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- 2026-03-18 15:06:09
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- 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.
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- 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.
- Company
- Domestic approval of Ajovy is imminent
- by Eo, Yun-Ho Mar 23, 2021 06:24am
- The second anti-CGRP mechanism following Emgality is expected to be approved in Korea. According to related industries, Teva Handok is in discussions for domestic approval of Ajovy(Fremanezumab), a migraine treatment targeting Calcitonin gene-related peptide (CGRP). Approval is possible within the first half of the year. The effectiveness of Ajovy in preventing migraine headaches was evaluated through two phase 3 placebo-controlled clinical studies in migraine patients who had difficulty in daily life, and proved the efficacy of reducing the number of migraine incidence days compared to the placebo group. As a result, Ajovy competes with Emgality (Galcanezumab) in the reimbursement and non-reimbursement market. Both drugs are humanized monoclonal antibody drugs that block binding to receptors by binding to the CGRP molecule, which plays a major role in triggering migraine symptoms in the brain. In the case of Ajovy, in addition to the once-monthly dosage form, it has a quarterly dosage form to improve medication compliance. It was approved by the European Commission (EC) in six months following the acquisition of marketing approval from the US FDA in September 2018. Emgality was launched in Korea in December 2019. Since no drugs have been registered, the process of insurance benefits is expected to be fierce. However, since CGRP is a relatively expensive drug, it is highly likely to be limited to at least tertiary therapy. However, since there are not many treatment options for migraine patients, the non-reimbursment market is also expected to be active. Shinchon Severance Hospital Neurology Professor Joo Min-kyung said, "Migraines are a pain that is more than expected and impair the quality of life of patients. Patients who experience migraine headaches more than 4-5 days a month can expect improvement in their quality of life through preventive treatment. CGRP drugs will be an encouraging option in situations where high blood pressure and epilepsy drugs have been recommended for preventive treatment." Last year, Emgality’s indications for reduction of headache attacks during cluster headache in adult patients suffering from cluster headache were expanded It occurs mainly in men in their 20s to 40s, and when the pain begins, it lasts for 15 to 180 minutes, and this pain occurs up to 8 times a day. Among them, patients who experience cluster headaches from 7 days to 1 year but experience painless periods for more than 3 months are classified as intermittent cluster headaches.
- Company
- Who’ll be the 2nd Korean-made COVID-19 drug?
- by Kim, Jin-Gu Mar 23, 2021 06:23am
- Product image of Nafabeltan Chong Kun Dang’s candidate COVID-19 treatment Nafabeltan has failed to get the South Korean health authority’s conditional approval. As the Ministry of Food and Drug Safety (MFDS) shut the first door of conditional approval to highly anticipated candidate Nafabeltan, the public is now curious of who would be the next second South Korean-made COVID-19 treatment. Currently, the public highly anticipates of GC Pharma’s investigative plasma treatment. Also the anticipation on Bukwang Pharm, Daewoong Pharmaceutical and Shin Poong Pharm are heightening as well. ◆MFDS “Needs additional clinical trial,” Chong Kun Dang “Phase III clinical trial planned” On Mar. 17, MFDS announced the result of the COVID-19 Treatment Advisory Panel’s discussion on the candidate’s efficacy and safety. The Advisory Panel stated approving Chong Kun Dang’s Nafabeltan as a COVID-19 treatment, only based on the Phase II trial outcome would be