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- 2026-04-15 15:34:46
- Policy
- SK-manufactured AZ vaccines for export exceeds domestic use
- by Lee, Tak-Sun Mar 12, 2021 06:22am
- The volume of AstraZeneca COVID-19 vaccine manufactured at SK Bioscience Andong plant for export cleared for lot release has exceeded the volume for domestic supply. The AstraZeneca Korea COVID-19 Vaccine manufactured by SK Bioscience was authorized on Feb. 10, which the National Lot Release cleared 1.57 million doses of it on Feb. 17. Since then, South Korea’s Ministry of Food and Drug Safety (MFDS) has been consistently approving the lot release for the export use. MFDS official reported on Mar. 10, 18 serialized batches were approved for export as of Mar. 9. As each serial number is given on 300,000 doses, basically about 5.4 million doses for export were cleared of lot release. The export volume triples the 1.57 doses approved of the lot release for domestic use. It means more of the domestically manufactured vaccines are supplied to foreign countries than to South Korea, as AstraZeneca is managing the batch distribution. An industry insider elaborated, “Apparently, they have stocked up COVID-19 vaccines manufactured at Andong plant. But because AstraZeneca, as a client for the consignment production, controls all steps from approval to lot release, it cannot be helped.” The exported lots are supplied as COVAX Facility, and recently those batches were designated to nearby Asian countries. Fortunately, South Korea would receive additional batch of AstraZeneca vaccines from COVAX Facility. The government announced AstraZeneca vaccine doses for about 350,000 people would be designated by COVAX Facility within this month and total doses for 1.05 million people, including the doses for 700,000 people in April through May, would be designated to South Korea. Highly likely the batches designated to South Korea would be manufactured by SK Bioscience. But the vaccine maker could speed up the approval process as the batch could be manufactured outside of South Korea. When applying for authorization in last January, AstraZeneca requested the authorization on two items—the vaccines made by SK Bioscience and imported from Italy.
- Opinion
- [Reporter's View] BINEX & NDMA Phobia
- by Lee, Jeong-Hwan Mar 12, 2021 06:21am
- It was said that it should never be done and it was malicious because it was deliberate. This is a concern from the National Assembly, the government, and the pharmaceutical industry looking at the situation of BINEX, which violated the pharmaceutical affairs law due to suspicion of manufacturing method and dosage manipulation, which is also a bad thing for the global prestige of domestic drugs. The confidence in the quality of domestic drugs, which only recovered after the detection of NDMA, a suspected carcinogen, has been broken again. In this case, the violation of the Pharmaceutical Affairs Law, such as the intentional manipulation of the manufacturing method of a specific pharmaceutical company, rather than the incorporation of impurities (NDMA) caused by unknown external factors, sparked the incident. Since the detection of NDMA such as Valsartan and Ranitidine is an overseas drug quality incident and is a common international issue, the impact on the quality and reliability of domestic drugs was not significant. The impact was further mitigated as no fatal safety issues were identified in the NDMA detection survey by the MFDS. This BINEX incident is very different from the NDMA incident. As one pharmaceutical company was suspected of manipulating the manufacturing method and the dosage of the active ingredient, it had a negative impact on the reputation of domestic generics. The MFDS, which is the main ministry, was also unable to escape responsibility. The MFDS has introduced a GMP system and an item approval renewal system and is operating a management system after marketing approval. BINEX violated the post-regulation system of the MFDS and the Pharmaceutical Affairs Act, ignored ethical management and pursued only profit. On the 8th, the MFDS issued the same disposition to 32 items from 24 generic companies made in the same factory following the suspension of manufacturing and sales of 6 drugs that violated the Pharmaceutical Affairs Act manufactured at BINEX Busan Plant 1 and voluntary recovery. Confidence in the consignment manufacturing generic system has collapsed. "If a pharmaceutical company decides to cheat, it will be impossible for the MFDS to detect violations of the Pharmaceutical Affairs Act one by one," experts in the pharmaceutical industry say. Medicines that treat sick patients should be perfect. Drugs are sometimes poisonous in that they can have unexpected side effects. The NDMA impurity crisis drove the public into drug phobia and