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- 2026-03-16 18:59:42
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- Bukwang applies for approval of Lurasidone
- by Nov 01, 2022 06:02am
- Bukwang Pharmaceutical announced on the 31st that it has applied for an item permit for Lurasidone, a new drug for treating schizophrenia and bipolar depression, from the Ministry of Food and Drug Safety. Lurasidone is a treatment for depression with schizophrenia and bipolar disorder developed by Sumitomo Pharma, Japan. Bukwang Pharmaceutical has exclusive development rights and copyrights in Korea. Bukwang Pharmaceutical recently announced that Lurasidone proved non-differential compared to the existing schizophrenia treatment "Quetiapine" in the top-line results of phase 3 clinical trials for schizophrenia patients. Lurasidone has lower metabolic adverse reactions such as weight gain, prolactin gain, dyslipidemia, and hyperglycemia than conventional atypical antipsychotics, improving patients' social life and quality of life. Lurasidone can also be used as a treatment for bipolar disorder depression, where drug selection is very limited. Lurasidone is an antagonist that blocks dopamine D2, serotonin 5-HT2A, and 5-HT7 receptors, which also partially act on serotonin 5-HT1A receptors and show little affinity for histamine H1 and muscarinic M1 receptors. According to Bukwang Pharmaceutical, Lurasidone has been approved as a treatment for schizophrenia and bipolar depression in more than 45 countries, including the United States and the European Union. The largest sales in the North American market reached about 2.6 trillion won. Bukwang Pharmaceutical said, "Lurasidone is expected to improve the quality of life of patients with proven treatment effects and safety for depression with schizophrenia and bipolar disorder."
- Company
- MET-targeted anticancer drug Tabrecta reattempts reimb
- by Eo, Yun-Ho Oct 31, 2022 06:06am
- Once again, the MET-targeted anticancer drug Tabrecta is attempting to receive insurance reimbursement in Korea. According to industry sources, Novartis Korea has recently started the reimbursement process for Tabrecta (capmatinib in Korea. As the agenda was unable to pass deliberation by the Health Insurance Review and Assessment Service’s Cancer Disease Drug Committee deliberations in August, whether the company will succeed in its second attempt for reimbursement remains to be seen. MET mutation is a rare type of cancer that is present in approximately 3-4% of patients with non small-cell lung cancer (NSCLC). No treatment option had been available in the type until now. Tabrecta targets c-MET and was first approved as a treatment for MET exon 14 skipping mutation in NSCLC in May 2020. The drug’s efficacy was confirmed through the GEOMETRY mono-1 trial in 97 patients with METex14. In the pivotal GEOMETRY mono-1 trial, Tabrecta demonstrated a 68% objective response rate (ORR) and 41% ORR in treatment-naïve and previously treated patients, respectively. The duration of response (DoR) was 12.6 months and 9.7 months, respectively. Meanwhile, Novartis is also actively studying the combined use of Tabrecta respective drugs with other therapies. In particular, the combined use is expected to be able to address the issue of resistance that patients acquire after treatment with EGFR inhibitors. As such, combined use of Tabrecta with AstraZeneca’s 3rd generation EGFR TKI Tagrisso (osimerbinib) is also underway. More specifically, the study will evaluate the treatment effect of Tabrecta+Tagrisso in comparison to platinum- based chemotherapy in NSCLC patients with epidermal growth factor receptor (EGFR) mutation, T790M negative, MET-amplified who progressed following treatment with 1st/2nd generation EGFR tyrosine kinase inhibitors (TKIs) or Tagrisso.
