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- 2026-05-11 15:31:14
- Opinion
- [Reporter's View] Rise of patients and concerns
- by Eo, Yun-Ho Apr 18, 2023 05:37am
- Medicine is a product with strong public goods characteristics. It is a means of curing human diseases and maintaining health. In Korea, national health insurance is also applied. Another fact is that it is the company that makes and sells it. The purpose is to make a profit. Pharmaceuticals are high-value-added products that can make a lot of money. In this situation, the awakening of patients now exerts its power again, raising the popularity of prescription drugs. Their actions are influencing the decision-making itself for entitlement to benefits. These days, new drug development trends are anticancer drugs and rare incurable diseases. Innovative new drugs are emerging one after another in various cancer areas directly related to human life. There is also hope for patients with rare incurable diseases who have been suffering without proper treatment because only a small number of patients suffer from them. But those drugs are expensive. Most of these drugs are super-expensive. It's been a long time since it was approved by the Ministry of Food and Drug Safety, but prescriptions have not been made and the process for listing benefits has not been completed. The HIRA and the NHIS are bombarded with complaints from patients. Complaints even reach the National Assembly. The Ministry of Health and Welfare and its affiliated agencies are inundated with questions and criticism. Even without determining whether or not to receive reimbursement itself, cases, where the patient's power was clearly demonstrated in the speed of registration, are gradually accumulating. Pharmaceutical companies say that when they promote a drug, it is for the sake of patients. That is true, but there are times when there is no inspiration. It is thanks to companies that are inclined towards 'products' without a dilemma. That's why we hope that the industry's approach to patients will be accompanied by rigorous prudence.
- Company
- Sales of Pfizer, Gilead, and MSD soared last year
- by Jung, Sae-Im Apr 18, 2023 05:37am
- Last year, Korean subsidiaries of multinational pharmaceutical companies made external growth in general. Pfizer Korea, MSD Korea, and Gilead Sciences Korea have enjoyed an increase in sales of COVID-19 vaccines and treatments. The high sales growth of new drugs such as Keytruda, Gardasil 9, and Prolia also contributed to the increase in sales. According to the Financial Supervisory Service on the 18th, combined sales in 37 of the 38 Korean subsidiaries of major multinational pharmaceutical companies, excluding Viatris totaled at KRW 11.72 trillion, up 27.7% from the previous year's KRW 9.18 trillion. During the same period, operating profits increased by 9.8% from KRW 361.2 billion to KRW 396.5 billion. The figure excludes Viatris Korea, which changed its settlement date from the end of November to the end of December last year. About 80% - 30 of 38 Korean subsidiaries of multinational pharmaceutical companies - increased sales. More than half (21) also saw an improvement in their operating profit. The sales expansion of multinational pharmaceutical companies' Korean subsidiaries can be attributed to the high sales growth of new drugs. The companies enjoyed the special procurement demand that arose due to the COVID-19 pandemic by developing vaccines and treatments for COVID-19. New drugs for diseases other than COVID-19 have also shown even growth in sales. According to the market research institution IQVIA, 9 of the top 10 drug sales last year were products from multinational pharmaceutical companies. MSD, Viatris, Amgen, AstraZeneca, Sanofi, and Roche evenly placed their names on the ranking list. Pfizer Pharmaceuticals Korea, which posted the highest sales last year, recorded an overwhelming annual sales of KRW 3.23 trillion last year. This is the highest figure recorded among pharmaceutical and bio companies in Korea. The company made more sales than Samsung Biologics, which recorded KRW 3.13 trillion last year. Operating profit also increased significantly to KRW 120.1 billion, a 102.8% increase from the KRW 59.2 billion won in the previous year. The COVID-19 pandemic drove the high growth for Pfizer Korea. Pfizer is the only one among domestic and foreign companies that supply both a COVID-19 vaccine and treatment. The COVID-19 vaccine ‘Comirnaty’ and the treatment ‘Paxlovid’ that was developed by Pfizer had been supplied through Pfizer Korea in Korea. Thanks to this, sales in its Korean subsidiary soared from KRW 391.9 billion in 2020 to RKW 1.70 trillion in 2021, then to KRW 3.23 trillion in 2022. As distribution and marketing for COVID-19 vaccines and treatments were virtually conducted by the government, the company