stopped prescribing and dispensing in pharmacies at front-line medical institutions. The BINEX crisis is highly likely to re-create the national turmoil caused by the NDMA crisis. Some media reported the response to BINEX's case. Among the numerous reports, BINEX's explanation of 'violation of the Pharmaceutical Affairs Act due to a change in manufacturing method rather than a major dose manipulation' is so much ridiculous. The intention is to clear the company's position that it acknowledges the manipulation of the manufacturing method, but does not manipulate the dosage of the active ingredient, thereby removing some unfair accusations. However, violation of the Pharmaceutical Affairs Act is another matter. Since it is difficult for the general public to know the professional pharmacist law and drug information, it does not seem important that the manufacturing method was manipulated and the dose manipulated. It is illegal to change the manufacturing method without permission from the MFDS, which can cause distrust in the pharmaceutical industry. The National Assembly Health and Welfare Committee's attitude toward the BINEX situation is strict and serious. This is because it is true that they deliberately tricked the people and the government into distributing and selling medicines, and negatively affecting the reliability of domestic and foreign medicines. The BINEX incident made subsequent legislation in the National Assembly inevitable. The illegality and deviation of a pharmaceutical company may increase the burden by strengthening the overall post-regulation of the pharmaceutical industry, including the good pharmaceutical companies who are properly complying with the law. BINEX must repeatedly reflect on the violations it has committed. The MFDS should prepare measures to prevent recurrence of BINEX as soon as possible. The National Assembly, which is in charge of legislative responsibility on behalf of the people, must consider a reasonable legislation without unnecessary over regulation. A reflection of illegal pharmaceutical companies, a transparent investigation by regulatory authorities, and smart and delicate legislation of the National Assembly are required.
- InterView
- “High pressure and hopes in the policy affairs at KRPIA"
- by Eo, Yun-Ho Mar 11, 2021 06:07am
- Director Kim Minyoung Some say this is the era where policy comes first than an academy, and pricing is more important than an approval. The top priority for pharmaceutical companies in South Korea supplying new drug is the National Health Insurance (NHI) coverage. The era of highly expensive drug has emerged, while the government and pharmaceutical industry are struggling to see eye-to-eye on drug pricing. And now the reimbursement listing and its timing became the deciding factor for the success of a new drug. The Korean Research-based Pharmaceutical Industry Association (KRPIA), representing the multinational pharmaceutical companies in South Korea, has appointed Kim Minyoung as a new Market Access and Policy Director after the position was vacant for about six months since a former Senior Director Sean Kim left the organization last April. Kim was in charge of Market Access (MA) at Korean branch of Eli Lilly and Sanofi-Aventis, and until last year, he was leading the MA within JAPAC region at Amgen Asia. Now at KRPIA, the director is to oversee internal and external activities in regards to the ‘adequate value of new drug’ the industry tries to resolve for a long time. KRPIA’s MA committee and Policy Committee would be managed by Director Kim from now on. “Started off with marketing and sales job, I have worked in policy and drug pricing related work at pharmaceutical companies for 25 years. And I have finally joined KRPIA. When I was working at Amgen Korea, I vaguely thought of drawing up a bigger picture of it all when I go back to South Korea, regardless of my humble experience. And I feel now I have a grip on a good opportunity. It’s burdening, but I also have big hopes for it.” But the pressure on Director Kim is real. The pressure of increased drug price entails delay in listing. Although the government is also trying to versatile with risk sharing agreement (RSA) and pharmacoeconomic evaluation (PE) exemption, their effort can hardly catch up with the speed of new drug development. And it casts a dark shadow on multinational pharmaceutical companies. Especially, at the movement KRPIA is considered to be missing personnel with former government affiliation. “I am aware of the raised concerns. But because we do not have staffs with previous government affiliation, it does not necessary mean the organization is incapable of operating policy related work. The organization does not operate only with the office staff, but with incorporated participation by 44 member