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- 2026-03-18 04:31:28
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- Chong Kun Dang applied for Lucentis biosimilar
- by Chon, Seung-Hyun Jul 30, 2021 05:47am
- Chung Kun Dang announced on the 28th that it has applied to the MFDS for permission for the item of the macular denaturation drug CKD-701. CKD-701(Ranibizumab) is a biosimilar product from Lucentis. Lucentis, sold by Roche and Novartis, is a drug used to treat ophthalmic diseases such as macular degenerative diabetes and macular edema. Lucentis' annual global sales amounted to about ₩4.6 trillion. Chung Kun Dang confirmed clinical equivalence with Lucentis through phase 3 of CKD-701, which was conducted at 25 hospitals including Seoul National University from September 2018 to March this year for 312 patients with 312 patients with age-related macular degeneration. Chung Kun Dang administered CKD-701 and original drugs respectively to patients with wet macular degeneration and analyzed the maximum calibration vision (BCVA) after three months. The assessment found that the proportion of patients with vision loss of less than 15 characters was 97.95%, or 143 out of 146 in the CKD-701 administration group, and 98.62%, or 143 out of 145 in the original drug administration group, which met the equivalence range. The average change in maximum calibration vision also showed no statistical difference between the two drugs as the CKD-701 administration group improved to 7.14 words and the original drug to 6.28 words. There were no statistically significant differences in drug efficacy and other pharmacokinetics, immunogenicity and safety in indicators such as the proportion of patients with less than 15 letters of vision loss and better vision, average changes in maximum calibration vision, and changes in central retinal thickness, respectively. If CKD-701 is approved, Chong Kun Dang will produce a second biosimilar. Chung Kun Dang was approved by Nesp's biosimilar Nesbell in late 2018. "If CKD-701 is approved, we expect patients to have a variety of treatment options. Starting with the domestic market worth ₩37 billion, we will expand the market to Southeast Asia and the Middle East," said an official at Chong Kun Dang.
- Company
- Sales of Takeda’s drugs 'acquired by Celltrion' drop 9%
- by Kim, Jin-Gu Jul 29, 2021 05:52am
- (clockwise from the upper left corner) Picture of Actos, Nesina, Edarbi, , Whituben, and Madipin Prescriptions of chronic disease drugs that Celltrion acquired from Takeda Pharmaceuticals dropped 9% year-on-year in the first half of this year. Sales of most of the products were already decreasing in the domestic market at the time of Celltrion’s acquisition, and the prolonged COVID-19 crisis contracted the prescription market and further decreased sales of the products. According to the pharmaceutical market research institution UBIST on the 28th, sales of all the prescription drugs that Celltrion acquired from Takeda Pharmaceutical last year amounted to 33.4 billion won in H1 of this year. This is a 9% drop from the 36.8 billion won earned from prescription drugs in H1 of the previous year. Last June, Celltrion had acquired business rights for Takeda Pharmaceutical’s primary care products in the Asia-Pacific region for 332.4 billion won. Under the deal, Celltrion has the right to 18 products ranging from treatments for diabetes, hypertension, as well as other OTC products in nine Asian Pacific markets including South Korea. Among the 18 brands, ‘Nesina,’ ‘Actos,’ and ‘Basen’ for diabetes, and ‘Edarbi’ and ‘Madipin’ for hypertension, and the OTC drugs ‘Whituben’ and ‘Albothyl’ are currently approved in Korea. Performance of all acquired prescription drugs had fallen in one year. In the case of the Nesina series -Nesina, Nesina Act, and Nesina Met – sales decreased 9% from 16.2 billion won in the H1 last year to 14.7 billion won in H1 this year. Prescription sales of the Actos series -Actos, Actos Met, and Actorsryl – also fell 8% from 12.3 billion won to 11.4 billion won in the same period. Edarbi and Edarbyclor’s prescriptions also decreased 7% from 5.1 billion won to 4.8 billion won, and Mardipin and Basen’s sales also fell 20% (2.1 billion→1.7 billion won) and 16% (1 billion→0.8 billion won), respectively. Most of the products have been in the Korean market for a long time. Mardipin and Basen were approved in 1991 and 1995, and have been in the market for over 30 years. Actos was approved in 2001 and has now been in Korea for 20 years. Nesina was approved in 2013. Their markets have naturally gotten more competitive since then. New products with improved efficacy and safety were released one after another, and generics also entered the market after patent expiry. Due to such various factors, sales of most of the products were already declining or barely maintaining their performance in Korea. Edarbi, which was released in 2017, was also unable to make a significant impact in Korea. In addition, the prolonged COVID-19 crisis had contracted Korea’s outpatient prescription market in general, leading to a larger decline in the performance of these products. Sales performance data on the OTC drugs Whituben and Albothyl for H1 of this year has not been released yet. However, due to the prolonged COVID-19 crisis and the fact that the OTC drug market had contracted more greatly than the prescription drug market, a considerable drop in their sales is expected for H1 this year. Only in the first quarter of this year, sales of the two OTC products had fallen to nearly half of what they made in the first quarter last year (based on IQVIA data). Whituben’s sales fell 51% (1.2 billion won→0.6 billion won), and Albothyl’s sales fell 49% (0.9 billion won → 0.5 billion won).
