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- 2026-05-11 19:09:18
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- “EMA authorizes Rekirona, sales projected at KRW 1.2 tln”
- by Kim, Jin-Gu Mar 31, 2021 06:06am
- The financial experts project Celltrion's COVID-19 monoclonal antibody treatment Rekirona injection’s (regdanvimab) sales in Europe would hit 1.2 trillion won as the European Medicines Agency (EMA) has granted conditional approval on the treatment. Leveraged by the Rekirona sales in Europe, the experts also projected Celltrion’s annual sales revenue this year would surpass 3 trillion won. Researcher Sun Min-jeong at Hana Financial Investment published a report with the said details. Previously, Celltrion announced EMA has issued advice on the use of Rekirona, prior to the formal marketing authorization. Based on the advice issued, European countries are authorized to use the South Korean drug to treatment patients with COVID-19. Researcher Sun Min-jeong explained, “Following the monoclonal antibody treatments by Regeneron Pharmaceuticals and Eli Lilly, Rekirona is now the third antibody treatment that received the conditional approval in Europe. However, unlike the U.S., European countries have not yet procured sufficient volume of the antibody treatments.” The researcher elaborated, “Due to the slow nature of monoclonal antibody treatment production, the drug makers would not be able to supply sufficient volume of the drugs promptly.” The COVID-19 treatments by Regeneron Pharmaceuticals and Eli Lilly would be unlikely to get supplied to the European market in time, which leaves a good window for Celltrion’s Rekirona to tackle the market. Celltrion expects to manufacture 3.2 million doses of Rekirona injection at maximum. The researcher stressed, “Besides the 100,000 doses secured from last year, the first and second plants and the overseas contract manufacturer would be able to produce 1.3 million doses, 1.3 million doses and 600,000 doses, respectively.” Regarding the pricing, the report estimated it would “differ depending on the contract signed with each country, but considering the U.S. government has settled with Eli Lilly to supply bamlanivimab for USD 1,250, Rekirona would be priced around the same level.” The reported explained, “Generally, the drug pricing in Europe is about 70 percent of the U.S. price. Rekirona is expected to be priced at 875 dollars (approximately 1 million won) per dose.” The researcher predicted, “Celltrion’s Rekirona sales revenue would reach 1.2 trillion won, based on the said pricing estimation. Accordingly, Celltrion’s overall sales revenue for the year would skyrocket by 77 percent compared against last year, and generate 3.3 trillion won.” In last year, the South Korean company has made 1.85 trillion won from sales only.
- Company
- Controversy over 7-day packaging Rx drugs
- by Nho, Byung Chul Mar 29, 2021 05:58am
- Packed with 56 Omethyl Cutielet Soft Caps. In the case of a prescription for 60 days (two months), a photo of 4 pieces is attached to one box. Although it is the product of the same company, the packaging units of Lipitor (28 tablets) and Norvasc (30 tablets) are different., and packaged every 7 days (clockwise at the top left)Due to the packaging unit different from the domestic prescription style, drug prescription and storage difficulties for pharmacists and patients in countries are increasing and improvement is required. According to the pharmacy, it is difficult to dispensing some high-frequency, long-term prescription drugs because the packaging unit is set for 7 days (28 days) rather than 10 days (or 30 days). Representative drugs related to this include Korea United Pharm's Omethyl Cutielet Soft Caps 2g and Pfizer Korea's hyperlipidemia treatment Lipitor 10mg. The packaging units of Omethyl Cutielet and Lipitor are 56 packets and 28 tablets, respectively. A pharmacist at Pharmacy A in Gangnam-gu, Seoul said, "Most of the drugs for hyperlipidemia are long-term prescriptions for 1 to 2 months. These drugs are packaged in 56 or 28 tablets, so another same product is opened and attached." . This is because the pattern of prescription days is different between Korea and foreign countries. In Korea, the unit is mainly used for 10 days (30 days, 30 tablets), but in Europe, it is based on 7 days (28 days, 28 tablets). However, in order to solve this problem, most pharmaceutical companies' production sites have replaced the 'packaging unit change device' to prevent the occurrence of the problem. The cost may vary depending on the facility line, but it seems that it usually costs about 10 million won. If the change part is modified, both 10 and 7 units can be packaged in both directions. An official from Korea United Pharm said, "It has been confirmed that there have been cases of phone calls from front-line pharmacists to related departments such as customer services at the head office. However, there is no plan to modify the packaging unit." Pfizer Korea said, "Lipitor 10·20mg is also available in 90T bottle type. Changing the packaging unit may be difficult to apply in a short period of time because various factors in the production process must be considered. However, in order to improve the discomfort of domestic pharmacists and patients, We will figure out what is possible, and we will work hard and take action.”
