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- 2025-12-23 20:00:40
- Policy
- AZ vaccine was approved in the second week of February
- by Lee, Tak-Sun Apr 07, 2021 06:00am
- The government said it expects the AstraZeneca COVID-19 vaccine to be approved in the second week of February. In the third week of February, the lot release is completed and the vaccination is started immediately. The MOHW, the MFDS, and the KCDA made such a statement at the President's Business Report (video conference) held on the 25th. According to the work report data, AstraZeneca vaccine will be approved for marketing in the second week of February after completion of the approval review within 40 days (existing 180 days). It is explained that the quality test of commercially available vaccines is completed within 20 days, and lot release is expected in the third week of February. Celltrion's COVID-19 treatment was expected to be approved in early February. The MFDS plans to approve COVID-19 vaccines and treatments through three expert consultations, including the existing Central Pharmaceutical Affairs Review Committee, Safety and Effectiveness Verification Advisory Group, and Final Inspection Committee. The policy for production cooperation of the Moderna COVID-19 vaccine was also mentioned. In order to independently secure domestic vaccines and treatments, it is planning to improve the system for Moderna production cooperation. A specific plan for this part is expected to be announced sooner or later.
- Policy
- Dongkoo is targeting the market as a vendor.
- by Lee, Tak-Sun Apr 06, 2021 06:08am
- Product photos shown in Atoeve marketing materials In January, Dongkoo started as a vendor of generic for Atozet (Atorvastatin·Ezetimibe), a licensed hyperlipidemia complex, and started targeting the market in April. Dongkoo is the most entrusted company of generic for Atozet. However, generics for Atozet are scheduled to release in May, but Dongkoo is going to enter the market a month ahead. According to the industry on the 26th, Dongkoo will be marketing from April as a sales industry of Atoeve (generic for Atozet) which was transferred to Hwail. It is a product that shares data with a drug for data-based re-evaluation Lipilouzet, which is generic for Atozet, which Chong Kun Dang approved in October last year. For data sharing and consignment production with Chong Kun Dang, 22 companies were licensed in January, and will be listed on the payroll list in April and released. Dongkoo surrendered Atoeve to Hwail. In order to consign generics to other companies, the company's generic drug license is required. Accordingly, a drug for data-based re-evaluation license was transferred to other companies, and a new generic drug license was obtained. Dongkoo's Zetstan was licensed last February. About 30 items consigned to other companies were also licensed. Generics in February are expected to be released on the list in May. It seemed that Dongkoo would turn to a late-release generic drug. However, it was achieved by Dongkoo as the seller of Atoeve, which was transferred to Hwail. Atoeve's manufacturer was Chong Kun Dang, the manufacturer was Hwail, and the seller was Dongkoo. Atoeve received the drug price at 85% of the highest price. Generics are expected to be listed at 61.4% of the highest price, so there is definitely a drug price premium. An industry official said, "Because Dongkoo is the company that paid for the contract with Chong Kun Dang, the transfer or transfer to another company does not seem to have given up the product copyright." 'Atozet', which Jinyang transferred and transferred to SH pharm, is also on the list in April. Industry analysts say that Jinyang is likely to become a seller of this item as well.
