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- 2025-12-25 19:20:52
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- Nitrosamines test plan must also be submitted
- by Chon, Seung-Hyun Jul 28, 2021 05:56am
- The government is further strengthening pharmaceutical companies' self-inspection of impurities. Plans should be submitted by the end of this month to test for possible Nitrosamine impurities.. The submission of test results is due in May next year. According to the industry on the 27th, the MFDS recently asked pharmaceutical companies to submit a test plan for drugs that are feared to develop Nitrosamine impurities by the 29th. Pharmaceutical companies should submit to the MFDS a list of products that are feared to cause impurities, a plan to proceed with the test inspection, and a scheduled date of submission of test results. If there is a possibility of impurities among the drugs currently being produced and sold, it should be informed in advance when the test inspection will be carried out and the results will be submitted. In November 2019, the MFDS ordered pharmaceutical companies to submit a report on the possibility of Nitrosamine-related impurities of all raw materials and finished medicines, and the data was submitted in a year and six months. Initially, the MFDS requested submission of data by May last year, but postponed it to May this year. Pharmaceutical companies submitted data indicating the possibility of impurity generation for all licensed raw and finished medicines. The data included the results of checking whether the drug's properties or manufacturing environment could produce Nitrosamine impurities such as N-Nitrosodimethylamine (NDMA). It only shows the list of raw materials and finished drugs in possession and the possibility of impurity generation. For example, if Sodium Nitrite or other Nitrite is used, it is classified as a product that is likely to produce Nitrosamine impurities. The MFDS ordered products that are considered to have a possibility of developing Nitrosamine impurities to report the results of the impurity test by May 31, 2022. It did not mention submission of the test inspection plan. An official from the MFDS explained, "The deadline for submitting the test is about 10 months, but the intention is to quickly conduct the test inspection on products that are at risk of impurities." As the risk of impurities has recently been raised in Sartan series of hypertension treatments and Varenicline, it is interpreted as an intention to check with strict standards by pharmaceutical companies. If Nitrosamine impurities are detected in the future in products that pharmaceutical companies have pointed out as unlikely to produce impurities, they may be held responsible. An official from a pharmaceutical company said, "We are once again looking at the possibility of generating impurities for products being produced and sold according to the MFDS' instructions to submit a test inspection plan."
- Company
- Samsung Biologics record-high earnings of ₩166.8 in Q2
- by An, Kyung-Jin Jul 28, 2021 05:55am
- Samsung Biologics Samsung Biologics posted positive records despite the prolonged COVID-19 crisis. The increased utilization rate of the company’s third plant and new product orders drove the company to record the highest-ever sales and operating profit this quarter. On the 27th, Samsung Biologics announced that its operating profit in Q2 this year was 166.8 billion won, which was a 105.6% year-on-year increase. Its sales revenue also rose 34.0% year-on-year to record 412.2 billion won. Both are the largest-ever quarterly records to be made by the company. The company’s cumulative sales revenue in the first half of this year was 673 billion won, a 30.7% increase from the previous year. Its operating profit also increased 67.8% to record 241.1 billion won. The company believes that the sales increase was possible due to increased new product orders in addition to COVID-19 related products, and the increased utilization rate of its third plant. Also, along with the increase in sales, profitability improved as the increased utilization rate of the third plant began to generate profit in full-scale. In May, Samsung Biologics had signed a CMO deal with Moderna to provide fill-finish manufacturing of Moderna’s COVID-19 vaccine and started production. The company plans to finish establishing a manufacturing facility that can produce the active ingredient of the mRNA vaccine in the first half of next year, and expects it will be able to provide an end-to-end service that covers the full process from manufacturing the active ingredient to the finished product. In addition, the company plans to focus on managing effective operation of its manufacturing facilities and winning early orders for its fourth plant. As a response to the surge in demand for biopharmaceutical products, the company has started building its fourth plant with a capacity of 256,000ℓ in August last year. The plant, when completed, will have the world’s largest production capacity for a single plant. The company plans to commence partial operations by the end of next year and start full operations in 2023. An official from Samsung Biologics said, “We are actively taking orders to complete early orders for our fourth plant, even though a considerable amount of time is left until its completion. We plan to contribute to bringing an early end to the COVID-19 pandemic by stably and promptly supplying COVID-19 vaccines and treatments to those in need around the globe.”
