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- 2026-04-16 14:43:38
- 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%.
- Policy
- HIRA says antibiotic prescription in flu down by 0.12%
- by Lee, Hye-Kyung Jul 22, 2020 06:16am
- [A look into Drug Reimbursement Evaluation Report 2019] Last year’s antibiotic prescription rate on acute upper respiratory tract infection fell by 0.21 percent from the previous year and was recorded at 38.30 percent. The number of drug item per prescription also climbed down by 0.05 item from 3.72 items in 2018 to 3.67 items in 2019. Korea’s Health Insurance Review and Assessment Service (HIRA) has recently published a statistic report on drug reimbursement evaluation in 2019 addressing some key trends found. The reimbursement evaluation was based on 12-month outpatient prescription records from January to December 2019 billed by tertiary hospital, general hospital, hospital, nursing institute, clinic, dental hospital and clinic, public health center, public health center regional offices and healthcare centers. The total 813,680,000 bills with total pharmaceutical expense of 14.97 trillion won were evaluated. ◆Prescription rate in antibiotics and injection: Compared to the previous year at 38.42 percent, last year’s antibiotics prescription rate in acute upper respiratory tract infection was at 38.30 percent with a 0.12-percent-point dip. The rates of 48.36 percent, 37.69 percent, 32.05 percent and 10.58 percent were recorded from hospital, clinic, general hospital and tertiary hospital. The prescription rate in third-generation cephalosporins or later antibiotics for acute upper respiratory tract infection was at 8.80 percent last year, with an increase of 1.14 percent point from the year before. But the prescription rate in quinolone antibiotics was same was the previous year. Meanwhile, macrolide antibiotics prescription rate was 15.03 percent in last year with 0.65 percent point increase from the year before. The antibiotics prescription rate in respiratory system disease (J00-J47) reached 48.76 percent last year and was increased by 0.35 percent point from the year before. The rates were recorded at 49.94 percent, 49.49 percent, 35.20 percent and 18.12 percent in hospital, clinic, general hospital and tertiary hospital, respectively. Last year’s antibiotics prescription rate in acute lower respiratory tract infections at 59.05 percent grew by 0.47 percent point from the year before. The rate was increased from all healthcare institutes and the biggest growth from 46.66 percent to 47.21 percent was in tertiary general hospitals. The antibiotics prescription rate in other respiratory system disease last year was average 47.25 percent based on 49.27 percent, 47.13 percent, 31.47 percent and 18.12 percent in clinic, hospital, general hospital and tertiary hospital, respectively. The respective antibiotic prescription rates in acute otitis media and unspecified otitis media in pediatric patients were at 81.52 percent and 83.98 percent last year. Within tertiary hospitals, the prescription rates in respiratory system disease was highest in acute lower respiratory tract infection (J20-J22) at 37.31 percent, followed by acute upper respiratory tract infection (J00-J06) at 32.49 percent, other upper respiratory tract diseases (J30-J39) at 19.32 percent, chronic lower respiratory tract infection (J40-J47) at 6.98 percent and influenza and pneumonia (J09-J18) at 3.91 percent. Acute lower respiratory tract infection was billed the most from hospitals and clinic, acute upper respiratory tract infection and chronic lower respiratory tract infection were billed the most in general hospital and tertiary hospital, respectively. In order of acute otitis media (52.24 percent), unspecified otitis media (43.41 percent) and chronic otitis media (4.35 percent) were prevalent in otitis media in pediatric patients. Hospitals and clinics billed the most for the disease, and tertiary hospital and general hospital billed the most on unspecified otitis media. Injection prescription rate in last year was marked at 15.13 percent, dropping by 1.22 percent point from the year before. The prescription rate was also recorded at 17.06 percent, 14.77 percent, 7.38 percent, and 1.81 percent in clinic, hospital, general hospital and tertiary hospitas, respectively. ◆Number of drug item per prescription: The number of drug item per prescription was tallied at 3.76 