- Policy
- The clean reporting center will be opened
- by Lee, Tak-Sun Apr 05, 2021 05:53am
- The MFDS opened the Clean Report Center for Drug Manufacturing and Quality Illegal Activities in order to revitalize public interest reporting after Binex drug manufacturing incident. The center operates anonymously to increase the reporting rate. The MFDS announced on the 1st that it has opened the Clean Report Center for Drug Manufacturing and Quality Illegal Activities in the representative website. The report center was opened by the MFDS to prevent recurrence when the fact of the voluntary manufacture of drugs was discovered at the Binex Busan Plant. In order to promote public interest reporting, it will be operated completely anonymously. The report center is established on the website of the MFDS and can be reported by phone (043-719-2699) or e-mail (cleancenter@korea.kr). In an official letter sent to each pharmaceutical organization, the MFDS said, "We have opened the Clean Report Center for Drug Manufacturing and Quality Unlawful Behavior to promote public interest reporting and raise awareness of intentional and illegal serious violations in relation to pharmaceutical GMP manufacturing establishments." The MFDS ordered, "Please publicize it so that all citizens can easily access and report intentional and illegal activities." Previously, the MFDS confirmed violations of the Pharmaceutical Affairs Act such as ▲Use of additives at will without permission to change ▲Double-write manufacturing records falsely ▲Without changing the manufacturing method ▲Randomly changing the amount of raw materials, etc. through administrative investigations on Binex and Vivozon. In the case of the two companies, especially in preparation for inspection by the MFDS, all processes from raw material weighing to completion of manufacturing were falsely written using a manufacturing record in the same format as the licensed matter, and the records used in actual manufacturing were found to have been discarded after manufacture. In addition, the MFDS uncovered the failure to conduct tests on finished products and raw materials at one site through additional inspections at 30 entrusted and entrusted manufacturing sites nationwide, and some of the product standards were not prepared. The MFDS plans to establish a special planning and inspection team for GMP to prevent recurrence of any manufacturing activity. This is the expansion of regular GMP surveys conducted every three years. It plans to operate a reporting center to activate public interest reporting, and cancel the GMP conformity determination for illegal acts such as intentionally changing manufacturing methods and creating false and double records.
- Policy
- Janssen vaccine was confirmed to maintain an immune response
- by Lee, Tak-Sun Apr 05, 2021 05:50am
- The COVID-19 vaccine license verification advisory group composed of external experts recognized the preventive effect of Janssen's COVID-19 vaccine. Janssen vaccine was confirmed that the immune response was maintained for up to 12 weeks with only one administration. The COVID-19 vaccine safety and effectiveness verification advisory group held a meeting on the 28th and made such a conclusion about the clinical trial results of Janssen's COVID-19 vaccine. Six people including infectious medicine specialists, vaccine specialists and clinical statistics specialists attended the conference. In the data submitted on the preventive effect of the vaccine, the advisory group confirmed the effect 14 days and 28 days after one dose of 18 years of age or older, and the immune response (conjugated antibody and neutralizing antibody) is maintained for up to 12 weeks. It was judged that the preventive effect was acceptable. The advisory group determined that the safety profile in the clinical trial was acceptable in relation to the abnormal case that occurred in the clinical trial, and additionally observed the abnormal cases that appeared during the clinical trial through the 'risk management plan' after approval. They expressed the opinion that it is reasonable to collect and evaluate information. Clinical trial data submitted to the MFDS include 1 clinical trial conducted in the United States and Belgium (Phase 1 and 2), 1 case in Japan (Phase 1), 1 case in multi-country such as Germany (Phase 2), and 8 countries including the United States ( Phase 3) was conducted in a total of 4 cases, including one multinational clinical trial, and safety and effectiveness were evaluated through a phase 3 clinical trial conducted in the United States. As a result of the efficacy evaluation, after 14 days of vaccine administration, 116 people in the vaccine group and 348 people in the control group showed a preventive effect of about 66.9%, and after 28 days, 66 people in the vaccine group and 193 people in the control group showed about 66.1. % Of the preventive effect was shown. After 14 days of vaccine administration, there was a prophylactic effect of more than 60% regardless of age and underlying disease. In addition, about 76.7% of the vaccine group 14 people and 60 control people after 14 days of vaccine administration, about 85.4% of the vaccine group after 28 days of vaccine administration, and 34 control people. In the case of the binding antibody that binds to COVID-19 antigen, the serum conversion rate was 95% or more, in which the antibody value increased by more than 4 times from 4 weeks after the vaccine was administered compared to before administration. In the case of neutralizing antibody, which can induce a preventive effect by binding to the surface of virus particles and neutralizing the infectivity of the virus, the serum conversion rate after one vaccine administration was more than 90%. Of all 43,783 subjects enrolled in the clinical trial, significant adverse events were reported in 0.4% (83) of the vaccine group and 0.4% (96 people) of the control group, and significant adverse drug reactions that cannot be excluded from being related to vaccine administration were brachial neuromyositis, Guillain-Barre syndrome, pericarditis, brachial neuromyositis, post-inoculation syndrome, hypersensitivity reaction in 1 each, and facial paralysis in 2 cases. However it was recovering at the time of submission of clinical trial data. The MFDS is planning to conduct another expert review by holding the Central Pharmaceutical Affairs Review Committee, a legal advisory body, on April 1, combining the results of this review. The results will be released in the afternoon of the day.
