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- 2026-04-13 14:48:09
- Policy
- Requests for confirmation of medical expenses, disclosed
- by Lee, Hye-Kyung Oct 15, 2021 05:57am
- After Avastin receiving the indication of macular degeneration, a patient who paid at his own expense requested confirmation of medical expenses, but the non-reimubrsed cases was justified. The HIRA released a case of requesting confirmation of non-reimbursed medical expenses in the third quarter. Patients can check the details of medical expenses on the HIRA's website and request confirmation of medical expenses if they pay for the benefits as non-reimbursement. In the case of Avastin, as a result of the HIRA confirmation, it was confirmed that the medical institution applied for approval for non-reimbursement use after IRB deliberation. When prescribed and administered to patients beyond the scope of the MFDS' permission, non-reimbursement can be used after IRB deliberation. In the case of Leuplin, it was decided that there was no refund for calculating the full amount of patient copayment. According to the MOHW's notice, medical benefits are recognized when ▲ girls are 9 years old (8 years and 365 days), and boys are 10 years old (9 years and 365 days), ▲ secondary puberty stage 2 or higher and bone age increases from that age, and ▲ the maximum concentration is 5 IU/L or more as the sulfur-forming hormone (LH) increases 2-3 times the basal value in the stimulation test of GnRH (renewal gland stimulation hormone). However, in the case of patients who received a request for confirmation of medical expenses, it was decided that pt would pay the full amount beyond the benefit standard because she was a 10-year-old girl. A refund decision was made on antibody tests to confirm antibody production after COVID-19 vaccination. The COVID-19 antibody test conducted for health examination purposes was paid as non-reimbursement to confirm medical expenses, because the COVID-19 antibody test conducted without an application for a new medical technology decision cannot be collected as non-reimbursement cannot be applied. Request was made to confirm medical expenses for emergency medical management fees, sedation endoscopy patient management fees, human tube locks, synthetic gauze dressing, ultrasonography, MRI, breast surgery, and liposuction.
- Company
- Rediscovery of Clopidogrel brings back generic boom
- by Kim, Jin-Gu Oct 15, 2021 05:57am
- Picture of Plavix, a clopidogrel original Development of generics using ‘clopidogrel,’ an antiplatelet drug, is regaining momentum. A company that already owned a clopidogrel generic has released a new dose product in 16 years. And the generic companies have been showing positive responses after the effect of clopidogrel was reilluminated in a study on stent-inserted patients, raising expectations that competition in clopidogrel will intensify again in the future. According to industry sources on the 13th, 13 bioequivalence tests on clopidogrel were approved just this year, 9 of which were approved after May this year. Compared to the average of 4.3 cases that were approved in the 3 years from 2018 to 2020, the number of tests increased significantly. Currently, 145 single compound clopidogrel products are approved in Korea. Most of the approvals were concentrated between 2005 and 2007. Around 40 products including Handok’s ‘Plavix,’ and Samjin’s ‘Platless’ were approved in this period. Since then, approvals continued sporadically until the second wave of approvals rushed in 2012-2013. A total of 35 items were approved during the period. And the atrial fibrillation prevention indication was added at the end of 2011, and the release of the aspirin combination has also increased approval of the single-ingredient clopidogrel. In addition, one of the reasons why bioequivalence tests are increasing for clopidogrel this year is because of the study results that were released last May. In May, Hyo-Soo Kim, Professor of Cardiology at the Seoul National University Hospital, presented the results of his study on patients who had undergone percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) comparing aspirin vs. clopidogrel as an antiplatelet agent. Professor Kim had directly compared the effect of clopidogrel and aspirin as a long-term maintenance therapy on patients who underwent PCI with a dual antiplatelet therapy (DAPT) regimen for 6 to 18 months. The study was conducted for 2 years in 37 hospitals in Korea, on 5,500 patients who underwent PCI. The results, which confirmed that clopidogrel is superior to aspirin, gained attention as all existing major treatment guidelines recommended