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- 2026-05-20 05:10:36
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- First-line Cyramza+Tarceva combo to treat NSLCL in Korea
- by Eo, Yun-Ho Jul 24, 2020 06:25am
- A targeted therapy combination option could be introduced to the non-small cell lung cancer (NSCLC) treatment area. The pharmaceutical industry sources reported, Lilly Korea has recently submitted an application to expand the drug’s indication to treat patients with NSCLC as a first-line combination treatment of vascular endothelial growth factor receptor (VEGFR)-2 antagonist Cyramza (ramucirumab) and epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tarceva (erlotinib).. The combination therapy has been approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) in last January and June, respectively. The new combination targeting VEGF and EGFR has demonstrated efficacy in patients with EGFR exon 19 deletion and exon 21 (L858R) mutation. The promising efficacy of the Cyramza-Tarceva combination therapy was confined in Phase III RELAY trial. In the study, ramucirumab-erlotinib combination has lowered the risk of disease progression or death by over 40 percent against erlotinib alone. And the patient group treated with the combination demonstrated progression-free survival (PFS) of 19.4 months, improving the figure more than erlotinib group by over seven months. The overall survival has not been evaluated, yet. The median time of follow-up was 20.7 months, and objective response rates (ORR) in Cyramza combination group (76.3 percent) and erlotinib group (74.7 percent) were similar. But the median duration of response in the two groups were contrasting with 18.0 months and 11.1 months. Currently in Korea, Cyramza is indicated to treat patients advanced or metastatic stomach cancer as second-line treatment; patients with advanced metastatic colorectal cancer, who have progressed on or after bevacizumab, oxaliplatin, or fluoropyrimidine treatment as combination therapy with FOLFIRI (irinotecan, folinic acid, 5-FU); and patients with metastatic NSCLC after disease progression on or after platinum-based chemotherapy as combination therapy with docetaxel. Besides Tarceva, Lilly also has other clinical trials in progress to confirm treatment efficacy of Cyramza combination therapies with other EGFR TKI like Iressa (gefitinib) or Tagrisso (osimertinib) in treating NSCLC.
- Company
- Genexine, promotes clinical trial of Hyleukin-7·Opdivo
- by An, Kyung-Jin Jul 24, 2020 06:24am
- Genexine announced on the 22nd that the anti-cancer drug 'Hyleukin-7' (GX-I7), which is under development with NeoImmuneTech, has entered a co-clinical trial with BMS. According to Genexine, phase II clinical trial that recently administered 'GX-I7' and BMS' immune checkpoint inhibitor 'Opdivo' (Nivolumab) in patients with metastatic gastric cancer, gastro-esophageal junctional cancer, and esophageal adenocarcinoma was approved by the Food and Drug Administration. Hyleukin-7 is an essential cytokine for the proliferation and maintenance of T cells, which play an important role in immunity in the body. The two companies expect that the combination of Hyleukin-7, which enhances T cells, and 'Opdibo,' a strategy to reactivate T cells that have lost activity, will be synergistic. In addition to Opdivo, 'Hyleukin-7' is being evaluated for its potential to be used in combination with various blockbuster immunocancer drugs. Hyleukin-7 by Genexine has previously entered a number of clinical trials such as ▲Phase Ib/IIa using Roche’s Tecentriq for high-risk skin cancer patients ▲Phase Ib/II in combination with Keytruda by Merck for patients with triple negative breast cancer ▲Phase Ib/IIa in combination with 'Keytruda' for pancreatic cancer, lung cancer, colorectal cancer, triple negative breast cancer, and small cell lung cancer, which have failed immunotherapy inhibitor treatment. In addition, Phase II clinical trials for patients with brain tumors (GBM) are in progress with I-MAB, a NASDAQ listed company. Sung Young-Chul, CEO of Genexine, said, "GX-I7 showed the possibility of treatment when combined with Keytruda in end-stage breast cancer patients based on the mechanism of restoring T-cell hypotension. We expect that Opdivo and GX-I7 combination therapy may be a new treatment option in patients with metastatic gastric and esophageal cancer."