- Company
- Boehringer is interested in open innovation with Yuhan
- by Mar 29, 2021 05:58am
- Boehringer Ingelheim emphasized the importance of open innovation and announced that it has a long-term partnership with Yuhan. It also mentioned the possibility of further open innovation for R&D materials in Korea. In addition, they expressed their will to do their best in the development of COVID-19 treatment and anticancer drugs targeting KRAS. Boehringer Ingelheim held an online global annual press conference on the morning of the 24th (local time in Germany) and announced last year's results and forecasts for this year. In spite of COVID-19 crisis, Boehringer Ingelheim showed good performance last year with its flagship items, Jardiance and Ofev. Total sales amounted to €19,570 million, an increase of 3% from the previous year. During the same period, operating profit rose 22.2% to €4,620 million. SGLT-2 inhibitor Jardiance posted the highest sales in the human medicine division at €2.48 billion, and Jardiance is expected to expand the range of treatment to heart failure and kidney disease. Ofev showed remarkable growth last year. It recorded €2,060 million, an increase of 41% year-on-year, ranking second in revenue contribution for the first time. Carinne Brouillon, director of the human medicine business unit, said "It's not because of COVID-19, because Ofev isn't related to COVID-19 comorbidity, This is because there is more room for finding and treating target patients with the development of diagnostic technology than in the past." Boehringer Ingelheim plans to focus on developing COVID-19 treatments, and it started development from the beginning of last year. BI767551, which is being developed as an inhalant, entered a phase 1/2a clinical trial in December last year in collaboration with the University of Cologne Hospital in Germany, the University of Marburg, and Deutsches Zentrum für Infektionsforschung. It is also developing COVID-19 neutralizing antibody that can be used in combination with BI767551, a low molecular weight substance that inhibits the replication of COVID-19, and a therapeutic agent for preventing microcoagulation. It also invests in the development of new drugs for diseases with high unmet medical demand.Boehringer Ingelheim showed high interest in KRAS anticancer drugs. It is developing therapeutics that target a wide range of KRAS mutations. The company said, "There is a lot of interest in KRAS mutant cancer. It is an important mutant gene that causes pancreatic cancer, colon cancer, and lung cancer, but there is no licensed agent yet." Boehringer Ingelheim said that it has a broad portfolio that can be used in combination with other substances as well as candidates that can target all important KRAS mutations as candidates that block SOS1 protein, so it could be the core of KRAS mutations. It also emphasized collaboration with partnerships for IMD development. Boehringer Ingelheim is building partnerships with pharmaceutical companies around the world, and a new drug for non-alcoholic steatohepatitis (NASH) is being developed with Yuhan in Korea. Yuhan technically exported the NASH candidate material to Boehringer Ingelheim in 2019. Director Carinne Brouillon said, "We have a long-term strategic partnership with Yuhan, Korea's leading pharmaceutical company, and we are working closely with R&D in the NASH sector." the director added, " As there are many interesting R&D activities in Korea, we are interested in additional open innovation if there is a good opportunity that matches the area we focus on or explore."
