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- 2026-03-17 19:30:53
- Company
- Hugel's toxin has been approved for national lot release
- by Nho, Byung Chul Nov 17, 2021 05:44am
- Status of approval for national lot release of Hugel toxin drugs published in the MFDS. As Hugel recently obtained approval from the Ministry of Food and Drug Safety for three types of botulinum toxin products, administrative measures such as "cancellation of permission" and "suspension of product sales" on the 10th proved once again that there was a difference in legal interpretation of indirect exports, not quality and safety issues. According to the status of national lot release approval for botulinum toxin posted on the website of the MFDS, Hugel received approval for 50 units of botulinum toxin formulation Botulax and 200 units of Botulax on the 15th. A day later, on the 16th, domestic sales of three Botulax products resumed as additional approval for 100 units of Botulax was obtained. Including the number of national lot releases, Hugel has obtained 156 cumulative approvals this year. It is the largest number of botulinum toxin companies in Korea. Competitors Daewoong Pharmaceutical, Medy Tox, and Huons have obtained national lot release approval for 84, 80, and 44 cases, respectively. Earlier on the 10th, the MFDS announced that it would start administrative disposition, collection, and disposal procedures for the company's products against Hugel for violating the national lot release. Hugel immediately announced its position and applied for cancellation and suspension of execution, including an order to suspend manufacturing and sales, to the Seoul Administrative Court on the same day. On the morning of the 11th, the next day, it submitted a provisional application for suspension of execution of the Ministry of Food and Drug Safety's disposition, and the court cited it, enabling the sale of four types of Botulax in Korea. An official from Hugel said, "This disposition by the MFDS is only a problem caused by differences in legal interpretation of indirect exports to the Pharmaceutical Affairs Act, and has nothing to do with the product quality of Botulax manufactured and produced by Hugel." He said, "Hugel has received the national lot release without any problems in terms of quality such as effectiveness and safety in compliance with the Pharmaceutical Affairs Act." Biological agents such as botulinum toxin must be approved for lot release to be sold in Korea.
- Company
- Rinvoq combo rises as optimal option in rheumatoid arthritis
- by Nov 17, 2021 05:44am
- AbbVie’s JAK inhibitor ‘Rinvoq (upadacitinib)’ in combination with MTX was found to improve the clinical remission achievement rate over the TNF-α inhibitor ‘Humira (adalimumab)’ combination therapy in rheumatoid arthritis. The Rinvoq combination therapy achieved a 20% range remission rate in the most commonly used DAS28 index as well as the strictest Boolean index. In the SELECT-COMPARE trial that was conducted on patients who had an inadequate response to MTX, 29% of the patients treated with Rinvoq+MTX achieved clinical remission per DAS28 at Week 12, which is a higher rate than the 18% in those treated with the adalimumab combination. Such results were consistent under other evaluation indexes such as the SDAI, CDAI, Boolean index. The differences were also consistent in the evaluations made at Week 26 and Week 48. At Week 48, Rinvoq’s remission achievement rate was 38% per DAS28, 25% per CDAI, and 21% per Boolean. Achievement of clinical remission in SELECT-COMPARE trial by disease activity evaluation index ◆Rinvoq maintained a 20% range remission rate with the Boolean index, a more stringent index than DAS28 DAS28 is the most widely used index to measure the achievement of clinical remission in rheumatoid arthritis, but Boolean is considered the most stringent index. First, DAS28 is evaluated using three thresholds in 28 joints - tender joint count (TJC), swollen joint count (SJC), and patient pain score on a visual analog scale (VAS). DAS28-CRP, which adds the C reactive protein (CRP) that is related to the progression of rheumatoid arthritis to DAS28, is most widely used. With the Boolean index, the ▲number of tender joints (TJC)≤1 ▲number of swollen joints (SJC)≤1 ▲CRP≤1mg/dL ▲Patient Comprehensive Assessment (PGA)≤1 (on a scale of 0-10) needs to all be satisfied to be