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- 2026-04-12 05:55:22
- Company
- BL’s COVID-19 treatment expands indication to pneumonia
- by Lee, Seok-Jun Jul 06, 2022 05:47am
- BL is aiming to adopt an indication expansion strategy and develop 'BLS-H01,’ its new drug for COVID-19 treatment for which a Phase II trial is underway, as a broad-spectrum treatment for pneumonia. According to BL on the 5th, BLS-H01 is an immunoregulatory treatment that contains a gamma PGA. A clinical trial is currently underway to assess its effect in preventing and treating pneumonia caused by COVID-19. BLS-H01’s core ingredient, ‘gamma PGA,’ stimulates the expression of dendritic cells that are necessary for the activation of natural killer (NK) cells and immune T cells to promptly remove virus-infected cells in the lung. This mechanism of action can respond to all virus types including influenza and SARs as well as their variants. In a research BL conducted with the Korea Mouse Phenotyping Center (KMPC) under the Ministry of Science and ICT last year, BLS-H01 demonstrated its effect in animal models infected with the COVID-19 virus. BL is now setting out to develop BLS-H01 as a broad-spectrum pneumonia treatment in addition to its development as a COVID-19 treatment based on such research results. The company aims to develop a drug that fundamentally treats pneumonia beyond the level of symptomatic treatment that is aimed at improving symptoms in the absence of an effective treatment. An official from BL said, “BLS-H01 is expected to significantly improve the survival rate of patients dying from pneumonia. As the drug can minimize respiratory complications and sequela caused by chronic pneumonia that arise with long-term treatment, there is high potential for its commercial success with new drug development.”
- Company
- 2nd generation EGFR TKI Vizimpro can be prescribed in Big 5
- by Eo, Yun-Ho Jul 06, 2022 05:47am
- Pfizer's second-generation EGFR TKI Vizimpro has settled in the Big 5 General Hospital. According to related industries, Pfizer's EGFR TKI Vizimpro recently passed all five major medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital. It was completed at major medical institutions nationwide, including the National Cancer Center, Seoul National University Bundang Hospital, Pusan National University Hospital, Chungbuk National University Hospital, and Chungnam National University Hospital. Vizimpro, which was listed on the insurance benefit list in December 2021, was designated as a priority review target by the US FDA in January 2018 and approved in September of the same year. Currently, it is licensed and used in the United States, the European Union, and Japan. In Korea, Vizimpro was approved as the first treatment for local progressive or metastatic EGFR mutation non-small cell lung cancer in February last year. VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung canker (NSCLC) with epidermal growth factor acceptor (EGFR) exection 19 deployment measurement 2185 or 85. Currently, EGFR TKI such as AstraZeneca's Iressa, the first-generation drug, Roche's Tarceva, AstraZeneca's Tagrisso, and Yuhan's Leclaza are prescribed in Korea. Competition to attract prescriptions for Giotrif and Vizimpro, the second-generation drugs, is expected to intensify in the future. The efficacy of Vizimpro has been demonstrated through ARCHER 1050, a phase 3 clinical trial. The study directly compared Vizimpro with Iressa, the first-generation drug, and a total of 452 non-small cell lung cancer patients were registered. Progression-Free Survival (PFS) reduced the risk ratio by 41% compared to Iressa, and the median PFS value was 14.7 months for Vizimpro, ahead of the Iressa administration group of 9.2 months. The results of the side effects of Vizimpro were poor. The common severe side effects of Grade 3 or higher were 14% acne and 8% diarrhea in the Vizimpro administration group, and 8% liver enzyme abnormalities occurred in the Iressa administration group. 60% of the Vizimpro administration group needed dose adjustment as a side effect.