- Company
- Bonviva generics dodge a bullet from patent dispute
- by Kim, Jin-Gu Mar 26, 2021 05:38am
- The generic makers won the patent dispute over an antiarthritis Bonviva (ibandronate) and now they are finally free from the risk of sales ban and damage compensation. According to the pharmaceutical industry source on Mar. 23, the Intellectual Property Trial and Appeal Board issued a trial decision that the dosage regimen patent for Bonviva was invalid. South Korean companies launched Bonviva generics in 2012. Sales continued for several years without special patent disputes. Roche owned the dosage regimen patent for the original Bonviva, but did not file a patent lawsuit at the time of the generic launch. At the time, the Patent Court and the Supreme Court did not recognize the dosage regimen patent. As for the original maker, a patent dispute meant nothing when the company was bound to lose it. However, in 2015, the table has turned. The Supreme Court abolished the precedent of the Baraclude (entecavir) patent dispute, and fully recognized the dosage regimen patent. Bonviva’s dosage regimen patent, initially affected by the precedent, gained its validity. Regardless, Roche did not file a patent dispute immediately. The company did not intend to overturn the decision that it concluded that there were no problems at the time of release. But a problem arose when Bonviva's patent rights were transferred from Roche to a British pharmaceutical company Atnas Pharma in 2018. More assertive Atnas Pharma took a sharp turn on the matter and filed patent infringement suit against Bonviva generic makers in South Korea. At the same time, they claimed for a colossus compensation for the damage. The companies then were struck with the crisis. Although they have been selling Bonviva generics for years without any problems, they were faced with sales ban and also cough up the revenue earned so far. Accordingly, 10 generic companies such as Theragen Etex, Korea Arlico Pharm, Wooridul Pharmaceutical, ChoA Pharmaceutical, Korea Kolmar, Huvist, and Dongkwang Pharmaceutical, which sold Bonviva generics, decided to respond together. A trial was filed to nullify the Bonviva dosage regimen patent. Considering the gravity of issue, the Intellectual Property Trial and Appeal Board allocated the case to the Special Joint Trial Board. Generally, a patent trial is handled by three judges, but the Special Joint Trial is conducted by five judges. Ultimately, the Intellectual Property Trial and Appeal Board decided to invalidate the case. South Korean companies are now relieved. As of now, there is a high possibility that Atnas Pharma, holding the patent right, would request for an appeal. Patent Attorney Park Jong-hyuk of Park Jong-hyuk Patent Law Firm said, “After the Supreme Court recognized the dosage regimen patent in 2015, the method of judging non-obviousness in dosage regimen patent was somewhat formed through the tadalafil case. He emphasized, “The Intellectual Property Trial and Appeal Board conducted an elaborate trial for a long term through a Special Joint Trial Board, and determined requirement of a dosage regimen patent, necessity of test data, improper description and non-obviousness. The latest decision would be used as a standard to other similar cases related dosage regimen patent.” A pharmaceutical market research firm UBIST reported Bonviva's outpatient prescription last year was 2.9 billion won. In South Korea, Handok is in charge of sales. Adding the prescription volume of Bonviva Plus (5.4 billion won), which combined with cholecalciferol, Bonviva makes about 8.3 billion won per year. Currently, 93 Bonviva generics have been approved for marketing in South Korea. These drugs combined generate about 10.3 billion won.