was able to generate high profits thanks to low SG&A expenses. Pfizer Korea’s operating profit, which suffered a loss of KRW 7.2 billion in 2020, succeeded in turning a profit in 2021 and exceeded KRW 100 billion last year. Gilead Sciences Korea showed the second most growth in sales after Pfizer Korea. Last year, Gilead's Korean subsidiary posted KRW 565.4 billion in annual sales, a 96.1% increase from the previous year's KRW 288.4 billion. Gilead Sciences Korea, whose sales did not belong in the Top 10 among Korean subsidiaries of multinational pharmaceutical companies, jumped to 5th last year. Operating profit increased by 84.1% from KRW 12.5 billion to KRW 23 billion. Sales of its COVID-19 treatment ‘Veklury (remdesivir)’ is deemed to have contributed to Gilead Sciences Korea’s marked growth. The number of COVID-19 patients increased significantly last year, and the number of critically ill patients also increased. Veklury was approved for use in hospitalized patients with severe COVID-19 whose oxygen saturation level is less than 94% or who need supplemental oxygen treatment. MSD Korea also posted an all-time high in terms of annual sales by making KRW 820.4 billion last year. Overtaking AstraZeneca Korea, the company ranked second in sales among multinational pharmaceutical companies’ Korean subsidiaries. Sales of the COVID-19 treatment ‘Lagevrio,' the immuno-oncology drug ‘Keytruda,’ and the cervical cancer vaccine ‘Gardasil 9’ drove the company’s growth. Last year, the government purchased 242,000 courses of LAgevrio from the company. If the contracted amount was introduced last year as planned, sales of KRW 169.4 to KRW 193.6 billion (KRW 700,000 to KRW 800,000 per person) were generated. In addition, sales of Keytruda, the lead product among domestic drug sales, and Gardasil9, which ranks 3rd, reached KRW 356.6 billion based on an IQVIA. On the other hand, the company’s operating profit halved to KRW 28.6 billion due to the rise in the price of finished products the company had purchased from its headquarters and a large amount of money spent on SG&A expenses. In addition, Organon Korea (20.8%), Sanofi-Pasteur (19.9%), Ipsen Korea (19.2%), Abbott Korea (17.6%), Merck (16.8%), Roche Korea (16.6%), Novo Nordisk (16%) %) achieved high sales growth. In particular, sales of Sanofi Pasteur Korea, the vaccine division of the Sanofi Group, surpassed KRW 100 billion in annual sales for the first time last year thanks to strong sales of influenza (flu) vaccines last year. In other words, more than half of the 38 Korean subsidiaries of multinational pharmaceutical companies saw an improvement in their operating profit. However, except for Pfizer Korea, which marked an explosive growth in operating profit last year, the operating profit of the remaining companies fell 8.7% from KRW 302.9 billion in 2021 to KRW 276.5 billion in 2022. This means that the deuteration experience by the other companies was greater than the improvement in operating profit seen by 20 companies other than Pfizer Korea. Also, 5 companies whose operating profits turned to or continued to be a loss. In particular, MSD Korea (-50.7%), Sanofi-Aventis Korea (-60.4%), Jansen Korea (-47.2%), GSK Korea (conversion to a deficit), Abbott Korea (increased deficit), Mandipharma Korea (conversion to a deficit), and Menarini Korea (conversion to a deficit) were among the companies that saw a significant drop in operating profit last year.
- Company
- Mitsubishi and Sanofi signs agreement to sell Rilutek in KOR
- by Jung, Sae-Im Apr 18, 2023 05:36am
- On the 17th, Mitsubishi Tanabe Pharma announced that the company had signed a domestic marketing agreement with Sanofi Aventis Korea for Sanofi’s amyotrophic lateral sclerosis (ALS) treatment ‘Rilutek (riluzole)’ on the 12th. Rilutek is the first treatment for ALS approved by the US FDA. The drug is used to extend survival or delay the need for a tracheostomy in ALS patients. Under the marketing agreement, Mitsubishi Tanabe Pharma Korea will own exclusive marketing rights for Rilutek. The company was able to offer a broader treatment option for the disease with the ALS injection treatment 'Radicut (ingredient: edaravone)' that was approved in the US in June 2016. ALS, which is better known as Lou Gehrig's disease, is a serious rare incurable disease that causes progressive paralysis and atrophy of the whole body muscles due to the degeneration of motor neurons. As the disease progresses, it can lead to paralysis of the limbs and respiratory muscles, leading to death within years. Mitsubishi Tanabe Pharma Korea’s General Manager Tae-hwan Ryu said, “Through sales of the injectable Radicut and the oral treatment Rilutek, we will now be able to offer diverse and effective treatment options for ALS patients in Korea. We are pleased to be starting this relationship with Sanofi-Aventis Korea.”