- Company
- There are many complaints about the revaluation of generics
- by Chon, Seung-Hyun Jul 06, 2022 05:46am
- Pharmaceutical companies complain of unnecessary waste of money on products being sold without problems. Pharmaceutical companies are struggling ahead of the general drug price revaluation. There are many concerns that the biological equivalent test, which was conducted with the aim of maintaining drug prices, could lead to a reduction in drug prices due to delays in submitting data due to COVID-19. The pharmaceutical industry continues to ask health authorities to extend the deadline for submitting data, but it has not yet been carried out. According to the industry on the 25th, the HIRA recently held a briefing session on the revaluation of the upper limit of registered drugs and proposed a schedule to receive revaluation data from October 1st to the end of February next year. The schedule for the generic drug price evaluation announced by the MOHW two years ago has been specified. It announced a plan to reevaluate the upper limit of drugs that maintain the previous drug price by submitting data on conducting biological equivalent test and using registered raw materials drugs by February 28, 2023. This is a follow-up measure to apply the new drug price system, which took effect in July 2020, to the registered generic. In the revised drug price system, generic products can receive an upper limit of 53.55% compared to the original before the patent expires only if they meet both the requirements for direct biological testing and the use of registered raw materials. Each time one requirement is not met, the upper limit is lowered by 15%. Once the pharmaceutical companies' submission of data is completed, they will go through procedures such as practical review and pharmaceutical companies' objections, and from July next year, generic drugs that have not submitted data will be lowered. Requirements for the use of registered raw materials can be met through the replacement of raw material drugs. Pharmaceutical companies are in a situation where they have to choose between accepting drug price cuts or maintaining drug prices through performing biological tests. Pharmaceutical companies are actively developing biological equivalent tests for licensed generics. The goal is to avoid drug price cuts through approval for change by creating generic through pharmaceutical research, conducting biological equivalent tests, and obtaining equivalent results. If the consignment manufacturing is converted to its own manufacturing and the permission is changed, it is using a strategy that meets the requirements of conducting biological equivalent test. However, COVID-19 has recently acted as a variable. Pharmaceutical companies faced difficulties in recruiting subjects as the number of COVID-19 confirmed patients exploded during the biological equivalent test. It is also said that there are frequent situations in which people registered as subjects leave due to COVID-19 confirmation. Due to the lack of subjects, it is inevitably difficult to perform a normal biological equivalent test. Looking at the drug equivalence standard, the biological equivalent test should be conducted on at least 12 people in the test group and the control group, respectively. This means that a biological equivalent test cannot be established unless a total of 24 or more subjects are registered. The test group or control group can be increased by recruiting additional subjects, in which case the biological equivalent test schedule is inevitably delayed. As the requirements for subjects are already strict, the biological equivalent test subjects recruitment difficulties are prolonged. According to the revised pharmaceutical affairs law, which passed the plenary session of the National Assembly in November 2018, only those who have not participated in clinical trials within six months before the test date should be selected as eligible. As it doubled from the previous three months to six months, the number of participants in the biological equivalent test has also decreased significantly. For this reason, pharmaceutical companies have recently asked health authorities to extend the deadline for submitting revaluation data through various channels, but no clear position has been made yet. Oh Chang-hyun, head of the insurance drug division at the MOHW, who attended the briefing session, said, "It is difficult to say for sure because the MFDS has yet to discuss the suspension of data submission." Moreover, pharmaceutical companies are in desperate need of a delay in submitting biological equivalent test data as they have endured a significant reduction in drug prices due to the abandonment of the biological equivalent test by consignment generic. Pharmaceutical companies have inevitably accepted drug price cuts if it is difficult to change the manufacturer of consignment generics by themselves, signaling huge losses. In July 2020, the MFDS officially banned the sale and recovery of non-equivalent products as a result of the biological equivalent test for maintaining drug prices. As a result of the biological equivalent test, the principle was established that measures such as recovery of non-equivalent products will be implemented based on the risk of grade 3. Other consignment products produced at the same manufacturing facility as generic, which has been judged to be unequal, are also likely to be recalled. With trust A supplying the same generics to 10 consignment companies, the logic is that if one of the products is non-equal, the other nine consignment generics may also be suspected of non-conformity. For pharmaceutical companies, they have no choice but to choose to accept the reduction of the drug because the risk they have to take when they start the biological equivalent test is high. It is not possible to try to convert into a company because there are no manufacturing facilities. Many companies cannot convert drugs that require separate factories from other drugs, such as PCNs, hormone drugs, biological drugs, Cephalosporins, and cytotoxic anticancer drugs, because not many companies have manufacturing facilities. Products that require special formulation manufacturing facilities such as soft capsules are also not easy to convert consignment generics' direct production. Pharmaceutical companies continue to complain that the license is an unnecessary waste of money to carry out the biological equivalent test of generic. This is because it is wasteful to conduct biological equivalent tests at a cost to maintain drug prices even though they are already being sold without problems after being recognized for safety and efficacy by the government.