- Company
- Problems with the most expensive CAR-T treatment Kymriah
- by Mar 26, 2021 05:38am
- The CAR-T treatment Kymriah (Tisagenlecleucel), which is considered the hope of terminal blood cancer patients, was launched in Korea after 4 years, but there are problems to be solved. Kymriah is treated in a completely different way from existing medicines, so it is not easy to calculate the drug price, and at a price of ₩500 million, there are many concerns about applying benefits. Kymriah is the first CAR-T treatment in Korea and is currently the most expensive drug. Indications are diffuse large B-cell lymphoma in adults and B-cell acute lymphocytic leukemia in children and young adults. In both cases, terminal patients who are ineffective after two or more treatments, recurrence, or recurrence after transplantation are targeted. CAR-T treatment is different from conventional drugs. Unlike conventional pharmaceutical products, CAR-T collects T cells in the patient's white blood cells at a hospital and then freezes them and sends them to the manufacturing site. Later, it will be sent to the hospital. When the hospital passes the raw material (patient T cells) to the pharmaceutical company, the company makes it into a finished product and sends it back to the hospital. Hospitals maximize the effectiveness of Kymriah by using lymphocyte depletion chemotherapy in patients to lower their white blood cell count. After about 4 to 5 weeks, all work is completed, and Kymriah is administered to the patient's body. Since Kymriah's steps in the manufacturing process are mandatory, the first task is how to calculate and handle these costs. Kim Won-seok, a professor of hematology and oncology at Samsung Medical Center, said at the Novartis Kymriah meeting held on the 23rd, "We have been discussing how to calculate incidental costs such as T-cell collection for patients for almost a year. There are no government guidelines, so this is the first time that we are making unexpected factors." Currently, Novartis is making payments by establishing Kymriah center in a hospital. The Kymriah Center is scheduled to open in May at Samsung Medical Center and Seoul National University Hospital respectively. However, in order to establish a center, hospitals must obtain permission for management business such as human cells in accordance with the newly established 'Advanced Renewable Bio Act'. Kymriah can be administered only in hospitals with centers. According to Novartis, the center will be expanded to Severance Hospital, Seoul St. Mary's Hospital, and the AMC. Since it is an ultra-high priced drug worth ₩500 million, it is not easy to apply the reimbursement. Kymriah is absolutely necessary in situations where life or death is critical, but from the perspective of the government, which has to spend the people's tax, it is questionable whether it is appropriate to spend hundreds of millions of dollars on the possibility of 50-60%. The second problem is to make a reasonable payment plan even for the super high-priced drugs that will come out more in the future. Professor Kang Hyung-jin of the Department of Pediatrics and Oncology at Seoul National University Hospital said, "The problem with Kymriah is how to take ultra-high-priced drugs with life as collateral. When Kymriah first appeared in the United States, patients were very happy. but there are completely different costs than before. Now, the number of patients is not very small, and the number of target patients will increase through additional clinical trials, so we have to think about how to solve the cost problem wisely. It's just the beginning.” Professor Kim also said, "Kymriah's treatment results are very remarkable. Half of the hopeless patients whose life expectancy is only 3-6 months can get new hope. According to the law, the patient's burden is uniformly 5%, but don't be too tied to it, and it's time to make flexible changes.” Professor Kang emphasized that it is imperative to create a virtuous cycle of costs. He said, "The cost of returning to Korea is very small among the costs paid by patients. MRI, CT, endoscopy, robotic surgery, and expensive drugs are all products of foreign companies, so much of the medical expenses are not recycled. Conversely, foreign countries circulate within them even if they spend medical expenses. This virtuous cycle structure is possible because ideas from hospitals and universities can be industrialized and come back." Kymriah is also a treatment developed by a research team at the University of Pennsylvania in the United States and commercialized by Novartis. This is a representative case in which the researcher's idea was made into a treatment. Professor Kang said, "In Korea, we need to raise a lot of human resources in hospitals and universities, and their ideas are industrialized through companies, so we need a breakthrough to create a structure in which medical costs can be circulated. And we will be able to pay enough for expensive drugs"
- Company
- Samchundang to start oral insulin clinical trial this year
- by Kim, Jin-Gu Mar 26, 2021 05:37am
