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- 2026-04-13 10:24:10
- Company
- All-round prostate cancer treatment Xtandi with solid growth
- by Nov 18, 2021 05:55am
- Xtandi (enzalutamide)' rose to the ranks and became a blockbuster drug last year after continuously extending its indication in prostate cancer, a field that lacked treatment options. Although the drug was approved later than its competitor, through its continuous expansion effort, Xtandi became the only single-agent drug that is approved for use in both metastatic and nonmetastatic prostate cancer. Enzalutamide inhibits the AR signaling pathway by binding to the male hormone Androgen receptor (AR) to suppress the proliferation of cancer cells. Although the drug was approved later than its competitors such as ‘Zytiga (Janssen)’ or ‘Jevtana (Sanofi),’ in June 2013, Xtandi was the first to be approved for reimbursement. Xtandi was listed for reimbursement in November 2014 under the refund-type Risk-Sharing Agreement (RSA) scheme. During the 3.5 years that other drugs it took for the other drugs to receive reimbursement, Xtandi gradually took over the market as a second-line treatment for metastatic castrate-resistant prostate cancer. Xtandi sold over 10 billion to 20 billion in sales according to IQVIA from 2015 to 2017, when it was the only drug approved for reimbursement, while Zytiga sold 1 billion won and Jevtana 0.4-0.5 billion won in the same period. The multinational pharmaceutical company Pfizer recognized the potential of Xtandi and added it to its portfolio through an M&A with its original developer, Medivation. In Korea, Xtandi is continuously being supplied by Astellas, which had entered into a sales agreement with Medivation. It is distributed by Pfizer and Astellas in the U.S. ◆Used for all castration-resistant prostate cancer regardless of metastasis…Rises to the rank as No.18 blockbuster drug Xtandi gradually expanded its indications from its first indication as second-line treatment for metastatic castration-resistant prostate cancer to first-line, then to non-metastatic castration-resistant prostate cancer, and metastatic castration-sensitive prostate cancer. Through its continuous expansion effort, Xtandi became the only single-agent drug that covers all metastatic and nonmetastatic, hormone-sensitive (castration-sensitive), and castration-resistant prostate cancer. The NCCN recommends Xtandi as a first-line treatment in metastatic castration-resistant prostate cancer, and as Category 1 in metastatic hormone-sensitive prostate cancer. With the recommendations, Xtandi has established its position as a leading prostate cancer treatment. Source: IQVIA In terms of domestic sales (based on IQVIA), Xtandi’s sales increased continuously since receiving reimbursement in November 2014 to record 13.9 billion won in 2015 to 18.8 billion won in 2016, 20 billion won in 2017 and 23.8 billion won in 2018. It is the highest-grossing new prostate cancer drug. It recorded the highest sales among new prostate cancer drugs. Although its sales briefly slowed down to 23 billion won in 2019, it rebounded last year to record nearly 30 billion won. Globally, Xtandi also outperformed the other drugs and rose to the ranks to become one of the top 20 blockbuster drugs for the first time last year. Last year, Xtandi sold 4.39 billion dollars (approx. 5.19 trillion won) in global sales and became the 18th best-selling drug in the world. Projected sales per Xtandi Furthermore, Astellas expressed its ambition to maximize Xtandi’s sales over the next five years. In the new strategic planning meeting that was held in May, Astellas projected that Xtandi will sell 600 billion to 700 billion yen (approx. 6.20 trillion-7.24 trillion won) at maximum by the fiscal year 2025 (March 2026). Astellas also plans to extend the indication to high-risk non-metastatic hormone-sensitive prostate cancer next year. ◆The introduction of new latecomer drugs and Zytiga’s late but rapid chase … use of PARP inhibitors allows for more specified treatment strategies The competition in the prostate cancer treatment market is intensifying. New drugs such as ‘Erleada (Janssen),’ ‘Nubeqa (Bayer)’ etc. are continuing to be introduced while PARP inhibitors that target BRCA mutation like ‘Lynparza (AstraZeneca)’ is expanding their scope to cover prostate cancer as well. Erleada is approved for non-metastatic hormone-sensitive and nonmetastatic castration-resistant prostate cancer in the US, and