- Policy
- Antiepileptic perampanel’s adverse event rate at 32%
- by Lee, Hye-Kyung Jul 05, 2022 05:59am
- Results of the 6-year post-marketing surveillance (PMS) on the antiepileptic ingredient perampanel showed that 17 cases of serious adverse reactions whose causal relationship cannot be ruled out were reported. As 287 cases of unexpected adverse reactions whose causal relationship cannot be ruled out were also reported, the indication for perampanel is set to be updated to account for these changes. The Ministry of Food and Drug Safety had announced that it had recently released an order (draft) to change the indication for 16 perampanel items owned by Eisai Korea, Whanin Pharmaceutical, and Myung In Pharm according to the reassessment results, and will be conducting an opinion inquiry on the proposed changes until the 14th. Eisai Korea received marketing authorization for its Fycompa Film Coated Tab on July 10th, 2015. Fycompa Film Coated Tab is indicated as monotherapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients 4 years of age and older, and as adjunctive therapy for the treatment of primary generalized tonic-clonic (PGTC) seizures in patients 7 years of age and older with idiopathic generalized epilepsy (IGE). Results of the PMS that was conducted on 3,354 patients for 6 years for the reassessment in Korea showed that the rate of reported adverse events, regardless of casualties, was 32.62% (1094 /3354 subjects, 1376 cases in total). Among the reported adverse events, the rate of serious adverse reactions whose causal relationship cannot be ruled out was 0.51% (17/3354 subjects), and neurological disorders such as dizziness, mental disorders such as suicide attempts, as well as encephalitis, anemia, and spontaneous abortion were found to occur. Unexpected adverse reactions whose causal relationship cannot be ruled out such as memory impairment, cerebrovascular accidents, sleep disorders, fever, abdominal pain, eye pain, weight loss, erectile dysfunction, and palpitations were reported at a rate of 7.87% (264/354 subjects, 287 cases). Also, the rate of adverse events reported when perampanel is not administered according to the approved dosage and regimen was rather high, at 44% (85/193 subjects). The MFDS plans to change the indication for perampanel after conducting the opinion inquiry and issuing a preannouncement notice for the change order (draft).
- Policy
- The revaluation of Streptokinase could be maintained for 1yr
- by Lee, Tak-Sun Jul 05, 2022 05:59am
- The pharmaceutical industry expects some components to be suspended in this year's benefit revaluation. The benefit revaluation of Streptokinase and Streptodornase, which are scheduled to submit a report on clinical revaluation results next year, could be suspended for one year. However, the final plan is expected to be decided through deliberation by the Drug Benefit Evaluation Committee of the HIRA, which will be held on the 7th. An official from the pharmaceutical industry said on the 4th, "Streptokinase and Streptodornase, which are components subject to benefit reevaluation this year, are also discussing a one-year grace period." "However, I understand that it is not a confirmed issue," he explained. Streptokinase and Streptodornase are enzyme drugs such as Hanmi Pharmaceutical's Mucolase and SK Chemical's Varidase. Since 2017, the drug has been conducting clinical re-evaluation by the MFDS, and the previous indications of sinusitis and thrombosis have been deleted. Next year, it is scheduled to submit a report on the results of clinical re-evaluation of the difficulty of ventilation accompanied by respiratory diseases. Accordingly, the industry suggested that the re-evaluation of the drug should be suspended until the clinical re-evaluation of the drug is completed. This is because the cost of clinical trials that were in progress cannot be compensated. However, the HIRA said that benefit revaluation and clinical revaluation are different. On the 14th of last month, Kim Ae-ryeon, head of the HIRA's Pharmaceutical Price Benefit Division, explained, "The review of benefit adequacy may include the target of clinical revaluation by the MFDS by selecting the target according to the selection criteria." She said, "It is difficult to consider arbitrarily delaying the evaluation of benefit adequacy only for components subject to clinical revaluation in terms of equity with other components." It remains to be seen whether the re-evaluation of Streptokinase and Streptodronase salary will be postponed as the industry suggests. Industries are also predicting some re-evaluation results. In the case of Celltrion's liver disease solvent Godex, which has the highest benefit claim among the ingredients this year, it is uncertain whether it will be maintained, and on the contrary, the antacid Almagate is likely to be maintained. In the case of Eperisone HCl, pain muscle contraction accompanied by musculoskeletal disease, which is the first indication, is likely to maintain, but it is uncertain about stiffness paralysis due to nervous system disease, which is the second indication. However, another industry official said, "The HIRA maintains strict security this time, so little has been confirmed in the industry." "It is said that only two of the six target ingredients will be maintained," he said. Since the announcement of the benefit adequacy revaluation plan in March, The HIRA received data from the pharmaceutical company and conducted a practical review on whether each ingredient meets the evaluation criteria. Therefore, on the 7th, the results will be announced after the first deliberation by the Pharmaceutical Benefit Evaluation Committee with the results. After that, during the fourth quarter, the Post-Pharmaceutical Evaluation Committee and the Pharmaceutical Benefit Evaluation Committee will be held once more to deliberate on the final plan.
