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- 2026-05-07 16:19:11
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- Clotinab, exclusive in the bio-anti-hemolysis market
- by Nho, Byung Chul Feb 01, 2023 05:54am
- In the anti-hemorrhagic biopharmaceutical market, Korean biosimilar Clotinab is dominating the market. According to data on drug distribution performance, ISU ABXIS Clotinab's 2021 performance was 2.8 billion won, dominating the Abciximab biosimilar market. The sales of the product in 2018, 2019, and 2020 are 3,048 million won, 2,920 million won, and 2.94 billion won, and the cumulative performance of 3Q in 2022 is about 1,88 billion won. Clotinab's dominance is attributed to the withdrawal of the original biopharmaceutical Lilly Reopro from the market. Clotinab, the first antibody biosimilar title in Korea, challenged Reopro, which boasts 400 billion won in global sales in 2007. In the early days of its launch, it recorded around 400 million won in performance, but gradually expanded its scope by passing the so-called "Big 5" hospitals DC such as Seoul National University Hospital, Asan Hospital, Severance Hospital, St. Mary's Hospital, and Samsung Seoul Hospital. It is understood that the decisive cause of crossing the barrier to entry into the original drug lies in securing drug equivalence with relatively low drug prices. The drug price of Clotinab 2.5ml·5ml is listed at 315,084 won and 378,102 won, while Reopro's insurance price was 472,627 won, about 100,000 won higher. Reopro was completely withdrawn from the domestic market in 2017, with the appearance of around 10 million won. This drug is used as an auxiliary treatment for Heparin and Aspirin to prevent ischemic heart complications in high-risk patients during PTCA procedures. As a medication guide be careful of antithrombotic drugs, bleeding can be suspected if symptoms such as brown urine, dizziness, and headache appear during administration. In addition, patients who are about to undergo procedures and surgeries that are expected to bleed should stop administering drugs for a certain period of time because they may have difficulty stopping bleeding.
- Company
- Imfinzi expands biliary cancer indication
- by Feb 01, 2023 05:54am
- AstraZeneca Korea held a press conference on the 31st to commemorate the approval of its immuno-cancer drug Impinzi"Although there are few clinical patients, effectiveness improvement and safety performance" A new option for immuno-cancer drugs has been born in biliary tract cancer, where chemotherapy has long been the standard treatment. The medical staff said, "We improved the treatment of biliary tract cancer, which has not progressed for more than 10 years." Imfinzi's biliary tract cancer indication is the first immuno-cancer drug. In particular, it is significant in that the beginning of the clinical trial of researchers, which became the basis for permission for biliary tract cancer indications, is Korea. The study could begin after Oh Do-yeon, a professor of oncology at Seoul National University Hospital, actively persuaded pharmaceutical companies. Biliary tract cancer is a rare and aggressive gastrointestinal cancer consisting of cancer cells from the bile duct, gallbladder, or papilla. Early biliary tract cancer has no clear symptoms, and it is not well established who has a high risk of biliary tract cancer. Early diagnosis is difficult due to the lack of effective screening programs. When diagnosed with biliary tract cancer, most of them have limited treatment options and poor prognoses. Biliary tract cancer does not have a high prevalence like lung cancer or stomach cancer, and the incidence is lower in the West, so there have been relatively few new drug studies. There have been attempts to combine some targeted anticancer drugs, but clinical trials have repeatedly failed. This is why Gemcitabine + Cisplatin, chemotherapy, has still existed as a standard therapy for more than a decade. Professor Oh found out that immuno-cancer drugs responded relatively high in biliary tract cancer about 10 years ago, and persuaded AstraZeneca to conduct a researcher clinical trial. The possibility was confirmed here, leading to the third phase of the global market. Professor Oh designed the clinical design after a long discussion as a PI. The TOPAZ-1 study results were successful. The Impinzi group improved the overall survival rate (OS) by 20% compared to the placebo group (placebo+ Gemcitabine + Cisplatin). At the time of 2 years, the OS of the Impinzi group was 25%, which was more than twice that of the placebo group. mPFS was 7.2 months in the Impinzi group, an improvement of 25% compared to 5.7 months in the placebo group. In terms of safety, the safety profile was similar to that of the placebo group. Professor Oh, who attended the meeting, said, "I was very happy to see the safety profile as well as the effectiveness of phase 3 clinical results." "Even though we added Impinzi, the adverse reaction was similar to that of the placebo group," he said. "The rate of discontinuing treatment with drugs was rather less than that of the placebo group." The U.S. Food and Drug Administration (FDA) approved Imfinzi biliary tract cancer indications based on Professor Oh's clinical and TOPAZ-1 results. Furthermore, NCCN recommended Impinzi as the standard treatment (Category 1) in the primary treatment of progressive and metastatic biliary tract cancer. For the first time, immuno-cancer drugs were listed as the first standard treatment option, which had only chemotherapy. It is a very unusual case that the clinical trial of researchers initiated by Korean medical staff led to global approval and standard treatment. Professor Oh said, "The TOPAZ-1 clinical trial is drawing attention in that it has proven improved results in efficacy and safety despite the relatively small number of participating patients at 685, and its interest has been confirmed at a recent academic conference."