- Company
- Samsung Biologics surpassed ₩2 trillion in sales
- by Kim, Jin-Gu Oct 31, 2022 06:06am
- Samsung BioLogics surpassed 2 trillion won in cumulative sales in the third quarter. It exceeded 1.568 trillion won in annual sales last year in three quarters. On the 26th, Samsung BioLogics announced that it achieved 873 billion won in sales and 324.7 billion won in operating profit in the third quarter. Both sales and operating profit rose 94% year-on-year. Cumulative sales are 2.358 trillion won on a consolidated basis. It is the first time since its foundation that Samsung BioLogics has surpassed 2 trillion won in sales. ◆ Samsung BioLogics exceeded sales last year in three quarters Samsung BioLogics explained that it recorded cumulative sales of 1.6896 trillion won and an operating profit of 659.5 billion won in the third quarter, exceeding its annual performance last year (sales of 1.568 trillion won and operating profit of 536.5 billion won). Samsung BioLogics incorporated Samsung Bioepis as a 100% subsidiary in April this year. Samsung BioLogics explained that this results from increased sales of raw material drug CMO (consignment production) and increased profits of CDO (consignment development). On top of that, it added that the rise in the exchange rate led to improved performance. Samsung BioLogics plans to strengthen its business by operating its fourth plant in earnest and expanding orders for CDMO. Samsung BioLogics' fourth plant has the world's largest production capacity with a total of 240,000 liters. It started partial operation this month and will be in full operation next year. When the fourth plant is operated next year, Samsung BioLogics' production capacity will be expanded to 604,000 liters. It is the largest in the global CDMO industry. In the CDO business sector, it has expanded its portfolio by launching a new dual antibody platform called 'S-dual'. The cumulative number of orders is 73 for CMO and 100 for CDO. Cumulative charges amount to $8.5 billion (about 12 trillion won). ◆ Samsung Bioepis' performance decreases Samsung Bioepis recorded 269.8 billion won in sales and 77.9 billion won in operating profit in the third quarter on a separate basis. Sales fell 0.5% year-on-year and operating profit fell 23%. In the third quarter of last year, it received licensed milestones for U.S. and European products. Although its performance declined due to the base effect, the company explained that sales and operating profit are steadily growing this year as product sales growth in the global market. Samsung Bioepis is selling a total of six biosimilars in the global market. In the third quarter of this year, it obtained U.S. permission for the "Humira" biosimilar (SB5) high-concentration formulation. It plans to complete phase 3 clinical trials of Prolia biosimilar (SB16) and Stella biosimilar (SB17) within this year.
- Company
- The commercialization of Camzyos is expected in Korea
- by Eo, Yun-Ho Oct 28, 2022 05:57am
- It is expected that the new HCM drug Camzyos will be commercialized in Korea. According to related industries, BMS Pharmaceutical Korea recently submitted an application to the Ministry of Food and Drug Safety for permission for the NYHA Class 2-3 (class II-III) HCM treatment Camzyos. Camzyos is acquired by BMS for $13.1 billion in 2020 and is a PO drug that targets and inhibits cardiac myosin for functional treatment and symptom improvement of HCM. Camzyos, which was approved by the U.S. FDA in April, is the first and only cardiac myosin inhibitor targeting the source of obstructive hypertrophic cardiomyopathy and has a mechanism to reduce heart muscle contractility and left ventricular hypertrophy by inhibiting the cross-binding formation of excessive myosin actin activity. This drug confirmed efficiency through a phase 3 clinical study of EXPLORER-HCM. As a result of the study, it was found that exercise ability, LVOT closure, NYHA function class, and health status were significantly improved in the Camzyos administration group. 37% of the Camzyos administration group achieved a complex primary evaluation variable defined by achieving pVO2 1.5mL/kg/min improvement, NYHA class improvement, or pVO2 3.0mL/kg/min improvement without NYHA class deterioration, compared to around 17% of these patients in the placebo group, and the most common side effects in the clinical case were dizziness and fainting. Meanwhile, BMS recently submitted an application to the FDA for approval to expand the indication to reduce the need for Camzyos' SRT (Septal Reduction Therapy).
