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- 2025-12-23 22:26:41
- Policy
- The MFDS plans to approve Daewoong's Fexuprazan
- by Lee, Tak-Sun Dec 30, 2021 05:51am
- Fexuprazan, a new drug for GERD that Daewoong Pharmaceutical has researched and developed for 14 years, is expected to obtain domestic approval soon. When Fexuprazan is released, Daewoong is expected to fill the gap in the PPI-based treatment Nexium. According to the industry on the 28th, the MFDS completed the safety and effectiveness examination of Fexuprazan and left only the final approval procedure. Fexuprazan applied for an item license to the MFDS in November 2019. Fexuprazan is P-CAB drug such as K-Cab (Tegoprazan, HK inno.N) licensed in July 2018. The advantage of P-CAB-based drugs is that they have a longer gastric acid secretion inhibition effect than conventional PPI-based drugs. Therefore, it is possible to administer regardless of meals. With the launch of K-Cab, the existing PPI-oriented GERD market structure is also changing. K-Cab is expected to achieve 100 billion won in sales this year and has risen to the No. 1 item in the market. Prior to the launch of K-Cab, the No. 1 item in the market was Nexium. Nexium is an imported drug developed by AstraZeneca and has long been sold by Daewoong Pharmaceutical in Korea. AstraZeneca recently terminated its Nexium co-promotion contract with Daewoong Pharmaceutical and chose Ildong Pharmaceutical as a new sales partner. Analysts say that Daewoo's termination of the contract for Nexium, which generates annual sales of 50 billion won, is due to the imminent approval of Fexuprazan. With K-Cab has become the next-generation leader in GERD, so it is predicted that Fexuprazan's launch will quickly resolve the gap in Nexium. If Fexuprazan is approved, it is likely to become the 34th new domestic drug. The MFDS approved two new domestic drugs this year, with No. 32 Leclaza and No. 33 Rolontis (Hanmi Pharmaceutical). If Fexuprazan is approved by the end of this year, three new domestic drugs will be released a year.
- 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.
- 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.
- 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.
- Policy
- Roche applies for approval of its new drug faricimab
- by Lee, Tak-Sun Dec 27, 2021 05:56am
- The global pharmaceutical company Roche has applied for the approval of its newly developed treatment for macular degeneration, ‘faricimab.’ The company had submitted an application for faricimab in the US, Europe, and Japan. If approved, the drug will be competing with Bayer’s ‘Eylea (aflibercept)’ and Novartis’ ‘Beovu (brolucizumab-dbl)’ in the next-generation treatment market for macular degeneration. According to the industry on the 24th, Roche applied for the marketing authorization of ‘faricimab’ to the Ministry of Food and Drug Safety. Faricimab was registered under the brand name ‘Bavismo inj.’ in Korea. Faricimab is the first bispecific antibody treatment developed for ophthalmologic diseases. It simultaneously blocks both pathways involving the Ang-2 that causes various retina conditions and VEGF-A and promotes vascular stability and improves the vision outcome of patients in the long term. A Phase III study that was disclosed earlier this year showed that faricimab was well tolerated with a consistent safety profile in four studies that assessed faricimab on age-related macular degeneration (nAMD) and diabetic macular edema (DME) under a dosing schedule that administers the drug at a maximum of 48 weeks apart. Macular degeneration is a major cause of vision loss in adults over the age of 60. With the aging society, the size of the treatment market has also been growing exponentially. Last year, the market size recorded 37 billion won, with the global market recording 13 trillion won. According to global data announced by a market research institution, the market size of the macular degeneration market is expected to spike to record 21 trillion won by 2028. The market is currently led by ‘Eylea (aflibercept)’ and ‘Lucentis (ranibizumab ).’ Also, the development of biosimilars for the two drugs is speeding up upon the imminent expiry of Eylea and Lucentis’s patents. Novartis has released Beovu in preparation for the Lucentis biosimilars. The prefilled syringe formulation of Beovu was approved in Korea last year, and reimbursed and sold since April this year. Beovu’s strengths lay in the improved patient convenience and compliance provided with its 12-weekly dosing schedule. On the other hand, Lucentis is administered every 4 weeks. Faricimab is administered every 16 weeks at most and therefore is expected to further improve patients’ convenience in administration. Roche had completed applying for the marketing euroization of farcical in Japan in June, and in Europe and the US in July, and is awaiting authorization from the respective authorities.
