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Forxiga will become a basic treatment for chronic kidney dz
by
Sep 06, 2021 05:58am
"SGLT-2 inhibitors are no longer diabetes drugs. It will be recognized by doctors of kidney medicine as a basic medicine that protects kidney function and is good for use with other medicines." Physicians expect SGLT-2 inhibitors, which have expanded their scope to kidney treatments. Choi Bum-soon, a professor of kidney medicine at the University of Catholic Medicine at Eunpyeong St. Mother's Hospital, commented on the new treatment option "Forxiga (Dapagliflozin)" that appeared in more than 20 years at an online press conference. From the left, Professor Ko Kang-ji of Korea University Guro Hospital, Professor Yang Chul-woo of Seoul St. Mary AstraZeneca's Forxiga was the first SGLT-2 inhibitor to obtain kidney medication. Forxiga, which began with diabetes drugs, was foreseen through several studies. Forxiga showed decreased cardiovascular events, kidney protection benefits, and decreased albuminuria in the DECLARE-TIMI 58 study of diabetics. The subsequent DAPA-CKD study demonstrated excellent kidney protection in patients with chronic kidney disease with a tetrahedron filtration rate of 25 to 75μg/min/1.73㎡, regardless of type 2 diabetes. "There have been few drugs to help patients not to deteriorate their kidney function," said Koh Kang-ji, a professor of kidney medicine at Korea University's Guro Medical School, at a meeting on the 30th to commemorate the addition of Forxiga chronic kidney disease. "The RAAS blocker worked, but it was 20 years ago that Forxiga was very welcome, and because it effectively reduces the pressure in the glomerulus as a different mechanism than the RAAS blocker, it can be used complementively." Professor Ko emphasized Forxiga's role in early patient treatment. "If we use Forxiga in early patients, we can effectively reduce chronic progression by increasing eGFR and we can use it effectively and safely," he said. "We need to make various efforts to increase the diagnosis rate of mild patients and quickly apply Forxiga." Choi gave advice on the proper use of drugs through Forxiga. The DAPA-CKD study found that the Forxiga administration group had a lower eGFR than the control group at the beginning. Professor Choi said, "Because the graph crossover over time, it is important for the medical team to confidently talk about patients' anxiety." "A 10% decrease compared to the baseline is a temporary phenomenon, and if more than 30% changes, we choose to temporarily stop and rewrite medicine." He added, "Since using Forxiga may cause dehydration, it is recommended to be careful of use in elderly people and patients scheduled for endoscopy and surgery the next day, and urinary tract infections are not worth worrying about." In its revised guidelines for treating heart failure announced this month, the ESC recommended SGLT-2 inhibitors such as Forxiga and Jardiance as primary treatments for patients with HFrEF. As Jardiance demonstrated its effectiveness in cardiac output coefficient-preserving heart failure (HFpEF) patients, the scalability of SGLT-2 inhibitors was further broadened. The medical team predicted that SGLT-2 inhibitors will become a major treatment option even in kidney disease. Yang Chul-woo, professor of kidney medicine at Catholic University's Seoul St. Mary's Hospital, said, "In order to live a long life as a joke, anti-hypertensive drugs such as Aspirin, Statins, and RAAS are essential, and the fourth drug is Forxiga (SGLT-2 inhibitor)." "We believe that SGLT-2 inhibitors will become a basic drug, and Forxiga is playing an important role as a leader," he said.
Company
Boryung released Avastin Biosimilar for the first time
by
An, Kyung-Jin
Sep 05, 2021 08:24pm
View of Boryung headquarters buildingBoryung announced that it will sell its anti-cancer biosimilar "Onbevezy" introduced by Samsung Bioepis in the domestic market from the 1st. Onbevezy is a biosimilar product of the blockbuster anti-cancer drug Avastin (Bevacizumab) developed by Roche. Samsung Bioepis proved the equivalent effect and safety of its original product Avastin through Phase 1 and Phase 3, and received approval for domestic items as the first biosimilar of Bevacizumab in March. It has indications such as metastatic direct colon cancer, metastatic breast cancer, non-small cell lung cancer, progressive or metastatic neoplasm, glioblastoma, epithelial ovarian cancer, ovarian cancer, primary peritoneal cancer, and cervical cancer. In May, Boryung signed an exclusive contract with Samsung Bioepis for Onbevezy 100mg and 400mg. It plans to expand its influence in the anti-cancer drug market by releasing products simultaneously with the listing of drug benefits on September 1. By adding biosimilar anti-cancer drugs to its portfolio, it is also expected to increase its competitiveness in the anti-cancer drug sector. As of 2019, Avastin recorded about ₩8.8 trillion in sales in the global market. In South Korea, it formed a market worth ₩118 billion (IQVIA) based on accumulated sales last year. Onbevezy is 37 % cheaper than the original Avastin. It has a longer expiration date from 24 months to 36 months. "Onbevezy is cheaper than Avastin," said Kim Young-seok, head of the Boryung anti-cancer drug division. It will be an alternative to ease the financial burden of patients and increase the performance of treatment. "We will actively try to settle in the market quickly through synergy between Samsung Bioepis' product power and Boryung's sales competitiveness."