- Company
- Pay attention to the animal drug market worth 3 trillion won
- by Nho, Byung Chul Apr 17, 2023 05:58am
- Traditional pharmaceutical bio companies are entering the companion animal medicine and feed market worth 2.5 trillion won, attracting attention as they seek new growth engines and external expansion. Yuhan Corporation, Daewoong Pharmaceutical, Donghwa Pharmaceutical, Dongkuk Pharmaceutical, Kwangdong Pharmaceutical, Ildong Pharmaceutical, and CMG Pharmaceutical are among the companies that have declared their entry into the pet market and are taking active steps. These companies are expanding their brands by launching veterinary professional treatment and prescription animal medicines such as injections, antibiotics, and anthelmintics, as well as zoonotic medicines, nutritional supplements, and feed. For this reason, a significant number of biopharmaceutical companies have the intention to preoccupy the market by mobilizing their strengths in formulation development, sales, and marketing to launch 'veterinary medicine/feed' variants of 'drugs/health functional foods' in the rapidly growing pet market. In particular, animal medicines and feed conversion products of OTC and health-functional foods are produced in so-called human-grade raw materials and human-grade manufacturing facilities and are competitive as they secure quality enough to be consumed by humans. In addition, China's pet market, which raises about 200 million pets, reaches 38 trillion won (feed 21 trillion won) as of 2020, making it an attractive industry because it can secure infinite cash cows if it is pioneered only in export markets. is evaluated as First of all, Yuhan Corp.'s veterinary medicine division (AHC), which is achieving external sales of 30 billion won, is leading the related market by increasing the number of veterinary hospital customers. One product that draws attention is GedaCure, a treatment for cognitive dysfunction in dogs launched in May 2021. Crisdesalazine, the main ingredient of GedaCure, is a new drug for Alzheimer's disease discovered with support from the Ministry of Science and ICT. The drug was approved as a domestic synthetic new drug for animals in February 2021 after its efficacy and safety were proven in dogs suffering from cognitive dysfunction syndrome similar to Alzheimer's dementia in humans. Currently, more than 1,300 veterinary hospitals through Yuhan Corp. prescribe it. The fact that GedaCure is effective for canine cognitive dysfunction syndrome as well as meningitis was disclosed at the Fall International Conference of the Korean Veterinary Society held at the Jeju International Convention Center in November 2022. It is expected to grow as a blockbuster drug in the future. In September 2021, Dongkuk Pharmaceutical entered the pet market by introducing Canidol, a veterinary medicine for periodontal disease, for the first time in Korea. Canidol is a pet-only product of Insadol, a 50-billion-dollar blockbuster over-the-counter gum treatment. Canidol contains herbal medicine ingredients, corn unsaponifiable quantitative extract, and silver leaf extract, and the composition of the ingredients is the same as that of insadol. The unsaponifiable corn extract helps to promote the formation of gum bone and strengthens the periodontal ligament. According to Canidol clinical trial results, clinical indicators of the gingival index and bleeding index improved immediately before scaling and 4 to 8 weeks after scaling for 40 dogs who visited the hospital with periodontal disease. In June 2022, Guangdong Pharmaceutical expanded the 20 billion-strong general medicine Kyungokgo brand to pet products. Gyeonokgo Bow, a nutritional supplement for dogs, has been approved and registered as a compound feed for animals, and in the form of pellets, the unique scent of pharmaceuticals is masked. The main ingredients include the mixed concentrate of Sukjihwang and Bokryeong, the main ingredients of Kyungokgo, as well as hydrolyzed duck, sweet potato, and red ginseng concentrate Gold CAD. Among them, MSM, Glucosamine, and Sukjihwang can help dogs' joint and cartilage health, and ginsenosides Rg1, Rb1, and Rg3 can help immune function. Kwangdong Pharmaceutical is building a pet-friendly brand image by conducting activities such as providing pet amenities in partnership with domestic 4-star or higher hotels that allow pets. Through this business agreement, the two companies plan to develop companion animal nutrients that are effective in reducing body fat and improving skin diseases by using the Akkermansia muciniphila EB-AMDK19 strain. Akkermansia is a strain that lives in the intestinal mucosa of the body and is one of the microorganisms important for health. According to