- Policy
- The suspension of execution for Legalon has been extended
- by Kim, Jung-Ju Dec 27, 2021 05:56am
- It is an extension of the grace period for deleting insurance drug benefits due to prolonged lawsuits. Abbott's Cholib, which item license has been revoked by the licensing authority, is automatically removed from the list according to the company's decision to withdraw from the market. The MOHW announced the court's decision to extend the suspension of execution of the drugs currently being sued and follow-up measures on insurance drugs following the cancellation of the MFDS' item license.12th division of the Seoul Administrative Court decided to extend the deadline for suspension of the execution of Bukwang Pharmaceutical, which was scheduled for the 17th, as the lawsuit was prolonged. The government previously conducted a re-evaluation of this year's benefit for a total of five ingredients, Vitis Vinifera, Avocado-Soya, Ginko X, Bilberry Gunjo X, and Silymarin. Milk-thistle Fruit Dry Extract, to which Bukwang Pharmaceutical products belong, was confirmed to be withdrawn, and the government deleted the list after three months of action (deferred). Accordingly, the company decided to file a lawsuit and applied for a suspension of execution to the court at the same time, and the suspension was extended this time. The period of suspension of execution is 30 days from the date of the sentence of the judgment, and during this period, the deletion of benefits is suspended. However, since the government suspended it for three months at the time of the announcement, medical institutions are not expected to undergo significant changes in prices for the time being. The insurance price of Legalon cap 70 is 137 won per capsule and 242 won per capsule for Legalon cap 140. Abbott's Cholib 145/20 mg and 145/40 mg products are removed from thel list according to the withdrawal of the company's market. Earlier on June 10, the MFDS suspended sales for six months (June 24th to December 23rd) due to a lack of the number of survey subjects required for the reexamination PMS. The disposition period has been extended due to the second violation, and if the reexamination data is not submitted again, the item permission will be automatically revoked. As a result, the insurance drug benefit list will also be deleted. The deletion period is on the 24th.
- Policy
- What are the variables for the release of Forxiga+ Januvia?
- by Lee, Tak-Sun Dec 24, 2021 05:49am
- MSD Januvia and AZ Forxiga Daewon Pharmaceutical and Dongkoo Bio's combination of Dapagliflozin (Forxiga) and Sitaglipin (Januvia) is approved. Since both ingredients are widely used in the diabetes treatment market, attention is being paid to whether there will be a change in the market due to the emergence of complex drugs. However, there are still steps to overcome, such as patents and benefits. On the 21st, Daewon Pharmaceutical was approved for "Dapacombi 10/100mg," a combination that combines Dapagliplozin and Sitaglipin. On the 23rd, Dongkoo was then approved for Sitagliptin 10/100mg, which combines Papaglipozin and Sitagliptin. The salt and solubilizing materials are slightly different, but the active ingredients are the same. Both drugs are administered as supplements to diet and exercise therapy to improve blood sugar control in patients with type 2 diabetes whose combined administration of Sitagliptin and Dapagliplozin is suitable. The original brands of Sitagliptin and Dabagliplozin are leading the domestic diabetes treatment market. According to UBIST's outpatient prescriptions, MSD's Januvia recorded 21.2 billion won in the first half of this year and AZ Forxiga recorded 18.3 billion won. It was also known that the proportion of combined prescriptions for the two drugs was also high. Therefore, it is analyzed that the emergence of a Forxiga+Januvia complex with convenience of use will have significant market value. However, the Forxiga+Januvia complex developed by a domestic pharmaceutical company has to wait until next year to be released in Korea. This is because Januvia's material patent will not end until September 1, 2023. Forxiga's material patent expires on April 7, 2023, ahead of that. Along with this, it is a variable for applying benefits. This is because the SGLT-2+DPP-4 complex, which was approved in Korea before the Forxiga+Januvia complex, has not yet obtained insurance benefits. Domestic approved SGLT-2+DPP-4 complexes are AZ "Qtern" (Dapagliflozin+Saxagliptin), Beringer Ingelheim Esglito (Empagliflozin+Linaglipin), and MSD "Stegluzan(Ertugliflozin L-pyroglutamic acid). Qtern was first released in November as a non-reimbursment. Recently, insurance authorities are discussing the improvement of benefit standards for the combined prescription of SGLT-2 and DPP-4 drugs. A growing number of domestic pharmaceutical companies are also developing SGLT-2+DPP-4 combination due to the possibility of entering the reimbursed market. Recently, SK Chemicas, Donghwa, and GL Pharm Tech have begun clinical trials for Dapagliflozin+Sitaglipin combinations.