inappropriate. They added it would need further clinical trial to be approved as a COVID-19 treatment. On Mar. 18, Chong Kun Dang announced its official position through an official statement. The statement explained, "The company has not received any official notification of the conditional approval rejection from MFDS. The related news would be officially announced immediately after the company receives an official notification." To this date in South Korea, Celltrion’s Regkirona (regdanvimab) was authorized as the first domestic COVID-19 treatment on last Feb. 5. After Celltrion snatched the honorable title first, the public started talking about Chong Kun Dang, GC Pharma, and Daewoong Pharmaceutical as the second domestically developed treatment. Among them, Chong Kun Dang was evaluated to be closest. In fact, Chong Kun Dang was the first of the three companies to apply for conditional approval to MFDS on Mar. 8. ◆GC Pharma “Approval application to be submitted in April,” while Bukwang, Daewoong and Shin Poong clinical trials well in process As the conditional approval on Chong Kun Dang’s Nafabeltan fell through for now, the interest of the pharmaceutical industry is again focused on the GC Pharma. Among all candidates of the second South Korean-made COVID-19 treatment, GC Pharma’s is considered to show the fastest progress. GC Pharma is developing a plasma treatment named, ’GC5131A'. On last Dec. 31, the company completed the administration of the drug on the Phase II participating patients. Currently, related data is being analyzed and organized. GC Pharma official said, "After completing data analysis within the first quarter, we plan to apply for approval to MFDS in April." The increasing cases of treatment-purpose use approval are also heightening the anticipation. According to MFDS, GC5131A has received approval for a total of 41 therapeutic uses since October last year. The public’s interest on Bukwang Pharm, Daewoong Pharmaceutical and Shin Poong Pharm is rising as well. Similar to Chong Kun Dang, the three companies are in process of repurposing an existing drug. Bukwang Pharm says that it is in the final stage of Phase II clinical trial. Bukwang Pharm is developing its own hepatitis B virus treatment, Levovir as a COVID-19 treatment. The Phase 2 clinical trial has completed administering 60 participants. Currently, the company is analyzing the gathered data for MFDS submission. Daewoong Pharmaceutical is repurposing a camostat-based chronic pancreatitis treatment Foistar as a COVID-19 treatment. The outcome of Phase IIa trial announced last year concluded the drug has statistically failed to meet the primary endpoint (cessation of viral shedding). However, the drug confirmed a meaningful improvement in symptom, which was a secondary end point. Based on the findings, Daewoong Pharmaceutical is currently conducting three cases of Phase IIb and Phase III trials—Phase II/III to evaluate Foistar’s efficacy and safety, Phase III to evaluate the candidate in combination with remdesivir and Phase III to evaluate the preventive effect against COVID-19. The specific plan for the approval application has not been disclosed. The company’s clinical trial protocol submitted to MFDS stated the trials would be done by coming December, but they could conclude earlier depending on the circumstances. Apparently, the company has not decided to apply for the full authorization after the Phase III trial is done, or for conditional authorization before completing the trial. Shin Poong Pharm plans to complete the Phase 2 clinical trial next month. Shin Poong Pharm’s trial is investigating the company’s malaria treatment, Pyramax, as a repurposed drug. The company announced that 76 out of 110 target patient size have been administered for Phase II trial as of Mar. 5. In order to expedite the progress of the remaining clinical trials, the company has added three clinical trial institutions to the existing 13.