numerous domestic and foreign studies, the number of Akkermansia muciniphila is significantly lower in patients with skin diseases such as atopy, intestinal diseases, and obesity compared to normal people. In particular, Enterobiome proved that Akkermansia is also effective for pet obesity. In a study conducted with a research team at the College of Oriental Medicine at Dongguk University, the weight of beagle dogs that consumed Akkermansia decreased by 15.1% compared to non-ingested beagle dogs. In addition, non-clinical toxicity tests are underway for Akkermansia muciniphila raw materials, and based on the data, the US Food and Drug Administration (FDA) New Food Ingredient (NDI) and European Food Safety Authority (EFSA) new raw material (NOVEL) along with registration of food raw materials in Korea. FOOD). In January of this year, CMG Pharmaceuticals acquired Ingmedix, a company specializing in animal nutritional supplements, and entered the companion animal nutritional supplement market. With excellent R&D technology, production capacity, and marketing know-how, we are developing and producing our own brand nutritional supplements for companion animals, and we are also conducting OEM (Original Equipment Manufacturer), ODM (Original Equipment Manufacturer), and OBM (Manufacturer Brand Development and Manufacturing) businesses. It is expected that synergistic effects will emerge when the distribution network is expanded, such as combining offline channels such as veterinary hospitals owned by Ingmedix with online channels such as home shopping and open markets owned by CMG Pharmaceuticals. After laying the groundwork for entering the market as nutritional supplements for companion animals, the company plans to proceed with the development of veterinary medicines. Donghwa is making a strategic investment of 5 billion won in Fitpet, a companion animal healthcare solution company, on the 21st of this month, and is paying attention to related industries. Through this strategic investment, Dongwha Pharm plans to research and develop animal medicines with its 126-year tradition of drug development know-how and large-scale drug manufacturing capabilities by utilizing Pipett's hundreds of thousands of companion animal healthcare databases. In addition, it has secured priority negotiation rights for the commercialization of medicines developed with this investment. Fitpet is a companion animal total healthcare solution company that has attracted more than 60 billion won in accumulated investment and is leading the market.
- MSD Korea’s sales rise 69% in 2 years
- by Jung, Sae-Im Apr 17, 2023 05:58am
- MSD Korea made its highest-ever sales last year, recording annual sales of KRW 820.4 billion last year. The strong sales of Keytruda and Gardasil 9 greatly contributed to the company’s external growth. However, the increase in sales costs and SG&A expenses cut the company’s operating profit by half. According to the Financial Supervisory Service on the 14th, MSD Korea recorded sales of KRW 820.4 billion last year. This is a 51% increase from last year's KRW 541.9 billion. MSD’s sales, which had been KRW 271.6 billion in 2019, then KRW 484.7 billion in 2020, had exceeded KRW 500 billion in 2021. Last year, sales surged by approximately KRW 280 billion to reach KRW 800 billion. Over the past 2 years, sales have increased by 69.3%. As a result, MSD Korea surpassed its pre-spinoff scale only 2 years after its Organon spinoff. According to MSD Korea's audit report in 2020, the company's sales before the spin-off were estimated to be around KRW 800 billion. Its flagship product, Keytruda, was the major contributor to this sales growth. The immuno-oncology drug Keytruda has been holding the highest sales among domestically marketed prescription drugs. According to IQVIA, a market research institute, Keytruda's annual sales exceeded KRW 100 billion in 2019 and KRW 200 billion in 2021. Sales last year were tallied at KRW 239.6 billion for Keytruda alone. Its growth has been accelerating recently. Quarterly sales had temporarily fallen in the aftermath of drug price cuts in Q1 last year but then rebound with the reimbursement expansion last year. In particular, higher growth is expected as its reimbursement was expanded to first-line treatment for non-small cell lung cancer, which has a large number of patients. In Q4 last year, Keytruda's quarterly sales increased to KRW 78 billion. Sales of the cervical cancer vaccine Gardasil9 had also contributed to the company’s increased sales. According to IQVIA, Gardasil 9 sold KRW 117 billion in sales last year and ranked third in domestic drug sales. This is a 61% increase over the previous year. The number of people looking to receive vaccinations