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- 2025-12-25 21:24:36
- Policy
- KDCA “All hands on deck to seek COVID-19 vaccine"
- by Kim, Jung-Ju Sep 16, 2020 06:25am
- The first director of Korea Disease Control and Prevention Agency (KDCA) Jeong Eun-kyeong stated the government agency would provide all possible support for seeking vaccine and treatment to completely overcome the COVID-19 crisis. Also, she added the rare disease designation and R&D for disease testing and treatment would be expanded as well. On Sept. 14, Director Jeong gave a celebratory address at the KDCA opening ceremony and vowed to fight against COVID-19 along with the people of South Korea. The opening of KDCA was supposed to be on Saturday Sept. 12 according to the revised legislation, but instead the agency was officially opened on Monday. Regarding the agency’s status elevation, Director Jeong expressed her commitment to serve the responsibility, as the change started with “the people’s grave wish and the government’s determination to overcome the COVID-19 as soon as possible, and to proactively prepare and thoroughly respond against such infectious diseases.” Moreover, Director Jeong stated the agency’s key goals—securing central and regional epidemiologic response and capability, taking responsibility as a comprehensive infectious disease control agency, reinforcing response against health risk caused by environmental changes, establishing aging society-related chronic and rare disease prevention program, strengthening future medicine R&D and personalized disease R&D in Korea National Institute of Health (NIH). Specifically, the director said COVID-19 is a barrier that must be overcome, and that the agency is putting the best effort to support the development of relevant vaccine and treatment. Director Jeong stressed, “Aiming to find Korean-made treatment and vaccine, the agency would reinforce collaboration with relevant companies and research institutes to accelerate the development procedure,” but also “the agency is to secure overseas COVID-19 vaccine in development to execute vaccination program as planned.” Additionally, the director said, “The rare disease designation would continue to expand, and relevant supportive policy would be strengthened,” and “Related R&D to develop testing and treatment would also be expanded.” The director concluded the address by saying, “Although we are still stranded in the middle of the stormy sea, I will be with all of you until we reach the shore safely as a new captain of the ship called KDCA, and as another sailor in the ship.”
- Policy
- Crovalimab by Roche is conducting phase III in Korea
- by Lee, Tak-Sun Sep 15, 2020 06:27am
- Soliris sold by HandokSoliris (Eculizumab), which has recorded high sales as a treatment for paroxysmal nocturnal hemoglobinuria (PNH), a rare disease, is undergoing phase III clinical trial in Korea. It is Crovalimab, excavated by Chugai in Japan and developed by Roche. On the 11th, the MFDS approved a phase III IND for 'RO7112689' submitted by IQVIA Korea. RO7112689 is the name of the development of Crovalimab that Roche is developing. IQVIA, a global CRO, is expected to conduct phase III clinical trial of Crovalimab. It is a multinational clinical trial, and out of the total 250 subjects, 5 were recruited in Korea. This is a phase III trial to evaluate the efficacy and safety of Crovalimab versus Eculizumab in adult and adolescent subjects with paroxysmal nocturnal hemoglobinuria (PNH) and currently receiving complement inhibitor therapy. Eculizumab is generic for Soliris sold by Handok in Korea. Soliris is a large-scale drug that is sold to patients with PNH, recording annual sales of ₩43.8 billion (as of IQVIA 2019). There are few patients as a treatment for rare diseases, but it is generating high profits with expensive drugs of ₩5.13 million per bottle. Ultomiris, an upgraded version of this drug, received item approval in May. PNH is one of the rare blood diseases in which red blood cells are destroyed by complement, which is a part of the immune system. If not treated after diagnosis, 4 out of 10 people die within 5 years. It is known that there are about 200 patients in Korea. Soliris, which was introduced in Korea in 2012, is the only treatment for now. Crovalimab, which was approved for phase III clinical trial this time, is known to have a mechanism to inhibit the complement chain reaction by inhibiting the C5 protein like Soliris. Japan's Chugai derives the substance, and Roche is currently developing commercialization. Lately, generic biotech companies such as Samsung Bioepis are also drawing attention to the PHN market, such as developing a Soliris biosimilar.It is noteworthy whether a new drug will become a rival drug for Soliris.
