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- 2026-04-11 06:00:36
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- First ASMD treatment Xenpozyme to land in Korea
- by Eo, Yun-Ho Nov 24, 2022 05:51am
- The first-ever pediatric storage disorder treatment is expected to be introduced to Korea. According to industry sources, Sanofi Genzyme’s treatment for acid sphingomyelinase deficiency (ASMD) ‘Xenpozyme (olipudase alfa)’ is undergoing processes for marketing authorization by the Ministry of Food and Drug Safety. Starting with Japan in March, the drug was also approved in Europe in July and by the US FDA in August and received Breakthrough Therapy designation in the countries. The efficacy of Xenpozyme, the only existing ASMD treatment, was identified through the ASCEND and ASCEND-Peds trials. The ASCEND trial evaluated the efficacy and safety of Xenpozyme in 36 adult patients with ASMD type A/B or type B. The patients were randomized to receive Xenpozyme or placebo for 52 weeks (primary analysis). At Week 52, Xenpozyme improved lung function from baseline by 22% in terms of the predicted diffusing capacity of the lung for carbon monoxide (DLco). Compared with the 3% improvement shown in the placebo group, the difference between the two treatment arms of 19% was statistically significant. Also, at Week 52, patients treated with Xenpozyme had a mean reduction in spleen volume by 39.5% compared with the 0.5% increase in the placebo group. All patients that were treated with Xenpozyme showed an improvement in one or two primary endpoints. The single-arm ASCEND-Peds trial studied 20 pediatric patients younger than 12 years of age with ASMD type A/B or type B. The primary objective of the trial was to evaluate the safety and tolerability of Xenpozyme for 64 weeks, and the explored efficacy endpoints of progressive lung disease, spleen, and liver enlargement, and platelet count were also explored in the trial. 9 patients who could take the test for diffusing capacity of the lung for carbon monoxide in the trial showed a 33% improvement in diffusing capacity after 1 year. The patients also showed a mean reduction in spleen volume of 49%. ASMD is caused by the lack of an enzyme needed to break down a complex lipid, called sphingomyelin, which accumulates in the liver, spleen, lung, and brain. Patients with ASMD experience enlarged abdomens that can cause pain, vomiting, feeding difficulties, and falls at 3 to 6 months of birth. The most severely affected patients have profound neurologic symptoms and rarely survive beyond two to three years of age.
- Company
- Shaperon applies for a patent for biomarkers,
- by Lee, Seok-Jun Nov 24, 2022 05:50am
- Shaperone announced on the 23rd that it has applied for a patent to prove the correlation between NuGel, an atopic dermatitis treatment under development, and biomarkers (biological markers). The patent is the result of analyzing the data of phase 2 patients with atopic dermatitis in Korea and confirming that biomarkers in the blood can be effectively used to predict the treatment reactivity of atopic dermatitis patients to NuGel. It is also a new technology that has revealed that the biomarkers can be used in Companion Diagnostics, which is required to maximize the therapeutic effect. Until now, most of the development of biomarkers for companion diagnosis has been focused on the field of anticancer drug development. It is evaluated that the Shaperon patent is meaningful because it has discovered a biomarker that can predict drug reactivity of new drugs in the field of atopic dermatitis for the first time in the world. It proposed a new paradigm that the diagnosis criteria for "Type A" (tentative name) atopic dermatitis can be prepared and the treatment effect can be maximized in the patient group. It is the same as requiring a different approach to the treatment of type 1 and type 2 diabetes. It is evaluated that it has developed a new personalized treatment technology based on NuGel for individual atopic patients through a patented technology that can differentiate between A-type atopic and non-atopic atopic patients with biomarkers discovered by Shaperon. The precision medical technology used in the patent is not limited to atopic dermatitis but plans to expand it to patients with intractable inflammatory diseases who have high market demand for accompanying diagnosis. In particular, it is expected that it can be used to develop new drugs that can increase the treatment effect by selecting patients with good treatment prognoses early. An official from Shaperon said, "In order to increase the success rate of new drug development in the era of precision medicine, it is important to develop joint diagnostic technology. The discovery of biomarkers has re-proven technology. "We will provide customized treatment options to patients with patent-based atopic dermatitis."
