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- 2026-03-18 15:06:09
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- SGLT-2 inhibitor Jardiance to expand HF indication
- by Eo, Yun-Ho Mar 15, 2021 06:28am
- Following after Forxiga, Jardiance is also preparing to introduce the heart failure indication in South Korea. According to a pharmaceutical industry insider, Boehringer Ingelheim Korea is waiting for the health authority’s review result in its sodium-glucose cotransporter 2 (SGLT-2) inhibitor Jardiance’ request to expand indication in treating adult patients with heart failure with reduced ejection fraction (HFrEF) regardless of diabetic status. The South Korean authority has approved the same indication in competing Forxiga (dapagliflozin) in last December. The U.S. Food and Drug Administration (FDA) has reportedly granted a fast-track status on Jardiance’ indication, which is also under review in other countries like Japan. The drug’s efficacy in heart failure treatment has been statistically confirmed by a Phase III EMPEROR-Reduced trial. The study verified Jardiance met the primary endpoint by demonstrating 25 percent lower risk in cardiovascular related death or hospitalization by a heart failure, compared against placebo. Evaluating the secondary endpoint, Jardiance lowered the risk of a first hospitalization by a heart failure and repeated hospitalization by 30 percent. And for a new indicator, the decrease in estimated glomerular filtration rate (eGFR) by the drug was significantly delayed compared to the placebo. In last year, American Society of Nephrology (ASN) also disclosed the result of sub-analysis on EMPEROR-Reduced trial at 'Kidney Week 2020.' The analysis studied various subgroups of patients, including groups with severe renal impairment, experienced the drug’s benefit regardless of the chronic renal disease. The president of the Korean Society of Heart Failure and a cardiology professor at Seoul National University Bundang Hospital, Dr. Choi Dong-ju noted, “The size of heart failure patients in South Korea has almost doubled within last decade. The prevalence in heart failure will increase continuously in the future due to the aging society. But it is satisfying to see the EMPEROR-Reduced trial showing a positive outcome in treating heart failure.” Meanwhile, the FDA has designated the fast-track review status on EMPEROR program, which consists of EMPEROR-Preserved and EMPEROR-Reduced trials on evaluating Jardiance’ efficacy in lowering the risk of cardiovascular related death and hospitalization by heart failure. The EMPEROR-Preserved trial aims to assess Jardiance’ effect on cardiovascular related death and hospitalization by heart failure in patients with Heart failure with preserved ejection fraction (HFpEF). Currently, the health condition does not have any specific treatment for it, and the trial result would be disclosed within this year.
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- HER2 targeted therapy market exceeds KRW 200 billion
- by An, Kyung-Jin Mar 15, 2021 06:28am
- The South Korean market for targeted therapy prescribed to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer has exceeded 200 billion won in sales last year. Two domestically developed biosimilars increased the market influence and made up for the sale revenue void in the original by the original maker’s follow-on drugs, such as Kadcyla and Perjeta, breaking the market sales record. On Mar. 11, a pharmaceutical market research firm IQVIA reported the trastuzumab drug market size last year dropped to 99 billion won by year-on-year 4.8 percent. The market size increased for two consecutive years since it plummeted from 103.4 billion won in 2016 to 83.6 billion won in 2017, and recovered up to annual sales of 100 billion in 2019. But it took a slight fall after a year. Trastuzumab is the key substance in a targeted therapy Herceptin by Roche. The drug is prescribed to HER2-positive patients with metastatic breast cancer and stomach cancer. In South Korea, two biosimilars of the original Herceptin—Celltrion’s Herzuma and Samsung Bioepis’ Samfenet—were released to the market after the original’s patent expired. The