- Policy
- Famvir licensed by Ildong is now manufactured locally
- by Lee, Tak-Sun Sep 15, 2020 06:26am
- Ildong Pharmaceutical is anticipating Famvir profit to improve as the drug licensed out by Novartis would be manufactured in South Korea. A shingles treatment Famvir is an original famciclovir drug that Novartis received approval to market in South Korea in year 2002. In 2018, Ildong Pharmaceutical acquired the sales rights over Famvir in South Korea, and signed a deal with Novartis to transfer relevant technology to directly manufacture and sell the drug locally. Since then, the Korean company has conducted a bioequivalence test and prepared local production of Famvir. According to Ministry of Food and Drug Safety (MFDS), Famvir 750 mg tablet and 250 mg tablet have been registered to be manufactured in Korea as of July 28 and Sept. 9, respectively. Previously, the drug was manufactured overseas and imported by Novartis. However, Ildong Pharmaceutical is not the actual manufacturer; Famvir 750 mg tablet and 250 mg tablet are respectively manufactured from JW Shinyak’s Pyeongtaek plant and Dong Wha Pharmaceutical’s Chungju plant. These plants also manufacture other generic drugs. The locally manufactured Famvir 750 mg tablet has changed its label and was distributed to vendors. But Famvir 250 mg tablet was just transferred to a local manufacturer, so the products from the Korean plant would be distributed around January next year. Although manufactured in Korea, Famvir is expected to maintain the high sales record as an original drug. According to IQVIA last year, the original drug generated 7.7 billion won and made the highest sales among the same substance drugs. In Korea alone, there are 125 famciclovir drugs in the market. And as the drug is now manufactured in Korea, Famvir is projected to generate even larger profits.
- Policy
- New osteoporosis drug Evenity passed deliberation
- by Lee, Hye-Kyung Sep 15, 2020 06:26am
- Amgen Korea's bone formation promoting and bone resorption inhibitor Evenity PFS (Romosozumab) passed the deliberation. On the 11th, the HIRA (President, Sun Min Kim) released the results of the deliberation on the adequacy of medical benefits for the drugs applied for decision deliberated by the '9th Pharmaceutical Benefits Advisory Committee in 2020'. The drug deliberated this time was one item of Amgen's Evenity, and the deliberation was made in writing for two days from 9 to 10 due to COVID-19. Evenity is a drug that has been recognized for the appropriateness of reimbursement in one year and four months after obtaining domestic approval in May of last year. Indications of Evenity are ▲treatment of postmenopausal female osteoporosis patients with a high risk of fracture ▲Bone density increase in male osteoporosis patients with high fracture risk. Effectiveness is based on phase III studies 'FRAME' and 'ARCH' studies and phase III clinical 'BRIDGE' study for male osteoporosis patients Through FRAME, a placebo-controlled phase III clinical trial, Evenity showed the effect of lowering the risk of vertebral fracture in postmenopausal female patients with a high risk of fracture, with a T-score of -2.5 to -3.5 in the total hip or femur neck. In the first year of treatment with Evenity, the risk of new vertebral fractures was reduced by 73% in the Evenity group compared to the placebo group. In the second year of treatment after 1 year of Evenity treatment, the risk of new vertebral fractures was reduced by 75% compared to the group of patients who switched from placebo to Prolia. On the other hand, the HIRA is evaluating the adequacy of reimbursement of medicines after deliberation on the committee in accordance with Article 11-2 of the Rules on the Standards of National Health Insurance Medical Care Benefits. In the case of drugs that have been evaluated for reimbursement appropriateness, the final evaluation result may be changed in the event of changes in the detailed drug reimbursement range and standard items, changes in the permission details of the item requested for determination, and withdrawal of permission (cancellation).
