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- 2026-05-06 09:54:44
- Company
- Pharma CEOs consider job cuts and reducing hiring in 2024
- by Kim, Jin-Gu Jan 05, 2024 05:41am
- 13% of pharmaceutical and bio company CEOs have announced plans to reduce employment this year. Apart from this, another 12% have indicated the possibility of reducing their workforce this year. Overall, the industry held a more cautious stance toward hiring this year. Compared to last year, the number of respondents who responded that they will increase hiring decreased, while the number of CEOs who plan to decrease employment has increased. Such figures suggest that the prolonged economic recession has deepened CEOs' concerns about hiring. Pharma CEOs more cautious about ‘expanding employment’…...15% last year→9% this year According to Dailypharm's 2024 survey of 53 CEOs in the pharmaceutical and bio industries on their plans for hiring in 2024, 77% (41 respondents) answered that they plan to keep hiring at the same level as last year. Only 9% (5 respondents) plan to increase hiring, and 13% (7 respondents) plan to decrease hiring. This differs from last year's employment plans of the companies. When asked how they expect employment to change compared with 2023, 74% (39 out of 53 CEOs) said it will ‘stay the same’, 15% (8) said it will increase, and 11% (6) said it will decrease compared with the previous year. Compared to the previous year, the companies’ inclination to expand hiring decreased from 15% to 9%, and their inclination to maintain hiring decreased from 77% to 74%. On the other hand, plans to reduce hiring increased from 11% to 13%. In just one year, plans for increasing or maintaining employment as is had decreased while plans for reducing hiring increased among the surveyed companies. Companies that performed worse last year were more likely to reduce employment this year. In fact, of the 6 CEOs who rated their company's performance as "poor" or "very poor" last year, 3 said they would reduce hiring this year. The other 3 said they would maintain their hiring levels. Only 1 CEO rated last year's business performance as "good" but said they would reduce hiring this year. When asked about the possibility of layoffs this year, 4% ‘is planning,’ 8% ‘is considering' reducing workforce Regardless of whether or not they are reducing hiring, 12% (6 out of 53) of respondents said they have ‘plans to reduce’ or ‘are reviewing reducing’ their workforce this year. Of these, 4%(2 respondents) clearly stated that they had plans to reduce their workforce, and 8% (4) said they were considering it. The remaining 89% (47) said they had no plans to reduce the workforce. Responses to the question of potential layoffs, the responses were consistent among domestic and multinational pharmaceutical companies, as well as large and small pharmaceutical companies. Of the 6 companies planning reductions, 4 were domestic pharmaceutical companies and 2 were Korean subsidiaries of multinational pharmaceutical companies. Also, the responses came 3 each from large and small pharmaceutical companies. While the majority of respondents have no plans to reduce their workforce, it is expected that the wave of restructuring in the pharma and bio industry that started last year may continue this year, with some companies taking the lead. Among domestic pharmaceutical companies, GC Biophamra, Ildong Pharmaceutical, KyungDong Pharm, Yuyu Pharma, Aprogen Pharmaceuticals, and Genome & Company started restructuring last year. Among the Korean subsidiaries of multinational pharmaceutical companies, MSD Korea, Pfizer Korea, and Novartis Korea conducted restructuring last year, and Sandoz withdrew its service in Korea. In particular, the restructuring decisions of large pharmaceutical companies like GC Biopharma and Ildong Pharmaceutical have spread anxiety across the pharma-bio industry. Both companies had received poor business reports last year. This raises concerns that the restructuring trend could spread across the industry if this year's results are weaker than expected. Hiring area priorities, Sales/Mareketing >R&D>Manufacturing/Control Amidst the overall hiring atmosphere, CEOs have forewarned plans that they aggressively hire for sales and marketing positions. Of the 53 respondents, 43% (23) said sales and marketing will be their top hiring priority this year. This was followed by 36% (19) in R&D, 13% (5) in production management, then 8% (4) in other roles. No respondents chose finance/accounting or IT/security. By company size, large and small/mid-sized pharmaceutical companies differed in their hiring plans for production management positions. 18% (6 out of 35) of the large pharma respondents indicated that they are prioritizing production management positions, compared to 1 out of 17 among small and midsize pharma respondents. Large pharma (38%) and small pharma (35%) were similarly likely to prioritize hiring R&D positions. There was no significant difference between large pharma (41%) and small pharma (53%) in their plans to focus on sales and marketing roles.