- Company
- Domestic DDP-4 inhibitors fare better amid sales decline
- by Kim, Jin-Gu Jul 28, 2021 05:55am
- Prescription of DPP-4 inhibitors, which used to drive the diabetes treatment market, are on the decline. In just a single year, the market size of DPP-4 inhibitors decreased 4%, and this is the third consecutive quarter the market saw a decline since Q4 last year. Also, multinational companies and domestic companies have seen opposite results in the sales performance of their products. While prescriptions of all DPP-4 inhibitors from multinational companies fell, most products from domestic companies continued to make growth. ◆Is the party over for DPP-4 inhibitors?... market decreased 4% in one year According to the pharmaceutical market research institution UBIST on the 27th, the diabetes drug market size for DPP-4 inhibitors was 141.6 billion won in Q2 this year. This was a 4% decline compared to the 148.2 billion won recorded in Q2 last year. Quarterly records show that the market has seen a steady decline since the Q3 last year. After first being formed in 2008 with the introduction of MSD’s ‘Januvia (sitagliptin),’ the market saw repeated growth with the release of latecomer drugs and became 'the most frequently prescribed diabetes drug.’ In Q1 2016, the market made the first quarterly sales that exceed 100 billion won. The market peaked in Q3 last year and made 156 billion won. However, since then, the market saw 3 consecutive quarters of decline, from 156 billion won. (4Q 2020) to 146.4 billion won (Q1 2021), to 141.6 billion won (Q2 2021). If this trend persists, the overall market size of antidiabetics is expected to fall below 600 billion won by the end of this year. ◆Market No.1 and 2 – ‘Januvia’ and ‘Trajenta’ both decline 8% Multinational pharmaceutical companies and domestic companies have seen opposite results in the prescriptions of their products. While prescriptions of products from multinational companies all declined, most products developed or introduced by domestic companies saw a growth in sales. The market’s leading product, MSD’s Januvia series saw an overall decline of 8% from the 43.4 billion won in Q2 last year to 40.1 billion won in Q2 this year. The sales drop was more vivid in its single-agent product. Januvia’s sales fell 11%, while sales of the combination drugs Janumet and Janumet XR decreased 8% and 3%, respectively. The same went for the market’s runner-up product ‘Trajenta (linagliptin).’ Its sales dropped 8% from 31.9 billion won to 29.3 billion won in the same period. Both the single-agent and combination drugs Trajenta and Trajenta Duo saw an 8% drop in sales. Sales of Novartis’ ‘Galvus (vildagliptin)’ series dropped 7% from 10.9 billion won to mark 10.7 billion won. Sales of Takeda Pharmaceutical's ‘Nesina (alogliptin)’ series fell 11% from 7.9 billion won to 7.1 billion won. Also, sales of AstraZeneca’s Onglyza (saxagliptin) series also fell 7% from 6.8 billion won to 6.3 billion won. ◆'Zemiglo' fares better…The latest latecomer DPP-4 inhibitor ‘Suganon’ shows rapid growth On the other hand, domestic DPP-4 inhibitor products performed well despite the overall market downtrend. Sales of LG Chem's 'Zemiglo (ingredient name: gemigliptin)' series, which had ranked third in the market, increased by 2% from 28.4 billion won to 29.1 billion won in a single year. Despite the 3% sales decline of the single-agent Zemiglo (8.8 billion won → 8.6 billion won), the overall prescriptions performance of the series increased with the 5% increase (19.4 billion won → 20.4 billion won) in sales of the combination drug Zemimet. However, it is evaluated that the overall growth drive has somewhat weakened compared to the past. LG Chem’s Zemiglo, Handok’s Tenelia, Dong-A ST’s