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- 2026-05-11 12:54:00
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- MFDS collects acetaminophen to confirm impurity
- by Chon, Seung-Hyun Jul 28, 2020 06:33am
- 식품의약품안전처 전경 The South Korean government is initiating an investigation on impurity contamination in an active pharmaceutical ingredient (API), acetaminophen. As the risk of impurity contamination in API manufactured by a Chinese manufacturer was raised recently, the government started proactively collecting and testing the API used in Korea. If the widely used acetaminophen were to be found with unacceptable level of impurity, the pharmaceutical industry would be unable to avoid a heavy blow. According to pharmaceutical industry sources on July 27, Ministry of Food and Drug Safety (MFDS) has recently visited pharmaceutical companies and taken samples of acetaminophen to confirm the impurity contamination in the API. The government’s action seems to be a follow-up of the concern raised of impurity risk in acetaminophen manufactured and supplied by a Chinese-based bulk pharmaceuticals manufacturer Anqiu Luan Pharmaceutical. A Dutch daily newspaper NRC has reported a few weeks ago that three batches of acetaminophen Anqiu Luan Pharmaceutical manufactured last year have been found with carcinogenic substance, 4-chloroaniline. The substance is apparently genetoxic. Regarding the accusation, Anqiu Luan Pharmaceutical disseminated an official statement to their clients on 15 explaining “4-chloroaniline was not found in the samples from the batch the Dutch client received in the first quarter of last year.” The Chinese manufacturer official said the voluntary investigation result was sent to European Directorate for the Quality of Medicines (EDQM) and elaborated “The acetaminophen manufacturing procedure does not create a chemical condition to generate 4-chloroaniline, and the level of impurity risk can be managed during the procedure.” According to the manufacturer’s explanation, the carcinogen can hardly generate during the acetaminophen API production line. But MFDS presumably has decided to take a deeper look into the API used in Korea to proactively check the impurity risk. Sources confirmed a significant volume of acetaminophen manufactured by the Chinese company has been exported to Korea. MFDS’ Drug Master File (DMF) registration shows that total 100 items of acetaminophen are available in the Korean market. And 20 of the items use API supplied by Anqiu Luan Pharmaceutical. DMF registration of products using acetaminophen manufactured by Anqiu Luan Pharmaceutical (Source: MFDS) If the ministry’s investigation find impurity in Anqiu Luan Pharmaceutical’s API, the impact on the Korean industry would be inevitable. MFDS has reportedly collected acetaminophen manufactured by other Korean and global companies as well. Analgesic substance acetaminophen is widely used in OTC drugs, such as Tylenol, Penzal and Geworin. And for prescription drugs, the API is used in brands like Ultracet. Curretnly, total 120 Korean companies are in the Ultracet market. In worst case scenario, the general Korean pharmaceutical industry would be shaken to the core by the Korean ministry discovering unacceptable level of impurity in acetaminophen. Since the impurity risk incident with valsartan in July 2018, the substance contamination issue has been spreading through ranitidine, nizatidine and metformin. All the incidents started from a foreign country sources addressing an impurity risk in specific pharmaceutical substance, which led to MFDS investigating the collected API and finished products and banning the sales of certain product in the Korean market. This is why the pharmaceutical companies are closely watching the MFDS’ investigation and following actions. MFDS official said, “The ministry is collecting and investigating acetaminophen to proactively confirm the risk of impurity.”
