- LOGIN
- MemberShip
- 2026-05-05 07:23:15
- Policy
- Omicron recombinant XL mutation found in Korea
- by Lee, Jeong-Hwan Apr 14, 2022 05:56am
- In Korea, the sub-variant XL in which the Omicron COVID-19 mutant virus has been modified (recombined) has been confirmed for the first time. The quarantine authorities predicted that the XL mutation is a subfamily of omicrons, and that caution is necessary, but there will be no excessive concern. The intention is that there is a possibility of natural extinction rather than a dominant mutation after omicron, and various inspection institutions, including the KDCA, can manage and respond during monitoring. On the 12th, the head of the KSLM epidemiological investigation and analysis team said, "In a confirmed case on the 23rd of last month, Omicron recombinant mutation XL was confirmed, and related epidemiological investigations are underway." According to the KSLM, the patient did not have any symptoms, and the COVID-19 vaccination was completed until the third round. XL is a mixture of genes from omicron (BA.1) and stealth omicron (BA.2). It is one of the 17 recombinant mutations identified so far, and no specific characteristics have been reported. According to the World Health Organization (WHO), 66 cases of XL have been confirmed in the UK alone since its first discovery in February. Health and Safety Executive said on the 25th of last month that most recombinant mutations disappear without special diffusion. The KSLM said, "XL recombinant mutations are classified as omicrons by the WHO, so it is not expected that there will be significant changes in characteristics. We will continue to strengthen mutation monitoring because there are no analysis data such as propagation power and severity."
- Policy
- P3T for Roche’s Giredestrant was approved in Korea
- by Lee, Hye-Kyung Apr 14, 2022 05:56am
- A Phase III trial for Roche’s next-generation breast cancer treatment ‘giredestrant’ will be conducted in Korea. The Ministry of Food and Drug Safety approved the company’s application to conduct a randomized, open-label Phase III trial to evaluate the efficacy and safety of ‘giredestrant+ Phesgo’ in comparison to Phesgo in treatment-naïve HER2-positive, estrogen receptor-positive locally advanced or metastatic breast cancer patients after ‘Phesgo+taxane’ induction therapy. The domestic Phase III trial will be conducted in Seoul St.Mary’s Hospital, Kyungpook National University Chilgok Hospital, the National Cancer Center, Seoul Asan Medical Center, Severance Hospital, and the Samsung Medical Center. Giredestrant is an oral anti-hormonal therapy in the selective estrogen receptor degrader (SERD) class that inhibits the proliferation of cells that bring estrogen to the breast cancer cells. In a Phase II study that administered giredestrant and anastrozole for two weeks in 191 treatment-naïve postmenopausal women with estrogen receptor-positive and HER2-negative early breast cancer, giredestrant showed a much greater effect than anastrozole. Also, comparison of the Ki67 protein levels produced when breast cancer cells divide and proliferate as identified through biopsies pre-and post- treatment showed that the mean relative Ki67 reduction from baseline to week 2 was 80% with giredestrant compared to the 67% with anastrozole. Meanwhile, the only SERD class drug to be approved by the US FDA is AstraZeneca’s ‘Faslodex inj. (fulvestrant),’ but the drug is an injection-type rather than an oral type.