with Gardasil 9 has been increasing with the recommended age for female vaccination expanded and the spreading perception that it is not a vaccine for only women. The supply price of Gardasil 9 also rose, and sales more than doubled from 2 years ago. Last year, the combined sales of Keytruda and Gardasil 9 in Korea reached KRW 356.6 billion. In addition, the COVID-19 treatment 'Lagevrio' that had been introduced last year is also analyzed to have contributed to the company's growth. The Korean government purchased 100,000 courses of Lagevrio earlier last year. The company’s operating profit, which turned into a profit in 2021, decreased by half last year. Last year's operating profit was KRW 28.6 billion. MSD Korea posted an operating loss of KRW 18.4 billion in 2019 and KRW 5.8 billion in 2020 and turned to a profit of 58 billion in 2021. This is because management costs such as severance pay due to the spin-off have now decreased. Last year, the company also made a profit, but the amount decreased by 51% compared to the previous year. The rising sales cost and higher SG&A expenses reduced the company’s operating profit. MSD Korea's sales cost had increased 76% from the previous year to record KRW 680.3 billion. This is greater than its sales growth rate. Last year's cost-of-sales ratio was 83%, up 12%p from the previous year. The amount of finished products that MSD Korea purchased from its headquarters last year amounted to KRW 715.9 billion. With the company spending more on sales, advertising, and R&D, its SG&A expenses rose 15% to reach KRW 111.5 last year.
- Policy
- Kyowa Kirin accepted the evaluation results for Nephoxil
- by Lee, Tak-Sun Apr 17, 2023 05:58am
- It is known that Kyowa Kirin Korea's hyperphosphatemia treatment 'Nephoxil 500mg' accepted the HIRA evaluation results. Accordingly, this drug is expected to move to the negotiation stage with the NHIS. Nephoxil is used for the treatment of hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis. Expectations are high because it is a product of Kyowa Kirin Korea, which stands out in the chronic kidney disease patient treatment market with Nesp·Regpara. Currently, non-calcium drugs such as Renvela are preferred in the hyperphosphatemia treatment market for hemodialysis patients, and the introduction of Nephoxil is expected to change the market structure. According to the industry on the 16th, Korea Kyowa Kirin of Nephoxil Capsule, which received conditional pass results at the Pharmaceutical Review Board meeting on the 6th, accepted the evaluation results. The HIRA judged that it was appropriate to receive reimbursement for this drug, which is used for hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis when it was accepted below the estimated amount. In other words, it is interpreted that the Korea Kyowa Kirin side accepted less than the estimated amount suggested by HIRA. The proposed valuation seems to have been based on the price of non-calcium-based drugs like Nephoxil. Calcium-based drugs and non-calcium-based drugs are used to treat hyperphosphatemia in dialysis patients. Although calcium-based drugs are relatively inexpensive, non-calcium-based drugs are increasing in use due to the risk of causing vascular calcification. Representative items of non-calcium-based drugs include Renvela, Invela (SK Chemicals), and Fosrenol (JW Pharmaceutical). As domestic drugs containing Sevelamer are released one after another, the price has become much cheaper. Accepting this evaluation result, Nephoxil will proceed with negotiations with NHIS in the future. When the negotiations are completed, they will go through a report to the Health Insurance Policy Deliberation Committee of the Ministry of Health and Welfare and be listed on the list of benefits. In the market, as Kyowa Kirin Korea stands out in the domestic chronic renal failure drug market, Nephoxil is also expected to settle down early. Kyowa Kirin Korea is recording a high market share with Nesp, a treatment for anemia in patients with chronic kidney disease, and Regpara, a treatment for secondary hyperparathyroidism in patients with chronic kidney disease. Furthermore, Kyowa Kirin took the top spot in the hyperphosphatemia treatment market with Renagel before Renvela was launched in Korea. The domestic supply of Renagel was discontinued in 2015. Renagel and Renvela are drugs developed by Genzyme, and it is rumored that Renagel withdrew from the market after Renvela was supplied through Sanofi in Korea. From the perspective of Kyowa Kirin Korea, Nephoxil is expected to serve as an opportunity to further strengthen its position in the chronic renal failure patient treatment market. Meanwhile, Nephoxil received domestic approval in May last year.