items, 3.72 items, 3.42 items, and 2.99 items in clinic, hospital, general hospital and tertiary hospital, respectively, with an average of 3.67 items. The average was reduced by 0.05 items from 3.72 items in the previous year. As for respiratory disease, the number of drug items was at 4.62 items, same as the previous year. By each healthcare institute, the number was tallied at 4.69 items, 4.63 items, 4.32 items, and 3.01 items in hospital, clinic, general hospital and tertiary hospital, respectively. The average number of drug items per prescription in musculoskeletal disease treatment was marked at 3.42 items and 0.09 item lower than the previous year average of 3.51 items. The number in clinics, hospitals, general hospitals and tertiary hospitals were at 3.44 items, 3.37 items, 3.35 items and 3.13 items, respectively. The ratio of six-or-more-item prescriptions reached 14.09 percent last year, lowered by 0.17 percent point from 14.26 percent in the previous year. The ratio was 15.30 percent, 14.66 percent, 13.77 percent, and 11.42 percent in hospital, clinic, general hospital and tertiary hospital, respectively. Most of the ratios in each healthcare institute were less than the year before. The pharmaceutical expense per each day of administration was 1,825 won, climbing up 23 won from the year before at 1,802 won. The pharmaceutical expense in tertiary hospital, general hospital, hospital and clinic reached 2,986 won, 2,169 won, 1,782 won and 1,435 won, respectively.
- 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."
- Company
- Hanmi returns with salt-modified Champix generic
- by Kim, Jin-Gu Jul 22, 2020 06:15am
- Product image of Nocotine S tablet Hanmi Pharmaceutical is trying the Champix (varenicline) generic market for the second time. Initially, the license on the Korean company’s generic Nocotine tablet was revoked, but it came back to the market with Nocotine S tablet with different substance. On July 20, Hanmi Pharmaceutical announced the launch of a varenicline generic Nocotine S indicated for smoking-cessation program. This marks Hanmi Pharmaceutical’s second trial in the Champix generic market. In 2018, Hanmi Pharmaceutical released Nocotine tablet, but its license was revoked by Ministry of Food and Drug Safety (MFDS) on July 14. The revocation was ordered due to the generic sales before the expiration of Champix patent. Nocotine and Nocotine S are not the same; they share the main active pharmaceutical ingredient of varenicline, but they each have different salt base. Nocotine has ‘oxalate hydrate’ and Nocotine S has ‘salicylate.’ According to the Pharmaceutical Affairs Act, a generic item may apply for marketing approval for the sales after the expiration of the original patent term, but selling it before the patent expiration would cancel the generic’s license. Hanmi Pharmaceutical originally reported MFDS to release the generic to the market after the original’s patent is expired, but apparently the Korean company sold the product before the expiration. MFDS has reportedly accused the company of the generic sales before the original patent expiration based on supply history and investigation. 18 items from nine companies including Hanmi Pharmaceutical were revoked of the marketing approval—two items each of Kyung Dong Pharm’s Renico tablet, Daehan New Pharm’s Nico-X tablet, Mediforum Pharm’s Nicofence tablet, Unimed Pharm’s Nicoban tablet, Jeil Pharm’s Zerofix tablet, Chong Kun Dang’s Chamclean tablet, Korea United Pharm’s Stobacco tablet, and Korea Prime Pharm’s Champion tablet. The original Champix’ substance patent was supposed to expire on Nov. 13, 2018. But as Pfizer Pharmaceutical Korea applied for patent extension, the expiration date was pushed to July 19, 2020. On Apr. 27, Hanmi Pharmaceutical returned and applied for marketing approval on Nocotine S with the same substance as Champix. The company’s proactive move was to immediately release the product from July 20, when the original’s extended patent term would end. Apparently, none of other eight companies with license revocation has applied for the varenicline generic’s license again like Hanmi Pharmaceutical has with the modified salt base. Regardless, the other companies who did not receive the license revocation order are allowed to release their varenicline generics from July 20 as the original’s patent has expired. MFDS confirms 66 items from 33 companies are ready for sales.
