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Policy
Paxlovid is a new weapon added to our fight against COVID-19
by
Lee, Jeong-Hwan
Dec 29, 2021 05:58am
Minister Gang-lip Kim “An oral-type treatment will be prescribed to patients with severe or critical COVID-19 that are unsuitable to be treated with an injection-type (antiviral). In other words, we have secured another option in our armory to use against COVID-19.” Ministry of Food and Drug Safety Minister Gang-lip Kim This is what Minister Gang-lip Kim of the Ministry of Food and Drug Safety said, explaining that a new viable strategy for the control and management of COVID-19 will be added with the early use authorization of the oral COVID-19 treatment ‘Paxlovid.’ Although it is too early to jump to a conclusion on whether the oral pill has a better effect than the injectable drug, Minister Kim sees that the added option for severe or critical COVID-19 patients can bring a synergetic effect with the national vaccination scheme and social measures and diversify the methods against COVID-19. Kim said the decisive difference between the oral and injectable drugs is in their convenience in storage, distribution, and intake, and that the oral option may be a more appropriate option for patients treated from home. Minister Kim explained so on CBS radio’s ‘Kim Hyun-Jung’s News Show’ on the 28th after the MFDS had granted emergency use authorization for Pfizer’s oral COVID-19 treatment Paxlovid on the 27th. Kim said although Paxlovid cannot be directly compared with the injection-type form of treatment, it is a reassuring ‘weapon’ added to the fight against COVID-19. Therefore, he said it is too soon to call it a game-changer. The oral COVID-19 pill Paxlovid is taken as three tablets at once. More specifically, a set of drugs (two pink pills, one white pill) is taken together orally every 12 hours for five days. Kim said even if Paxlovid is distributed, it would be difficult to purchase Paxlovid other general prescription drugs. The government handles all of the purchased Paxlovid and will coordinate its provision to the patients. “The government plans to first purchase all of the pills then provide them to those in need. The authorities with the Korea Disease Control and Prevention Agency (KDCA) are discussing the best way to distribute and administer the drug in the field.” In addition, Kim said that the oral pill is significantly different in terms of storage, distribution, and administration compared to the injected-type drug that is being used in severe patients. “Subjects eligible for the oral pill are virtually the same as those for injections. The biggest difference is that the injection needs to be administered by another person for an hour. The oral pill may be self-administered with prescription every 12 hours for 5 days, and therefore is appropriate for patients treated at home.” “Also, in terms of storage, the drug can be stored at room temperature. Therefore, the decisive difference between the oral and injectable drug is in its convenience in storage, distribution, and intake.” On the question of whether the injection and oral pill has the same effect, Kim said that the two options cannot be compared horizontally. Rather, the use of oral drugs should be considered as an additional option to the injection already in use, and one more option in the fight against COVID-19. Kim said, “The most difficult question to answer is whether the treatments have the same effect. The treatments had different subjects in clinical trials and we cannot tell whether the drugs have the same effect or which is superior. Paxlovid and the existing injection-type treatment both showed a significant effect on severe and critical COVID-19 patients at analysis. We will be able to provide treatments appropriate for every patient -injection for hospitalized patients and oral pills for those that cannot receive the injections - with the added option. In other words, we have secured another weapon against COVID-19.”