- Policy
- Drug purchase per Korean is OECD average 1.3 times higher
- by Kim, Jung-Ju Jul 24, 2020 06:24am
- It was found that the sales of medicines per capita in Korea amounted to USD 643 US PPP. This is 1.3 times more than the OECD 49 PPP average among OECD member countries. Antidepressants are about one-third of the average in member countries, but antibiotics are still high, with 1.6 times more. The MOHW (Minister Park Neung-Hoo) analyzed the level and status of Korea and each country by major indicators of OECD Health Statistics 2020 published by the OECD. As a result of analyzing the behavior of health care use, the number of outpatient visits per capita in 2018 was 16.9 per year, the highest among OECD countries. This is 2.5 times higher than the average of 6.8 times in member countries. Looking at representative countries, Japan visited 12.6 times and was the second most frequent after Korea. On the other hand, some countries were less than three times. It was counted as 1.9 times in Colombia, 2.7 times in Sweden, and 2.8 times in Mexico. Looking at the amount of pharmaceutical sales and consumption in 2018, the amount of pharmaceutical sales per capita in Korea was 642.6 US dollars PPP, which was higher than the OECD average of 499.6 US dollars PPP. By country, countries such as Belgium (759.6), Czech Republic (740.0), and Germany (697.5) had more drug sales per capita than Korea. Looking at the consumption of major drugs, antidepressants were 21.0DDD/thousand/day (hereinafter referred to as DID), about 1/3 of the OECD average (64.3DID), while antibiotics were 29.8DID, about 1.6 of the OECD average (18.1DID). The life expectancy of Koreans is 82.7 years, which is higher than that of OECD countries (80.7 years), and the mortality rate of major diseases is generally lower than the OECD average. On the other hand, the percentage of people over the age of 15 who think they are healthy (32.0%) was the lowest among OECD countries. As a result of analyzing the health risk factors, the proportion of overweight and obesity (34.3%) among the population over 15 years old, which is a major cause of chronic diseases, was the second lowest among OECD countries. However, the daily smoking rate (17.5%) and the annual alcohol consumption per capita (8.5ℓ) of the population aged 15 years or older in Korea were OECD average. The average OECD smoking rate was 17% and alcohol consumption was 8.8l. Among medical resources, the level of physical resources such as magnetic resonance imaging (MRI) and computed tomography (CT) is higher than the OECD average, and Hospital beds are 12.4 per 1,000 population, about 2.8 times the OECD average (4.5).. On the other hand, the MOHW explained that the number of physicians (including doctor of oriental medicine) is 2.4 per 1,000 population and the nursing workforce is 7.2 per 1,000 population, which means that human resources are small among OECD countries. In fact, the average number of physicians per 1,000 population of OECD is 3.5 and nursing staff is 8.9.
- Company
- 4 years on KOSPI Samsung Biologics to earn over KRW 1 tln
- by Lee, Seok-Jun Jul 24, 2020 06:24am
- Samsung Biologics is now in full swing to generate sales. This year’s sales are projected to exceed 1 trillion won as its profitability improves every year. In the first half of the year, the Korean company has inked a few contracts valued approximately at 1.8 trillion won, which would propel the company forward as future growth engine. The contracts would expand out to establish the fourth factorry and the second bio campus leveraging the economy of scale. On July 21, Samsung Biologics disclosed earning report that found the company’s sales have reached 514.9 billion won in the first half of the year, making a growth of 153.08 percent from the same time last year at 203.4 billion won. In the first and second quarter, the Korean company generated 207.2 billion won and 307.7 billion won, respectively. The second quarter sales have marked the second highest figure following last year’s fourth quarter (313.3 billion won). Based on the first two quarters, Samsung Biologics projects this year would be first year to break through the 1 trillion won mark. Samsung Biologics’ external growth has surged steeply since the listing. Starting from 294.6 billion won in 2016 when the company went public on KOSPI, Samsung Biologics has reached 464.6 billion won, 535.8 billion won and 701.6 billion won in 2017, 2018 and 2019, respectively. The company would triple sales in 2016 in merely four years, when the company surpasses the 1 trillion won mark this year. New deals in 2020 to make 1.8 trillion won Apparently, the Korean company’s sales growth would continue for a while. Samsung Biologics has sealed 440 billion won deal with Vir Biotechnology and 280 billion won deal with GSK this year alone. The two deals with the global companies are totaled at 1.8 trillion won, easily doubling last year’s sales of 701.6 billion won. Compared to last year’s order (approximately 450 billion won), the new