- Company
- Anterogen to finish analysis for its diabetic foot ulcer Tx
- by Lee, Seok-Jun Jul 29, 2021 05:52am
- Anterogen will be completing data cleaning on its Phase III trial (DFU-301) that was conducted in Korea at the end of August at the earliest. If the analysis goes as planned, the company plans to seek marketing authorization for its product after completing the analysis. 자료: 안트로젠 Anterogen announced these plans at the IR meeting on the 28th. According to IR, Anterogen is currently developing a dressing-type stem cell therapy product for the treatment of diabetic foot ulcers. Two Phase III trials - DFU-301and DFU-302 – had been ongoing for the said product in Korea. Regarding the DFU-301 trial that is now complete, a company official said, “The company aims to complete data cleaning of the Phase III DFU-301 trial in Korea by late August to early September at the latest., and then apply for marketing authorization of the product.” 164 patients participated in the Phase III DFU-301 trial. Grade 1 (106) and Grade 2 (44) patients under the Wagner Diabetic Foot Ulcer Grade Classification System were included in the study. The trial was conducted at 9 institutions. The other Phase III clinical trial, DFU-302, is being conducted on 104 Grade 2 (44) patients under the 'Wager Grade.’ 5 institutions are currently registering participants for the trial. 자료: 안트로젠 Two other Phase II trials on the diabetic foot ulcer treatment are also being conducted in the U.S. Unlike in Korea, the two trials are separately being conducted on 'Wager Grade' Grade 1 and Grade 2 patients. The DFU-102 is being conducted on 56 Grade 1 patients, and the DFU-103 is being conducted on 64 Grade 2 patients. 40 patients are currently registered in the DFU-102 trial.
- Company
- Viatris and Organon's sales are sluggish
- by Kim, Jin-Gu Jul 29, 2021 05:52am
- Viatris, which was officially launched at the end of last year, had low sales in the first half of this year. The amount of outpatient prescriptions for major products decreased by 8% compared to the first half of last year before independence from the Pfizer. Organon, separated from MSD, has a similar situation. Prescription performance of major products decreased by 8% during the same period. Foreign prescription sales were low due to prolonged COVID-19 outbreak. ◆The first half of Lipitor prescription was reduced by 8% According to UBIST, a pharmaceutical market research institute on the 28th, Viatris' total amount of prescriptions for major out-of-the-road prescriptions in the first half of this year is ₩14.4 billion. Compared to ₩217.8 billion in the first half of last year, it decreased by 8%. Viatris was officially launched in November last year. Pfizer Upjohn and Mylan, the Pfizer patent expiration business units, have merged to form a new corporation. Lipitor, Norvasc, Lyrica, Celebrex and Viagra, which were previously sold under the name of Pfizer, have been transferred to Viatris. Most of the major products' outpatient prescriptions have decreased simultaneously. In the case of Lipitor, which is the top item in the domestic outpatient prescription market, it decreased 8% from ₩94.1 billion to ₩86.5 billion during the period. The same is true of other products. Norvasc decreased by 7% (₩33.6 billion → ₩31.1 billion), ·Lyrica 10% (₩32.4 billion → ₩29.3 billion), and Celebrex 4% (₩20.2 billion → ₩19.4 billion). In addition, sales for Caduet ·Neurontin·Xalatan·Cardura XL·Zoloft·Xanax·Efexor-XR SR·Detrusitolalso decreased. Although Xalacom·Zyvox·Lyrica CR increased year-on-year, the prescription amount was only around ₩500 million. The prolonged COVID outbreak has had some impact. The domestic foreign prescription market has entered a slump due to the prolonged COVID crisis. In fact, the domestic foreign prescription market fell 3% year-on-year in the first half of this year. It has fallen in a row since the third quarter of last year. Since COVID outbreak, the number of patients visiting clinics has decreased, and the market has stagnated as pharmaceutical companies' sales and marketing activities have shrunk. Multinational