- Policy
- Fluarix Tetra, full-scale competition for flu vaccines
- by Lee, Tak-Sun Sep 14, 2020 06:15am
- Fluarix Tetra by GSKThe quadrivalent flu vaccine 'Fluarix Tetra', which was first introduced in Korea in 2015, was approved by the Ministry of Food and Drug Safety, and began to compete in the market in earnest. GSK's Fluarix Tetra is a representative imported vaccine that has been ranked at the top since its launch in 2015. However, it is expected to act as a variable in the competitive market as it does not participate in the quadrivalent flu vaccine NIP (National Immunization Program) project starting this year. On the 8th and 10th, the Ministry of Food and Drug Safety approved Fluarix Tetra PFS, an imported quadrivalent flu vaccine from GSK. As a result, the approval of most products expected to be sold this year was achieved. As the NIP began this week, the flu vaccine market entered a rebound competition. Among them, Fluarix Tetra is attracting attention as it is a quaternary vaccine aid and top-notch product. Fluarix Tetra was the first tetravalent vaccine to be launched in the domestic market in 2015. In Korea, it has been sold through Yuhan Corporation, and GC Pharma has been selling it since last year. Last year, sales amounted to ₩7.9 billion, followed by 'SKY Cellflu Quadrivalent (₩13.1 billion) by SK Bioscience and GC Pharma's 'GCFLU Quadrivalent (₩12.4 billion)'. The fourth place was Sanofi Aventis Vaxigriptetra with ₩4.6 billion based on IQVIA. Last year, it was pushed down to the third place after being pushed by domestic products, but from 2015 to 2018, it continued to be the number one. However, there are many variables this year. Above all, the tetravalent vaccine NIP starting this year is expected to have an impact. While most of the products participate in the NIP, Fluarix Tetra is only launching products in the market without NIP. Accordingly, it is unclear whether Fluarix Tetra will maintain its existing market share. It is also of interest how the sales company GC Pharma will conduct marketing through differentiation from its own 'GCFLU Quadrivalent'. For the first time, it is expected to take a dual strategy of actively promoting GCFLU Quadrivalent in the NIP, and putting the first tetravalent vaccine and imported product, Fluarix Tetra, in the market. However, as the price of products in the market is expected to decrease due to the participation of many products in the NIP, the price of which Fluarix Tetra chooses will also act as a variable. This year, the demand for flu vaccines is expected to be higher than ever due to the COVID-19 epidemic. The government also recommends influenza vaccination because COVID-19 and flu have similar symptoms, and confusion in quarantine is expected if they occur simultaneously. There are a total of 12 flu vaccines scheduled to be distributed in Korea this year. GSK and Sanofi are the only foreign pharmaceutical companies to import and sell flu vaccines.
- Policy
- GSK withdraws adult TD vaccine from Korea
- by Lee, Tak-Sun Sep 11, 2020 06:28am
- Green Cross TD vaccine successfully localized in 2016GSK will stop supplying the adult TD vaccine 'Td-pur', which was imported and sold in Korea. The company said there was no additional import after November 30. Until now, adult TD vaccines have been dependent on imports, but GC Pharma succeeded in localizing them in 2016. With GSK's supply discontinuation of Td-pur, the localization of GC Pharma is in the limelight. According to the MFDS, GSK announced the shutdown of the supply of TD-pur in July. TD-pur is an adult TD vaccine. It is a vaccine that prevents diphtheria and tetanus. Four adult TD vaccines are licensed in Korea. SK Td Vaccine Inj by SK Bioscience, Access Pharma's TD Booster SSI', 'Green Cross TD Vaccine PFS' by GC Pharma, and TD-pur by GSK have been competing. Among them, the only domestic product is Green Cross TD Vaccine PFS. It was approved for an adult TD vaccine made with its own technology in November 2016. This product is regarded as a case of successful localization by receiving consulting support from the MFDS since 2010. The MFDS at the time explained that the localization of the TD vaccine is expected to replace imports for 450,000 people every year. SK TD vaccine is a product that is imported from GSK Germany and sold as a finished product in Korea. In addition, DT Booster SSI is imported from Denmark SSI in finished form. With the withdrawal of GSK TD-Pur in Korea, the market will now compete for these three items. GSK said that it was unavoidable in the process of consolidating and overhauling the production line for business efficiency after the acquisition of Novartis Vaccine Division in 2015 due to the reason for the interruption of the supply of TD-Pur. In Korea, competitiveness has also been lost since the launch of Green Cross TDI vaccine. Last year, the sales of TD-Pur based on IQVIA amounted to about ￦300 million. On the other hand, SK TD vaccine and Green Cross TD vaccine ranked first and second with ￦1.9 billion and ￦1.3 billion. This year, the Green Cross TDI vaccine was ranked first for the first time. The cumulative sales in the first half of the year were ￦600 million for Green Cross TD vaccine and ￦460 million for SK TD vaccine. The domestic product has risen to the No. 1 market after 3 years of launch. The localization of Green Cross TD vaccine is shining even more with the withdrawal of TD-Pur from GSK. An industry insider said, "Since we can not guarantee a stable supply of imported vaccines as in this case of TD-Pur, there is no need to say the need for a domestic vaccine for the management of infectious diseases."