- Company
- Zerbaxa's benefit in 5 Years
- by Oct 28, 2022 05:57am
- After five years of domestic approval, the MSD super antibiotic "Zerbaxa (Ceftolozane/Tazobactam)" was registered. It is expected to help reduce the recent surge in carbapenem antibiotic resistance. MSD Korea held a press conference at the Koreana Hotel in Jung-gu, Seoul on the 27th to commemorate the registration of Zerbaxa, a multidrug-resistant antifungal antibiotic. Zerbaxa is a combination of new cephalosporin-based antibiotics Ceftolozane and beta-lactam degrading enzyme inhibitors Tazobactam. In response to the main resistance mechanism of pseudomonas aeruginosa, it has proven its activity in multidrug-resistant pseudomonas aeruginosa and ESBL-producing intestinal bacteria. ESCMID and IDSA recommend Zerbaxa as the first treatment in severely infected patients who are difficult to treat due to carbapenem-resistant pseudomonas aeruginosa. Antibiotic resistance has been an issue that has emerged worldwide for many years. In 2016, the British government predicted that 700,000 people worldwide die of antibiotic-resistant bacteria every year and that the death would reach 10 million by 2050 unless special measures were taken. In response, the World Health Organization (WHO) proposed an "Action Plan" in 2015 to prevent the occurrence and spread of resistant bacteria across borders and urged national countermeasures and international cooperation. Korea is also not free from antibiotic resistance. As the use of carbapenem, a wide range of antibiotics increased, the number of strain infections resistant to carbapenem antibiotics increased. According to the Korea Centers for Disease Control and Prevention, 23,311 CRE infections were classified as second-class infectious diseases last year, up 28.7% from the previous year. This year, 24,009 cases of infection were reported by October, already exceeding the number of infected people last year. In particular, it is analyzed that the use of antibiotics increased during the COVID-19 epidemic, which did not have adequate treatments, encouraging resistance. Choo Eun-joo, an infectious medicine professor at Soonchunhyang University Bucheon Hospital, who attended the meeting, said, "In the early 2000s, I didn't think much about carbapenem resistance. However, resistance has increased to more than 80% in eight years, he said. "In Korea, the problem of antibiotic resistance is likely to become more serious due to the rapid aging and the expansion of long-term care facilities." "Antibiotic resistance causes serious problems in that it limits the treatment options that can be selected," he explained. Carbapenem is an antibiotic that was considered the last alternative in severely infected patients. Before the Zerbaxa license, there was no antibiotic that could be replaced if carbapenem resistance occurred in Korea. The American Society of Infectious Diseases presented various new antibiotics as alternative drugs, but Zerbaxa was the only drug in Korea that was approved and released. However, Zerbaxa has been in a state of non-reimbursement for five years due to difficulties in economic evaluation. This is because Zerbaxa was considered to be cost-effective because other antibiotics selected as alternative drugs were so inexpensive. Usually, patients were not convinced that antibiotics were used as non-reimbursement, so Zerbaxa was rarely used in the field for five years. During that period, the number of cases of CRE infection more than quadrupled from 5,717 to 24,000. Professor Choo said, "Even if the effect of Zerbaxa was twice as high as before, the cost was more than 10 times different, so I had no choice but to use colistin, which came out 40 years ago, and this drug was less effective than a new antibiotic and had poor kidney function." Dramatically, as the government included antibacterial agents in the PE exemption list, there was an opportunity to register Zerbaxa's reimbursement. Since October, Zerbaxa has been reimbursed in cases where carbapenem antibiotics have failed to treat complex intra-abdominal infections, complex urinary tract infections, and in-house infectious pneumonia, or if multidrug-resistant rust bacteria have been proven. Professor Choo predicted that Zerbaxa's benefits will help reduce carbapenem resistance. Choo said, "It is difficult to see a dramatic effect in a short period of time, but it will generally reduce cases of infection with Zerbaxa." Of course, Zerbaxa also poses a risk of developing resistant bacteria in the future if its usage increases. No matter how severe a patient is, antibiotics should be used properly to create fewer resistant bacteria and receive other new treatments," Choo said. "In particular, long-term care facilities increase, and antibiotics are frequently used without knowing what resistant bacteria are present. The best way to reduce resistance is to use antibiotics well, Choo explained.
- Company
- AZ-Abbott to copromote diabetic kidney disease treatments
- by Eo, Yun-Ho Oct 28, 2022 05:56am
- Director Jeong-Seon Heo (left) and Director Il Shim (right) On the 26th, AstraZeneca Korea announced that it had signed a joint promotion agreement with Abbott Korea for the early diagnosis and treatment of patients with diabetic kidney disease. The signing ceremony was held at AstraZeneca Korea’s headquarters in Samseong-dong, Seoul on the 25th ,in the presence of key officials from both companies, including AstraZeneca Korea’s Director Il Shim and Abbott Rapid Diagnostics’ Director Jeong-Seon Heo. The agreement was made between AstraZeneca Korea and Abbott for their mutual cooperation in improving the treatment environment for patients with diabetic kidney disease in Korea to establish a more systemic diabetes treatment and management system. In diabetes, AstraZeneca has been supplying various treatments including ‘Forxiga (dapagliflozin)’ and ‘Onglyza (saxagliptin),’ and Abbott has been supplying technologies such as the point-of-care testing (POCT) ‘AFINION 2™ ANALYSER.’ Il Shim, Director of the Cardiovascular, Renal, and Metabolism (CVRM) Business Unit at AstraZeneca Korea, said, “The current kidney disease screening rate is very low in Korea, especially when considering how 30% of the diabetes patients in Korea are present with diabetic kidney disease. This is why early diagnosis and treatment are important. For this, we will work together to establish a management system for the early detection and treatment of diabetic kidney disease.”