companies at respective committees. Particularly, the Policy Committee consists of experts with various backgrounds from the National Assembly, government and media. The committee can assert the variety of opinions by the stakeholders.” Besides the MA and Policy Committees, he noted the importance of the Government Affairs staffs. Technically, the MA and GA within the industry have been ambiguously categorized, and the government affairs were limited to directly relevant institutes like the Ministry of Health and Welfare (MOHW), the Health Insurance Review and Assessment Service (HIRA), and the National Health Insurance Service (NHIS). Many companies have their MA staffs to also cover GA tasks. Director Kim said, “As the public’s interest is heightening not only in patients but also in new drugs, we are suddenly faced with more stakeholders to engage with like the National Assembly, civic groups and patient groups. To reflect the needs, the Policy Committee must be invigorated. This is one of our key agenda for the year.” If vitalizing the Policy Committee is the last piece of puzzle to achieve the goal, the policy recommendation would be outcome. KRPIA has to be nimble to improve the industry’s access to pipeline currently concentrated to rare disease area. Multinational pharmaceutical companies are taking steps to market targeted therapy, immunotherapy and gene therapy like CAR-T. Director Kim carefully mentioned of HIRA and NHIS regarding the core process in reimbursement listing. “As for HIRA, we could talk about the reimbursement standard expansion procedure. Previously, the Expert Committee used to deliberate clinical adequacy of reimbursement anticancer treatments, but now the agency demands for financial impact evidences besides clinical efficacy report. Financial impact can be reviewed once the clinical adequacy deliberation is completed. It would be wonderful if they could streamline the committee operation and deliberation process.” “And for NHIS, the fundamental predicament the industry faces regarding the negotiation procedure is largely the asymmetry in financial impact related information. NHIS has said the revised system would demand the negotiating company to confirm the financial impact evidences. As an industry representative, we welcome the agency’s decision and hope the system works as expected.”
- Policy
- Italy restricts export of AZ vaccine, including Korea
- by Lee, Tak-Sun Mar 11, 2021 06:07am
- It is an analysis that the EU's policy to restrict the export of the COVID-19 vaccine produced in Korea is highly likely to affect Korea. In particular, it is expected that the recent restriction on the export of AstraZeneca vaccine produced in Italy to Australia could directly affect the supply and demand of vaccines in Korea. This is because the AZ imported vaccine, which is currently undergoing approval review, is a product manufactured in Italy. According to foreign media, on the 4th, AstraZeneca requested export to Australia for 250,000 doses of COVID-19 vaccine produced at the Italian factory, but was rejected by EU authorities. The EU has a policy to allow export by examining the quantity requested for export other than the supply within the EU. The Italian-made AstraZeneca vaccine is also highly related to Korea. In January, AstraZeneca applied for a COVID-19 vaccine license, including a vaccine produced by SK Bioscience in Korea and two imported vaccines supplied by an Italian factory. Among them, COVID-19 vaccine produced by SK Bioscience received final approval on February 10, and the imported vaccine produced in Italy is currently under review. Some are raising the possibility of including Italian imported vaccines among the AZ vaccines supplied by COVAX for 1.05 million people that will be introduced from the end of this month to May. Therefore, it is interpreted that prompt product approval is necessary for the smooth supply of imported vaccines. It is known that the MFDS is also in a hurry to permit the AZ vaccine. However, even if permission is obtained prior to supply, it is analyzed that there is little possibility to receive normal supply as the EU restricts exports from overseas. Therefore, it is expected that all of AZ vaccines by Covax must be supplied as a product of SK Bioscience to relieve supply and demand anxiety. It is reported that the government is also in consultation with Covax for this purpose. An official from the government said, "There is a possibility that some imported vaccines will be included in the quantity of AZ vaccines by COVAX, so I know that the government is in consultation with COVAX. However, it is expected that an import license will come out soon, so even if the actual import volume arrives, it is unlikely that it will undergo special import procedures like the case of Pfizer vaccine."