- Company
- Will the leukemia ADC Mylotarg be reimb this time?
- by Eo, Yun-Ho Apr 17, 2023 05:58am
- whether the new drug for acute myeloid leukemia (AML), ‘Mylotarg’ will be reimbursed in its second attempt is gaining attention. Mylotarg (gemtuzumab ozogamicin), which submitted an application for reimbursement listing earlier this year, is likely to be presented to the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service this month. Also, another ADC drug, Enhertu (trastuzumab deluxtecanis also expected to be presented for review at the CDDC meeting. Mylotarg was deliberated by the HIRA’s CDDC in May last year but was unable to pass review and set reimbursement standards at the time. Therefore, whether Mylotarg will be able to pass CDDC this time and start on its journey to receiving reimbursement in Korea remains to be seen. The drug is an antibody-drug conjugate (ADC) approved as a first-line treatment for patients with newly-diagnosed CD33-positive AML. The drug, which received marketing authorization in Korea in December 2021, is an ADC composed of a CD33-targeting monoclonal antibody linked to calicheamicin, a potent cytotoxic agent. The drug works on cells that express the CD33 antigen, which is expressed on more than 90% of AML patients. This blocks cancer cell growth and induces apoptosis. Mylotarg’s approval was based on a clinical trial (ALFA-0701) conducted on 271 patients aged between 50 to 70 with newly-diagnosed AML with no prior treatment experience. The ALFA-0701 trial was an open-label, randomly assigned, multicenter Phase III study that compared the existing standard front-line chemotherapy, daunorubicin+cytarabine combination therapy, with Mylotarg+ daunorubicin+ cytarabine combination therapy. Results showed that the median event-free survival (EFS) in the Mylotarg+daunorubicin+cytarabine combination arm was 17.3 months, a 7.8-month extension compared to the 9.5 months in the daunorubicin+cytarabine combination arm. Also, the Mylotarg combination therapy reduced the risk of induction failure, relapse, or death by 44% compared to chemotherapy alone. Also, the median relapse-free survival (RFS) was 28.0 months in the Mylotarg+daunorubicin+cytarabine combination arm and 11.4 months in the daunorubicin+cytarabine combination arm, showing a significant difference of 16.6 months. In the case of median overall survival (OS), the median OS was 27.5 months in the Mylotarg+daunorubicin+cytarabine combination arm and 21.8 months in the daunorubicin+cytarabine combination arm, and the difference was not statistically significant.
- Company
- Sales of cepha antibiotics make a rebound
- by Kim, Jin-Gu Apr 14, 2023 05:49am
- Biopharmaceutical companies that produce the so-called ‘cepha antibiotics' have taken a breather with the increased demand for related products due to the rapid increase in confirmed COVID-19 cases last year. This is in stark contrast to the situation of the previous year when many companies were contemplating whether to withdraw their cepha businesses. However, the dominant opinion is that the sales increase last year was a temporary phenomenon due to the rapid increase in confirmed COVID-19 patients. The frontline companies unanimously agree that they are still contemplating whether to reduce or discontinue their cepha business amid the recent trend of a steady decline in antibiotic prescription rates and a steady rise in production costs. ◆Sales of cepha antibiotics make a rebound...influenced by the surge in confirmed COVID-19 patients According to the Financial Supervisory Service on the 13th, Yungjin Pharm's antibiotic-related sales increased 15% in one year from KRW 59.6 billion in 2021 to KRW 68.6 billion last year. Sales of products it directly produces and sells such as Clamonex, Cefaclor, and Ceftazidime have increased 40% from KRW 30.6 billion to KRW 42.7 billion. In the same period, special sales of Cepha antibiotic APIs soared from KRW 200 million to KRW 1.8 billion. However, exports of cefcapen, cefditoren, and ceftazidime fell 16% from KRW 28.9 billion to KRW 24.2 billion. Yungjin Pharm's antibiotic-related sales have steadily declined until 2021. Its related sales, which reached KRW 102.2 billion in 2019, decreased 42% in two years to KRW 85.6 billion in 2020, then to KRW 59.6 billion in 2021. However, sales made a successful rebounded last year. It is analyzed that this is due to the increase in prescriptions to relieve COVID-19-related symptoms in line with the