Nubeqa is approved for the high-risk nonmetastatic castration-resistant prostate cancer indication. Also, a PARP inhibitor was recently approved for prostate cancer and settled as a new treatment strategy and option for castration-resistant prostate cancer patients with BRCA 1/2 and DNA Damage Response (DDR). In particular, Lynparza in combination with Zytiga emerged as a stronger option by meeting the primary endpoint of radiological progression-free survival. The Lynparza+Zytiga combination aims to become a first-line treatment for metastatic castration-resistant prostate cancer regardless of genetic mutations. In Korea, the fact that Xtandi’s sales fell short in metastatic hormone-sensitive prostate cancer, which is the second-most on-demand area after metastatic castration-resistant prostate cancer, also leaves much to be desired in terms of expanding Xtandi sales. Zytiga added the indication in June 2018, and the latecomer Erleada was also approved for the indication at the end of last year, Xtandi only received approval for the indication in September this year. While Xtandi made no further progress since expanding reimbursement to first-line treatment in metastatic castration-resistant prostate cancer in May 2019, Zytiga persisted on the path to be approved for selective reimbursement in high-risk groups among metastatic hormone-sensitive prostate cancer patients in April this year. Although Xtandi was approved for both the high-risk and low-risk groups, Zytiga, which received limited approval for the high-risk group, holds the immediate upper hand in prescriptions. After the reimbursement expansion, Zytiga’s quarterly sales surged from 2 billion won to approximately 4 billion won. In response, Astellas is seeking a way to extend its indication and expand reimbursement of Xtandi from the current metastatic hormone-sensitive indication to cover all patients. In addition, the company is seeking a new treatment strategy through a clinical trial in combination with Pfizer’s PARP inhibitor ‘Talzenna.’ The clinical trial is expected to end in three years. Astella said, “We expect sales of Xtandi is to continue to grow due to its competitive price and the yearly increase of prostate cancer, the fourth most common cancer in men. Depending on the domestic situation, we are also considering adding further indications, and are planning to expand reimbursement to the treatment of metastatic hormone-sensitive prostate cancer regardless of the degree of risk.”
- Company
- Domestic approval of Tabrecta is imminent
- by Eo, Yun-Ho Nov 18, 2021 05:54am
- According to related industries, the MFDS is conducting a final review for marketing approval of Tabrecta (Capmatinib) of Novartis Korea. Approval is possible within this year. MET mutations account for about 3% to 4% of metastatic non-small cell lung cancer, and as there have been no treatments, interest in these new drugs is increasing. Tabrecta targets hepatocyte growth factor receptor (c-Met) and was first approved in the United States in May last year as a treatment for MET exon14 mutated metastatic non-small cell lung cancer (NSCLC). It was confirmed to be effective through a phase 2 GEOMETRY mono-1 study of 97 patients with METex14. As a result of the study, the overall response rate was 68% in patients who had never been treated and 41% in patients who had previously been treated. Among the patients who took Tabrecta, the median response duration (DoR) of previously untreated patients was 12.6 months and the patients treated were 9.7 months. Tabrecta is also spurring research for future combination therapy. In particular, it is expected to be able to solve the resistance problem of EGFR TKI in lung cancer. In fact, Tabrexta is conducting a clinical trial in combination with AstraZeneca's third-generation EGFR TKI Tagrisso. Combination therapy of Tabrecta and Tagrisso are compared with platinum-based chemotherapy in patients with EGFR mutated non-small cell lung cancer with T790M negative and amplified MET genes during treatment with 1st and 2nd generation EGFR TKI or Tagrisso. Janssen Korea has also applied for permission for Rybrevant (Amivantamab) to lower the MET. In the case of Rybrevant, it obtained US permission in May, blocking EGFR and MET mutations at the same time. The first indication of this drug is non-small cell lung cancer with EGFR Exon20 mutation.Rybrevant is conducting a study in combination with Leclaza (Lazertinib) of Yuhan Corporation, a new domestic drug.