deals would quadruple the amount. The company has strengthened its ‘one-stop service’ strategy and enhanced cost competitiveness based on vertical integration consisting contract research organization (CRO), contract development organization (CDO) and contract manufacturing organization (CMO), The notion of one-stop service has contributed to the company signing the global deals, but also it improved the company’s profitability. In the first half of the year, Samsung Biologics’ operating profit alone has reached 143.7 billion won. Although last year’s operating profit (91.7 billion won) set the historic high for the company, six months into this year the last year’s record is already 50 billion won behind. The company official elaborated, “The stable management over selling and administrative expense combined with increased profit margin have pushed up the operating profit by over 180 billion won compared to last year (-38.8 billion won).” Creating a positive cycle of ‘investment and performance’ The industry sources evaluate the company has created a positive cycle to generate revenue. As investment and performance are feeding each other, the company is also gaining more means to invest further. In fact, Samsung Biologics’ two manufacturing facilities are at full throttle with the consecutive signing of the global deals in last six months and expanded CMO deals with global companies. Its third facility is also filling up the order. The company is proactively reviewing the plans for the fourth facility and the second bio campus. The plan would be disclosed when the investment scale, peak performance and prospective business development timeline are drawn out.
- Policy
- SK Bioscience participates in supply of COVID-19 vaccine
- by Kim, Jung-Ju Jul 24, 2020 06:23am
- A domestic pharmaceutical bio company has been recognized for its production technology and has joined the world development leader multinational companies and the global production supply chain of COVID-19 vaccine. The government is trying to supply domestically some of the vaccines produced in Korea. The MOHW (Minister Park Neunghoo), today (21st) at 4 pm at the SK Bioscience Research Institute (Seongnam Pangyo), with AstraZeneca (CEO Pascal Soriot) and SK Biosciences (CEO Ahn Jae-yong), The AstraZeneca-Jenner Institute (University of Oxford) has signed a Letter of Intent (LOI) for a global supply of vaccine candidates under development and cooperation in securing domestic supplies. According to the World Health Organization (WHO), the vaccine being developed by the AstraZeneca-Zener Institute is currently attracting attention from around the world as one of the most likely vaccines to enter Phase III of COVID-19 vaccine candidates. The vaccine has been in Phase III clinical trials in the UK, Brazil and South Africa since June. AstraZeneca and SK Biosciences have been participating in discussions as partners for global manufacturing and production. And the government explained that the result was achieved by signing LOI ( a Letter Of Intent) today. The signing ceremony for this LOI was attended by Minister Park Neunghoo, British Ambassador to the Republic of Korea Simon Smith, CEO Sang-Pyo Kim of AstraZeneca Korea, The vice president of SK Discovery Chey Chang-won , and SK Bioscience chief Ahn Jae-yong, It was conducted by the participation of AstraZeneca Global Chief Executive Officer (CEO) Pascal Soriot participated in the video conference. LOI included ▲ fast and stable production and export cooperation for the fair global supply of vaccines ▲ strengthened production capacity to respond to increasing demand ▲ domestic supply efforts, and three-way cooperation. The government explained that this is the first time that a domestic company has joined the global supply chain of excellent vaccines, which is gaining global attention, for the first time. The MOHW will continue to discuss that some of the vaccines produced by SK Biosciences will be supplied to Korea. It is expected to be a representative example of cooperation between the government and companies in the global epidemic of infectious diseases, in that it will secure a stable supply and demand system for successful vaccine development. The government will continue to pursue two-track strategy centered on the 'COVID-19 Treatment and Vaccine Development Support Committee,' which will continue to be shared by related ministries, and will continue to provide support for domestic companies' own vaccine development, as well as the rapid acquisition of overseas vaccines that are rapidly developing. At the signing ceremony, Minister Park said, "We are proud that Korean technology can contribute to the production of vaccines that are supplied to the world, and it is also a great achievement to establish a preemptive domestic supply and demand system," He also added, "The Korean government will also actively participate in the international community's solidarity efforts to ensure equitable distribution and accessibility since the development of the vaccine."