- Policy
- First drug for ultra rare Batten disease Brineura approved
- by Lee, Tak-Sun Sep 11, 2020 06:28am
- The first treatment for a pediatric rare disease, Batten disease, has received the South Korean health authority’s approval. As Batten disease is an inherited metabolic disorder that can cause loss of sight, the new treatment could give hopes to the patients and their families. Ministry of Food and Drug Safety (MFDS) has approved Brineura 150 mg injection, supplied by MediTip, on Sept. 8. The product is indicated to treat ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency. Recently, TPP1 or CLN2 is widely known as Batten disease. The disease is an inherited metabolic disorder, discovered by a Pediatric Doctor Batten in 1903. It is considered as an ultra rare disease with prevalence rate of one out of 100,000 in the U.S. Symptoms of Batten disease Symptoms, such as slow deterioration of eyesight, cognitive decline and behavioral change, would be expressed from age of four to 10. When the symptoms worsen, the patient could lose vision. The medication is injected with a catheter to cerebrospinal fluid once in two week. Developed by the U.S.-based BioMarin Pharmaceutical, Brineura won the U.S. Food and Drug Administration’s (FDA) approval as a first Batten disease treatment in April 2017. BioMarin Pharmaceutical is an emerging global pharmaceutical company specializing in rare disease treatment. For the Korean market, a healthcare consulting company MediTip applied and received the marketing approval on Brineura.
- Policy
- The MOHW’s new budget focuses on new drugs·COVID-19 trial
- by Lee, Jeong-Hwan Sep 10, 2020 06:23am
- While the budget plan of the MOHW for 2021 was released, it was found that the new budget focused on the treatment field, such as the national new drug development project and non-clinical support for COVID-19 treatment and vaccine. The new budget for the national new drug development project was ￦150.5 billion, and the new budget for non-clinical support for COVID-19 treatment and vaccine was ￦7.4 billion. In particular, compared to the previous year, the budget for clinical support for COVID-19 treatments and vaccines increased by ￦17.7 billion to ￦62.7 billion, and vaccines increased by ￦19.7 billion to ￦68.7 billion. Looking at the 2021 budget for the Ministry of Health and Welfare, Health Industry Policy Bureau of the Ministry of Health and Welfare on the 8th, 27.0% of the total ￦934.3 billion requested by the MOHW is adjusted to ￦79.37 million. Among them, the new net increase budget next year was ▲general government regenerative medical technology development project (R&D) ▲national drug development project ▲disease-centered mediation research project (R&D) ▲public interest medical technology research (R&D) ▲digital pathology-based Cancer-specialized AI analysis solution development project (R&D) ▲ Big data construction specialized for critically ill patients and AI-based CDSS development (R&D) ▲ Multilateral life research resource advancement project ▲ COVID-19 treatment/vaccine non-clinical support. What stands out are the national new drug development project and non-clinical support for COVID-19 treatments and vaccines. The national new drug development project, with a net increase of ￦15.1 billion, aims to become a competitive blockbuster new drug in the global market, and supports the entire cycle of new drug development from discovery of candidate substances to phase II clinical trials. It is conducted by the Ministry of Welfare, the Ministry of Science and ICT, and the Ministry of Industry, and the next year's budget is only reflected for six months, considering the preparation period for the first year. The main contents are the 'new drug base expansion research' budget of ￦3.93 billion, which aims to continue supplying excellent initial pipelines, and the'new drug clinical development' budget of ￦3.7 billion, to vitalize the entry of basic research results into the clinical stage. Non-clinical support for COVID-19 treatment and vaccine was allocated ￦7.4 billion. ￦6.4 billion is for non-clinical support, and ￦1 billion is for medical product evaluation support using advanced animals. ￦7.17 billion was allocated for the development of a digital pathology-based AI analysis solution specializing in cancer. It costs ￦2.62 billion for the expansion of the pathology data digital curation base, ￦1.68 billion for the development of a digital pathology data platform for AI development, and ￦2.62 billion for the development of intelligent pathology AI SW specializing in cancer. In addition, ￦6.41 billion was allocated for the regenerative medical technology development project of all ministries. It consisted of ￦1.98 billion for regenerative medicine source technology development, ￦2.64 billion for regenerative medicine-linked technology