Company
Academia supports 1st-line reimbursement of Tagrisso
by
Eo, Yun-Ho
Sep 03, 2021 06:03am
The lung cancer societies are supporting the need to extend insurance benefits for ‘Tagrisso’ to 1st line treatment in lung cancer. In July, AstraZeneca Korea had reduced the standards and reapplied to extend reimbursement to the reduced scope for its 3rd generation EGFR TKI Tagrisso (osimertinib). However, the Health Insurance Review and Assessment Service had decided not to deliberate Tagrisso’s reimbursement as an agenda at the Cancer Disease Deliberation Committee meeting in September. However, still, HIRA had sought opinions from relevant societies, including the Korean Association for Lung Cancer, the Korean Society of Medical Oncology, and the Korean Cancer Study Group. All the societies have expressed support for Tagrisso’s 1st-line indication and submitted opinion statements that a reimbursement extension is necessary, even for the reduced standard. The key strategy for approval of the insurance benefit this time is in the reduced benefit standards. In its application, AstraZeneca reduced the scope of its reimbursement to ‘1st-line treatment of patients with EGFR exon 19 deletion or those with brain metastasis’ rather than in line with its indication of ‘NSCLC patients whose tumors have EGFR mutations, with exon 19 deletions or exon 21 (L858R) mutations.’ In other words, the company adopted the strategy to increases the justification of Tagrisso’s efficacy and treatment benefits. Narrowing the scope of reimbursement would naturally allow for a broader discussion on its fiscal impact. So HIRA decided to collect the society’s opinion on the proposal for the reduced scope of reimbursement. On this, the lung cancer societies have submitted an opinion statement that states “Tagrisso needs to be reimbursed for 1st line NSCLC according to its indication. Therefore, the society sees no problem reimbursing the drug for the reduced scope of standards, and support its coverage extension.” An official from one lung cancer society said, “The drug has already demonstrated statistically significant benefit through a Phase III study and should be reimbursed according to this indication. However, as the agenda continues to be unable to pass the CDDC review stage, we submitted an opinion statement that reimbursement should be first approved for patients in urgent need of such prescriptions.” Tagrisso had added the indication for 1st-line treatment of lung cancer in Korea in December 2018 and aimed to expand its reimbursement to the indication in 2019. However, at the Cancer Disease Review Committee meeting in October, the committee decided to defer the decision until the full data from the Phase 3 FLAURA trial that studied the overall survival (OS) of NSCLC patients in 1st line is disclosed. Although AstraZeneca had submitted the full FLAURA data and expressed their will to accept most of the cost-sharing plan proposed by the government, the reimbursement fell through due to opposition from committee members (specialists) due to issues on the drug’s clinical efficacy. AstraZeneca had attempted to reverse the decision by submitting the OS evidence confirming Tagrisso’s OS benefit in Asian patients from the FLAURA China study, but the committee’s response was, once again, a ‘No.’ After Tagrisso failed to receive reimbursement in April, 1,713 lung cancer patients and their families sent an appeal to the government, the Korean Association for Lung Cancer, and AstraZeneca, “imploring approval for the 1st-line reimbursement of Tagrisso.”.
