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Policy
Upper limit re-evaluation of drugs in the negotiation stage
by
Lee, Tak-Sun
Mar 16, 2023 05:45am
The re-evaluation of the drug cap amount according to the standard requirement has now moved to the negotiation stage with the NHIS. Pharmaceutical companies that submitted their primary drugs to the HIRA by last February will proceed with prior consultation with the NHIS in March. After that, the main negotiations will be completed and the final drug price adjustment results will be announced in July. The NHIS announced on the 15th that it will hold prior consultations with pharmaceutical companies from this month in accordance with the re-evaluation of the standard requirements for the maximum amount of drugs. Accordingly, the NHIS plans to hold a briefing on the reevaluation negotiations on the 27th. An official from the corporation said, "We recently shared matters related to negotiations on standard requirements through a meeting with pharmaceutical organizations." About 15,000 drugs will be targeted for the first round, and prior consultations will be held until May. During the preliminary consultation period, the items to be negotiated will be checked and an agreement will be sought, so it is expected that the agreement will be concluded during the main negotiations in June. Based on this, the contents of the final drug price adjustment will be announced in July after going through the review committee in June. Negotiations are underway for the second target drug. The secondary target drugs are about 5,000, and if data are submitted to the HIRA by July, negotiations will proceed with the NHIS again. Negotiations will be conducted by the NHIS Pharmaceutical Control Office's Generic Management Division. An official from the generic management department explained, "Based on our experience over the past two years, we are thoroughly preparing to complete the negotiations within the deadline." The re-evaluation of the upper limit amount is being carried out by maintaining or lowering the upper limit amount depending on whether the company's own BA test and DMF registration criteria are met. If both of the BA and DMF requirements are met, the upper limit is maintained, and if one is met, the price is reduced to 85% of the adjusted standard price, and if both are not met, the price is reduced to 72.25%.
Policy
MFDS, approval of Vadadustat for anemia tx of renal disease
by
Lee, Hye-Kyung
Mar 15, 2023 05:56am
Vadadustat, which is used to treat anemia in patients with chronic kidney disease, has received domestic product approval. The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) announced on the 13th that it had approved two doses (150 and 300mg) of Vadadustat from Mitsubishi Tanabe Pharma Korea Co., Ltd., a new drug for the treatment of anemia in patients with chronic kidney disease. Vadadustat is a treatment for anemia in adult patients with chronic kidney disease undergoing hemodialysis. Vadadustat is a treatment for anemia in adult patients with chronic kidney disease undergoing hemodialysis. The drug promotes red blood cell production by inhibiting proline hydroxylase, which breaks down hypoxia-inducible factor (HIF). Sufficient iron stores should be ensured when Vadadustat treatment is initiated, and transferrin saturation (TSAT) and ferritin concentrations should be checked. If not previously treated with erythropoiesis-stimulating agents (ESAs), the criterion for initiation of this drug is a hemoglobin (Hb) concentration of less than 10 g/dL. Patients receiving erythropoiesis-stimulating agents (ESAs) may be switched to this drug. As Vadadustat, 300mg once a day is orally administered as a starting dose, and after the start of treatment, the dose is appropriately increased or decreased according to the patient's condition. The highest dose can be up to 600 mg once daily. If looking at the precautions for use, there is a risk of death due to serious thromboembolic events such as stroke, cerebral infarction, myocardial infarction, deep vein thrombosis, and pulmonary embolism during the administration of this drug. Since the administration of this drug may cause liver dysfunction, liver function tests should be performed regularly. The Ministry of Food and Drug Safety said, "We will continue to do our best to expand treatment opportunities for patients by promptly supplying treatments whose safety and effectiveness have been sufficiently confirmed based on regulatory scientific expertise."
