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Company
Merck makes large investments in Korea’s science tech
by
Jan 31, 2023 05:59am
With President Suk Yeol Yoon prioritizing fostering talent in science and technology as the government’s key task, one global company has attracted attention for being committed to strengthening domestic talent in science and technology in Korea. According to industry sources on the 31st, Merck Life Sciences, a global life science company, has long been investing in Korea’s science and technology through awards, researchers and academic society support, and talent development programs. Science and technology directly translate to national competitiveness. This is why countries around the world make efforts to further their competitiveness in science and technology. The US Biden administration emphasized that the development of science and technology will become a 'game changer' in the field of healthcare, and the medical and pharmaceutical industry will become indispensable for national security over the next 10 years. The Korean government has also been prioritizing science and technology in all its policies. At a recent meeting with senior secretaries, President Yoon stressed that growth can only be achieved through scientific and technological innovation, saying, "science and technology are important to ensure sustainable growth of the country." President Yoon also emphasized the importance of science and technology in the past, saying, "This is an era where science and technology are directly linked not only to the nation's future but our survival.” Merck Life Science has shown interest in strengthening Korea’s science and technology from early on. It has been supporting the research of Korean scientists for over 20 years and striving to cultivate pharmaceutical and bio talent with leading universities in Korea. This is a rare case where a global company has taken the initiative to invest in the development of science and technology in Korea. ◆Full support to foster talents that will lead the development of science and technology in the future SNUH Bio-day Specifically, the company signed an academic-industry cooperation and exchange agreement with the Jeonbuk National University College of Pharmacy in 2020. Through the program, Merck provided support for scholarships and mentoring, business development to establish a safe laboratory environment, to foster industry leaders and life-respecting pharmaceutical care experts. The company also supported human and material resources necessary for the research and development of new bio drugs. Since 2021, at Sungkyunkwan University’s Institute of Quantum Biophysics, the company has been collaborating with the school, cooperating in the research and development of diagnosis and disease treatments based on quantum biophysical theory and phenomena. For this, the company has been providing seminars and training programs for knowledge and information exchange, as well as scholarship support and internship programs to procure talent in the life sciences sector. Also, the company has provided opportunities for students to experience the industry and provided information on the pharmaceutical and bio industry. Last year, Merck Life Science participated in the ‘SNU Bio-Day’ hosted by Seoul National University’s Bio-MAX Institute and introduced how the technology of the global company Merck is applied in the field to derive scientific results. Also, the company hosted a field trip to Merck Life Science’s Custom Synthesis Lab as part of the Kiuri Project workshop program run by Seoul National University’s Bio-MAX Institute. ◆Has awarded outstanding scientists in Korea for 20 years...promoting active research Also, the company has been supporting the research activities of scientists in Korea in partnership with prestigious academic societies in Korea through awards. The Sigma-Aldrich Chemist Award that Merck Life Science held with the Korean Chemical Society has celebrated its 20th year this year. The award is given every year to 2 chemists with outstanding research achievements and outstanding creativity in the field of chemistry. This traditional award has a long history and has been given even before the merger of Merck and Sigma Aldrich. The award is presented every year at KCA’s regular autumn conference. Merck The ‘350 Future Researcher Award’ was co-established by Merck and the Korean Society for Molecular and Cellular Biology in celebration of Merck’s 350th anniversary in 2018 to continue supporting research for the next-generation bio-industry. Every year, three first authors (research professors) and postdoctoral researchers that performed outstanding research achievements related to molecular cell biology are selected for the award. The award ceremony is held at the Autumn Conference of the Korean Molecular Cell Biology