- Policy
- Why Galvusmet is priced same as salt-modified and generics
- by Lee, Tak-Sun Apr 13, 2022 06:03am
- Prices of DPP-4 inhibitor Galvus (vildagliptin) and Galvusmet (vildagliptin+metformin) latecomers show that the original Galvus’s price is still set high, but the price of the original Galvusmet (50/500mg) is set at the same level as its salt-modified and generic versions. Also, Galvus’s price had fallen 30% with premium pricing after the introduction of generics, but Galvusmet’s price fell only 25.3%. Why the difference? This is due to the different standards in pricing between single-agent and combination drugs. Galvusmet’s pricing did not follow the general formula. First, combination drugs are not applied the premium pricing formulas. For original single agent drugs, the drugs’ price falls 30% in the first year due to premium pricing, then to 53.55%, same as generics after 1 year. Reimbursement listing status of vildagliptin(50mg)/metformin(500mg) However, original combination drugs are not provided a premium and therefore are discounted and set at 53.55% like its generics at the time of entry. If so, why did Galvusmet’s price drop only 25.3%? It was because its price had been set at a lower level during its initial listing. This is why the drug’s price was set at ₩310, which is a sum of ₩240, the ceiling price of Galvus before premiums, and ₩70, the ceiling price of metformin 500mg. The price of KB Pharma’s salt-modified drug Vildamet tab 50/500mg was also set at ₩310 under the same calculations. Also, United Pharma Korea’s generic version of Galvusmet, ‘Healusmet tab’ was listed at ₩310 like the adjusted price of Galvusmet by satisfying both the direct bioequivalence testing and Regulation on Registration of Drug Substances (DMF) requirements. This is why the original, salt-modified drug and generics were set at the same price upon market entry. On the other hand, the price of generics from companies that were not able to satisfy the direct bioequivalence testing requirements – those from Samjin, Ahn-gook, Ahn-gook New Pharm, and Shinpoong- were set at ₩264. Meanwhile, Hanmi Pharmaceutical’s ‘Vildaglmet 50/500mg,’ which was allowed the same price as KB Pharma’s at ₩310, was voluntarily listed at a lower price of ₩300. Yoon-Hee Choi, Team Head of the Health Insurance Review and Assessment Service’s Drug Pricing Department, said, “No premium is provided for combination drugs, therefore, the price of original combination drugs may be set at the same level as its generics upon entry of generics. However, as Galvusmet’s price had been set at a lower price in its initial listing, the price was not discounted 53.55%, but under a different standard.”
- Policy
- Korea loses $9 billion a year in exports
- by Lee, Jeong-Hwan Apr 13, 2022 06:02am
- If low- and mid-income countries such as Africa and Central America fail to raise their collective immunity levels sufficiently, it will have a negative impact on the economy, such as a decrease in export profits of high-income countries. This is because countries around the world are linked to each other by trade and investment, and the country that is expected to lose the most is expected to hit the U.S. with $50 billion a year, while Germany is expected to hit $30 billion a year as the second country to lose. Korea is also expected to lose $9 billion a year, and it is analyzed that having an international cooperation system that can fairly inoculate the COVID-19 vaccine will eventually bring economic benefits to rich countries. On the 11th, Kim Joo-kyung, a legislative investigator at the National Assembly's legislative investigation office, made the announcement through the "significance and task of international cooperation to respond to the pandemic of infectious diseases." The main point of the analysis is that in order to minimize economic losses caused by the COVID-19 pandemic, vaccine inequality between countries should be minimized and international cooperation should be strengthened. According to the international statistics site Our World in Data, the rate of COVID-19 vaccine booster shots per 100 people as of the 4th was very low in African continental countries and some Central American countries. Chile (83.3%) and Singapore (70.7%) finished booster shots, and Korea had a high vaccination rate along with 64.6% of Korea, Iceland (67.9%) and Italy (64.9%). Gabon and Cameroon accounted for 0.1% and Ethiopia 0.3%, with most of the African continent countries and Central American countries such as Jamaica (1.1%). The Legislative Research Service pointed out that vaccine nationalism poses health risks such as increasing death and morbidity by continuing the public health crisis situation, while also seriously affecting the global