original generated sales of 69.9 billion won last year. Compared against the year before, it was dropped by 11.2 percent. And compared against 103.4 billion won raised in 2016, before the biosimilars were released, one-third of the sales were evaporated. Herceptin’s pricing was brought down by 20 percent, from 517,628 won to 414,103 won per 150 mg injection, two months after Celltrion’s Herzuma was listed for National Health Insurance (NHI) reimbursement in April 2017. And with another pricing drop, the original drug is currently maintaining the pricing at 362,340 won since April last year. By principle of the South Korean drug pricing system, a biosimilar can be priced at 70 percent of the original’s pricing before the patent expiration. And from October 2016, an item ‘developed by a company recognized as an innovative pharmaceutical company or a company with collaborative deal between South Korean and global companies, released first time internationally in South Korea, or manufactured in South Korea’ can be priced up to 80 percent of the original. Meanwhile, an off-patent original’s pricing is reduced to 70 percent to 80 percent of the initial pricing when a biosimilar is launched. The trastuzumab drug market shrunk down to 83.6 billion won due the pricing reduction in Herceptin in 2017. But as biosimilars developed with South Korean technology pushed the sales, the market growth is catching up with the original’s gap. Celltrion’s Herzuma sales last year grew by 10.4 percent from the year before and generated 25.4 billion won. The Ministry of Food and Drug Safety (MFDS) authorized the sales of Herzuma in January 2014 and the drug started making sales revenue from the third quarter of 2017. The 2018 sales was stale with 7.7 billion won, but the sales surged to 23 billion won in 2019 and it is keeping the growth ever since. However, the domestic market share of Samsung Bioepis’ Samfenet is still insignificant. Samfenet generated 3.6 billion won last year. Although the sales grew by 65.8 percent compared to the year before, the gap with the competitor is rather substantial. Currently, Daewoong Pharmaceutical is in charge of Samfenet sales. Within three years of releasing the biosimilars, their market share in the trastuzumab drug market grew exponentially. The two biosimilars took 29.3 percent of the last year’s trastuzumab drug market sales. Herzuma’s share is at 25.7 percent, when Samfenet took up 3.6 percent. Basically, Herzuma led the biosimilar market expansion. And the targeted therapy market for the HER2-positive breast cancer patients expanded vastly as Herceptin developer Roche released follow-on drugs Kadcyla (trastuzumab emtansine) and Perjeta (pertuzumab). Around 15 percent to 20 percent of the total breast cancer patients are confirmed positively with HER2, which has fast relapse and short survival period. Roche’s Kadcyla generated 43.5 billion won last year, growing 22.7 percent from the year before. Kadcyla is the first antibody drug conjugate (ADC) Roche first show cased for the breast cancer sector. The drug can be prescribed to treat unresectable locally advanced or metastatic breast cancer in patients previously treated with trastuzumab and taxane. During the same time, Roche’s Perjeta generated 74.1 billion won. Growing 33.1 percent compared to the year before, the sales surpassed Herceptin for the first time. The drug, in combination with docetaxel and trastuzamab, can be prescribed to patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous HER2 targeted therapy or chemotherapy. As it was listed for selective reimbursement in May 2019, the combination therapy with trastuzumab became the standard adjuvant treatment before a surgery. Five drugs including the three trastuzumab drugs, Kadcyla and Perjeta, have raised 216.6 billion last year together and increased the market by 11.0 percent from the year before. Compared to 116.1 billion won in 2016, the market sales have almost doubled in four years and broke the record. The industry evaluates Roche has overcome off-patent Herceptin’s sales drop with the follow-on drugs. Also the HER2-positive breast cancer patients would benefit from the expanded treatment options.