Association, with lectures by the awardees. For objectivity and transparency, candidates are nominated by regular members of KSMCB, and the awardee is selected through a strict review by the Academic Research Award Committee, without any involvement on Merck Life Science’s part. ◆Merck’s science journal issued a special feature on Korea...shed light on domestic science and technology research Korean Scientist Feature of Material Matters, Merck Merck’s interest in Korean science and technology research can also be seen in its scientific journal. Recently, in its global science journal ‘Material Matters,’ Merck issued a special feature on Korean scientists, introducing 4 renowned professors in Korea and their research Material Matters is a scientific journal prepared to provide information on material science and nanotechnology necessary for scientific research. The journal reviews technologies and their applications by world scholars on a specific subject, and is distributed to research institutes around the world. Korea’s special edition of Material Matters featured:▲Seoul National University Professor Yung-Eun Sung’s discussion on ‘PGM and PGM-free Catalysts for Polymer Electrolyte Membrane Fuel Cells’, ▲Korea Advanced Institute of Science and Technology (KAIST) Professor Byeong-Soo Bae’s review of Sol-Gel Derived Siloxane-Encapsulated Luminescent Nanocrystal Composites for Optoelectronics and Display,’ ▲ Yonsei University Professor Woo-Dong Jang’s research on ‘Poly (2-isopropyl-2-oxazoline)-based Multimodal Stimuli-responsive Functional Materials,’ and ▲Yonsei University Professor Wooyoung Shim’s research on ‘Phyllosilicate Clay Minerals: Principles and Applications’
Company
MSD Korea to replace its leader for the first time in 2 yrs
by
Jan 31, 2023 05:59am
Kevin Peters, president of MSD KoreaThe head of MSD Korea will be replaced for the first time in about two years. Kevin Peters, the current president, will leave Korea at the end of this month. According to the pharmaceutical industry on the 28th, Kevin Peters, CEO of MSD Korea, will be appointed as the general representative of the German branch from February. It has been two years and three months since he became the representative of MSD Korea. He recently reportedly had a farewell ceremony with Korean MSD employees. Kevin Peters has led MSD Korea since November 2020, succeeding former president Avi BenShoshan. It is evaluated that he actively communicated with employees even in a situation where he was converted to telecommuting due to COVID-19. After Kevin Peters took office as president, MSD Korea signed its first collective agreement since the establishment of the labor union. This is considered to be a result of mutual cooperation between labor and management ahead of the corporate division of Organon Korea. At the time of the replacement of the president, MSD Korea was at odds with the union in the process of spin-on. Immediately after taking office, Kevin Peters traveled around the country to communicate directly with employees and actively accepted employees' opinions to lead labor-management cooperation. He also succeeded in expanding the primary benefit for Keytruda lung cancer, which had not crossed the threshold for four years. Keytruda had a very good effect in terminal non-small cell lung cancer without major mutations, but discussions on salary have not progressed for four years due to a large number of patients and expensive new drugs. President Kevin Peters drew the primary benefit for lung cancer in Kitruda with an unconventional proposal of a 'trade-off'. Instead of expanding Keytruda's benefit, the plan calls for lowering drug prices for 15 items, including the "Januvia," a diabetes treatment with large domestic sales. At the time, Kevin Peters, president of the company, said in an interview with Dailypharm, "We presented an unprecedented level of sharing to the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service." Since then, the benefit has expanded in March last year as discussions on Keytruda's benefit have accelerated. It also contributed to the rapid approval and supply of Lagevrio, a COVID-19 treatment developed by MSD. Peters also appealed, "Lagevrio can be supplied from the day of approval." Kevin Peters was scheduled to continue his term as president of MSD Korea this year, but the sudden resignation of the German branch representative led to Peters serving as the German general representative. The successor to MSD Korea has not been decided. For the time being, David Peacock, president of MSD Asia-Pacific, is expected to temporarily work on MSD in Korea. Kevin Peters joined MSD in the UK in 1996 and performed various tasks at the relevant national/regional and global levels in the Asia-Pacific, China, and Europe. He served as vice president of MSD in China, chief marketing officer (CMO), and CEO of MSD in Thailand.