Company
IIT seeks use of Leclaza in the first line in Korea
by
Jin-Joong Hwang
Mar 15, 2023 05:56am
New third generation lung cancer drug developed by Yuhan Corp Investigator-Initiated trials (IIT) are being conducted on the use of ‘Leclaza (lasertinib),’ Yuhan Corp’s new third-generation drug for non-small-cell lung cancer (NSCLS), as a first-line treatment. Over the past 3 years, a total of 11 IITs have been approved for Leclaza, indicating the high interest among HCPs in finding a new treatment method using Leclaza. According to industry sources on the 14th, the Ministry of Food and Drug Safety approved a randomized Phase IIb trial the day before that compares Leclaza monotherapy with Leclaza+Avastin combination in patients with advanced EGFR mutation-positive NSCLC who have a smoking history. The Phase IIb trial that compares Leclaza as monotherapy with the Leclaza+Avastin combination will be led by the National Cancer Center and conducted in 5 institutions including the Ajou University Hospital, Severance Hospital, Gangnam Severance Hospital, and St. Vincent Hospital. The trial is an investigator-initiated trial that uses Leclaza as the primary treatment. According to Yuhan Corp, this is the first clinical trial that investigates Leclaza’s use in the first line. Leclaza is a third-generation EGFR TKI class drug that received conditional approval in Korea in January 2021. It inhibits the signaling pathway involved in tumor cell growth and supresses lung cancer cell proliferation and growth. In Korea, Leclaza received conditional approval as a second-line treatment in patients with locally advanced or metastatic NSCLC who developed T790M resistance after prior treatment with a first- or second-generation EGFR TKI. Avastin is a drug used for the treatment of metastatic colorectal cancer, metastatic breast cancer, NSCLC, etc. The drug is approved for use in combination with platinum-based chemotherapy regimens to treat inoperable, locally advanced or metastatic non-squamous NSCLC. Also, the drug can be used in combination with erlotinib as a first-line treatment for inoperable EGFR mutation-positive, advanced, metastatic, or recurrent non-squamous NSCLC. During the past 3 years, a total of 11 IITs have been approved for Leclaza. This rise in number of clinical trials for Leclaza reflects the HCPs' rising interest in finding new treatment methods with Leclaza. Among the trials, major IITs include the Phase II trial being led by Seoul National University Hospital that is investigating the use of Leclaza+’Alimta (pemetrexed)’ combination in EGFR mutation-positive NSCLC patients with leptomeningeal metastases. The Phase II trial was approved in April 2021, and patient recruitement for the trial in complete, enrolling 43 patients. Also, patient recruitment is underway for a Phase II trial for NSCLC patients including those with rare EGFR mutations. The trial, which is led by Severance Hospital, has been approved in 2021 Since 2021, Seoul St. Mary’s Hospital has been conducting a Phase II trial studying the combined use of Leclaza, Alimta, and ‘Neoplatin (carboplatin)’ in EGFR mutation-positive metastatic NSCLC patients with asymptomatic or mild symptomatic brain metastases who have failed treatment with ‘Tagrisso (osimbertinib).’ Also, Samsung Medical Center has received approval for a single-arm Phase II trial investigating the use of Leclaza in EGFR mutation-positive NSCLC patients with no prior TKI treatment experience and is currently recruiting patients.
Opinion
[Reporter’s View] ‘The smart office system’s great, but…
by
Eo, Yun-Ho
Mar 15, 2023 05:56am
The smart office system has become an industry trend. The term, which originally refers to an IT-based office near a residential area that allows employees to work remotely from satellite offices rather than commute to an office downtown, is applied a bit differently in the pharmaceutical industry. Taking into account the characteristics of the industry, as employees often have to move from office to hospital or government office, the companies created workspaces fit for such mobile environment and implemented free seating systems. Due to the telecommuting culture that naturally settled during the pandemic, the number of resident workforce had also decreased. In their place, conference rooms with various concepts and phone booths for long-term calls were added like frosting to the cake. The transition to a smart office had let companies catch two birds with one stone. The reduced number of resident workforce allowed the company to save office expenses, while more space became available for those who came to work. In fact, many multinational pharmaceutical companies that have applied the smart office system moved their offices to relatively less expensive areas. The executive-level employees gave up their space as well. To embrace the horizontal organizational culture and make space for spacious conference rooms with a view, the executives left their rooms to work next to other employees. Even the ‘bosses’ gave up their office space. “I don’t have a room either. It was awkward at first, but the change has turned out for the better. Working next to the employees, we were able to become closer and communicate better." Some companies went on to further remove the honorific expressions altogether. These companies asked employees to call their bosses ‘Mr./Ms.OO’ or by their English names. Unlike in domestic companies, many multinational company employees are known to have a more candid relationship with their bosses. However, not everyone would agree that these changes are all for the good. For example, contrasting views exist on ‘owners that dine together at employee cafeterias.’ One employee confessed “You would naturally feel nervous and uncomfortable if your boss is sitting next to you. I understand the intention and my boss is a good person, but I can’t say I am all for the situation where I have to face the highest-ranking officer of my company continuously during work.” Just as in this employee's confession, although the changes are in the right direction and follow the trend of the times, the system may need to be somewhat adjusted to suit Korea. In the cutest sense, hold a friendly ear out to the complaint and let the ‘boss’ stay in his or her room.