- Company
- Vaccine Development in 100 Days of Pandemic
- by Oct 28, 2022 05:55am
- Vaccine and bio leaders around the world have set a goal of "100 days of vaccine development" as a countermeasure to the "Next Pandemic." To achieve this, it requested organic cooperation from governments, industries, international organizations, and academia. It also predicted that Korea will play an important role in resolving the deepening inequality in vaccine access between countries during the pandemic. The Ministry of Health and Welfare and the World Health Organization (WHO) held the 2022 World Bio Summit at the Grand Walkerhill Hotel in Gwangjin-gu, Seoul for two days from the 25th. The event was co-hosted by the Korean government and the WHO and held for the first time this year. It is a place to invite leaders in the vaccine and biofields of countries, companies, and international organizations around the world to share their experiences in responding to COVID-19 and discuss international cooperation measures to respond to future infectious disease pandemics. Starting with President Yoon Suk Yeol and WHO Director-General Tedros Adhanom Ghebreyesus, President of the Asian Development Bank (ADB) and Ban Ki-moon, Chairman of the Foundation for Better Future, Richard Hatchett, CEO of the International Vaccine Institute, and others delivered keynote speeches. In the ensuing corporate session, representatives of domestic and foreign vaccine, treatment, and raw material companies such as Pfizer and Moderna, SK Bioscience, MSD, Ildong Pharmaceutical, Shionogi, Merck, and Biovac shared their opinions on the theme of "Future Strategy for Post-Pandemic." They cited speed, cooperation, and equality as the most important points in responding to the pandemic, and emphasized active cooperation to ensure that vaccines developed and developed can be supplied equally to the world. CEPI CEO Richard Hatchett stressed that the vaccine development period should be shortened to 100 days to quickly respond to the next epidemic. He said, "There could be more frequent pandemics on a larger scale in the future. Even now, there are risks such as Ebola and monkeypox, he said. He said, "The development of vaccines is essential to prepare for new infectious diseases. "Our goal is to have the ability to develop a vaccine that can respond to new infectious diseases in 100 days," he said. CEO Iso Teshirogi also said, "Japan has established a new emergency system, established a 100-day mission to develop a new vaccine, and is strategically investing research funds to collect information on the development of a new vaccine." Reducing the vaccine development period, which usually takes 10 years, to 100 days, requires full investment and efforts in R&D, flexible regulatory procedures, and close cooperation with domestic and foreign partners. At the time of the COVID-19 pandemic, it took about a year even though Pfizer, Moderna, and Janssen succeeded in developing a vaccine record quickly. Pfizer, Moderna, and SK Bioscience, which developed the COVID-19 vaccine, agreed that the vaccine development period could be shortened due to cooperation with governments, academia, industries, and international organizations. Ahn Jae-yong, CEO of SK Bioscience, said, "SK Bioscience has developed its own vaccine in close cooperation with domestic and foreign partners. Without the partnership, the development would not have been possible, he said. "SK Bioscience recently prepared its own growth strategy 3.0, which is to strengthen global cooperation while preparing for the pandemic." Based on this, we will promise to develop a vaccine within 100 days of the next pandemic, he said. They also stressed Korea's role in achieving the new mission. "Korea is a great example of self-sufficiency in the COVID-19 vaccine," said CEO Hatchett. "We set visible goals and implemented active policies to achieve them," he said. "As we went through this COVID-19, we felt that there was a big gap between inequality in vaccine development and manufacture." "Korea has the ability to share a lot of things with countries around the world," he said. Jan Van Acker, president of MSD Emerging Market, said, "It is important to work with regulatory agencies to find ways to quickly obtain approval for drugs and supply drugs, and I felt that the Korean government could play an important role here. "Korea has also demonstrated flexibility in the regulatory process," he said. He added, "In the future, Korea will play an intermediate role between developed and low-income countries to resolve inequality in infectious diseases."