- Company
- Sales for Antibiotic Rx declined significantly
- by Chon, Seung-Hyun Jul 23, 2020 06:11am
- The prominent feature of the outpatient Rx drug market in the first half is that it was sluggish than in 2Q. COVID-19 also had an impact. When the fears of COVID-19 spread in February and March, the analysis revealed that patients had been receiving long-term prescriptions in advance and that prescription performance was poor. The prescription market was sluggish in April and May, but began rebounding all in June. The market for large-scale prescription drugs for chronic diseases showed a similar pattern. However, prescriptions of antibiotics or expectorants, which are frequently used in the Department of Pediatrics and Adolescents, were significantly reduced. According to UBIST on the 22nd, the Rx amount for the first half of Statins used to treat dyslipidemia was ₩497.4 billion, up 2.4% from the same period last year. Statins prescriptions in the first quarter were ₩247.6 billion, a 3.0% increase over the previous year. In the second quarter, it was ₩249.8 billion, up 1.9% from the same period last year. The growth rate slowed somewhat in 2Q. Rx amount of Statins in the second quarter decreased by 2.8% and 5.1%, respectively, in April and May. However, it jumped 14.9% from last year in June. Rx trend for major chronic dz by month (Unit: ₩ 100 million, Source: UBIST) The most frequently used combination drug for hypertension, 'ARB+CCB', showed a prescription increase of 9.3% in the first half of the year to ₩398.7 billion. The growth rate of 'ARB+CCB' was 10.0% in the first quarter, higher than 8.7% in the second quarter. The prescription amount of the “ARB+CCB” was increased only 3.2% and 1.4%, respectively, in April and May, but rose by 22.6% in June. In the industry, the RX drug market in April and May was temporarily sluggish due to the fear of COVID-19 in the first quarter, and from June, it seems that outdoor activity has been revitalized and the growth rate has been restored. The Rx drug market seems to have recovered since the spread of COVID-19 patients began to stabilize in April, and the trend has changed after the end of social distance campaign, One of the drugs with the highest growth rate in recent years, the lipid-regulating drug combination increased by 24.0% in the first quarter, compared to the same period last year, but declined to 15.1% and 15.2%, respectively, in April and May. However, in June, the prescription scale expanded 39.9% from the previous year. Outpatient Rx amount for the first half of major chronic disease treatments (Unit: KRW 100 million, Source: UBIST) The Rx amount of ARB in the first half was ₩198.4 billion, up 3.6% from the same period last year. However, it decreased by 1.6% and 4.9% in April and May, respectively, and increased by 14.8% in June again. DPP-4 and Metformin increased by 0.8% in April compared to last year and by 1.4% in May. The growth rate was 18.3% in June. The Rx amount of antibiotics continued to decrease. The prescription performance in the first half of the year was ₩110.4 billion in the first half, down 16.6% from the previous year. It decreased by 1.5% from the first half of last year, but the decline was even greater in one year. Rx amount for oral Cephalosporins fell 1.3% in the first quarter of last year, while prescription declines in the second quarter reached 31.1%. oral , the increase of Cephalosporin preparations was 8.0% and 9.3%, respectively in January and February. It decreased by 20.6% from March of the previous year and decreased by 41.2% and 37.1% in April and May, respectively. The oral prescription of Cephalosporins in June was down 10.5% from last year. Rx amount for Oral Penicillins also increased by 7.0% and 2.9% in January and February, respectively, compared to the previous year, but decreased by 42.9% in March from April (-60.8%), May (-52.8%), and June (- 24.5%) all showed a significant decline. Outpatient prescription amount (Unit: ₩100 million, Source: UBIST) Unfortunately, since February, when COVID-19 began to spread in earnest, the Rx amount of antibiotics began to decrease suddenly. It is analyzed that the decrease in antibiotic prescription is closely related to the decrease in the number of patients. This is because after the spread of COVID-19, outdoor activities were limited and personal hygiene management, such as washing hands and wearing a mask, strengthened, and the incidence of infectious diseases such as cold decreased. According to statistics recently released by UBCare, prescriptions for acute nasopharyngitis in April were 71% less than in the same period last year. In April, the amount of prescriptions from Pediatrics decreased by 52% from the previous year, and the number of prescriptions dropped by 76%. The size of prescription for expectorant which is frequently used in pediatric patients, has also decreased significantly. The amount of prescription for expectorant in the first half was ₩71.7 billion, down 22.2% from the same period last year. The amount of prescription was also 12.3% and 16.0% higher than the previous year in January and February, but in March (-26.2%), April (-52.2%), May (-49.9%), and June (- 24.7%) fell sharply.