Policy
Gov-National Assembly introduce oral treatment for COVID-19
by
Lee, Jeong-Hwan
Dec 29, 2021 05:57am
First Deputy Director Kwon Deok Cheol of CDSCHQ. As COVID-19 spreads to the Omicron mutation following the delta mutation, and the number of deaths and new confirmed patients increases, the attention of the National Assembly and the government is focusing on treatments.The National Assembly's Health and Welfare Committee is urging the U.S. FDA to preemptively secure domestic antibody treatments that are actively considering introducing COVID-19 oral drugs Poxlovid와 Lagevrio. The quarantine authorities are also expressing their willingness to respond quickly to securing oral drugs because they had difficulty in early vaccinations due to failure to secure vaccine supplies in the early stages of the spread of COVID-19. The Central Disaster and Safety Counters Headquaters announced on the 27th that it has signed a pre-purchase contract for COVID-19 oral medicine for a total of 604,000 people. CDSCHQ's Deputy General Manager Kwon Deok-cheol (Minister of Welfare) explained, "Following the United States, the government is also rapidly proceeding with the oral EUA process," adding, "We will be able to administer COVID-19 treatment as early as the end of January next year." The CDSCHQ is taking procedures for the oral drug EUA of COVID-19. The MFDS has announced that it will hold a "Safety Management and Supply Committee for Medical Products Responding to Public Health Crisis" to decide whether to approve the emergency use of COVID-19 oral drugs. In the case of the United States, approval for use has already been completed. The FDA approved the use of Lagevrio on the 23rd following the EUA approval of the Pfizer's Poxlovid on the 22nd (local time). The National Assembly Welfare Committee is also calling for securing COVID-19 treatments, citing cases in advanced countries. Rep. Kang Ki-yoon pointed out the reality that Korean quarantine authorities focused only on securing oral treatments. Kang's view is that next year's government budget bill could also be insufficient to respond to securing various COVID treatments by arranging only the cost of purchasing oral drugs. In particular, he also questioned the treatment effect of Lagevrio, which the quarantine authorities have started purchasing. He pointed out that unlike Merck's 50% reduction in hospitalization and death rates, FDA submission reports fell sharply due to a 30% reduction. The intention is that various treatments need to be secured as the effectiveness of the COVID-19 oral drug has not yet been clearly proven. Furthermore, through expert opinions, he said that measures should be prepared to diversify the use of antibody treatments such as Regkirona and Xvudy so that patients can be treated customized. Advanced countries such as the United States and Europe are actively purchasing various treatments in preparation for the increasing number of COVID-19 patients due to mutations, Kang said. "The United States, Europe, and Australia have started to secure Xvudy supplies, and Regkirona is also approving conditional permits." "Overseas countries are making efforts to select and secure drugs that are effective for severe coronavirus due to the increase in the number of people infected with Omicron," he said. "Korea should also prioritize securing various treatments considering continuous mutations." Customized treatment is required for each patient, he added.
Company
LegoChem transfers candidate technology to British company
by
Chon, Seung-Hyun
Dec 29, 2021 05:57am
LegoChem Biosciences announced on the 27th that it has signed a technology transfer contract with Iksuda for joint development of a new anti-cancer drug candidate LCB14. The contract is worth up to $1 billion (about 1.2 trillion won). With this contract, LegoChem Biosciences secured $50 million (about 60 billion won) in advance payments and short-term milestones. Milestones according to the development, permission, and commercialization stages are up to $950 million. Iksuda will have the right to develop and commercialize LCB14 globally except for China and Korea. LegoChem Biosciences will jointly conduct clinical trials in the United States with Iksuda in a way that pays part of the initial clinical cost. This contract also includes the conditions of receiving advance payments received by Iksuda and additional Revenue Sharing at a fixed rate for all milestones if third-party technology transfers are made during development. LCB14 is a new anticancer drug developed by LegoChem Biosciences using ADC original technology, and phase 1 clinical trials in China are underway. Iksuda is known to have the world's best ADC development capabilities, including Dr. Robert Lutz, who led the preclinical and early clinical trials of global blockbuster ADC drug Kadcylla. Iksuda CEO David Simpson said, "We will continue to develop valuable treatments by focusing on cancer species with limited treatments and establishing competitive pipelines using partners and self-developed toxin and ADC platforms." Cho Young-rak, vice president of LegoChem Biosciences, said, "We will do our best to strengthen our own clinical development capabilities and quickly develop subsequent ADC programs by actively accepting the highest level of development capabilities and know-how through this U.S. clinical joint progress."
