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- Policy
- HIRA, promote 'COVID-19' outcome at OECD
- by Lee, Hye-Kyung May 14, 2020 02:21pm
- The meeting of the Working Party on Healthcare Quality and Outcomes (HCQO) of Organisation for Economic Co-operation and Development (OECD) was held on 12 May 2020, chaired by Dr. Sun Min Kim, president of Health Insurance Review and Assessment Service (HIRA) of Korea. OECD HCQO was started in 2001 to develop, collect, and compare a set of indicators that reflect a robust picture of healthcare quality across countries using comparable data. HCQO Working party is made up of representatives of OECD countries and international organizations such as WHO, European Commission, International Hospital Federation and ISQua, and more than 100 experts participated in this meeting. HIRA has represented Republic of Korea for OECD HCQO Working Party since 2007, and President Kim has been actively involved from 2009. President Kim was elected as the chairperson of HCQO Working Party for 2019-2020 as the first women and Asian to hold the chair, and re-elected for 2020-2021. Given the unprecedented challenges from global pandemic, the OECD HCQO meeting was held as virtual meeting and dedicated to the health system readiness and COVID-19 response. The meeting was divided into two sessions; overview of HCQO original work streams and health system readiness and COVID-19 response. In Session 1, Dr. Katherine de Bienassis of OECD Secretariat provided brief overview of agenda documents for feedback and committee actions on ongoing HCQO work on people-centered health data systems, performance of integrated care delivery systems, patient-reported indicators survey, broadening the patient safety measurement agenda, quality indicators for end of life care, and process and updates for the HCQO 2020-2021 data collection. The delegates were invited to comment on the progress made and provide written feedback for further discussion on the next HCQO Working Party Meeting in October. In session 2, participants discussed how health system readiness and emergency preparedness fit into the HCQO’s patient safety and health system performance agenda. Dr. NiekKlazinga of OECD Secretariat provided COVID-19 and the work of the HCQO Working Party, noting the importance of health system preparedness and data infrastructure as a component of the patient safety agenda. Emergency management is comprised of four stages and domains - preparedness, response, mitigation, and transition towards recovery. At this stage, a number of countries beyond the peak of pandemic, health systems should be ready to address challenges in transition towards recovery. COVID-19 poses dual challenges for health care quality and outcomes to ensure high quality, safe and coordinated care both for COVID-19 and non-COVID patients. The transition phase may last more than a year and health systems have to balance the increased demands of acute care related COVID-19 with on-going needs of healthcare system to maintain and provide essential services for all non-COVID patients including but not limited to vaccination, chronic care and cancer care. Next with the Secretariat, selected three countries shared their experiences in response to the COVID-19 pandemic. Dr. Kim representing Republic of Korea provided country kick-off presentation on national response to COVID-19 utilizing real-time healthcare resource and claims data to detect high-risk group, prevent spread in community, collect patient information centrally, and monitor the status of resources including negative pressure isolation room, mask and drug supply. Representative of Australian Commission on Safety and Quality in Healthcare shared the national containment and mitigation strategies and measurement of health system approach. Finnish representative provided national data registries on hospital discharge and intensive care and pilot patient data repository to highlight the data collection and utilization. The delegates carried out a poll on their national experiences in data infrastructure, patient safety and integrated care to tackle the pandemic. As a result of polling, it was significantly noted that all participating countries faced safety challenges regarding COVID-19 in long-term care and ensuring the safety of healthcare workforce, technologies and supplies which were rooted from massive outbreak in long-term care setting and shortage in supplies. The participants provided a comprehensive opinion on the capacity of health data infrastructure including timely data collection, person-based data generation, new or improved data linkage to deal with COVID-19, as well as privacy concerns about personal data use. Lastly, the polling results addressed the importance of integrated care approach to track patient outcomes outside of the hospital, monitor the flow of COVID-19 and non-COVID patients, and emphasize the role of primary care during the mitigation phase of the crisis. The OECD HCQO will continuously work together to measure health system resilience and readiness to strengthen collaboration and generate potential candidates for international benchmarking and further OECD analysis. In this regard, Dr. Kim, as a chairperson of OECD HCQO Working Party and a president of HIRA, said that she would share institutional experiences and lessons of HIRA with global communities and support for member countries’ policy to tackle the pandemic and global health crisis.