development, ￦702 million for regenerative medical treatment technology development, and ￦1,158 million for operating expenses. The government’s regenerative medicine technology development project secures core and source technologies in the field of regenerative medicine, and supports the development of linked technologies, treatments, and treatment technologies and early clinical application. The disease-centered mediation research project was allocated ￦3.63 billion, the public medical technology research project was ￦4,17 million, and the critically ill-specialized big data construction project was allocated ￦7.06 billion. The public medical technology research project aims to verify the concept and secure clinical basis by supporting the development of practical technology for solving public medical demand such as low birthrate, rare diseases, and patient safety. On the other hand, the MOHW has organized the budget for clinical support for COVID-19 treatment and vaccines, which is also higher than the previous year. In the case of clinical support for treatment, ￦62.7 billion was allocated, an increase of ￦17.7 billion (39.3%) from ￦45 billion, and vaccine clinical support was allocated ￦68.7 billion, an increase of ￦19.7 billion (40.2%) from ￦49 billion.
- Policy
- MFDS to shorten fast-track review by a month
- by Lee, Tak-Sun Sep 10, 2020 06:23am
- With the latest reorganization effective from Aug. 31, South Korea’s Ministry of Food and Drug Safety (MFDS) has formed ‘Fast-track Review Division’ and ‘Preliminary Consulting Division’ under National Institute of Food and Drug Safety Evaluation (NIFDS) to expedite the review process on innovative new drugs. The pharmaceutical industry is expecting the fast-track review on Korean-made new drug and incrementally modified drug (IMD) would expand as MFDS has added ‘new drug developed by Innovative Pharmaceutical Company’ to the expedited review subject scope. However, MFDS clarified only the drugs defined under the Article 58 of Pharmaceutical Approval Review Regulation are eligible for the fast-track review, which means even a new drug developed by an innovative pharmaceutical company may not be eligible for the fast-track review unless the regulation defines so. Recently, the pharmaceutical industry’s anticipation was heightened as MFDS newly established an operational plan to provide fast-track review on healthcare products meeting any one of following conditions—pharmaceuticals aiming to treat life-threatening diseases or severe diseases (including orphan drug or orphan drug in development), and have no alternative option or demonstrate efficacy significantly better than the existing option; pharmaceuticals aiming to prevent or to treat infectious disease with risk of threatening public health, such as bioterrorism or infectious disease pandemic (including outbreak of infectious disease with potential to develop as a pandemic), and have no alternative option or demonstrate efficacy significantly better than the existing option; new drugs developed by an innovative pharmaceutical company; rare medical devices; innovative medical devices; and innovative healthcare products with convergence technology. The MFDS operation plan would have the ministry to designate subjects for fast-track review among products the companies applied for. A MFDS official said, "The operation plan would cut the current fast-track review period by 30 days from 120 days and complete it in 90 days.” And the applicant may accelerate the commercialization by having a pre-review consulting and fully preparing for the review without submitting supplementary materials. The Korean pharmaceutical industry seems to be anticipating on adding ‘new drugs developed by innovative pharmaceutical company’ as subject for the fast-track review. So far, 31 companies—mostly Korean companies like Hanmi Pharmaceutical and Yuhan—are designated as ‘innovative pharmaceutical company.’ Moreover, MFDS elaborated IMDs could also be designated to take the fast-track review. Such MFDS regulation on fast-track review is nothing new. But such specific application procedure for pharmaceutical company did not exist. The fast-track review regulation is described in Article 58 of the Pharmaceutical Approval Review Regulation According to the regulations, companies with following pharmaceuticals may apply for the fast-track review—pharmaceuticals with treatment efficacy expected on life-threatening or severe diseases such as AIDS or cancer; urgently needed pharmaceuticals due to existing treatment options unable to treat or tend to develop resistance; and pharmaceuticals the Minister of Food and Drug Safety deems necessary for patient treatment or industrial development, such as anticancer treatment, orphan drug and DNA chip. Some of evidential materials can be submitted after