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- 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 Initially, the license on the Korean company’s generic Nocotine tablet was revoked, but it came back to the market with Nocotine S tablet with different substance.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 In 2018, Hanmi Pharmaceutical released Nocotine tablet, but its license was revoked by Ministry of Food and Drug Safety (MFDS) on July 14.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."
- Company
- Complaint on how NHIS unveiled pricing negotiation guideline
- by Eo, Yun-Ho Jul 20, 2020 06:19am
- The pharmaceutical industry in Korea is complaining on how National Health Insurance Service (NHIS) announced the drug pricing negotiation guideline. According to the industry sources, Korean Research-based Pharmaceutical Industry Association (KRPIA) has recently submitted a statement to NHIS regarding the public opinion collection procedure. At the second biannual meeting convened between NHIS and pharmaceutical industry organization on July 8, the government body has presented the detailed guideline on risk sharing agreement (RSA)-covered drug pricing negotiation, general drug pricing guideline and detailed operation guideline on price-volume agreement (PVA) negotiation. However, NHIS officials retrieved the disclosed guideline information, regardless of the organizations’ prior demand, immediately after presenting them. The participants of the meeting had to suggest limited opinions without the time to thoroughly review the guideline. And as NHIS stated the guideline would not be disclosed properly in the future, the industry organization criticized the government body for the lack of proper communication. Accordingly, KRPIA urged the government to disclose the revision for all industry entities to thoroughly review the material and to collect their opinions for further improvement in the system. In fact, the Health Insurance Review and Assessment Service (HIRA) has previously accepted the public opinion on the guideline and detailed evaluation criteria on negotiating drug for 80 days, as much as Ministry of Health and Welfare (MOHW) does for the administrative notice period. The industry source said, “The government demanding for suggestion when creating a situation without letting the industry fully understand the details is completely unfair. A guideline is practically a regulation that realizes criteria and statutes, therefore, disclosing the details to collect the public opinion is essential.” Meanwhile, the revision NHIS has unveiled included adding drug requiring negotiation or pricing calculation, fine-tuning regulations and expanding subject for RSA among drugs approved with Phase III clinical evidence development, and revising the detailed guideline on the PVA negotiation.
- Company
- Prescription performance has been recovering since June
- by Chon, Seung-Hyun Jul 20, 2020 06:19am
- The overall outpatient prescription growth in the first half of this year has slowed. It remained at the same level as last year in the aftermath of COVID-19. However, prescription performance has been recovering since June, unlike April and May. As the fear of COVID-19 spread in the first quarter, patients received prescriptions all at once and total prescription volume decreased in April and May, but it is analyzed that the prescription market has also been revitalized after the return to normal social activities. According to UBIST on the 15th, the total outpatient prescription amount in the first half of last year was ₩7.35 trillion, a 0.02% decrease from the previous year. Although the prescription performance has been growing every year, it has been slowing down this year. Rx amount & increase/decrease rate in the first half of each year (Unit: ₩100 million, %, Source: UBIST)The prescription amount in the first half of last year rose 6.9% from the previous year. In the first half of 2017 and the first half of 2018, the prescription amount increased by 5.6% and 8.1%, respectively. The prescription amount in the first quarter was ₩3,703 billion, an increase of 2.7% from the previous year. However, the prescription amount in the second quarter decreased by 2.7% to ₩3,647.4 billion. In the first and second quarters of 2019, the outpatient prescription prices rose 5.5% and 8.3%, respectively, compared to the previous year, but the prescription market was sluggish in the second quarter of this year. It is analyzed that the prescription market in 2Q was slow in the aftermath of COVID-19. It is analyzed that a large number of prescription gaps occurred in the second quarter as patients who were reluctant to visit medical institutions, especially those with chronic diseases, were prescribed large quantities of medicines at a time. It has been reported that the number of patients receiving prescriptions for 3 to 6 months in advance increased significantly when the number of COVID-19 confirmed patients increased. In addition, it is estimated that the number of visits to hospitals may have decreased as the frequency of disease occurrence among infants and children has decreased due to factors such as postponement of school, social distance, and strengthening of personal prevention of epidemics. Quarterly Rx amount