- Policy
- Issues on e-cigarette·NDMA were raised again
- by Choi sun May 14, 2020 06:25am
- Issues related to medicines that were quiet due to the COVID-19 outbreak were raised again. There are big issues waiting to be investigated, from sampling investigations of Metformin to conducting work on overseas manufacturing plants and publishing results of risk studies of electronic cigarettes. According to the MFDS on the 13th, it recently announced that it has been tested for incorporation of NDMA (N-nitrosodimethylamine), a carcinogen related to Metformin, and will release it soon. #Last year, the MFDS tested the NDMA incorporation by collecting the entire manufacturing lot numbers and the four same ingredients of Nizatidine, which have similar chemical structures, as well as Ranitidine. The MFDS disclosed the test results of 395 items in two weeks after September 14 when the possibility of NDMA impurities of Ranitidine. Metformin, on the other hand, has begun investigations since December last year, but the results have not been released. An official from the Ministry of Food and Drug Administration said, "Metformin may have a different NDMA content depending on the production process’ lot numbers." and he added that the same drug substance also secured a large number of samples for each process and investigated the contents of about 900 samples. " He explained that it took time for a large number of samples and more time to investigate finished products as well as to correct the content variation. He said that the administrative work was paralyzed because of the COVID-19 outbreak, saying that the prosecution had already been completed and that the results would be published soon in the stage of collecting and analyzing the results. The MFDS is planning to calculate the daily allowable dose and the likelihood of carcinogenesis according to the daily dose, based on the results of this survey of Metformin’s NDMA. In March, the MFDS announced that it would convert the current survey of overseas factories into document review due to the global spread of COVID-19. An official from the MFDS said the transition was a temporary measure to ensure that there was no disruption to the domestic medical product approval schedule and supply and demand, and that due diligence in overseas factories, including pharmaceutical production plants in Fukushima, would be restarted after confirming the status of COVID-19. Meanwhile, safety measures for Belviq remain unchanged. In January, the FDA warned of the risk that Belviq would develop cancer, and the MFDS decided to discontinue sales of Belviq in February. The FDA analysis showed that more patients in the Belviq group compared to placebo were diagnosed with cancer in the clinical trials of approximately 12,000 patients for 5 years, but there was a disagreement over statistical significance. This is because primary cancer was diagnosed in 462 (7.7%) out of 5,995 patients receiving Velviq and 423 (7.1%) out of 5,992 patients receiving placebo. Some medical practitioners have judged that the figure is difficult to have statistical significance within the margin of error. Officials from the MFDS said that the suspension and recovery measures were preemptively responded to the unknown cancer controversy rather than the basis for actual judgment. he added that they had obtained and analyzed raw data because it was not possible to verify statistical differences with cancer rates of only 7.7% versus 7.1%. He added that, after reviewing the FDA data, there was no change in the decision and that will remain until further new action, such as the FDA, is taken. On the other hand, the results of the research on the dangers of liquid cigarettes next month are also coming out. The research results on the hazards jointly conducted by seven related ministries, such as the MOHW, have been attracting attention because it can serve as a basis for kicking out liquid electronic cigarettes. The MFDS has been conducting liquid electronic cigarette inhalation and human toxicity studies since June last year by the request of the MOHW. An official from the Ministry of Food and Drug Safety explained that in December last year, we disclosed the results of the investigation of the composition of liquid e-cigarettes. and he also added that the current research is related to the correlation between liquid e-cigarettes and human health. "It took time because the capacity and product container specifications were different between the items and the test method was not established, and the content will be released as early as next month." he said.
