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- 2026-04-14 06:57:08
- Policy
- The number of items has plummeted due to regulatory impact
- by Lee, Tak-Sun Jun 28, 2021 05:49am
- Recently, More and more items are being removed due to the expiration date. Pharmaceutical companies have sorted out the items due to strong regulations on impurities and penalties for drug prices of consignment items. According to the MFDS on the 23rd, a total of 63 new drugs have been approved this month. On the contrary, there are 226 items which permits have been deleted, almost four times more. From January 1 to June 23 this year, 1,224 items were licensed. On the other hand, 2,229 items were deleted, nearly doubling. Most of the deleted items have expired five-year period, and they have not submitted data that proves the safety and validity of the license renewal. Since 2018, the MFDS has operated a renewal system for item evaluation and has been evaluating it every five years. Pharmaceutical companies are required to submit data such as safety management, quality, and status of foreign use to renew their permits. As a result, items withdrawing from the market are often given up their permits. Analysts say that this pattern has become worse recently. An industry official said, "We submitted an evaluation of the possibility of impurities for all medicines by June, and decided not to renew the license because some items are difficult to proceed." An official from another company said, "Most of the consignment items are given permission as penalties are given at drug prices." "There have been far more cases of deletion recently because there are no items to put on the market," he said. Items subject to regulation due to the detection of impurities are likely to be removed. Satan or Tidin drugs, which have been a problem recently, are representative. Even if these items are sold, lot release is possible only when tests prove that there are no impurities.
- Company
- Intra-articular injection Conjuran can be reimbursed
- by Moon, sung-ho Jun 28, 2021 05:49am
- As the age of aging population begins in earnest, the number of osteoarthritis patients is increasing, and the market for related treatments is also heating up. Competition among pharmaceutical companies is fierce as various products of "Intra-articular injection," which has recently been in the spotlight, are newly included in the benefit. According to the pharmaceutical industry on the 23rd, the HIRA has recently been confirmed to have changed the reimbursement standard related to "treatment materials for Intra-articular," which is called joint strength injections, since June. Collagen is added to the existing intra-pulmonary infusion treatment material. Specifically, patients with knee osteoarthritis were added not only sodium polynucleotide but also collagen, including a total of two components of joint strength injections. An official from the HIRA said, "The addition of collagen is the result of the application for the benefit registration while the related products are recognized as new medical technology." The HIRA clarified the method and number of injections with Polynucleotide administered up to five doses per six months and collagen administered up to five doses per six months (within 180 mg of total collagen dose). These categories set patient copayment rate of 80% for Selective Health Benefit targets. PharmaReaserch's Conjuran is a Polynucleotide-based joint strength injection, and CartiZol is a collagen-based joint strength injection. Among them, PharmaReaserch's Conjuran has been subject to Selective Health Benefit since the second half of last year, leading the osteoarthritis treatment market as the administration of patients has increased, led by orthopedic and rehabilitation clinics. Recently, it had an influence on general hospitals by conducting a co-promotion with SK chemicall. Conjuran began competition with Sewoncellontech's CartiZol, a collagen-based injection of joint strength. Due to the increase in arthritis patients due to the aging population, competitors such as CGBIO also predicted challenges in the joint steel injection market. Osteoarthritis treatments market is growing. According to the NHIS, the number of arthritis patients increased by about 10% in five years from 4.4 million in 2014 to 4.86 million in 2018. "As the population ages and the number of patients with knee osteoarthritis increases, joint strength injections are in the spotlight recently," an official from a pharmaceutical company said. "In particular, the treatment market will begin to compete with companies." "The current market for this treatment is worth ₩100 billion a year, and it will grow year by year," he predicted
- Company
- Will the new social distancing benefit the prescription mkt?