- Company
- Sales of statin-ezetimibe combo rise threefold in 3 yrs
- by Chon, Seung-Hyun Feb 01, 2023 05:54am
- Statin-ezetimibe combination drugs greatly expanded their influence in Korea’s dyslipidemia treatment market. Their total prescription amount increased by over threefold in the past 5 years, and its annual market size exceeds KRW 750 billion. In the market, rosuvastatin-ezetimibe combinations drove market growth, and the bulk of generic atorvastatin-ezetimibe combination drugs that were recently released also supported the strong growth. ◆Sales of statin-ezetimibe combos rise from KRW 228.4 billion to KRW 750.4 billion in 5 yrs According to the market research institution UBIST on the 31st, outpatient prescriptions of statin-ezetimibe combination drugs reached KRW 750.4 billion last year, recording a 23.0% YoY increase. Its market size had increased 51.5% in two years from KRW 495.3 billion in 2020. The prescription market for statin-ezetimibe combination drugs had recorded KRW 228.4 billion in 2017 and then expanded over threefold in just 5 years. This analysis is that the increased preference for statin-ezetimibe combinations due to its excellent effect in lowering LDL-C and cost, which is not greater than taking the two drugs separately, has attributed to market growth. Currently, four types of statin-ezetimibe combinations that combine four types of statin - simvastatin, rosuvastatin, atorvastatin, and pitavastatin - with ezetimibe have been introduced to the market. ◆Rosuvastatin·ezetimibe combo occupies 65% of market...atorvastatin·ezetimibe combo expands market In the statin-ezetimibe combination market, rosuvastatin·ezetimibe combinations occupy the greatest share of the market. Last year, rosuvastatin·ezetimibe combination drugs raised KRW 488.5 billion last year, recording a 12.0% YoY increase. This is a 33.1% increase in 2 years from KRW 367.1 billion in 2020. Compared to the KRW 136.6 billion the combination had made in 2017, its market size has increased 257.8% in 5 years. Last year, the rosuvastatin·ezetimibe combination occupied 65.1% of the statin-ezetimibe combination market. Hanmi Pharmaceutical’s Rosuzet was the first product to enter the rosuvastatin·ezetimibe combination market. Hanmi Pharmaceutical entered the market earlier than its competitors by securing the right to use ezetimibe from its patent holder, MSD. Prescription sales of Rosuzet last year recorded KRW 123.2 billion, a 17.4 increase YoY. Among all combinations, the product made the second-most sales for two consecutive years, led only by Lipitor. Rosuzet’s prescriptions rose over threefold in 5 years from KRW 41.5 billion in 2017. Since 2020, sales exceeded KRW 100 billion for 3 consecutive years and showed off its status as the flagship statin-ezetimibe combination drug product. Yuhan Corp’s Rosuvamibe had shown prominence in the rosuvastatin-ezetimibe combination market. Rosuvamibe’s sales recorded KRW 66.8 billion last year, showing a 7.7% YoY increase. Rosuvamibe’s sales rose over twofold in 5 years from the KRW 23.7 billion it had made in 2017. Recently, atorvastatin·ezetimibe combination drugs have shown explosive growth in the market. Prescription of atorvastatin·ezetimibe combination drugs had recorded KRW 197.5 billion last year, which is a 53.4% YoY increase. Also, its market size expanded over fourfold in only 5 years from the KRW 44.2 billion it had made in 2017. The bulk of Atozet generics that entered the market rapidly expanded the market in a short period of time. Until 2020, the only atorvastatin-ezetimibe combination drug available was Organon Korea's Atozet. Then, the market size started to increase with around 100 companies in Korea simultaneously entering the atorvastatin-ezetimibe combination market with their generic versions in 2021. In October 2020, Chong Kun Dang received approval for ‘Lipilouzet’, a combination drug that contains the same ingredients as Atozet. During the same period, 22 companies received approval for their authorized generics of Lipilouzet and were listed for reimbursement from April 2021. Then, 88 more pharmaceutical companies received approvals for their Atozet generics from February 2021 and were reimbursed in May, one month after the reimbursement listing of authorized generics of Lipilouzet. In June 2021, 2 more companies have additionally received approval for their Atozet generics, raising the count of Korean companies that entered the Atozet market to 113. The atorvastatin-ezetimibe combination market had recorded KRW 82.8 billion in 2020 with only Atozet in the market, then grew 138.6% in 2 years after a load of generic drugs entered the market. Atorvastatin-ezetimibe combinations, which had only occupied 19.3% of the total statin-ezetimibe combination market in 2017, rose to 26.3% last year. On the other hand, sales of simvastatin-ezetimibe combinations have somewhat slowed down. Prescription sales of simvastatin-ezetimibe combinations had recorded KRW 35.9 billion last year, which is a 16.6% YoY decrease. Its sales fell for two consecutive years after recording KRW 45.4 billion in 2020. Prescription of simvastatin-ezetimibe combinations last year had decreased 21.0% compared with 2 years ago. Organon Korea’s Vytorin was the original drug to entered the simvastatin-ezetimibe combination market. However, the prescription market gradually shrunk compared to other combinations. In the statin-ezetimibe combination market, the share of the simvastatin-ezetimibe combination had shrunk to 4.8% last year from the 20.9% in 2017. In 2021, JW Pharmaceutical's first pitavastatin and ezetimibe combination, Livalozet, has recently shown good momentum. Pitavastatin is the main active pharmaceutical ingredient used in JW Pharmaceutical's flagship hyperlipidemia treatment, Livalo. Livaloaet was released in October 2021, and the drug made a successful debut raising prescriptions to KRW 28.5 billion last year in the first year of its release.
- 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.