Company
Kymriah was virtually pending at the Committee
by
Eo, Yun-Ho
Sep 02, 2021 05:59am
It wasn't easy: the listing of the super expensive one-shot treatment 'Kymriah's insurance benefits was discussed but put on hold. According to related industries, Novartis Korea's world's first CAR-T treatment, Kymriah(Tisagenlecleucel), was virtually pending at the HIRA Cancer Drugs Benefit Appraisal Committee on the 1st. However, based on the amendments mentioned in the commission, it is said that the discussion will proceed quickly. Kymriah's indications are Diffuse Large B-Cell Lymphoma (DLBCL) and B-cell Acute Lymphocytic Leukaemia (ALL) in children and young adults. Both are subject to terminal patients who are not effective in treating more than one or who have recurred after re-occurrence or transplantation. The Cancer Drugs Benefit Appraisal Committee reportedly responded positively to ALL, especially to children with high life expectancy, and skeptical responses to lymphoma. Kymriah, which was licensed in March, quickly submitted the benefit using the "Medicine Approval-Patent Linkage System." However, the Korea Leukemia patients organization criticized the government and Novartis after the Cancer Drugs Benefit Appraisal Committee failed to be presented in July. However, it is hard to predict whether ALL indications will be registered. The drug costs about ₩500 million per dose, and variables such as the NHIS negotiation can occur. Yoo Chul-joo, a professor of pediatric blood oncology at Severance Hospital, said, "Although recurrence and non-responsiveness ALL patients in Korea are extremely rare, we expect similar cases in Korea as the government, pharmaceutical companies, and medical community work together to treat them quickly with Kymriah." If Kymriah is listed, it is likely to be linked quickly to actual prescriptions. Currently, Big 5 general hospitals such as Seoul National University Hospital, Asan Medical Center, Seoul St. Mary's Hospital and Sinchon Severance Hospital are undergoing management procedures, including human cells, and Samsung Medical Center has already completed approval. In the case of Seoul National University Hospital, Kymriah passed the DC in April, and passed at SMC in May .
Company
First IV acetaminophen+ibuprofen combo lands in Korea
by
An, Kyung-Jin
Sep 02, 2021 05:59am
Product picture of Maxigesic IV being sold abroadAn acetaminophen+ibuprofen solution for infusion will soon be released in the Korean pharmaceutical market. Whether the introduction of a new combination therapy option in the single drug-oriented nonopioid analgesic infusion space is gaining attention. According to industry sources on the 1st, Kyongbo Pharmaceutical had received marketing authorization for ‘Maxigesic IV’ from the Ministry of Food and Drug Safety on the 30th of last month. ‘Maxigesic IV’ solution’ is a unique solution combining two nonopioid analgesics- 1000mg acetaminophen with 300mg ibuprofen - for intravenous infusion. Recently, a different pharmaceutical company had applied for an oral drug that contains the same ingredients as an OTD drug but failed. Maxigesic IV was first developed in a tablet form by AFT, a New Zealand pharmaceutical company, to be sold as an OTC, but had switched formulations to be used to manage moderate-to-severe post-operative pain. In November 2018, Kyongbo Pharmaceutical had signed an exclusive development and sales agreement for ‘Maxigesic’ with AFT. The company will be importing the finished product from AFT to sell domestically. The agreement is valid for 15 years from the date of the product release. The two ingredients contained in ‘Maxigesic' -acetaminophen and ibuprofen- are the most widely used antipyretic analgesics. A Phase III clinical trial conducted by AFP on 276 adult patients with at least moderate pain following bunion surgery demonstrated that Maxigesic IV significantly relieved pain within 10 minutes after IV infusion. As a combination solution for infusion, the drug offers higher pain relief than acetaminophen or ibuprofen alone and develops fewer cardiovascular or gastrointestinal side effects. The drug has been received as a potential option that may reduce the use of opioid analgesics that even may replace the market for such drugs. With those strengths, AFP has finished submitting applications for drug approval in 21 countries worldwide, including in major European countries and Australia. The Belgian pharmaceutical company Hyloris Pharmaceuticals, which signed a licensing agreement with AFP for ‘Maxigesic,’ has also been taking steps to receive approval for the drug by the U.S. FDA. Analgesic effect of Maxigesic IV solution(Source: AFP, Hyloris Pharmaceuticals) With the domestic approval, Kyongbo Pharmaceutical is planning to hasten the release of the first IV solution that combines acetaminophen and ibuprofen. An official from Kyongbo Pharmaceutical said, “With a high unmet need remaining in the nonopioid analgesic market, an IV solution that combines two of the most commonly used analgesic ingredients may have the potential to exert and expand its influence in the field of analgesics.