surge in confirmed COVID-19 patients in Korea. According to the market research institution UBIST, prescriptions of oral cephalosporins last year were KRW 259.6 billion, up 33.4% from the previous year. The ‘cepha antibiotics,’ or cephalosporins are widely used antibiotics for pneumonia, laryngopharyngitis, tonsillitis, and bronchitis. The situation has turned drastically from the first and second years of COVID-19. The cephalosporin antibiotic prescription market, which was worth KRW 271.1 billion in 2019, shrank to KRW 211.5 billion in 2020, then to KRW 194.6 billion in 2021. In the early phases of COVID-19, the market shrank greatly with the plummeting number of cold and flu patients, but last year, along with cough and cold preparations, their use for the purpose of relieving COVID-19 symptoms increased explosively. ◆Presciptions rise 33% in 1 year...companies that pondered market withdrawal breathe a sigh of relief Other cepha antibiotic manufacturers also experienced a similar situation. In particular, companies that had been considering withdrawing their businesses due to a steady decline in sales until the previous year were able to take a breath of relief. Boryeong's sales related to cepha antibiotics shrank from KRW 25.3 billion in 2019 to KRW 20.4 billion in 2020. However, sales rebounded to KRW 21.7 billion last year. Korus Pharm has been manufacturing cepha-class antibiotics such as Korus Cefaclor, Korus Ceftriaxone, K Axone, Cefozol, etc. The company’s combined antibiotic sales decreased 24% in 2 years from KRW 6 billion in 2019 to KRW 4.5 billion in 2021, but rebound to 5.3 billion last year. Withus Pharm’s Withus Cefaclor Cap’s sales fell to KRW 0.6 billion in 2020 from KRW 1.5 billion in 2019, then increased over threefold in 2 years to reach KRW 2.1 billion last year. Withus Pharm’s antibiotic sales, including Cefaclor Cap, increased 2.5 times in 2 years from KRW 2 billion in 2020 to KRW 5 billion last year. Daewoong Bio also saw its cepha antibiotic Ceclor’s sales increase 32% from KRW 7.4 billion in 2021 to KRW 9.8 billion last year. In addition, finished cepha antibiotic products from Kyungbo Pharmaceuticals, Kukje Pharm, and Jeil Pharm increased last year. However, Kyungbo’s sales of cepha-class antibiotic APIs decreased 4% from KRW 37.6 billion in 2021 to KRW 36.3 billion. ◆”Rise in cepha-class drugs temporary...still not profitable” This is in contrast to the years 2020 and 2021 when many companies were contemplating whether to withdraw their cepha antibiotic business. In 2020, a large pharmaceutical company A decided to discontinue consignment production of cephalosporin antibiotics. Company A has stopped manufacturing products contracted by other pharmaceutical companies and is only currently producing only its products. Another large pharmaceutical company, B, put up its cephalosporin antibiotic manufacturing plant for sale last year. A few companies considered taking over, but pharmaceutical company B withdrew its intention to sell. Company C, a mid-sized pharmaceutical company, also contemplated withdrawing from the cepha antibiotics business last year. On the surface, the company pointed to the decrease in prescriptions of cephalosporin antibiotics in the process of prolonged COVID-19, but the analysis was that the chronic deterioration of profitability caused them to consider withdrawing from the business. In line with the trend, the industry anticipates the companies’ withdrawal from the cepha antibiotics business will be repeated this year. Front-line companies all agree that the deteriorating profitability of antibiotics will not improve due to the rising cost of APIs day by day, while supply prices are unchanged under Korea’s health insurance. The price of APIs of cephalosporin antibiotics imported from China and India has risen by 10-20% during the past 2 years. On the other hand, the reimbursed product prices have stayed the same for a long period of time. The fact that the government is constantly trying to reduce antibiotic prescriptions is also cited as a reason for the deteriorating profitability. The antibiotic prescription rate for acute upper respiratory infections has decreased from 52% in 2010 to 36% in 2020. An official from a pharmaceutical company that produces cepha antibiotics said, “We have almost no profit gain from the manufacture of 1st and 2nd generation cephalosporin antibiotics. Labor costs have also risen significantly, so it is difficult to make any profit.”