economy. Countries around the world are interconnected by trade and investment, leading to a decrease in economic demand in low- and medium-income countries leading to negative effects such as a decrease in exports to the economies of high-income countries. Kim explained, "If low-income countries fail to raise their collective immunity levels sufficiently, the cumulative economic cost to 30 high-income countries is estimated to be $216 billion in 2022-2023 alone and $258 billion in 2023-2024. Kim added, "The country that is expected to be hit the hardest among the 30 countries will incur $41.3 billion in 2022-2023 and $493 in 2023-2024, and Germany will lose $26.1 billion in 2022-2023 and $31.1 billion in 2023-2024. Korea is expected to suffer economic losses of $8.2 billion from 2022 to 2023 and $9.7 billion from 2023 to 2024, he said. "Quick vaccination is important because potential economic costs arising from the lack of vaccines to poor countries increase over time." Kim stressed that vaccine inequality should be improved through international cooperation. In particular, as Korea has been selected as a "global bio-human resource training hub," it said that it should start seeking international cooperation measures. The global bio-human resources training hub, organized by the World Health Organization (WHO), is a project that provides education and training across the production of vaccines and biopharmaceuticals. Korea will be selected alone and conduct vaccine and biopharmaceutical manufacturing training for 370 global bio-workers from July. Kim said, "The way to solve the COVID-19 pandemic is to improve the current vaccine and vaccinate the most vulnerable people," adding, "To this end, the WHO is trying to supply vaccines fairly through COVAX Facility and transfer vaccine technology to low-income countries." Kim said, "Korea did not have the original technology for COVID-19 vaccines, so it was difficult to supply and demand vaccines in the early days of the pandemic. In response, we have the task of becoming a leading country in the bio-pharmaceutical industry. As Korea has been selected as a global bio-human resource training hub, we need to seek international solidarity and cooperation to contribute to health security around the world."
- Policy
- Galvusmet latecomers face a price war since launch
- by Lee, Tak-Sun Apr 12, 2022 06:05am
- How price will affect sales of the DPP-4i antidiabetic treatment Galvusmet’s latecomers is gaining attention. Hanmi Pharmaceutical, which had been the first to release a drug to the market, had opted to set its price lower than planned, and the price of the original Galvusmet had also fallen due to the introduction of generics. The price of the generics had also been set accordingly. According to industry sources on the 11th, starting with Hanmi’s Vildaglmet, sales of Galvusmet generics had started in earnest in February, along with sales of KB Pharma’s salt-modified drug in March, all of which as latecomers of Novartis’s Galvusmet (vildagliptin/metformin). The latecomers have been eyeing the Galvusmet market as this fixed-combination drug has been prescribed more than the single-agent Galvus. According to UBIST, Galvus sold ₩8.5 billion and Galvusmet ₩38 billion last year in Korea. Among the latecomers that were newly introduced, only a generic version of the Galvusmet’s main dose - vildagliptin 50mg/metformin 500mg – was released in the market. The introduction of Galvusmet 50/500mg generic had reduced the price of the original by 25.3%, leaving no difference in price between it and the latecomer drugs. In particular, KB Pharma’s salt-modified Vildamet tab 50/500mg, and Korea United Pharm’s Healusmet tab, which received a pricing premium as an innovative pharmaceutical, were listed at ₩310, which is the same price as its original drug. However, Hanmi Pharmaceutical opted to set the price of its salt-modified Vildaglmet tab 50/500mg ₩300, and how this will affect market competition is receiving attention. 빌다글립틴(50mg)/메트포르민(500mg) 동일제제 급여등재 현황 Galvusmet latecomers were able to enter the market earlier after successful patent challenges. Although the original's substance patent was set to expire on March 4th this year, Hanmi and Ahn-gook succeeded in invalidating part of the extended term of the patent and released their generics earlier than the patent expiry date. On this, Novartis has filed an active trial to confirm the scope of its patent against companies other than Hanmi – KB Pharma, Korea United Pharm, Ahn-gook Pharmaceutical, Ahn-gook New Pharm, and Samjin Pharm – on grounds of patent infringement. With patent and drug prices so intricately intertwined, who will be the last to smile in this ₩40 billion market is expected to continue to draw attention.