considered to be in remission, therefore the range considered and accepted as remission is narrower with the Boolean index. This is why a study that analyzed the remission achievement rate of 3,209 rheumatoid arthritis patients in Korea with five disease activity indexes showed that the Boolean index had the lowest patient remission rate. ◆Remission achievement rate low for existing treatments when measured by various indexes…”We should consider new treatment options to meet new treatment goals” Based on data from the Korean College of Rheumatology Biologics Registry (KOBIO), the KCR Clinical Research Committee had previously presented the reemission achievement rate of rheumatoid arthritis patients who have been treated with biologics and oral targeted therapies during the past 5 years. Treatments included in the analysis were TNF-α inhibitors such as Humira, etc.; ‘Actemra (tocilizumab),’ ‘Orencia (abatacept),’ and ‘Xeljanx (tofacitinib).’ The KCR analyzed the remission achievement rate of the treatments above with five disease activity assessment indexes - DAS28-CRP, DAS28-ESR, CDAI, SDAI, Boolean - and the result showed that the achievement rate differed greatly by index. At week 48 after starting treatment, the remission achievement rate was near 56.0% per DAS28-CRP, but the dropped greatly to 10.4%, 12.7%, and 12.9% per more stringent indexes such as CDAI, SDAI, and Boolean, respectively. The rate of patients that maintained remission for 2 or more years, or ‘continuous remission,' was 62% per DAS28-CRP, but 8%, 11%, 13% per CDAI, SDAI, Boolean, respectively. With the remission rate of existing treatments falling to a 10% range in indexes that are relatively stringent compared to DAS28, the analysis was that a more detailed consideration is needed in setting a treatment strategy. Young-Il Seo, professor of Rheumatology at Hallym University Sacred Heart Hospital Pyeongchon, said, “the low remission achievement rate observed with CDAI, SDAI, and Boolean index suggests that patients experience greater difficulties in reality and that improvements are needed to increase treatment satisfaction. In this sense, we would need to more actively consider using treatment options that meet various indexes.”
- Company
- Exports of Botulinum drugs to the U.S. doubled
- by Kim, Jin-Gu Nov 17, 2021 05:44am
- The cumulative exports of domestic botulinum toxin drugs amounted to 220 billion won this year, the report showed. Exports to China, which had consistently accounted for a high proportion, have decreased, but exports to the U.S. and other countries have increased. According to the Korea Customs Service on the 15th, the cumulative exports of domestic botulinum toxin drugs amounted to $190.28 million between January and October this year. Compared to $161.09 million during the same period last year, it increased 18%. Looking at major exporters, dependence on China has decreased significantly compared to last year. Instead, exports to the U.S. and Brazil increased. Between January and October this year, domestic botulinum toxin exports to China amounted to $78.11 million, down 13% from $89.97 million during the same period last year. During the period, China's share of total botulinum toxin exports decreased by 15%p from 57% to 42%. Exports to the United States increased 110% from $12.2 million to $25.61 million. The share of U.S. exports increased from 8% to 13%. It is analyzed that exports to the U.S. more than doubled due to the end of the Nabota-related dispute. Earlier this year, Daewoong Pharmaceutical's U.S. partner Evolus concluded the dispute with Medy Tox and Allergan by agreement. Since then, Nabota's monthly exports to the U.S. have been around $2.5 million to $3 million. This is in contrast to exports from the second half of 2019 to the beginning of last year, when the dispute was in full swing. In addition to the U.S., exports to Brazil and Japan have increased. In Brazil, it increased 59% from $10.5 million between January and October last year to $16.74 million between January and October this year. In the case of Japan, it increased 39% from $6.54 million to $9.11 million during the period. Thailand, a major exporter, fell 16% from $13.83 million to $11.58 million. As exports to Brazil increased significantly during the same period, the third-largest exporter of domestic Botulinum toxin changed from Thailand to Brazil.
