the 14th, Celltrion’s Avastin biosimilar is awaiting approval in the US and European market this year. Also, Samsung Bioepis’s Lucentis biosimilar eye drug, ‘Byooviz’ is preparing its release in the US market. Also, 9 other biosimilars from the two companies that target trillion-won market items such as the psoriasis treatment ‘Stelara,’ macular degeneration treatment ‘Eylea,’ SKE treatment ‘Prolia’ are awaiting release into the global market. Both companies are working to create new growth engines in addition to their existing flagship biosimilars. Celltrion’s pipeline as of December 31st last year (Data=Celltrion)◆CT-P16 expected to be approved this year… clinical trials for 5 of biosimilars to start this year In the case of Celltrion, its 6th biosimilar following Remsima, Remsima SC, Truxima, Herzuma, and Yuflyma, CT-P16, is expected to be approved within the year. Celltrion applied for the approval of CT-P16 in September and October in the US and Europe. In general, since the approval process takes around a year in the two regions, T-P16 is likely to be approved this year. Also, since Avastin’s patent has already expired in the US and Europe, CT-P16 can be released immediately upon approval. Avastin was developed by Roche for the treatment of metastatic colorectal cancer, metastatic breast cancer, NSCLC, and glioblastoma. According to IQVIA, Avastin’s global market size is around 8 trillion won. As CT-P16 has the same indication as Avastin, the company plans to grow the drug into its next flagship biosimilar. Pfizer’s Zirabev, Amgen’s Mvasi, Samsung Bioepis’s Aybintio are currently competing in the Avastin market. Celltrion is also working to expand its biosimilar portfolio. Celltrion is currently conducting global Phase III trials for its Stelara biosimilar ‘CT-P43,’ Xolair biosimilar ‘CT-P39,’ Eylea biosimilar ‘CT-P42,’ and Prolia biosimilar ‘CT-P41,’ among others. Celltrion started the development of its Actemra biosimilar ‘CT-P47’ in December last year. Also, the company may enjoy a market preoccupation effect if it succeeds in commercializing its Zolair and Stelara biosimilars, as the two products are being developed at a faster pace than the biosimilars of competitors. Samsung Bioepis’s pipeline as of December 31st last year (Data=Samsung)◆ Byooviz to be released in the US in the first half of the year … 4 Phase III trials underway Samsung Bioepis’s ‘Byooviz’ is awaiting entry into the US market. Byooviz respectively received marketing approval in the EU and the US in July and September last year. Its release in Europe is being coordinated with the company’s partner, Biogen, and is set to be released in the US in the first half of this year. With the release, a total of 6 biosimilars including its 5 existing biosimilars Benepali, Flixabi, Ontruzant, Imraldi, Aybintio will be penetrating the global market. Lucentis, which was developed by Genentech, is used to treat ophthalmologic diseases such as macular degeneration and macular edema. Its annual sales have recorded approximately 4 trillion won. As the first Lucentis biosimilar, Byooviz is expected to greatly enjoy a market preoccupation effect when released in the US. Samsung Bioepis is diversifying its pipeline from eye diseases to rare diseases. The company has completed Phase III trials for its Soliris biosimilar ‘SB12.’ With the completion, it is expected that the company may apply for the approval of SB12 in Europe and the US within the year. Also, Phase III trials for its 3 other pipelines - Eylea biosimilar ‘SB15,’ Prolia biosimilar ‘SB16,’ Stelara biosimilar ‘SB17’ – are underway.