- Policy
- Are there less than 20 licensed generic drugs?
- by Lee, Tak-Sun Apr 02, 2021 06:05am
- The pharmaceutical industry is looking for generics with less than 20 identical ingredients/same content due to the effect of stepped drug prices. This is because there is a large difference in drug price depending on whether there are more than 20 or less than 20 outsourced generics permitted to use bioequivalence test data. The recent increase in 1mg of generic for Livalo has the same effect. According to the MFDS on the 1st, generics for Livalo (Pitavastatin), a hyperlipidemia drug, are increasing recently. Livalo is a blockbuster product approved by JW Pharma in 2005. As of last year's UBIST, outpatient prescription sales amounted to ₩73.4 billion, ranking in the top ranks among single drugs for hyperlipidemia. There are 1mg, 2mg and 4mg by dose. Generic for Livalo was first approved in 2011. So far, about 90 items have been approved, mainly at a dose of 2mg. However, generics for Livalo 1mg are increasing recently. Generic for Livalo 1mg has been approved for the first time by Arlico in May of last year, and 8 generics have been approved this year. Most of them are consignment products. Genuonesciences manufactures seven, including its own, and Arlico produces four. The reason generic for Livalo 1mg was licensed late is that the government's cascading drug prices, which have been in force since July last year, are affecting. For stepped drug prices, if 20 generics with the same dose of the same ingredient are listed, then the next listed generic is determined at 85% of the existing lowest price. Therefore, it is advantageous to register when there are less than 20. Since the number of generics for Livalo 1mg has not yet exceeded 20, subcontractors and consignees are less likely to lose drug prices. A total of 11 generics for Daewoong Zoledronic Acid were launched in 2011. Six generics were approved, all of which are drugs produced by Penmix. The industry expects this kind of entrusted generics to become popular in the future as there are not many new generics. However, since many of the licensed items existed in the market, it is expected that it will not be easy to be competitive in the market even if there is no loss in the drug price.
- Policy
- Levitra was withdrawn from the Korean market after 20 years
- by Lee, Tak-Sun Apr 02, 2021 06:05am
- Levitra, which Bayer launched on the Korean market for erectile dysfunction drugs, withdrew completely on the 1st. It was withdrawn due to expiration of the validity period because Bayer Korea did not renew the license. Only Kyongbo Vardenafil HCl of Kyongbo, a subsidiary of Chong Kun Dang, remains in the active ingredient containing Vardenafil HCl. According to the MFDS on the 1st, it was withdrawn due to the expiration of all four items of Bayer Korea's erectile dysfunction treatment Levitra. In January, Bayer has informed distributors of the suspension of supply. It is explained that supply was inevitably stopped due to unstable supply and reduced demand due to the modernization of the plant in Leverkusen, German. It seems that the decline in demand rather than supply was attributable to it. According to IQVIA, Levitra remained at about ₩300 million in 2018, about ₩200 million in 2019, and about ₩100 million in 2020.It is explained that the market competitiveness was completely lost due to the introduction of the original drugs Viagra and Cialis, and the release of generics after 2012. Chong Kun Dang, who conducted initial co-marketing with Levitra, re-launched Yailla (Vardenafil) in 2018, but it was also withdrawn. This is because it was sold before the expiration of Levitra's patent in July of last year. However, Kyongbo, a subsidiary of Chong Kun Dang, was approved for two items of Kyongbo Vardenafil HCl in April of the same year.