- Company
- Celltrion's COVID-19 tx is approved for sale in Europe
- by Chon, Seung-Hyun Nov 17, 2021 05:44am
- Regkirona, a COVID-19 antibody treatment developed by Celltrion, has been approved in Europe. Celltrion announced on the 15th that the EC approved Regkirona on the 12th (local time) for the final sale for the purpose of treating COVID-19. Regkirona has been approved for the treatment of adult patients aged 18 or older who have been confirmed with COVID-19 who do not require oxygen supply and are likely to be severely transmitted. It is a single administration of 60 minutes intravenously, the same as domestic item permission. Regkirona officially received an item license from the EC a day after obtaining an approval recommendation from the CHMP under the European Medicines Agency (EMA) on the 11th. Celltrion said, "If CHMP usually recommends approval for new drug approval, EC's final item approval will be completed 1-2 months later, but in this case, official item approval continued in a day," and explained, "It can be interpreted as an EC-level effort to quickly cope with the surge in the number of COVID-19 confirmed cases in Europe." Regkirona is the first new antibody drug developed in Korea to obtain an official item license in Europe. Regkirona obtained emergency approval from the BPOM and the ANVISA in July and August, and in September, it obtained a formal item license from the MFDS in Korea. Regkirona is administered to 22,587 patients in 129 hospitals as of the announcement of Central Disaster and Safety Counters Headquaters (CDSCHQ) on the 12th and is actively used to treat COVID-19 patients in Korea. Regkirona confirmed the safety and effectiveness of the global phase 3 clinical results conducted on 1,315 mild and moderate COVID-19 patients in 13 countries around the world, including Korea, the United States, Spain, and Romania. In the high-risk group of patients administered Regkirona, the incidence of severe patients decreased by 72% compared to the placebo group, and the clinical symptom improvement time was also reduced by more than 4.7 days compared to the placebo group in the high-risk group. An official from Celltrion said, "We will do our best to help many COVID-19 patients in Europe benefit from Regkirona's proven safety and effectiveness, and to contribute to the end of the global COVID-19 crisis."
- Company
- Drug price negotiations for Xospata began
- by Eo, Yun-Ho Nov 16, 2021 05:53am
- The new leukemia drug Xospata is in the final procedure for insurance benefit registration. According to related industries, Astellas recently entered into drug price negotiations with the NHIS for Xospata(Gilteritinib), a treatment for Acute Myeloid Leukemia (AML). The negotiation deadline is until the 20th of next month. After receiving a conditional benefit decision at the HIRA's Drug Reimbursement Evaluation Committee in September, the drug accepted the proposed valuation amount and went through a drug price negotiation process. It remains to be seen whether Xospata will be able to complete negotiations with the government until the end and be listed. Xospata is the first FLT3 targeted anticancer drug in Korea to be approved by the MFDS as a target treatment for FLT3 mutation positive (FLT3mut+) recurrence or refractory (R/R) AML. This drug targets both FLT3-ITD and FLT3-TKD, which are divided into two mutant forms, and is a monotherapy that is taken once a day and can be treated on its own at home without frequent hospital visits. It also showed higher effectiveness and safety than conventional chemotherapy. In addition, Xospata has been classified as 'Category 1', the highest recommended grade for the treatment of patients with recurrent or refractory AML with positive FLT3 mutation in the latest guidelines of NCCN. Kim Hee-je, a professor of hematology at Seoul St. Mary's Hospital, said, "With the approval of Xospata in Korea, patients can relieve anxiety. Of course, there are still cost issues, but we expect it to become a standardized treatment as soon as possible after registering benefit, the professor said.