- Policy
- The adverse drug reaction rate of Trulicity is 19%
- by Lee, Hye-Kyung Apr 11, 2022 05:58am
- As a result of a six-year post-marketing survey of Type 2 diabetes treatment Trulicity in Lilly Korea, 15 cases of serious adverse drug reactions that cannot be excluded from causal relationships were reported. The permit will be changed as 62 unexpected adverse drug reactions, which cannot exclude causal relationships, also occurred. The MFDS recently announced that it will pre-announce and reflect the order to change the permission according to the results of the re-examination of Trulicity 1.5 mg/0.5ml and Trulicity 0.75 mg/0.5ml disposable pens from July 6. Trulicity was developed as a disposable syringe formulation as a long-acting GLP-1 analog and obtained domestic permission in 2015. As a result of a post-marketing survey of 3,022 people for 6 years for re-examination in Korea, the incidence of abnormal cases was reported to be 19.49% (589/3,022 people, total 819 cases), regardless of causality. Significant adverse drug reactions were found to be 0.46% (14/3022 patients, 15 cases), with occasional blood sugar increases and rare dizziness, poorly controlled diabetes, diabetic gastritis, gastroesophageal reflux disease, acute kidney damage, and diabetic kidney disease. In the case of unexpected adverse drug reactions such as weight loss, weight gain, sensory degradation, and gastroenteritis, 1.99% (60/3,022 cases, 62 cases) occurred. Trulicity is administered as an adjuvant to dietary and exercise therapy to improve blood sugar control in adult type 2 diabetes patients. Among patients who have difficulty controlling sufficient blood sugar with Metformin and Sulfonylurea combination therapy, insurance benefit is being applied to the combination therapy of patients who cannot perform body mass index ≥25kg/㎡ or insulin therapy. Last year, it recorded 47 billion won in outpatient prescriptions based on UBIST, up 23% from 38.2 billion won in the previous year.
- Policy
- NHIS to study measures on improving the PVA system
- by Lee, Tak-Sun Apr 11, 2022 05:58am
- With a study on improving the price-volume agreement (PVA) system in plan, the possibility that the improvement may increase drugs subject to PVA is being raised. According to industry sources on the 8th, the National Health Insurance Service is preparing to conduct a research to ‘evaluate the performance of and improve the Price-Volume Agreement system’ and will post a bid for its research services soon. Its plan, as disclosed by the NHIS, indicates that the study will be conducted for 6 months from the period of its initiation and be completed at the end of the month. Through the study, the authorities plan to establish a mid-to-long-term roadmap for the PVA system and ensure the appropriateness of the drug expenditures to save excess resources and strengthen Korea’s NHI coverage. Feasibility reviews on alternatives that go beyond the existing agreement system and reference formulas will also be developed in the study. For example, the current system applies the rate of increased claims in the formula, but the study will review the application of a reference formula that considers the absolute claims amount and the amount of increase. In addition, the study will be used to prepare a reasonable plan that considers the fiscal impact of the selection/exclusion criteria that were already revised this month, and review diversifying the method used to make PVA. Based on the research results, NHIS also plans to hold public hearings with relevant institutions to improve the PVA system to prepare a system improvement plan that can enhance both acceptability and negotiation power, and propose a mid-to-long-term development direction for the PVA system based on legal and institutional review. NHIS announced its plan to research measures to improve the PVA system earlier this year. At a policy roundtable meeting on the ‘Rational improvement of the PVA system’ that was held by the National Assembly in January, Hyun-Deok Kim, Director-General of the Pharmaceutical Management Department, said, “We are aware of the issue caused by reviewing only the rate of increase without consideration of the absolute increase in claims amount. We agree that there is a need to conduct a comprehensive review on the PVA system and prepare improvements, and will be posting a bid for research services within the year.” As the main purpose of the study is to save NHI pharmaceutical expenses, friction with pharmaceutical companies seems inevitable in the process of its implementation. An industry official expressed regrets, "Contrary to the pharmaceutical industry’s opinion of reducing or deferring the PVA system, the government’s only plan seems to be to reduce its expenses. By the contents of the study alone, it seems that subject drugs and discount rate would only increase further."