trend (Unit: ₩100 million, Source: UBIST) The size of the prescription market in January was ₩1.25 trillion, a 4.4% decrease from the same period last year. However, the prescription amount in February increased by 13.0% to ₩1.21 trillion. As New Year holidays were pulled to January earlier than the previous year, the increase/decrease rate of the prescription amount in January and February was analyzed to vary. In March, the total prescription amount increased to ₩1.23 trillion, up 1.4% from the previous year, and the prescription market in the first quarter remained stable despite the spread of COVID-19. In the second quarter, the outpatient prescription amount in April was ₩1.19 trillion, a 8.7% decrease from the same period last year. In April 2018 and April 2019, the prescription amount increased 8.3% and 13.1%, respectively, compared to the same period last year, but this year it has declined. In May, the total outpatient prescription amount was ₩1.16 trillion, a decrease of 9.4% from the previous year. It fell 1.8% from April, the lowest this year. Monthly outpatient Rx amount trend (Unit: ₩100 million, Source: UBIST) It is interesting to note that the prescription market has recovered rapidly since June. The prescription scale last month was ₩1.26 trillion, 11.7% higher than last June. Prescriptions in June 2018 and 2019 rose 5.0% and 3.0%, respectively, from the previous year. It was significantly higher than the previous year despite COVID-19 outbreak. the prescription drug market in April and May was temporarily sluggish due to the fear of COVID-19 in the first quarter, and it seems to have regained growth from June. In particular, when the number of COVID-19 confirmed patients surged mainly in Daegu & Gyeongbuk, the sales activities of pharmaceutical companies also contracted significantly. Since the first COVID-19 confirmed patient in Korea on January 20, pharmaceutical companies have refrained from visiting salesmen to medical institutions. Since the middle of February, the number of COVID-19 patients has increased rapidly, and most of the pharmaceutical companies' salespeople have entered telecommuting. A significant number of patients received long-term prescriptions at one time and it is analyzed that they caused a prescription gap in April and May. The prescription drug market seems to have recovered since the spread of COVID-19 patients began to stabilize in April and social distance campaign had shifted to distancing in daily life. The size of prescription amount in the market is also estimated to have stabilized since June. In the industry, it is continually increasing due to the increase of the elderly and chronic patients. It is said that the entire industry will not contract due to short-term issues such as infectious diseases. According to the analysis, unlike the tourism and cultural industries, it is difficult to lead to a sudden recession because the pharmaceutical industry is affected by patient demand rather than the external environment.
- Company
- Rx of NOAC is recommended in COVID-19 epidemic
- by Eo, Yun-Ho Jul 17, 2020 05:55am
- NOAC products in KoreaThe need for prescription of New Oral Anti-Coagulant (NOAC) is also emerging in COVID-19 outbreak. NOAC does not require periodic INR (International Normalized Ratio) monitoring, thus reducing visits to clinics unlike Warfarin. For this reason, NOAC is a good treatment option for patients who are unable to go to the hospital or need long-term prescription due to self-isolation. At the Anticoagulation Forum (AC Forum), which consists of antithrombotic therapists around the world, Warfarin-treated patients who can convert to NOAC are recommended to switch to NOAC to minimize the risk of COVID-19 exposure because frequent hospital visits increase the risk of exposure to COVID-19. Similarly, the National Institutes of Health (NIH) published in the '2020 COVID-19 Treatment Guidelines' included the need to consider switching from Warfarin to NOAC for isolated patients, and many societies including the Royal Pharmaceutical Society in the UK have worked together to establish guidelines for the safe switching from Warfarin to NOAC in March this year. The guidelines provide detailed information, including a patient population that can switch from Warfarin to NOAC, a safe switching process, and features and checklists for each NOAC product. .An official from the Korean Heart Rhythm Society said, “I agree with the recommendation to expand the NOAC prescription in COVID-19 situation .I think NOAC is a drug that can be prescribed by clinics ."Things are different now .I think it will not be a problem if the condition of the patient, such as renal function, is checked and prescribed according to the permission,." Meanwhile, according to the '2018 KHRS Expert Consensus Recommendation for Oral Anticoagulants Choice and Appropriate Doses: Specific Situation and High Risk Patients', 'Eliquis (Apixaban, NOAC)' is first recommended for high-risk patients with advanced age, decreased renal function, and gastrointestinal bleeding .This drug has been confirmed by ARISTOTLE, a major clinical trial, to reduce the risk of stroke and systemic embolism, and to reduce the risk of major bleeding and mortality, compared to Warfarin in patients aged 75 years and older.