- Company
- Influenza epidemic and the launch of generic products
- by Kim, Jin-Gu Oct 28, 2022 05:55am
- GC Pharma Peramiflu, JW Pharmaceutical Fluenpera, Chong Kun Dang Peraonce Product Photo (clockwise from top left)The Peramiflu-based flu treatment market, which was monopolized by GC Pharma, will be reorganized into a system in which 15 companies compete during the flu season this winter. In particular, unlike the past two years, when the number of flu patients plunged due to the prolonged COVID-19, the competition in this market is expected to be very fierce, given that the flu is expected to spread significantly this winter. ◆Peramiflu patent is released, the generic license is expanded According to the pharmaceutical industry on the 11th, a total of 15 companies have been approved for flu treatment containing Permiflu until that day. This original product is GC Pharma's Peramiflu. GC Pharma introduced the product from BioCryst in the United States in 2010. Last year, three companies, Chong Kun Dang, HK inno.N, and JW Lifescience, received generic permits after winning a patent dispute with GC Pharma. This year, an additional 11 companies were added. Analysts say that generic permits are expanding as Peramiflu patents are released. Chong Kun Dang, HKinno.N, and JW Lifescience filed for invalidation of Permiflu's sole patent in December 2019. Generics won the first and second trials in a row. GC Pharma abandoned the Supreme Court appeal after losing the second trial in July this year. The patent court upheld the judgment against the plaintiff. GC Pharma's waiver of appeal completely lifted the Permiflu patent. Three companies, including Chong Kun Dang, have been challenged by invalidating patents, not avoiding them. If it was a challenge to avoid, only three companies that won the first and second trials could have released generic. Still, Chong Kun Dang and others succeeded in invalidating the patent itself, and even companies that did not enter the dispute were eligible to release generic. The three generic companies' generic for exclusivity ended in April this year. All obstacles to the release of the generic have disappeared. As a result, 11 additional companies, starting with Dongkwang in February this year, have received peramiflu generic licenses. ◆ Competition is expected to resume for the first time in three years due to the severe increase in flu patients Unlike the past two years, the pharmaceutical industry predicts that demand for flu treatments will increase significantly this winter. In particular, considering that Peramiflu was rapidly expanding its influence in the flu treatment market just before COVID-19, some predict that competition for heterogeneous generic components will be very fierce this winter. Over the past two years, the market for Peramiflu-based flu drugs has virtually disappeared. This is because the flu has not been prevalent since the COVID-19 crisis due to the effects of wearing masks, personal hygiene management, and social distancing. According to IQVIA, a pharmaceutical market research firm, sales of Peramivir flu drugs steadily increased to 3 billion won in the winter of 2015-2016, 3.6 billion won in the winter of 2016-2017, 4.4 billion won in the winter of 2017-2018, 5.5 billion won in the winter of 2018-2019 and 6.7 billion won in the winter of 2019-2021. Things are different this year. The KDCA issued a flu pandemic warning on the 16th of last month. No pandemic warning has been issued for the past two years since the COVID-19 crisis. The KDCA estimates that this year's flu epidemic is two to four months older than usual. It is the first time in 12 years since 2010 that the Korea Centers for Disease Control and Prevention issued a flu epidemic warning in September. The number of suspected flu patients has rapidly increased since the pandemic warning was issued. In the 40th week of this year (September 25 to October 1), the number of suspected flu patients per 1,000 outpatients was 7.1, up 45% from 4.9 in the previous week. For this reason, the pharmaceutical industry predicts that competition in the generic market for Peramivir will take place in earnest this year. Depending on the situation, some predict that more companies will receive generic permits through consignment and consignment contracts in addition to existing companies. Analysts say that while the Tamiflu generic market is saturated, the Peramiflu generic market has not yet begun to compete in earnest and that the Peramiflu market was growing rapidly until just before the Corona crisis, more companies are entering the competition. Currently, there are eight manufacturers of Peramivir-based flu drugs. Genuonescience entrusts the production of Union Korea Pharm, Hana Pharm, QL Pharm, Genu Pharma, and Kolong Pharmaceutical. JW LifeScience commissioned and produced Shinpoong products, and Penmix commissioned and produced Ilyang Pharmaceutical products. The rest is self-produced.