Suganon, JW Pharm’s Guardlet (clockwise from the left upper corner). Zemiglo and Suganon and self-developed new durgs, Tenelia and Guardlet were introduced to Korea Sales of Handok’s ‘Tenelia (teneligliptin)’ increased 4% from 10.3 billion won to 10.7 billion won in the same period. Sales of the single-agent drug Tenelia grew 4%, and the combination drug Tenelia M grew 5%, respectively. Tenelia is a diabetes drug from Japan’s Mitsubishi Tanabe that Handok introduced to Korea. Using Tenlia, Handok had self-developed the combination drug Tenlia M by adding metformin. Currently, the combination drug is prescribed more than the single-agent drug. Dong-A ST’s self-developed new drug ‘Suganon (evogliptin)’ series has been showing the most rapid growth among all drugs recently. Its prescriptions only amounted to 5.7 billion won in Q2 last year, however, this increased 31% to mark 7.4 billion won in just one year. The Suganon series, which was introduced in Q2 2016, was the last to enter the DPP-4 inhibitor market. At that time, its prescriptions amounted to only 0.6 billion won. However, this had increased over tenfold in just 5 years. The ‘Guardlet (anagliptin)’ series that JW Pharmaceutical introduced from Sanwa Kagaku Kenkyusho, was the only product to see a decline in prescriptions among all domestic products. Its prescriptions, which amounted to 2.9 billion won in Q2 last year, decreased to 1.5 billion won. This decline was influenced by impurities detected in some of the metformin products. JW Pharmaceutical's Guardmet’s sales were suspended due to the detection of impurities. Without Gaurdmet, which accounted for over half of the sales in the Guardlet series, prescriptions of the whole family also decreased to around half of what it was before. However, prescription for the single-agent drug Guardlet itself had increased 7% from 1.4 billion won to 1.5 billion won in one year.
- Company
- 3 generics for Champix have been withdrawn in just one year
- by Lee, Tak-Sun Jul 28, 2021 05:54am
- Anti-smoking treatment Varenicline, a smoking cessation drug, is being withdrawn. It is believed that the impurity incident, which occurred last month, affected the cancer. According to the MFDS on the 26th, eight items of Varenicline have been withdrawn since June. On the 22nd of last month, the MFDS also began a safety survey after recovering Pfizer's Champix due to concerns over cancer-causing substances in countries such as Canada. As a result, pharmaceutical companies with Varenicline will have to conduct tests on impurities by August 31. The MFDS recommended that Varenicline are needed to use only the minimum amount for treatment and consider other treatments if possible until the results of the impurity test were published. It released a product developed in November 2018 with different salt from Champix, but later in December 2019 all sales were suspended due to the loss of patent litigation. It was released again after seven months. However, it has already lost trust due to the suspension of sales, and the sales performance of generics has fallen short of expectations. Currently, there are 62 generics for Champix. Only CTC Bio and Jeil are producing Varenicline. The rest of the pharmaceutical companies are supplied by two pharmaceutical companies. An official from related companies said, "We were originally going to clean up because it does not produce generic directly, and we have decided not to delay further because of the impurity incident." Other companies are similar. It is known that two additional items have been submitted to the MFDS. Including this, 30% of all licensed products will be canceled or dropped within a year of release. Eight of them were revoked on charges of selling them during the patent period.