- Company
- Sanofi & MDsquare co-promote Digital Healthcare Business
- by Jul 05, 2022 05:58am
- Sanofi Korea Corporation announced on the 4th that it held a (MOU) signing ceremony with MDsquare to promote digital healthcare business on the 30th of last month. With this agreement, Sanofi provides chronic disease management and prevention information, and MDsquare develops premium health care programs to cooperate so that patients with chronic diseases can effectively manage their health. It is planning to expand cooperation plans through connection with digital healthcare products to be launched in the future and joint promotions of both companies' products. As the first step to discover and promote new businesses, MD Square provides MDCare, a premium health care service, to Sanofi executives and employees. MDCare is a non-face-to-face treatment service that helps manage diseases of elderly chronic diseases, and can receive periodic health care and health counseling through professional medical staff. The opinions and reviews delivered by Sanofi executives and employees after experiencing MDCare in person will be reflected to enhance service and improve accessibility. Sanofi-Aventis Korea CEO Bae Kyeong-eun said, "Through this agreement, we will be able to get closer to the company's goal of improving the health of patients through scientific innovation that combines digital and data." "The year 2022 will be a year to promote relationships with Korean digital healthcare stakeholders by exploring various innovative collaboration opportunities in Korea," she said. Oh Soo-hwan, CEO of MDsquare, said, "Starting with this collaboration, we will find various ways to help more patients with MDCare's premium health care service."
- Company
- RDK introduces monkeypox PCR test kits to Korea
- by Jul 05, 2022 05:58am
- Pic of Roche Diagnostics Korea On the 4th, Roche Diagnostics Korea announced that it had introduced PCR diagnostics kits for the detection of the monkeypox virus in Korea. The three kits that were introduced to Korea this time -▲ LightMix Modular Orthopox Virus, ▲ LightMix Modular Monkeypox Virus, and ▲ LightMix Modular Orthopox Virus typing1- were developed by Roche and its subsidiary TIB Molbiol in May this year. The first kit detects all forms of orthopoxviruses. The second kit, LightMix Modular Monkeypox Virus, targets and diagnoses all monkeypox viruses, and the third kit, LightMix Modular Orthopox Virus typing1, checks whether the subject has the monkeypox virus while detecting orthopoxviruses. All three tests may be conducted using Roche Diagnostics Korea’s equipment LightCycler 480 II2 or Cobas Z 4803 analyzer. The diagnostic kits are in use for research in many countries and have also been introduced to Korea for research purposes. Monkeypox, which had been a rare endemic that typically occurs in Central and West Africa, has been rapidly spreading to various countries around the world after the first case was reported in the UK on May 7. Recently, monkeypox has been spreading to non-endemic areas outside Africa, including the US, Europe, and the Middle East. In Korea, the authorities have raised the country’s risk alert level for monkeypox from “of interest” to “caution” after the first patient was confirmed in Korea. In June 2022, the authorities designated monkeypox as a Class 2 infectious disease and reinforced monitoring for the disease. Kit Tang, General Manager of Roche Diagnostics Korea, said “Roche Diagnostics has quickly released a diagnostics kit for the monkeypox virus just as it had released a diagnostics kit for COVID-19 immediately after its outbreak. Innovative diagnostic solutions play a key role in controlling infectious diseases, and we look forward to working with HCPs and institutions in Korea to contribute to improving public health and its response to the monkeypox virus.”