the market release, and the review process can be prioritized to accelerate the procedure. Moreover, the regulation clarifies, the fast-track review would be accessible to pharmaceuticals meeting the following conditions—new drug or IMD; pharmaceuticals submitted evidence on clinical trial outcome conducted in South Korea; pharmaceuticals underwent preliminary review on evidential material submission standards regarding toxicity, pharmacology test, and clinical outcomes according to the Article 35-2; pharmaceuticals, applicable by Item 3 of Paragraph 2 of Article 25, that submitted common technical document (CTD) according to Paragraph 1 of Article 6. But as the fast-track review is not stipulated in the Pharmaceutical Affairs Act, the ministry would have limitations in expanding the system. Regarding the limitation, the ministry is in process of supporting a lawmaker’s bill. On the contrary, fast-track reviews on cell and gene therapies are stipulated under the recently legislated Advanced Regenerative Medicine and Biopharmaceutical Act. The newly established Fast-track Review Division would not handle pharmaceuticals managed under the Advanced Bio Act, but the Cell and Gene Therapy TF Team would process their fast-track review under the new law. For the time being, the Fast-track Review Division plans to prioritize and review COVID-19 treatments and vaccines over other subjects. A MFDS official noted, "The COVID-19 treatment and vaccine would be processed first,” and “the fast-track review subjects stated by the operational regulation would be processed under the Article 51 of Pharmaceutical Review and Approval Regulation." Meanwhile, MFDS plans to hold an online seminar on the issue from Sept. 9 to 10 to inform about the preliminary consulting and fast-track review system and related procedure in detail.
- Policy
- Kang Do-tae & Jeong Eun-Kyeong were promoted
- by Kim, Jung-Ju Sep 09, 2020 05:49am
- Kang Do-tae, the current head of the Planning and Coordination Office (51, Seoul National University, Master of Public Administration), was appointed as the first multiple vice minister to lead the health sector of the Ministry of Health and Welfare. The next Vice Minister, Kang Do-tae, the first multiple Vice Minister of the MOHW, is in charge of all areas of the health sector encompassing the pharmaceutical industry within the Ministry of Health and Medicine, including health care and medicine. In addition, the first director of the Korea Disease Control and Prevention Agency (KDCA), who is promoted to a central administrative agency, succeeds and continues the head of the Korean Centers for Disease Control and Prevention Jung Eun-kyung (56, MD & Ph.D Preventive Medicine of Seoul National University ) Through a briefing on the afternoon of the 8th, Cheong Wa Dae announced the new members of the Ministry of Health and Welfare and the KDCA, which are reorganizing the government in accordance with the partially amended laws of the Government Organization Act. First, Kang Do-tae was appointed as the second vice minister of the Ministry of Health and Welfare, the current head of the Planning and Coordination Office. Vice Minister Kang was a graduate of the 35th Public Administration Examination, and has been in charge of policy practices in various fields in the field of health, including the Welfare Administration Support Officer, the Health and Medical Policy Officer, and the Health and Medical Policy Officer at the Ministry of Welfare. When the new Vice Minister Kang is appointed, the Ministry of Health and Welfare plans to reinforce the health care policy capacity by reinforcing 3 departments and 44 people to implement more active health care policies. As expected, the first head of the KDCA, which is promoted from the headquarters unit to the central administrative agency, is Jeong Eun-Kyeong, the current head of the KCDC. She was from Department of Medicine, Seoul National University and worked as a health researcher at the Ministry of Health and Welfare to gain administrative experience. Afterwards, she served as the head of the emergency medical department and the head of the disease policy department of the MOHW, and then served as the head of the KCDC and the Head of the Emergency Situation Center, gaining high knowledge and experience in responding to infectious diseases. It is evaluated that the rapidly evolving performance was remarkable while promptly and accurately commanding the response to the COVID-19 incident. As a result, she is the head of the organization that conducts full-cycle management from Korea's infectious disease monitoring and research, health crisis response and prevention, while leading a total of 1,476 personnel from the 5 Bureaus 3 Offices and 41 divisions at the National Disease Administration, which will be launched in earnest on the 12th.