- Company
- Koselugo commences prescription with insurance coverage
- by Eo, Yun-Ho Jan 05, 2024 05:41am
- AstraZeneca Korea’s Koselugo (selumetinib), a neurofibromatosis treatment, has recently passed the Drug Committee (DC) of tertiary hospitals. Hospitals have started prescribing Koselugo, a treatment for pediatric neurofibromatosis. AstraZeneca Korea’s Koselugo (ingredient: selumetinib), a neurofibromatosis, has recently passed the Drug Committee (DC) of tertiary hospitals, including Seoul National University Hospital, Samsung Seoul Hospital, Seoul St. Mary's Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. Some of these hospitals have assigned a prescription code for Koselugo following emergency DC. Koselugo has been listed for reimbursement starting this year. As a result, it is anticipated that more hospitals will be able to prescribe the drug in the future. On the third try, Koselugo passed the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Committee on the 7th of last month and settled in negotiations for reimbursement pricing with the National Health Insurance Service (NHIS) at the end of the year. Koselugo was the first drug to be designated by the ministry as a priority drug under the accelerated review system in October 2020. Subsequently, in May 2021, Koselugo won approval from the Ministry of Food and Drug Safety (MFDS) and was listed for reimbursement after approximately two and a half years. The reimbursement criteria for Koselugo apply to pediatric patients aged 3 to 18 years who have neurofibromatosis Type 1 (NF1) with inoperable plexiform neurofibromas and their condition meets any of the following: ▲Located in the head, neck, or other areas with a risk of airway obstruction or vascular damage ▲Causing compression or functional impairment of major nerves or nerve structures ▲Encasing vital blood vessels or organs, leading to significant functional impairment ▲Physical deformities resulting in motor or sensory dysfunction ▲Severe pain that persists despite the use of neuropathic pain medications, significantly affecting daily life ▲Other conditions where drug therapy is deemed necessary. Until now, patients with neurofibromatosis have relied on general remedies with no specific treatments available. Neurofibromatosis is a rare disorder characterized by tumors that develop in nerve tissue, bones, skin, and other parts of the body. Approximately 85% of cases are classified as type 1 (NF1), resulting from a mutation in the NF1 gene on chromosome 17. The prevalence of NF1 is about 1 in 3,000 individuals. The onset of neurofibromatosis typically starts during childhood. In most cases, the first symptom appears as 1-3cm sized coffee-colored patches on the skin. Around the age of 6, some children develop optic pathway glioma, a type of tumor, and between the ages of 6-10, many children develop scoliosis. In adult patients, Lisch nodules, which are tiny hamartomas affecting the iris, are commonly found. Currently, the treatment regimen for neurofibromatosis involves surgical removal when possible or anti-cancer and radiation therapies. However, even with surgery, these tumors often recur, and most surgeries are major procedures, posing a significant burden on both medical professionals and patients. Particularly in pediatric patients, frequent recurrences may require multiple surgeries, leading to the need for ongoing pain management and potentially resulting in language and motor impairments in many cases. Koselugo is a treatment jointly developed by AstraZeneca and MSD. The drug inhibits the activation of MEK and suppresses the growth of the cancer. In the Phase 2 SPRINT clinical trials that served as the basis for approval, Koselugo achieved an objective response rate (ORR) of 68% by reducing tumor size by 20% or more in treated patients. Furthermore, among patients who showed partial response, 82% maintained their response for over 12 months. Patients who did not receive treatment typically experienced disease progression within 1.5 years, while those treated with Koselugo had only about 15% experiencing disease progression even up to 3 years. “NF1 with plexiform neurofibroma is a severe condition that can involve symptoms such as severe pain, visual impairment, and spinal deformities. Furthermore, it can progress into a life-threatening malignant disease. The listing of Koselugo for reimbursement will be of great help in extending the lives and improving the quality of life for pediatric patients in the future,” Lee Beom-hee, Professor of Pediatric Endocrinology and Metabolism at Asan Medical Center, commented.
- Policy
- Need to specify conditions for postponing PE data submission
- by Lee, Tak-Sun Jan 05, 2024 05:41am
- Study on Improving the Pharmacoeconomic Evaluation Data Waiver (PE exemption) System The results of the research service that was ordered by the Health Insurance Review and Assessment Service to devise measures on improving the pharmacoeconomic data submission waiver system, or the PE exemption system, have been disclosed in full. The improvements suggested by the researchers include redesigning the PE exemption system into a PE deferral system, and establishing a process to demonstrate economic feasibility after listing. It was also suggested that a reevaluation system should be established for drugs that have already been listed through the PE exemption track. Based on the study, HIRA plans to come up with a follow-up and reevaluation plan for the PE exemption drugs. According to the results of the ‘Study on Improving the PE evaluation data waiver system (Seoul National University R&DB Foundation, Professor Tae-jin Lee, Principal Investigator)' that was released on the 3rd, ithe PE exemption system needs to be redesigned into a system that defers proof of economic feasibility for drugs when necessary, rather