Policy
RET mutant target anticancer drug has been approved
by
Lee, Tak-Sun
Mar 15, 2022 05:57am
For the first time in Korea, a new anticancer drug targeting a REarranged during Transfection (RET) mutation has been approved. RET is a phosphorylation enzyme that can cause cancer and is known to promote the proliferation of cancer cells when mutated or combined with other genes. The MFDS approved "Retevmo Capsule 40·80mg (Selpercatinib)" in Lilly, Korea, on the 11th. This drug is used for metastatic RET fusion non-small cell lung cancer, progressive or metastatic RET-variable thyroid cancer requiring systemic therapy, and RET fusion-positive thyroid cancer requiring systemic therapy with previous Sorafenib or Lenvatinib treatment experience. This is the first time in Korea that a drug targeting RET gene mutations has been approved. Retevmo was effective in inhibiting RET mutations that promote tumor cell proliferation. In a clinical trial (LIBRET-001) in 105 patients with metastatic RET fusion-positive non-small cell carcinoma who had previously undergone platinum chemotherapy, the overall response rate was 64%, of which 1.9% were complete and 62% were partial. The reaction period was 17.5 months, and the reaction rate over 6 months was 81% of the subjects. It is known that RET mutations are found in about 2% of non-small cell carcinoma patients. Accordingly, it is expected to be a new treatment option for non-small cell carcinoma patients with RET mutations. With the approval of Retevmo, more RET mutant target anticancer drugs are expected in the domestic market. Currently, Roche's Gavreto is also being introduced in Korea. Among domestic pharmaceutical companies, HK inno.N introduced the RET target anticancer drug "VRN061782" from Voronoi in February last year and is conducting commercialization development.
Policy
Yoon Seok-yeol was elected president
by
Lee, Jeong-Hwan
Mar 15, 2022 05:57am
Attention is focusing on the pledge to establish a global vaccine hub and quickly register health insurance for severe treatments. In the 20th presidential election, Yoon Seok-yeol, the power of the people, was confirmed to win the election, beating Lee Jae-myung of the Democratic Party of Korea. Candidate Yoon Seok-yeol won 48.56% (16,394,815 votes) as a result of the final vote counting, beating Candidate Lee Jae-myung with 47.83% (16,147,738 votes) by 0.73%p. With candidate Yoon's election, the domestic pharmaceutical bio industry will be able to positively predict the realization of pledges such as the establishment of a "pharmaceutical bio-innovation committee" directly under the Prime Minister. In the JTBC exit survey with the three terrestrial broadcasters released shortly after the end of the 20th presidential election at 7:30 p.m. on the 9th, candidate Yoon and candidate Lee showed a close race with a 0.6% to 0.7%. The situation between the two candidates continued to be close enough to gauge Yoon's election potential only at 2 a.m. on the 10th, a day after the voting day, when the nation's vote counting rate was close to 90%. Candidate Yoon was not sure of his election until after 3:30 a.m. on the same day. The end time of the vote counting was 6:18 a.m. on the 10th, with the final vote rate of 48.56% for candidate Yoon and 47.83% for candidate Lee. Candidate Yoon, who was elected president, pledged to establish a pharmaceutical bio innovation committee directly under the Prime Minister in the pharmaceutical bio field. This is evaluated as a pledge that actively reflects the "establishment of a pharmaceutical bio control tower directly under the President" proposed by the KPBMA to the government and ruling and opposition presidential candidates. Along with the national R&D expansion policy to build a global vaccine hub, candidate Yoon's pledge is to strengthen access to new drugs for patients by introducing expensive anticancer drugs and rapid registration of new drugs for severe and rare diseases. The COVID-19 infectious disease response system is expected to be reorganized quickly. Candidate Yoon plans to completely reorganize the COVID-19 response system within 100 days of power to conduct scientific and data-based quarantine. In addition, some expect that the policy pledge of the People's Party Ahn Cheol Soo, which agreed to dramatically unify with candidate Yoon before the presidential election, will be absorbed into candidate Yoon's pledge in the future. In an interview with Dailypharm, candidate Ahn Cheol Soo expressed his vision to enter the G5 country using the pharmaceutical bio industry as a new growth engine. The intention was to secure super-difference technology in the pharmaceutical bio sector to foster world-class pharmaceutical companies such as Pfizer and Moderna and discover new global blockbuster drugs. Candidate Ahn agreed to unify and merge with Candidate Yoon, handing over his policy pledge to Candidate Yoon. Shortly after the election, candidate Yoon said, "If we prepare for a new government as elected and officially take over as president, we will respect the constitutional spirit, respect Congress, cooperate with the opposition party, and try to serve the people well." The provisional turnout for the 20th presidential election, compiled by the Central Election Commission, was 77.1%. The figure is 0.1%p short of the final turnout of the 19th presidential election of 77.2%.