- Company
- Ibrance and Verzenio settle pricing for Faslodex combination
- by Eo, Yun-Ho May 14, 2020 06:24am
- At last, Faslodex plus CDK4/6 inhibitor combination therapy would be accessible as an actual treatment option for patients. According to Korean pharmaceutical industry sources, two cyclin-dependent kinases 4/6 (CDK4/6) inhibitors including Pfizer’s Ibrance (palbociclib) and Lilly's Verzenio (abemaciclib) treating patients with HER2-negative breast cancer have successfully settled on drug pricing with National Health Insurance Service (NHIS) as combination therapy with AstraZeneca’s Faslodex (fulvestrant). The listing would be finalized in June, if the Health Insurance Policy Deliberation Committee (HIPDC) would approve of it. Since the first reimbursement expansion, Pfizer took two years and Lilly took a year for the Faslodex combination therapy to get listed. The demand for the combination therapy has been present since the so-called Ibrance incident from 2017. However, Ibrance was freshly listed as a first-line therapy in Nov 2017, and individual listing for Faslodex was not even cleared. In fact, Faslodex has been approved in the Korean market for over a decade. The Korean health authority and the drug maker have struggled to find a middle ground on the cost-effectiveness of the monotherapy. However, the demand on the providing reimbursement on the drug has surged since the Ibrance combination therapy started receiving the public’s interest. Despite the challenges, the first attempt to list the combination therapy has been submitted in 2018. AstraZeneca applied for reimbursement on the Ibrance-plus-Faslodex combination therapy, while Pfizer also requested for reimbursement expansion. As the monotherapy of Faslodex has not been listed, the Korean health authority, however, requested AstraZeneca to withdraw the reimbursement application and rejected Pfizer’s application. Since then, AstraZeneca has decided to accept the pricing below the weighted average of alternative options to list Faslodex’ monotherapy, and successfully listed the drug in April last year via negotiation-exemption track. Pfizer then jumped on and submitted the second application to expand reimbursement for the Faslodex combination therapy, as soon as the drug’s listing was finalized in March. Lilly also submitted the listing application in May last year, immediately after its marketing approval. Verzenio was able to apply for the healthcare reimbursement via the risk sharing agreement (RSA) track as CDK4/6 inhibitor-plus-Faslodex combination therapy as a main indication has not been listed by any other drug.
- Company
- Korean companies to showcase clinical data at ASCO 2020
- by An, Kyung-Jin May 14, 2020 06:24am
- A view of ASCO 2019 from last year in Chicago The American Society of Clinical Oncology Annual Meeting (ASCO) 2020 is coming up in a couple of weeks. The 56th ASCO is one of the biggest pharmaceutical and bio industry events along with JP Morgan Healthcare Conference. Every year, about 40,000 pharmaceutical and bio industry and academic representatives are invited to the conference in Chicago from 76 countries around the world to see the up and coming research trends and technologies. For five days from May 29 to June 2 local time, thousands of new anticancer treatment clinical results are scheduled to be presented, virtually. Affected by the COVID-19 pandemic, the organizer of the event has announced the event would be held online. On May 3, the organization official stated, “Due to the COVID-19 pandemic, all events of ASCO 2020 would be conducted virtually in late May. Putting the safety of oncology researchers and their patients first, the online presentations would be provided according to the announced schedule.” Korean pharmaceutical companies like Yuhan, GC Pharma, Genexin Hanmi Pharmaceutical and Alteogen are planning to unveil data from their novel anticancer treatment in development at ASCO 2020 Virtual Scientific Program. At 5 p.m. local time on May 13, ASCO would publish their selection of research abstracts its website. In the poster presentation session, Yuhan is presenting three sets of clinical data related to a next-generation lung cancer treatment Lazertinib (YH25448). The data is collected from a follow-up study on the phase 1/2 study conducted in Korea, which was presented during the poster session in ASCO 2019. Three Korean healthcare provider participants—Professor Kim Sang-we (Seoul Asan Medical Center), Professor Han Ji-youn (National Cancer Center Korea) and Professor Lee Ki Hyeong (Chungbuk National University Hospital)—are to respectively provide detailed analysis and key findings in efficacy and safety of Lazertinib 240 mg in patients with epidermal growth factor receptor (EGFR) T790 mutation; Lazertinib’s antitumor effect on patients with non-small cell lung cancer (NSCLC) and brain metastases; and Lazertinib’s impact on circulating tumor DNA (ct DNA) in the bloodstream. Yuhan’s third generation EFGR-targeted therapy Lazertinib has been licensed out to Janssen Biotech in 2018. The novel anticancer treatment has been evaluated as a promising first-line treatment