Company
HKinno.N exports new drug K-CAB technology to Brazil
by
Chon, Seung-Hyun
Jan 30, 2023 05:54am
K-CABHKinno.N announced on the 26th that it has signed a technology export contract with Brazilian pharmaceutical company Eurofarma for the new drug K-CAB for gastroesophageal reflux disease. HKinno.N will transfer the manufacturing technology of K-CAB to Eurofarma, and Eurofarma will develop and sell K-CAB in Brazil. Along with the down payment, HKinno.N receives technical fees step by step, such as permission and release, and royalties according to sales. The contract period is 10 years after the launch of the product in Brazil. Eurofarma is the third-largest pharmaceutical company in the region with sales power throughout Latin America, mainly in Brazil. Brazil's digestive ulcer solvent market is the largest market in Latin America with an annual amount of about 800 billion won as of 2020. K-CAB announced its entry into the Americas with this Brazilian technology transfer following the US and Canada technology transfer. K-CAB, a Tegoprazan ingredient released in Korea in March 2019, is an anti-allergic drug based on P-CAB). It shows an action mechanism that inhibits gastric acid secretion by competitively combining a proton pump located in the final stage of acid secretion and potassium ions in gastric wall cells. K-CAB has entered a total of 35 countries and has recently been released in the Philippines following China. Twenty-seven countries, including Mexico, have been approved for permission in Mongolia, Indonesia, and Singapore, and are currently reviewing or preparing for permission. Development is underway in three countries, the United States, Canada, and Brazil. Kwak Dal-won, CEO of HKinno.N, said, "Recently, K-CAB's export contracts, follow-up clinical trials, item permits, and local launches are progressing at a rapid pace in the global market, and we will further accelerate our global business with the goal of entering 100 countries by 2028."
Company
SK Bioscience proposes building a vaccine hub in Middle East
by
Jan 30, 2023 05:54am
Jae-Yong Ahn, CEO of SK Bioscience SK Bioscience announced on the 27th that the company’s CEO, Jae-Yong Ahn, participated in the ‘2023 Riyadh Global Medical Biotechnology Summit’ that was held in Riyadh, the capital of the Kingdom of Saudi Arabia, and proposed a partnership for vaccine supply on the 25th (local time). The Riyadh Summit, which celebrated its second event this year, is a national bio event where major bio-industry officials from the US and Europe gather to share future R&D prospects and investment strategies for the bio industry. At the event, CEO Ahn gave a session presentation on the theme, 'Preparing for Next Pandemic through Global Partnership'. During presentations, CEO Ahn shared his company’s experience in successfully developing Korea’s first homegrown COVID-19 vaccine and proposed a partnership that builds on the company’s R&D and manufacturing capabilities. CEO Ahn said, “We can establish a bilateral partnership if the country is willing to provide funds, human resources, and an overall pharmaceutical manufacturing environment based on global initiatives. Then, building on the partnership, the country can stably supply necessary vaccines within the region during Peace Time, which can also switch to a pandemic vaccine production system during Pandemic Time.” He added, “Having already experienced the human casualties, economic loss, and crises in national systems with the COVID-19 pandemic, we all know that this is the time to consider ensuring self-sufficiency of vaccines for national security. The cooperation model we are proposing requires strong will and commitment from each government and can only be achieved when reasonable compensation is provided to participating institutions." SK Bioscience has been pursuing a ‘Glocalization’ business based on its R&D capabilities, global partnerships, and its Ahndong Plant’s manufacturing capacity. The project is expected to contribute to addressing the inequity in access to vaccines in countries that lack technology and infrastructure and further create social and economic values by pioneering new markets for its vaccine. SK Bioscience is currently conducting specific discussions with various countries in the Middle East, and Southeast Asia including Saudi Arabia, and plans to expand the project to other countries and regions in the future.