Policy
Yoon Seok-yeol expands R&D for telemedicine & bio
by
Lee, Jeong-Hwan
Mar 14, 2022 05:51am
After the inauguration of the Yoon Seok-yeol administration, legal experts analyzed that the biohealth industry policy paradigm will shift, such as expanding digital healthcare and strengthening government R&D support in advanced medical fields of vaccines and treatments. It is predicted that the biohealth sector will be transformed compared to the Moon Jae In government, with elected Yoon Seok-yeol selecting biohealth as one of the five mega-tech and promising to establish a pharmaceutical bio-innovation committee directly under the Prime Minister. On the 13th, Shin & Kim's presidential TF team made the remarks in a special report that analyzed the results of the 20th presidential election and major pledges. Shin & Kim's presidential TF team judged that Yoon Seok-yeol's election will increase the possibility of the next government expanding digital healthcare and introducing telemedicine, and increase government R&D support in vaccines, treatments, and cutting-edge medical fields. It is expected that the biohealth industry market will also expand, including strengthening health insurance coverage. They predict that the new government will promote policies to foster the digital medical bio-industry, train digital hospitals, and digital medical professionals, and expand pilot projects for non-face-to-face treatment in islands and mountains. R&D related to healthcare ICT companies and policy support related to service development will be provided, and measures to alleviate personal information leakage and medical information concentration problems of large companies will be discussed. As the new government has pledged to double the size of R&D support from the biohealth industry government, a policy focusing on securing original technologies centered on pharmaceutical bio researchers is also expected. It is expected to expand government R&D on high-speed vaccine development and manufacturing technology, post-corona vaccine, treatment, and essential vaccines, and expand government R&D in state-of-the-art medical fields such as regenerative medicine, precision medicine, brain science, aging, gene editing, and synthetic biology. If the new government implements such a policy, it is expected that domestic pharmaceutical companies will perform government tasks, boost R&D investment expansion movements, and increase global pharmaceutical companies' interest in the domestic market. The new government has also promised specific measures to strengthen health insurance coverage. These include health insurance support for Continuous Glucose Monitoring, health insurance support for treatment using rehabilitation robots, expansion of national examinations for osteoporosis and depression, support for Gardasil 9, expansion of cochlear implant surgery, and reduction of health insurance for anticancer and severe disease treatments. As a result, consumer and business interest in biohealth is expected to increase and related markets will increase as measures such as health insurance registration and compensation expansion are expected to be taken to commercialize pharmaceuticals and medical devices and form markets. Shin & Kim's presidential TF team said that the adjustment of financial conditions and insurance premiums will be the primary focus of discussions on pension reform, which is an important pledge in the health and welfare sector, but discussions will also take place on changes in the fund management structure. In addition, their analysis is that discussions will be held on the development of ultra-high-priced new drugs, including RSA, which partially bears uncertainties in the efficacy of new drugs and insurance finances.
Policy
P3T for Sarepta’s DMD treatment approved in Korea
by
Lee, Hye-Kyung
Mar 14, 2022 05:51am
A Phase III trial for the Duchenne muscular dystrophy treatment 'SRP-4045(casimersen)’ and 'SRP-4053 (golodirsen)' will be conducted in Korea. The Ministry of Food and Drug Safety has recently approved Ppdd Velllovement Pte Ltd’s application for the double-blind, placebo-controlled, multicenter clinical trial to evaluate Sarepta Therapeutics’s casimersen and golodirsen. Ppdd Velllovement Pte Ltd is a contract research organization that conducts multinational clinical trials. The domestic Phase III trial will be conducted in Pusan National University Yangsan Hospital and Kyungpook National University Chilgok Hospital. DMD is a type of rare genetic disorder characterized by progressive muscle degeneration and weakness due to a defect in the p21 gene in the X chromosome that causes alteration of a protein called dystrophin that helps keep muscle cells intact. DMD arises 1 in 3,600 newborn males, and its age of onset is usually between 3 and 5 years of age. Children affected with DMD rely on a wheelchair in their early teenage years and progresses to experience loss of cardiac and respiratory muscle strength and die before reaching 20 years of age. Sarepta has been developing an exon-skipping medication that removes specific exons from dystrophin. Starting with its first DMD treatment ‘Exondys 51’ in September 2016, the company received approval for its ‘golodirsen’ in December 2019 and ‘casimersen’ in February 2021 from the US FDA. However, as golodirsen and casimersen were approved through the Accelerated Approval Program by the FDA, the company is required to additionally submit Phase III trial data to confirm the clinical efficacy of the two ingredients. According to the clinical trial protocol submitted by Sarepta, the company expects to complete the study by 2024.