Company
SK Bioscience will complete major facilities in Songdo
by
Chon, Seung-Hyun
Dec 28, 2021 05:51am
SK Bioscience, the third-largest pharmaceutical bio company in market capitalization, will build a new construction in Songdo, Incheon. It will invest 300 billion won by 2024 to build a new factory and laboratory. Along with Samsung Biologics, Celltrion, and Celltrion Healthcare, the first to fourth place in the pharmaceutical bio market will gather in Songdo side by side. ◆SK Bioscience will complete the facility in Songdo in 2024 and invested 300 billion won SK Bioscience announced on the 27th that it has signed a land sale contract with the Incheon Free Economic Zone Authority. The plan calls for the construction of a global R&PD (Research & Process Development) center on a 34,414㎡ site in Sr14 district 7, Songdo-dong, Incheon. Earlier in August, SK Bioscience signed a contract with the Incheon Free Economic Zone Authority to acquire 33 billion won worth of land and buildings. The newly created global R&PD center will house research institutes, factories, and offices for basic research and process development and production in the vaccine and bio sectors. SK Bioscience plans to invest about 300 billion won in business expenses with the aim of completing it in the fourth quarter of 2024. SK Bioscience plans to invest about 200 billion won by 2024 to expand manufacturing facilities for L-House, which has the latest vaccine production facilities such as cell culture, bacterial culture, gene recombination, and protein bonding, and build new platform facilities such as mRNA and next-generation viral vectors. When SK Bioscience moves to Songdo, all the first to fourth largest pharmaceutical bio companies in Korea will be located in Songdo. SK Bioscience, which was listed on the KOSPI market in March, has a market capitalization of 17.978 trillion won, ranking third after Samsung Biologics and Celltrion among pharmaceutical bio companies. Samsung Biologics, a bio-captain, was established based in Songdo in 2011. Samsung Biologics is currently operating three biopharmaceutical plants in Songdo. Samsung Biologics is building its fourth plant with the aim of operating it in 2023. The fourth plant is the largest ever with 256,000 liters of production. When the fourth plant is in operation, Samsung Biologics will secure a total of 618,000 liters of production facilities along with its third plant (3,000 liters of first plant, 152,000 liters of second plant, and 180,000 liters of third plant). Celltrion, which ranks second in the market capitalization of pharmaceutical bio companies, is the main player in growing Songdo, Incheon, as a mecca for biopharmaceuticals. Celltrion's market capitalization is 28.1412 trillion won. Founded in 2002, Celltrion operates two factories in Songdo. In 2005, the first factory of 100,000 liters was completed in Songdo, and in 2011, the second factory of 90,000 liters was joined. Celltrion is building a 60,000-liter plant with the aim of completing it in 2023. Celltrion is also planning to build a 20-liter plant. When the fourth plant is completed, a total of 450,000 liters of production facilities will be secured in Korea. Celltrion Healthcare, an affiliate of Celltrion, is also evaluated as a bio company representing Songdo. Celltrion Healthcare receives antibody biosimilar products from Celltrion and sells them to global retailers. Celltrion Healthcare is located with Celltrion in Songdo, Incheon. The market capitalization totaled 13.2084 trillion won. The market capitalization of four companies, Samsung Biologics, Celltrion, SK Bioscience, and Celltrion Healthcare, totaled 117.696 trillion won. These companies are by far one of the best among domestic pharmaceutical bio companies. Among the major pharmaceutical bio companies that handle medicines in the third quarter, only three companies recorded operating profits of more than 100 billion won, including Samsung Biologics, Celltrion, and SK Bioscience. The operating profit ratio of SK Bioscience and Celltrion to sales amounts to 45.5% and 40.9%. Samsung Biologics also recorded a high purity return of 37.1%. Along with Celltrion Healthcare, the average profit margin of the four Songdo bio companies exceeds 30%. Recently, SK Bioscience saw its operating profit rise 175.3% year-on-year to 100.4 billion won in the third quarter and sales rise 123.8% year-on-year to 220.8 billion won. The biggest factor in the surge in performance is the consignment production of the COVID-19 vaccine. SK Bioscience signed a consignment production (CMO) contract with global pharmaceutical company AstraZeneca in July last year to supply COVID-19 vaccines. It is a condition to produce the COVID-19 vaccine under development by AstraZeneca at L House in Andong, Gyeongsangbuk-do. In August last year, the MOHW and Novavax also signed a three-way contract to supply the COVID-19 vaccine NVX-CoV2373 and began production.