- by Chon, Seung-Hyun Jun 25, 2021 05:51am
- New social distancing rules will be applied from next month. The restrictions set on private gatherings will be eased, and the operating hours of multi-use facilities will also be extended. The pharmaceutical industry has its eyes on whether the outpatient prescription market, which has contracted due to a decrease in outdoor activities, will take a turn for the better under the new regulations. According to the pharmaceutical research institution UBIST on the 21st, outpatient prescription in May this year was around 1.15 trillion won, down 1.1% YoY. This is a 10.4% fall compared to the market’s performance in May 2 years ago. This downward trend has been continuing since last month, as outpatient prescription in April was also reduced by 0.3% YoY to record 1.18 trillion won. The accumulated outpatient prescription in May this year was 5.91 trillion won, down 2.4% from the same period of the previous year. The aggregate prescription sales in May were 5.91 trillion won, down 2.4% YoY. The prescription market was hit the hardest in April to May last year due to the aftermath of the COVID-19 outbreak. Monthly outpatient prescription sales trend (Unit: 100 million won, Source: UBIST) Prescription in April and May last year were each lower by 8.7% and 9.4% YoY. At that time, with the COVID-19 spreading in full pace, patients with chronic diseases such as hypertension and diabetes chose to avoid visiting medical institutions by receiving prescriptions for the long-term, creating a void in the prescription market. However, performance in April and May this year are even worse off than the prescription void period of the previous year. The prescription market, in general, has been sluggish compared to the previous year. Prescription sales in January and February this year were also down by 7.0% and 5.6% YoY, respectively. Experts pointed to the prolonged COVID-19 as the cause of sluggish sales in January and February this year. The increased interest in personal hygiene after the spread of COVID-19, including hand-washing and mask-wearing, may have greatly reduced the incidence of infectious diseases, leading to a decrease in visits to medical institutions. Although the performance had improved temporarily in March, marking a 1.9% increase, sales has again turned downward from April. Analysis predict that the increased personal hygiene management in the prolonged COVID-19 will inevitably continue to impact the prescription market for infectious diseases, etc., even though the flu season had ended. Another reason that was raised was that the social distancing level that was elevated since the end of last year due to a surge in COVID-19 cases may have led to decreased visits to medical institution. However, with eased social distancing restrictions to be applied from next month, many are expecting the prescription market to pick up. According to the Ministry of Health and Welfare’s Central Disaster and Safety Countermeasures Headquarters (CDSCH), a new, 4-level social distancing plan will be applied from next month. The key indicator used will be the weekly daily average confirmed cases per 100,000 people. Level 1 applies when the rate is less than one in 100,000, Level 2 when the rate is between 1 and 1.9, Level 3 when the rate is between 2 and 3.9, and Level 4 for 4 or greater. In the capital area, Level 1 will be applied if the weekly daily average is less than 250, Level 2 for 250 or more, Level 3 for 500 or more, and Level 4 for 1,000 or more. Regarding private gatherings, no restriction will apply in Level 1, and up to 8 people may meet at Level 2. Local governments may choose not to apply the 8-person restriction at their own discretion. In other words, the restrictions on private gatherings for 5 or more people that was enforced since December 23rd of last year may be eased down from next year. Also, the closing hours may be extended for multi-use facilities. Industry officials expect the increase in outdoor activities will increase the number of visits to medical institutions, and benefit the prescription market. Many believe that the sluggish sales in the prescription market will not continue long as drug use continues to increase with the increase in the elderly population and people with chronic conditions. Contrary to the tourism and culture industry, which is facing an extreme crisis after the COVID-19 outbreak, the pharmaceutical industry is more influenced by the patients’ demand rather than the external environment. Therefore, experts believe, the continued social distancing restrictions set in Korea will not lead to a sudden recession of the pharmaceutical market. Also, hopes that that the prescription market will rebound due to increased COVID-19 vaccination area also present. Recently, vaccination has sped up, and the cumulative total number of those vaccinated exceeded 15 million. This means that over 15 million people visited medical institutions in about four months since March, when vaccinations first begun. With more patients visiting medical institutions for COVID-19 vaccinations, some expect this will also lead to an increase in other drug use. An industry official said, “There is a high possibility that the prescription market will recover as some people who have been hesitant to visit hospitals due to COVID-19 have been requesting additional prescriptions for their usual medications during their vaccination visits.”