- Company
- Chong Kun Dang CKD-701, equivalent to Lucentis' original
- by Chon, Seung-Hyun Nov 24, 2022 05:50am
- A panoramic view of Chong Kun DangChong Kun Dang announced on the 23rd that the results of phase 3 clinical trials of the macular degeneration treatment Lucentis biosimilar CKD-701 were published in the SCI-level international academic journal PLoS One. Chong Kun Dang conducted phase 3 clinical trials of CKD-701 in 312 patients with neovascular age-related macular degeneration at 25 hospitals, including Seoul National University Hospital, from September 2018 to March 2021. In phase 3 clinical trials, the percentage of patients with vision loss of fewer than 15 characters in the primary efficacy evaluation index comparing the maximum calibration vision (BCVA) at 3 months after drug administration was 97.95% (143/146) in the CKD-701 administration group and 98.62% (143/145) in the original drug administration group. The change in maximum corrected vision (BCVA) improved by 7.14 characters in the CKD-701 administration group and 6.28 characters in the original administration group, showing no significant difference between the two drugs. It was confirmed that drug efficacy, safety, immunogenicity, and pharmacokinetic characteristics were clinically equivalent to the original drug through indicators such as the ratio of patients with less than 15 characters of vision loss and vision improvement, respectively, after 3, 6, and 12 months of drug administration. CKD-701, which was approved by the Ministry of Food and Drug Safety last month, is a high-purity Lucentis biosimilar mainly composed of Ranibizumab. Chong Kun Dang's pure independent technology, which is an antibody fragment raw material manufacturing technology, has been applied. CKD-701 is a drug with clinical equivalence compared to Lucentis, the original drug, in significant indicators, including maximum calibration vision, the primary evaluation index, said Professor Hyung-gon. "Pro Re Nata (PRN) is expected to stabilize the condition of macular degeneration disease and reduce the patient's burden of treatment." PLoS One is an online journal specializing in science and medicine published by the Public Library of Science (PLoS) since 2006. It has been listed on SCIE and SCOPUS, a global academic paper database platform for the past five consecutive years.
- Company
- SK Bio "hasn't manufactured SKYCovione after first batch"
- by Kim, Jin-Gu Nov 24, 2022 05:50am
- SK Bioscience On the 23rd, SK Bioscience publicly announced that the manufacture and supply of its self-developed COVID-19 vaccine ‘SKYCovione’ have currently been discontinued. SK Bioscience received marketing authorization for SKYCovione in Korea in July this year. In September, the company supplied an initial batch of 60 thousand doses of the 10 million doses that the government pre-purchased through an agreement. However, further manufacture and supply of the vaccine have been discontinued. One reason is that the overall vaccination rate has fallen with the slowdown of the COVID-19 outbreak and the increasing number of people with immunity. According to the Korea Disease Control and Prevention Agency, the cumulative number of people vaccinated with SKYCovione in Korea as of November 22nd was only 3,787. In other words, only 0.6% of the 600,000 doses supplied to the government were used. Its performance is sluggish compared to its competitors. The government has been recommending winter season COVID-19 vaccinations from October 11. People can choose from vaccines including SKYCovione, Pfizer’s BA1·BA.4/5-adapted vaccines, Moderna’s BA.1-adapted vaccine, and Novavax’s winter season vaccine. Among these, a cumulative 1,530,332 people received vaccination with Moderna’s vaccine. 754,058 received Pfizer’s vaccine, and 23,156 received Novavax’s vaccine. In the same period, only 1,759 people opted to receive SKYCovione. Due to such circumstances, SK Bioscience plans to continue producing the vaccine solution and wait for additional orders from the government. An official from SK Bioscience said, “Basically, the finished vaccine product is manufactured when requested by the government. We are not producing additional finished vaccines because we have not received additional requests after the initial supply." “Apart from the finished product, we have been manufacturing the vaccine solution. We will resume production and supply the request of the government in the future” The official added, “We are also undergoing global approval processes.” In July, the company applied for a Conditional Marketing Authorization (CMA) of SKYCovione (SKYCovion™ in Europe) to the Medicine and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), and then submitted an Emergency Use Listing (EUL) application to the World Health Organization in September. However, the applications have not been approved yet.