aspirin as maintenance therapy after PCI. Professor Kim announced the results above at ACC 2021. As around 70,000-80,000 patients receive PCIs every year, and clopidogrel demonstrated a superior effect in Korean patients compared with aspirin, the front-line pharmaceutical companies have been positively responding to the study results. In fact, 9 of the 13 clopidogrel bioequivalence tests newly approved this year were submitted after the study was presented. And industry sources believe Samjin Pharmaceutical’s recent release of the high-dose product is not unrelated to the study results as well. Samjin Pharmaceutical was the first to release a 300mg clopidogrel product on the 12th. This was the first product line extension made by the company, 16 years after the 75mg dose was approved. Only 75mg products including the original are currently approved in Korea. However, the inconvenience of the ACS patients needing to take 4 tablets as the initial loading dose before receiving PCI was pointed out. The high-dose Platless that was released recently has improved this convenience with a single tablet, once-daily dose. An industry official said, “The clopidogrel ingredient treatment market has been continuously growing for the 20 years since its release with the popularization of PCIs. Also, with the latest study results demonstrating that clopidogrel is superior to aspirin as a long-term maintenance therapy, the competition in the clopidogrel treatment market will continue to intensify in the future.” According to the market research institution UBIST, the clopidogrel market last year sold ₩360 billion. In the market, the original Plavix was prescribed the most with ₩91.6 billion. Among the generics, Samjin’s Platless sold ₩61.2 billion, and Chong Kun Dang’s Pregrel sold ₩25.8 billion last year.
- Policy
- A new drug preferential law will be promoted
- by Lee, Jeong-Hwan Oct 15, 2021 05:57am
- The MOHW announced that it will start enacting subordinate laws to substantially implement and secure the effectiveness of the "clause for preferential treatment of new domestic drugs" developed by innovative pharmaceutical companies under the Special Act on the Pharmaceutical Industry. The "upper limit price preferential treatment of drugs" stipulated in Article 17-2 of the Special Act on the Pharmaceutical Industry was newly established on December 11, 2018, but criticism has been raised as the Presidential Decree and enforcement regulations have not been created for nearly three years. On the 12th, the MOHW responded to individual written inquiries from Rep. Nam In-soon of the Democratic Party of Korea, a member of the National Assembly's Health and Welfare Committee. Rep. Nam asked why, background, and cause sub-laws related to the preferential provisions for new drugs developed in Korea, including Article 17-2 of the Pharmaceutical Industry Act, have not been made for years. The pharmaceutical preferential provisions in the Pharmaceutical Industry Act are of great interest not only in the National Assembly but also in the domestic pharmaceutical industry. Domestic pharmaceutical companies say that they need a system that recognizes drug prices higher when pharmaceutical companies selected as innovative pharmaceutical companies make new drugs in Korea to promote their willingness to develop new drugs in Korea. Domestic companies are calling for the MOHW to show some preferential treatment in terms of follow-up management of drug prices if it fails to create subordinate laws due to concerns over trade friction with foreign countries such as the United States. The intention is that the introduction of measures such as delaying the start of PVA negotiations or limiting the number of times will provide an environment that actually favors the price of new domestic drugs without having to think about ordinary problems. An official from pharmaceutical company A, which owns a new domestic drug, said, "The drug price depends on the first registration after development and post-marketing follow-up management.""If it is difficult to give preferential treatment to drugs when registering as a normal problem, if we give preferential treatment to new domestic drugs during follow-up management such as PVA, the system will be effective without any problems," he said. An official from Company A added, "If the start of follow-up management such as PVA is delayed further, the follow-up price will be applied after the new domestic drug has sufficiently established itself in the Korean market. I think it is one of the ways to realize the system's goals without ordinary friction. Rep. Nam In-soon, who sympathized with the domestic pharmaceutical