- Company
- Telemisartan is excluded from impurity survey
- by Kim, Jin-Gu Jun 25, 2021 05:51am
- The MFDS has expanded the scope of the impurity investigation to ARB drugs as a whole. However, Telmisartan·Azilsartan·Eprosartan were excluded from the list of additional investigations. The pharmaceutical industry understands that Telmisartan was excluded from the impurity survey because it does not have a tetrazole ring. The MFDS said on the 23rd, an official letter was sent to analyze and evaluate the possibility of impurities occurring in Olmesartan, Fimasartan, and Candesartan. The company that owns the drug in question shall analyze and submit the possibility of 'AZBT/Azido Methyl Bipheny Tetrazole' by the 22nd of next month. The scope of impurity investigation has been expanded from the existing Irbesartan·Losartan·Valsartan to the entire ARBs. A total of nine ARB-based drugs are licensed in South Korea. Losartan, Valsartan, Azilsartan, Eprosartan, Olmesartan, Fimasartan, Candesartan, Irbesartan and Telmisartan. Telmisartan, Eprosartan and Azilsartan were excluded from further investigations by the MFDS. 797 products containing Telmisartan such as Micardis, 5 Azilsartan products such as Edarbi, and 2 items of Eprosartan such as Teveten do not need to be further investigated. ◆AZBT and NDMA can occur during the synthesis of tetrazole rings Tetrazole ring molecular structure. Many ARBs contain this molecular structurThe pharmaceutical industry understands that the shape of each component's molecular structure influenced the MFDS' decision on the scope of the investigation. The MFDS ordered an investigation into impurities, limiting only ingredients with "tetrazole rings" in molecular structure. The MFDS estimated that Azido impurities are produced by reacting 'Br-OTBN (4'-Bromomethyl-2-cyano-biphenyl) and 'Sodium Azide (NaN3). Br-OTBN is the main intermediate in the synthesis of tetrazole rings. Add a reagent called Sodium Azide and the tetrazole ring is synthesized. In other words, the reagent (azide) used to synthesize tetrazole rings may have been produced as a "suspicious substance (AZBT)" in response to certain conditions. It is estimated that NDMA (N-Nitrosodimethylamine), which was detected during the Valsartan crisis in 2018, also occurred after a similar process. At that time, the MFDS (DMF), which was used as a solvent to make the tetrazole ring, was decomposed into dimethylamine during the high temperature process, and was produced by reacting to NaNO2. The same is true of NDEA (Nitrosodiethylamine). It is believed to have been produced by reacting to the impurities dimethylamine and nitrite contained in the triethanolamine (TEA) itself used as reagents. The MFDS judges that ARB drugs, including tetrazole rings, are likely to develop AZBT or NDMA and NDA at any time. ◆Of 9 ARB drugs, six contain tetrazole rings Looking at the molecular structure of ARB drugs, tetrazole rings are found only in Eprosartan, Olmesartan,Fimasartan,Candesartan,Irbesartan, Losartan. This is not the case with Telmisartan, Azilsartan, and Eprosartan. The tetrazole ring determines whether the Ministry of Food and Drug Safety will order an investigation into the possibility of impurities. An official from a pharmaceutical company said, "Even if it is the same ingredient, the possibility of detecting impurities is divided depending on which reagent or solvent is used." "In addition, the possibility of occurrence varies depending on whether or not there is a tetrazole ring in the molecular structure. "In Telmisartan's case, there is little chance of impurities occurring because there is no tetrazole ring."
- Policy
- NA LJC to review ‘1+3 bill for generics’ tomorrow
- by Lee, Jeong-Hwan Jun 25, 2021 05:51am
- The National Assembly's Legislation and Judiciary Committee will review the revision of the Pharmaceutical Affairs Act that contains the bill for the ‘1+3 restriction for bioequivalence and clinical test’ of generics and drugs requiring data submission an agenda for review at the NA Legislation and Judiciary Committee’s general meeting that will be held on the 25th. If the revision passes the Legislation and Judiciary Committee, it will be processed and deliberated at the plenary session that is planned on the 29th, and may likely be legislated by June. On the 24th, the vice-chairpersons of the ruling and opposition party of NA’s Legislation and Judiciary Committee are discussing the agendas that will be presented at the plenary session on Monday. One thing to note is that the bills passed by the Health and Welfare Committee on the 16th, including the one to revise the Pharmaceutical Affairs Act, have also been included as agendas at the Legislation and Judiciary Committee meeting. The revised Pharmaceutical Affairs Act passed by the Health and Welfare Committee includes the ‘1+3 restriction for bioequivalence and clinical test’ of generics and drugs requiring data submission, designation of Day of Medicine as a Statutory Anniversary, mandatory preparation and submission of Contract Sales Organization (CSO) expenditure report, penalizing illegal purchasers of specialty drugs, and compulsory marking of safety precautions in Braille and voice codes. The revision also includes the bills to legislate the conditional approval system for Phase III trials, mandatory registration of oversees API manufactories, increasing the number of Central Pharmaceutical Affairs Council members to 300 at most, strengthening regulations for the cancelation of false or unlawfully approved National Lot Release drugs, and the establishment of the Vaccine Safety Technology Support Center. In other words, whether the bill to regulate generics and drugs requiring data submission will be able to pass the final legislative threshold by passing the plenary session of the National Assembly this month will depend on deliberations of the Legislation and Judiciary Committee on the 25th. The Legislation and Judiciary Committee can decide to pass or continue to review the bills passed by the Health and Welfare Committee. If the bill is passed by the Legislation and Judiciary Committee, the final procedure will be carried out at the plenary session on the 29th. When the government finally promulgates the bill, the individual bills will then come into effect according to the by-laws. An official from the Legislation and Judiciary Committee said, “Discussions on the agenda for the plenary session have not yet been completed by the vice-chairpersons. For now, the bill by the Health and Welfare Committee, including the revised Pharmaceutical Affairs Act, is included in the agenda for the plenary session."