Company
Sputnik V's lot release is imminent
by
Kim, Jin-Gu
Sep 02, 2021 05:59am
The Russian COVID vaccine Sputnik V is about to be released, Korus Pharm said on Tuesday. According to Korus Pharm, local administrative procedures for Sputnik V's lot release are being finalized. The production of finished products with a capacity of 1000L has already been completed, and it is expected that the product will be released in earnest once the quality check is completed at the Gamaleya Institute in Russia. In late July, Korus Pharm completed quality verification of Sputnik V's validation badge from the Gamaleya Institute in Russia. Production of 1000L DS was completed in mid-August. Korus Pharm has maintained production of 4 million doz per share, and is expected to increase production to 6 million doz per share starting this month. If bio-reactor is added, it will have a production capacity of more than 10 million doz per week. In addition, Korus Pharm explained that Kirill Alexandrovich Dmitriev, CEO of Russia's RDEF, will visit Korea to commemorate the full-fledged lot release, and is currently discussing his visit to Korea. Kirill Alexandrovich Dmitriev will visit to discuss contracts for additional supplies under the lot release of commercial supplies. "As soon as Russia's local administrative procedures are completed, we will start mass production and establish a shipping process," "As soon as the Russian administrative process is completed, we will mass-produce and establish a shipping process," a Korus Pharm company official said. "We hope that more vaccines will be supplied around the world to help with collective immunity of COVID-19."
Company
SK Bioscience has started clinical trial of GBP510
by
Chon, Seung-Hyun
Sep 02, 2021 05:59am
Phase 3 of COVID vaccine developed in Korea have begun in earnest. SK Bioscience announced on the 30th that it has started administering the first subjects of phase 3 clinical trials of GBP510, jointly developed by the Institute for Protein Design (IPD) at the University of Washington. This is the first phase 3 clinical trial of a candidate substance for COVID vaccine developed in Korea. Previously, SK Bioscience received approval from the MFDS on the 10th for clinical trial of GBP510. Phase 3 of GBP510 will be held in 14 domestic institutions, including Korea University and Guro Hospital, and 4,000 domestic and foreign adults over the age of 18 in Europe and Southeast Asia. GBP510 is mixed with GSK's Pandemic Immunostimulator (Adjuvant) and is injected twice every 28 days. SK Bioscience, along with the International Vaccine Institute (IVI), a non-profit international organization in East Europe and Southeast Asia, is applying for approval of each country's Phase 3 clinical trial plan. It is planning to start clinical trials overseas as early as next month. SK Bioscience plans to secure interim data in the first half of next year by evaluating the immunogenicity and safety of GBP510 through Phase 3 clinical trial conducted at home and abroad. With prompt permission from Korean health authorities, it will also begin preparation for the WHO certification and acquisition of Emergency Use Authorization by each country. SK Bioscience confirmed that as a result of Phase 1/2, Phase 1 clinical trial conducted on 80 healthy adults, 100% of neutral antibodies that neutralize COVID were formed in the dosing group that administered both GBP510 and immune enhancer. This is measured through international standard substances and evaluation methods established by the WHO and the NIBSC. In terms of safety, no significant adverse event has occurred that is related to the administration of GBP510. SK Bioscience is also monitoring safety of 247 participants in the second stage, which includes senior citizens. No particular safety issues have occurred so far. The company predicted, "When the development of the GBP510 is completed, the difficulty of supply and demand of COVID vaccine in Korea, which relies on imports, will be resolved." If GBP510 successfully enters the commercialization stage, it can establish and supply its own production and supply plan as it is a vaccine for domestic development. In the long term, it is expected that it will contribute to securing vaccines as it can quickly cope with mutant viruses based on platform technology. The synthetic antigen vaccine platform applied to GBP510 can be stored under refrigeration conditions of 2 to 8°C, so it can be distributed using the existing vaccine logistics network and can be stored for a long time, so it can easily secure accessibility globally. GBP510 was selected as the first target of the Wave 2 project, which CEPI operated last year to support differentiated COVID vaccine candidates, and hundreds of millions of vaccinations will be supplied to the world including South Korea through the COVAX facility once the development is completed. SK Bioscience' vaccine factory in Andong has the capacity to produce hundreds of millions of commercial products a year immediately after developing the vaccine and manufacturing various types of vaccines simultaneously through independent spaces in nine areas of the plant. "With the rapid and systematic cooperation of health authorities and clinical institutions, we have successfully started to administer subjects. We will thoroughly verify safety and effectiveness through clinical trials."