- Policy
- MFDS reviews emergency use of Merck’s oral COVID-19 pill
- by Lee, Tak-Sun Nov 18, 2021 05:54am
- The Ministry of Food and Drug Safety announced that it has started review for the Emergency Use Authorization of US Merck’s oral COVID-19 treatment, ‘Lagebvrio (molnupiravir).’ Also, the ministry added that a preliminary review is also in progress for US Pfizer’s ‘Paxlovid.’ On the 17th, the Korea Disease Control and Prevention Agency requested an emergency use authorization for US Merck’s oral COVID-19 treatment ‘Lagebvrio’ to the MFDS. Lagebvrio is a ribonucleoside analog that is inserted in place of the normal RNA needed in the viral replication process to induce lethal mutagenesis. The MFDS plans to carefully review the clinical and quality data submitted by the company, conduct an expert advisory meeting, and hold deliberations with the ‘Committee for the Safe Management and Supply of Medical Products for Public Health Crisis Response’ to verify the product’s safety and efficacy before deciding whether to authorize emergency use. On the 10th, Pfizer Korea applied for the preliminary review of quality and nonclinical data on ‘Paxlovid,’ an oral COVID-19 treatment developed by Pfizer US. The MFDS is conducting a preliminary review on Paxlovid upon the company's request. ‘Paxlovid’ inhibits 3CL protease, which plays an essential role in viral replication, to inhibit the multiplication of the coronavirus. The MFDS plans to carefully review the non-clinical and quality data submitted by the company, and promptly conduct required processes if the KDCA requests an emergency use authorization for Paxlovid as well.
- Policy
- Major bills have been piled up
- by Lee, Jeong-Hwan Nov 18, 2021 05:54am
- Review site of the first bill of the Welfare Committee The National Assembly's Health and Welfare Committee held the first subcommittee on bills on the 23rd and 24th and agreed between the ruling and opposition parties to review the medical law and the Pharmaceutical Affairs Act. The second subcommittee on the bill will be held for two days on the 24th and 25th, and both subcommittees are still before the agreement. The problem is that there are many major bills to be reviewed in preparation for the two-day schedule. The bill, which was not reviewed by the subcommittee, is likely to not be reviewed until the presidential election in March next year. On the 16th, Kim Min-seok, chairman of the Welfare Committee, and the secretaries between the ruling and opposition parties confirmed the schedule of the subcommittee on the bill. The secretariat will go through a consultation process on the 17th to finalize the list of bills to be reviewed by the subcommittee. The Welfare Committee completed next year's budget review by the relevant government department by the 12th. There are 272 new bills and bills that have not been reviewed earlier. As the government has decided to implement with COVID-19, restrictive telemedicine allowances are pending in the National Assembly. In addition, eradication of illegal hospital support, CSO government reporting system, regulation of health functional food note prescription, regulation of suspension of drug price reduction avoidance, and bill to revitalize Generic Substitution are waiting for review. The bill, which will not be reviewed this time, is likely to not be resolved until the 20th presidential election scheduled for March 9 next year. For this reason, the ruling and opposition parties have scheduled consultations on the direction of handling or discussing bills that are highly urgent or highly controversial during the With COVID-19 outbreak. This is because the National Assembly must set the direction of the bill review to some extent so that discussions and consultations on related matters can be carried out. Even so, the schedule of the bill subcommittee, which has been confirmed immediately, is too short, so there is no time for hundreds of bills to be reviewed enough or it is difficult to even present them at all. This means that many of the bills waiting for review will soon be in a situation that will not proceed until the end of next year's presidential election without obtaining a chance to review at the subcommittee on bills. An official from the ruling party's secretariat, Kim Sung-joo, said, "The schedule of the subcommittee on the bill has been agreed, but the agenda has yet to go through an agreement process between the ruling and opposition parties." He explained, "We believe that controversial bills will be introduced due to consultations scheduled on the 17th, but the screening schedule is tight." The official said, "Important bills that will affect the health's weaknesses are waiting," adding, "The problem is that if they are not reviewed by the subcommittee this month, it will be difficult to get a chance to review them until next year's presidential election. This month's subcommittee on legislation is the last of this year, he added.