- Company
- The New Testament Era of Rosuzet and K-CAB
- by Chon, Seung-Hyun Oct 28, 2022 05:55am
- Domestic developed drugs continued to be strong in the foreign prescription drug market. Hanmi Pharmaceutical's complex new drug Rosuzet exceeded 100 billion won in prescriptions in three quarters, while HK inno.N's new drug K-CAB booked 100 billion won for the second consecutive year. According to UBIST, a drug research institute, on the 23rd, Viatris' hyperlipidemia drug Lipitor took the lead with a cumulative outpatient prescription amount of 147.7 billion won in the third quarter of this year. Although it decreased by 3.2% compared to the same period last year, it maintained a gap of more than 40 billion won with the second-ranked group and continued to take a relaxed lead. Lipitor was released in Korea in 1999. It has been more than 20 years since its launch in Korea, and more than 100 generics and various combinations are intensively checking Lipitor, but it still has a strong influence in the prescription drug market. Lipitor has been the leader in outpatient prescriptions since 2018, and if this trend continues, it is likely to be the No. 1 for five consecutive years. Rosuzet and K-CAB, developed by Korean companies Hanmi Pharmaceutical and HK inno.N, continued to be super strong. Rosuzet ranked second overall by recording 103 billion won in cumulative prescriptions up 13.3% from the previous year until September. Rosuzet, released in late 2015, is a hyperlipidemia complex composed of two ingredients, Rosuvastatin and Ezetimibe. Rosuzet continues to grow rapidly due to its market preoccupation effect and the popularity of statin and Ezetimib complexes. Statin and Ezetimib complex drugs show excellent effects in lowering LDL-C, and their preference is increasing because the burden of drug prices is not as high as taking two drugs separately. Rosuzet is the first domestic developed drug to surpass 100 billion won in prescription in three quarters. Rosuzet exceeded 100 billion won in prescription performance in 2020 and last year, and confirmed that it exceeded 100 billion won for the third consecutive year. Rosuzet more than tripled in five years from 11.2 billion won in prescriptions in the third quarter of 2017 to 35.6 billion won in the third quarter of this year. Rosuzet has been breaking a new quarterly prescription record for 10 consecutive quarters since it recorded 23.5 billion won in the first quarter of 2020. Since June last year, the monthly prescription has been around 10 billion won for 16 consecutive months. K-CAB's cumulative prescription performance in September was 92.2 billion won, up 18.0% from the previous year. K-CAB, released in March 2019, is a 'P-CAB' anti-an ulcer drug. In gastric wall cells, a proton pump and potassium ion located in the final stage of acid secretion are competitively combined to exhibit an action mechanism that inhibits gastric acid secretion. K-CAB has a faster medicinal effect than existing PPI products and can be taken regardless of before and after meals. K-CAB posted 30.9 billion won in sales in the first year of its release and surpassed 100 billion won last year, the third year of its launch. K-CAB's growth slowed down from 31.5 billion won in prescription performance in the fourth quarter of last year to 30.1 billion won in the first quarter of this year, but it showed an upward trend again in the second quarter. It broke a new record in three quarters, recording 31.6 billion won in prescriptions in the third quarter. K-CAB sequentially secured five indications, including erosive and non-erosive gastroesophageal reflux disease, antibiotic combination therapy for Helicobacter pylori eradication in patients with gastric ulcers and chronic atrophic gastritis, and maintenance therapy after treatment for erosive gastroesophageal reflux disease. Among them, health insurance benefits are being applied to gastroesophageal reflux disease and gastric ulcers. It is analyzed that the demand for prescriptions has increased further as health insurance benefits have been applied to gastric ulcer treatment since November last year. In the third quarter of last year, K-CAB continued to rise despite the release of Fexuclu, a P-CAB-based anti-ulcerative drug that is the same as K-CAB. Fexuclu is a new drug product developed by Daewoong Pharmaceutical. It was approved at the end of last year and was listed on the health insurance benefit list in July, and began selling in earnest. Fexuclu became a sensation in the first quarter of its release, recording 4.5 billion won in prescriptions. It posted a prescription performance of 1.1 billion won in July, and increased