Company
Pharma·Biopharmas make or break COVID-19 CMO deals
by
Ji Yong Jun
Mar 14, 2022 05:51am
Domestic pharmaceutical companies are experiencing mixed results regarding their CMO businesses for COVID-19 vaccines. Samsung Biologics and SK Bioscience are already in the process of manufacturing COVID-19 vaccines. On the other hand, GC Pharma and Huons Global gave up their COVID-19 vaccine CMO business. In addition, uncertainties continue in Hanmi Pharmaceutical and Hankook Korus Pharm’s COVID-19 CMO businesses. ◆Korea-US CMO likely to dismantle due to discontinuation of Genexine’s COVID-19 vaccine development According to industry sources on the 12th, Genexine applied to discontinue its ongoing Phase II/III trial for its COVID-19 vaccine, GX-19N, on the 11th. In other words, Genexine is virtually letting go of its COVID-19 vaccine development business. (From the left) Genexine CEO Young-Chul Sung, Hanmi Pharmaceutical President & CEO Se-Chang Kwon Accordingly, Hanmi Pharmaceutical’s plan to CMO Genexine’s vaccine has been disrupted. Hanmi Pharmaceutical has signed a CMO agreement with Genexine for Genexine's vaccine candidate in May last year. An official from Genexine said, “With the trial withdrawal, it seems that the CMO deal the company made with Hanmi Pharmaceuticals for the COVID-19 vaccine would also be terminated." With the CMO deal virtually dismantled, the only card left in Hanmi’s hand is the CMO deal for the Indian Zydus Cadila’s COVID-19 vaccine, ZyCoV-D. Hanmi Pharmaceutical had signed a CMO agreement with Enzychem Lifesciences and Zydus for the COVID-19 vaccine ZyCoV-D in January. Hanmi Pharmaceutical expects to sign the formal deal in the second quarter of this year. Once the contract is signed, Hanmi Pharmaceutical will be in charge of the global supply of ZyCoV-D. ◆GC Pharma and Huons gives up… Korus lot release of ‘Sputnik’ delayed indefinitely The CMO decisions for companies other than Hanmi Pharmaceutical have already been finalized. Huons Global had closed its CMO business for the Sputnik V vaccine due to the Russia-Ukraine war. Huons Global said, “In consideration of the unstable international situation, we have decided that it will be impossible to maintain the contract and decided to discontinue the business.” Previously, GC Pharm had also been continuing discussions with CMO Janssen's COVID-19 vaccine since August last year. The discussions went on for 4 months until GC Pharm discontinued the discussions in December of the same year. Hankook Korus Pharm’s CMO deal on Russia’s COVID-19 Sputnik V vaccine has also not been finalized yet. The uncertainty around its CMO business is growing with the international and social direction set to impose financial and logistics sanctions on Russia. The company is currently waiting for a supply request from Russia. Pic. of Samsung Biologics’ Plant 3, SK Bioscience◆Samsung Biologics·SK Bioscience enters second year into CMO deals for their COVID-19 vaccine businesses In Korea, three types of COVID-19 vaccines - vaccines developed by Moderna, AstraZeneca, and Novavax - have been approved and are being produced. in Korea. Moderna’s COVID-19 vaccine is being supplied in Korea and abroad by Samsung Biologics under the CMO agreement that was made in May last year. SK Bioscience is in sole charge of the CMO of Novavax’s vaccine to supply in Korea and abroad. SK Bioscience’s CMO deal for AstraZeneca’s vaccine has been terminated in December last year. Samsung Biologics plans to sign additional CMO deals for other mRNA vaccines in addition to the one made for Moderna. The company has already signed a CMO deal to produce the API for US company GreenLight Bioscience's COVID-19 mRNA vaccine and is set to manufacture the product in the second quarter of this year. SK Bioscience plans to concentrate on manufacturing Novavax’s COVID-19 vaccine. SK Bioscience secured three Novavax vaccine consignment production lines at L House in Andong. The company will be in charge of direct sales of Novavax’s vaccine in Korea, Thailand, and Vietnam.
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