- Policy
- MFDS investigates impurities of Sartan and Varenicline
- by Lee, Tak-Sun Jun 25, 2021 05:50am
- The MFDS has launched a full investigation as the risk of impurities in Sartan and Varenicline, a non-smoking treatment supplement, has been raised among hypertension drugs. Recently, some products have been recalled due to the detection of impurities such as carcinogens in Canada and other countries. However, in the case of Sartan, both raw materials and finished products are planned to be investigated, and in the case of Varenicline, only the finished products were ordered to be tested by related companies. The MFDS announced on the 22nd that it is conducting a safety investigation of high blood pressure treatment containing satan series and Varenicline, a non-smoking treatment aid. Antihypertensive drugs including satan are the three components of Irvesartan, Losartan, and Valsartan. The survey will be conducted to verify the safety of domestic products as impurities exceeding provisional management standards were detected in overseas-related medicines. The MFDS has already sent an official letter to a local pharmaceutical company to encourage them to review their own investigation as a precautionary measure. An official from the MFDS said, "We will work closely with related companies to obtain test results as soon as possible, and put safety first according to the results and promptly take necessary measures." "There have been no cases of impurities detected in the drug in Korea yet," he added. AZBT which is not a nitrosamine, but is known to have a mutation (the property that causes genetic mutations). The MFDS estimates that AZBT occurs due to the reaction of Br-OTBN (4'-Bromomethyl-2-cyano-biphenyl) and Sodium Azide (NaN3). The impurity of Varenicline is "N-nitroso-varenicline," which is said to be caused by the reaction of nitrite and Varenicline remaining in the finished drug manufacturing process. The MFDS said that Varenicline is an example of the original company Pfizer's own discovery of the problem, and that drugs from the same manufacturer as those recovered from overseas have not been distributed in Korea, and are under investigation by Pfizer's own investigation.
- Company
- Sillajen acquirer GFB seeks further partnership opportunity
- by Jun 24, 2021 05:55am
- "Using ShillaJen’s anticancer virus platform, we can add many new substances to be developed as novel drugs. Korea owns many excellent early-stage novel drug candidates, and we also may additionally introduce promising new substances in Korea." At the interview with DailyPharm, Ajit Gill, CEO of Greenfire Bio, Ajit Gill expressed his strong will to build additional partnerships with Korean bio-ventures in Korea. CEO Ajit Gill Greenfire Bio (GFB), a U.S. joint bio-venture firm of M2N that recently acquired Sillajen for 6 billion won, has been established by various industry experts including the company’s CEO Agit Gill who had previously headed Nektar Therapeutics, and CBO Sanjeev Munshi who had served over 20 years at MSD (U.S. Merck) as a BD reviewing and introducing new substances. During his service as head of Nektar Therapeutics from 1999 to 2006, Gill had contributed to raising the company’s market value to more than 20 trillion won. CBO Munshi had been in charge of searching biotech companies around the world to develop new drugs for intractable diseases such as Alzheimer's and NASH at MSD. Hanmi Pharmaceutical’s ‘efinopegdutide’ for nonalcoholic steatohepatitis (NASH) is also one of the numerous new drug substances he introduced at MSD, GFB, which has been developing the bio business with M2N Chairman Seo Hong-min, has been interested in developing new drugs using next-generation technology. In this context, Sillajen’s anticancer virus platform has caught the company’s interest. Anticancer virus, or oncolytic virus, induces immunogenic cell death (ICD) by loading viruses that have excellent penetration capabilities with anticancer substances. Globally, the interest in oncolytic virus is high, but no ‘game changer’ has emerged yet. Amgen’s Imlygic that was first introduced in the field did not produce a satisfactory return compared to the investment. However, GFB has a strong belief in the potential of the oncolytic virus market. Gill said, “With immuno-oncology drugs having a response rate around 30%, adding oncolytic virus to the immunotherapy can increase the rate to 50 to 60%. The vaccinia virus used in Sillajen’s next-generation platform