industry's position, also pointed out the responsibility for the situation to the MOHW and urged for improvement. In particular, Rep. Nam presented an example in which foreign countries provide drug preferential treatment for locally approved new drugs. According to data submitted by the MOHW to Rep. Nam, in Japan, 10-20% is applied to new drugs that were first approved prior to other countries. In addition, in Japan, 5-20% of new drugs that explicitly contain dosages for children are subject to additional calculation. However, if there is no clinical result that includes Japanese children in the country, the relevant addition is excluded. Taiwan is applying an additional 10% to new drugs that have conducted clinical trials on a certain scale or larger that have proven their effectiveness in the country. The MOHW plans to consult with related agencies such as the KPBMA regarding the absence of subordinate laws and regulations under the Pharmaceutical Industry Act. Regarding the reason for not enacting subordinate laws for more than two years, the MOHW explained that it had no choice but to be cautious because it could lead to trade disputes with foreign countries. In addition, the MOHW says that some preferential measures are already being implemented for generics and biosimilars made by innovative pharmaceutical companies.The MOHW adds the first one-year drug price to innovative pharmaceutical companies when applying insurance after developing generic products based on "drug decision and adjustment standards." An additional rate of 68% for innovative pharmaceutical companies and 59.5% for other pharmaceutical companies were set. The MOHW said, "On December 11, 2018, a provision for preferential drug treatment for innovative pharmaceutical companies was prepared under the Special Act on the Pharmaceutical Industry." It said, "However, drug treatment for certain companies can lead to trade disputes with foreign countries, so careful review is necessary." It said, "The global innovative drug preferential system, which favored drug prices developed by innovative pharmaceutical companies, has been excluded from the FTA revision negotiations between Korea and the U.S.," adding, "There are no sub-laws for domestic new drugs, but some preferential treatment such as generic and biosimilars are being implemented." The MOHW then promised, "We will consult with related agencies to review drug support measures, including the enactment of subordinate laws, so that innovative pharmaceutical companies can be supported while avoiding trade friction in the future."
- Company
- ‘Ibrance’ opens new horizon as the lead CDK4/6 inhibitor
- by Oct 14, 2021 05:38am
- The breast cancer treatment ‘Ibrance (palbociclib)’ was what established Pfizer Korea as the ‘anticancer drug power’ in Korea. The company had other excellent anticancer drugs such as ‘Xalkori,’ and ‘Sutene,’ but none had received as much spotlight as Ibrance. As the ‘first CDK4/6 inhibitor,’ and ‘the first new breast cancer drug in 50 years,’ Ibrance had quickly rose to the ranks and became a blockbuster drug. ◆ The first CDK4/6 inhibitor, unrivaled status despite controversy Ibrance selectively inhibits Cyclin-dependent kinases (CDK) 4/6 that regulate cell division and cell growth to block the proliferation of tumor cells. Lilly’s Verzenio (abemaciclib),’ and Novartis’s ‘Kisqali (ribociclib)’ belong to CDK4/6 inhibitor class drugs. Among these drugs, Ibrance is the first drug in its class, the ‘first-in-class’ CDK 4/6 inhibitor. Ibrance is indicated for the treatment of breast cancer in combination with an aromatase inhibitor as first-line endocrine therapy in postmenopausal women or combination with fulvestrant in pre-and post-menopausal women with disease progression following endocrine therapy. For a year Ibrance was launched in Korea in August 2016, the field was full of expectations, disappointment, longing, and appeals. The introduction of a new drug with a new mechanism of action was blissful news. In particular, the patient population for Ibrance was wider than other drugs, as it targeted f hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, which accounts for 60% of all breast cancers. These patients had to use anti-hormonal drugs such as aromatase inhibitors or chemotherapy, which had many systemic side effects if not managed until Ibrance appeared. Before the introduction of Ibrance, this patient group had to use antihormonal therapy such as aromatase inhibitors, and if their condition was not managed with such therapies, use chemotherapy, which had many systemic side effects Korea was the fifth country to approve the drug. In December of