- Policy
- Support for online conferences will be extended for 1 yr
- by Kim, Jung-Ju Jul 05, 2022 05:58am
- On-off events can be supported on an offline basis if certain conditions are met Temporary support for online academic conferences in medical, pharmaceutical, and medical devices will be extended for another year. This is because infectious diseases such as COVID-19 and monkeypox continue to occur, leaving room for reinforcement of social distancing. However, in the case of online and offline parallel academic conferences, which are called hybrid, flexibility has been increased so that they can apply on an offline basis by setting a certain standard in a rigid method that was previously applied only on an online basis. Branches and online academic conferences held by individual nursing institutions, which have been evaluated as having poor support effects in the industry, will not be able to apply except for exception collection support. The Fair Trade Commission recently approved a one-year extension by partially revising the "temporary support extension plan for online academic conferences." The support for online academic conferences is the first extension in 2021 and the second extension this time since temporary approval was made due to the outbreak of COVID-19 in 2020. In response, the Fair Trade Commission explained, "Despite the end of the limited time period to support online academic conferences, we decided to extend the support period in consideration of the situation where non-face-to-face events will continue as COVID-19 becomes commonplace and the academic exchange environment changes." Subject to the support are academic conferences held by affiliated organizations, medical societies, and pharmacological branches under the articles of association of the Medical Association and the Hospital Association. It also includes academic societies (including overseas societies), academic institutions, organizations, research institutes, and organizations approved and recognized by doctors' associations, dental societies, oriental medicine societies, pharmacological societies, and herbal societies. The most noticeable change in this extension is the change in the existing policy that was supported online at both online and off-line events. If more than 20% of the total participants, including the speaker, attend offline academic conferences, they will be supported on an offline basis and up to two offline booths will be installed. In addition, the cost can be provided to the society by 2 million won to 3 million won per booth and 500,000 won to 1 million won for nursing institutions. However, in the case of academic conferences held by organizations affiliated with individual academic societies, branches, and individual nursing institutions, it was stipulated that they would not apply except for exception collection. The Fair Trade Commission and the MOHW decided to discuss again if the government's policies, such as re-strengthening social distancing, make it impossible to hold offline academic conferences.
- InterView
- "Leclaza’s mOS data of 38.9 months is remarkable"
- by Kim, Jin-Gu Jul 04, 2022 05:55am
- “The fact that Leclaza (lasertinib) achieved an OS (overall survival) of over 3 years is remarkable.” New OS data on the homegrown novel lung cancer drug Leclaza that was presented at the AOS 2022 & KCA Annual Meeting 2022 that was held recently in Seoul drew the pharmaceutical industry's attention. The results were from a trial that evaluated the efficacy and safety of continuous daily oral administration of Leclaza 240mg on 78 adult patients with EGFR mutation-positive NSCLC whose disease had progressed after EGFR TKI that was conducted in 17 centers in Korea. Analysis results on the 76 EGFR T790M mutation-positive patients showed that the median overall survival (mOS) was 38.9 months This updated data is being received with significance in the field. The OS data is comparable to the results of the 3rd-generation EGFR mutation-positive NSCLC treatment ‘osimertinib (product name: Tagrisso),’ while owning the potential for its use as monotherapy. Ji-Youn Han, Professor of Hemato -Oncology at the National Cancer Center who presented Leclaza’s OS results at the AOS 2022 & KCA Annual Meeting 2022, said, “The most important index used to assess the efficacy of anticancer drugs in clinical trials ultimately comes down to the patients' OS improvement. Long-term follow-up results of LASER201 trial showed that mOS of patients that received Leclaza reached 38.9 months. This is remarkable performance.” ◆"Cannot make direct comparisons…but results are as good as Tagrisso’s” Han highly rated the fact that Leclaza showed comparable performance to existing targeted therapies, although a direct comparison cannot be made to