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- 3 companies have abandoned Pelubi's patent challenge
- by Kim, Jin-Gu Mar 12, 2021 06:22am
- Pelubi Pharmaceutical companies that were trying to overcome the patent of Daewon's anti-inflammatory pain reliever Pelubi (Pelubiprofen) gave up. After Mother's and Hutecs voluntarily withdrew the request for a referee last year, Nexpharm was recently added, leaving only three of the six challengers. Some of the companies that voluntarily withdrew are said to have failed to develop the formulation. According to the pharmaceutical industry on the 10th, Nexpharm withdrew the trial to confirm the passive scope of rights for the Pelubi recently filed against Daewon. The third step after Mother's and Hutecs. Hutecs gave up its patent challenge in September of last year and in October of the same year. As a result, only three companies are left to challenge the Pelubi patent. Youngjin Pharm, Huons, and Chong Kun Dang, who first requested a patent trial, are planning to continue the patent challenge. Pelubi is a Korean new drug No. 12 developed by Daewon. After launching in 2008, the initial sales did not meet expectations. Until 2014, Pelubi's outpatient prescription was less than ₩5 billion. Then, as Daewon released the Sustained Release type as a generic, sales increased as additional indications were secured through follow-up clinical trials. Daewon launched the Pelubi SR in June 2015. In 2017, Pelubi's prescription amount surged with the addition of an indication of antipyretic action. Since 2019, it has produced more than ₩30 billion in prescriptions. Then the patent challenge continued. Starting with Youngjin Pharmaceutical in December 2019, Huons, Chong Kun Dang, Nexpharm, Hutecs, Mother's, etc., challenged the drug patents that expire in November 2028. At the same time, it started to develop generic for Pelubi. Excluding Chong Kun Dang, the remaining five companies were approved for generic for Pelubi bioequivalence test. The bioequivalence test was recently completed. However, it is confirmed that some companies have failed to prove bioequivalence. An official in the pharmaceutical industry said, "Pelubi ( Pelubiprofen) is a product with improved dissolution rate and stability, and development is difficult due to the nature of the formulation." He said, "I know that some of the companies that gave up the patent challenge have failed to develop the formulation they were aiming for."
- Company
- Genuone is licensed to manufacture Pariet
- by Kim, Jin-Gu Mar 11, 2021 06:07am
- Genuone received permission to change the manufacturer of Pariet (Rabeprazole) with an annual prescription amount of ₩15 billion. This is the first achievement since its independence from Kolmar Korea and officially launched earlier this year. Genuone announced on the 9th that it has received permission to change the manufacturer of Pariet 10mg/20mg from the MFDS. Pariet is a PPI (proton pump inhibitor)-based anti-ulcer drug developed by Japanese pharmaceutical company Eisai. According to the drug market research institute UBIST, the amount of outpatient prescriptions last year was ₩10 billion. Janssen Korea introduced it in 2000. However, when it decided to withdraw from the Hyangnam factory, the manufacturer had to change. Genuone has been pursuing the conversion of Pariet manufacturers before becoming independent from Kolmar Korea. In August 2019, the bioequivalence test was approved. This is to confirm the equivalence between the existing Pariet and the product to be produced by Genuone. Subsequently, manufacturing technology was transferred through collaboration with Eisai, and in April of last year, item approval for Pariet 10mg/20mg was acquired from Janssen Korea. Through this, the company has acquired ₩10 billion worth of items per year while obtaining approval for the relocation of the manufacturer. The first lot release is expected in April. Sales are jointly handled by Eisai and Yuhan as before. This is the first achievement since Genuone was officially launched in January of this year. Genuone is a corporation formed by the acquisition of Kolmar Korea's pharmaceutical division and Kolmar Pharma's CMO division by IMM Private Equity, a domestic private equity fund. After the acquisition of CJ Healthcare, Kolmar Korea promoted the sale of Kolmar with the pharmaceutical division, and the sale was completed last year. Kim Mi-yeon, CEO of Genuone, said, "Starting with the production of Pariet, we will further strengthen our partnership with Eisai and expand our partnership with global pharmaceutical companies."
