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- 2025-12-26 15:39:16
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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%).
- Company
- 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.
- Company
- Pantogar's Sales cut in half
- by Mar 08, 2021 06:19am
- OTC hair loss treatment by Merz, Pantogar, was delayed in import, and sales were cut in half. According to the pharmaceutical industry on the 4th, import of Pantogar has been temporarily suspended from the middle of last year due to changes in overseas manufacturing sites. It was sold out as Pantogar's domestic distribution was stopped. Pantogar is out of stock at major online pharmaceutical shopping malls. This caused Pantogar's sales to plummet. According to the pharmaceutical market research firm IQVIA, Pantogar sales decreased 53.8% from about ₩1.3 billion in 2019 to ₩600 million last year. Pantogar's competitors include DongKook's Pansidil and Hyundai's Minoxyl. Pansidil beat Pantogar with number one in sales. An official from Huhpharma, who is in charge of distribution of Pantogar in Korea, said, "We cannot import due to the change of the factory last year, but The stock remains until May. It will be normalized within the year."
- Company
- Hepatitis C treatment Vosevi was refocused
- by Eo, Yun-Ho Mar 05, 2021 06:26am
- Gilead is aiming to enter the market for hepatitis C treatment Vosevi, which has failed to designate an orphan drug in Korea. According to related industries, Gilead Science Korea is in the process of marketing approval of the three-drug combination Vosevi (Sofosbuvir + Velpatasvir + Voxilaprevir) along with the hepatitis C combination drug Epclusa (Sofosbuvir / Velpatasvir). Vosevi's designation as an orphan drug was canceled because it did not meet the criteria for orphan drug designation in 2018. This drug, like AbbVie's Maviret (Glecaprevir + Pibrentasvir), relieved the discomfort of using Ribavirin in combination with a pangenic hepatitis C treatment, or the duration of treatment. Indications for this drug include therapy with NS5A inhibitors, treatment with genotypes 1-6 or Sofosbuvir without NS5A, and treatment of adult hepatitis C patients with type 1a and 3 treatment experience. In the POLARIS-1 and POLARIS-4 studies, Vosevi achieved a primary endpoint in 340 out of 353 chronic hepatitis C patients with treatment experience (SVR12 96%). Gilead, through Sovaldi (Sofosbuvir), first established the concept of'cure' in the area of hepatitis C. However, the introduction of pangenetic therapeutics in Korea was relatively delayed. As the number of hepatitis C patients is decreasing and Maviret's sales are high, it is unknown how the entry of Gilead's generics will affect the market. The World Health Organization's (WHO) latest treatment guidelines for hepatitis C recommend pangenetic treatments such as Maviret that do not require additional testing.
- Company
- Sales of Tagrisso tripled in four years
- by An, Kyung-Jin Mar 05, 2021 06:25am
- The market for targeted anticancer drugs for EGFR, which is prescribed to patients with non-small cell lung cancer with specific mutation findings, set a record for sales last year. The benefit of Tagrisso, a third-generation drug that is effective in the treatment of resistance to existing drugs, has been listed. According to IQVIA on the 2nd, the domestic epithelial growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) market in Korea was ₩152 billion, up 15.0% from the previous year. Compared to ₩57.6 billion in 2016, the sales volume increased 2.6 times over the past four years. 'Four types of EGFR-TKI, including Iressa (Gefitinib), Tarceva (Erlotinib HCl), Giotrif (Afatinib), and Tagrisso (Osimertinib), formed a domestic market worth ₩57.6 billion in 2016. In 2017, the growth slowed down to ₩55.4 billion, but after nearly doubling to ₩104.3 billion in 2018, it is a new record for 3 consecutive years. The third-generation drug Tagrisso (Osimertinib) was listed, driving the expansion of the EGFR-TKI market. EGFR-TKI is a targeted anticancer drug prescribed for patients with metastatic non-small cell lung cancer (NSCLC) with EGFR mutation. EGFR mutations occur between exons 18 and 21. It is a very common genetically modified cancer observed in 30% to 40% of non-small cell lung cancer, which accounts for 80% to 85% of lung cancer, and is known to have a higher incidence rate in Asians than in Westerners. This means that there is a lot of demand for prescriptions in Asia including Korea. Tagrisso's sales were ₩106.5 billion in the domestic market last year. It increased 34.5% compared to the previous year, setting a record high. The market share of'Tagrisso' based on last year's cumulative sales reached 70.1%. It maintains an overwhelming market gap with Iressa, the second-largest item. Tagrisso received marketing approval from the MFDS in May 2016 for local advanced or metastatic non-small cell lung cancer patients with EGFR-T790M mutation confirmed after administration of EGFR-TKI in May 2016. It is used as a secondary treatment for patients with non-small cell lung cancer who developed resistance after administration of the existing 1st and 2nd generation EGFR-TKI such as Iressa, Tarceva, and Giotrif. Tagrisso's sales