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- 2026-05-16 03:42:04
- 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."
- Company
- HK inno.N's K-CAB has ended Phase 1 in US
- by Kim, Jin-Gu Apr 11, 2022 05:58am
- HK inno.N announced on the 7th that its flagship drug, "K-CAB (Tegoprazan), has successfully ended phase 1 clinical trials in the U.S., a treatment for gastroesophageal reflux disease. The clinical trial was conducted on 30 healthy adults with random assignment, double blinding, placebo control, and repeated administration. K-CAB 25 mg, 50 mg, and 100 mg were administered to clinical participants orally for 7 days, respectively, and pharmacokinetic characteristics and safety were evaluated. As a result of pharmacokinetic evaluation, the blood concentration of K-CAB was proportional according to the content, and similar profiles were maintained on both the 1st and 7th days of administration. In the pharmacological evaluation to measure the acidity (pH) in the stomach, both the 1st and 7th days of administration showed higher acidity than the placebo for 24 hours. In particular, it showed rapid medicinal effects regardless of the dose on the first day of administration. In terms of safety, all doses of K-CAB did not differ from placebo. HK inno.N has been conducting a phase 1 clinical trial of K-CAB with the aim of entering the U.S., the world's largest pharmaceutical market. HK inno.N signed a technology export contract worth about 640 billion won to Braintree Laboratories, a subsidiary of Sebela, a U.S. digestive medicine company, last year when it was undergoing local clinical trials. HK inno.N explained that Braintree Laboratories will be in charge of follow-up clinical trials in the United States and Canada. Braintree Laboratories plans to carry out follow-up clinical trials in the U.S. and Canadian markets as soon as possible. Starting with the smooth completion of the phase 1 clinical trial in the U.S., It will work closely with our local partners to ensure that the Korean new drug K-CAB can be successfully launched in the U.S. market, said Kwak Dal-won, CEO of HK inno.N. K-CAB recorded 109.6 billion won in outpatient prescriptions in Korea last year. Cumulative prescriptions amount to 236.4 billion won over the three years after release. Based on its domestic success, HK inno.N is actively seeking overseas expansion. It has made inroads into 27 countries around the world, including the U.S. In the Chinese market, Luoxin, a local partner, is planning to license and release items in the first half of this year.
- 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.
- Company
- Rising COVID-19 cases impede progress of bioequivalence test
- by Chon, Seung-Hyun Apr 08, 2022 06:08am
- Pharmaceutical companies are having trouble conducting bioequivalence tests for the development of generics due to COVID-19. The spread of COVID-19 has made it difficult for companies to recruit subjects, and even those recruited are dropping out after being confirmed with COVID-19, causing disruptions in the companies’ schedules. With delays inevitable due to the unexpected pandemic, pharmaceutical companies have been asking authorities to extend the drug pricing reevaluation deadlines that were set for February next year. According to industry sources on the 8th, several pharmaceutical companies have expressed their difficulties in progressing their ongoing bioequivalence tests due to the surge of COVID-19 cases. With hundreds of thousands of people being confirmed with COVID-19 every day, recruiting patients for the bioequivalence test itself is difficult. According to KDCA, 1,683,111 people were confirmed with COVID-19 over the past 1 week since the 6th. With over a million people in self-isolation due to COVID-19, the companies are complaining of difficulties in recruiting necessary subjects. With subject requirements are already stricter than before, difficulties in recruiting subjects for bioequivalent tests have been ongoing for some time. In accordance with the revised Pharmaceutical Affairs Act passed by the National Assembly in November 2018, people who have no experience participating in a clinical trial within 6 months prior to the trial date should be selected as subjects for clinical trials. With the restriction period extended from 3 months to 6 months. the number of participants viable for the tests has also decreased significantly. Also, even the registered subjects are frequently leaving trials to COVID-19. This renders it difficult to conduct a normal bioequivalence test due to the lack of subjects. The drug equivalence standards require 12 or more people