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- Tecentriq as liver cancer first-line treatment green lit
- by Mar 11, 2021 06:07am
- The South Korean health authority is seemingly giving a green light to an immunotherapy Tecentriq for its combination therapy as a first-line treatment in liver cancer. A pharmaceutical industry source reported on Mar. 9 that the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee approved of the clinical efficacy in Roche’s Tecentriq (atezolizumab) plus Avastin (bavacizumab) combination therapy for patients with unresectable hepatocellular carcinoma, who have not received prior systemic therapy. The first threshold for the reimbursement was passed at the committee meeting convened on Feb. 24. The Tecentriq combination therapy has won the first-line treatment indication for hepatocellular carcinoma from the Ministry of Food and Drug Safety (MFDS) on July 31, 2020. It is the first and only hepatocellular carcinoma indication for an immunotherapy in South Korea. Moreover, Tecentriq combination therapy has overcome the biggest impediment of the Cancer Deliberation Committee in last February. Apparently, the committee did not demand for specific condition. The rest of the process is HIRA Drug Reimbursement Evaluation Committee (DREC) and National Health Insurance Service (NHIS) drug pricing negotiation. Considering rarely any Cancer Committee-approved drug fails to pass DREC these days, the next big issue with listing the Tecentriq liver cancer indication would be the pricing negotiation with NHIS. Meanwhile, the efficacy of Avastin combination therapy treating patients with hepatocellular carcinoma was confirmed in the IMbrave150 study. The result found the patient group using Tecentriq in combination with Avastin reduced the risk of disease worsening or death by 42 percent, compared with Nexavar (sorafenib) patient group. The Tecentriq plus Avastin therapy was also confirmed superior than Nexavar therapy as the combination therapy group’s mPFS marked 6.8 months, which was significantly longer than Nexavar group’s 4.3 months. The combination therapy has not reached the mOS, but the median value during the monitoring phase was at 8.6 months. Nexavar had mOS of 13.2 months. Also the combination therapy’s response rate at 27 percent doubled Nexavar therapy’s at 12 percent. However, the Cancer Deliberation Committee rejected the indication expansion requests on a combination therapy with paclitaxel in treating patients with triple-negative breast cancer (TNBC) as a first-line treatment, and a combination of bevacizumab, paclitaxel and carboplatin in treating patients with non-squamous non-small cell lung cancer (NSCLC) as first-line treatment.
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- Sales of erectile dysfunction generic drugs are increasing
- by An, Kyung-Jin Mar 11, 2021 06:06am
- Sales of the domestic erectile dysfunction treatment market decreased due to COVID-19. Sales declined, mainly for large items in the early days of the COVID-19 spread, and recovered after the second half of the year. Although sales of major products were low, generic products sold by Korean companies such as Hanmi and Chong Kun Dang were launched. According to IQVIA, a drug research institute on the 5th, the domestic erectile dysfunction treatment market last year was ₩11.2 billion, a 1.3% decrease from the previous year. After the expiration of patents for blockbuster drugs such as Viagra and Cialis, generics were released, increasing sales in the erectile dysfunction treatment market. It increased from ₩97.8 billion in 2016 to ₩104.5 billion in 2017, ₩108.2 billion in 2018, and ₩113.9 billion in 2019. However, the size of the market has shrunk in four years after experiencing COVID-19 incident. In the first quarter of last year, the erectile dysfunction treatment market fell 4.8% year-on-year with a joint venture of ₩26.9 billion in sales. In the second quarter, sales rebounded to ₩27.6 billion, which was down 0.4% from the same period last year. In the first half of last year, the number of confirmed cases peaked in Daegu and Gyeongbuk since January 20, last year when the first COVID-19 confirmed in Korea. In the industry, as the fear of unexpected infectious diseases spread rapidly, sales of patients decreased due to fewer visits to hospitals and inability to conduct sales marketing activities. This is because the erectile dysfunction treatment market is less severe than chronic diseases such as high blood pressure and diabetes, and is not an essential drug. The erectile dysfunction treatment market has recovered in earnest since 2H. It rose for 3 consecutive quarters to ₩28.6 billion in the third quarter of last year and ₩29.4 billion in the fourth quarter. Compared to the initial spread of COVID-19, the market for erectile dysfunction treatments also recovered as people's social activities became more active. Even large-sized items that were leading the market could not avoid the aftermath of COVID-19. However, generics sold by domestic companies were less damaged than original products. Hanmi's PalPal sales were ₩21.2 billion last year. Compared to the previous year, sales decreased by 5.3%, accounting for 18.9%. PalPal is a product released immediately after the expiration of the patent for Viagra (Sildenafil) in 2012. After overtaking Viagra in 2013, it has continued to dominate by surpassing the sales of Cialis (Tadalafil) in 2015. Last year's sales of Cendom by Chong Kun Dang, generic for Viagra, fell 1.8% from the previous year to ₩10.2 billion. And it surpassed Viagra and ranked second in sales. Among generic products, Hanmi Pharmaceutical's Gugu was remarkable. Gugu grew 13.6% year-on-year with sales of ₩7.9 billion last year. It is the only product in the top 5 sales in both original and generic sales that has increased its annual sales. Gugu is generic for Cialis. Pfizer Korea's Viagra reduced its annual sales by 11.1% from ₩9.6 billion in 2019 to ₩8.6 billion last year. Based on last year's cumulative sales, Viagra's market share was 7.6%. It fell 3.3 %p in four years from 10.9% in 2016. Cialis' sales last year amounted to ₩6.1 billion. The market share was 5.5%, which was cut in half from 2016 (10.1%).