has the benefit of being able to load various anticancer substances, due to its large size. Just looking at the monoclonal antibody market, we see many cases in which the bio-industry makes explosive growth with follow-up products that have been improved to complement the shortcomings of the earlier drugs, so there is no concern about the potential of the anticancer virus market." CBO Sanjeev Munshi He added, “For new technology, securing safety is important. Sillajen has the advantage in the market as the company had identified the safety of its platform through clinical trials for many years,” and expects that their accumulated new drug development know-how and financial firepower will create synergy when met with Sillajen’s leading technology. Regarding the increased market concern over the discontinuation of the Phase III trial on Pexa-Vec in 2019, Gill said, “Failing Phase III trials is common in the bioindustry. The point to focus on is whether we own a potential platform. However, we would need to establish a richer pipeline. Just one success is all we need to significantly raise the value of the company.” However, Gill took a cautious stance on the development of Pexa-Vec will continue, stating that the decision will be made after observing the data that will be released after a year. Instead, GFB is eagerly searching for new substances to apply to Sillajen’s platform. CBO Munshi has been focusing on discovering a substance with the highest possibility of success based on his experience at MSD as BD. Munshi said, “We have reviewed over 200 substances over the past 6 months. We want to find the most promising pipeline. Self-development is also a possibility, but it is more likely that we will acquire a substance through external partnerships.” In this sense, GFB is deeply interested in partnering with Korean bio ventures. Munshi said, “Korea owns abundant early-stage research data, but lacks development experience in the US., which is the world’s largest market. GFB can complement this area as the company has a high understanding of the global market and owns extensive global network experience. Please don’t hesitate to reach out anytime if you have an innovative new drug technology. Gill said, “Nektar Therapeutics was also once a 4-person company. It grew to a company with 800 employees when I left. In that time, I had signed countless contracts and raised the 1.5 billion fund in various ways. When combined, GFB’s BD expertise, M2N’s high capital, and SillaJen’s technology will be the right mix of all the essential elements necessary for the development of a blockbuster drug.”
- Company
- Benlysta can be reimbursed in general hospitals
- by Eo, Yun-Ho Jun 24, 2021 05:55am
- Benlysta, which has been covered by insurance benefits for the first time in seven years, can be reimbursed in general hospitals. According to related industries, GSK's Benlysta (Belimumab) has passed the drug committee (DC) of 20 hospitals nationwide, including Aju University Hospital, Chungnam National University Hospital and Hanyang University Hospital. Benlysta, prescribed for treatment of active systemic erythema lupus adult patients who are autoantibody positive, was non reimbursed by the Pharmaceutical Benefits Advisory Committee twice in December 2015 and November 2018. This is because it was difficult to prove cost-effectiveness as old drug such as Prednisolone, Hydroxychloroquine and Azathioprine are alternative drugs. Benlysta is eligible for active systemic ▲Lupus 18 years of age or older, who has been treating autoantibody positive for more than 3 months with standard therapy, if both ▲SELENA-SLEDAI 10 and above ▲ Anti-dsDNA antibody positive ▲ low complement (C3 or C4) conditions. Patients can be treated with 10% of their copay through special cases of calculating rare diseases. The administration method according to the benefit standard is recognized for an additional 6 months if SELENA-SLEDAI is reduced by more than 4 weeks after initial administration ▲ If the evaluation results of the first 24 weeks are maintained, the use is recognized for an additional 6 months. Lupus invades a variety of organs throughout his life, especially in major organs such as the heart, lungs, kidneys, and nerves, which can lead to irreversible damage and death Due to the nature of the disease, most patients are women of childbearing age, and 19% of pregnant women suffer from fetal death, loss of fetal development, low birth weight, and premature birth.