- Company
- MFDS to tighten up regulations on appetite suppressant
- by jung, sae-im Jul 27, 2020 06:31am
- The South Korean health authority drafted regulations preventing the abuse of psychoactive appetite suppressants. The draft contains high-level of regulations like adopting active substance designation system used in narcotics control, which can heavily impact the relevant industry. According to pharmaceutical industry sources on July 24, Korea’s Ministry of Food and Drug Safety (MFDS) is planning to manage psychoactive appetite suppressants. Some of the approaches unveiled were introducing quarterly active substance designation system like the narcotics control, notifying amfepramone and mazindol as restricted substance, and designating psychoactive appetite suppressants as subjects to submit a risk management plan (RMP). Psychoactive appetite suppressant management plan drafted by MFDS First, the quarterly substance designation system is used by the government to control narcotic drugs in Korea in accordance to the Single Convention on Narcotic Drugs of 1961. The government intends to enforce the system to handle the appetite suppressant on the equivalent level to narcotic drugs. The current system designates each company on which narcotic substance to supply after reviewing the projected yearly use volume of narcotic substance and quarterly plan of active psychoactive drug use submitted by each supplier company from the previous year. When the result is notified to each company, the narcotic drug manufacturers are allowed to purchase the active substance strictly following the designation conditions. MFDS sketched out a plan to survey each company’s inventory this year, and enforce the new regulation from 2021 after finalizing and notifying the appetite suppressant manufacturing approval plan in November. When the new regulation comes in effect, the drug manufacturers can only manufacture the suppressant drugs as much as the government allows. Basically, the government would be invested with the power to set down the manufacturing volume of psychoactive appetite suppressant. Moreover, the government aims to newly restrict approval on amfepramone and mazindol. The official notification would be issued around August. In the past, the approval on phentermine and phendimetrazine has been restricted due to frequent reports of abuse. The ministry now plans to expand the restricted scope of substances and include amfepramone and mazindol. The designated substance drugs may be restricted when seeking for narcotic drug handling approval, manufacturing or importation approval. Lastly, the ministry plans to designate psychoactive appetite suppressants as drugs required to submit a RMP. The system usually targets new drug or orphan drug, but a drug the Minister of Food and Drug Safety acknowledges the need for RMP submission due to severe adverse reaction reported may also be designated. MFDS is shooting for early next year to enforce the designation. Pharmaceutical companies with drugs required to submit RMP have to comply with the plan and regularly submit evaluation result. Until the final designation is announced, the ministry is to recommend the companies to voluntarily practice risk minimization actions as a pilot program. Also the government body would soon survey demands on the pilot program from the participating companies. On July 21, MFDS convened a conference with the affected industry and shared the said details. The ministry would make final decisions after reviewing the industry’s opinion. Regardless of the abuse prevention and safe use policies enforced on appetite suppressants so far, MFDS has decided to take the stricter action as the drugs were still excessively prescribed. In 12 months time from July 2018 through June 2019, 24,000 healthcare institutes prescribed the appetite suppressants to 1.29 million patients, which adds up to 6.11 million cases of dispensing and use of the drugs. According to 2018-2019 technical reports published by International Narcotics Control Board (INCB), Korea’s phentermine and phendimetrazine substance importation volume is one of the highest in the world. Analyzing appetite suppressant prescription and administration data, the report confirmed frequent cases of abnormal use suspected of abuse. And apparently, these drugs have been globally criticized for the wide discrepancies between the submitted projection psychoactive drug substance use volume and the actual manufactured volume. However, the relevant industry points out the blueprint of the regulation do not match with the goal of preventing drug abuse. An industry insider who requested anonymity noted, “The government should rather actively promote drug administration instruction or safe use, if the drug abuse is the issue. Many of the industry associates say regulating and controlling the actual manufacturing and production of the drugs is inadequate.” Meanwhile, the obesity treatment market in Korea, including the psychoactive appetite suppressant market, is valued at approximately 150 billion won.
- Company
- 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."
- 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.
- 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.
- 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%.
- Company
- Samsung Biologics signed a contract with Lundbeck
- by Jul 22, 2020 06:16am
- Samsung Biologics announced on the 20th that it has signed a contract for biopharmaceutical contract worth ₩ 19.3 billion with global pharmaceutical company Lundbeck. The two companies signed their first contract on September 27, last year, and the size of the contract increased to ₩19.3 billion ($15.99 million) under further agreement. This corresponds to 2.75% of Samsung Biologics' recent sales. The end date of the contract period will be disclosed after December 31, 2023, subject to management confidentiality conditions. Samsung Biologics said, "In the future, the amount of the contract can increase to about ₩44.7 billion ($37 million) through further consultations."