the same year, the drug's efficacy and safety in Asian patients were verified through a clinical trial and rose as the drug that could change the breast cancer treatment paradigm. The National Comprehensive Cancer Network’s ‘Category 1’ recommendation of CDK4/6 inhibitors as combination therapy for the treatment of HR+/HER2- advanced/metastatic breast cancer had also contributed greatly to establishing the drug as standard care in breast cancer. However, Ibrance did not immediately rise and become the star after its release. The drug had suffered receiving reimbursement due to its high drug price, costing over ₩5 million per month. In particular, 2017 was the time when many high-price anticancer drugs were introduced and rejected reimbursement, and Pfizer Korea was put at a difficult price due to its difficulty in demonstrating cost-effectiveness, and the issue that Ibrance was more expensive in Korea than abroad. The Health Insurance Review and Assessment Service recognized Ibrance’s feasibility of reimbursement in July 2017, after rounds of review. However, the approval left much to be desired among patients because the reimbursement was only allowed as first-line endocrine therapy in postmenopausal women in combination with letrozole. Its use as second-line therapy in combination with fulvestrant was non-reimbursed, and premenopausal patients, which are much more prevalent in the East than in the West, were unable to receive the reimbursement benefit at all. The 2nd-line reimbursement of Ibrance+fulvestrant was only approved last July, 4 years after Ibrance’s approval. In addition, the fact that the drug was reimbursed at the same time with the CDK4/6 class latecomer Verzenio, left much to be desired for Ibrance. However still, Ibrance is fully exerting its strength as the ‘first’ introduced to its market. Among the three products in the CDK4/6 market, Ibrance has been dominating the market as the second drug, Verzenio, was approved in Korea three years later than Ibrance, in May 2019. The third CDK4/6 inhibitor Kisqali was approved 5 months after Verzenio, in October 2019 and listed for reimbursement in November last year. 자료: 아이큐비아 Ibrance raised annual sales of ₩40 billion in three years in the competitor-free market. According to the market research institution IQVIA, sales of Ibrance, which was ₩6.6 billion in 2017, surged 283% in 2018 to reach ₩25.3 billion after being listed for reimbursement. Then, sales rose 73% again to record ₩43.7 billion in 2019. Last year, Ibrance sold around ₩60 billion and is expected to sell near ₩70 billion this year. Compared to Ibrance’s quarterly sales, which is around ₩15 billion, Verzenio’s sold ₩3 billion, and Kisqali sold mid-₩1 billion range. ◆Three-way competition starts now… data will decide the winner With all three products now approved for reimbursement, the competition is finally in full pace. Of course, the other two drugs have a long way to go because they need to break down the solid position held by Ibrance in the market. Therefore, the latecomer drugs are betting in areas where Ibrance has not reached, as preoccupying new areas is easier than breaking down Ibrance's established position. The attempt will also support the expansion of the overall CDK4/6 inhibitor market amid the increased introduction of new-class drugs. One of the areas being targeted is early breast cancer. Despite its strength in metastatic breast cancer, Ibrance did not show as a good result in early breast cancer. In both the PALLAS study that tested Ibrance+endoctrine therapy as adjuvant therapy in hormone receptor-positive (HR+)/HER-2 negative (HER2-) metastatic breast cancer and the PENELOPE-B study that tested Ibrance+endoctrine therapy after neoadjuvant chemotherapy, Ibrance did not show a difference in invasive disease-free survival (iDFS) compared to placebo (primary endpoint). Pfizer believed the high early discontinuation rate due to the strict dose restriction and the short period of administration had an effect. On the other hand, Verzenio achieved its primary endpoint in a median follow-up period of 15.5 months as adjuvant therapy, suggesting the potential for scope expansion. Of course, whether using CDK4/6 inhibitor as adjuvant therapy in early breast cancer patients is more beneficial, remains a question that needs to be addressed. Kisqali can be used in combination with an aromatase inhibitor as first-line endocrine therapy in pre/perimenopausal women that cannot use Ibrance, and therefore may resolve the unmet needs of Ibrance. Also, Kisqali has demonstrated the longest overall survival period among all drugs, threatening Ibrance’s sole lead in the market.