- Policy
- COVID vaccine side effects proven by the Government
- by Kim, Jung-Ju Nov 24, 2022 05:50am
- In order to prevent new infectious diseases such as COVID-19, a revision to the related law will be promoted to allow the government to receive medical and nursing expenses first if it is damaged by side effects after being vaccinated. Chung Chun-sook, a member of the Democratic Party of Korea's Health and Welfare Committee, proposed today (22nd) a bill to partially revise the Infectious Disease Prevention and Management Act. The revision aims to prevent damage as most of the people voluntarily participated in vaccination for community safety when new infectious diseases such as COVID-19 are prevalent around the world, but some people suffer from diseases, disorders, or deaths due to abnormal reactions caused by vaccination. The application of this amendment is limited to cases where new infectious diseases are prevalent. It also includes special cases such as expanding the scope of compensation for existing vaccination damage, providing medical and nursing expenses first, and ensuring that the state is responsible for proving the causality with vaccination to compensate the public for damage caused by new infectious diseases. Lawmaker Chung's office explained, "The main purpose is to apply the revised law from the beginning of vaccination due to COVID-19 and to compensate the public as much as possible by applying it even when compensation for vaccination is set." Meanwhile, it included Kang Byung-won, Kang Hoon-sik, Kim Won-i, Kim Han-kyu, Yang Kyung-sook, In Jae-geun, Choi Hye-young, Huh Jong-sik, Kang Eun-mi of the Justice Party, and independent Kim Hong-gul.
- Policy
- The government are in full swing discussing support
- by Lee, Jeong-Hwan Nov 24, 2022 05:50am
- The ruling party and the government's move to expand access to patients with severe and rare diseases, which was President Yoon Suk Yeol's presidential pledge, is notable. On the 21st, the People's Power, the Ministry of Health and Welfare, and the Ministry of Strategy and Finance will hold a policy meeting at the National Assembly to prepare measures to support the treatment of severe and rare diseases. The move is aimed at collecting opinions from private experts on the establishment of nursing hospitals specializing in severe and rare diseases and supporting medical expenses for new drugs for rare diseases and reflecting them in related policies and budgets. The policy meeting will be attended by People's Power figures, including Sung Il-jong, chairman of the policy committee, Lee Chul-kyu, secretary of the Special Committee on Budget and Accounts, and Lee Jong-sung, a member of the Health and Welfare Committee. In the government, Park Min-soo, the second vice minister of welfare, Hwang Soon-kwan, the Ministry of Economy and Finance, and the director of chronic disease management at the Korea Centers for Disease Control and Prevention will attend. In the private sector, the co-CEO of the Seungil Hope Foundation, permanent directors, and chief-level officials will be present. Ahead of the review of the Special Committee on Budget and Accounts, the People's Power announced that it would set up a regional specialized institution to deal with rare diseases of children and adolescents, establish a nursing hospital for rare incurable diseases such as amyotrophic lateral sclerosis(ALS), and increase the budget by 34.5 billion won to support medical expenses for non-reimbursed new drugs. Analysts say that it is unusual for the ruling party's policy committee to directly mention medical expenses for new drugs for severe and rare diseases. It is interpreted as a move to fulfill President Yoon's presidential campaign pledge and meet the demand for access to new drugs for incurable diseases raised by the private sector. President Yoon has made a pledge to resolve policy blind spots on treatments for severe and rare diseases and inject finances where practical guarantees are needed.