- Product
- Expansion of non-face-to-face tx little by little
- by Nov 18, 2021 05:54am
- Despite opposition from the KMA to expand non-face-to-face treatment using regulatory sandboxes, it is judged that the satisfaction of overseas Koreans is high and it will help resolve medical blind spots. However, concerns about allowing regulatory special cases are also expected to increase, taking advantage of regulatory sandboxes. Ministry of trade, industry and energy deliberated and resolved a total of 14 cases such as on-face-to-face overseas Koreans' care services including digital switching of tasks and tasks, such as carbon neutral through the 5th Industrial Convergence Regulation Special Deliberation Committee. Temporary permission for the non-face-to-face overseas Koreans' care and counseling is a major medical foundation Myongji. Myongji Hospital provides services such as medical counseling and medical treatment to overseas Koreans through telephone and video using an online platform, and medical staff judges and issues prescriptions when requested by patients. This is the same as the approval agenda for Life Semantics Corp. and Inha University Hospital from 20 to 2021. There are many people who have difficulty using medical services due to language and medical accessibility problems or are excluded from access to local hospitals due to their citizens' priority policy abroad. In particular, temporary permission was granted through sandboxes with the aim of "protecting the Korean people to the end," saying that SOS is lined up from overseas workers in the Middle East, where the number of COVID-19 confirmed cases is soaring. This year, Ministry of trade, industry and energy said, "Under the current medical law, telemedicine is only allowed for doctor-medical people, and medical practices such as doctor-patient diagnosis and prescription are prohibited in principle. The Special Regulatory Committee approved additional temporary permits." However, to prevent diplomatic and trade problems, services were provided to the extent that they did not violate local laws, and the same conditions as the existing approval agenda, such as medical mediation, were added. Ministry of trade, industry and energy "non-face-to-face overseas Koreans ' care services, currently on projects on the table is high user satisfaction." said. The Ministry expected that in the future, overseas Koreans will be able to use various non-face-to-face medical services at more domestic medical institutions, which will increase their medical options. Last year, the KMA pointed out in a statement that telemedicine for overseas Koreans is ineffective. At the time, the KMA argued, "Telemedicine is likely to trigger competition between companies and industries that provide platforms and increase unnecessary demand, abandoning the basis of face-to-face treatment and the people's right to health."
- Policy
- Will impurities again in losartan trigger full recalls?