- Policy
- Quadrivalent flu vaccines by GC and SK Bio get lot release
- by Lee, Tak-Sun Jul 23, 2020 06:11am
- Korea’s top influenza vaccine manufacturers GC Pharma and SK Bioscience have passed the government’s lot release side-by-side for their quadrivalent vaccines. Korea’s Ministry of Food and Drug Safety (MFDS) explained the approval was about a couple of weeks earlier than previous years, as the seasonal influenza could spread with COVID-19 at the same time. As of July 22, MFDS announced the approval of three lots of GC Fluquadrivalant pre-filled syringe injection by GC Pharma (Q60220002, Q60220003 and Q60220004) and three lots of SKY Cellflu Quadrivalent prefilled syringe by SK Bioscience (Q022002, Q022003 and Q022004). The six lots all together can immunize total 875,000 recipients. MFDS elaborated the ministry cut over ten days from the usual lot release period (35 days) for the vaccines to be flawlessly distributed and used in the healthcare system, while COVID-19 shows similar symptoms as a seasonal flu. The first lot release was green lit in early August last year. Director Jung Ji-won of Vaccine Testing Division at National Institute of Food and Drug Safety Evaluation (NIFDS) stated, “While the healthcare system has to focus on COVID-19, unnecessary confusion could be caused by influenza demonstrating similar symptoms and spreading along with COVID-19,” so the ministry “accelerated the lot release for the influenza vaccines.” Accordingly, the influenza immunization season can start earlier depending on the decisions by general healthcare institutes. But the National Immunization Program (NIP) would still be provided from September like previous years. Sources report all influenza vaccines to be distributed in the domestic market would be quadrivalent vaccines as the NIP newly added quadrivalent vaccine this year. A quadrivalent vaccine is used to prevent all four influenza viruses the World Health Organization (WHO) designates every year. Although the vaccines manufactured by GC Pharma and SK Bioscience are quadrivalent vaccines, GC Pharma uses egg-derived vaccine and SK Bioscience uses cell-cultured vaccine. MFDS projected influenza vaccine lot for approximately 27 million recipients would be released this year, and noted a special lot release team for influenza vaccine was formed as of July 21 to process double the supply of the demand before the immunization season.
- Company
- Asthma drug montelukast prescription plummets amid COVID-19
- by Kim, Jin-Gu Jul 23, 2020 06:11am
- The prescription volume of montelukast widely used for asthma and allergy treatment has plummeted. The industry experts analyze the market was heavily impacted by pediatric and adolescent patients’ scarce visit to hospital amid COVID-19, and also by the U.S. Food and Drug Administration (FDA) labeling the top level the adverse reaction risk warning on the drug. On July 20, a pharmaceutical market research firm UBIST found the first half of the year’s outpatient prescription of montelukast in Korea has marked 51.1 billion won. Compared to 59.8 billion won made in the first half of last year, this year’s figure was dropped by 14.5 percent. The drop was even bigger with 15.2 percent, compared to the second half of last year at 60.3 billion won. To this date, Ministry of Food and Drug Safety (MFDS) has approved of 377 montelukast items by 117 companies. Among 52 companies that generated more than 100 million won from the first half of the year’s prescription, 32 companies had a negative growth in prescription volume. The top selling montelukast drug Singular’s prescription took a heavy blow of 14.5% this year compared to last year (Unit: KRW 100 million) Source: UBIST The original montelukast, MSD’s Singulair took the steepest fall. From 19.1 billion won in last year to 14.4 billion this year, the prescription fell by 4.7 billion won (24.6 percent). Coming second in the market, HK inno.N’s Lukio’s prescription also took a significant fall from 6.2 billion won to 5.2 billion won in a year by 1 billion won (16.3 percent). Hanmi Pharmaceutical’s