in patients with EGFR-mutation positive NSCLC and as a second-line option for EGFR T790-mutated patients with NSCLC. Yuhan has signed the joint development deal potentially worth USD 1.25 billion with Janssen Bitotech for all exclusive rights around the world, except in Korea. The Korean company has received upfront payment of 50 million dollars (approximately 56 billion won) and another 35 million dollars recently as the targeted therapy was a part of an initiated combination therapy clinical study with Janssen’s investigational anticancer treatment 'JNJ-372.' As a poster, GC Pharma is to present phase 1b/2a study outcome on its investigational drug ‘GC1118’ in joint development with Mogam Institute for Biomedical Research. The interim report analyzes outcome of combining GC1118 and other chemotherapies including irinotecan and FOLFIRI for treating patients with metastatic colorectal cancer (mCRC). The company is coming back to ASCO meeting in four years since 2016 to present the newest findings in the drug. GC1118 is a novel monoclonal antibody targeting overexpressed EGFR. By binding with EGFR that triggers proliferation of tumor cell and metastasis, the targeted therapy inhibits proliferating cancer while promoting killing of tumor cells by activating lymphocytes. The Korean company would showcase GC1118’s promising data as a second-line treatment option in EGFR mutation positive patients with metastatic colorectal treatment. Hanmi Pharmaceutical is planning to release various clinical data with a number of license out partners. The company’s U.S. partner Athenex is reportedly preparing for a presentation on phase 2 clinical study on Oraxol, developed based on Hanmi Pharmaceutical’s platform technology, Orascovery. The study has tested the anticancer treatment’s effect and safety in patients with unresectable cutaneous angiosarcoma. In December 2011, Hanmi Pharmaceutical has licensed out novel anticancer medicine candidate Oraxol to the U.S.-based Athenex (then named Kinex). The Korean company combined Orascovery platform technology to turn intravenously injected paclitaxel into an oral form, and enhanced the absorption rate by integrating an oral absorption enhancer, encequidar. The enhancer blocks off p-glycoprotein that inhibits oral absorption of anticancer treatment. With the upcoming ASCO presentation, the U.S. company plans to initiate the commercialization procedure of Oraxol. Last month, Athenex representative reportedly had a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) officials to fine-tune the application submission date. The company plans to expand the market scale in the future by adding more indications in treating metastatic breast cancer, angiosarcoma, gastroesophageal cancer, bladder cancer and NSCLC. Hanmi Pharmaceutical’s another partner, Spectrum Pharmaceutical is anticipated to present a new lung cancer drug Poziotinib, following the presentation at American Association for Cancer Research Annual Meeting (AACR) 2020. Similar to the prior presentation, the company would talk about the first cohort analysis from phase 2 global clinical study, ZENITH20 conducted on EGFR Exon 20 insertion-mutated patients with NSCLC. Poziotinib is a pan-HER2 anticancer therapy licensed out by Hanmi Pharmaceutical in 2015. The partner company, Spectrum now owns the development and commercialization rights over poziotinib in the global market, except for in Korea and China, and it has been seeking for the drug’s various oncologic uses including the treatment in NSCLC. Late last year, the company has gone through a detrimental experience as its stock price dropped by more than 60 percent after announcing it has failed to meet primary phase 2 trial endpoint. Regardless, the company reaffirmed its determination to press on with the pipeline by recently revising the research model. Other Korean biopharmaceutical companies are getting ready to give presentations at the ASCO 2020. Unveiling positive outcome in DNA vaccine 'GX-188E' at AACR 2020, Genexin is planning to present another set of clinical data in a combination therapy at ASCO 2020. The findings are from phase 1b/2 clinical study testing the hyleukin-7 plus immune checkpoint inhibitor Keytruda (pembrolizumab) combination therapy in patients with advanced triple-negative breast cancer (TNBC). Apparently, the TNBC advances faster than other types of breast cancer and shortens patient’s survival period. According to Genexin, the immune checkpoint inhibitor’s treatment rate in relapsed patients was recorded at around 5.2 percent. The company’s poster at ASCO 2020 would list out detailed outcome of enhancing TNBC patient’s treatment rate in different dosage of hyleukin-7 plus pembrolizumab. ASCO 2020 also selected the abstract of a first-in-human clinical study on Alteogen’s breast cancer treating antibody-drug conjugate (ADC) ‘ALT-P7.’ MedPacto is to reveal phase 1 clinical data testing a transforming growth factor beta (TGF-β) inhibitor vactosertib plus leukemia treatment Gleevec. NK Max reported it would publish phase 1/2a clinical study results in ‘SNK01,’ used to enhance anti-tumor effect in targeted therapy.