its competitor, osimertinib. Although various clinical trials are in progress for the first 3rd-generation EGFR targeted therapy. osimertinib, due to varying clinical trial designs and characteristics of registered patients, it is difficult to individually compare each trial's results with Leclaza’s. Also, Leclaza's trials are in their Phase I/II stage, but osimertinib's trials have progressed to Phase III. However, according to the Phase III AURA trial, osimertinib’s representative trial, the mOS was around 26 to 28 months in general, with some differences between countries. “Compared to osimertinib, which is used as the global standard of care, Leclaza is only available for use in Korea. However, data shows that Leclaza’s results are as good as the standard of care. Leclaza’s clinical data as demonstrated through LASER201 is being received without disagreement globally.” ◆" Leclaza has a low incidence of interstitial pneumonia·thrombocytopenia" Han also emphasized Leclaza’s safety. Leclaza has a lower incidence of adverse events than even its competitor osimertinib as well as 1st- and 2nd-generation EGFR targeted therapies. 1st and 2nd generation EGFR targeted therapies had higher skin toxicity. The drugs, although effective against lung cancer cells, also targeted normal skin cells, resulting in patients suffering from skin troubles such as rashes or itching. On the other hand, 3rd generation-targeted therapies selectively target mutations and therefore is less toxic and more efficient. This comes as a significant difference to the patients in terms of quality of life. In particular, Han explained that the two 3rd generation targeted therapies – osimertinib and Leclaza -differ in the adverse events aspect. With her experience prescribing Leclaza over the past year, Han explained that “long-term use of osimertinib may cause interstitial pneumonia or thrombocytopenia in the patients. One aspect I found interesting while monitoring the long-term safety profile of Leclaza demonstrated through the Phase I/II trial was that it had a very low incidence of interstitial pneumonia or thrombocytopenia. “ Han added, “From the patient’s perspective, Leclaza’s lower incidence of adverse events during the 3 years of intake may come as a great advantage. Grade I or II level numbness has been found with the use of Leclaza, but was infrequent.”
- Opinion
- [Reporter's view] Looking forward to another K-COVID vaccine
- by Lee, Hye-Kyung Jul 04, 2022 05:55am
- A pure domestic COVID-19 Vaccine No. 1, which was conducted by a domestic pharmaceutical company in charge of the entire process from development to production of raw materials and finished products, was released. The MFDS approved SK Bioscience's SKY Covione on the 29th. It took 549 days (1 year and 6 months) from approval of the initial clinical trial to approval of the item. SKY Covione was developed as GBP510 in May 2020 conduct non-clinical tests with the support of the Gates Foundation On December 31 of that year, phase 1 was obtained from the MFDS. Phase 3 approval, the final stage of the clinical trial, took place on August 10 last year, and it was the first time that a COVID-19 vaccine developed by a domestic company entered phase 3, and a comparative clinical method that proved its effectiveness compared to an already approved vaccine became the second in the world. Analysts say that the reason why the launch of K- COVID-19 vaccine No. 1 was moved forward has also had a significant impact on comparative clinical trials. The background of the comparative clinical design was the support of the MFDS. The MFDS operated a clinical support consultative body and supported companies to design and perform clinical trials without trial and error. It is rumored that SKY Covione chose a comparative clinical method that compares immunogenicity with AstraZeneca's Vaxzevria thanks to the design support of the MFDS. This is because it was difficult to perform clinical trials to see how much placebo and test drugs prevent the outbreak of COVID-19 at a time when most people were vaccinated during phase 3 of SKY Covione. The MFDS is operating our vaccine project to actively support the entire vaccine process from research and development of domestic vaccines to permission, and on April 25, a productization strategy support group was launched to systematically support all stages from development of public health crisis, new and new drugs, innovative medical devices, and rare drugs. Currently, EuBiologics' EuCorVac has entered phase 3 clinical trials after SKY Covione. ST Pharm, Cellid, and Quratis are in phase 1, and EyeGene and Geneone are in phase 1/2a. We hope that these companies will also be able to be approved as the second and third COVID-19 K vaccines through cooperation with the MFDS.