Company
It is necessary to provide Kymriah treatment accessibility
by
Sep 02, 2021 05:59am
Novartis Korea (CEO Kim Skafte Mortensen) announced on the 30th that the ICBMT released the results of a study that analyzed the treatment of DLBCL patients in Korea from August 26 at ICBMT. DLBCL is an aggressive lymphoma that accounts for about 40% of non-Hodgkin lymphoma. Although most standard treatments show abnormalities in part, it is known that 10 to 15% of patients do not respond to primary treatments and 20 to 35% experience recurrence. The study was conducted to identify the demographic characteristics and treatment patterns and prognosis of DLBCL patients in Korea. Led by Professor Park Mi-hye, College of Pharmacy, Sungkyunkwan University, a total of 4931 claims of the HIRA were analyzed from January 1, 2013 to July 31, 2019. The analysis found that the median of the overall survival of DLBCL patients who failed secondary treatment was 4.73 months. In addition, about 70% of patients who failed the second treatment were repeatedly undergoing salvage chemotherapy, and the duration of the second treatment to the third treatment was gradually shortened to 2.86 months (median) and 1.81 months (median) to the fourth treatment. "This study confirmed the poor treatment prognosis and limitations of current treatment of recurrence and non-responsiveness DLBCL patients in Korea," said Park Mi-hye, a professor at Sungkyunkwan University, who led the study. "There are no alternative treatments and poor prognosis. "This is the first study that has been analyzed for all patients in Korea using all data on claim data." She added, "In the end, the patients were repeating salvage chemotherapy, which is difficult to expect a life extension due to the absence of treatment options, and as the number of treatment increases, the length of failure will be shorter, so patients who are unable to expect further reactions need available treatment options." Poor prognosis and the need for effective treatment options in patients with recurrent and non-responsive DLBCL have already been confirmed through global research. According to the SCHOLAR-1 study, the first patient-level analysis result for non-responsive DLBCL patients, the complete response rate for non-responsive DLBCL patients was 7% and the median duration was only 6.3 months. Further analysis of the CORAL study, a multi-organ, randomized clinical trial, also showed that the expected survival rate for one or two years among patients with recurrent and non-responsive DLBCL, especially those who failed secondary relief chemotherapy, was 23% and 15.7%, respectively. "This analysis is encouraging in that we can see the treatment patterns or prognosis of most patients in the actual benefit care environment," said Yoon Duk-hyun, a professor of oncology at Asan Medical Center in Seoul who participated in clinical consultation and research on DLBCL disease and domestic treatment status. Professor Yoon said, "Even though patients with recurrent and non-responsive DLBCL use repeated salvage chemotherapy, the period until the next treatment period was very short, with a median of two to three months, showing very poor prognosis because there are no effective alternative treatments." The new option CAR-T treatment, Kymriah, was the only one in Korea in March to prove a high response rate and persistence in a single treatment in a recurrent and non-responsive DLBCL patient. "Fortunately, new targeted treatments and cell treatments, which are completely different from conventional anticancer drugs, are under development or approval," Professor Yoon said. "However, most new treatments require improvement due to the high cost of patients."