- Samchundang Pharm announced its plan to start clinical trial on 'oral insulin' within this year. Also the South Korean company explained that four vaccines were added to the pipeline of the 'S-Pass' platform, a technology converting injection into oral drug. In the case of Eylea (aflibercept) biosimilar, the company expects to complete a global Phase III clinical trial in April next year. With the trial data, the South Korean company is to initiate marketing in the U.S. and Japan from 2023. On Mar. 25, Samchundang Pharm convened an investor relations event for institutional investors and individual stockholders, and briefed about the S-Pass platform and the progress in Eylea biosimilar clinical trial. Samchundang Pharm predicts the global clinical trials for oral insulin will begin this year. The company is developing oral drugs such as insulin, vaccine, and TNF inhibitor using a formulation conversion technology platform named S-Pass. Among these, the company is pushing the oral insulin the strongest. Samchundang Pharm explained that its oral insulin under investigation showed almost the same level of efficacy and safety as injections. Based on the outcome, the company is to kick off clinical trials. The trials would be conducted in the U.S. and China scheduled to finish in 2024. Moreover, Samchundang Pharm announced that it has expanded the S-Pass platform pipelines. In addition to oral insulin, the company is developing GLP-1 diabetes treatment Victoza, TNF inhibitor Enbrel, and growth hormone drug Zinotropin. On top of them, the company added four types of vaccines—influenza, COVID-19, cervical cancer and pneumococcus—on the pipeline. The company also reported the development status of Eylea biosimilar, undergoing global Phase III clinical trials at the moment. Investigated under the name 'SCD411,' the Eylea biosimilar is expected to complete the global Phase III clinical trial in April next year. The goal is to apply for a market authorization to the U.S. Food and Drug Administration (FDA) by December of that year when the Phase III clinical trial is completed in April of next year. He explained that it plans to start marketing the drug in the U.S. and Japan from 2023. Samchundang Pharm started its first clinical administration in 15 countries including the U.S. in August last year. 155 clinical institutions worldwide and 560 patients are participating in the trial. It has already obtained related patents in the U.S., Europe and Japan. Samchundang Pharm explained that the local partners have been selected for Eylea biosimilars global sales. In Japan, it has already signed an exclusive sales and supply contract with SENjU. In the U.S., Europe, and China, the partners have been selected. And it reported that the terms of the contract are being discussed. It would be highly likely that the profit distribution would be 50-50 in Japan, the U.S., Europe, and China. Eylea is a macular degeneration treatment developed by the U.S.-based Regeneron. The blockbuster drug has made 8.5 trillion won worldwide as of 2019. Given that the Eylea patent expiration is approaching but would still maintain high growth for the time being, many pharmaceutical companies home and abroad are jumping in to the biosimilar development. Besides Samchundang Pharm, Celltrion, Samsung Bioepis, and Alteogen are conducting clinical trials in Eylea biosimilars.
- Company
- The patent dispute for the combination drug Ducarb expanded
- by Kim, Jin-Gu Mar 25, 2021 05:58am
- From left, Dukarb, Tuvero & Kanarb The patent challenges of 34 domestic companies for Boryung's Dukarb are following one after another. It is analyzed that the expiration of the substance patent of Fimasartan is approaching two years in the future, and it is aiming for the early release of generics for combination drugs including Fimasartan. According to the pharmaceutical industry on the 19th, there are a total of 34 companies that have applied for a trial to confirm the scope of passive rights to Dukarb's complex composition patents until this day. Companies that have additionally challenged for patents are ▲Navipharm ▲Dongkoo ▲Shin Poong ▲Kims Pharma ▲HLB ▲Futecs ▲Daehan New Pharm ▲Daewoong Bio ▲NBK ▲Youngil ▲Global pharm ▲Korea Prime ▲Theragenbio ▲Ilsung ▲Yuyu ▲SCD Pharm ▲Korean Drug Co.,Ltd ▲Sungyi ▲Wooridul ▲Binex ▲Kuhnil Bio ▲Nexpharm ▲Mothers ▲Young Poong ▲Ahn-gook ▲Eden Pharma ▲JW Shinyak ▲Samjin ▲Youyoung ▲Aprogen ▲Aju ▲Ilhwa ▲DongKook ▲Whanin ▲Union Korea ▲Hana Pharm ▲CTC Bio ▲Hanwha ▲CMG ▲Guju ▲GL Pharma ▲Huons ▲Medica Korea. These companies have obtained the 'first appeal' requirement to obtain generic exclusivity. There are two remaining requirements. The patent challenge to Dukarb is analyzed because material patent of Fimasartan will be expired soon. Boryung launched Kanarb as a new drug for hypertension in March 2011. Ten years have passed since Kanarb was launched, and the expiration of the substance patent is two years ahead. Kanab Family In the case of the composition patent dispute that proceeded earlier, the challenge of generic companies has been successful. Following Kanarb (₩49.2 billion), Dukarb's outpatient Rx amount last year was ₩35.1 billion. This was followed by Lacor (Fimasartan+HCTZ) ₩7.4 billion, Dukaro (Fimasartan+Amlodipine+Rosuvastatin) ₩6.4 billion, Tuvero (Fimasartan + Rosuvastatin) ₩4.8 billion , and Akarb ((Fimasartan+Atorvastatin) ₩1.2 billion. Dukaro and Akarb have had high prescription sales since their launch in February and September of last year, respectively. It is known that some companies are considering a patent challenge for Dukaro and Akarb.