- Company
- 19% of valsartan Rxs disappear 3 years after impurity issue
- by An, Kyung-Jin Jul 27, 2021 05:35am
- Three years have passed since the valsartan impurity issue swept across the pharmaceutical industry, however, the valsartan market is still showing no signs of recovery. Prescriptions of products containing valsartan as monotherapy and combination therapy both decreased by nearly 20%. Analysts believe that distrust in valsartan after the impurity issue has led to switching prescriptions to similar drugs. According to the pharmaceutical research institution UBIST on the 26th, outpatient prescriptions for valsartan monotherapy products recorded ₩29.9 billion in the first half of this year, a 5.4% decrease from the same period of the previous year. This is the second consecutive year of decline since the 4.1% decrease to ₩31.6 billion last year. Compared to the ₩34.1 billion in 1H of 2018, prescription of valsartan monotherapy products decreased by 12.4% in three years. With losartan, valsartan used to occupy the largest share of the angiotensin II receptor blocker (ARBs) market for the treatment of hypertension. The valsartan market had contracted much since an N-Nitrosodimethylamine (NDMA) impurity was detected in the valsartan active ingredient from China's Zhejiang Huahai Pharamceutical, which led to unprecedented mass recalls and sales suspensions around the world. This incident had delivered a hard blow to the growing domestic prescription market for valsartan products. On July 8th, 2018, the Ministry of Food and Drug Safety had suspended the sale of 209 pharmaceutical products containing valsartan that were being distributed in Korea for using an active ingredient that was found with NDMA. Afterward, the authorities made remedies for products that did not use the active ingredient in question and additionally uncovered products that use NDMA containing active ingredients, resulting in a total of 175 products being suspended from sales. The valsartan combination prescription market, which had a larger market than the monotherapy market, was also unable to escape the aftermath of the impurity crisis. In the first half of this year, the prescription volume for valsartan in combination with a calcium channel blocker (CCB) class amlodipine amounted to ₩98.1 billion. This was a 19.0% decline from the ₩121.1 billion in the first half of 2018, just before the impurity was detected. The market had somewhat recovered – by 6.6% - compared to the first half of 2019 when the valsartan issue just hit the industry. The combination of valsartan and the diuretic hydrochlorothiazide sold ₩19.3 billion in prescriptions in the first half of this year. From the ₩25.5 billion that was recorded in 2018 to ₩21.5 billion in 2019, and to ₩21.1 billion in 2020, the record has continued to fall. Compared to 3 years ago, prescriptions of the valsartan and hydrochlorothiazide combination fell 24.5%. Combined, the monotherapy and combination therapy market for products containing valsartan recorded ₩147.3 billion in the first half of this year. This was an 18.5% decrease from the ₩180.8 billion recorded in 2018. Until the first half of 2018 before the impurity issue broke, the monthly prescription of valsartan monotherapy and combination therapy products exceeded ₩30 billion per month. The monotherapy market by itself had recorded ₩6 billion in prescriptions every month. However, the prescription of valsartan monotherapy and combination therapies that reached ₩30.5 billion in July of 2018, fell immediately after the impurity issue, falling sharply to ₩25.8 billion in August, and ₩22 billion in September. And for three years since then, the monthly prescription has never exceeded ₩30 billion. As of June this year, the prescription for valsartan monotherapy and combination therapy combined recorded ₩24.3 billion. In other words, one-fifth of the prescriptions for valsartan disappeared after the impurity issue. Analysts believe that the distrust built in valsartan after the impurity issue has led to an avoidance of prescriptions containing valsartan. It is highly likely that some of the existing valsartan prescriptions have been switched to similar drugs. In fact, the ARB-based anti-hypertensive drug market itself did not contract after the valsartan impurity issue. The prescription for ARB-class monotherapies in the first half of this year amounted to ₩188.2 billion. As the pharmaceutical market had contracted in general due to the prolonged COVID-19 pandemic, the ARB market had also seen a decrease of 5.1% compared to the same period of the previous year but had increased by 2.9% compared to the ₩182.8 billion in 2018. The dual combination therapy market for the ARB+CCB class of antihypertensive ingredients had grown even more steeply. The accumulated prescription amount for the ARB+CCB combination in the first half of this year was ₩399.5 billion. This was an 0.2% increase from the same period last year and an overwhelming 19.1% increase from the ₩335.5 billion in the first half of 2018.