- Policy
- Gov’t to increase drug price reference countries
- by Lee, Tak-Sun Nov 23, 2022 06:04am
- The Health Insurance Review and Assessment Service made a preannouncement of a revision plan to expand the number of reference countries used to evaluate new drugs from 7 to 9 (US, UK, Germany, France, Italy, Switzerland, Japan, Canada, Australia·A9). After opinion inquiries, the revised plan will take effect in January next year. Although the reference countries are used to evaluate the adequacy of reimbursement of new drugs that are waived submission of pharmacoeconomic evaluation data, domestic pharmaceutical companies that own more generics than new drugs are also voicing opposition due to concerns over the next step HIRA will take afterward. According to industry sources on the 22nd, HIRA is also preparing reevaluations on listed drugs based on the revised plan to expand the number of price reference countries. Therefore, it is analyzed that reevaluations will be carried out sequentially from 2024 at the earliest after making preparations next year. The industry had expressed concerns about the very low price of generic drugs in Australia, which was added as a drug price reference country in the revision. Australia is known to introduce the cheapest drugs through competition. According to research, some generic drugs in Australia are set at one-fifth of the price in Korea. Therefore, using the drug price of 9 countries including Australia when conducting reevaluations on the adequacy of listed drugs will likely reduce the price of listed drugs in Korea. In other words, it will have the same effect as the unilateral price cut that had been made in 2012. Another industry concern is that such reevaluations are also being driven by policies after the ruling party pointed out that generic prices in Korea are high at the last NA audit. An industry official said, “If the expanded reference countries are used not only for pricing of new drugs but also reevaluations of all listed drugs, the price of generic drugs will inevitably be cut.” The reevaluation plan of listed drugs was also discussed with the expansion of pricing reference countries at the public-private working group meeting that had been held previously. Thus, HIRA is expected to start preparations after including the reevaluation plan for listed drugs in the 2nd Comprehensive Plan of National Health Insurance according to the expansion of reference countries. As a result, the industry believes that the criteria will be set next year and the drug price of listed drugs adjusted after sequentially receiving reevaluations from 2024.
- InterView
- The key to treating stroke tx is preventing the recurrence
- by Kim, Jin-Gu Nov 23, 2022 06:04am
- Stroke is a battle against time. Whether the blood vessels in the brain are blocked (brain infarction) or burst (brain hemorrhage), blood should be supplied to the brain normally within a short period of time. The medical community explains that the golden time of stroke is 4.5 hours. This means that the problem can be solved only when the symptoms occur and arrive at the hospital within 4 hours and 30 minutes. The importance of preventive treatment has been increasing. As the results of stroke treatment have improved compared to the past, drug treatment to prevent the recurrence of patients with stroke once has become more important. Park Jong-kyu, a professor of neurology at Cheonan Hospital affiliated with Soonchunhyang University, said, "The key to treating stroke drugs is to prevent a recurrence," adding, "Various drugs are used differently depending on the cause. Since the brain is a drug used in special areas, it should be used carefully in consideration of the side effects of bleeding, he said. ◆ Antiplatelet agents for vascular stroke and anticoagulants for embolic stroke There have been changes in the treatment of stroke over the past decade. In the past, even if a stroke occurred, it often came late. Many patients fell down holding the back of their necks and visited the emergency room. As such, the treatment period has been delayed. Major surgery was needed and the prognosis was not so good. As public awareness of stroke has been aroused, treatment performance has improved significantly recently. Unlike in the past, more and more patients visit the hospital due to initial