- Company
- Genuone is licensed to manufacture Pariet
- by Kim, Jin-Gu Mar 11, 2021 06:07am
- Genuone received permission to change the manufacturer of Pariet (Rabeprazole) with an annual prescription amount of ₩15 billion. This is the first achievement since its independence from Kolmar Korea and officially launched earlier this year. Genuone announced on the 9th that it has received permission to change the manufacturer of Pariet 10mg/20mg from the MFDS. Pariet is a PPI (proton pump inhibitor)-based anti-ulcer drug developed by Japanese pharmaceutical company Eisai. According to the drug market research institute UBIST, the amount of outpatient prescriptions last year was ₩10 billion. Janssen Korea introduced it in 2000. However, when it decided to withdraw from the Hyangnam factory, the manufacturer had to change. Genuone has been pursuing the conversion of Pariet manufacturers before becoming independent from Kolmar Korea. In August 2019, the bioequivalence test was approved. This is to confirm the equivalence between the existing Pariet and the product to be produced by Genuone. Subsequently, manufacturing technology was transferred through collaboration with Eisai, and in April of last year, item approval for Pariet 10mg/20mg was acquired from Janssen Korea. Through this, the company has acquired ₩10 billion worth of items per year while obtaining approval for the relocation of the manufacturer. The first lot release is expected in April. Sales are jointly handled by Eisai and Yuhan as before. This is the first achievement since Genuone was officially launched in January of this year. Genuone is a corporation formed by the acquisition of Kolmar Korea's pharmaceutical division and Kolmar Pharma's CMO division by IMM Private Equity, a domestic private equity fund. After the acquisition of CJ Healthcare, Kolmar Korea promoted the sale of Kolmar with the pharmaceutical division, and the sale was completed last year. Kim Mi-yeon, CEO of Genuone, said, "Starting with the production of Pariet, we will further strengthen our partnership with Eisai and expand our partnership with global pharmaceutical companies."
- Company
- Tecentriq as liver cancer first-line treatment green lit
- by Mar 11, 2021 06:07am
- The South Korean health authority is seemingly giving a green light to an immunotherapy Tecentriq for its combination therapy as a first-line treatment in liver cancer. A pharmaceutical industry source reported on Mar. 9 that the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee approved of the clinical efficacy in Roche’s Tecentriq (atezolizumab) plus Avastin (bavacizumab) combination therapy for patients with unresectable hepatocellular carcinoma, who have not received prior systemic therapy. The first threshold for the reimbursement was passed at the committee meeting convened on Feb. 24. The Tecentriq combination therapy has won the first-line treatment indication for hepatocellular carcinoma from the Ministry of Food and Drug Safety (MFDS) on July 31, 2020. It is the first and only hepatocellular carcinoma indication for an immunotherapy in South Korea. Moreover, Tecentriq combination therapy has overcome the biggest impediment of the Cancer Deliberation Committee in last February. Apparently, the committee did not demand for specific condition. The rest of the process is HIRA Drug Reimbursement Evaluation Committee (DREC) and National Health Insurance Service (NHIS) drug pricing negotiation. Considering rarely any Cancer Committee-approved drug fails to pass DREC these days, the next big issue with listing the Tecentriq liver cancer indication would be the pricing negotiation with NHIS. Meanwhile, the efficacy of Avastin combination therapy treating patients with hepatocellular carcinoma was confirmed in the IMbrave150 study. The result found the patient group using Tecentriq in combination with Avastin reduced the risk of disease worsening or death by 42 percent, compared with Nexavar (sorafenib) patient group. The Tecentriq plus Avastin therapy was also confirmed superior than Nexavar therapy as the combination therapy group’s mPFS marked 6.8 months, which was significantly longer than Nexavar group’s 4.3 months. The combination therapy has not reached the mOS, but the median value during the monitoring phase was at 8.6 months. Nexavar had mOS of 13.2 months. Also the combination therapy’s response rate at 27 percent doubled Nexavar therapy’s at 12 percent. However, the Cancer Deliberation Committee rejected the indication expansion requests on a combination therapy with paclitaxel in treating patients with triple-negative breast cancer (TNBC) as a first-line treatment, and a combination of bevacizumab, paclitaxel and carboplatin in treating patients with non-squamous non-small cell lung cancer (NSCLC) as first-line treatment.