- Policy
- Zopista's price cut by 23%, Gefitinib by 22%
- by Kim, Jung-Ju Jun 24, 2021 05:54am
- The premium pricing period for Huons' Zopista has ended., and the price will fall by 23.9% at most for its strengths. Also, Hanmi Pharmaceutical applied for a voluntary price cut of its ‘Gefitinib Tab,’ and its price will fall by 22.1%. The premium pricing term for five zoledronic acid monohydrate products including Boryung Pharmaceuticals’ ‘Zoledron inj. 5mg/100mL’ will return to its original price upon expiry of their premium pricing term. The MOHW will make an amendment to the ‘Drug benefit list and maximum ceiling price table’ that contains the abovementioned changes on July 1st. ◆Term expiry for newly listed premium pricing items = The government has been providing a premium of 59.5% for newly listed generics for 1 year from the date of its initial listing. The premium rate applied increases to 68% for innovative pharmaceutical companies. However, if products of the same ingredient are produced in 3 or fewer companies even after the 1-year term has expired, the premium applied is maintained for a maximum of 5 years until the number of products increases to 4 or more. Five newly listed zoledronic acid products face premium pricing term expiry next month. The products are Boryung Pharmaceutical's Zoldron Inj. 5mg/100mL, Penmix's Penmix Zoledronic Acid Inj. 5mg/100mL, PharmGen Science's Oncebone Inj. 5mg/100mL, Dongkwang Pharm.'s Dongkwang Zoledronic Acid Inj. 5mg/100mL, and Dong Sung Bio Pharm's Zomedron Inj. 5mg/100mL. The products will be applied a price of 164,163 won from next month. ◆Term expiry for extended premium pricing items = The government allows products to maintain the premium pricing until 4 or more products of the same ingredient are listed even after the period of 1 year if the products with the same ingredient are produced in 3 or fewer companies. Nine extended premium pricing products containing the eszopiclone ingredient face premium pricing term expiry next month. The discounts that will be applied for each product and strength are as follows: Huons' Zopista Tab. 1mg, 2mg, 3mg by 23.9%, 23.7%, 23.2%, respectively; Yungjin Pharmaceuticals Yungjin Zopiclone Tab. 1mg, 2mg, 3mg by 4.1%, 5.4%, and 6% respectively; and Myungin Pharm's Zoss Tab. 1mg, 2mg, and 3mg by 10.3%, 10.3%, and 9.9% respectively. ◆Price ceiling adjustments according to voluntary price cut applications = When a pharmaceutical company submits a request to lower its drug price to an amount lower than the ceiling price set for the product, the government adjusts the insurance drug price of the product to the requested amount. The price of Hanmi Pharmaceutical's ‘Gefitinib Tab.’ will be reduced by 22.1%, and Jinyang Pharm’s ‘Jintozet Tab. 10/40mg’ will be adjusted to a 17.3% lower price.
- Policy
- Leclaza will be reimbursed for non-small cell lung cancer
- by Lee, Hye-Kyung Jun 24, 2021 05:54am
- From July 1, Yuhan Corporation's "Leclaza (Lazertinib)" will be reimbursed at the stage of secondary administration of non-small cell lung cancer. The HIRA announced that it will conduct an opinion inquiry until the 25th on the revised announcement (proposal) based on drugs prescribed and administered to cancer patients. If there is no disagreement, it will be applied from 1 July. Leclaza was approved by the MFDS on January 18 as an anti-cancer drug used to treat patients with EGFR-TKI-positive local progressive or metastatic non-small cell lung cancer. According to the HIRA's review of textbooks, guidelines, and clinical papers to set the standards, there was no mention of the drug in textbooks or guidelines as a new drug developed domestically. As a result of a single-group, phase I/II of clinical trial of local progressive or metastatic non-small cell lung cancer patients previously treated with EGFR-TKI, the median value of the progressive survival period was reported to be 9.5 months. In addition, T790M positive patients with 240mg of FDA approval content showed a median value of 11.0 months and an objective response rate of 57.9%, which is currently approved and paid for the same certificate of medical utility. The standard was set the same as Tagrisso( Osimertinib). Cross-dosing benefits are not recognized if a Tagrisso-administered patient intends to change to Leclaza after the disease progresses. However, if a patient want to change the administration to Leclaza due to serious side effects after Tagrisso is administered, it can be recognized on a case-by-case basis.