in each group -the test group and control group for bioequivalence tests. This means the bioequivalence tests cannot be conducted unless over 24 people register for the tests. If subjects in the test group or control group are reduced to less than 12 due to COVID-19, the bioequivalence test itself may turn to waste. The companies can increase the test group or control group can by recruiting additional subjects, but this would inevitably push back the schedule. An official from a pharmaceutical company said, “We are planning to recruit more subjects than originally planned due to the rapid increase in the number of confirmed COVID-19 cases, but it isn’t easy. Even those who already registered are leaving trials after being confirmed with COVID-19, so we’re having much difficulty conducting the required bioequivalence test” Also, if the fallouts are concentrated in a specific group, such as the control or test group, the test itself may not derive significant results. For example, if 30 people were recruited for each group but 15 people from the test group leave due to COVID-19, the reliability of the test statistics may be undermined. Pharmaceutical companies have also had difficulty conducting bioequivalence tests in the early stages of the COVID-19 pandemic. In the early stages of the outbreak in 2020, the tests had been delayed with medical institutions discontinuing face-to-face work related to bioequivalence tests such as administration, screening, and monitoring. The main reason why pharmaceutical companies are expressing concern over their difficulties is because of the pressing deadline of the drug pricing re-evaluations for generic drugs. The Ministry of Health and Welfare announced a plan to re-evaluate the price ceiling of drugs, under which generics that do not meet the highest-price requirements in June 2020 are required to submit data on their ‘performance of bioequivalence tests’ and ‘use of registered APIs’ by February 28th, 2023 to maintain their previous drug price. This is a follow-up measure to apply the new drug pricing system which took effect in July 2020 to registered generic products. Under the revised drug pricing system, generic products can only be priced at the maximum price, which is 53.55% of the original drug’s price before patent expiry only when it satisfies both the requirements – directly-conducted bioequivalence tests and the use of registered raw materials. If either of the requirements is not met, the price cap is lowered by 15%. This means that a generic, which is approved by consigning the entire process to other companies without developing or producing it, will receive a drug price discount and be set at 72.25% of the previous price cap. The requirement of using a registered raw material can be met by switching the API. Due to the revised law, companies were left to decide between accepting the drug pricing discounts or maintaining the previous price by conducting bioequivalence tests. This is why companies have been actively conducting bioequivalence tests on their registered generics. According to the Ministry of Food and Drug Safety, a total of 768 plans for bioequivalence tests were approved in 1.8 years from July 2020 to February this year, which averages at 38 plans per month. Compared to 445 (22 per month on average) that were approved during the 1.8 years prior to July 2020 (November 2018 to June 2020), this is a 72.6% increase. Over half of the bioequivalence test plans approved recently are for registered generics. Of the 51 bioequivalence test plans approved in February, 39 were already on sale as registered generic products. Most of the bioequivalence tests are being conducted for ‘'in-house conversion' of the generics to manufacture in their own companies. If the companies make generics through formulation research and conduct bioequivalence tests that demonstrate bioequivalence, the companies can avoid the price cuts by obtaining change approvals. If companies convert consigned manufacturing to in-house manufacturing while applying for license changes, the companies can satisfy the ‘conducting bioequivalence test’ condition. Whichever way, it is said that it takes up to six months or more for bioequivalence tests to be imitated and render results. However, if the bioequivalence test data cannot be submitted by February next year due to a delay in the test schedules caused by the surge in confirmed COVID-19 cases, generic drugs will have no choice but to bear the drug price cuts. This means that the price of generic drugs may be reduced by 15%, even after the companies spent a lot of money and effort to avoid such discounts.