- by Lee, Tak-Sun Nov 17, 2021 05:45am
- Once again, impurity was detected in ‘losartan,’ an ingredient used in hypertension treatments. The impurity in issue was detected during self-inspections conducted by the individual pharmaceutical companies under the direction of the Ministry of Food and Drug Safety, upon which some companies have been discontinuing the lot release of their products. In particular, the companies are concerned that a large number of the drugs will be subject to recall, as they believe the raw materials imported from India and China that are used by most generic companies may be the cause of the problem. The MFDS plans to take additional measures after receiving the companys’ test results by the end of this month. According to the industry on the 16th, azido impurities were detected in their hypertension drugs containing losartan. The azido impurity detected this time is known to be a different substance from the AZBT(5-(4'-(azidomethyl)-[1,1'-biphenyl]-2yl)-1H-tetrazole) that was detected in losartan last September. At the time, excessive amounts of AZBT were found, and 22 lot numbers of 12 products in 11 companies were recalled. The ministry's measures then were applied not only to losartan but also to other sartan drugs such as valsartan and irbesartan that were used to treat hypertension. However, the impurity detected this time was only found in losartan. Based on information overseas in late September, the MFDS ordered companies producing ingredients and finished products containing losartan to conduct individual tests for azido impurities, and submit their inspection results by the 30th of this month. Pharmaceutical companies that detected excess impurities before submitting the results to the Ministry of Food and Drug Safety had stopped lot releases of their products as a precautionary measure. A pharmaceutical company official said, “We have CMO agreements with 3 places, and all 3 places have told us that they will stop supplying their products due to impurity detection. The word is that the ingredients from India and China that most generic companies use may be the cause of the problem.” Another company official said, “The impurity is presumed to be caused in the course of synthesizing raw materials. Pharmaceutical companies that finished inspections reported their results to the Ministry of Food and Drug Safety last week and are preparing voluntary recalls." However, the MFDS has not made any statements yet. The industry expects the ministry to make an official statement in early December after all the test results are submitted and the authorities prepare measures based on the results. The industry has also requested an extension of the deadline for data submission, claiming that there was not enough time to derive results. If the ministry accepts the deadline extension, the MFDS announcement is also expected to be delayed further. Upon news of the impurities, the pharmaceutical sales market has been intent on finding alternatives. The companies have been encouraging healthcare professionals to prescribe alternatives with a list of other sartan drugs that could replace losartan. Currently, 376 drugs containing losartan are approved by the MFDS. Depending on the magnitude of the recall, the impact on the pharmaceutical industry may also be significant. Depending on the situation, there is also the possibility that pharmacies will also suffer from conducting the recalls.
- Company
- Hugel's toxin has been approved for national lot release
- by Nho, Byung Chul Nov 17, 2021 05:44am
- Status of approval for national lot release of Hugel toxin drugs published in the MFDS. As Hugel recently obtained approval from the Ministry of Food and Drug Safety for three types of botulinum toxin products, administrative measures such as "cancellation of permission" and "suspension of product sales" on the 10th proved once again that there was a difference in legal interpretation of indirect exports, not quality and safety issues. According to the status of national lot release approval for botulinum toxin posted on the website of the MFDS, Hugel received approval for 50 units of botulinum toxin formulation Botulax and 200 units of Botulax on the 15th. A day later, on the 16th, domestic sales of three Botulax products resumed as additional approval for 100 units of Botulax was obtained. Including the number of national lot releases, Hugel has obtained 156 cumulative approvals this year. It is the largest number of botulinum toxin companies in Korea. Competitors Daewoong Pharmaceutical, Medy Tox, and Huons have obtained national lot release approval for 84, 80, and 44 cases, respectively. Earlier on the 10th, the MFDS announced that it would start administrative disposition, collection, and disposal procedures for the company's products against Hugel for violating the national lot release. Hugel immediately announced its position and applied for cancellation and suspension of execution, including an order to suspend manufacturing and sales, to the Seoul Administrative Court on the same day. On the morning of the 11th, the next day, it submitted a provisional application for suspension of execution of the Ministry of Food and Drug Safety's disposition, and the court cited it, enabling the sale of four types of Botulax in Korea. An official from Hugel said, "This disposition by the MFDS is only a problem caused by differences in legal interpretation of indirect exports to the Pharmaceutical Affairs Act, and has nothing to do with the product quality of Botulax manufactured and produced by Hugel." He said, "Hugel has received the national lot release without any problems in terms of quality such as effectiveness and safety in compliance with the Pharmaceutical Affairs Act." Biological agents such as botulinum toxin must be approved for lot release to be sold in Korea.