- Company
- Will interferon have the potential to treat mild COVID-19?
- by Jul 22, 2020 06:15am
- Efforts have been made to continue to identify the potential for interferon preparations as a treatment for COVID-19. Interferon is one of the antiviral immune substances and increases the activity of innate immune cells (T cells, B cells, macrophages, etc.) to strengthen the human immune system. As the existing antiviral drugs such as Kaletra and Hydroxychloroquine have been discontinued due to lack of efficacy and side effects, rather than targeting the highly mutated virus itself, they are focusing on developing a therapeutic agent that activates the immune system in the body to increase resistance. Recently, studies have shown that interferon is exacerbated in severe COVID-19 patients in Korea, but it is still evaluated that interferon can be 'good' in mild or early patients. Clinical results support this. Dr. Eleanor Fish, PhD team at the University of Toronto, Canada, conducted on 77 patients hospitalized with early symptoms of COVID-19 in Wuhan, China in May, when interferon alpha and beta (α2b) were administered alone or in combination with Arbidol. It was found that the virus removal time in the body was as fast as 7 days. In addition, decreased levels of interleukin-6 (IL-6) and C-reactive protein (CRP), which are inflammatory markers, were confirmed. Similar results were obtained in the following clinical trials. In clinical trials conducted in patients with infectious pneumonia caused by COVID-19 in Hubei and Guangdong, China (patients without artificial respiration), pneumonia symptoms improved when interferon α2b and Arbidol were administered in combination. Based on this, clinical trials of COVID-19 using interferon preparations at home and abroad are ongoing. Earlier, the British biotechnology company Synairgen said it would enter COVID-19 clinical trials based on interferon beta, which has been demonstrated to protect cells from a wide range of respiratory viral infections such as MERS and SARS in vitro. In addition, several clinical trials have been conducted, including clinical trials for the recovery and mortality of COVID-19infected patients following combination therapy of Ribavirin and interferon beta 1b. In Korea, Selma began clinical trials of COVID-19 through anti-viral agents that enhance interferon. It is conducting clinical trials with the Russian pharmaceutical company 'Pharmsynthez' as an interferon formulation 'Neovir', and the results of the study will be released soon. "The antiviral effect of interferon is achieved by targeting the activation of the immune system of pre- or mid- and early-stage infected individuals, so it is expected that COVID-19 may have a greater therapeutic effect in the early or middle period of infection than in severe patients. COVID-19."
- Company
- Ranitidine risk comes back as opportunity for Boryung
- by An, Kyung-Jin Jul 21, 2020 06:10am
- Korea’s Ministry of Food and Drug Safety (MFDS) has banned all sales of ranitidine drugs from Sept. 26 last year. After collecting and investigating ranitidine drugs, the ministry discovered unacceptable level of N-nitrosodimethylamine (NDMA). Also a month later, the ministry banned the sales of 13 nizatidine drugs with the same reason. While the Korean pharmaceutical industry was still shaken by the hypertension drug valsartan, another active pharmaceutical ingredient (API) found with NDMA fluctuated the antiulcer prescription drug market in Korea. Without ranitidine, the H2 receptor antagonists (H2RAs) prescription drug volume shrunk down to one-thirds. But as demand for other H2RAs like famotidine and lafutidine skyrocketed, other antiulcer drug makers like Boryung Pharmaceutical, Dong-A ST and Hanmi Pharmaceutical benefited from the impurity risk. ◆ H2RA prescription volume plummets by 64 percent as an aftermath of ranitidine sales ban According to pharmaceutical market research firm UBIST on July 20, the outpatient prescription for H2RA drugs generated 63.2 billion won in the first half of the year, falling rapidly by 64.4 percent from last year at 177.4 billion won. Monthly outpatient prescription volume in H2RA and PPI (Unit: KRW 100 million) Source: UBIST The staggering result is an aftermath of ranitidine, once dominated the biggest pie in H2RA prescription drug market, and its sales ban imposed after finding unacceptable level of NDMA. While the prescribers turned their heads toward proton-pump inhibitors (PPI) and other antiulcer drugs, approximately two-thirds of H2RA prescription volume disappeared into the thin air in a year. The market research firm analyzes the ranitidine impurity incident would have impacted the prescription drug market even