Policy
Entry of FDA-approved new Chinese blood cancer drug imminent
by
Lee, Tak-Sun
Dec 28, 2021 05:51am
A new blood cancer treatment that was developed by a Chinese pharmaceutical company and approved by the US FDA will be soon introduced to Korea. The drug awaiting entry is BeiGene Korea’s ‘Brukinsa.’ If approved, Brukinsa will be the second new drug approved by a Chinese pharmaceutical company following Antengene’s ‘Xpovio tab 20mg.’ According to the industry on the 27th, the Ministry of Food and Drug Safety completed the safety and efficacy review of BeiGene Korea’s ‘Brukinsa,’ and the countdown for its marketing authorization has started. Brukinsa is a Bruton's Tyrosine Kinase inhibitor used in patients with B-cell primary central nervous system lymphoma. A BTK inhibitor is a targeted anticancer therapy that suppresses the survival and proliferation of malignant B-cells by blocking Bruton's tyrosine kinase protein, a signal that affects the survival and growth of B-cells. Other BTK inhibitors approved in Korea include Janssen’s ‘Imbruvica,’ AstraZeneca’s ‘Calquence,’ and ONO’s ‘Velexbru.’ Brukinsa is also famous as the first drug that was approved by the FDA based on a clinical trial conducted in China by a Chinese pharmaceutical company. It received FDA approval in November 2019. In the same year, the global pharmaceutical company Amgen acquired 20.5% of BeiGene’s shares. In particular, Beigine’s new innovative drug is being received with anticipation in Korea with the news that the company sells its drug at a reasonable price. Beigine had established its Korean subsidiary and prepared entry into the domestic market since October 2019. In addition to Brukinsa, the company has also been working to commercialize its immuno-oncology drug ‘tislelizumab.’ Antengene’s ‘Xpovio Tab. 20mg (Selinexor),' the first new drug developed by a Chinese pharmaceutical company to be approved in Korea, was introduced in July this year. It was approved in Korea for the treatment of refractory multiple myeloma and refractory diffuse large B-cell lymphoma and marked the start of the Chinese pharmaceutical companies’ entry into the Korean market. In addition to Beigine Korea that is working to receive marketing authorization for its new drug, Dizal Pharmaceutical is also conducting a clinical trial for a non-small cell lung cancer treatment, driving the entry of Chinese pharmaceutical companies into the Korean market in earnest.