Company
Practice manual issued for COVID-19 treatments in Korea
by
Jan 30, 2023 05:54am
Doctors have issued a ‘Practice Manual’ to provide an understanding of how to use the COVID-19 treatment in one glance. The manual was prepared to directly address difficulties HCPs experienced prescribing COVID-19 treatments in the field due to a large number of contraindicated drugs. The Korean Society for Antimicrobial Therapy (KSAT) recently distributed a manual for the actual prescription of Paxlovid, Pfizer's oral COVID-19 treatment. The manual was designed to allow easier understanding for HCPs on whether to refrain prescription of Paxlovid or make dosage adjustments according to a patient's medication status. Paxlovid is the first oral COVID-19 treatment that was approved in Korea. The drug was granted Emergency Use Authorization in December 2021 and was indicated for moderate-to-severe COVID-19 patients at high risk of progressing to severe disease. At the time the authorities initiated the supply of Paxlovid, the authorities had also issued treatment prescription guidelines, however, the guidelines issued then were more than 100 pages long and were not easy to use in the field. un-Joo Choo, Professor of Infection, Soonchunhyang University College of Medicine, The Guidelines on Paxlovid use that was recently announced by KSAT is a practice manual that addresses such difficulties experienced in the field. The KSAT collected the main areas of consideration of up to 100 drugs that require attention so that they could be applied to practice right away. The manual summarized the cautions that do not appear in the Drug Utilization Review (DUR) program. The guidelines also contain, a list of over-the-counter drug products that contain ingredients that require special attention. In an interview with Daily Pharm, Eun-Joo Choo, Director of the Insurance Committee at KSAT and Professor of Soonchunhyang University College of Medicine, who contributed to the preparation of the guidelines for Paxlovid, said, “The existing guidelines were too detailed to identify what precautions apply for each patient's medication. We hope that the guideline can contribute to increasing the practical prescription rate of oral COVID-19 treatments that lower disease severity rate,” stressing the importance of prescribing the COVID-19 treatment. The full interview transcript of Daily Pharm’s interview with Professor Choo is as follows. - A Paxlovid prescription guideline that the government issued already exists. Why did KSAT see a need to prepare a separate guideline?? =KSAT’s practice guideline is more of a ‘practical manual' that allows healthcare professionals to understand contraindicated drugs and dose adjustment at a glance in the field during prescriptions. The Paxlovid prescription guidelines issued by the government are over 100 pages long. It contains too much detail for HCPs to immediately absorb and apply in the field. This is why HCPs had difficulty prescribing the drug in the field, being an unfamiliar drug that is difficult to use. Paxlovid KDCA’s guideline categorizes the list of drug-drug interactions as ▲ 7 contraindicated drugs ▲21 drugs that can be temporarily discontinued or substituted to a different drug during Paxlovid use, ▲List of OTC drugs that contain the ‘St. John’s Wort’ substances that are contraindicated, ▲drugs that require use with caution when co-administered, etc. In particular, the drug substances that require caution in the use and key recommendations were summarized in a table format so that they can be applied immediately in practice. -I first thought the contraindicated drugs will be easy to identify as they immediately show up in the DUR database, but it seems that I was wrong. In particular, it seems that it would have been difficult to identify all the products that contain St. John’s Wort, as the substance is commonly used in OTC drugs and health functional foods. =That’s right. Only the 7 contraindicated drugs that must not be prescribed together pop up on the DUR, which includes epilepsy substances such as St. John's Wort. Substances commonly used by patients for hyperlipidemia, heart failure, gout, etc., that can be temporarily discontinued or substituted to administer Paxlovid, but such information is not reflected in the DUR. In addition, there are about 100 drugs that require attention, such as dose reductions, etc. It's not easy for doctors to know all this during prescriptions. In particular, the St. John's Wort substance is contraindicated, regardless of whether it is a prescription drug, general OTC drug, or health functional food. Since doctors need to check directly with the patient on whether or not they use the substance, a list of the OTC drugs was prepared that specifies the product and company names. The self-checklist also asks patients once more to confirm whether they are taking OTCs or health functional foods. Fortunately, St. John's Wort is mainly used in women, but the rate of those taking it at the age of over 60 is not that high. Patient self survey to identify patient -The prescription rate of oral COVID-19 treatments has remained in the 30% range for several weeks. What do you believe is the reason behind this? = During our webinar, one of the most common concerns that the doctors had was ‘Whether they should use COVID-19 treatments in mild COVID-19 patients with few symptoms.’ Being a drug that the doctor hasn’t used before, in addition to the fact that the drug has many drug-drug interactions, and the treatments for COVID-19 are mainly conducted non-face-to-face, it is natural that doctors may be hesitant in using such unfamiliar drugs. The part I want to emphasize is that oral COVID-19 treatments prevent patients with mild symptoms from progressing to severe diseases. Patients may have minor symptoms at first, but if they do not take the right medicine at the right period, their disease can progress to severe disease, in particular in patients that are over the age of 60 or have underlying diseases. In fact, quite a lot of inpatients who had COVID-19 were sent to the intensive care unit when there were no available vaccines or treatments. However, this number decreased significantly after the introduction of COVID-19 vaccines and oral treatments. Real-world data also showed that the rate of progressing to severe disease was reduced by about 50% with the prescription of Paxlovid. I believe prescriptions will naturally increase after such data on Paxlovid’s actual effect and HCP prescriptions increase and accumulate. -The majority of Korean people have been vaccinated several times. Also, with so many having a history of COVID-19 infections, not many are concerned about reinfections. Do you believe these people also should receive vaccinations with booster shots? If they are high-risk groups, would they need to be prescribed oral COVID-19 treatments when reinfected? If you look at the government’s reinfection rate data, the age-standardized risk of death in case of reinfection is 1.58 times higher than that at initial infection. Just as people receive vaccination for the flu every year and then use Tamiflu when infected, COVID-19 also requires regular vaccination and treatment. In fact, COVID-19 requires more caution as it has a higher rate of complications and disease progression than the flu. Patients who have pneumonia due to COVID-19 suffer complications such as difficulty in breathing due to pulmonary fibrosis even after completing treatment. Some people describe COVID-19 as a 'highly contagious cold', but I do not agree, as no one dies of a simple cold. Also, the experience of the patient that receives the treatment is as important as the HCP that prescribes Paxlovid. There is little positive feedback yet because not many patients have experienced the treatment. However, the treatment has been proven to be effective, and in particular, it is more beneficial for patients that opt for at-home treatments. Because of the definite benefits, I hope that patients do not worry too much and take their prescribed oral COVID-19 treatment as indicated.
Company
HK inno.N introduces biosimilar for Prolia & Xgeva
by
Lee, Seok-Jun
Jan 27, 2023 05:51am
HK inno.N announced on the 25th that it has signed an exclusive license contract for Denosumab biosimilar, a treatment for preventing osteoporosis and cancer-related skeletal complications in Mabxience, Spain. HK inno.N will receive an exclusive supply of two Denosumab biosimilars from Mabxience to apply for and sell domestic licenses. Denosumab is an antibody treatment that targets the RANKL protein, which is key to the survival and function of osteoblasts and exhibits a strong bone absorption inhibitory effect. The original is Prolia60mg, a cancer osteoporosis treatment, and Xgeva 120mg, which is used to prevent skeletal complications in patients with metastatic cancer and treat osteoporosis. Both products were released in Korea in 2016. Based on IQVIA, it recorded a total of 120 billion won in sales from October 2021 to September 2022 and is about to expire in 2025. HK inno.N aims to obtain a domestic license for Denosumab biosimilar in 2025, the expiration date of the original patent. Mabxience, which signed a contract with HK Innoen, was acquired by Fresenius Kabi in Germany last year as a company specializing in the development, production, and commercialization of biopharmaceuticals based in Spain. Mabxience is currently undergoing an original equivalence confirmation clinical trial with a Denosumab biosimilar.