- Company
- Big 5 to prescribe a novel antifungal drug Cresemba
- by Eo, Yun-Ho Mar 22, 2021 06:17am
- The Big Five South Korean general hospitals have registered a novel antifungal drug Cresemba for prescription. Pharmaceutical industry sources reported the Drug Committee (DC) at all of the Big Five general hospitals in South Korea, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital and Severance Hospital, have recently passed Cresemba (isavuconazonium). However, the drug faces an issue with the healthcare reimbursement. In last year, the Health Insurance Review and Assessment Service (HIRA) internally revised the regulation on the pharmaceutical reimbursement subject evaluation standard and procedure. HIRA narrowed the scope of prospective subject for pharmacoeconomic (PE) analysis exemption, initially suggested as ‘antibiotics,’ to ‘antibacterials.’ Both the industry and academic scholars supported the government’s plan to expand the subject scope of the PE analysis exemption. But their definition of antibiotics was controversial. Medically speaking, an antibiotic means antimicrobial medicines that cover antibacterial, antifungal and antiviral. And the constant increase of antimicrobial resistance (AMR) is considered as the most critical public health risk around the world. Due to the major public health risk, some were disputing over unifying the definition of the new PE exemption subject—antibiotics—as ‘antibacterial’ based on the variant definitions of antibiotics. And the government sealed the deal by ‘limiting the exemption to ‘antibacterial’.’ Cresemba, categorized as an antifungal, is in shock of the government’s decision. Including South Korea, the number of fungal infection cases around the world has been surging as more than one million people are reportedly dying annually from fungal infection. However, the number of developed antifungal is limited. Among all fungal infection, the invasive aspergillosis is considered as one of three most deadliest invasive fungus to the human race. Even in Korea, the infection is counted as one of most frequent causes of death in patients with immune deficiency, due to increased number of patients receiving anticancer therapy and fighting against AIDS. President Choi Jung-hyun (Catholic University of Korea Eunpyeong St. Mary's Hospital) of Korean Society for Antimicrobial Therapy (KSAT) said, “The risk of secondary nosocomial infection increases higher, when a patient with COVID-19-like severe disease is hospitalized for a long term or uses respirator for a long term. While the demand for securing sufficient amount of infectious disease drug is becoming ever more important to respond against novel infectious disease and secondary nosocomial infection, it is regretful that the government had to neglect the academic society’s advice and narrow down the definition of antibiotics.” In January last year, the Ministry of Food and Drug Safety (MFDS) has approved Cresemba, indicated to treat adult patients in age of 18 and older with invasive aspergillosis, and adult patients in age of 18 and older with mucormycosis for whom amphotericin B is inappropriate. With a wide variety targeted antifungal spectrum, Cresemba can treat both invasive aspergillosis and invasive mucormycosis. The drug is currently the only azole antifungal in South Korea indicated for invasive mucormycosis.
- Company
- Keytruda is expected to expand its indications
- by Eo, Yun-Ho Mar 19, 2021 06:29am
- Keytruda, an immune anticancer drug, is expected to expand its indications for the first-line therapy for colon cancer and esophageal cancer. According to industry sources, MSD Korea recently submitted an application for additional indications about PD-1 inhibitor Keytruda's (Pembrolizumab) ▲MSI-H, microsatellite instability high or dMMR, first-line therapy in patients with advanced colorectal cancer with mismatch repair deficient and ▲ combination therapy of first-line platinum-based chemotherapy drugs for unresectable, locally advanced or metastatic esophageal cancer and gastroesophageal junction cancer (GEJ). The study was conducted in 307 patients with advanced colorectal cancer with MSI-H/dMMR with poor prognosis. Keytruda alone and conventional chemotherapy (5-FU-based therapy ± Bevacizumab or Cetuximab) was compared and evaluated. As a result of the interim analysis, the median follow-up period was 32.4 months, the median progression-free survival (mPFS) of the Keytruda-treated group was 16.5 months, and more than twice that of 8.2 months of the chemotherapy group, and reduced the risk of disease progression and death by 40%. The objective response rate (ORR) was 43.8% in the Keytruda-treated group and 33.1% in the chemotherapy group. In these patients, 83% of the Keytruda-treated group and 35% of the chemotherapy group maintained a response even in the second year. In the case of stomach cancer, the efficacy was proven through the KEYNOTE-590 study. As a result of interim analysis, the combination of Keytruda and platinum-based chemotherapy improved both overall survival (OS) and PFS compared to standard therapy, and passed safety indicators such as duration of response (DOR) and ORR. Keytruda is also in the process of approving indications for first-line therapy for metastatic triple-negative breast cancer (TNBC) in Korea. The effectiveness of Keytruda in triple-negative breast cancer was proven through the KEYNOTE-355 study. In this study, Keytruda improved progression free survival (PFS) and an objective response rate of 53% (17% for complete, 36% for partial) in the entire patient group including patients with poor prognosis who recurred rapidly for more than 6 months.), with a high rate of complete relevance, suggesting the possibility of cure in metastatic triple-negative breast cancer.