- Company
- Somavert can be prescribed at general hospitals
- by Eo, Yun-Ho Nov 16, 2021 05:52am
- According to related industries, Pfizer Korea's Somavert (Pegvisomant) has currently passed the Drug Committee (DC) of medical institutions such as Seoul National University Hospital and Sinchon Severance Hospital, and is also undergoing procedures at medical institutions such as Seoul National University Bundang Hospital, Wonju Severance Hospital, and Samsung Medical Center. In the case of terminal hypertrophy, Sinchon Severance Hospital is taking care of the largest number of patients, so it is expected to lead to prescription fast. Somavert has been listed on the insurance benefit list since September. Somavert demonstrated its validity through a 12-week randomized, double-blind study of 12 patients with terminal hypertrophy. The study found that the median serum IGF-I concentration at 12 weeks of study compared to the baseline was 4.0±16.8%, 26.7±27.9%, 50.1±26.7%, and 62.5±21.3%, respectively, in the placebo group, Pegvisomant 10 mg group, Pegvisomant 15 mg group, and Pegvisomant 20 mg group. The proportion of patients whose serum IFG-I concentration returned to normal compared to baseline was also found to be significantly higher than that of placebo, Pegvisomant 10 mg/day administration group, Pegvisomant 15 mg/day administration group, and Pegvisomant 20 mg/day administration group, respectively, indicating that Pegvisomant was significantly higher than placebo. Meanwhile, Somavert was approved in Korea in September last year for the treatment of adult terminal hypertrophy patients who do not respond appropriately to surgery and radiation therapy, or whose IGF-I (Insulin-like growth factor I) concentration is not normalized by somatostatin analog therapy, and was designated as a rare drug in 2018.
- Company
- Sales of Arcoxia (Etoricoxib) are sluggish
- by Kim, Jin-Gu Nov 16, 2021 05:52am
- Generics for Arcoxia, an anti-inflammatory pain reliever based on COX-2 inhibitors (Etoricoxib) have been released, but sales in the market are sluggish. This is because there is still a high preference for original drugs at the medical site, and even the original drugs are pushed back by Celebrex, a leading item in the same family market. According to UBIST, a pharmaceutical market research firm on the 11th, the total prescription amount for generics for Arcoxia from June to September is around 31 million won. During this period, the original prescription amount is around 730 million won. Generic prescriptions account for only 4% of the original. Generics challenged Arcoxia's patent in September 2019. In April last year, it won the passive trial to confirm the scope of rights. It succeeded in avoiding patents that were scheduled to expire in 2023. Theragen Etex, Guju, Hana, Hutechs, Union Korea, Aju, Daewoo, Boryung, Arlico, and Reyon received generic for exclusivity from April this year to January next year. Generics have been released in earnest since June this year. Aju, Arlico, Hutechs, Hana, Theragen, and Etex are confirmed to have released generics one after another. However, for four months, their total prescription amount is only 31 million won. Hana's sales are the highest at 19 million won, and sales of the other generics are less than 10 million won. This is because the original preference is still high at the prescription site. As of last year, outpatient's prescription for Celebrex amounted to 44.7 billion won. It is more than 12 times Arcoxia's sales of 3.5 billion won.42 billion won and 2.7 billion won worth of prescriptions were prescribed by the third quarter, respectively, widening the gap by 15 times. Since 2010, more than 200 generics for Celebrex have been competing. Generics for Arcoxia have little time to compete. The generic for exclusivity period will end in January next year, but no company has started developing generics for Arcoxia yet.