symptoms, such as poor speech, narrow vision, and poor finger grip. Treatment methods are also changing. The importance of drug treatment is increasing as a secondary preventive treatment to prevent recurrence after treating an initial stroke. Professor Park Jong-kyu said, "Depending on the cause of stroke, drugs are used differently," adding, "In the doctor's opinion, if it is a vascular stroke caused by blood clots accumulating in the cerebral blood vessels, an anticoagulant is used." Professor Park emphasized, "In the case of anticoagulants, it may look better to prevent the recurrence of stroke in that it prevents blood itself from coagulating, but it should be used carefully because there is a high risk of side effects of bleeding." ◆"Anticoagulants have a high risk of bleeding side effects, so they should be used carefully for stroke" According to Professor Park, anticoagulants are mainly used for patients suffering from arrhythmia or heart valve disease at the same time. The problem is when heart disease is not clearly diagnosed. In this case, the doctor's judgment is involved. Professor Park explains, "Clinically, it seems that an embolized blood clot came from under the heart and blocked the cerebral blood vessels, but if there is not enough evidence." It is right to use antiplatelet drugs, but he explains that he uses anticoagulants on a limited basis because there is often a high risk of stroke recurrence. Multiple cerebral infarctions, in which several blood vessels in the brain are blocked at the same time, are a typical example. If the left blood vessel of the brain is observed to be blocked when the blood vessel of the brain is photographed, the cerebral infarction area should also be on the left side of the brain. However, there are patients who often have cerebral infarction on the right side of the brain. At this time, the location where the blood clot occurred is presumed to be below the heart, not the brain. At this time, if the patient has no history of heart disease, the anticoagulant is used under the judgment of a doctor that the patient lacks the basis for anticoagulant treatment, but the risk of recurrence is high. If multiple cerebral infarctions are not the first time, or if cerebral infarction occurs during recurrence prevention treatment with antiplatelet drugs, anticoagulants are used. Professor Park said, "Most of the patient's risk factors and mechanisms for cerebral infarction are identified and drug treatment is carried out accordingly to prevent a recurrence." ◆ Stroke is the fourth leading cause of death in Korea, and the number of young patients is increasing recently Severe or acute stroke is still treated surgically. Patients with blocked large blood vessels in the brain or blocked heavy blood vessels and poor symptoms are the targets. The key is to treat it as soon as possible. Generally, patients should visit the hospital within 4.5 hours. Professor Park said, "Finding and operating blood vessels is only possible when large blood vessels are blocked. In the case of heavy blood vessels and small blood vessels, surgery is attempted only when the symptoms are severe. He said, "Because there is a risk to the treatment itself, we solve it with thrombolysis through veins instead of surgery." Professor Park explained, "It can be rather harmful to perform surgery after golden time." He added, "This is because the bleeding occurs in weak areas in the process of penetrating blood vessels and supplying blood again, which can be dangerous for patients." Stroke is the fourth most fatal disease in Korea. According to the HIRA, 590,000 patients were diagnosed with stroke as of 2020. The perception of stroke has changed and the number of patients is increasing faster as the population ages rapidly. This is due to the increase in patients with hypertension and hyperlipidemia, which are the underlying diseases of stroke. The medical community estimates that the incidence rate doubles every 10 years after the age of 55. Professor Park explained, "As you get older, the risk factors you have are more likely to cause problems, so it will affect the increase in stroke." He said, "Recently, the number of young stroke patients under the age of 45 is increasing rapidly increasing. "There are concerns as risk factors for stroke, such as sleep apnea, are diversifying," he said.