- Company
- Sales of erectile dysfunction generic drugs are increasing
- by An, Kyung-Jin Mar 11, 2021 06:06am
- Sales of the domestic erectile dysfunction treatment market decreased due to COVID-19. Sales declined, mainly for large items in the early days of the COVID-19 spread, and recovered after the second half of the year. Although sales of major products were low, generic products sold by Korean companies such as Hanmi and Chong Kun Dang were launched. According to IQVIA, a drug research institute on the 5th, the domestic erectile dysfunction treatment market last year was ₩11.2 billion, a 1.3% decrease from the previous year. After the expiration of patents for blockbuster drugs such as Viagra and Cialis, generics were released, increasing sales in the erectile dysfunction treatment market. It increased from ₩97.8 billion in 2016 to ₩104.5 billion in 2017, ₩108.2 billion in 2018, and ₩113.9 billion in 2019. However, the size of the market has shrunk in four years after experiencing COVID-19 incident. In the first quarter of last year, the erectile dysfunction treatment market fell 4.8% year-on-year with a joint venture of ₩26.9 billion in sales. In the second quarter, sales rebounded to ₩27.6 billion, which was down 0.4% from the same period last year. In the first half of last year, the number of confirmed cases peaked in Daegu and Gyeongbuk since January 20, last year when the first COVID-19 confirmed in Korea. In the industry, as the fear of unexpected infectious diseases spread rapidly, sales of patients decreased due to fewer visits to hospitals and inability to conduct sales marketing activities. This is because the erectile dysfunction treatment market is less severe than chronic diseases such as high blood pressure and diabetes, and is not an essential drug. The erectile dysfunction treatment market has recovered in earnest since 2H. It rose for 3 consecutive quarters to ₩28.6 billion in the third quarter of last year and ₩29.4 billion in the fourth quarter. Compared to the initial spread of COVID-19, the market for erectile dysfunction treatments also recovered as people's social activities became more active. Even large-sized items that were leading the market could not avoid the aftermath of COVID-19. However, generics sold by domestic companies were less damaged than original products. Hanmi's PalPal sales were ₩21.2 billion last year. Compared to the previous year, sales decreased by 5.3%, accounting for 18.9%. PalPal is a product released immediately after the expiration of the patent for Viagra (Sildenafil) in 2012. After overtaking Viagra in 2013, it has continued to dominate by surpassing the sales of Cialis (Tadalafil) in 2015. Last year's sales of Cendom by Chong Kun Dang, generic for Viagra, fell 1.8% from the previous year to ₩10.2 billion. And it surpassed Viagra and ranked second in sales. Among generic products, Hanmi Pharmaceutical's Gugu was remarkable. Gugu grew 13.6% year-on-year with sales of ₩7.9 billion last year. It is the only product in the top 5 sales in both original and generic sales that has increased its annual sales. Gugu is generic for Cialis. Pfizer Korea's Viagra reduced its annual sales by 11.1% from ₩9.6 billion in 2019 to ₩8.6 billion last year. Based on last year's cumulative sales, Viagra's market share was 7.6%. It fell 3.3 %p in four years from 10.9% in 2016. Cialis' sales last year amounted to ₩6.1 billion. The market share was 5.5%, which was cut in half from 2016 (10.1%).