than a system for waiving submission of PE evaluation data overall. The PE exemption system was introduced in May 2015 and applied to 26 drugs until July 2022. Explaining the background of their proposal, the researchers said, "The introduction of the PE exmpetion system has had some positive effects on improving patient access, such as by improving the rate of new drug listings and shortening the listing period. However, when considering the various characteristics of subject drugs, there seems to be a high need for the PE exemption drugs to be managed within the basic principles of the positive listing system that is based on the demonstration of cost-effectiveness.” In this regard, the research team proposed ▲ redesigning the system into an economic feasibility demonstration deferral system ▲ establishment a post-listing economic feasibility demonstration process through a specific agreements on items that need to be clarified in advance ▲ establishment of a post-marketing and reevaluation system based on cost-effectiveness evaluations ▲ and others, such as increasing the practicality of total expenditures by setting a set amount for each disease unit or an expenditure cap and setting a reasonable baseline for the evaluation amount based on foreign drug price. The researchers also saw the need to reestablish the current PE exemption conditions. More specifically, the condition, ‘anticancer drugs or rare diseases for which no substitute or therapeutically equivalent product or treatment exist,' needs to be specified. On this, the researchers proposed limiting the condition to ‘rare disease drugs or anticancer drugs used for serious conditions that threaten survival, such as those for diseases with a life expectancy of less than 2 years,’ and to set specific requirements such as ‘drugs that bring a significant clinical improvement over nontreatment and has no other alternative treatment,’ or ‘provide a significant clinical improvement over existing treatments, such as a significant prolongation of survival.’ The reseachers also believed that the current grounds for lacking evidence were also inadequate. The current requirement is: drugs for a small number of patients, ▲ that were approved with single-arm clinical data without a control group, ▲ approved with a Phase II clinical trial that has a control group but without a conditional Phase III trial, or ▲ have other difficulties in producing evidence. More specifically, the researchers proposed ▲ cases where no clinical trial with a control group has been conducted and indirect comparison is difficult, ▲cases where PE evaluations have not been conducted in other countries as well, ▲cases where it is difficult to confirm the final effect due to immature clinical data, and it is not appropriate to conduct PE evaluation by estimating the final result through modeling. However, ▲if the size of the required finances is above a certain level, economic feasibility must be demonstrated. Also, the researchers pointed out that the requirement of a ‘small number of patients’ should also be revised to a ‘diseases with a prevalence 200 or less patients per independent condition.' In addition, the researchers claimed that drugs used for pediatric patients and tuberculosis treatments, which were added as PE exemption drugs last year, should be removed again as drugs that are not considered to be rare diseases but are life-threatening were waived PE data submissions even before the revisions were made. The researchers concluded that real-world evidence (RWE) can be recognized as a source of evidence after listing. They also suggested the need for a collective reevaluation of the listed PE exemption drugs. "In the case of PE exemption drugs they have already been listed, all other HTA-based countries have evaluated their economic feasibility after listing. Therefore, it is necessary to reevaluate the drugs even if their control period has been completed to manage the appropriate listing price of latecomers that will be listed using the PE exemption drugs as a comparator."
- Company
- Celltrion to divest prescription drugs acquired from Takeda
- by Kim, Jin-Gu Jan 04, 2024 05:33am
- (Credit: Celltrion) The Celltrion group is selling divestiture of primary care business rights in the Asia-Pacific region acquired from Takeda Pharmaceutical in 2020. Among the business rights acquired from the previous deal, Celltrion group will initiate the sales of business rights for prescription drugs, excluding those intended for the domestic market. They will also engage in separate negotiations with a different company for the business rights related to the over-the-counter (OTC) drugs. Celltrion group announced on the 2nd that the company will sign a contract to divest the primary care business rights in the Asia-Pacific region, which it acquired from Takeda Pharmaceutical. In 2020, Celltrion acquired the primary care business rights of Takeda Pharmaceutical for US$278.3 million (approximately 310 billion won). This acquisition included prescription drugs such as the DPP-4 inhibitor class diabetes medicine ‘Nesina (alogliptin)’ series, TZD class diabetes medicine ‘Actos (pioglitazone)’ series, and ARB class of hypertension treatment ‘Edarbi (azilsartan)’ series, as well as OTC drugs such as cold medicine ‘Whituben’ and stomatitis medicine ‘Albothyl’. The current divestiture encompasses the business rights for prescription drugs like Nesina and Actos in the Asia-Pacific region. The business rights of OTC drugs and domestic prescription drugs are excluded from the divestment. Major items that Celltrion acquired from Takeda Pharmaceutical in 2020. (Clockwise from the upper left) Product photos of Nesina, Actos, Edarbi, Albothyl, Whituben, and Nesinamet. The acquisition target is CBC Group, a Singapore-based global healthcare-focused