- Policy
- Addpharma, entering phase 3 of low-dose Dutasteride
- by Lee, Tak-Sun Apr 01, 2021 06:06am
- Avodart for prostatic hypertrophy and hair loss Addpharma, a subsidiary of Yuhan's improved drug development, has entered phase 3 clinical trials of low-dose tablets of Dutasteride (Avodart, GSK), a hair loss treatment. Currently, Dutasteride is already on the market, but the value of Addpharma's developed products is high as there is no low dose product. The MFDS approved Addpharma's phase 3 clinical trial protocol for AD-208 on the 29th of last month. This trial is a multicenter, randomized, double-blind, placebo-controlled, parallel, phase 3 clinical trial to evaluate the efficacy and safety of AD-208 in male androgen alopecia patients. AD-208 is Yuhan's IMD. However, it is not known in detail what type of drug it is. As a result of the interviews, it was found to be Dutasteride 0.2mg, not conventional Dutasteride 0.5mg. Avodart is released in 0.5mg capsule type. Generics were released due to the expiration of the patent in 2016, and tablet types were also released. JW Pharma was the first to develop Dutasteride in tablet form based on its underlying technology in 2018. It relieves the discomfort of the capsule sticking to the mouth and esophagus. It also became possible to split pills. Due to the long half-life of Dutasteride, some patients with hair loss may take one pill every two days. When taken in half, it is possible to maintain the drug agonism in the blood for a day. Since the drug developed by Addpharma contains only half of the existing content, there is no need for splitting tablets. It is easy to prescribe or dispense, and the patient's adherence to medication is increased. Pharmaceutical companies can expect cost reduction because only half of the ingredients are included. Phase 3 is conducted at 8 hospitals including Seoul National University Hospital. It plans to recruit a total of 130 patients. It is noted whether it will be validated and commercialized.
- Policy
- Baricitinib, Heparin, & NOAC were added as COVID-19 benefits
- by Lee, Jeong-Hwan Apr 01, 2021 06:05am
- Benefits are recognized when Baricitinib is co-administered with Remdesivir for the treatment of COVID-19. Low-molecular-weight heparin and new anticoagulant (NOAC) are also newly added as COVID-19 benefits. Lopinavir / Ritonavir (combination therapy), Hydroxychloroquine, and Ribavirin are eliminated from drugs covered by COVID-19. On the 31st, the MOHW revised and issued some 'details on the standards and methods for applying medical care benefits' with the above contents. The amendment applies to treatments for MERS-CoV and COVID-19. With regard to the target of administration, the standard for COVID-19 treatment will be clarified from the person who is conducting the confirmation test to the confirmed person. And, Corticosteroids are recommended for use in severe COVID-19 patients. Low-molecular-weight heparin and novel anticoagulant (NOAC) are added as reimbursable drugs because COVID-19 increases the risk of blood clots. However, NOAC only recognizes benefits when low-molecular-weight heparin cannot be administered to patients. Baricitinib is also eligible for the benefit, when used in combination with Remdesivir. The opinion that Remdesivir and Baricitinib can be administered in situations in which Remdesivir and corticosteroids cannot be administered in clinical practice guidelines had an impact. Low-molecular-weight heparin and novel anticoagulant (NOAC) are added as reimbursable drugs because COVID-19 increases the risk of blood clots. Meanwhile, the revised regulations for COVID-19 treatment should be reviewed once a year from the effective date.