- Company
- Sales in the SGLT-2 diabetes drug market rose by 10%
- by Kim, Jin-Gu Jul 27, 2021 05:35am
- Xigduo·Jardiance Duo Prescription performance of compound drugs has increased significantly in the market for diabetic drugs in the SGLT-2 inhibitors. Outpatient Rx increased by 23% in the second quarter of the year. The single formulation only increased by 4% during the same period, showing slowing down. According to UBIST, a pharmaceutical market research agency on the 23rd, the total amount of outpatient prescriptions for diabetes treatments related to SGLT-2 inhibitors in the second quarter is estimated at ₩32.2 billion. Compared to ₩29.2 billion in the second quarter of last year, it increased by 10%. Market growth was led by combination formulations. The combined prescriptions for Xigduo (Metformin HCl+ Dapagliflozin Propanediol Hydrate) and Jardiance Duo (Empagliflozin +Metformin HCl) increased from ₩10.6 billion in the second quarter of last year to ₩13 billion in the first quarter of this year. Sales of Jardiance Duo rose 42% from ₩3.7 billion to ₩5.2 billion. Xigduo rose 13% from ₩6.9 billion to ₩7.8 billion. Boehringer Ingelheim launched the product a year later than AstraZeneca. The total amount of prescriptions for AstraZeneca's Forxiga and Boehringer Ingelheim's Jardiance, Astellas' Suglat and MSD’s Steglatro rose from ₩18.7 billion to ₩19.3 billion in the second quarter. By item, Forxiga increased 4% from ₩8.8 billion in the second quarter of last year to ₩9.2 billion in the second quarter of this year. Jardiance increased 5% from ₩8.5 billion to ₩8.9 billion over the same period. Suglat posted a prescription record of ₩800 million in the second quarter of this year, following the second quarter of last year. Steglatro fell 27% from ₩600 million to ₩400 million during the same period.
- Company
- Ultomiris can be prescribed in general hospitals
- by Eo, Yun-Ho Jul 26, 2021 05:51am
- According to related industries, Ultomiris (Ravulizumab), a treatment drug for paroxysmal nocturnal hemoglobinuria (PNH) supplied by Alexion to the domestic market, recently passed the D.C. of Seoul National University Hospital. It will be quickly prescribed after obtaining approval from the MFDS in May last year and being listed on the insurance benefit list on April 7. Solaris (30ml), at ₩5,132,364, so if three vials are administered bi-weekly per patient, ₩400 million is needed per year alone. Ultomiris was listed at ₩5,598,942 per bottle, and Ultomiris can be administered once every eight weeks from two weeks after initial dose administration, which is expected to lower the annual dose per patient compared to Soliris. However, like Solaris, a pre-approval system is introduced, and health authorities inspect monitoring before and after administration. PHN disease is one of the rare life-threatening blood diseases characterized by the destruction of red blood cells by the body, which is part of the immune system. In particular, it is a serious disease in which four out of 10 people die within five years if they are not treated after diagnosis. It is known that there are about 200 patients in Korea. Soliris (Eculizumab), which was released in Korea in 2012, is the only treatment of PHN, and patients treated with soliris improved their 5-year survival rate by 95.5%. Ultomiris demonstrated its validity through two studies conducted on PNH patients ( study 301, study 302). In the studies, Ultomiris demonstrated non-equality of treatment results compared to conventional Eculizumab in primary evaluation metrics such as transfusion avoidance, LDH normalization, LDH rate of change, FACIT-Fatigue score change. In addition, 93% of patients preferred Ultomiris in a preference evaluation study conducted on patients with seizures night haemoglobinosis who had received treatment with both Solaris and Ultomiris as an extended treatment study in the study 302.