- Company
- The price reduction of PE waiver drugs
- by Eo, Yun-Ho Nov 15, 2021 06:29pm
- KRPIA expressed serious concern in a comment on the 10th that the HIRA was confirmed to evaluate the cost effectiveness at 80% of the lowest A7 adjustment price when asked about the cost-effectiveness criteria of Kim Mi-ae, a member of the National Assembly. KRPIA said, "In the course of discussions with the HIRA, we have repeatedly expressed opinions that uncertainties arising from the application of the risk-sharing system in A7 countries should be flexibly evaluated according to the characteristics of each drug." In addition, it pointed out, "If the figure of 80% for which the basis for calculation is not clear is applied collectively, access to drugs subject to PE exemption, which are limited to patients with rare and severe diseases, may be severely reduced." The PE waiver drug system is mandatory to limit the total amount of annual use in response to uncertainties in A7 national indicators, and if overseas prices are further lowered during the follow-up period, tight financial management is already taking place. KRPIA said, "If we have to further cut the drug price by 20% to 80% of the lowest price in A7 countries, PE waiver drugs will actually be privately cultured. In addition, considering the purpose of the system to guarantee drug prices for drugs that need to be registered, if the HIRA sets the lowest price as an internal operating standard and applies it collectively to all drugs, there is a possibility of abuse of discretion in violation of the principle of trust protection." In addition, it pointed out that it could violate the national treatment regulations of the Korea-US FTA and the Korea-EU FTA, stressing that if the administration is operated based on an undisclosed internal operation standard and the evaluation criteria of PE waiver drugs are changed, it can be seen as a de facto discrimination measure. KRPIA said that the HIRA-industry meeting on June 17 and the MOHW's public-private consultative body on July 28 consistently argued that the application of specific figures is inappropriate and should be evaluated according to the characteristics of each drug.
- Company
- Will sales of flu treatments be recovered?
- by Chon, Seung-Hyun Nov 15, 2021 05:56pm
- According to UBIST, a drug research institute, on the 14th, the amount of outpatient prescriptions for flu treatments in the third quarter was only 7.97 million won. It fell 31.1% year-on-year. It decreased by 75.2% from the same period two years ago. The flu treatment market has been prescribing less than 100 million won for six consecutive quarters since the second quarter of last year. The market size has been insignificant since it plunged 99.8% to around 10 million won in the second quarter after hitting 8.4 billion won in the first quarter of last year. The prescription amount in the fourth quarter of last year and the first quarter of this year, which are flu epidemic seasons, was only 20 million won and 10 million won, respectively. Quarterly outpatient Rx amount for flu tx (unit: 1 million won, data: UBIST) Sales in the Oseltamivir market, the most prescribed flu treatment, have decreased significantly. Oseltamivir is the active ingredient of Tamiflu. In the third quarter, the prescription for Oseltamivir was only 7.97 million won. It fell 31.1% year-on-year and 74.3% year-on-year. Oseltamivir prescription performance soon becomes sales in the entire flu treatment market. Since the third quarter of last year, the overall prescription performance of Oseltamivir has occurred only in one item of Tamiflu. Since the third quarter of last year, there seems to be no flu treatment except for Tamiflu. This is a change in the prescription market due to the prolonged COVID-19. This is because after the spread of COVID-19, the incidence of infectious diseases has decreased significantly due to strengthening personal hygiene management such as washing hands and wearing masks, and only Tamiflu has been prescribed when patients occasionally occur. According to The KDCA, the number of suspected flu patients per 1,000 outpatients has never exceeded the epidemic standard of 5.8 this year. Status of influenza suspected cases per 1,000 outpatients (unit: name, data: the KDCA) In the ninth week of last year, the number of suspected flu patients per 1,000 outpatients recorded 6.3 and remained at the level of two to three. There have been few flu patients for about a year and eight months since early March last year. Even this month, when the winter season began in earnest, the number of suspected flu patients per 1,000 outpatients was only 3.3. In this situation, the possibility of the spread of infectious diseases such as the flu is being raised as face-to-face contact expands due to the lifting of the time limit for multi-use facilities due to the daily recovery of COVID-19. However, it is unlikely to lead to a sudden spread of infectious diseases as hygiene management such as wearing a mask is still strictly observed. An industry official said, "Since there have been few flu patients this year, production and supply of flu treatments have been virtually suspended," adding, "We will consider expanding the production and supply of treatments while looking at the increase in the number of patients."