- Policy
- Obesity treatment Mounjaro, soon to launch in Korea
- by Lee, Hye-Kyung Apr 14, 2023 05:49am
- Eli Lilly's Mounjaro, called a 'game changer' for obesity treatment, is imminent in Korea. Maunjaro GLP-1 agonists act on GLP-1, a hormone that makes patients feel full by acting on the hypothalamus of the brain, activates incretin, an intestinal hormone, and promotes insulin production to lower blood sugar levels. In this process, it slows down the movement of food from the stomach to the small intestine, increases satiety, and has been proven to be effective, becoming a 'hot' obesity treatment in the United States. According to the pharmaceutical industry on the 14th, the Ministry of Food and Drug Safety completed a safety and efficacy review of Maunjaro. Completing this review means that sooner or later, the product approval process will begin. Mounjaro is a successor to Lilly's blockbuster diabetes treatment 'Trulicity,' and was approved by the US FDA in May of last year as a dietary and exercise supplement to improve blood sugar control in patients with type 2 diabetes. The dosage includes 5mg, 10mg, and 15mg, and it can be used as monotherapy or combination therapy with 'Metformin', 'SGLT2 inhibitor', 'Sulfonylurea', and 'Insulin Glargine'. Last year, Lilly conducted a phase 3 clinical trial to study the effect of reducing morbidity and mortality in obese adults, including in Korea. The phase 3 clinical trial was a randomized, double-blind, placebo-controlled trial involving 15,000 participants worldwide and 60 obese and overweight patients in Korea. Meanwhile, representative drugs such as GLP-1 agonists include Novo Nordisk's 'Saxenda' and 'Wegovy'.
- Policy
- SGLT2+DPP4 combinations are to be released next month
- by Lee, Tak-Sun Apr 14, 2023 05:49am
- Domestic DPP-4·SGLT-2 diabetes complex ZemidapaAs the three-drug regimen of diabetes treatment Metformin + SGLT2i + DPP4i is also covered from this month, the SGLT2i + DPP4i complex is expected to be released next month. A total of five items are expected to hit the market in May. However, according to the reimbursement standard, these drugs are reimbursed only when used in combination with Metformin. According to the industry on the 13th, MSD Stegluzan, Boehringer Ingelheim Esglito, AstraZeneca Qtern, LG Chem Zemidapa, and Dong-A ST Sugadapa are expected to release benefits in May. Since April, regardless of ingredients, the three-drug regimen of Metformin + SGLT2i + DPP4i has been applied, allowing these items to enter the market. However, these combinations are difficult to use as monotherapy. This is because the three-drug regimen, including metformin, in the clinical trial for approval proved the blood sugar-enhancing effect, and the SGLT2i + DPP4i two-drug regimen is not covered under the reimbursement standard. The competitiveness of the combination drug, which contains two ingredients in one pill and enhances the convenience of taking it, has not been revealed due to the additional intake of metformin. This is because benefits are applied even if a DPP-4 single drug is added to the commercially available Metformin + SGLT2 complex. Metformin + SGLT2 combinations have been pouring out in droves due to the expiry of Dapagliflozin's patent on the 8th. Perhaps conscious of this, some SGLT2i+DPP4i combinations, such as Qtern and Zemidapa, all of a sudden went on non-reimbursement sales this month. Discussions on the two-drug regimen of SGLT2i + DPP4i are highly likely to resurface starting in September when Januvia's patent expires. This is because many domestic pharmaceutical companies have received approval for the combination of Dapagliflozin + Sitagliptin and are aiming to release a benefit when the patent expires. This is because the two-drug regimen of Dapagliflozin + Sitagliptin can still be used according to the approval. However, the full co-payment is applied to one of the two drugs. It is expected that there will be many reimbursement inquiries about the two-drug therapy in the field, conscious of confusion, and it is expected that the insurance authorities will somehow sort it out. Meanwhile, the domestic SGLT-2i new drug Envlo, developed by Daewoong Pharmaceutical, recently concluded negotiations with the NHIS. By accepting 90% of the price of this drug compared to alternative drugs, only the expected billing amount is negotiated without negotiation of the upper limit, and the reimbursement list is expected to be accelerated.