- Policy
- Govn’t to prepurchase 10 mil of SK Bio’s COVID-19 vaccine
- by Kim, Jung-Ju Dec 24, 2021 05:49am
- The government plans to purchase 10 million courses of domestic COVID-19 vaccine in advance this year. Also, the government will support a total of ₩545.7 billion on overcoming COVID-19 next year - ₩321 billion in the development of vaccines and treatments, ₩119.3 billion in the establishment of research and manufacturing infrastructure, ₩36.4 billion in the advancement of disease control and prevention material and devices, ₩69 billion in the advancement of basic research. On the 23rd, the government held the 12th meeting of the Pan-Government Committee for COVID-19 Treatment and Vaccine Development to review the progress and discuss ▲COVID-19 treatment and vaccine development status and support, ▲reinforcing R&D support for the development of COVID-19 treatment and vaccine, ▲budget allocation for COVID-19 treatment and vaccine development support. At the meeting, Minister of Science and ICT (co-chair) Hyesook Lim, Second Vice Minister of Health and Welfare Ryu Geun-hyuk, and other relevant ministries and domestic experts in the field of treatments and vaccines participated in the meeting. ◆ COVID-19 treatment and vaccine development status and support = Other than the COVID-19 antiviral treatment that was officially approved on September 17th, 16 companies are currently conducting clinical trials on 17 local COVID-19 treatment candidates. The government has been increasing the number of residential treatment centers, short-term·outpatient treatment centers, and long-term care facilities while conducting efficacy assessments of the antivirals developed on COVID-19 variants. The government has also prepared measures to improve clinical trials on COVID-19 treatments so that latecomer COVID-19 treatments can continue to be developed. Also, with the increased at-home COVID-19 treatment cases for trials, the government prepared measures to more easily accommodate these patients into clinical trials. Eligible patients who are treated from home may participate in clinical trials through outpatient care or researcher visits from research nurses or other researchers. The government will also pursue the advance purchase of 10 million courses of the local COVID-19 vaccine developed by SK Bioscience to support local COVID-19 vaccine development. SK Bioscience’s vaccine has met the pre-purchase requirements set by the government at the 10th Pan-Government Support Committee (announcement of Phase II trial at interim results and approval of Phase III trial protocol). After a comprehensive review of the safety, immunogenicity, and utilization of the vaccine based on the interim results of the Phase II clinical trial, the government decided to purchase the vaccine in advance. The advance purchase agreement will be made as soon as possible after the details on the practical terms of the agreement are discussed. ◆ Reinforcing R&D support for the development of COVID-19 treatment and vaccine = To government also plans to support clinical trials of COVID-19 treatments and vaccines to the end and reinforce R&D support of clinical trials to accelerate development and improve the probability of success. Also, in consideration of the public interest and potential of succeeding in the R&D of COVID-19 treatment/vaccine, the government also plans to strategically review measures to reduce corporate out-of-pocket expenses for clinical trial R&D projects. Companies that participate in the COVID-19 treatment·vaccine clinical trial support project need to cover a fixed proportion of the R&D expense (50-25% of the total R&D expense) themselves. The government plans to review measures to reduce the clinical expenses borne by small-and-mid sized companies by easing regulations made to support the rate borne by private companies in cash, but only for ▲(vaccine) Phase I-III trials and ▲(treatment) Phase II-III trial and new drugs (excluding repurposed drugs) ◆ budget allocation for COVID-19 treatment and vaccine development support= The government will be supporting a total of ₩545.7 billion for the development of COVId-19 treatments and vaccines. This is a 107.7% (₩283 billion) increase from the main budget that was set for COVID-19 in 2021. The government plans to reinforce research support at clinical and non-clinical stages and seek advance purchase of locally developed COVId-19 vaccines by investing ₩321 billion in the development of COVID-19 treatment and vaccines and the success of their clinical trials. More specifically, the Ministry of Health and Welfare is investing ₩89.3 billion in the clinical support of COVID-19 treatments and vaccines and ₩10.5 billion in the clinical support of mRNA vaccines; the Ministry of Science and ICT investing ₩10 billion in bio and medical technology development; and the Korea Disease Control and Prevention Agency investing ₩192 billion on the advance purchase of local vaccines. Also, the authorities plan to support ₩119.3 billion on the development of test methods for COVID-19 treatments and vaccines while establishing testing facilities and devices to lay the foundation for manufacturing. Specifically, the MOHW will invest ₩4.8 billion to establish a system for clinical trial support, KDCA ₩8.2 billion to establish a national healthcare research infrastructure, the MFDS ₩22.7 billion to strengthen the international competitiveness of biopharmaceuticals, the MSTI ₩12.2 billion to the Center for National Preclinical Trial Support, and the MOTIE ₩16.7 billion to support companies that promote the industrialization of vaccines using the vaccine demonstration support center. Ryu Geun-hyuk, Second Vice Minister of Health and Welfare, said, “We will reinforce support on clinical trials to provide support for vaccine and treatments to the end. Through this, we will establish a development system for biopharmaceuticals that can rapidly respond not only to COVID-19 but also to other infectious diseases that may arise in the future.”