- Policy
- Exports of the health industry in April rose 20%
- by Lee, Tak-Sun May 14, 2020 06:24am
- As the export of diagnostic reagents and disinfectants increased in the aftermath of COVID-19, the export amount of the health industry increased by more than 20% from the same period last year. The KHIDI (Korea Health Industry Development institute (Director Kwon Deok-cheol) announced monthly health industry export performance. In April, exports of the health industry totaled $ 1.7 billion, an increase of 20.2% compared to the same month last year, followed by $ 640 million in medicines (+ 23.4%), $ 570 million in cosmetics (-0.1%), and $ 490 million in medical devices (+ 50.8%). K- quarantine items such as domestic biopharmaceuticals and diagnostic kits have led the growth of exports in the health industry. In particular, export growth of diagnostic reagents and disinfectants has been high due to the surge in overseas demand following the global expansion of COVID-19. By country, as exports of medical devices (diagnostic kits) increased significantly, Brazil (14th to 7th) and India (13th to 9th) entered the top 10 countries for export. and exports to the United States (2nd place), Japan (3rd place), and Germany (4th place) are expanding. By item, biopharmaceuticals accounted for 48.7% of the total exports of pharmaceutical products, and K-prevention items such as diagnostic reagents ($ 146 million) and disinfectants ($ 44 million). The cumulative export amount of the health industry (Jan 2020~April 2020) was $ 6 billion, an increase of 21.9% from the same period of the previous year, and by industry, cosmetics ($ 2.3 billion, +11.8%), pharmaceuticals ($ 2.3 billion, +38.3%) and medical devices ($ 1.4 billion, +16.8%) were followed. An official from the KHIDI said that the domestic health industry exports remained strong despite COVID-19 continues to exist worldwide, and are recognized as a K-defense model and expect that related products will continue to lead the health industry exports in the future. The KHIDI will analyze the monthly export trend of the health industry starting in May of this year and provide it through the website of the KHIDI and the Health Industry Statistics Portal at the beginning of each month.
- Company
- α-GPC has been prescribed more than twice in 3 years
- by Chon, Seung-Hyun May 14, 2020 06:23am
- Sales of Choline alfoscerate, a brain function improving agent, continue to grow. The effectiveness controversy has recently been raised, but the market size has increased by more than 20% this year. Over the past three years, the market size has doubled, exceeding the quarterly prescription size of ₩100 billion. However, the decline was slightly lower than in the fourth quarter of last year, and the upward trend was somewhat slow. According to UBIST, a drug research agency on the 6th, the outpatient prescription amount of Choline alfoscerate-based drugs in the first quarter was ₩109.9 billion, up 22.2% from the same period last year (₩89.9 billion). Choline alfoscerate is a drug used to improve brain function, such as decreased sense of memory and confusion and reduced concentration. The prescription amount of Choline alfoscerate has been increasing rapidly over the past few years. The total prescription amount in the first quarter of 2015 has more than tripled in 5 years from ₩34.7 billion. it has doubled comparing to the first quarter of 2017, three years ago. Since the prescription amount exceeded ₩100 billion in the third quarter of last year, it has been recording ₩100 billion for the third consecutive quarter. Quarterly outpatient Rx amount for Choline alfoscerate (Unit: ₩1 million, Source: UBIST) Despite the recent controversy over the effectiveness of choline alfoscerate, it continued to rise. 식품의약품안전처는 지난해 11월 제약사들로부터 콜린알포세레이트제제의 유효성 자료를 제출받았다. 허가사항의 효능·효과별 유효성을 입증하는 자료와 국내외 사용현황을 토대로 허가변경 여부를 검토하겠다는 의도다. 복지부도 콜린알포세레이트제제의 급여 타당성을 검토 중이다. The MFDS received data on the effectiveness of Choline alfoscerate formulations from pharmaceutical companies in November last year. The intention is to examine whether or not to change the permit based on data proving the efficacy and effectiveness of the permit, and the status of domestic and foreign use. The MOHW is also considering the feasibility of supplementing Choline alfoscerate. Since last year's government audit questioned the effectiveness of Choline alfoscerate formulations and spending on health insurance finances, it began to verify efficacy. In a state audit, In-Soon Nam, Democratic Party of Korea asked that we should promptly re-evaluate the clinical usefulness and efficacy of the Choline alfoscerate formulation and reasonably re-establish health insurance coverage standards.” Although Choline alfoscerate is not a drug that fundamentally treats dementia, it is analyzed that the market size has expanded rapidly as pharmaceutical companies have focused on the brain functioning market aimed at the rapidly growing elderly. However, compared to the previous quarter, the growth trend is somewhat slow. Prescription results for choline alfoscerate in the first quarter fell 0.2% from the fourth quarter last year. The market for Choline alfoscerate products has declined from the previous quarter for only two years since the fourth quarter of 2017. The industry has analyzed that the market growth has slowed somewhat