private equity firm. CBC Group has established an overseas special purpose company (SPC) called 'HP Bidco 2 Limited' to proceed with the acquisition. The future business rights transfer agreement will be signed between Celltrion APAC and HP Bidco 2 Limited. The sales price is 5.58 billion Thai Baht (THB, approximately 210 billion won). Celltrion explained that the sale price for the business rights was determined based on a 3-year post-acquisition evaluation, considering increased business value resulting from revenue growth for related items (with an average regional sales growth rate of 13%) and cost savings through production internalization after the acquisition. The value of the business rights for prescription drugs in current sales represent approximately half of their value compared to when Celltrion acquired them in 2020. Celltrion explained that if the value of the items were recalculated based on 2020, it would amount to approximately 138 billion won, equivalent to 46% of the total value at that time. Celltrion will retain the business rights for domestic prescription drugs that were excluded from this sale. The company expects to maintain sales revenue from products like Nesina and Edarbi in the domestic market as before. Additionally, Celltrion plans to use these products as a foundation for developing incrementally modified drugs. At the same time, Celltrion has secured exclusive supply rights for Edarbi and Nesina series within the Asia-Pacific region. Celltrion Pharm will produce Edarbi and Nesina for supply to the CBC Group, which will then distribute these products in the Asia-Pacific region. This arrangement is anticipated to provide Celltrion Pharm with a stable source of revenue through the exclusive supply of the Edarbi and Nesina series. Celltrion is currently in negotiations with another company regarding the sale of the entire OTC drugs business rights for the rest of the Asia-Pacific region, including Korea. Celltrion has stated that it is in the final stages of negotiations with a strong candidate company. After re-selling the licensing rights after three years, Celltrion has generated considerable profit. By selling the licensing rights for prescription drugs in the Asia-Pacific region, excluding Korea, Celltrion has generated a profit of around 70 billion won compared to the initial investment of around 140 billion won. If the remaining negotiation for the sale of licensing rights for OTC drugs proceeds smoothly, Celltrion is expected to generate even higher investment profit. Celltrion views the sale of these business rights as a steppingstone to creating a foundation for integrated Celltrion to focus on its core businesses. "Selling the business rights was based on the strategic decision at a time when we are on the verge of significant growth upon the launch of integrated Celltrion. We have successfully concluded the sale, securing stable revenue through maintaining domestic business rights for core prescription drugs and acquiring exclusive product supply," a representative from Celltrion Group stated. "The proceeds from the sale will be invested in strengthening the new product portfolio and establishing a foundation for the sustainable growth of the Celltrion Group," the representative added.
- Company
- Industry is less inclined to expand investment this year
- by Kim, Jin-Gu Jan 04, 2024 05:33am
- One in four CEOs of pharma and biotech companies announced that they will expand their investment in 2024. This is down by half compared to the response received in the survey last year when one in two CEOs said they would expand investment. This is likely a reflection of the growing economic uncertainty in Korea and abroad. 1 in 4 CEOs "will expand investment"...half of last year's level According to the 2024 Business Management Strategy Survey Dailpharm conducted for 2024 on 53 CEOs of pharma and biotech companies, 25% (13 respondents) responded that they plan to expand investments this year compared to the previous year. 68% (36 out of 53) said they plan to keep the scale of investment at a similar level to last year, while 8% (4) said they plan to reduce it. Compared to the results of the 2023 survey, the number of respondents who responded that they will increase investment has decreased significantly. Last year, when Dailypharm asked the same question to 61 pharma and bio industry CEOs, 53% (32) said they would increase, 33% (20) said they would maintain, and 15% (9) said they would decrease their investment this year. So in just one year, CEOs who plan to increase investment have decreased from 53% to 25%. The number of respondents who plan to reduce their investment is similar to last year, while the number of respondents who plan to maintain their investment at the same level more than doubled from 33% to 68%. Overall, this suggests that companies are taking a conservative approach to new investments this year despite the strong performance that they had made last year. In the pharmaceutical industry, it is believed that the increased uncertainty due to the prolonged economic downturn has led to a reduced capacity for new investments. When asked about their business performance in 2023, 49% of respondents (26) chose ‘very good’ or ‘good.’ 40% of the respondents (21) said ‘moderate,’ and only 11% (6) said ‘poor’ or ’very poor.’ In particular, small and medium-sized pharmaceutical companies were more cautious about making new investments. Of the 17 CEOs of small and medium-sized pharma companies with less than 300 employees, 18% (3) said they would increase investment. In contrast, 28% (10 out of 36) of CEOs of pharma companies with 300+ employees said they have plans to increase investment. 7 in 10 CEOs "expects operating profit to improve this year" In contrast to the investment expansion plans, CEOs were optimistic about their performance results in 2024. 