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- Chong Kun Dang applied for COVID-19 treatment
- by An, Kyung-Jin Mar 10, 2021 06:27am
- Nafabelltan Chong Kun Dang announced on the 8th that it has applied to the MFDS for approval of the conditional marketing authorization (CMA) and phase 3 clinical trial plan of Nafabelltan (Nafamostat) as a treatment for COVID-19 for patients with severe and high risk. Nafabelltan is a drug used as a therapeutic agent for acute pancreatitis and as an anticoagulant. Nafabelltan inhibits the proteolytic enzyme TMPRSS2, which is known to be involved in the cell penetration process of COVID-19. Chong Kun Dang confirmed the possibility of developing it as a COVID-19 treatment in a drug re-creation study by Institut Pasteur Korea, and has been promoting the development of COVID-19 treatment with Institut Pasteur Korea and Korea Institute of Radiological Medical Sciences since last June. Through phase 2 clinical trials conducted on 104 severely ill patients with COVID-19 in Russia last year, it has secured the results of preventing worsening of symptoms and significantly improving the treatment period and treatment rate. According to Chong Kun Dang, 104 severely high-risk patients were randomly assigned to Nafabelltan-treated group or standard treatment group, administered drugs for 10 days, and analyzed the results of 36 high-risk groups with a National Early Warning Score (NEWS) of 7 or more. The P value was 0.012. It is explained that statistical significance was secured as the P value, which is the verification target, was confirmed to be less than 0.05. The Nafabelltan group showed superior effects compared to 11.1% of the standard treatment group, with 61.1% reaching a recovery state immediately after 10 days of drug administration. After 28 days, the total clinical period, the recovery rate of the Nafabelltan group was 94.4% and that of the standard treatment group was 61.1%, showing a statistically significant difference. 4 cases of death due to worsening symptoms of COVID-19 occurred in the standard treatment group, but not one in the Nafabelltan group, suggesting the possibility of preventing the death of high-risk patients. Based on the results of this phase 2 clinical trial, Chong Kun Dang is conducting consultations on supply of Nafabelltan with a number of countries including the UK, France, Japan, and Russia. Through this application for approval from the MFDS, it is planning to promote the rapid export of domestic COVID-19 treatments while securing a clear basis for approval for overseas emergency use. The MFDS also announced its intention to thoroughly verify the submitted non-clinical and clinical data through consultation with external experts. Chong Kun Dang is speeding up commercialization by submitting a large-scale phase 3 clinical trial plan along with the conditional marketing authorisation. It targets about 600 severely high-risk patients and are conducted in more than 10 institutions including Seoul National University Hospital in Korea. Global clinical trials are also planned for rapid patient recruitment. An official from Chong Kun Dang said, "Nafabelltan is the only drug that has reliably proved its therapeutic effect in the absence of COVID-19 treatment for severely high-risk patients. It can be applied to various mutant viruses, so it is expected that it will greatly contribute to preventing the re-proliferation of COVID-19 caused by mutations." Chong Kun Dang is participating in the clinical trials of ASCOT, a global clinical trial project in Australia, New Zealand and India. Phase 2 clinical trials are also in progress in Mexico and Senegal. The MFDS initiated a review of the approval of Nafabelltan. An official from the MFDS said, "We plan to carefully review the submitted non-clinical and clinical data, and plan to thoroughly verify the submitted data through external expert advice and decide whether to approve the change."