due to COVID-19 outbreak along with the recent controversy over effectiveness. It is possible that the number of new patients has decreased as patients are reluctant to visit medical institutions, Looking at the prescription amount by item, Daewoong Bio's 'Gliatamin' recorded the highest prescription amount of ₩23.6 billion. It was 4.3% higher than the same period last year. Chong Kun Dang's 'CKD Gliatilin' recorded prescription results of ₩19.6 billion in the first quarter, up 7.9% from the previous year. Both the prescription amounts of Gliatamin and CKD Gliatilin were slightly lower than the previous quarter. Gliatamin's 1st quarter prescription amount decreased 3.2% from the fourth quarter of last year and CKD Gliatilin decreased 1.1% from the previous quarter. Yuhan's Alfoatilin, Korea Prime Pharm’s Gria, and Daewon Pharmaceutical’s Alfocholine were prescribed more than ₩4 billion in the first quarter with a growth rate of more than 15% compared to the previous year.
- Policy
- KAPO demands MFDS to swiftly approve Lutathera
- by Lee, Jeong-Hwan May 13, 2020 05:54am
- A patient group once again urged for a prompt approval review on neuroendocrine tumor treatment Lutathera (lutetium Lu 177 dotatate). The group demanded the Korean government to take action fast for the patients with neuroendocrine tumor in agony with inevitable overseas treatment and burdensome pharmaceutical expense amid COVID-19 pandemic. On May 11, Korea Alliance of Patients Organization (KAPO) held a press conference in front of the Ministry of Food and Drug Safety (MFDS) headquarter office in Osong and insisted the government to urgently take necessary action. KAPO officials explained currently about 100 patients with neuroendocrine tumor in Korea have been traveling to Malaysia to get access to radiopharmaceutical injections containing similar substance as Lutathera from 2018. The organization claimed patients in France and the U.S., where Lutathera is accessible, pay approximately 26 million won per shot, and at least 140 million won for a single cycle with four injections. KAPO also stated MFDS has been neglecting on their duty as the ministry has not expedited the approval procedure on Lutathera, when the drug has been designated as an orphan drug to meet urgent medical needs. The patient organization explained Korea Orphan and Essential Drug Center (KOEDC), specially distributing the drug for emergency purpose for now, has exceptionally requested for insurance reimbursement to Health Insurance Review and Assessment Service (HIRA). Apparently, however, HIRA has been sluggish with the listing review due to the prospective financial burden and concern of multinational pharmaceutical companies abusing the system. Ultimately, they argued, it is up to MFDS to officially approve the marketing of Lutathera in Korea and HIRA to officially review the reimbursement to improve the state the patients are in. KAPO official stressed, “MFDS should approve Lutathera and stop neglecting patients in life-threatening situations and letting them suffer in series of overseas treatment and financial struggle,” and “Novartis should also closely cooperate with the government approval procedure.”
- Opinion
- [Reporter’s view] Yuhan's CEO Lee made a big decision
- by Lee, Seok-Jun May 13, 2020 05:54am
- Jung Hee Lee, Yuhan CEO, is due until March next year. This is due to the company's policy of having two consecutive terms in three years. It will end in March next year. since he started working in March 2015. Most CEOs make their performances within their tenure. This is because 'maximum performance since its founding' can be a 'decoration' for their career. However, CEO Jung Hee Lee does not care about performance. Last year's (0.84%) and the first quarter's (0.35%) operating margin were the lowest, but the technology fee, which is a positive factor in earnings, is divided as conservatively as possible. The recent business report confirms this trend. Yuhan extended the expiry date of LO’s upfront fee for three cases. This is different from the report of the third quarter of last year. LO’s upfront fee for Lazertinib (anti-cancer drugs) exported to Janssen ($30 million) has extended from 2020 to 2021. The upfront fee for non-alcoholic steatohepatitis treatment, (NASH) YH2574 ($38 million), licensed out to Beringer, was extended from 2020 to 2022. the upfront fee for NASH treatment, sold to Gilead was set to be until 2021. Previously, only the principle of split recognition was disclosed, and the end date was not disclosed. In short, Yuhan delayed the completion of unfront fee accounting until 2022. The intention is to secure a fixed profit by dividing the down payment by 2022. This is a big decision for CEO Lee. If all of the LO’s upfront fee were reflected within the term, better results were possible in terms of sales and operating profit. The LO’s upfront fee left by Lee can strengthen the next CEO. This is because fixed profits are the driving force for maintaining R&D continuity without compromising earnings. Yuhan has a tradition of competing for two vice presidents and choosing a president. Either Wook-je Jo, Vice President (Management Division) or Jong-hyun Park, Vice President (Pharmaceutical Business Division) is a strong candidate. For one of them, CEO Lee's management to prepare for the future can be a valuable asset.