8 of 10 CEOs (81%) expected revenue to increase and 7 in 10 (68%) expect profitability to improve in 2024. 81% (43 of 53) responded that they expect revenue to increase. Of these, 11% (6) expected an increase of 20% or more, 36% (19) expected an increase of 10-20%, and 34% (18) expected an increase of 0-10%. Only 6% (3) expected sales to decrease this year compared to the previous year. The remaining 13% (7) expected their revenue to remain similar to last year. In terms of operating profit, 68% of respondents (36 out of 53) expected an increase over the previous year. 17% (9) expected an increase of 20% or more, 23% (12) expect an increase between 10-20%, and 28% (15) expected an increase between 0-10%. Only 8% (4) expected a decrease in operating profit, while 25% (13) expected their operating profit to remain at the same level as last year. Managerial priority focuses on 'Launching new products' the most...followed by R&D investment, then strengthening sales power ‘New product launches’ was selected as the most common managerial priority (26 responses) by the CEOs. This was followed by ▲ R&D investment (25), ▲ strengthening sales power (22), ▲ improving manufacturing facilities and expanding production capacity (18), ▲ improving cost structure (17), ▲ securing excellent human resources (14), ▲ entering new businesses (9), and ▲ external investment such as mergers and acquisitions (M&A) (5). 3 other priorities - Expanding exports, expanding markets, and improving access to patients – were also selected once each. There were some differences in management priorities by company size. CEOs of large pharmaceutical companies (300+ employees) often chose "R&D investment" (18) as their top managerial priority for the year. This was followed by improving manufacturing facilities, expanding production capacity, and launching new products (15 each). Small and medium-sized pharmaceutical companies focused more on ’new product launches (11).’ This was followed by strengthening sales power (10) and then securing talent and R&D investments (7). In general, large pharmaceutical companies are focusing on long-term investments such as investing in R&D improving manufacturing facilities, and expanding production capacity, while small and medium-sized pharmaceutical companies are focusing on short-term results such as launching new products and strengthening sales power. There were also differences between domestic pharmaceutical companies and the Korean subsidiaries of multinational pharmaceutical companies. CEOs of domestic pharmaceutical companies most often cited "strengthening R&D" as their management priority (22), followed by improving manufacturing facilities and expanding production capacity (17) and improving cost structure, and launching new products (16 each). On the other hand, Korean subsidiaries of multinational pharmaceutical companies selected ‘new product launches’ as their top managerial priority (10). All but one of the 11 CEOs of Korean subsidiaries of multinational pharmaceutical companies responded that they would focus on launching new products this year. This was followed by strengthening sales power and talent acquisition (7 each).
- Policy
- Moderna produced the most drugs in Korea in 2023
- by Lee, Hye-Kyung Jan 04, 2024 05:33am
- Moderna Korea has surpassed Celltrion and Hanmi Pharmaceutical and became the largest domestic pharmaceutical manufacturer in Korea in 2022. The item that drove Moderna’s lead was the COVID-19 vaccine ‘Spikevax Inj,’, which accounted for 100% of Moderna Korea's total production value of KRW 1.275 trillion. According to the '2023 Food and Drug Statistics Yearbook' recently published by the Ministry of Food and Drug Safety, the top 20 domestic pharmaceutical companies in 2022 in terms of the amount of drug production are Moderna Korea, No. 1, Celltrion, No. 2, Hanmi Pharmaceutical, No. 3, Chong Kun Dang, and No. 5, GC Biopharma. Hanmi Pharmaceutical, which ranked first in 2018 and 2019, and Celltrion, which ranked first in 2020 and 2021, lost the top spot to Moderna Korea in 2022 due to the rise in supply of vaccines amid the spread of COVID-19. Among the top 20 pharmaceutical companies in Korea, the companies with the highest manufacture amount exceeding KRW 1 trillion were Moderna Korea (KRW 1.275 trillion), Celltrion (KRW 1.226 trillion), Hanmi Pharmaceutical (KRW 1.018 trillion), and and Chong Kun Dang (KRW 1.594 trillion). Two dosage forms of Spikevax were ranked first and second in terms of production of single products, followed by Celltrion's Remsima 100mg at KRW 184.9 billion, Handok's Plavix Tab 75mg at KRW 153.4 billion, and HK Inno.N's K-Cab 50mg at KRW 152.3 billion, Daewoong Pharmaceutical's 'Nabota' at KRW 127 billion, GC Biopharma’s 'GC Fluquadrivalent Prefilled Syringe Inj' at KRW 116.6 billion, and Chong Kun Dang’s ‘Chong Kun Dang’s Gliatorin Soft Cap' at KRW 107.9 billion, among drugs with an annual production amount that exceeds KRW 100 billion for a single item. In particular, although reimbursement was reduced due to reimbursement revaluations for choline alfoscerate, the production of Chong Kun Dang’s Gliatorin Soft Capsule and Daewoong Bio's Gliatorin Soft Capsule (KRW 97.2 billion), representative choline alfoscerate products, still ranked 8th and 9th in Korea. Among the top 20 global pharmaceutical companies, in 2022, AbbVie ($73 billion) ranked first, followed by Johnson & Johnson ($71 billion), then Novartis ($57 billion), Novo Nordisk ($50 billion), then Bristol-Myers Squibb ($49 billion). The top 10 finished drug imports for 2022 were also listed, with Comirnaty Inj Veklury Intravenous Lyophilized Powder for Injection ranking No. 1, followed by Comirnaty 2 Injection 0.1mg/m, Spikevax Inj, Keytruda Inj, then Prolia Prefilled Syringe ranking the fifth.