Company
Flu activity rises...revives Tamiflu market
by
Jan 27, 2023 05:51am
The influenza treatment market, which had virtually disappeared after the spread of COVID-19, has revived for the first time in 3 years. With the number of flu patients surging due to the flu epidemic, the number of quarterly prescriptions soared from less than KRW 100 million to KRW 10 billion. According to the market research institution UBIST on the 26th, outpatient prescriptions of oseltamivir in A4 last year had recorded KRW 10 billion. Oseltamivir is the most commonly used substance to treat influenza, and the original product is Roche's 'Tamiflu'. This is the first time since Q4 2018 that quarterly prescriptions of the substance recorded KRW 10 billion. By product, Roche Korea’s ‘Tamiflu’ occupied over half of the market, recording KRW 6 billion in sales. Hanmi Pharmaceutical’s ‘Hanmiflu’ followed, raising KRW 1.7 billion in sales. The flu treatment market had been dissolved after the spread of COVID-19 in 2020. With the breakout of the pandemic, personal hygiene management such as social distancing, the mandatory wearing of masks, and hand washing have been strengthened, resulting in a significant decrease in the incidence of infectious diseases, including the flu. The market, which raised prescriptions of KRW 7.8 billion in Q4 2019 and KRW 8.7 billion in Q1 2020, plunged 99.7% YoY to KRW 27 million in Q4 of 2020 after Corona 19 became prevalent. Since then, the market recorded less than KRW 100 million won in quarterly prescriptions for 9 consecutive quarters and then showed signs of a rebound in Q3 last year. The first flu epidemic warning in 12 years since 2010 was issued in Q3 last year. The Korea Disease Control and Prevention Agency issued a flu epidemic warning earlier than in previous years with the fraction of flu-like patients (patients with suspected flu symptoms) meeting the epidemic standards of 5.1 per 1,000 people from September 4 to 10 last year. Data: KDCA Weekly Report on Infectious Disease Sample Surveillance The number of flu patients really started to surge rapidly in the winter. The fraction of suspected patients, which was 13.2 in the 46th week of last year (November 6-12), increased by 130% to 30.3 a month later. In the 53rd week, the last week of last year, the fraction peaked to 60.7. This was a higher rate than that in the 2019-2020 season. Due to the surge in the number of patients and the limited quantity of treatments, a treatment shortage issue had also risen last year. In addition to the original oseltamivir, many generic versions have been approved for manufacture, but their manufacture was limited. Even before COVID-19, the majority of drugs other than Hanmi Pharmaceutical’s ‘Hanmiflu’, Yuhan Corp’s ‘Yuhan N Flu’, Kolon Pharmaceutical’s ‘Comyflu,’ and Vivozon Pharm’s ‘Seltaflu Flu,’ etc sold less than KRW 100 million per quarter. Also, many products withdrew their licenses in the aftermath of COVID-19. According to the Ministry of Food and Drug Safety, licenses of ▲Dong-A ST’s ‘Newraflu,’ ▲Ahngook New Pharm’s ‘New Flu,’ ▲Dongkoo Bio Pharm’s ‘Dongkoo Oseltamivir,’ ▲Samsung Pharm’s ‘Samsung Oselta,’ ▲Dae Han New Pharm’s ‘Enphiflu Cap,’ ▲Seoul Pharma’s ‘ OD Flu,’ ▲Yuyu Pharm’s ‘Yuyu Tami,’ ▲Inist ST’s ‘Inist ST Oseltamivir,’ ▲CTC Bio’s ‘Easy Flu Cap,’ ▲Genu Pharma’s ‘Genupharma Tamiro,’ ▲Kolon Pharmaceutical’s ‘Comiflu Suspension Powder,’ ▲GC Corp’s ‘Taminewra,’ ▲Hawon Pharm’s ‘Tami-One,’ ▲Roche Korea’s ‘Tamiflu Suspension Powder,’ ▲Aprogen Biologics ‘Tamflu,’ ▲Kwang-dong Pharm’s ‘Phenflu,’ ▲HK Inno,N’s ‘Flucle Cap,’ ▲Han Lim Pharm’s ‘Hanlim Oseltamivir,’ ▲ Hanmi Pharmaceutical’s ‘Hanmi Flu-S’ had automatically expired or voluntarily withdrawn during the COVID-19 pandemic. With many of the approved drugs not in circulation in the market, a shortage of flu treatments had risen last month. To address the shortage, the KDCA supplied 780,000 courses of flu treatments from the government stockpile to the market on the 9th. With the flu epidemic subsiding this year, the number of prescriptions is also expected to decrease slightly. According to KDCA, the fraction of suspected patients in the second week of January (8th to 14th) was 40.2, a 12.3 (23.4%) person decrease from 52.5 in the previous week.