worse, when also counting the ranitidine combination drugs. In the first half of last year, ranitidine combination drug prescription generated 111.4 billion won, a quadruple of ranitidine single drug generating 27.7 billion won. Two of the top selling ranitidine combination drugs—Daewoong Pharmaceutical’s Albis and Albis D—together raised 32.4 billion won in the first half of last year. ◆Famotidine and lafutidine sales surge, while nizatidine returns Since October last year, the prescription volume of H2RA drugs besides ranitidine has drastically fluctuated. Five H2RA medicines including famotidine, lafutidine, cimetidine, roxatidine and nizatidine together have made 63.2 billion won. Compared to 38.3 billion won from last year, the figure was pushed up by 65.1 percent. Although the majority of prescription drug market in the first half of the year showed unstable trend amid COVID-19, H2RA market except ranitidine expanded abruptly. It could be viewed as the other H2RAs sharing the ranitidine prescription volume. Monthly outpatient prescription volume in major H2RA drugs from 2018 to 2020 (Source: KRW 1 million) Source: UBIST The shift in prescription preference is more apparent in the monthly trend of H2RA prescription volume. Since August last year, all H2RAs except for cimetidine recorded increase in prescription volume. For a single drug, famotidine had the steepest rise in prescription volume. In the first half of this year, famotidine drug made 24.8 billion won. Soaring over 3.8 times of last year’s volume, famotidine became one of the top sellers among the H2RAs. In the same time, 16.2 billion won of lafutidine single drugs were prescribed. The volume almost doubled from last year. Nizatidine drugs have made 15.6 billion won, making 1.1 times more than last year. As 13 of nizatidine products were banned in last October, the overall nizatidine prescriptions stagnated for a while. But it bounced back up from early this year, and the overall nizatidine prescription volume surpassed lafutidine from last April. Meanwhile, cimetidine prescription volume fell, although there was no report of NDMA contamination. Cimetidine single drug prescription generated 4.1 billion won in the first half of this year and halved the figure in a year. The setback in API supply seems to have affected a long-term shortage of the finished product and reduced prescription volume. Roxatidine single drug almost doubled in the prescription volume from last year and raised 2.5 billion won, but it still takes the smallest pie in the overall market. ◆Stogar makes 10 billion won and Dong-A Gaster makes 5.2 billion won In the H2RA market, Boryung Pharmaceutical, Dong-A ST and Hanmi Pharmaceutical presumably have benefitted the most from the ranitidine impurity incident. Major H2RA drug prescription volume in H1 2018-2020 (Unit: KRW 100 million) Source: UBIST Boryung Pharmaceutical’s Stogar generated 10 billion won from outpatient prescription volume only and became the most prescribed H2RA single drug. It is on par with Ildong Pharmaceutical’s Curan making 10.5 billion won in the first half of last year. As a result, Stogar’s prescription volume has surged by 58.3 percent from last year. Consisting of lafutidine, Stogar is the first H2RA peptic ulcer treatment to be indicated to eradicate Helicobacter pylori. Boryung Pharmaceutical voluntarily tested four nitrosomines contamination including NDMA, after the government ordered sales ban on ranitidine, and actively promoted the safety of its product supported by the negative test result. 5.2 billion won of Dong-A Gaster by Dong-A ST has been prescribed for outpatients. Leaping by 244.0 percent from last year at 1.5 billion won, the drug came second in the H2RA prescription drug market. Dong-A Gaster with famotidine has been indicated to treat gastic and duodenal ulcer, anastomotic ulcer, upper gastrointestinal bleeding, gastroesophageal reflux disease (GERD), Zollinger–Ellison syndrome (ZES), and to improve acute gastric mucosal lesion induced by chronic gastritis. Before the ranitidine risk arose, Dong-A ST signed a co-promotion deal with Ildong Pharmaceutical on Gaster. Ildong Pharmaceutical created an strong synergy effect by concentrating its sales force on Gaster, when ranitidine single drug Curan was banned. As for Ildong Pharmaceutical, it seems to have somewhat recovered from the damage taken with Curan sales ban. Other famotidine drugs like Hanmi Pharmaceutical’s Hanmi Famotidine and Hutecs Korea Pharmaceutical’s Hutecs Famotidine grew sixfold in a year and placed themselves on the leader board. Hanmi Famotidine and Hutecs Famotidine have generated 3.1 billion won and 2.4 billion won, respectively, in the first half of the year.