- Company
- First CAR-T treatment Kymriah was approved in Korea
- by Eo, Yun-Ho Mar 09, 2021 06:24am
- The first CAR-T treatment drug Kymriah was approved in Korea. The MFDS announced on the 5th that it has approved the world's first chimeric antigen receptor T cell (CAR-T) treatment Kymriah (Tisagenlecleucel), which was applied for approval by Novartis Korea, as the first advanced biopharmaceutical under the Advanced Renewable Bio Act. Chimeric antigen receptors (CARs, also known as chimeric immunoreceptors, chimeric T cell receptors or artificial T cell receptors) are receptor proteins that have been engineered to give T cells the new ability to target a specific protein. The receptors are chimeric because they combine both antigen-binding and T-cell activating functions into a single receptor. Kymriah is an anticancer drug in which genetic information is introduced into the patient's body so that specific antigens of cancer cells can be recognized on the surface of immune cells (T cells) collected from patients. This drug is an innovative immune cell anticancer drug that has clearly shown improved benefits in a single administration to patients with relapsed and refractory hematologic cancer, who have limited choice of other treatments. It was approved after being designated “Breakthrough Designation” in the United States and “PRIME” in Europe. Specific indications are relapsed and refractory ▲B-cell acute lymphocytic leukemia under 25 years old and ▲substantial giant B-cell lymphoma. The MFDS has thoroughly scientifically reviewed and evaluated the quality, safety and effectiveness, and post-marketing safety management plans of pharmaceuticals in accordance with the review criteria of the Advanced Renewable Bio Act. It explains that the Central Pharmaceutical Affairs Review Committee has consulted on the validity of the item approval and conformity to the system. Kymriah is a drug subject to long-term follow-up investigation pursuant to Article 30 of the Advanced Renewable Bio Act. Abnormal cases of Kymriah should be followed for 15 years from the date of administration, and the contents and results of the long-term follow-up survey should be reported to the MFDS every year from the date of initial sale. An official from the MFDS said, "We expect that the approval of Kymriah will provide a new treatment opportunity for patients with recurrent and refractory hematologic cancer who do not have an alternative drug or have not established standard treatment methods."
- Company
- Antihypertension Zofenil and Adalat Oros to halt supply
- by Mar 09, 2021 06:24am
- Zofenil (zofenopril calcium) tablet and Adalat Oros (nifedipine) 60 mg tablet that had shortage issues are ultimately ceasing the supply. On Mar. 5, pharmaceutical distribution industry source reported Menarini Korea has informed of halting the supply of an antihypertension drug Zofenil in 7.5 mg, 15 mg and 30 mg doses. Menarini Korea explained the reason behind halting the drug supply and stated, “The drug composition amended by the manufacturer does not agree with the South Korean regulation, therefore the new version of the drugs cannot be imported to South Korea.” Without further import, the company is to supply the drug until the outstanding stock is depleted. The company commented, “The supply suspension was decided abruptly. A limited stock of the product would be supplied regardless of bulk order amount.” An angiotensin converting enzyme (ACE) inhibitor Zofenil was first approved in South Korea in 2010. Although it was once the best-selling ACE inhibitor in Italy, Zofenil had its label revised due to adverse reaction like dry cough and some of the batches failed to pass solubility testing. And recently, the manufacturer’s delay in shipment impeded the supply of 7.5 mg dose. Bayer’s headquarter has apparently decided to permanently cease the supply of an antihypertension drug Adalat Oros 60 mg tablet. The drug has been out of stock for a long time due to the maintenance work at the German factory. Initially, the company promised to resume supplying the drug, but the headquarters’ decision has been made otherwise. Currently, the Health Insurance Review and Assessment Service (HIRA) grants the healthcare reimbursement when multiple doses of Adalat Oros 30 mg tablet are prescribed. However, the reimbursement listing term was extended to coming July 31, because of the permanent supply suspension on the 60 mg dose. The company said the listing after July 31 would be informed after negotiating with HIRA. The pharmacies around South Korea have been complaining of shortage in Adalat Oros 60 mg tablet frequently occurred since 2017.