Company
Will the 3 asthma biodrugs finally be reimbursed this year?
by
Eo, Yun-Ho
Jan 27, 2023 05:50am
Whether the 3 new biologics for asthma will be listed for insurance reimbursement in Korea is receiving attention. According to industry sources, treatments for severe asthma including GSK Korea’s Nucala (mepolizumab), Teva-Handok’s Cinqair (reslizumab), and AstraZeneca Korea’s Fasenra (benralizumab) are undergoing processes for reimbursement in Korea. As interleukin-5 antagonists, the drugs reduce levels of blood eosinophils, a type of white blood cell that is involved in the development of asthma exacerbation. At the time of their approval, the drugs received attention for being an effective treatment option that had not been available before. All 3 drugs have been approved for over 3 years in Korea. However, no other drug has been reimbursed since the reimbursement approval of Novartis Korea’s ‘Xolair (omalizumab)’ in 2020. At the time, the companies had foregone the listing process as they deemed it would be difficult to narrow the differences in opinion on setting the drug price with the government. However, at the end of last year, GSK, Teva-Handok, and AstraZeneca started discussing reimbursement listing again at about the same time. However, it remains to be seen whether the pharmaceutical companies will be able to derive positive results from cost-effectiveness discussions with the Health Insurance Review and Assessment Service under different their different situations. One of the main purposes of asthma management is to reduce the risk of asthma exacerbations Nucala, Cinqair, and Fasenra directly bind to the alpha subunit of the interleukin-5 receptor (IL-5Rα) to induce apoptosis. The drugs demonstrated efficacy in reducing asthma exacerbation and improving lung function.
Company
JAKi Cibinqo attempts reimb in both adolescents and adults
by
Eo, Yun-Ho
Jan 26, 2023 06:06am
Pfizer is attempting to receive approval to reimburse its JAK inhibitor ‘Cibinqo’ in atopic dermatitis (AD) for both adults and adolescents in Korea. According to industry sources, Pfizer Korea resubmitted an application for the reimbursement approval of its new janus kinases (JAK) inhibitor ‘Cibinqo (abrocitinib)’ at the end of last year. After the drug passed the review of the National Health Insurance Review and Assessment Service’s Drug Reimbursement Standard Subcommittee in August last year, no news had been heard of its deliberation by the Drug Reimbursement Evaluation Committee. This time, the company is attempting to receive reimbursement approval for the drug in adolescents aged 12 years or older as well as adults that the company had previously applied for. As a latecomer, Pfizer is seemingly attempting to receive reimbursement for its combined indication as its competitors, Lilly Korea’s ‘Olumiant (baricitinib),’ ‘Abbvie’s ‘Rinvoq (upadacitinib),’ has already been receiving reimbursement for the atopic dermatitis indication since May and Rinvoq is also attempting to extend its reimbursement to adolescents. As a result, competition among JAK inhibitors is expected to widen from the adult atopic dermatitis market to the adolescent market as well. Sanofi-Aventis Korea’s ‘Dupixent (dupilumab),’ which is of a different class, has also been receiving attention after its pediatric-adolescent AD indication passed DREC review. Cibinqo demonstrated its efficacy through the Phase III trials JADE MONO-1, MONO-2, COMPARE, etc. The drug reduced the Eczema Area and Severity Index (EASI) by over 70% at Week 12 and demonstrated improvement in itch relief 2 weeks after initiating treatment. Its pivotal study, JADE Mono-1, was designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of Cibinqo monotherapy vs placebo in randomly assigned patients 12 years of age and older with moderate-to-severe AD for 12 weeks. Results showed that 63% of the Cibinqo 200 mg administered group had achieved EASI-75 (improvement of at least 75% in lesion extent and severity) at week 12, which was a significant improvement compared to the 12% in the placebo group. Also, the rate of patients that achieved EASI-90 at week 12 had been 39% in the Cibinqo group, 5% higher than that in the placebo group.