Company
‘Somavert’ is reimbursed and starts landing in GHs
by
Eo, Yun-Ho
Sep 01, 2021 05:57am
The new acromegaly drug ‘Somavert’ was listed for insurance benefit and has begun landing in general hospitals. According to industry sources, Pfizer Korea’s Somavert (pegvisomant) has submitted landing applications to drug committees at major medical institutions including the Seoul National University Hospital, Severance Hospital, and Seoul National University Bundang Hospital. As the Severance Hospital at Sinchon treats the most amount of acromegaly patients in Korea, Somavert is expected to be prescribed as soon as it passes the DC review. Somavert’s reimbursement has been approved and will be applied from the next month in September. Somavert was approved in Korea in September last year to treat patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with Somatostatin analogues did not normalize IGF-I concentrations or was not tolerated. The drug demonstrated its efficacy in the randomized, double-blind, pivotal study SEN-3614 that was conducted on 112 acromegaly patients for 12 weeks. The 112 patients were randomly assigned to administer 10mg, 15mg, 20mg of pegvisomant or placebo every day, and its primary efficacy endpoint was the percent change in serum IGF-I concentration from baseline to Week 12. Study results showed that in Week 12, the median serum IGF-I concentration reduction level was 16.8%, 26.7±27.9%, 50.1±26.7%, 62.5±21.3% for the placebo arm, and 10mg, 15mg, 20mg pegvisomant arm, respectively. Pegvisomant significantly reduced serum IGF-I concentrations in all three doses compared to placebo. The rate of patients whose serum IGF-I concentrations normalized compared to baseline were 10%, 54%, 81%, and 89% for the placebo arm and 10mg, 15mg, 20mg pegvisomant arm, respectively. Pegvisomant showed a significantly higher rate in all three doses compared to placebo. Also, pegvisomant significantly improved the overall sign and symptoms of acromegaly in all doses, and the incidence of adverse events was similar for all doses of the pegvisomant and placebo arm. Acromegaly is a rare condition characterized by the excessive secretion of growth hormones that causes abnormal, excessive secretion of IGF-I, and is most often caused by a benign tumor of the pituitary gland. Acromegaly is associated with clinical changes including reduced life expectancy, cardiovascular issues, enlargement of hands, feet and other organs, facial deformity, fatigue, joint pain, metabolic disorder, etc, and may be accompanied by and various secondary systemic complications including osteoarthritis, metabolic complications (insulin resistance, hyperglycemia, hyperlipidemia, etc), risk of neoplasms, hypopituitarism, vertebral fractures, and reduced quality of life. The annual incidence of acromegaly is estimated to be around 3.3 cases per 1 million population, and the worldwide prevalence is about 60 cases per 1 million. Retrospective analysis results that were announced in 2013 for Korea shows that around 1,350 acromegaly patients are registered in 74 secondary and tertiary medical institutions from January 2003 to December 2007, making the annual incidence rate in Korea to be 3.9 cases per 1 million, and prevalence to be 27.9 cases per 1 million in 2007.
Company
Sales of PARP inhibitor Zejula surpassed Lynparza in 2 years
by
Sep 01, 2021 05:56am
PARP inhibitor Zejula (Niraparib tosylate monohydrate) outpaced its competitor Lynparza (Olaparib) in about 2 years. According to IQVIA, a pharmaceutical market research firm on the 31st, Zejula, Takeda's ovarian cancer treatment drug, recorded ₩3.5 billion in sales in the second quarter, surpassing Lynparza, which recorded ₩3.4 billion. Zejula, which started its first sales in the fourth quarter of 2019, started to grow rapidly in December 2020. Sales jumped from around ₩1 billion last year to ₩3.2 billion in the first quarter of this year. In the second quarter, it increased by 289% year-on-year to ₩3.5 billion. In the first quarter of last year, AstraZeneca's Lynparza, which previously dominated the market, showed ₩2.3 billion, ₩2.9 billion, ₩3.3 billion and ₩3.7 billion, respectively, but sales in the second quarter fell slightly to ₩3.4 billion. Zejula is also estimated to be ahead of Linpaza in the number of patients. As a result of converting the adjusted daily average number of pills into sales, Zejula was prescribed 34,900 days, Lynparza capsule and Lynparza tablet were prescribed 18,900 days and 7,700 days, respectively, in the second quarter. Lynparza and Zejula are both competing fiercely for ovarian cancer treatments before the PARP inhibition. Lynparza was approved in 2015. Zejula received a domestic permit in March 2019, much later than this, but it was applied to the secondary treatment in December 2020. Zejula outpaced Lynparza. This is because Lynparza and Zejula have concluded drug price negotiations with the NHIS over the expansion of primary maintenance benefits for ovarian cancer. The benefit range will be expanded together through the Health Insurance Policy Committee next month. Although the scope of ovarian cancer primary therapy indications for both products is expanded for Zejula, which can be used regardless of BRCA mutation, insurance benefits apply under the same conditions. This is because the HIRA Cancer Drugs Benefit Appraisal Committee recognized clinical usefulness only for BRCA training. Therefore, the two products are expected to compete from October when benefits are expanded.
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