- Policy
- MFDS recruits companies to develop 6 National Essential Drug
- by Lee, Hye-Kyung Nov 23, 2022 06:04am
- The government is busy recruiting institutions to develop domestic manufacturing technology for items that are heavily dependent on imports and have unstable supply to achieve self-sufficiency of national essential medicines. The Ministry of Food and Drug Safety had recently selected 11 products, including 5 raw materials and 6 finished products, as candidates for Stage 1 development after deliberation by the Product Selection Committee, and posted an open recruitment for developers on the webpages of research institutions including Korea Orphan & Essential Drug Center and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. The government will additionally recruit developers for items only a single company had applied for, which include 2 finished products (‘Amiodarone Inj,’ ‘stiripentol Cap’) and 4 APIs (‘amiodarone (amiodarone tablet, injection),’ ‘ibuprofen (ibuprofen injection 5mg/ml),’ ‘ketoconazole (ketoconazole tablet),’ ‘benserazide (levodopa, benserazide tablets)’). Although there is no limit to the number of development projects each institution may apply for, if the same applicant applies to develop the APIs that are candidates for a stable supply of national essential drugs and use them for the development and production of the finished drugs, the items will be recognized as two separate items and be supported separate R&D expenses. The MFDS selected drugs that are heavily dependent on imports and have unstable supply to achieve self-sufficiency of national essential medicines and has been carrying out the ‘Research Project for Managing Stable Supply of National Essential Drugs’ from this year until 2026. Despite the need to maintain a stable supply of national essential drugs at all times, there recently has been a shortage of raw materials as well as finished drugs internationally due to the COVID-19 outbreak. In particular, Korea is heavily dependent on imported drugs, therefore criticism had been raised on the need to prepare a supply chain for essential drugs in case of the rise of public health crises in the future. in The MFDS will invest a total of KRW 5 billion for 5 years - KRW 1 billion each year- to build a stable supply system for national essential drugs that have supply concerns and will aim to develop raw materials and finished drug production technology for domestic production. In the first stage (first-second year) of the project, the development targets will be selected and over 40% of the technology for the target drugs will be developed. In the second stage (third-fifth year), the remaining technology will be developed and be subject to comprehensive assessments. The MFDS said, "In addition to developing the technology for the localization and self-sufficiency of API manufacturing, we will also expand the recognition of multiple specifications of APIs when adding API manufacturers to diversify the supply chain for APIs. Also, if a disruption in supply is expected, we will promptly handle related complaints including adding drug substance manufacturers, etc."
- Policy
- Forxiga Prodrug will be reimbursed for five months
- by Lee, Tak-Sun Nov 23, 2022 06:04am
- ForxigaProdrug of Forxiga, an SGLT-2 diabetes treatment drug that Dong-A ST succeeded in avoiding patents through the development of drugs, will be listed on the 1st of next month. It is five months before the expiration of the patent. Earlier this month, it was possible because it succeeded in avoiding the duration of the material patent, which ends in April next year. The Ministry of Health and Welfare recently disclosed this fact through an administrative notice of the revision of some details on the criteria and methods for applying for medical care benefits. Dong-A ST's "Dapapro 10mg" will be newly registered on the 1st of next month and added to the standard for diabetes treatment. Dapapro was granted permission on 23 August. At that time, it was unclear whether Dapapro would be released before the expiration of its patent. This is because Dong-A lost the second trial of a patent suit against AstraZeneca, a patent holder of Forxiga, in February. Dong-A challenged the patent that Dapapro, a prodrug with a different chemical structure from the original, was not within the scope of Forxiga's material patent rights, but it was blocked in the second trial. The Korean Intellectual Property Tribunal, which is the first trial, decided that it was not within the scope of rights as requested by Dong-A. The ruling could have put Dong-A ST's early launch efforts in vain. This is because there is not much time left until the patent expires. However, Dong-A succeeded in avoiding patents on the 2nd of this month through a new patent lawsuit. This time, it was argued that Dong-A ST products were not included in the rights on the 917th day of the duration added to a material patent for Forxiga. For now, Dong-A ST is reportedly coordinating internally with the goal of releasing it before February next year if it is paid on the 1st of next month. Currently, the Ministry of Food and Drug Safety has approved 225 products containing Dapagliflozin. However, among them, only seven items from AstraZeneca, the original company, are on the market. It is virtually difficult to sell the remaining items until the patent expires in April next year. Dong-A ST is launching early alone. It is the first SGLT-2 generics in Korea. However, there is a possibility that the direction of patent litigation will emerge as a variable. It is not known whether AstraZeneca, who lost the patent tribunal, will appeal. If AstraZeneca expresses her intention to appeal, it will have to fight again in the patent court. If the ruling is overturned in the patent court, the sale of the product must be stopped. If there is a record of selling before then, AstraZeneca can also file a compensation suit based on this. It is highly expected that Dong-A ST will not miss this opportunity to dominate the market. Although it actively responds to patent lawsuits, it is expected to focus its efforts on marketing to preoccupy the market regardless of the outcome. It is reported that Dong-A ST believes that the patent issue has been resolved and judges the early release before the expiration of the patent.