- Policy
- The benefit adequacy of Lorviqua was recognized
- by Lee, Tak-Sun Apr 08, 2022 06:08am
- Pfizer Pharmaceutical's Lorviqua has taken a step closer to insurance benefits in recognition of benefit adequacy as a treatment for non-small cell lung cancer. If negotiations with the NHIS are smoothly concluded in the future, the final benefit will be successful. The HIRA announced on the 7th that it held the 4th Drug Reimbursement Evaluation Committee in 2022 and recognized the benefit adequacy of Pfizer Pharmaceutical. The target products were Lorviqua 25 mg and Lorviqua 100 mg, and the Drug Reimbursment Evaluation Committee judged that there was benefit adequacy as a treatment for adult patients with ALK positive progressive non-small cell lung cancer (NSCLC). Results of deliberation by the 4th Drug Reimbursement Evaluation Committee in 2022 Lorviqua was approved in Korea in July last year to use Alecensa Cap or Zykadia Cap as a sole therapy for adult patients with ALK-positive progressive non-small cell lung cancer or as treated with Xalkori and at least one other ALK inhibitor. The Drug Reimbursement Evaluation Committee judged that Sonazoid and Duchembio's Dopa check at GE Healthcare's Korean branch had benefits when accepting less than the evaluation amount. It is subject to acceptance conditions below the evaluation amount. Sonazoid applied for benefits when used for liver gastric tumor lesion ultrasonography in adult patients, and Dopa check applied for use in positron emission tomography (PET).
- Company
- GC Pharma’s Hunterase ICV approved for P1T in Korea
- by Kim, Jin-Gu Apr 08, 2022 06:08am
- On the 7th, GC Pharma announced that it had received approval for a Phase I trial of its severe Hunter syndrome treatment ‘Hunterase ICV’ in Korea from the Ministry of Food and Drug Safety. Hunterase ICV comes in a new formulation that is inserted as a device in the head, through which a drug is directly administered into a patient’s cerebral ventricle. It overcomes the limitations of existing IV-type formulations that were unable to penetrate the blood brain barrier (BBB) and reach the cerebral parenchyma. The clinical trial will be conducted in 3 institutions in Korea - the Samsun Medical Center, Seoul National University Hospital, and Pusan National University Yangsan Hospital – on 12 patients with a severe type of Hunter syndrome to evaluate the safety and efficacy of the drug. GC Pharma said that the unmet medical need is high in the area as 70% of the patients have the severe, neuropathic form of Hunter syndrome. An official from GC Pharma said, “We will continue our efforts to improve the quality of life of our rare disease patients. As the product has already been successfully commercialized abroad, we will make the best effort so that the drug could be supplied to our patients in Korea as soon as possible.” GC Pharma received marketing authorization for ‘Hunterase ICV,’ the world’s first treatment for sever-type Hunter syndrome in Japan in January last year. In a clinical trial conducted in Japan, "Hunterase ICV" significantly reduced ‘heparan sulfate (HS),’ a key substance that causes central nerve damage, and demonstrated an effect in maintaining and improving the developmental age.
- Policy
- Bavencio by Merck passed the Cancer Drugs Benefit Committee
- by Lee, Tak-Sun Apr 08, 2022 06:08am
- Bavencio by Merck Immuno-cancer drug Merck Bavencio passed the Cancer Drugs Benefit Appraisal Committee as an indication for urinary tract epithelial cell cancer. The HIRA's Cancer Drugs Benefit Appraisal Committee held the 4th meeting in 2022 on the 6th and announced that Bavencio's standards for urinary epithelial cell cancer have been set. Cancer Drugs Benefit Appraisal Committee also set standards only for WM in the case of BeiGene's Brukinsa, which applied for benefits on the same day. It is expected to be used as a monotherapy in adult WM patients who have previously received more than one treatment. However, Brukinsa failed to set the standard for "single therapy in adult patients with osmotic cell lymphoma (MCL) who have previously received more than one treatment." Lynparza of AstraZeneca, Korea, known as an ovarian cancer treatment, also started to expand the standard, but it was bittersweet. The standards were set for the treatment of adult patients with BRCA mutagenic castration resistant prostate cancer, who had previously experienced disease progression after treatment with new hormone treatments, but the remaining three indications were not set. Combination maintenance therapy in adult patients with highly epithelial ovarian cancer, ovarian cancer, or primary peritoneal cancer, which is HRD-positive (defined as BRCA mutation or dielectric instability) in response to primary platinum-based chemotherapy and Bevacizumab combination therapy, did not pass the Cancer Drugs Benefit Application Committee. The treatment of gBRCA mutant HER2-negative metastatic breast cancer adult patients with previous chemotherapy experience and maintenance therapy of gBRCA mutant metastatic pancreatic cancer adult patients who did not undergo primary platinum-based chemotherapy for at least 16 weeks were not recognized.