- Policy
- National Responsibility for the Side Effects of Vaccines
- by Lee, Jeong-Hwan Apr 11, 2022 05:58am
- Ahn Cheol Soo, the chairman of the presidential transition committee/the special chairman of the COVID-19 emergency response committee said they would provide wide support for adverse reactions to the COVID-19 vaccine while significantly easing the burden of public proof. On the 7th, Chairman Ahn held the 6th meeting of the COVID-19 Special Committee at the Transition Committee in Samcheong-dong, Jongno-gu, Seoul, and discussed ways to realize a national responsibility system for adverse vaccine reactions and secure treatments. Chairman Ahn said, "We have emphasized the importance of scientific quarantine and focused on policy implementation measures based on objective data such as the national antibody positive rate and vaccine abnormalities." "From next week, we plan to release related data one by one with the KDCA and the NHIS," he said. The COVID-19 Emergency Response Special Committee asked the government to come up with measures to compensate for damage from adverse reactions to vaccines, expand diseases subject to support, and ease the burden of public proof to provide quick and fair damage compensation. The KDCA promised to strengthen support by reflecting this request. Specifically, abnormal reactions registered by pharmaceutical departments in major overseas countries will be recognized as related diseases first, and the scope of causal recognition will be expanded if the COVID-19 Vaccine Safety Committee comprehensively analyzes the causalities of related diseases. A project to be supported will also be established, and if the disease is suspected after vaccination and is treated or tested, actual expenses will be provided for the cost. In order to ease the public's burden of submitting evidentiary documents, rapid compensation procedures will also be implemented, such as simplifying submission centered on necessary evidentiary documents in the case of related diseases. The number of objections will also be expanded from one to two. The transition committee said, "We decided to provide consolation money for sudden deaths within 30 days of vaccination, where the cause of death is unknown even as a result of the autopsy." In addition, he said, "There was no support if not diagnosed as a disease subject to vaccine abnormal response compensation and support, but in the future, if the disease is suspected and treated or tested, we plan to provide actual support for the cost."
- Policy
- CAR T-cell therapy has shown the disappearance of leukemia
- by Kim, Jung-Ju Apr 11, 2022 05:57am
- A research team of domestic CAR-T (Chimeric Antigen Receiver-T Cell) treatment confirmed the disappearance of leukemia cells in clinical trials of pediatric and adolescent leukemia patients. The government plans to positively evaluate the treatment of children and adolescents with leukemia through advanced regenerative medical clinical research and continue to provide related policy support. The MOHW (Minister Kwon Deok-cheol) announced on the 7th that the results of the disappearance of leukemia cells in children and adolescents through advanced regenerative medical clinical research research at Seoul National University Hospital (Director Kang Hyung-jin). CAR-T introduces a gene that combines the receptor site of an immune cell (T cell) and the characteristic antigen recognition site on the surface of a cancer cell into a patient's T cell and is a cell with a function of specifically recognizing and attacking the surface antigen of a cancer cell. This study is a high-risk clinical study, which was approved and approved as the first high-risk clinical study by the Advanced Regenerative Medical and Advanced Biopharmaceutical Review Committee and the MFDS in December. Seoul National University Hospital said it administered its own CAR-T treatment to an 18-year-old leukemia patient on February 28, and that a bone marrow test conducted on March 28 confirmed that leukemia cells completely disappeared. This project is to support research funds for clinical studies approved or approved by the Council and the MFDS. In addition to this clinical study at Seoul National University Hospital, it is also supporting clinical research conducted by Samsung Medical Center and Catholic University Industry-Academic Cooperation. Seoul National University Hospital receives 1.25 billion won in research funds from 2022 to 2023, Samsung Medical Center 1.83 billion won from March 2022 to December 2023, and Catholic University Industry-Academic Cooperation Group 1 billion won from 2022 to 2023. As of the end of March, a total of five clinical studies were finalized and approved by the Deliberation Committee and the MFDS, and one high-risk clinical study and one medium-risk clinical study will also apply for research funding to the Advanced Regenerative Clinical Research Support Group. The MOHW explained that the number of applications and applications for advanced regenerative medical clinical research has been on the rise since the Advanced Regenerative Bio Act took effect in August 2020 and the deliberation committee began to form and operate in January 2021. The deliberation committee is determining whether or not to make a decision on the suitability of clinical research in consideration of the validity and safety of the research plan, and the proportion of clinical research that has recently been approved is increasing. Among them, the number of suitable resolutions through the deliberation committee so far has been 10. Recently, the advanced regenerative medical field is attracting attention as a future food in the biohealth field, and as the number of advanced regenerative medical institutions capable of conducting clinical research continues to increase, advanced regenerative medical research is expected to be further activated. Accordingly, the government will strengthen legal essential education for clinical research personnel, R&D for virus production and human transplantation, and GMP support to promote joint research between hospitals and startups. "It is encouraging to provide treatment opportunities for pediatric leukemia patients through the first high-risk clinical study," said Kim Young-hak, head of the MOHW. "We will do our best to provide treatment opportunities to more patients through pan-ministerial regenerative medical technology development projects."