Montezal prescription was brought down from 3.5 billion won to 2.6 billion won by 900 million won (27.2 percent), while Hutec’s Singule Down prescription slipped from 2.6 billion won to 2.2 billion won by 400 million won (14.8 percent). Regardless of the safety concern, some of montelukast products actually showed growth in the year. Hanmi Pharmaceutical’s other montelukast product Monterizine’s prescription jumped from 3.8 billion won last year to 4.2 billion won this year by 400 million won (11.0 percent). Monterizine is a combination drug consisting of single drug Montezal and levocetirizine. Dongkook Pharmaceutical’s Singule-mon’s prescription has also doubled from 900 million won to 1.8 billion won. Celltrion Pharm’s Montera prescription also grew by 3.8 percent from 600 million won to 1 billion won. Outpatient prescription in major montelukast drug from the first half of 2019 and 2020 (Unit: KRW 100 million) Source: UBIST The research firm evaluates the safety issue has affected the plunge in the prescription volume. In last March, the U.S. Food and Drug Administration (FDA) has announced it would require Boxed Warning on montelukast products. It is the highest level of warning labeled on a drug. In particular, the U.S. health authority strongly recommended patients with mild allergic rhinitis to avoid the drug. FDA sees that there are an alternative drugs and the risk of taking montelukast is greater than the benefit. According to the agency, there have been reports of adverse reaction as serious as suicidal behavior from using Singulair since 2008. Some of the cases have been discovered during montelukast treatment, and the adverse reactions were gone when halted using the drug. Also the research firm pointed out COVID-19 as a major cause of the market fluctuation. Since the outbreak, hospital and clinic visits by pediatric and adolescent patients have plunged. The ratio of pediatric and adolescent patients in asthma and allergic rhinitis is far greater than any other diseases.
- Company
- Ildong expands collaboration with Evotec
- by Kim, Jin-Gu Jul 23, 2020 06:11am
- Ildong announced on the 21st that it will expand its cooperation with global new drug development company Evotec to conduct clinical trials on NASH (non-alcoholic steatohepatitis) treatment research project 'ID11903'. Evotech's drug research platform, 'INDiGO', is used to conduct various tasks necessary for clinical entry, such as nonclinical toxicity studies, preparation of drugs for clinical research, and securing of relevant data. NASH is a disease that causes liver damage and deterioration due to inflammation caused by accumulation of fat in liver cells as a factor other than drinking. While the number of patients is on the rise, there is no clear drug treatment developed so far, and thus it is evaluated as a field with sufficient marketability. Ildong's ID11903 is an agonist of Fanesoid-X receptor, a type of nuclear receptor. It is a mechanism that controls bile acids and lipid metabolism. In particular, it is said that in vitro studies confirmed advantages in terms of drug activity and target selectivity. The company expects that it will be able to avoid side effects, such as itchiness, appearing in competitor candidates. Ildong expects that it will take more than one year to cooperate with Evotec related to ID11903, and plans to quickly enter phase I clinical trials upon completion. An official from Ildong said, “The speed of development is very important when considering the market value and rights of drugs and the possibility of success.” In addition, he said, "We expect to increase the quality and speed of research by utilizing Indigo, which is an integrated solution for drug development of Evotec." Earlier in March, Ildong signed a research service contract with Evotec for new drug projects including type II diabetes treatments. The company plans to focus more on discovering promising new drug candidates, and to enter into clinical trials of more than three to four tasks each year through partnerships with partners such as Evotec.