- Company
- New CKD drug Kerendia is expected to receive reimb soon
- by Eo, Yun-Ho Jan 04, 2024 05:33am
- Bayer’s new chronic kidney disease drug ‘Kerendia’ is expected to receive reimbursement status in Korea. New chronic kidney disease drug ‘Kerendia’ is expected to receive reimbursement status. According to the industry, Bayer has reached a settlement with National Health Insurance Service (NHIS) in negotiations for the reimbursement pricing of its drug Kerendia(finerenone), which is used to treat chronic kidney disease in patients with type 2 diabetes, at the end of the year. When it passes the Heath Insurance Policy Review Committee in January, Kerendia is expected to be listed for reimbursement starting February. Kerendia received approval in Korea last year. It is indicated to reduce the risk of sustained eGFR (estimated Glomerular Filtration Rate, eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes. CKD is one of the most common complications in type 2 diabetes and is an independent risk factor of cardiovascular diseases. While CKD is a progressive disease, it can be difficult to detect because the disease can progress without showing obvious signs until just before the late-stage renal failure occurs. Also, with late-stage renal failure, patients require dialysis or kidney transplants to sustain life. This can pose a socio-economic burden and have a profound impact on a patient’s quality of life. For patients with type 2 diabetes, frequent monitoring and assessment of kidney damage and kidney function are essential. Early detection and appropriate treatment are critical to slowing down the progression of the disease and reducing the risk of cardiovascular diseases. In type 2 diabetes, the three key factors causing kidney disease are hemodynamic changes, metabolic abnormalities, and inflammation or fibrosis. However, in current therapy, treatments targeting hemodynamic and metabolic factors are only available, while treatments targeting inflammation and fibrosis are lacking, highlighting the need for new treatment approaches. Kerendia is a novel therapeutic approach targeting inflammation and fibrosis in adult chronic kidney disease patients with type 2 diabetes. It is the first non-steroidal, selective mineralocorticoid receptor antagonist. Overactivation of the mineralocorticoid receptor can lead to inflammation and fibrosis, which can result in permanent damages to kidney. Kerendia inhibits the overactivation of the mineralocorticoid receptor, reducing inflammation and fibrosis, and thereby preventing kidney damage. Kerendia demonstrated its effectiveness in the Phase 3 FIDELIO-DKD trial. The FIDELIO-DKD trial enrolled approximately 5,700 patients from 48 countries globally, and Kerendia is indicated to inhibit the progression of chronic kidney disease and reduce the risk of cardiovascular events in adult patients with chronic kidney disease accompanying type 2 diabetes. Patients participating in the study received either Kerendia at doses of 10mg or 20mg in addition to standard therapy or a placebo. The primary composite endpoint of the study was a sustained decline of more than 40% in eGFR, end-stage kidney disease. In the trial, Kerendia reduced risk of death by approximately 18% compared to placebo. In addition, the secondary endpoint was cardiovascular death, nonfatal myocardial infarction, and a reduction of approximately 14% in hospitalization for stroke or heart failure. The outcomes of major adverse events or the rate of adverse events related to acute kidney damage were comparable between the two groups. Meanwhile, the European Society of Cardiology (ESC) revised its ‘2021 ESC Guidelines for the Diagnosis and Treatment of Acute or Chronic Heart Failure’ and listed Kerendia as a Class 1A recommendation to prevent hospitalization due to heart failure in patients with chronic kidney disease accompanying type 2 diabetes. Additionally, the ESC recommended an annual measurement of eGFR and urinary albumin levels to screen for the development of chronic kidney disease in diabetes patients.
- Company
- Only 1 of 10 CEOs ‘positive’ about drug regulations in KOR
- by Chon, Seung-Hyun Jan 03, 2024 07:28pm
- 2024 Pharma-Bio CEO Survey: Business strategies and perceptions on regulations in Korea A survey showed only 1 in 10 CEOs of pharmaceutical companies were found to be satisfied with the Korean health authorities' regulatory policies for the pharmaceutical industry. In all major regulatory areas such as approvals, drug pricing, and sales, the satisfaction rate of CEOs was more negative than positive towards the set regulations. In particular, the CEOs expressed the least satisfaction with Korea’s drug pricing and reimbursement regulations. According to a survey Dailypharm conducted on 53 CEOs of pharmaceutical companies on their perception of government regulations in Korea, only 8% of the respondents expressed positivity towards the government regulations made for the pharmaceutical industry in Korea. Of the 53 CEOs surveyed, only two responded that they were "very positive" and "positive” towards the regulations each. The proportion of respondents who showed a negative attitude towards government regulations (42% was more than 5 times higher than the proportion of respondents who expressed a positive attitude towards government regulations. Those who expressed "very negative" and "negative" feelings toward the government regulations accounted for 8% and 34% of the respondents, respectively. Around half of the