- Policy
- No need to extend the benefit period of Keytruda
- by Lee, Jeong-Hwan Oct 14, 2021 05:38am
- The MOHW said there is little need to extend the benefit period of Keytruda, an immuno-cancer drug, for patients who are effective in secondary treatment of non-small cell lung cancer by more than two years. This is because the clinical period of Keytruda was designed to be two years, and related societies such as the Korean Association for Lung Cancer also submitted a position that the benefit period should be set based on medical grounds such as clinical trials. On the 13th, the MOHW's insurance drug department responded like this to a written inquiry from Democratic Party of Korea's Kang Sun-woo. Representative Kang asked patients who showed efficacy in the second treatment of small cell lung cancer if they needed to extend the Keytruda benefit period to more than two years. The MOHW replied that there is virtually no need to extend the benefit period. The MOHW's position is that Keytruda's clinical trial was designed for two years, and that the Korean Association for Lung Cancer also suggested that the benefit period should be set on medical grounds such as clinical trials. In particular, it was suggested as a basis that all four countries, including the UK, which refer to the benefit evaluation, have limited the administration period to two years. The MOHW replied that equity should also be considered with other carcinomas that are not covered by immuno-cancer drugs.
- Policy
- Poor ‘Benefit Adequacy Assessment' in controversy
- by Lee, Jeong-Hwan Oct 14, 2021 05:38am
- (Pic. by National Assembly Press Corps) A bill to specify the basic definition of the Insurance Benefit Adequacy Assessment and stipulate the submission period for its data for assessment is being promoted. On the 13th, the National Assembly member Jong-Sik Heo announced that he had presented a bill for the partial amendment of the National Health Insurance Act that contained the above measures. The insurance benefit adequacy assessment system evaluates whether all medical services provided with health insurance are medically and pharmaceutically reasonable and cost-effective, then provides the results to healthcare providers. The purpose of the system was to promote public health by inducing voluntary improvement in the quality of medical care and supporting the rational medical choice of the people using assessment results disclosed to the public. Heo pointed out that the current law only regards the insurance benefit adequacy assessment as one of the tasks performed by HIRA, and that the legal basis necessary to perform the assessment is insufficient because even the required basic definition for the assessment is not stipulated in the Act. In particular, Heo pointed to how the submission period for the data assessment, which is the basis for deriving assessment results and payment adjustment, is not clearly defined. The unclear period unnecessarily prolongs the assessment period to 1-2 years from data collection to its assessment result. Due to such delay, the medical reality is not adequately reflected in the assessment results, which then acts as a limitation by making it difficult for the authorities to provide reliable information for the public or induce healthcare providers’ voluntary improvement of their medical behavior. Thus, Heo proposed a bill to raise the predictability of the system by stipulating the purpose, target, and result of the insurance benefit adequacy assessment. The revised bill also clarified the data submission period so that the results could be derived in a timely manner. Heo explained, “The legal basis necessary to perform the assessment is insufficient and even the basic definition for the assessment is poorly defined. Also, the period of data submission is unclear, which acts as a barrier in inducing the healthcare providers’ voluntary improvement of their medical behavior. Ultimately, we aim to contribute to improving public health by guaranteeing our people their right of medical choice.”