Policy
MFDS approves emergency use of Pfizer’s oral COVID-19 drug
by
Lee, Tak-Sun
Dec 28, 2021 05:50am
Pfizer’s oral COVID-19 treatment ‘Paxlovid’ received emergency use authorization in Korea as well. Authorities plan to use the drug to treat adults and pediatric patients over the age of 12 with mild-to-moderate COVID-19 at high risk of progressing to severe disease. Pharmacies will be supplying the pills for patients treated from their homes. On the 27th, the Ministry of Food and Drug Safety announced that it had authorized the emergency use of ‘Paxlovid,’ an oral COVID-19 treatment developed by the US company Pfizer. The decision was made after a comprehensive deliberation into the need to introduce oral treatment options that patients can self—administer amid the growing number of confirmed severe/critical COVID-19 cases and the MFDS’s safety/efficacy review results, as well as expert advisory meeting results at the ‘Public Health Crisis Response Medical Product Safety Management and Supply Committee.’ ‘Paxlovid’ is the first oral treatment to be introduced to Korea. The government said that it plans to diversify treatment options that may be used by patients in addition to the shot-type treatment used in the field and expect the addition of Paxlovid to support the prevention of patients treated at residential treatment centers and home from progressing to severe diseases. Paxlovid Paxlovid inhibits a proteolytic enzyme (3CL protease) to prevent the production of proteins needed for virus replication and virus proliferation. In a clinical trial that enrolled 2,246 non-hospitalized, mild-to-moderate COVID-19 patients at high risk of progressing to severe disease, the drug reduced COVID-19 hospitalization or death by 88% in patients who took the pill within 5 days of symptom onset. In particular, the drug also showed the same effect in a clinical trial that enrolled around 300 Asians, including 19 Koreans. The drug may be administered on adult patients and pediatric patients (12 and older weighing at least 40 kg) with mild-to-moderate COVID-19 that are at high risk of progressing to severe COVID-19 due to age, underlying disease, etc. Paxlovid is administered as ‘three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally, twice daily for five days, and should be initiated as soon as possible after the diagnosis of COVID-19 and within five days of symptom onset. The Korea Disease Control and Prevention Agency (KDCA) has requested a priority review of ‘Paxlovid’ on the 22nd to the MFDS due to the rising need to introduce oral COVID-19 treatments that patients can take on their own in the process of returning to normal. The MFDS has been conducting a preliminary review on the quality, clinical, and nonclinical data of ‘Paxlovid’ from November 10th before the KDCA requested a review for the emergency use approval. Also, the ministry had received advice from external experts (9 people) in various fields including infectious diseases, respiratory medicine, toxicology, and virology. As a result, experts agreed on the need to grant emergency use approval for ‘Paxlovid’ in consideration of the COVID-19 pandemic situation and the nonclinical and clinical trial results, and the feasibility of the subject patient population as proposed by the MFDS. The MFDS said it will continue its efforts after granting the emergency use approval to collect information on adverse events that may arise in the process of using ‘Paxlovid’ while preparing further safety measures. In addition, the authorities will request the company that imports Paxlovid to actively collect and report safety information on the drug and has improved related systems so that medical experts, as well as patients receiving treatment at residential treatment centers and homes, may report their side effects. Also, through continuous analysis·assessment of safety information on Paxlovid in Korea and abroad, the authorities will make the safety measures necessary including precautions, discontinuations, and recalls. With patient safety as a top priority, the authorities plan to take measures such as compensating for damages after evaluating the causality of the side effects that may occur. An MFDS official said, “The drug may be used with doctors’ prescriptions. However, as it is an oral pill rather than a shot, it will be distributed through pharmacies and supplied to patients that receive treatments at home.” Meanwhile, Paxlovid received emergency use authorization from the US FDA on the 22nd.
Company
ST Pharm has applied for phase 1 of the COVID-19 vaccine
by
Kim, Jin-Gu
Dec 28, 2021 05:50am
ST Pharm will join the ranks of COVID-19 vaccine development. It introduced mRNA vaccine platforms such as Pfizer and Moderna vaccines. ST Pharm announced on the 24th that it has applied for a phase 1 clinical trial plan for the mRNA-based COVID-19 prevention vaccine STP-2104 to the MFDS. Clinical trials were planned in stages of capacity increase, multisystem, and disclosure to evaluate the safety and immunogenicity of the COVID-19 vaccine STP-2104 for healthy adults aged 19 to 55. The clinical scale is at least 30, and the subjects will be divided into two groups, and STP2104 will be administered twice with doses of 25㎍ and 50㎍, respectively, to confirm safety and immunogenicity. According to ST Pharm, STP2104 contains mRNA designed based on modified nucleosides. 5-Capping Agent (SMARTCAP) technology developed by itself was used to improve the capping and transcription effects. In addition, lipid nanoparticles (LNPs) that have already been proven to be safe through global clinical trials are used as mRNA carriers. ST Pharm said, "If we confirm the safety and immunogenicity of STP2104 targeting delta mutations, we expect to be able to respond quickly by changing only the mRNA sequence to new corona mutations such as omicrons." ST Pharm said, "We plan to conduct follow-up clinical trials at home and abroad through the K-mRNA consortium in the future," adding, "We will then seek commercialization in Korea and ASEAN countries with conditional approval for use and sales." Currently, there are nine companies and institutions in Korea that have been approved for COVID-19 clinical trials. SK Bioscience, Genexine, Cellid, Geneone, EuBiologics, Curitas, HK inno.N, Eyegene, and International Vacuum Institute are challenging the development of vaccines. Among them, SK Bioscience is the only one to enter phase 3. By vaccine platform, there are three genetically recombinant vaccines (SK Bioscience, EuBiologics, HK inno.N), three DNA vaccines (Genexine, Geneone, International Vaccine Institute), one virus vector vaccine (Cellid), and two mRNA vaccines (Quaratis, Eyegene).