- Company
- ↑Sales of local subsidiaries in Japan & Southeast Asia
- by Kim, Jin-Gu Mar 24, 2021 07:28am
- While the earnings of subsidiaries in China and North America, which were relatively affected by COVID-19, decreased significantly, the performance of local subsidiaries in Japan and Southeast Asia increased relatively. ◆↓20% sales of Beijing Hanmi / ↓13%, Ilyang / ↓12%, China According to the Financial Supervisory Service on the 23rd, the total sales of 24 local subsidiaries in China last year was ₩453.9 billion won. It decreased by 13% from ↓519.7 billion in 2019. During the same period, net income decreased by 17% from ₩58.8 billion to ₩48.8 billion. It is an analysis that it was directly affected by COVID-19 crisis. China has implemented a strong control policy in the early days of COVID-19 outbreak. As a result, the earnings of most Chinese subsidiaries in the first half of the year fell sharply. From left: Beijing Hanmi Pharmaceutical, Yangju Ilyang Pharmaceutical, Green Cross Biological Products Co., Ltd. Beijing Hanmi Pharmaceutical, a Chinese subsidiary of Hanmi Pharmaceutical, had sales of ₩254.4 billion in 2019, but fell 20% to ₩203.5 billion last year. It was ₩92.8 billion in the first half and ₩110.7 billion in the second half. In the case of 2019, the results were equal at ₩126.7 billion and ₩127.8 billion, respectively, in the first and second half of the year. In the case of Ilyang Pharmaceutical, the total sales of Yangzhou Ilyang Pharm and Tonghua Ilyang Health Products decreased by 13% from ₩140 billion to ₩132.3 billion. Similarly, it is observed that it was sluggish in the first half. However, their net profit was found to have improved from ₩18.6 billion to ₩19.8 billion. GC Pharma's Green Cross China and Anhui Gerinker Pharmaceutical Sales Co., Ltd. decreased 12% from ₩64.9 billion to ₩57.1 billion over the same period. Net income decreased by 18% from ₩6.3 billion to ₩5.2 billion. Kwangdong Pharmaceutical has established a total of 4 corporations in Yanbian, Yeondae, and Suzhou. The total sales of the four corporations decreased by 9% from ₩39.6 billion to ₩36 billion. Kwangdong Pharmaceutical also disposed of Kwangdong Industrial Co., Ltd. located in Yanbian last year. ◆GC Pharma's sales decline by 7% until immediately before the sale of its North American subsidiary It is analyzed that the North American subsidiaries centered on GC Pharma's GCNA (GC North America) were also affected by COVID-19. GC Pharma sold its North American subsidiary to Grifols, a Spanish blood plasma-based product company, in last October. For this reason, as of the end of last year in the business report, the sales of the North American subsidiary were recorded as '0'. However, until 3Q, overall sales and net profit for the year are expected to decline compared to the previous year. Green Cross' total sales of its North American subsidiaries in the third quarter of last year were ₩39.9 billion, down 7% from ₩42.6 billion in 2019. Net loss for the period increased from ₩31.6 billion to ₩41.4 billion. Huons newly established a local subsidiary,Huons USA last year. The sales in the first year of establishment were ₩7.8 billion. ◆Daewoong's Japanese and Southeast Asian subsidiaries increased their performance despite COVID-19 outbreak In Japan, Daewoong Pharmaceutical and Handok respectively established local subsidiaries. Daewoong Pharmaceutical's Japanese subsidiary increased its sales from ₩13.8 billion in 2019 to ₩19.5 billion last year. Handok's Japanese subsidiary decreased its sales from ₩7.6 billion to ₩6.8 billion over the same period. In Southeast Asia, it is confirmed that Daewoong Pharmaceutical, Chong Kun Dang, JW Pharma, and Celltrion have established 14 local subsidiaries. Their total sales increased 54% from ₩23.1 billion in 2019 to ₩35.5 billion last year. In particular, Daewoong Pharmaceutical made ₩20.1 billion in sales in Indonesia, the Philippines, and Thailand. It increased by 7% compared to ₩18.7 billion in 2019. Daewoong Pharmaceutical's local subsidiaries in Southeast Asia suffered a net loss of ₩3.4 billion in 2019, but it recorded a net profit of 3.2 billion won last year.