- Company
- Celltrion, commercially produce CT-P59 starting in September
- by An, Kyung-Jin Jul 21, 2020 06:10am
- Seo Jung-jin, Chairman at Celltrion from Youtube Seo Jung-jin, Chairman at Celltrion Pharm, announced that the company will begin the production of COVID-19 antiviral antibody treatment that have entered the clinical stage. It is intended to quickly enter the commercialization stage by completing the verification of the adequacy and validity of production facilities early on. On the morning of the 20th, Celltrion held the 3rd online meeting on the new COVID-19 and introduced the progress of R&D. This is an update according to the approval of the phase I clinical trial plan of the antibody 'CT-P59' for the treatment of COVID-19 from the MFDS on the 17th. At the end of February, Celltrion discovered the antibody 'CT-P59', which shows the strongest neutralizing ability, through an antibody screening process that can neutralize the virus by securing the blood of a patient recovered from COVID-19 at the end of February. The first animal experiment with Ferret last month confirmed that the level of COVID-19 in the body was reduced to one-hundredth. Chairman Seo said, “As a result of the hamster experiment conducted in a similar way, the virus fell to less than 1/190. No specificity was found in the toxicity test of monkeys. "The MFDS has comprehensively judged the results of these animal experiments and approved the administration to human subjects," he said. The Celltrion Group plans to focus its entire efforts on clinical development of 'CT-P59' this year. According to Celltrion, there are currently 51 companies that have started developing COVID-19 antibodies similar to Celltrion. Only Celltrion and Regeneron, are conducting their own processes from antibody selection. Celltrion suggested the goal of starting trial administration at Chungbuk National University Hospital this week and completing phase I clinical trial within three quarters. In addition to healthy subjects, consultations with several European countries such as the UK are ongoing in order to evaluate the therapeutic effect of 'CT-P59' in mild and moderate COVID-19 patients, On this day, Chairman Seo dismissed public concern about the risk of development failure due to the mutation of COVID-19. Since it was developed by targeting the S1 region of COVID-19 surface projection protein from the beginning, it is judged that there is no problem with the therapeutic effect of 'CT-P59' at the current variation level. Celltrion confirmed the strong neutralizing ability of 'CT-P59' both before and after mutation as a result of the recent antibody neutralization capacity test conducted by the KCDC. As a plan to prepare for the newly developed mutant virus, the super antibody 'CT-P27', which binds to the S2 site, is being developed at the same time. Celltrion officially announced the start of production of 'CT-P59' in September. It means that about 10 batches are attempted to be used for validation purposes to verify the adequacy and effectiveness of production facilities. It is also intended to review the availability of therapeutic supplies in the first half of next year as soon as they are developed. "It is necessary to secure low cost and production capacity (CAPA) that can be supplied to countries around the world in order for commercial COVID-19 treatment to be commercially successful" said Seo. It is a step that is closely examining how much to keep the inventory of existing products according to the clinical course of 'CT-P59'. It is also considering whether to contract with a contract manufacturing company (CMO) for the smooth supply of COVID-19 antibody. Chairman Seo said, "So far, we are confident of the treatment effect and safety of 'CT-P59' as animal test data. I think it is possible to approve urgent use according to the results of phase II clinical trials." “we will do our best to complete the development and production of COVID-19 antiviral antibody treatment while contributing to the end of COVID-19 crisis."