- Company
- Korea Otsuka Pharma’s Hyangnam Plant rises as a global hub
- by Nho, Byung Chul Oct 14, 2021 05:38am
- Pic. of Korea Otsuka Pharmaceutical Korea Otsuka Pharmaceutical, which is soon to face its 40th anniversary in Korea, is receiving attention with its Hyangnam Plant rising as a forward base for global exports and production. Korea Otsuka Pharmaceutical is a global total healthcare enterprise that covers a wide range of businesses from clinical research, R&D, manufacturing, and export of pharmaceuticals. The company will celebrate its 40th anniversary in Korea in 2022. It is one of the rare multinational pharmaceutical companies in Korea that owns and operates a large-scale production facility locally in the Hyangnam Pharmaceutical Industrial Complex in Gyeonggi-do. 99% of the company’s pharmaceutical products released in Korea are supplied through the local Hyangnam plant, and Korea Otsuka Pharmaceutical has continuously invested in the manufacturing facility to expand the facility's role as Otsuka’s global hub. Established in 1989, Korea Otsuka Pharmaceutical’s Hyangnam Plant obtained KGMP approval in December 1990, and BGMP approval in December 1999. By obtaining approval from the US FDA as an API manufacturing facility in July 2000, the plant had grown into a production facility that covers the entire process of drug production from raw material synthesis to the finished product. Ever since its establishment, the company has been continuously investing in the production facility, gradually transforming the plant into a world-class production facility that can produce pharmaceuticals that meet global quality standards. In 2018, the plant was also selected as the first-ever Digital Medicine (DM) manufacturing site, raising expectations of expanding exports to North America after obtaining cGMP approval from the US FDA as well as contributing to further progressing the domestic pharmaceutical industry's production capability. Since the company started to reexport its products to Japan in 1991, Korea Otsuka Pharmaceutical has expanded exports to 13 countries in Asia including China, the Philippines, and Indonesia. In 2014, the company’s facility obtained EU-GMP approval and expanded its exports to 44 countries including those in Europe, raising over 40 billion won in annual exports. Based on the growing export sales, the company had been awarded the ‘$10 million export Tower’ in 1998, ‘$20 million export Tower’ in 2009, and ‘$30 million export Tower’ in 2015 for its outstanding export performance, contributing to the development of Korea's pharmaceutical industry through continuous job creation and the development of the domestic economy. Also, through continuous R&D investment and its independent R&D activity, the company has obtained new indications and developed new formulations, demonstrating the superior development capability of domestic researchers while increasing exports and expanding global approvals. In April this year, Korea Otsuka Pharmaceutical had succeeded in developing a global product- ‘Mucosta SR Tab.’ - for the treatment of gastric mucosal lesions using only domestic infrastructure through open innovation development with a domestic venture company, IMD Pharm, and Aju University Industry-Academic cooperation foundation. Such R&D investment activities are not irrelevant to the virtualization of its Hyangnam plant. The development of various new items with new indications and formulations led to expanded approvals in Korea and nearby countries, based on which the company has expanded exports of pharmaceuticals produced at its Hyangnam plant in Asia, Arab, and Europe regions. With the increased exports, the Hyangnam plant has been exerting its influence as a well-established production base of Otsuka Pharmaceutical. Meanwhile, Korea Otsuka Pharmaceutical has been the only multinational pharmaceutical company to be nominated as an ‘innovative pharmaceutical company’ for 4 consecutive years in recognition of its continuous investment in production facilities and activation of the domestic pharmaceutical industry.
- Policy
- # of COVID-19 confirmed medical staff doubled in 3 months
- by Lee, Jeong-Hwan Oct 14, 2021 05:37am
- Rep. Choi Yeon-sook (Photo by Korea Special Press Association)Among domestic medical personnel, the cumulative number of confirmed cases of COVID-19 has more than doubled compared to three months ago. Out of a total of 321,352 COVID-19 confirmed patients as of 0 o'clock on the 5th, 5,444 were medical personnel or medical institution workers. On the 12th, Choi Yeon-sook of the People Party made this announcement through data submitted by Central Disease Control Headquarters. According to the data, the cumulative number of confirmed patients of medical personnel (doctors, nurses, dentists, and oriental medicine doctors) increased from 977 as of 0 o'clock on July 6 to 1,861 as of 0 o'clock on July 5, up 884 (90.5%). About half (47.5%) of the confirmed medical personnel who have occurred in about a year and nine months since the first confirmed case came out in Korea in January last year have been confirmed in the past three months. The fourth pandemic of COVID-19 since July seems to have affected the confirmation of medical staff. Dentists and oriental doctors with relatively little contact with COVID-19 confirmed patients increased slightly compared to three months ago (13% for dentists and 12% for oriental doctors), but the cumulative number of confirmed patients more than doubled (158%) from 213 to 550. The number of nurses also increased 78.4% from 685 to 1,222 during the same period. As of 0 o'clock on the 5th, out of a total of 321,352 COVID-19 confirmed patients, a total of 5,444 medical personnel or medical institution workers were counted. This is the status of COVID-19 confirmed patients reported to the KDCA Corona Information Management System. According to the status of COVID-19 infection by medical personnel, 550 doctors, 61 dentists, 28 oriental doctors, 1,222 nurses, 894 nursing assistants, 423 nursing care workers, 85 clinical pathologists, and 2,181 others were confirmed. Others included physical therapists, radiologists, pharmacists, emergency medical technicians, medical recorders, and dental hygienists.