- Company
- Korean-made IMD Rosuzet and Zemimet prevail over COVID-19
- by An, Kyung-Jin Jul 17, 2020 05:55am
- Apparently a number of incrementally modified drugs (IMDs) developed with Korean-made technology excelled in the prescription drug market amid novel coronavirus (COVID-19) pandemic. A dyslipidemia combination drug Rosuzet and an antidiabetic combination drug Zemiglo recorded two-digit growth and settled on the top chart in the prescription drug market. On the contrary, other off-patent drugs by multinational pharmaceutical companies seemed to have stagnated in the growth. According to pharmaceutical market research firm UBIST on July 17, Pfizer Pharmaceutical Korea’s Lipitor was prescribed the most in the first half of the year, making 94.1 billion won. Although the sales fell by 0.9 percent compared to 95 billion won in last year, Liptior made more than double the sales of Daewoong Bio’s Gliatamin. Lipitor product image Lipitor, indicated to treat dyslipidemia, is an atorvastatin Pfizer Pharmaceutical Korea has launched for the Korean market in 1999. When its patent was expired, over 130 generics flooded the market, but the dyslipidemia drug has never been ranked below second place in the prescription drug market. Daewoong Bio’s cognitive enhancer Gliatamin generated total 48 billion won in the first half of the year, and came second on the rank. Compared to last year same time with 46 billion won, the drug made 4.4 percent growth. Gliatamin is a choline alfoscerate generic. Another competitor Chongkundang Gliatirin has made 39.8 billion won with 6.9 percent growth from last year, but it could not narrow the gap of 8 billion won with Gliatamin. Rosuzet (left) and Zemimet product images Among the top products, Hanmi Pharmaceutical’s Rosuzet had the highest yearly growth. Rosuzet generated 46.9 billion won in the first half of the year and leapt 24.4 percent from last year. Bascially, it was prescribed 8 billion won a month. Released in late 2015, Rosuzet is a combination drug (rosuvastatin plus ezetimibe) indicated for treatment of hyperlipidemia. Hanmi Pharmaceutical signed a deal with the ezetimibe patent owner MSD over the use of the drug, and entered the market first. The drug is dominating the same substance market among other competitors by far. The monthly Rosuzet prescription volume maintained over 10 percent growth compared to last year, regardless of the difficulties in sales and marketing caused by COVID-19. When the confirmed case of COVID-19 in Korea skyrocketed from February through March, the prescription volume growth broke through the 30-percent and 40-percent line. Continuing the current trend, the drug could generate over 100 billion won at the end of the year. Zemimet, an antidiabetic combination drug by LG Chem, also scored a high growth rate. In the first half of the year, Zemimet’s prescription surged by 18.5 percent from last year at 32 billion won to 37.9 billion won this year. LG Chem independently developed the dipeptidyl peptidase 4 (DPP-4) inhibitor by combining the novel antidiabetic treatment Zemiglo (gemigliptin) and metformin. With the co-promotion deal signed in 2016, Daewoong Pharmaceutical has been in charge of the drug’s sales. Atozet, MSD Korea’s combination drug for hyperlipidemia treatment, also demonstrated two-digit growth. The accumulated prescription volume in the first half of the year was increased by 17.5 percent from last year and generated 36.4 billion won. Atozet is a combination drug, consisting of atorvastatin and ezetimibe, which competes against Rosuzet. The drug is currently in a co-marketing deal with Chong Kun Dang since 2018. Top 20 outpatient prescription drug market in 2020 H1 (Unit: KRW 100 million) Source: UBIST Similarly to previous years, the outpatient prescription drug market in the first half of this year was vastly dominated by off-patent drugs. But their growths were underwhelming than previous years. Two hepatitis B treatments once led the prescription drug market plummeted down the rank together. Gilead Science Korea’s Viread (tenofovir disoproxil fumarate) made 43.1 billion won with a 27.3-percent plunge from last year at 59.2 billion won. This year’s prescription of BMS Pharmaceutical Korea’s hepatitis B treatment Baraclude (entecavir) marked 34.8 billion won, dipping 10.8 percent from 39 billion won last year. Eisai Korea’s cognitive enhancer Aricept (donepezil) and Astellas Pharma Korea’s benign prostatic hyperplasia (BPH) Harnal-D (tamsulosin) generated 8.0 percent and 8.2 percent less than last year, respectively. AstraZeneca’s anticancer treatment Tagrisso (osimertinib) placed itself on the top sixth spot by generating 44.7 billion won with 7.9 percent growth from last year. Tagrisso is a second-line treatment for patients with non-small cell lung cancer, who developed tolerance after administering epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) like Iressa (gefitinib), Tarceva (erlotinib) or Giotrif (afatinib). After it was listed for healthcare reimbursement in December 2017, the treatment’s prescription volume has been surging significantly. Despite the expensive treatment costing 120,000 won even for a reimbursed prescription, it is the only anticancer treatment ranked high in the outpatient prescription drug market, due to its convenience in oral administration.