- Policy
- MFDS reviews sales ban on Binex-manufactured generics
- by Lee, Jeong-Hwan Mar 10, 2021 06:27am
- The impact of the allegation on Binex manipulating the manufacturing method and active ingredient dosage in six drugs including antidiabetics and antidepressants is snowballing within the pharmaceutical industry. Source confirmed South Korea’s Ministry of Food and Drug Safety (MFDS) has started reviewing administrative measure to be ordered on generics produced by Binex Busan Plant 1 as a contract manufacturing organization (CMO), which was found to have violated the Pharmaceutical Affairs Act. The ministry has already ordered manufacturing and sales ban on the six products the company decided to voluntarily recall. On Mar. 9, MFDS official explained “The ministry is reviewing the necessity and validity of ordering manufacturing and sales ban or recall on bulk generics manufactured in the same manufacturing plant as six items Binex voluntarily reported of illegal change in manufacturing method. The decision in administrative measure would be officially announced promptly.” The health authority’s action would much complicate the impact the Binex incident has brought onto the South Korean pharmaceutical industry. Four out of six Binex items the ministry imposed the administrative measure were generics manufactured as CMO. CMO generics are drugs by a pharmaceutical company with marketing authorization and another manufacturer with production facility entrusted to manufacture the product. For instance, a pharmaceutical company wins a MFDS marketing authorization on a certain generic, and signs a consignment deal with another pharmaceutical company capable of drug production to manufacture the authorized generic. Basically, the products are made by the CMO, as entrusted by the authorized company, and because the generics made by the both companies are exactly the same, they are labeled as “bulk generics” or “twin drugs.” MFDS is now considering on imposing same level of administrative order as the six items on those bulk generics manufactured at Binex Busan Plant 1 under the consignment deal. On Mar. 7, the ministry imposed administrative measure on six Binex items including antidiabetic Amorin tablet (glimepiride), antidepressant Xelectin capsule and Xelectin 10 mg capsule (fluoxetine hydrochloride), antiarthritic Daxfen tablet (dexibuprofen), anti-inflammatory Rofsin 250 mg tablet (ciprofloxacin hydrochloride) and antihypertension Cadil 1 mg tablet (doxazosin mesylate). And four items—Amorin tablet, Xelectin capsule, Xelectin 10 mg capsule and Rofsin 250 mg tablet—are manufactured by Binex under consignment deals. Three pharmaceutical companies, 13 companies, 15 companies and seven companies have entrusted Binex to manufacture Amorin tablet, Xelectin capsule, Xelectin 10 mg capsule and Rofsin 250 mg tablet, respectively. These are twin drugs manufactured in the same production line at the Binex Busan Plant 1, where generics that accused of fabricating manufacturing method and ingredient dosage and received administrative order were manufactured. As the health authority is considering on ordering sales ban and recall on the bulk generics, the pharmaceutical companies with the products would take a massive hit on their business. MFDS official said, “A related department is currently reviewing the administrative measures on the bulk generics manufactured at Binex Busan Plant 1. The decision has not been made, yet. The on-site inspection at the Busan plant started from Mar. 8. And when the issue is confirmed, the department would make the final decision.”
- Policy
- Sales of 6 BINEX items have been temporarily suspended
- by Lee, Jeong-Hwan Mar 10, 2021 06:27am
- he MFDS decided on the 8th to temporarily suspend the manufacture and sale of six medicines manufactured by BINEX and to collect them. The MFDS is also launching an investigation into a factory located in Busan. Drugs subject to disposal are Amorin (Glimepiride), Xelectin (Fluoxetine), Daxfen (Dexibuprofen), Rofsin 250 mg (Ciprofloxacin), Xelectin 10 mg (Fluoxetine), Cadil 1 mg (Doxazosin). This measure was decided by the MFDS as a precautionary measure against BINEX's submission of a recovery plan for the item manufactured differently from the licensed or reported items to the MFDS, Busan Office. The MFDS policy is to conduct an investigation to confirm the overall manufacturing and quality control of the factory. The MFDS distributes safety bulletins to doctors, pharmacists, and consumers, asking experts such as medical and pharmacists to convert the products to other alternative medicines and cooperate so that product collection can be performed properly. The MOHW and the HIRA also requested restrictions on prescriptions for the product in hospitals and clinics. The MFDS said, "We plan to expedite on-site investigations and necessary measures for BINEX."