- Company
- Mercilon's sales fell 16%
- by Kim, Jin-Gu Mar 08, 2021 06:20am
- The OTC oral contraceptives market is fluctuating. Sales of Mercilon and MYVLAR, the existing No. 1 and 2 items, declined significantly for each reason. Sales of new products such as Senseday and Daon succeeded in establishing a very stable market. The cause of the change in the market is the change of vendor and the launch of new products. Mercilon and Alesse's sales have changed in the last two years, and Yuhan and Ildong launched their own items and joined them as generic companies. Another reason is the long-term out-of-stock and the resulting base effect. As MYVLAR sold out for more than a year, sales of Melian and Minulet increased. ◆Mercilon ↓16%·Alesse ↓15% & ↑ sales of Senseday and Daon According to the drug market research agency IQVIA on the 8th, last year, Alvogen Korea Mercilon posted the most sales among OTC oral pre-contraceptives last year. Mercilon's sales last year were ₩7.7 billion. However, compared to ₩9.1 billion in 2019, it has decreased by 16%. From 2018 (₩9.9 billion), sales declined for the second consecutive year. It is analyzed that the change of the retailer and the addition of generics have had an effect. Mercilon, which is owned by Alvogen Korea, has been sold by Yuhan since May 2016. However, the sales contract ended in May 2019. It was sold by Chong Kun Dang instead of Yuhan. Unfortunately, sales have been falling since Chong Kun Dang took over the sales. Mercilon, which had quarterly sales of the second half of ₩2 billion until the second quarter of 2019, declined to the second half of the ₩1 billion from the third quarter of 2019. In the pharmaceutical industry, intensifying competition due to the addition of generics is also affecting the decline in sales. In recent years, generics have been released in the oral contraceptive market. The most representative product is Yuhan's Senseday. Yuhan released Senseday as its own item after ending the sale of Mercilon. Senseday posted ₩1.3 billion in sales last year. It quickly rose to fourth place. It is analyzed that Alesse, the third-largest item in the market, was also affected by the change of sales location. Alesse's sales last year were ₩1.8 billion, down 15% from ₩2.1 billion in 2019. Ildong was in charge of distribution and sales of Alesse. However, the sales contract ended in December 2019. Currently, it is known that Pfizer is in charge of direct sales. Ildong released Daon and Baraon as their own products after ending the sale of Alesse. This is the same strategy as Yuhan launched Senseday. The two products launched in the second quarter of last year generated total sales of ₩700 million. Daon entered the 7th place in the market in its first year of launch. ◆Last year's sales of zero, Melian and Minulet sales increased due to prolonged sales of MYVLAR Dong-A's MYVLAR, which was in second place until 2019, continues to be sold out. MYVLAR has been out of stock since the second half of 2019. Accordingly, sales from ₩3.9 billion in 2018 decreased to ₩2.7 billion in 2019, and last year, as inventory was exhausted, it decreased to less than ₩10 million. Bayer's overseas plant, which supplies the product, was relocated, resulting in a disruption in production. Not only MYVLAR, but also Minivlar & Melian were sold out. Fortunately, supply of Melian has resumed, but MYVLAR and Minivlar are still out of stock. Dong-A focused on selling Melian, which had normalized supply, as a substitute for MYVLAR. It is ranked second in the market with ₩1.8 billion in sales last year. However, MYVLAR is still out of stock. MYVLAR has generated sales of around ₩1 billion each quarter, while Melian's sales are limited to around ₩500 million despite Dong-A's sales power. Pfizer's Minulet received the most due to the sold-out of MYVLAR. Minulet's sales last year were ₩700 million, an increase of 119% from ₩300 million in 2019. Minulet, like MYVLAR, contains ethinylestradiol 0.03mg and gestoden 0.075mg. Minulet is the only product sold in Korea.