Company
Ildong's new DM GLP-1 analog has acquired a new patent
by
Dec 28, 2021 05:49am
Ildong (CEO Yoon Woong-seop) announced on the 24th that it has obtained a patent for domestic substances for ID110521156, a new drug candidate for type 2 diabetes treatment under development. ID110521156 is a drug in the GLP-1 receptor agonist family that acts as a analog to the Glucagon-like peptide-1 (GLP-1) hormone that regulates blood sugar levels by inducing insulin secretion. GLP-1 hormones are produced and secreted in β cells of the pancreas and are known to be involved in the secretion and blood sugar control of insulin in the body, digestive organ exercise, and appetite suppression. ID110521156 has the same function as GLP-1 hormone and has a low molecular weight compound structure, so it is expected to be developed as an oral drug that is advantageous in terms of marketability and convenience of administration. Earlier, Ildong Pharmaceutical confirmed safety not only in excellent pharmacological activity but also in the effect on cardiovascular relations as a GLP-1 receptor agonist through ID110521156 study. Currently, the company is conducting nonclinical research to develop an oral type 2 diabetes treatment.
Policy
AstraZeneca Xigduo’s latecomers consecutively approved
by
Lee, Tak-Sun
Dec 27, 2021 05:57am
AstraZeneca’s SGLT-2 inhibitor diabetes combination, Latecomers of AstraZeneca’s SGLR-2 antidiabetic combination therapy ‘Xigduo XR (dapagliflozin propanediol/metformin) are receiving approval. Due to the patent period set for the original’s substance patent, the latecomers will only be available for sale from April 2023, however, due to its commerciality and patent issues, companies are racing to commercialize their latecomers. According to the industry on the 24th, four companies including KyungDong Pharm have recently received approval for their Xigduo latecomers. The approved drugs are fixed combinations of dapagliflozin L-proline and metformin hydrochloride. The latecomers contain a different active ingredient solvate from the original Xigduo XR tab. With the addition of the 4 companies, a total of 24 companies have now received approval for Xigduo XR latecomers. However, only three companies will be manufacturing the drugs. Richwood Pharmaceutical, the first company to receive approval in October, Chong Kun Dang that completed independent development in November, and KyungDong Pharm will be manufacturing the latecomers. Richwood Pharmaceutical’s latecomer is a combination of dapagliflozin citric acid and metformin hydrochloride and Chong Kun Dang’s is a combination of dapagliflozin and metformin hydrochloride, all of which use a different solvate from the original drug. The drugs decided to use a different solvate to evade the solvate patent. The patent was set to expire on June 21st, 2027, but the invalidation claims filed by latecomers in Korea have been accepted and therefore invalidated. Latecomer companies have also filed and won the first and second trials to invalidate Xigduo’s second substance patent that is to expire on January 8th, 2024. Therefore, the possibility of invalidating the patent is rising, raising the probability of latecomers being sold from April 7th, 2023 after the expiry of the first substance patent. Even if this becomes a reality, around 2 years are still left until the companies may release the latecomers. However, the companies have initiated their development early as Xigduo’s outpatient prescription last year amounted to 28.6 billion won (UBIST), and the PMS expiry date for latecomers was due November 26th, 2019. If some companies obtain generic exclusivity, the release date of the other companies' products could be further delayed. At the time of development, there were no restrictions regarding consigned bioequivalence studies, therefore many companies have made CMO agreements to outsource their products. Richwood Pharmaceutical has orders from18 companies and KyungDong Pharm from 3 companies to produce Xigduo latecomers.