- Company
- Pneumococcal vaccine Prevenar 13 lowers COVID-19 risk
- by Eo, Yun-Ho Mar 24, 2021 05:46am
- A study found a pneumococcal vaccine Prevenar 13 could lower the risk related to COVID-19. The Kaiser Permanente Southern California (KPSC) has recently presented the study result of the effect of Prevenar 13 (PCV13) on elderly patients’ COVID-19 infection progress. The study was published in the Journal of Infectious Diseases. The study has shown that in a cohort of U.S. adults aged 65 and older, PCV13 vaccination has been correlated with a decline in COVID-19 diagnosis, hospitalization, and post-hospital mortality. As of March 2020, 3,677 out of 531,033 adults 65 years of age and older, who joined KPSC and were vaccinated by PCV13, were diagnosed with COVID-19, whereas 1,075 were hospitalized, and 334 died. The adjusted hazard ratio (aHR) of COVID-19 diagnosis, hospitalization, and mortality, which are related to PCV13 vaccination record, was 0.65, respectively. Sara Y. Tartof, PhD, MPH Research Director of KPSC said, "Kaiser Permanent members who received PCV13 vaccine had a lower rate of COVID-19 infection, and the prognosis for diagnosed patients was better." However, in South Korea, the adult vaccination rate of the PCV18 vaccine is declining amid COVID-19. According to the 2020 national vaccination rate (January through November 2020), the vaccination rate for pneumococcal vaccinations over 65 years of age (born 1955) in 2019 was close to 66.4 percent, but the vaccination rate in 2020 (born 1956) was close to 44.3 percent. And the vaccination rate in all major cities like Seoul (35.3 percent in 2020 vs. 57.2 percent in 2019), Busan (47.9 percent in 2020 vs. 53.7 percent in 2019) and Gwangju (44.1 percent in 2020 vs. 73.1 percent in 2019) dropped. Using the ‘Guideline for Practicing Social Distancing in Daily Life, the Korea Disease Control and Prevention Agency (KDCA) is now emphasizing that the elderly aged 65 and over must receive necessary vaccinations, such as pneumococcal vaccine. The management guideline of the National Immunization Program (NIP) 2020 says one dose of a 23-valent pneumococcal protein polysaccharide vaccine (PPSV23) is required for elderly people aged 65 and over as a principle, but for patients with underlying condition 13-valent pneumococcal conjugate vaccine (PCV13) could be prioritized, depending on the condition’s severity and status. Meanwhile, a study of 257 patients confirmed with COVID-19 reported that pneumococcal pneumonia was the most common bacterial infection. A common complication of respiratory viral diseases such as COVID-19 is a secondary bacterial infection, and most viral infections (influenza virus, respiratory syncytial virus, parainfluenza virus, human metapneumovirus and etc.) can cause secondary complications due to bacterial infections (pneumococcal, haemophilus influenza, staphylococcus aureus and etc.). A survey on pneumococcal pneumonia patients in South Korea showed one out of three patients were infected with pneumococcal pneumonia after diagnosed with respiratory viral infection.