Company
54 billion won ⟵ 3.7 billion won in four years
by
Kim, Jin-Gu
Jan 26, 2023 06:06am
In the high blood pressure and hyperlipidemia complex market, the pace of generational replacement between the second and third complexes is accelerating. The size of outpatient prescriptions for the third-party complex of the ARB+CCB+statin combination has tripled in the past three years, expanding to the market of more than 50 billion won a year. The ARB+statin combination's second-generation complex market has been on the decline since its peak in 2021. In the case of last year, the market size fell below 90 billion won, down 7% year-on-year. ◆ Three-drug complex last year's prescription amount was 54 billion won, 3.4 times in three years According to UBIST, a pharmaceutical market research institute on the 25th, the outpatient prescription amount of the three-drug combination of hypertension and hyperlipidemia last year was 54 billion won. This market has exploded recently. The market size expanded from 3.7 billion won in 2018 to 15.7 billion won in 2019, 34.9 billion won in 2020, and 50.8 billion won in 2021. In other words, the size of the market has expanded 3.4 times in the past three years. The market was formed in October 2017 when Hanmi Pharmaceutical launched "AmosartanQ" in a combination of Amlodipine + Losartan + Rosuvastatin. The following year, Ildong Pharmaceutical, Jeil Pharmaceutical, Daewon Pharmaceutical, Celltrion Pharmaceutical, and Samjin Pharmaceutical introduced the third-generation complex to the market. In 2019, Yuhan, Hana, Daewoong, Ahngook Pharmaceutical, and HK inno.N launched their products, and in 2020, Boryeong, Myungmoon, Kyungdong Pharmaceutical, and Unimmed Pharmaceutical launched their products. Most of them are products that have improved their second-order composite. The market leader is Boryung Dukaro. Dukaro made a soft landing in the market with a prescription performance of 6.4 billion won in the first year of its launch in 2020. In 2021, it doubled to 12.7 billion won. At the same time, it surpassed Hanmi Pharmaceutical's AmosartanQ, which is the No. 1 product in the existing market, and took the lead in the market. Last year, prescription performance increased further to 14.1 billion won. Hanmi Pharmaceutical's "AmosartanQ" steadily increased to 2.7 billion won in 2018, 6.8 billion won in 2019, 10.5 billion won in 2020, and 11.4 billion won in 2021. Still, its growth seems to have slowed to 11.3 billion won last year. In addition, Daewoong Pharmaceutical's Ollomax (8.7 billion won), Ildong Pharmaceutical's Telostop Plus (4 billion won), Yuhan Duowell A (2.8 billion won), and HKinno.N Exone-R (2.8 billion won) produced more than 2 billion won last year. Since the success of the third-party complex, competition for the fourth-party complex is also in full swing. Likewise, Hanmi Pharmaceutical first pioneered the market and other companies entered the competition with drugs from the same combination of ingredients. Hanmi Pharmaceutical was approved for Amozaltan XQ in November 2020. The prescription amount of Amozaltan XQ increased 2.7 times from 2.3 billion won in 2021 to 6.4 billion won last year. Following Hanmi Pharmaceutical's Amozaltan XQ, Yuhan Duowell A Plus, GC Pharma Rozetelpine, Jeil Pharmaceutical's Telmican-Q, and Chong Kun Dang Nuvorozet were approved one after another. The pharmaceutical industry predicts that competition for the fourth-generation complex will take place in earnest this year. ◆2nd Compound Market Decreases to Less than 90 Billion won As the 3rd and 4th composite markets grow explosively, the pace of generational replacement with the existing 2nd composite is also accelerating. Last year, the market size of the ARB+Statin combination's second-generation complex was 89.6 billion won, down 7% from 2021. The second complex market has steadily expanded to 86.9 billion won in 2018, 90.4 billion won in 2019, 94.5 billion won in 2020, and 96.5 billion won in 2021, but it has been reduced for the first time last year. Most of the major products are also on the decline. Yuhan Duowell's prescription amount increased to 20 billion won in 2018 but has steadily decreased since then. Last year, prescriptions fell to 16.5 billion won. Hanmi Pharmaceutical's Rovelito also peaked at 22.7 billion won in 2018 and steadily decreased to 15 billion won last year. JW Pharmaceutical's Livaro V, LG Chem's Rovatitan, and Ildong Telostop also saw their prescriptions fall more than 10% year-on-year last year. The prescription performance of Akarb and Tuvero in Boryung increased. Akarb recorded a prescription amount of 7.4 billion won last year. It increased by 14% compared to 6.5 billion won in 2020. Tuvero, which combines fimasartan with Rosuvastatin, increased slightly from 6.4 billion won to 6.5 billion won.
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