Company
The development of Kcav's Mucovac is in full swing
by
Dec 27, 2021 05:57am
A spray-type COVID-19 vaccine sprayed on the nose, not on injections, is being developed by domestic company. Amid the trend of muscle injection, attention is focused on claims that mucosal immunity is more effective in defending the COVID-19 virus. Kcav (CEO Song Chang-seon) announced on the 27th that Mucovac, a COVID-19 mucosal vaccine candidate that is jointly researching with Konkuk University and Bionote, has succeeded in entering the second stage of the "Bio Medical Technology Support Project" supported by Ministry of Science and ICT and National Research Foundation of Korea. Accordingly, Kcav will receive 2 billion won in research funds for non-clinical trials and clinical sample production necessary for submitting the clinical trial plan (IND) of the COVID-19 mucosal vaccine Mucovac. Mucovac, which is being developed by Kcav, is a candidate substance for the COVID-19 mucosal vaccine derived by combining the ECSL immune enhancer, which signed a contract with Eubiologics in March, with a new antigen developed by Bionote. Mucovac confirmed that nasal administration using hACE2 TG Mice and Ferret animal Model enhances body fluidizing antibody and cellular immunity (IFN-r ELISPOT) to the COVID-19 virus. In addition, as a result of conducting attack vaccination tests using Wuhan and Delta, the Mucovac vaccine group showed a 100% survival rate. In particular, Kcav is planning to analyze Mucovac's ▲MoA-related analysis ▲ Evaluation of defense ability through attack inoculation after the sale of Omicron mutant and ▲ Boostershot application test (existing muscle vaccination + Mucovac inoculation). Since many pathogens, including COVID-19, invade through mucous membranes, mucosal vaccines can be said to serve as the first defense mission against pathogens invading from the outside. Since injection needles are not used, they can be administered safely and easily. It has been argued that vaccines using nasal cavity are more effective against COVID-19 than through veins and muscles. Currently, there are about 100 vaccines being developed worldwide, of which seven are vaccines using nasal cavity. This is why the Korean government desperately needs support for the success of commercialization of Mucovac while global efforts are underway to overcome the COVID-19 pandemic situation. An official from Kcav said, "The mucous membrane vaccine currently under development is a spray-type vaccine sprayed on the nose, not a conventional injection vaccine." He explained, "When applied with booster shots to existing vaccinations, it induces not only systemic immunity but also mucosal immunity." "We expect Mucovac to increase the ability to prevent infection through the respiratory tract of COVID-19 and respond to various mutant viruses," he said. "We have already confirmed our defense against delta mutant as well as Wuhan." Kcav has already confirmed its ability to defend against the SARS-Cov-2 virus of COVID-19 mucosal vaccine candidates using ECLS immunostrengthening agents by receiving research funding from the Global Health Technology Research Fund "RIGHTFUND," co-invested by the Bill & Melinda Gates Foundation, and eight domestic life science companies in 2020. Meanwhile, Kcav was established in 2014 by Professor Song Chang-sun of Veterinary Science College as the first subsidiary of Konkuk University's technology holding company. It has secured a variety of vaccine pipelines for animals and humans using core platforms such as Live attenuated vaccines and Newcastle Disease vector vaccines.
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