- Company
- Rx amount for Choline alfoscerate is the largest ever
- by Chon, Seung-Hyun Jul 22, 2020 06:16am
- Rx market for brain function-enhancing drug 'Choline alfoscerate' has grown significantly. Despite the controversy over the effectiveness and the bad news of COVID-19, the rate was over ₩200 billion the first half of this year and continued to rise. The monthly prescription amount was ₩40 billion. Not only Daewoong Bio and Chong Kun Dang, which led the expansion of the market, but also Yuhan, Daewon, Korea Prime, Celltrion, and Jeil produced good result. According to UBIST, a pharmaceutical research institute on the 21st, the outpatient prescription amount of Choline alfoscerate formulation in the first half of 2020 was ₩224.1 billion, an increase of 19.6% from the same period last year. Choline alfoscerate is a drug used to improve brain function, such as decreased sense of memory and confusion, impaired sense of direction due to motivation and spontaneity, decreased motivation and spontaneity, and decreased concentration. Despite the recent validity controversy, it has the best prescription performance this year. Choline alfoscerate’s outpatient Rx amount (Unit: ₩1 million, Source: UBIST) In the second quarter, the Rx amount of Choline alfoscerate was ₩114.2 billion, up 17.2% from the same period of the previous year, setting a new record for the previous quarter. This is more than tripled in 4 years compared to ₩35.8 billion in the second quarter of 2015. Choline alfoscerate formulations rose 22.2% from the same period last year in the first quarter. By month, Choline alfoscerate formulations amounted to ₩ 40.7 billion, a 30.0% increase from the same period last year. The larger the prescription size, the upward trend is even greater. Choline alfoscerate formulations exceeded ₩10 billion a month for the first time in February 2015, and exceeded ₩20 billion in March 2017. It was recorded at ₩30 billion in January of last year, and it rose to ₩40 billion in one year and 5 months. As the government recently questioned its effectiveness, Choline alfoscerate formulations are struggling but demand in the market is even higher. The HIRA held the Pharmaceutical Benefits Advisory Committee on the 11th and deliberated the appropriateness of the benefits of Choline alfoscerate, and decided on the benefits based on efficacy and effectiveness. When a patient diagnosed with dementia uses this drug for the purpose of improving symptoms such as cognitive impairment, the copayment (30%) is maintained as before. However, because dementia patients only pay 10% of the medical expenses, the average copayment for this drug is estimated at an average of 10%. However, if a patient who has not been diagnosed with dementia is prescribed a Choline alfoscerate product, the drug cost burden increases from 30% to 80%. Pharmaceutical companies have recently filed a complaint that the benefit reduction of Choline alfoscerate is unfair. Gliatamin & Chongkundang Gliatirin Choline alfoscerate formulations are also expected to undergo clinical re-evaluation. The MFDS recently requested the submission of clinical trial data to companies possessing Choline alfoscerate. It was instructed to submit a clinical trial plan by December 23. If pharmaceutical companies fail to demonstrate the efficacy of Choline alfoscerate in clinical trials, the approval can be revoked in the worst case. The high sales performance of Choline alfoscerate is analyzed due to the high demand for brain function improving agents, especially among elderly patients. Although Choline alfoscerate is not a drug that fundamentally treats dementia, it seems that the market size has expanded rapidly as pharmaceutical companies have focused on the brain functioning market to target the rapidly growing elderly. In the aftermath of COVID-19 this year, although the performance of prescriptions centered on chronic disease treatments was poor, the performance of RX for Choline alfoscerate were very good. Some industries have expressed doubts that pharmaceutical companies induced long-term prescriptions in advance to prepare for reduced benefits of Choline alfoscerate. The growth of generic companies was stronger than that of Daewoong Bio and Chong Kun Dang, which have led the market. Daewoong Bio's prescription for 'Gliatamin' in the first half was ₩48 billion, a 4.4% increase over the same period last year. With this trend, the prescription amount of ₩100 billion is also possible this year. The prescription amount of Chongkundang Gliatirin recorded ₩39.8 billion, up 6.9% from last year. Generic companies such as Yuhan Corporation, Daewon, Korea Prime Pharm, and Celltrion showed high gains. Yuhan's Alfoatilin was 23.6% higher than the previous year with Rx amount of ₩9.7 billion in the first half. Daewon's Alfocholine increased 21.1% from ₩7.1 billion in the first half of last year to ₩8.6 billion this year. Korea Prime's Gria posted prescriptions of ₩8.4 billion in the first half with a 12.8% growth rate. Celltrion, Jeil Pharm, Arlico Pharm, and Korea Hutecs recorded prescriptions of around ₩5 billion with a growth rate of over 30%.