- Company
- Rinvoq combo rises as optimal option in rheumatoid arthritis
- by Nov 17, 2021 05:44am
- AbbVie’s JAK inhibitor ‘Rinvoq (upadacitinib)’ in combination with MTX was found to improve the clinical remission achievement rate over the TNF-α inhibitor ‘Humira (adalimumab)’ combination therapy in rheumatoid arthritis. The Rinvoq combination therapy achieved a 20% range remission rate in the most commonly used DAS28 index as well as the strictest Boolean index. In the SELECT-COMPARE trial that was conducted on patients who had an inadequate response to MTX, 29% of the patients treated with Rinvoq+MTX achieved clinical remission per DAS28 at Week 12, which is a higher rate than the 18% in those treated with the adalimumab combination. Such results were consistent under other evaluation indexes such as the SDAI, CDAI, Boolean index. The differences were also consistent in the evaluations made at Week 26 and Week 48. At Week 48, Rinvoq’s remission achievement rate was 38% per DAS28, 25% per CDAI, and 21% per Boolean. Achievement of clinical remission in SELECT-COMPARE trial by disease activity evaluation index ◆Rinvoq maintained a 20% range remission rate with the Boolean index, a more stringent index than DAS28 DAS28 is the most widely used index to measure the achievement of clinical remission in rheumatoid arthritis, but Boolean is considered the most stringent index. First, DAS28 is evaluated using three thresholds in 28 joints - tender joint count (TJC), swollen joint count (SJC), and patient pain score on a visual analog scale (VAS). DAS28-CRP, which adds the C reactive protein (CRP) that is related to the progression of rheumatoid arthritis to DAS28, is most widely used. With the Boolean index, the ▲number of tender joints (TJC)≤1 ▲number of swollen joints (SJC)≤1 ▲CRP≤1mg/dL ▲Patient Comprehensive Assessment (PGA)≤1 (on a scale of 0-10) needs to all be satisfied to be considered to be in remission, therefore the range considered and accepted as remission is narrower with the Boolean index. This is why a study that analyzed the remission achievement rate of 3,209 rheumatoid arthritis patients in Korea with five disease activity indexes showed that the Boolean index had the lowest patient remission rate. ◆Remission achievement rate low for existing treatments when measured by various indexes…”We should consider new treatment options to meet new treatment goals” Based on data from the Korean College of Rheumatology Biologics Registry (KOBIO), the KCR Clinical Research Committee had previously presented the reemission achievement rate of rheumatoid arthritis patients who have been treated with biologics and oral targeted therapies during the past 5 years. Treatments included in the analysis were TNF-α inhibitors such as Humira, etc.; ‘Actemra (tocilizumab),’ ‘Orencia (abatacept),’ and ‘Xeljanx (tofacitinib).’ The KCR analyzed the remission achievement rate of the treatments above with five disease activity assessment indexes - DAS28-CRP, DAS28-ESR, CDAI, SDAI, Boolean - and the result showed that the achievement rate differed greatly by index. At week 48 after starting treatment, the remission achievement rate was near 56.0% per DAS28-CRP, but the dropped greatly to 10.4%, 12.7%, and 12.9% per more stringent indexes such as CDAI, SDAI, and Boolean, respectively. The rate of patients that maintained remission for 2 or more years, or ‘continuous remission,' was 62% per DAS28-CRP, but 8%, 11%, 13% per CDAI, SDAI, Boolean, respectively. With the remission rate of existing treatments falling to a 10% range in indexes that are relatively stringent compared to DAS28, the analysis was that a more detailed consideration is needed in setting a treatment strategy. Young-Il Seo, professor of Rheumatology at Hallym University Sacred Heart Hospital Pyeongchon, said, “the low remission achievement rate observed with CDAI, SDAI, and Boolean index suggests that patients experience greater difficulties in reality and that improvements are needed to increase treatment satisfaction. In this sense, we would need to more actively consider using treatment options that meet various indexes.”