- Policy
- Whanin, begins development of first generic for Fycompa
- by Lee, Tak-Sun May 13, 2020 05:54am
- Antiepileptic drug Fycompa by EisaiWhanin, for the first time as a domestic pharmaceutical company, started developing generics for antiepileptic drug Fycompa by Eisai. If the generic development proceeds smoothly, it is expected that it will be aprproved next year as soon as possible. The MFDS approved the bioequivalence test plan for 'Peranel 6mg' submitted by Whanin on the 8th. Peranel is an imaginary item that has not yet been approved, and is the same ingredient as Fycompa. The bioequivalence test is conducted for the purpose of securing equivalence by comparing the absorption rates of Peranel and Fycompa in 56 healthy adults. The test was designed to run through May next year. Anyway, application for permission is possible only in July of next year. This is because Fycompa's PMS will expire on July 9th next year. Generics can be applied for approval only after the PMS period of the original has ended. Since Fycompa's material patent is due to expire on October 13, 2023, it will take three years to get to the market. Whanin filed a decision to confirm the passive scope of the right to evade the crystalline form patent scheduled to expire on October 14, 2026 in February. Since Myungin Pharmaceutical also requested the relevant judgement, it is highly likely to develop generics along with Whanin. Fycompa is a selective non-competitive a new mechanism of epilepsy treatment that antagonizes the AMPA (α-amino-3-hydroxy-5-methylisoxazole-4-propionic acid) receptor, and has been designated as a new drug for six years of reexamination (PMS) by the MFDS. In 2017, it was approved by the US FDA as a monotherapy for patients with epilepsy (epileptic) partial seizures over 12 years of age with or without secondary systemic seizures. Based on UBIST, last year's domestic prescription amount was ₩3.4 billion. It has the advantage of being convenient for epilepsy patients to use, especially once a day.
- Company
- Boryung, acquires domestic sales rights for Lilly's GemZar
- by Kim, Jin-Gu May 13, 2020 05:53am
- GemZarBoryung acquired the domestic right for the anticancer drug 'GemZar (Gemcitabine HCl)' held by Eli Lilly. Boryung announced on the 8th that it had signed a contract to transfer assets to Eli Lilly and Gemzar. Through this agreement, Boryung has all rights, including domestic rights and licenses of Gemzar. Boryung and Eli Lilly have been conducting 'Gemzar' co-promotion since 2015. Gemzar is widely used in pancreatic cancer, non-small cell lung cancer, bladder cancer, breast cancer, ovarian cancer, and biliary tract cancer. It is used alone or in combination therapy in primary and secondary treatment. As of last year, Gemzar's domestic sales totaled ₩14.2 billion (based on IMS). Boryung expects to strengthen its anticancer drug portfolio and maximize its market share and profit margin. Currently, Boryung has a high market share in the domestic anticancer drug market with Oxalitin (Oxaliplatin) and Genexol (Paclitaxel). As of the fourth quarter of last year, among domestic pharmaceutical companies, it ranked No. 1 in the market for anti-tumor drugs and immunomodulators. David A. Ricks, chief executive officer of Eli Lilly said "I hope this contract will help further improve the treatment performance of Korean cancer patients," Jae-Hyun Ahn, Boryung’s CEO, emphasized, "Boryung, which is building the best anti-cancer drug business in Korea, can strengthen the line-up of anti-cancer drugs and make more stable profits with this brand acquisition." He said, "In the future, we will strengthen our portfolio for the anti-cancer area as well as grow it as a representative business of Boryung through active investment such as open innovation."