- Policy
- Suspicions of preferential tx for SK Bioscience & Celltrion
- by Lee, Tak-Sun Oct 14, 2021 05:37am
- The appearance of the parliamentary audit of the National AssemblySuspicions have been raised during a parliamentary audit, led by opposition lawmakers, that the MFDS may have provided preferential treatment to the company for domestic COVID-19 drugs. Kim Kang-rip, head of the MFDS, dismissed the suspicion, saying he approved it based on evidence. Fentanyl Patch, a drug pain reliever, is being used by teenagers and requested to eradicate drug abuse. There was also an opinion that a doctor who prescribed drug abuse needs to temporarily suspend his license. It was found that opinions between the ruling party and the opposition party were divided on drugs to suspend pregnancy. The MFDS plans to carefully examine the product. Various issues such as COVID-19 treatment and vaccine screening were raised at the National Assembly Health and Welfare Committee's parliamentary audit held on the 8th. Opposition lawmakers pointed out that SK Bioscience's approval of phase 3 clinical trials of the COVID-19 vaccine and Celltrion's conditional approval of Regkirona, an antibody treatment, had inflated K-Bio's performance. "Isn't the government giving preferential treatment to domestic COVID-19 pharmaceutical companies?" Rep. Lee Jong-sung of the People Power Party pointed out, "In the process of approving the phase 3 clinical trial of the SK Bio COVID vaccine, the MFDS did not comply with the 10% domestic regulations and approved the phase 3 clinical trial even though the phase 2 clinical trial was not completed." Rep. Lee Jong-sung said, "It is very unusual to approve phase 3 before the results of phase 2 confirming the proper dosage and use of the SK vaccine are released."He said, "There is a reasonable suspicion that the MFDS was over-enthusiastic to make Moon Jae In government results rather than drug safety, or that Cheongwadae put pressure on K-Bio performance ahead of next year's election." He also claimed, "Celltrion's COVID-19 treatment Regkirona is suspected of giving preferential treatment to the MFDS even though the virus-negative conversion rate, which was the primary evaluation variable in clinical trials, failed to prove statistical significance." Kim Kang-rip, head of the Ministry of Food and Drug Safety (left), and Seo Kyung-won, president of the National Institute of Food and Drug Safety Evaluation (right) (Photo = provided by the National Assembly Korea Special Press Association) In response, Director Kim Kang-rip replied, "This is the result of expert advice that it will not be a problem at all if statistically significant patients are recruited to verify the validity of Koreans," adding, "We also confirmed more than five times the standard serum price in phase 2 and approved phase 3 with scientific judgment." Kang Ki-yoon, a member of the People Power Party, urged, "Samsung Biologics' GMP review of Moderna vaccine consignment production should be approved as soon as possible." Heo Jong-sik, a member of the Democratic Party of Korea, also said, "The Korean people can be vaccinated only with the production of COVID-19 vaccines at domestic production bases such as Samsung Biologics and SK Bioscience," adding, "This requires approval for use." Ko Min-jung, a member of the Democratic Party of Korea (photo by the National Assembly Korea Special Press Association) Samsung Biologics' GMP survey was conducted on September 25. Director Kim said, "We have completed an on-site investigation of production facilities and requested Samsung Biologics to supplement the GMP review," and explained, "The review will be completed within this month." Mifegymiso, ruling party and opposition party are also divided. Kang Ki-yoon, a member of the People Power Party (Photo provided by the National Assembly