- Company
- Exports of Botulinum drugs to the U.S. doubled
- by Kim, Jin-Gu Nov 17, 2021 05:44am
- The cumulative exports of domestic botulinum toxin drugs amounted to 220 billion won this year, the report showed. Exports to China, which had consistently accounted for a high proportion, have decreased, but exports to the U.S. and other countries have increased. According to the Korea Customs Service on the 15th, the cumulative exports of domestic botulinum toxin drugs amounted to $190.28 million between January and October this year. Compared to $161.09 million during the same period last year, it increased 18%. Looking at major exporters, dependence on China has decreased significantly compared to last year. Instead, exports to the U.S. and Brazil increased. Between January and October this year, domestic botulinum toxin exports to China amounted to $78.11 million, down 13% from $89.97 million during the same period last year. During the period, China's share of total botulinum toxin exports decreased by 15%p from 57% to 42%. Exports to the United States increased 110% from $12.2 million to $25.61 million. The share of U.S. exports increased from 8% to 13%. It is analyzed that exports to the U.S. more than doubled due to the end of the Nabota-related dispute. Earlier this year, Daewoong Pharmaceutical's U.S. partner Evolus concluded the dispute with Medy Tox and Allergan by agreement. Since then, Nabota's monthly exports to the U.S. have been around $2.5 million to $3 million. This is in contrast to exports from the second half of 2019 to the beginning of last year, when the dispute was in full swing. In addition to the U.S., exports to Brazil and Japan have increased. In Brazil, it increased 59% from $10.5 million between January and October last year to $16.74 million between January and October this year. In the case of Japan, it increased 39% from $6.54 million to $9.11 million during the period. Thailand, a major exporter, fell 16% from $13.83 million to $11.58 million. As exports to Brazil increased significantly during the same period, the third-largest exporter of domestic Botulinum toxin changed from Thailand to Brazil.
- Company
- Celltrion's COVID-19 tx is approved for sale in Europe
- by Chon, Seung-Hyun Nov 17, 2021 05:44am
- Regkirona, a COVID-19 antibody treatment developed by Celltrion, has been approved in Europe. Celltrion announced on the 15th that the EC approved Regkirona on the 12th (local time) for the final sale for the purpose of treating COVID-19. Regkirona has been approved for the treatment of adult patients aged 18 or older who have been confirmed with COVID-19 who do not require oxygen supply and are likely to be severely transmitted. It is a single administration of 60 minutes intravenously, the same as domestic item permission. Regkirona officially received an item license from the EC a day after obtaining an approval recommendation from the CHMP under the European Medicines Agency (EMA) on the 11th. Celltrion said, "If CHMP usually recommends approval for new drug approval, EC's final item approval will be completed 1-2 months later, but in this case, official item approval continued in a day," and explained, "It can be interpreted as an EC-level effort to quickly cope with the surge in the number of COVID-19 confirmed cases in Europe." Regkirona is the first new antibody drug developed in Korea to obtain an official item license in Europe. Regkirona obtained emergency approval from the BPOM and the ANVISA in July and August, and in September, it obtained a formal item license from the MFDS in Korea. Regkirona is administered to 22,587 patients in 129 hospitals as of the announcement of Central Disaster and Safety Counters Headquaters (CDSCHQ) on the 12th and is actively used to treat COVID-19 patients in Korea. Regkirona confirmed the safety and effectiveness of the global phase 3 clinical results conducted on 1,315 mild and moderate COVID-19 patients in 13 countries around the world, including Korea, the United States, Spain, and Romania. In the high-risk group of patients administered Regkirona, the incidence of severe patients decreased by 72% compared to the placebo group, and the clinical symptom improvement time was also reduced by more than 4.7 days compared to the placebo group in the high-risk group. An official from Celltrion said, "We will do our best to help many COVID-19 patients in Europe benefit from Regkirona's proven safety and effectiveness, and to contribute to the end of the global COVID-19 crisis."