- Policy
- Chinese companies are set to debut in the domestic market
- by Lee, Tak-Sun Apr 11, 2022 05:57am
- Chinese pharmaceutical companies' new anti-cancer drugs, which were approved in Korea last year, are more likely to be listed on the Korean health insurance. Expectations for benefits are growing as BeiGene's Bruxinsa passed the HIRA's Cancer Disease Review Committee as a sole treatment for WM adult patients the previous day. Another Chinese pharmaceutical company, Antengene's Xpovio, will also continue to challenge the domestic market. On the 6th, the deliberation committee set a benefit standard for BeiGene's Brukinsa, which applied for a new benefit, for VM that have received more than one treatment before. If the HIRA's Drug Benefit Evaluation Committee recognizes the appropriateness of the benefit and if the drug price negotiation is concluded with the NHIS, it will be on the domestic health insurance benefit list so that patients can easily receive medication. This is expected to be the first case in which a new anti-cancer drug developed by a Chinese pharmaceutical company enters the domestic benefit market. Brukinsa is a target anticancer drug that inhibits the survival and spread of malignant B cells by blocking Bruton kinase protein, a signaling molecule that affects the survival and development of B cells as a Brutons Tyrosine kinase inhibitor. It was first approved as an MCL treatment by the U.S. FDA in November 2019, and was also approved as a WM treatment in September last year. To be approved as a WM treatment, Bruxinsa conducted a comparative clinical trial with Janssen's Imbruvica, the same BTK inhibitor. American businessman John V. Oyler and biochemist Xiaodong Wang, Ph.D co-founded BeiGene in 2010. As the name of BeiGene suggests, it is headquartered in Beijing, China. Brukinsa is currently in 23 countries with approval from around the world. It has established a branch office early in October 2019 and has been preparing to enter the market. Brukinsa, which was approved by the MFDS on February 25, passed the WM indication committee in less than two months, raising expectations for a high-speed listing. The Chinese pharmaceutical company's new anti-cancer drug approved prior to Brukinsa is Antengene's Xpovio. Xpovio received approval from the MFDS in July last year. This drug is a new mechanism that selectively inhibits XPO1, a nuclear export protein. In January, it was submitted to the cancer screening and discussed setting benefit standards, but failed. In recurrent or refractory polymyeloma, it applied for benefits as a combination therapy with Dexamethasone, and treatment for recurrent or refractory diffuse B-cell lymphoma, but failed to pass. Antengene is expected to continue to challenge the domestic benefit market while watching the situation of overseas registration. Xpovio has already passed the so-called Big 5 DCs such as Samsung Seoul Hospital, Seoul National University Hospital, Seoul St. Mary's Hospital, and Seoul Asan Hospital and is being used as non-reimbursement. Founded in 2017, Antengene is a major developer of anticancer drugs invested by global pharmaceutical company BMS and is headquartered in Shanghai, China. In March last year, a local corporation was established.