- Company
- Yuhan's gastric atony tx has completed the registration
- by Nho, Byung Chul Apr 08, 2022 06:08am
- Yuhan Corporation (CEO Cho Wook-je) announced on the 6th that it has completed the first patient registration in phase 2A of clinical trial for patients with gastric atony of the new drug candidate "YH12852 (PCS12852)" exported by Technology to Processa Pharmaceuticals. Gastric atony is a chronic gastric motor disorder that causes severe heartburn, nausea, vomiting, and bloating due to delayed gastric emptying. In the United States, millions of patients suffer from dysentery, and there is a high demand for more effective treatment development. Currently, the only FDA-approved gastric atony treatment is Metoclopramide, a dopamine D2 receptor antagonist. However, the drug has been approved only for diabatic gastric atony and has a limited duration of up to 12 weeks due to serious potential side effects. Although past 5-HT4 agonists are effective, they bind non-selectively to other 5-HT receptors, resulting in serious side effects. YH12852 developed by Yuhan shows more than 200 times higher binding power to 5-HT4 receptors than other 5-HT receptors and has excellent selectivity and efficacy. Preclinical and clinical studies using YH12852 also showed minimal side effects in effective doses, so more clinical results are expected. Dr. Sian Bigora, head of development at Processa Pharmaceuticals, said, "We expect that this clinical 2A will have a similar effect on the gastric emptying rate of patients with gastric atony, as we confirmed that the gastrostomy rate was significantly improved while using YH12852 for constipation patients." He said, "The results of this study will provide important data to confirm the effect of YH12852 on the symptoms of patients with idiopathic and diabatic gastric atony, and will be useful for further designing clinical phase 2B." This clinical trial is a phase 2A clinical trial aimed at evaluating safety, pharmacokinetic properties, and efficacy of 13C-Spirulina Gastric Emptying Breath Test (GEBT) according to the dose of YH12852 in moderate or severe gastric atony patients, and will be conducted in a total of 24 patients in the U.S.
- Policy
- Phase 3 of Voclosporin has been approved in Korea
- by Lee, Hye-Kyung Apr 07, 2022 06:10am
- Phase 3 clinical trials of Voclosporin, the first oral treatment for lupus nephritis, will be conducted in Korea. On the 6th, the MFDS approved a clinical trial of Voclosporin, an LN treatment of Aurinia Pharmaceuticals, a subsidiary of Iljin SNT. Phase 3 clinical trials will be conducted at Seoul National University Hospital and Kyungpook National University Hospital as a double blindfold, placebo-controlled, and dose-increasing test to evaluate the efficacy, safety, and pharmacokinetics of Voclosporin for adolescents with lupus nephritis. Voclosporin was approved by the FDA in January last year for the treatment of adult patients with active lupus nephritis. Voclosporin, a calcineurin inhibitor, blocks interleukin (IL)-2 expression and T cell-mediated immune response and stabilizes podocytes in the kidney. According to the results of a study released by Aurinia Pharmaceuticals in November last year, Voclosporin showed continuous safety and weakness compared to placebo in the interim analysis of phase 3 clinical continuous research. Patients in the Voclosporin group maintained a significant decrease in proteinuria. From the baseline prior to treatment of AURORA 1 to 30 months of AURORA 2, UPCR was found to be -3.32 mg/mg for the Voclosporin group and –2.55 mg/mg for the control group (n=90). The eGFR, an important measure of renal function, remained stable until 30 months, and there were no unexpected new side effects reported in the Voclosporin group compared to the control group. Treatments for lupus nephritis include Cyclophosphamide, Cellcept, and Prednisone.