respondents expressed a ‘moderate’ feeling towards government regulations. Also, CEOs of pharmaceutical companies perceived that the government regulation was having a negative impact on their company’s business management. Nearly half of the respondents (49%) said government regulations had a negative impact on their business. "Very negative" and "negative" responses accounted for 9% and 40% of all responses, respectively. Only 6% said government regulations had a positive impact on their company management. In particular, the CEOs expressed the most dissatisfaction with the government’s drug pricing and reimbursement regulations. When asked to name the most unreasonable regulation, 57% of the respondents cited reimbursement and drug pricing regulations. This means that 3 out of 5 pharma CEOs perceive reimbursement and drug pricing regulations as the most unreasonable. 25% of respondents cited approval, production, and quality control regulations as the most unreasonable. Only 11% said distribution, sales, and marketing regulations were the most unreasonable. In terms of satisfaction for each type of regulation, the average satisfaction rate was in the 3-4 range for all categories. In all 3 major categories of regulations – approval/production/quality control, drug pricing/payment, and distribution/sales/marketing – the scores were rated below 5. To quantify the CEOs’ degree of satisfaction, respondents were asked to answer on a scale from 0 to 10. A higher score indicated greater regulatory satisfaction. Pharma CEOs were the least satisfied with drug pricing and reimbursement regulations. When asked about their satisfaction with drug pricing and reimbursement regulations, they gave an average score of 3.15. Only 2 respondents gave scores above 5 regarding satisfaction with Korea’s drug pricing and reimbursement regulations. More than half (53%) of the CEOs gave satisfaction scores below 3 for Korea’s drug pricing and reimbursement regulations. The most urgent area in need of improvement among drug pricing and reimbursement regulations was new drug listings, which 22% of the respondents had selected. Companies expressed dissatisfaction over the disruptions they experience in their businesses from delayed listing or non-designation of an appropriate price for their new drugs after spending a long time and considerable expense on developing a new drug based on their R&D capabilities. The next urgent area in need of improvement, which 18% of respondents selected, was improving the post-listing drug price cuts of generics. This is due to the great deal of dissatisfaction that arose from last year's generic drug price reevaluations. Last year, the government lowered the drug prices of more than 7,000 generic drugs through generic drug price reevaluations. After the reform of the drug pricing system, which was implemented in July 2020, was applied to listed generic drugs, the prices of products that had not undergone bioequivalence tests were lowered in large quantities. It is analyzed that pharmaceutical companies' dissatisfaction grew as the drug price cuts made on the products already in the market affected the companies’ performance. More than 10% of the respondents said that it is urgent to reform the drug pricing system, by improving the reimbursement evaluation system, price-volume agreement system, external price referencing, and listing of generic and incrementally modified drugs. The average satisfaction level of pharma CEOs gave for the approval, production, and quality control regulations was 4.00. This is higher than the CEO’s satisfaction rate for drug pricing or reimbursement regulations, but there were still more complaints than compliments. Only 4 of the 33 respondents rated their satisfaction level as 6 or higher. 9 out of 10 respondents had a negative stance in terms of satisfaction with Korea’s approval, production, and quality control regulations. In terms of the area in need of the most urgent improvement among approval, manufacturing, and quality control regulations, an overwhelming majority of respondents (55%) pointed to the period of approval. The companies saw that the development of new drugs and incrementally modified drugs were not leading to the prompt approval expected by the companies, and has negatively affected company business. Clinical reevaluations and improved GMP regulations were the next top priorities, accounting for 15% and 12% of all CEO respondents, respectively. On average, pharma CEOs rated their satisfaction with distribution, sales, and marketing regulations at 4.22. This was higher than the satisfaction they expressed for approval, production, quality control, or drug pricing and reimbursement, but still more negative than positive. The CEOs most frequently cited the regulation of CSOs (CSOs) as the area in need of most improvement among distribution, sales, and marketing regulation. 48% of respondents cited the need to regulate CSOs. Recently, there has been an increase in companies using CSOs and reducing their own sales force, especially among small and medium-sized pharmaceutical companies. There is a growing recognition of the need for strong regulations to regulate the CSOs' aggressive sales activities that can lead to overheated and confused market competition. Among the distribution, sales, and marketing regulations, 33% of respondents said that advertising regulations should be improved. There is a common perception that strict drug advertising regulations hinder companies' sales.