its increase to 1.5 billion won and 1.9 billion won, respectively, in August and September. It is evaluated that Fexuclu is leading the expansion of the P-CAB-affiliated market by creating a new market or targeting the PPI-affiliated drug market without encroaching on the prescription market for the same drug. Among the domestically developed drugs, Daewoong's Gliatamin, Chong Kun Dang's CKD Gliatilin, and LG Chem's Zemimet ranked at the top of the prescription. Gliatamin and CKD Gliatilin, brain functional stimulants composed of Choline alfoscerate, continued to rise with accumulated prescriptions of 83.7 billion won and 72.2 billion won, respectively, in the third quarter. Zemimet, a diabetes complex developed by LG Chem, ranked eighth overall in the total, recording 69.9 billion won in prescription performance, up 4.8% from the previous year, until September. Zemimet is a complex that combines Metformin with Zemiglo, a DPP-4 inhibitor-based diabetes drug developed by LG Chem. Daiichi Sankyo's anticoagulant Lixiana ranked in the top 10 with 66.4 billion won in the third quarter, up 6.4% from the previous year. It also promoted patent-expired new drugs from multinational pharmaceutical companies such as Flavix of Sanofi Aventis and Twynsta of Beringer Ingelheim. Plavix, an anti-thrombotic drug, ranked fourth overall, up 4.6% from the previous year with 88.3 billion won in prescriptions until the third quarter. Plavix has joined the sale of Dong-Wha since 2017. Twynsta's cumulative prescription amount in the third quarter was 70.8 billion won, up 3.0% from the previous year.
- Company
- Dexeryl for atopic dermatitis lands in Korea
- by Oct 27, 2022 05:52am
- Pierre Fabre Korea announced that it had launched its medical device cream ‘Dexeryl’ in Korea on the 26th. Dexeryl is an MD cream that represents the 60-year-old French pharmaceutical company, Pierre Fabre. It is used to treat dryness of the skin and symptoms from skin conditions, such as atopic dermatitis, pruritus, diabetic foot disease, itching, psoriasis, ichthyosis, and radiodermatitis. It consists of a minimum formula of 13 ingredients that excludes the 43 types of steroids, 7 types of parabens, lanolin, or odoriferous substances. As an O/W(Oil in Water) formulation, it applies smoothly and has excellent moisturizing power. Dexeryl, called the ‘Nation’s MD cream’ in France, recorded No.1 in sales in Europe It is currently sold in 57 countries around the globe and can be prescribed at hospitals and clinics in Korea starting at the end of November. At the product launch press conference held the same day, Alain Delaurue, Global Medical Director of Pierre Fabre Group, said, “Dexeryl was developed based on our company’s extensive clinical experience and expertise, and owns clinical data on skin conditions such as atopic dermatitis published in renown journals including the Journal of the European Academy of Dermatology And Venereology (JEADV).” In a clinical trial conducted on 335 children aged 2-6 years with mild to moderate atopic dermatitis, Dexeryl lowered the frequency of acute exacerbation of atopic dermatitis and steroid use compared to the patient group that did not use moisturizers or used comparators. During the clinical trial period, the rate of patients who experienced acute exacerbation more than once was 67.6% in patients who did not use MD creams, 52.6% in the control group, and 35.1% in the Dexeryl-treated group. Also, the steroid use in the Dexeryl group decreased by 57.1% compared to those that did not use any MD creams. Also, Dexeryl was found to be effective in treating xerosis, one of the major symptoms of atopic dermatitis. In a Phase III trial on 251 children aged 2-6 years with atopic dermatitis xerosis for 28 days, The Dexeryl-treated group’s lesions from xerosis improved by 42.5%. The rate was 29% for the control group. Patients who discontinue the use of MD creams during the study period showed relapse, but then showed improvement in symptoms again when resuming the use of creams. Also, regular use showed improvement even in a group of patients who did not respond to initial use, demonstrating the importance of long-term use of Dexeryl. Hye-One Kim, Professor of Dermatology at Hallym University Kangnam Sacred Heart Hospital, said, “Patients with atopic dermatitis need to regularly use moisturizers such as MD cream twice a day because their skin barrier function is damaged, even if the symptoms are invisible. Although the common perception is that MD cream is a cosmetic product due to the low awareness but for patients suffering from skin diseases, it is an important item that should be used every day like a treatment.”