- Company
- K-COVID-19 vaccine developers will ‘power through till end'
- by Kim, Jin-Gu Nov 15, 2021 05:56am
- Domestic vaccine developers have been accelerating the last phases of their clinical trials. SK Bioscience and Genexine have started Phase III trials in Korea and abroad, and Cellid has submitted its Phase IIb/III clinical trial plan. Domestic developers have come up with new strategies to continue the development of their vaccines with the value of latecomer vaccines lowering due to the domestic vaccination rate reaching nearly 80% in Korea and the introduction of oral COVID-19 treatments imminent. ◆Cellid applied for Phase 2b/3 trial… starts development of a vaccine against variants If the clinical trial protocol is approved, the Phase IIb clinical trial will be conducted on 125 participants, and Phase III on 4,100 participants. The Phase III trial will compare AdCLD-CoV19-1 with AstraZeneca’s COVID-19 vaccine. Cellid has started a new clinical trial for its existing candidate ‘AdCLD-CoV19' after revising its virus vector. The production yield rate change has improved with the revision of the virus vector. Upon completing the phase 2a trial, Cellid said in June that it would newly develop AdCLD-CoV19-1, a revised version of the virus vector vaccine, for mass production. In addition, the company obtained the regulatory nod for a phase 1 study of AdCLD-CoV19. Apart from this, Cellid is also concurrently developing a new vaccine candidate that responds to COVID-19 variants including the Delta variant. Animal testing is currently underway for the new vaccine candidate. Cellid expects it would be able to enter Phase I clinical trials for its variant vaccines next year at the earliest. The company’s experience with its Phase IIb/III trial for AdCLD-CoV19-1 is expected help accelerate its development. Cellid’s two-track development strategy is not unrelated to the COVID-19 vaccine and treatment development situation in Korea and abroad. With the market value of latecomer vaccines decreasing, the companies have explained that the changes in their development strategies were inevitable. As of midnight on the 12th, the domestic COVID-19 vaccination rate in Korea reached 77.6 % (full vaccination rate). Therefore, the possibility of not many candidates being left for vaccination even if the company completes its vaccine development by the first half of next year as planned. Remains. In addition, the value of the latecomer vaccine has been rated even lower with the imminent introduction of oral coronavirus treatments. ◆SK Bioscience signs agreement to supply its vaccine to developing countries… Genexine to develop a vaccine as booster shot SK Bioscience and Genexine, which have started their Phase III trials ahead of Cellid, have also been facing the same dilemma. SK Bioscience plans to finish development and expand its supply to developing countries around the world by early next year. SK Bioscience signed a supply agreement with CEPI (The Coalition for Epidemic Preparedness Innovations) for the provision of its vaccines. After GBP510 is developed and is selected for the “Wave 2” (next-generation COVID-19 vaccine) project, the vaccine will be supplied globally, in Africa, South America, and Southeast Asia through the COVAX Facility. The global vaccination rate has reached around 51.3%. In developing countries, the rate is around 10% or less. Therefore, unlike in the domestic market, a sufficient supply market remains for the vaccines globally. SK Bioscience initiated its Phase III trial in August. The company expects the trial to be finalized and be approved by 1H next year. In the case of Genexine, the company changed its vaccine development strategy to developing booster shots. In August, the company applied to change its clinical trial plan for the global Phase II/III trial it has been conducting for ‘GX-19N’ in Indonesia in August. The new strategy is to develop a booster vaccine with its vaccine candidate. The clinical trial will confirm the protective efficacy of GX-19N in 1,000 participants who had been vaccinated with Sinovac or Sinopham’s inactivated vaccines 3 months earlier. Genexine plans to expand the clinical trials in Indonesia to Argentina and other countries in 14,000 patients. However, the analysts are that the decision may have been influenced by the fact that the drug, if developed, will not have much marketability, like other vaccine developers.