- Policy
- NECA-KSID publish COVID-19 clinical treatment guideline
- by Lee, Hye-Kyung Apr 01, 2021 06:05am
- The South Korean clinical experts issued advices each on anti-COVID-19 antiviral drug (remdesivir, hydroxychloroquine, lopinavir, ritonavir and favipiravir), steroid, interleukin inhibitor, interferon, convalescent plasma therapy and general intravenous immunoglobulin. For antibody treatments with social issues, such as Rekirona, the experts are currently reviewing literature, and planning to update the guideline every month. National Evidence-based Healthcare Collaborating Agency (NECA) and Korean Society of Infectious Diseases (KSID) co-published a latest RWE-based clinical treatment guideline for treating COVID-19 patients with the said details. An Ebola treatment remdesivir is conditionally allowed (recommended grade B) to be used in patients who require oxygen therapy but do not need a ventilator or extracorporeal membrane oxygen therapy (ECMO) treatment. Also, hydroxychloroquine, a well-known treatment for malaria, was not recommended either alone or in combination (recommended grade C). Meanwhile, the experts highly recommended using steroid for patients with moderate to severe symptoms (recommended grade A). The global clinical scene was in confusion due to uncertainty in COVID-19 treatments, and the World Health Organization (WHO) has informed of some drugs having no efficacy and advised to suspend some drug use. The reviewed literatures used for the clinical guideline in South Korea were from latest worldwide publications (June through December 2020) related to COVID-19. The level of the ultimately selected evidence was categorized by four levels—high, moderate, low and very low—using the evaluation and recommendation GRADE methodology, and the experts deliberated on issuing advice of highly recommended (A), conditionally recommended (B), not recommended (C) or decision deferred (I). The guideline contains advices on using antiviral drug, steroid and 19 key anti-COVID-19 treatments depending on the state of a patient. Taking in account that COVID-19 related research evidences are presented fast around the world, NECA has started researching with KSID to promptly develop the clinical treatment guideline. The two organizations plan to expand the research scope to develop a guideline covering from COVID-19 screening to treatment (both pharmaceutical and non-pharmaceutical treatment) based on the severity of patient symptoms. Principal investigator of the research, Professor Yeom Joon Sup at Severance Hospital said, “The clinical scene has shown high demand for evidence-based clinical treatment guideline on treating pneumonia and other long-term infectious disease. This research would set credible standards in minimizing the confusion on site and providing the best treatment for patients.” Clinical Evidence Research Team Lead Choi Mi-young at NECA commented, “As the world is actively conducting COVID-19 related clinical research and publishing related literature every day, we need to confirm and update the guideline with the latest findings. NECA would continue to research with the healthcare providers from multidisciplinary approach to overcome the COVID-19.”
- Policy
- Tamsulosin-mirabegron drug opens competition in Korea
- by Lee, Tak-Sun Apr 01, 2021 06:05am
- KyungDong Pharmaceutical is to start a Phase III trial on a combination drug consisting of a prostatomegaly treating agent tamsulosin and an overactive bladder treating agent mirabegron. The drug is expected to begin a commercialization race against Dongkoo Bio & Pharma that already received approval on Phase III trial. Without any preceding combination drug with the two agents in the market, the patients would get to appreciate more convenient regimen if the drugs are successfully launched. On Mar. 25, South Korea’s Ministry of Food and Drug Safety (MFDS) granted an approval on KyungDong Pharmaceutical’s 'KDF1905’ Phase III clinical trial protocol. The trial would use tamsulosin and mirabegron as test subject. Tamsulosin is a well-known prostatomegaly treatment, and mirabegron is an overactive bladder treatment. Astellas have developed and been supplying the brands of Harnal-D (tamsulosin hydrochloride) and Betmiga (mirabegron). Particularly, the two drugs have been popular among the South Korean urologic treatment market. UBIST reported Harnal-D has generated 72.6 billion won and Betmiga 65 billion won last year for outpatient prescription. A study result on confirming the improvement in lower urinary tract symptoms expressed in patients with prostatomegaly has been already published. In 2018, a team of researchers led by Professor Hidehiro at Asahikawa Medical University, Japan, observed the voiding symptom in 656 patients using both mirabegron and tamsulosin, and found the patient who used the drugs showed statistically significant improvement compared against the placebo group. Also the combination showed outstanding improvement in treating overactive bladder symptoms compared against the placebo. As the prostatomegaly and overactive bladder treatments are frequently prescribed in combination, the South Korean pharmaceutical companies have been focused on developing a combination drug. But none of them have been commercialized, yet. Besides KyungDong Pharmaceutical, Dongkoo Bio & Pharma has also initiated the Phase III clinical trial from last January on the tamsulosin-mirabegron combination drug. The South Korean company has a strong portfolio with drugs used for dermatologic and urologic treatment. As two companies started the Phase III trials on the same-agent drug, the pharmaceutical industry is closely following the companies to see who nabs the market authorization first. And because the two single-agent drug markets are big, other pharmaceutical companies may change their competition strategy depending on the combination drug’s success in the market.