- Company
- Tagrisso expands benefits as a first-line treatment
- by Mar 24, 2021 05:45am
- Tagrisso, a targeted treatment for EGFR mutant non-small cell lung cancer, is not receiving benefits from the first-line treatment in Korea. The medical staff emphasized the need for Tagrisso's benefit. On the 19th, AstraZeneca Korea held an online press conference to commemorate the 5th anniversary of Tagrisso's postoperative adjuvant therapy acquisition and its launch in Korea. National Cancer Center’s Chief Researcher Ji-Yeon Han and Professor Min-hee Hong, Department of Oncology, Yonsei University Medical School, presented as speakers. Tagrisso, a third-generation EGFR TKI agent, started as a second-line treatment for EGFR mutant patients and acquired indications for the first-line treatment. Recently, it was used as an adjuvant therapy after surgery for patients with early stage (1B~3A) lung cancer among the first EGFR target treatments. Tagrisso is currently being used as a second-line treatment in Korea. This is because the most important insurance benefits are applied only to secondary treatment. This is in contrast to the insurance benefits applied to primary treatments in major countries around the world, such as the UK, the US, Japan, Germany, France, Italy and Switzerland. In recent years, in Canada, Russia, Australia, and Taiwan, benefits have also been expanded through primary treatment. The National Comprehensive Cancer Network (NCCN) also recommends Tagrisso the most (category 1) for the first-line treatment of EFGR mutant non-small cell cancer patients. In Korea, the results of sub-analysis on the Asian subgroup during the clinical trial of Tagrisso's FLAURA were controversial. Although the overall survival benefit was demonstrated in the entire global FLAURA patient population, the risk ratio (HR) of the Asian sub-analysis was 0.995. In fact, there was no difference from the control group, so there were opinions that there was no OS benefit for Asians. Accordingly, Chief Researcher Han Ji-yeon said, "One-third of the Asian subgroups were Japanese patients, which may have been due to different types of treatment than global ones." She explained, "In Japan, patients with recurrence after surgery, not general stage 4 lung cancer patients, were especially enrolled in the control group. Patients with recurrence after surgery are known to have a better prognosis than general stage 4 patients." Here, in the case of Japan, if there is any possibility of progressing to pneumonia, the drug is stopped immediately and there is a characteristic of switching to another drug. AstraZeneca admitted to the cross-over prescription of patients with confirmed T790M mutations in the first-generation drug from an ethical perspective, and taking this into account, it is encouraging to improve OS. Tagrisso is an EGFR TKI drug that has proven OS for more than 3 years in clinical practice. In a recent FLAURA China study of Chinese, OS showed a similar pattern to global clinical trials. Korea, which follows global treatment standards, will be similar. In particular, among other EGFR TKI agents, Tagrisso has the best BBB permeability, reducing the risk of disease progression or death due to central nervous system metastasis by 52%. One Chief Researcher explained, "The first principle in cancer treatment is to administer the most effective treatment to everyone first." "If Tagrisso resistance develops, there is no follow-up treatment option, so if it is used as a second-line drug, more than half of the patients who can actually be treated with Tagrisso will not have a chance. It is correct to use the best treatment for the first time." Professor Hong Min-hee also said, "From the point of view of the medical staff, the OS may be considered the most important part, but it is also very important for patients to live long and healthy. So, the primary evaluation indicators were disease-free survival (DFS) and progression-free survival (PFS)." Jin MYEONG, Managing Director of Korea AstraZeneca's anticancer drug business division, said, "We are sincerely discussing with the health authorities about the expansion of the primary benefits." We hope to make good progress." It is the first among EGFR TKIs, and it is very encouraging considering the cross-over prescription of a patient whose T790M mutation was confirmed in the first-generation drug for research ethics.