surged as it was reimbursed as a second-line treatment in December 2017. Tagrisso sales, which started at ₩2.3 billion in the first year and ₩10.3 billion in 2017, jumped 5.8 times in a year to ₩59.4 billion in 2018. Since then, it has maintained a steep growth rate of more than 30%. In December 2018, a first-line therapy indication was added in Korea, but the expansion of benefits has been pending for more than two years. Sales of EGFR-TKI were sluggish excluding Tagrisso. Iressa's sales last year were ₩19.6 billion, down 30.7% from the previous year. Iressa's market share, which occupied 51.1% in 2016, fell 38.2%p in 4 years to 12.9%. Last year, Roche Tarceva's sales fell 10.9% year-on-year to ₩7.3 billion. Compared to ₩17.3 billion in 2016, the scale of sales has halved in four years. Boehringer Ingelheim's Giotrif's sales last year were ₩18.6 billion, up 12.2% from the previous year. Sales are increasing from ₩8.6 billion in 2016 to ₩10.9 billion in 2017 and ₩13.6 billion in 2018. However, the market share decreased by 2.7 percentage points from 14.9% in 2016 to 12.2% in 2020. Even though it was a second-generation drug, it did not overcome the resistance that occurred after the first-generation EGFR-TKI treatment and did not secure differentiation. The industry observes that there will be a big change in the EGFR-TKI market this year. Pfizer's Vizimpro, a second-generation drug, was listed at the end of last year, and it became possible to prescribe a general hospital. In February of last year, Vizimpro received item approval from the MFDS as a primary treatment for'local advanced or metastatic non-small cell lung cancer with EGFR exon 19 defect or exon 21 L858R substitution mutation. Tagrisso's rival drug, Yuhan's Leclaza, can also be prescribed within the year. Leclaza, a third-generation drug, was approved by the MFDS in January as a treatment for patients with EGFR T790M mutation-positive local progressive or metastatic non-small cell lung cancer who had previously been treated with EGFR-TKI.
- Company
- Roche has applied for insurance benefits of Polivy
- by Eo, Yun-Ho Mar 04, 2021 06:10am
- According to related industries, Roche Korea has submitted an application for Polivy (Polatuzumab), an antibody-drug conjugate (ADC) that is used in combination with conventional BR therapy (Bendamustine+Rituximab) for the treatment of Diffuse Large B-Cell Lymphoma and DLBCL. DLBCL, which accounts for the highest proportion of Non-Hodgkin lymphomas, is an aggressive lymphoma that requires immediate treatment due to its rapid disease progression. More than half of the patients have a good response rate to the extent of reaching remission, but 30-40% of patients do not respond to the standard therapy R-CHOP or experience recurrence after the first treatment. Relapsed/refractory DLBCL has not been an effective treatment option so far, although most patients experience recurrence within 2 years and the survival period is only 6 months. Polivy is the first ADC drug that targets CD79b, and has a mechanism to induce apoptosis by binding to CD79b expressed in B cells. Polivy was validated in a phase 1b/2 clinical study that confirmed the clinical efficacy and safety of Polivy combination therapy in 80 patients with relapsed/refractory DLBCL who were unable to receive hematopoietic stem cell transplantation and had more than one treatment experience. It was designated as an orphan drug in Korea in October of last year. As a result of the study, Polivy combination therapy group had higher complete remission rate (CR, Complete Response) and overall survival (OS, Overall Survival) longer than BR therapy (Bendamustine+Rituximab) group. Professor Ko Young-il, hematology and oncology at Seoul National University Hospital, said, "DLBCL patients who are difficult to transplant hematopoietic stem cells have a poor prognosis, and if they recur after hematopoietic stem cell transplantation, the survival period is only about 6 months. "Polivy has been clinically proven to be useful and is a recommended treatment option in international guidelines. It is significant in that it presents a new alternative to the previously limited relapsed/refractory DLBCL treatment," he added.
- Company
- Samsung Bioepis enters phase 1 of Stelara
- by Lee, Seok-Jun Mar 04, 2021 06:10am
- Samsung Bioepis has begun phase 1 clinical trial of the 10th biosimilar pipeline SB17. SB17 is a biosimilar for Stelara (Ustekinumab). Samsung Bioepis launched Phase 1 in February to confirm the pharmacokinetics, safety, and immunogenicity of SB17 for 201 healthy volunteers in France. Stelara is a treatment for autoimmune diseases such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis sold by Johnson & Johnson in the United States. The volume of global sales in 2020 is about ₩8.4 trillion. Samsung Bioepis was founded in 2012, and has developed three types of autoimmune diseases (SB2: biosimilar for Remicade, SB4: biosimilar for Enbrel, SB5: biosimilar for Humira) and two anticancer drugs (SB3: biosimilar for Herceptin & SB8: biosimilar for Avastin). It is also developing treatments for eye diseases (SB11: biosimilar for Lucentis, SB15: biosimilar for Eylea), blood diseases (SB12: biosimilar for Soliris), and skeletal diseases (SB16: biosimilar for Prolia).