- Company
- Chong Kun Dang applied for COVID-19 treatment
- by An, Kyung-Jin Mar 10, 2021 06:27am
- Nafabelltan Chong Kun Dang announced on the 8th that it has applied to the MFDS for approval of the conditional marketing authorization (CMA) and phase 3 clinical trial plan of Nafabelltan (Nafamostat) as a treatment for COVID-19 for patients with severe and high risk. Nafabelltan is a drug used as a therapeutic agent for acute pancreatitis and as an anticoagulant. Nafabelltan inhibits the proteolytic enzyme TMPRSS2, which is known to be involved in the cell penetration process of COVID-19. Chong Kun Dang confirmed the possibility of developing it as a COVID-19 treatment in a drug re-creation study by Institut Pasteur Korea, and has been promoting the development of COVID-19 treatment with Institut Pasteur Korea and Korea Institute of Radiological Medical Sciences since last June. Through phase 2 clinical trials conducted on 104 severely ill patients with COVID-19 in Russia last year, it has secured the results of preventing worsening of symptoms and significantly improving the treatment period and treatment rate. According to Chong Kun Dang, 104 severely high-risk patients were randomly assigned to Nafabelltan-treated group or standard treatment group, administered drugs for 10 days, and analyzed the results of 36 high-risk groups with a National Early Warning Score (NEWS) of 7 or more. The P value was 0.012. It is explained that statistical significance was secured as the P value, which is the verification target, was confirmed to be less than 0.05. The Nafabelltan group showed superior effects compared to 11.1% of the standard treatment group, with 61.1% reaching a recovery state immediately after 10 days of drug administration. After 28 days, the total clinical period, the recovery rate of the Nafabelltan group was 94.4% and that of the standard treatment group was 61.1%, showing a statistically significant difference. 4 cases of death due to worsening symptoms of COVID-19 occurred in the standard treatment group, but not one in the Nafabelltan group, suggesting the possibility of preventing the death of high-risk patients. Based on the results of this phase 2 clinical trial, Chong Kun Dang is conducting consultations on supply of Nafabelltan with a number of countries including the UK, France, Japan, and Russia. Through this application for approval from the MFDS, it is planning to promote the rapid export of domestic COVID-19 treatments while securing a clear basis for approval for overseas emergency use. The MFDS also announced its intention to thoroughly verify the submitted non-clinical and clinical data through consultation with external experts. Chong Kun Dang is speeding up commercialization by submitting a large-scale phase 3 clinical trial plan along with the conditional marketing authorisation. It targets about 600 severely high-risk patients and are conducted in more than 10 institutions including Seoul National University Hospital in Korea. Global clinical trials are also planned for rapid patient recruitment. An official from Chong Kun Dang said, "Nafabelltan is the only drug that has reliably proved its therapeutic effect in the absence of COVID-19 treatment for severely high-risk patients. It can be applied to various mutant viruses, so it is expected that it will greatly contribute to preventing the re-proliferation of COVID-19 caused by mutations." Chong Kun Dang is participating in the clinical trials of ASCOT, a global clinical trial project in Australia, New Zealand and India. Phase 2 clinical trials are also in progress in Mexico and Senegal. The MFDS initiated a review of the approval of Nafabelltan. An official from the MFDS said, "We plan to carefully review the submitted non-clinical and clinical data, and plan to thoroughly verify the submitted data through external expert advice and decide whether to approve the change."