- Product
- KPDS demands gov. action to end chemotherapy drug shortages
- by Kang, Hye-Kyung Jan 03, 2024 05:40am
- The Korean Pharmacists for Democratic Society (KPDS) The Korean Pharmacists for Democratic Society (CEO: Hyeong-geun Shin, KPDS) has criticized the government’s system for the stable supply of essential medicines. The KPDS stated on the 28th that “5-fluorouracil, referred to as 5-FU, is a chemotherapy drug used to treat several types of cancers, including colorectal cancer, esophageal cancer, pancreatic cancer, and breast cancer. It is considered essential for treatments that it has been listed in the WHO’s list of essential medicines, and in Korea, it has been designated and managed as a shortage prevention drug (SPD) since 2010. However, over the past month, the unstable supply and demand of 5-FU have led to delays in chemotherapy schedules, by 1 to 4 weeks, and frequent switches to alternative drugs in cancer patients. The gravity of the current issue concerning drug availability for cancer patients is evident in online communities. Many patients have shared their experiences of traveling from other cities to hospitals in Seoul, only to find that they cannot receive necessary treatments due to drug shortages. Furthermore, these online communities serve as a platform for patients to exchange information on which hospitals currently have the essential medications in stock. “The concern is that the drug-producing companies have not disclosed the reasons behind the causes of drug shortages and have failed to propose alternative solutions to resolve this issue. Instead, the company has only explained the challenges in the CRO processes as their explanation for the difficulties,” the KPDS insisted. And “The government's response to the issue has been inadequate,” the KPDS criticized, “The government claims that there is a system, through collaboration with related agencies and experts, in place for essential medicines for monitoring supply and demand stages and receiving reports from companies on supply halts. However, there is a lack of publicly available information on the government's actions and corrective measures. Additionally, the Ministry of Food and Drug Safety (MFDS) website does not provide the latest reports on supply halts, as required by the reporting system for supply-halted medicines.” The KPDS has requested a release of several information related to the 5-FU supply issue: ▲Reporting by JW Pharmaceutical regarding the supply halt of 5-FU (Products: 5-FU Injection Choongwae 5ml/10ml/20ml), as required by the reporting system for supply-halted medicines ▲Details on the government’s review of JW Pharmaceutical’s reports, as required by the reporting system for supply-halted medicines ▲Drug monitoring reports from MFDS and Korea Orphan & Essential Drug Center regarding the supply halt of 5-FU ▲Supply and demand monitoring results from HIRA’s Korea Pharmaceutical Information Service (KPIS) regarding the supply halt of 5-FU ▲Content of the contract between the government and JW Pharmaceutical regarding the designation of 5-FU as shortage prevention drug (SPD) ▲Additional reports submitted by JW Pharmaceutical to the Ministry of Health and Welfare (MOHW) and MFDS concerning the 5-FU issue, besides the reporting system for supply-halted medicines ▲Corrective measures implemented by MOHW regarding the fair distribution of 5-FU supply to patients in need ▲Additional corrective measures implemented by MOHW and MFDS to facilitate the 5-FU supply ▲Corrective measures to stabilize 5-FU supply in the future. “The government should take effective measures, or show responsible actions, to instill trust in citizens that essential medicines taken today will continue to be available in the future,” the KPDS urged, “We expect that the government will put efforts to ensure that citizens can access essential medicines without difficulty.”
- Policy
- Comprehensive Health Insurance Plan to be released soon
- by Lee, Jeong-Hwan Jan 03, 2024 05:40am
- With the government's plan to announce the 2nd National Health Insurance Comprehensive Plan being postponed from December last year to January of this year, the pharmaceutical industry is anxiously awaiting what policy direction will be included in the new plan regarding drug expenditures. The pharmaceutical industry’s wishes are that the plan should include policies to promote and revitalize domestic generics and incrementally modified drugs that can serve as cash cows in securing research and development (R&D) investment costs for new drug development. On Jan. 1, the Ministry of Health and Welfare is known to be in the final stages of formulating the second health insurance plan, which will be in place for 5 years from this year (2024) to 2028. The MOHW had aimed to release the plan in December last year, but postponed the announcement, saying it needed more time to reflect the newly announced policies. This implied that the MOHW was not finished organizing the policies it had finalized last year, such as setting a public policy fee to support essential healthcare and the reform of the drug pricing system to reflect innovation value, into the comprehensive plan. The industry’s eyes are on the drug expenditure management direction that will be included in the new health insurance plan. In particular, domestic pharmaceutical companies are concerned that if the MOHW includes a new mechanism for reducing drug prices in addition to the post-listing reimbursement management of generic drugs that are already in place, this will dampen the industry’s drive for new drug R&D. In the study on the establishment of a comprehensive health insurance plan released by the Korea Institute for Health and Social Affairs in October last year, no mention had been made of the need to introduce a new drug price reduction model for generic drugs. However, the study suggested a policy to expand the targets subject to reevaluation for drug reimbursement adequacy review and to reevaluate generics by comparing their drug prices with the overseas A8 countries (Japan, France, Germany, Italy, Switzerland, the United Kingdom, the United States, and Canada). It also revealed plans to improve the effectiveness of the actual transaction price investigation and management system, reorganize the targets of the Price-volume Agreement system, and revise its formula. Furthermore, the MOHW had set criteria for easing the application of the PVA system for drugs made by innovative pharmaceutical companies or equivalent in the reform plan for the drug pricing system that recognizes the innovation value of drugs. Despite such improvements, domestic pharmaceutical companies are nervous as the MOHW is still known working on a drug price reduction model for generics. A domestic pharmaceutical company official said, "We hope that the new health insurance plan will not include a new price reduction mechanism. We also need to up with a reasonable reorganization plan for the post-listing management measures that are already in place. Also, we would like to discuss the permanence of the drug price reduction dispositions." The official added, "Although a drug pricing system that reflects innovation value has been introduced, it is partly focused on new drugs or essential drugs with low monetization. We need more measures to encourage generic development, which is the source of cash generation, to strengthen Korea’s new drug development momentum.” Another domestic company official said, "I hope that the MOHW will hold a closer ear to the voices of companies with the aim of advancing post-management mechanisms including the PVA system. In the big picture, I hope that the new plan will include short- and long-term policies to save health insurance finances and revitalize the pharmaceutical market to exceed the performance made this year.”