- Company
- Mother's and Kyung Dong won the patent dispute
- by Kim, Jin-Gu Jul 26, 2021 05:50am
- Tenelia M SR Mother's and Kyungdong Pharmaceutical won the patent dispute over DPP-4 Inhibitor Series Diabetes Complex Tenelia M SR (Metformin HCl + Teneligliptin Hydrobromide Hydrate). This is expected to compete with Genuonescience, which won ahead of the two companies with the early release of generic for Tenelia M SR. According to the pharmaceutical industry on the 22nd, the Intellectual Property Trial and Appeal Board decided on the 21st at the Defensive Confirmation Trial for the Scope of a Right, which Mother's and Kyung Dong filed against Korea. The patent applied to Tenelia M SR is a formulation patent that expires in 2034. In January this year, Genuonescience filed a trial alone. Then in April, Mother's and Kyung Dong claimed. However, Mother's and Kyung Dong did not meet the "first request for trial" requirement to acquire generic for exclusivity. This is because the trial was not filed within 14 days of the filing date of the patent trial by Genuonescience. Genuonescience, which filed a trial three months earlier, won. On May 24, it was billed by the Intellectual Property Trial and Appeal Board. Two months later, Mother's and Kyung Dong succeeded in the challenge. Three companies are expected to compete with the early release of generics for Tenelia M SR in the future. However, Genuonescience is said to be one step ahead in this competition. This is because two out of three requirements have already been acquired for generic for exclusivity. The key is the initial application for permission. Earlier last month, Genuonescience and Mother's applied for permits at the same time. It is not clear which of the two submitted the application first. If Genuonescience had applied first, it would be possible to obtain generic for exclusivity from the MFDS. The company can monopolize the generics market without competing with other companies for nine months after Tenelia M's material patent expires on October 25 next year. If Mother's first submitted an application, no company can obtain generic for exclusivity. Thus, Genuonescience, Mother's, and Kyung Dong can release the generic regardless of generic for exclusivity. Tenelia is a DPP-400 inhibitor series of diabetes treatments introduced in Korea by Handok from Mitsubishi Tanabe Pharma. Korea developed its own compound Tenelia M SR by adding Metformin to a single-agent Tenelia. According to UBIST, a pharmaceutical market research firm, Tenelia posted a prescription record of ₩19.7 billion and Tenelia M, ₩22.8 billion last year. It was prescribed ₩10 billion and ₩11.7 billion respectively until the first half of this year.
- Company
- Glaucoma tx Taflotan demonstrates long-term effectiveness
- by Jul 26, 2021 05:49am
- Santen (CEO Lee Han-woong) announced on the 21st that an open-angle glaucoma high-pressure treatment called Taflotan has confirmed the effects of long-term intraocular pressure lowering and glaucoma inhibition in comparison with PGA. The results of the PGA analysis were published in the Journal of Clinical Medicine. The LOTUS study is the first multi-organ retrospective cohort study that compares and analyzes the long-term effects and safety profiles of PGA, the primary treatment for glaucoma, in Korean patients. From January 2010 to June 2016, we evaluated the progression of visual impairment and the effect of reduced intraocular pressure on primary glaucoma or normal intraocular glaucoma patients, including Taflotan, Latanoprost, and Travoprost. Based on electronic medical records (EMR), the patient group was classified into primary glaucoma or normal eye pressure glaucoma group (216 patients) and normal eye pressure glaucoma group (177 patients). The study found that the MD Slope in the Taflotan treatment group remained stable for a long time in the early open-angle glaucoma or early normal eye pressure glaucoma, similar to that in the case of administration of Latanoprost and Travoprost. Measurements of eye pressure changes after administration of Taflotan showed a decrease of -1.89±2.77mmHg in the primary open angle glaucoma or normal intraocular pressure glaucoma group and -2.20±2.64mmHg in the normal intraocular pressure glaucoma group. The reduced eye pressure remained stable for a long time. The effects between the three PGA's were