Korea Special Press Association) Lee Sang-joon, CEO of Hyundai Pharmaceutical, was the only pharmaceutical company to be summoned as a witness during the parliamentary audit. This is to inquire about The objective media Mifegymiso. Mifegymiso is currently being reviewed by the MFDS. However, the pros and cons are mixed over the Bridging Study for Koreans. While civil society and women's organizations omit the Bridging Study and urge rapid approval, the obstetrics and gynecology society say it should be carefully introduced through the Bridging Study. The arguments of women and opposition parties are also mixed. In response, the head of the MFDS said, "We will review the submitted clinical data and refer to WHO guidelines and real data from 76 countries. The Central Pharmaceutical Review Committee said it could review the Bridging Study exemption, but we will comprehensively consider safety such as how to take it." Lee Sang-joon, CEO of Hyundai Pharmaceutical, who is sworn as a witness (photo = provided by the National Assembly CEO Lee Sang-joon, who served as a witness, said, "Hyundai has the ability to proceed with Bridging Study." Asked by Rep. Seo Jung-sook whether she predicts an increase in annual sales due to the introduction of Mifegymiso, CEO Lee replied, "The total number of abortions is reported in Korea, but it is difficult to predict Mifegymiso's market information, which can only be used within the first nine weeks."
- Company
- Tabrecta/ Rybrevant are expected to enter the market
- by Eo, Yun-Ho Oct 13, 2021 05:47am
- Two types of anticancer drugs targeting MET gene mutations are expected to enter the domestic market. According to related industries, Novartis Korea and Janssen Korea submitted applications to the MFDS for approval of the new anticancer drugs Tabrecta (Capmatinib) and Rybrevant (Amivantamab), respectively, and are currently undergoing screening. MET mutations are rare types that account for about 3% to 4% of metastatic non-small cell lung cancer, and interest in these new drugs is increasing as there have been no treatments. The two drugs have something in common that they target hepatocellular growth factor receptors (c-Met), but the indications are somewhat different. Tabrecta was first approved in the United States in May last year as a treatment for MET Exon14 mutated non-small cell lung cancer (NSCLC). In the case of Rybrevant, it obtained US approval in May, blocking epithelial cell growth factor (EGFR) and MET mutation at the same time. The first indication of this drug is non-small cell lung cancer with EGFR Exon20 mutation. Tabrecta and Rybrevant are spurring research for future combination therapy. In particular, it is expected to be able to solve the resistance problem of EGFR TKI in lung cancer. In fact, Tabrecta is conducting a clinical trial in combination with AstraZeneca's third-generation EGFR TKI Tabrecta (Osimertinib), while Rybrevant is conducting a study in combination with Yuhan's 'Leclaza(Lazertinib), a domestic new drug. Meanwhile, Tabrecta confirmed its validity through a phase 2 GEOMETRY mono-1 study of 97 patients with METex14. As a result of the study, the overall response rate was 68% in patients who had never been treated and 41% in patients who had previously been treated. Among the patients who took Tabrecta, DoR of previously untreated patients was 12.6 months and the patients treated were 9.7 months. Leclaza proved its efficacy through CHRYSALIS, a phase 1 clinical trial. According to the study, the objective response rate (ORR) was 40% when 81 patients with non-small cell lung cancer with 20 mutations of EGFR Exon were administered with Rybrevant. There were three patients with complete response (CR) with complete tumor disappearance, and 29 patients reached partial response (PR) with tumor size decreasing by more than 30%.