pharmaceutical companies are believed to have reduced prescription performance due to their weaker sales power to lawmakers compared to domestic companies. For example, in the case of Lipitor, prescription sales reached around ₩48 billion every quarter by 2019, but only ₩46 billion from last year when COVID outbreak began in earnest. Sales fell further to ₩43 billion in the first and second quarters of this year. ◆ Atozet ↑2% - Cozaar ↓11% - Singulair ↓18% Organon was officially launched last June. Biosimilar distributed by MSD through Samsung Bioepis has been transferred to Organon in foreign markets such as Atozet, Cozaar, Singular, and Vytorin, products from the Women's Health Business Department, and Renflexis·Brensis·Ontruzant. Among major products, Atozet's prescription performance has increased. It increased 2% from ₩36.4 billion in the first half of last year to ₩37.1 billion. Sales of Cozaar fell 11% from ₩25.3 billion to ₩22.4 billion during the same period. Singulair decreased 18% from ₩14.4 billion to ₩11.8 billion, and Vytorin 17% ( ₩10.4 billion→ ₩8.6 billion), Proscar 9% ( ₩8.6 billion→ ₩7.8 billion), Fosamax 12% ( ₩7.6 billion → ₩6.7 billion), and Nasonex 10% ( ₩3.5 billion→ ₩3.2 billion).
- Company
- Daewoong's COVID drug PO is effective for patients over 50
- by Lee, Seok-Jun Jul 29, 2021 05:52am
- Daewoong's COVID drug PO has cut the time to improve respiratory symptoms of patients aged 50 or older by half compared to placebo. Daewoong announced the results of Topline in clinical 2b of Coviblock (Camostat), which is being developed as a treatment for COVID-19. Clinical trials were conducted in 24 institutions from February to July this year for 342 patients with mild COVID. The main evaluation variable is the "time it took for clinical symptoms to improve. Other key evaluation variables are 'safety' and 'worsened proportions of patients'. Clinical symptoms include fever, cough, difficulty breathing, chills, muscle aches, headaches, and sore throat, and the degree of symptoms (0-3) has improved to "None" or "Weakness (1)" and remained for 24 hours. The analysis confirmed safety in all patients given Camostat. The time it took for clinical symptoms to improve was 7 days for Camostat compared to 8 days for placebo. A Daewoong Pharmaceutical official said, "Because of the characteristics of mild patients, it was difficult to identify the difference in time taken to improve symptoms due to patients with good symptom management, high natural healing rate, and low drug use conformity." "There is also a limitation in clinical symptom determination standards that are subjective to patients." However, significant results were obtained in patients with high drug conformity. During the test period, the company observed patients taking more than 70% of Camostat or placebo. As a result, the improvement time for 175 patients (86 patients in Camostat group and 89 in placebo group) who are representative symptoms of coughing or having difficulty breathing was reduced by about 40% compared to the placebo group (8 days), indicating statistically significant results. The time to improve respiratory symptoms has been reduced by less than half in patients in their 50s and older, who are more likely to spread to severe diseases. According to an analysis of the symptom improvement time of 98 patients (48 Camostat groups and 50 placebo groups) who had at least one cough or difficulty breathing, Camostat improved more than twice as fast as 9 days in placebo groups on the 4th. Daewoong Pharmaceutical is developing a cure for chronic pancreatitis called "Foistar" as a treatment for COVID-19. Daewoong applied for Coviblock in December last year and completed registration in May this year.
- Company
- 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.”
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- 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.
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- 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.
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- 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.