identified at similar levels in both patient groups, with no significant adverse reactions. Glaucoma is a disease in which the optic nerve becomes weaker due to increased intraocular pressure, and it is fatal because it can lead to blindness. Glaucoma is divided into open-angle glaucoma and angle-closure glaucoma, one of the most common types of open-angle glaucoma in domestic glaucoma, depending on whether the discharge passage for waterproofing the eye pressure is open. Normal eye pressure glaucoma is within the normal range of 21mmHg or less, but active drug treatment is needed because the optic nerve is vulnerable and easily damaged. PGA is the drug family with the highest intraocular pressure drop effect among glaucoma single drugs developed so far, and is most often used as a primary treatment for glaucoma due to its high patient conformity and little systemic side effects. "LOTUS research is meaningful in that it compares the long-term effects and safety profiles of PGA, which are most commonly used in glaucoma treatment, for the first time in Korea," said Kim Joon-mo, an ophthalmologist at Sungkyunkwan University's medical school. "In particular, we expect that it will help patients preserve their vision and vision from an early stage, as the glaucoma progression of Taflotan-only treatment has been confirmed to be equivalent to that of the existing PGA," he said. Meanwhile, Taflotan is a glaucoma treatment released by Santen in 2010 and is available for patients with open-angle glaucoma and ocular hypertension, including normal eye pressure glaucoma.
- Company
- Generics for Betmiga, ↑19% market share in just one year
- by Kim, Jin-Gu Jul 23, 2021 05:57am
- Betmiga, Mirabek & Selebeta Generics for Betmiga (Mirabegron) are gaining market influence. Two generics for market share expanded to 19% in just one year after its launch. The release of generics resulted in a 14% drop in the amount of outpatient prescriptions for the original over a year. According to UBIST, a pharmaceutical market research institute on the 21st, the size of outpatient prescription market for irritable bladder treatments with Mirabegron ingredients in the second quarter was ￦17.3 billion. Compared to ￦16.5 billion in the same period last year, it increased by 5 %. The second-quarter prescription for the original Betmiga is ￦14 billion, down 14% from a year earlier. Hanmi and Chong Kun Dang released Mirabegron and Sellebeta in June and July last year, respectively. The amount of the original product decreased from ￦16.4 billion in the second quarter of last year to ￦16.1 billion in the third quarter, ￦15.9 billion in the fourth quarter, ￦15.4 billion in the first quarter and ￦14 billion in the second quarter. The market share fell from 99% to 81%. Considering that Betmiga's prices are almost the same as before, it is interpreted that the generics directly affected the original performance decline. Astellas has postponed the decision to lower the price of generics due to administrative litigation. However, since March of this year, the upper limit of insurance has been reduced by 5.5% in accordance with the price-volume agreement negotiation system. The total amount of prescription for two generics in the second quarter is ￦3.2 billion. Its share in the overall market is 19%. It succeeded in taking up one fifth of the market within a year of its release. Hanmi is ahead in the competition between the two generics. As of second quarter, Mirabek recorded ￦2.4 billion and Selebeta recorded ￦800 million. In particular, Mirabek is expected to achieve ￦10 billion per year. The key is the additional release of generics. Generic exclusivity period for Mirabek and Selebeta ended in February this year. Currently, 26 companies, excluding Hanmi and Chong Kun Dang, are preparing to launch with generic approval. Betmiga is an irritant bladder drug released by Astellas in October 2015. Annual prescriptions include ￦28.8 billion in 2016, ￦41.9 billion in 2017, ￦54.8 billion in 2018, ￦64.7 billion in 2019, and ￦65.1 billion in 2020. There are about 40 domestic companies that have entered into patent challenges. Since 2015, the company has filed defensive confirmation trial for the scope of a right. Among them, Hanmi and Chong Kun Dang won the generic exclusivity. The generic exclusivity period was from May 4 last year to February 3 this year.