- Company
- 2nd single-agent immunotherapy added for NSCLC first-line
- by Eo, Yun-Ho Jul 16, 2020 05:55am
- Another immunotherapy is expected to be added as a first-line treatment option in lung cancer. The pharmaceutical industry sources reported, Roche Korea has recently submitted an application to Korea’s Ministry of Food and Drug Safety (MFDS) to indicate programmed death-ligand 1 (PD-L1) inhibiting immunotherapy Tecentriq (atezolizumab) as a first-line treatment in non-small cell lung cancer (NSCLC). When Tecentriq’s indication expands in Korea, it would directly compete against MSD’s PD-L1 inhibitor Keytruda (pembrolizumab) in the NSCLC treatment market. Tecentriq’s efficacy as a first-line treatment in NSCLC was confirmed in a clinical trial ‘IMpower110.’ The study compared the immunotherapy against chemotherapy in treating 572 of PD-L1-selected, chemotherapy-naïve patients with Stage 4 or later NSCLC without ALK or EGFR mutations. The result found the efficacy of Tecentriq performed better than chemotherapy in patient group with PD-L1-stained in over 50 percent of tumor cells (TC), or PD-L1-statined tumor-infiltrating immune cells (IC) covering over 10 percent of tumor area. The Tecentriq administered group reached overall survival (OS) at 20.2 months, improving the figure by 7.1 months compared with chemotherapy at 13.1 months. Also for progression-free survival (PFS), the Tecentriq group (8.1 months) demonstrated better than the chemotherapy group (5 months). However, comparing the groups with TC over 1 percent but less than 50 percent, and IC over 1 percent but less than 10 percent, the improvement by Tecentriq is statistically insignificant. Accordingly, the U.S. Food and Drug Administration (FDA) has indicated Tecentriq for the first-line treatment of patients with TC over 50 percent or IC over 10 percent, and the company applied for indication expansion in Korea with the same standard. Meanwhile, Keytruda has been in a discussion with the government for over two years about extending the coverage on single and combined-agent first-line treatment in NSCLC. After the Cancer Deliberation Committee has deferred the decision last month, the coverage extension has returned to the Cancer Deliberation Subcommittee. But reportedly, the health authority and the company have not reached a clear agreement.
- Company
- Influenza vaccine inoculation rate doubled from last year
- by Jul 16, 2020 05:54am
- n the aftermath of COVID-19, the number of influenza vaccination in the National Essential Immunization Vaccine (NIP) increased significantly in the first half of this year. On the other hand, for the same reason, other essential vaccination rates are rather have declined. According to the KCDC on the 13th, the number of NIP inoculations from January to June 2020 was 5,305,373 cases. This is a 13% decrease from the same period last year. The prominent part is the flu (influenza) vaccination rate. The only number of inoculants increased. Adults and the elderly increased 234% from 4,035 cases in the first half of last year to 13,462 this year. During the same period, the number of vaccinations for children's flu also increased by 16% from 144,080 to 166,483 cases. It is analyzed that this change has a large impact on COVID-19. The industry believes that the spread of COVID-19 has increased the number of patients who are concerned about worsening respiratory immune function and are looking for a flu vaccine as a preventive measure. Data: The KCDC In particular, in the case of the flu in the 2019-2020 season, the number of inoculums increased slightly from last year due to the aftermath of COVID-19 in the second quarter, despite the release of the watch on March 27, three months earlier than last year. Another change is the NIP range of adult flu vaccination that has expanded since the third quarter of last year. The government has added a pregnant woman to the adult flu vaccine NIP since September of last year. However, the vaccination rate of the vaccines excluding the flu fell significantly. The vaccination rate of BCG (tuberculosis) vaccine fell 41% year-on-year, and the MMR (measles, mumps, rubella) vaccine also decreased by 35%. The number of MMR vaccines in the first half of last year was 553,875 cases, but this year only 359,022 cases. In the same period, the vaccination rate of the IPV (poliomyelitis) vaccine also decreased by 31% from 101,225 to 69,999 cases. The pneumococcal vaccination rate targeting people over 65 also decreased by 17%, raising concerns that vaccination is urgent. Pneumococcus is one of the leading causes of pneumonia, especially fatal in the elderly. The KCDC focused on emphasizing pneumococcal immunization by expanding the number of inoculation institutions to private hospitals and clinics (designated medical institutions), fearing that the utilization rate of the intensive care unit in COVID-19 outbreak will increase due to the occurrence of serious ill patients due to pneumococcal infections and complications. In addition to this, vaccination rates, such as Japanese encephalitis vaccines (inactivated vaccines·live attenuated vaccine), hepatitis A (HepA), hepatitis B, and pneumococcal (PCV), all decreased, except for the human papillomavirus (HPV) vaccine. The KCDC urged the mandatory immunization to be immunized, saying, "If the immunization is delayed or discontinued, it may be necessary to respond to the epidemic of infectious diseases targeted for immunization such as measles in addition to COVID-19 response by the end of 2020."