Company
Pfizer pays an average of 1.1 billion won per person
by
Jung, Sae-Im
Mar 15, 2023 05:56am
It was found that Pfizer Korea Pharmaceutical, which implemented an ERP system through organizational reorganization last year, paid 11.5 billion won as compensation for retirement. It is known that about 10 employees applied for voluntary retirement. It is calculated that each person received an average of 1.1 billion won. According to an audit report submitted by Pfizer Pharmaceutical Korea to the Financial Supervisory Service on the 15th, the company paid a total of 17.8 billion won last year as employee severance pay. Retirement benefits are 6.4 billion won and honorary severance pay is 11.5 billion won. The notable part is the honorary severance pay. Retirement pay refers to the severance pay paid by the company upon resignation. Honorary severance pay is in the nature of consolation money. This is an expense paid to employees who applied for voluntary retirement when the company conducts a manpower reduction due to a change in management. Last year, Pfizer Pharmaceuticals Korea conducted an organizational reorganization according to the business environment that changed with Corona 19. As the proportion of digital-centered non-face-to-face sales increases, the direction is to establish a new sales department. As a result, the size of the existing sales team, which was divided into business divisions, was partially reduced. During the reorganization process, the company conducted an in-house 'job posting' to readjust the arrangement of employees who applied for a job transfer and also implemented an early retirement program. About 10 people are said to have left the company due to voluntary retirement. The reorganization was completed in November last year. The total amount of severance pay paid by the company to applicants for voluntary retirement is 11.5 billion won. Although there are variations depending on the number of years of service, each employee received an average of 1.1 billion won as compensation. Pfizer's ERP conditions are not known, but the average condition commonly used in the industry is 2n+8. This means that an additional 8 months' salary is paid for twice the number of years of service. Depending on the company, there are cases where additional special consolation money is paid according to annual leave. This is to induce managers with a long service life to apply for voluntary retirement. The amount of honorary severance pay paid by Pfizer Korea last year was the largest since 2015. Pfizer Korea is often considered a company that implements voluntary retirement programs. In 2013 and 2015, the company paid 18 billion won and 19.2 billion won in honorary retirement benefits, respectively, as a large-scale voluntary retirement program. In 2016, it also spent 6.9 billion won. In 2018, ahead of the spin-off of the out-of-patent drug division (Pfizer Upzone), 9.4 billion won was paid as an honorary severance pay. For 10 years from 2013, the total amount of honorary severance pay paid by Pfizer Korea reached 71.2 billion won. The number of employees is maintained at a similar level by sending out high-ranking managers and recruiting young people. Pfizer Pharmaceuticals Korea, which had about 730 to 750 people before the spin-off of Pfizer Upzone, has grown to 460 people after the separation. Since then, the number has dropped to 406 due to continued voluntary retirement but rose to 420 last year. Recently, it has also started to recruit new sales staff on a large scale. About 10 new employees are selected to be in charge of selling the Corona 19 vaccine and treatment. It is interpreted as a measure to prepare for the private market after the end of the Corona 19 pandemic.
Policy
MOHW provides real-time confirmation service
by
Lee, Jeong-Hwan
Mar 15, 2023 05:56am
When the government requests pharmaceutical companies to expand drug reimbursement standards, the government plans to use the information system to provide administrative services to check the progress of evaluation tasks at each stage. Drugs with clear efficacy for survival-threatening diseases will strengthen patient accessibility by implementing a pilot project that simultaneously proceeds with permission from the Ministry of Food and Drug Safety, benefits evaluation by the Health Insurance Review and Assessment Service, and drug price negotiations with the National Health Insurance Corporation. It also announced a plan to legalize public late-night pharmacies that provide pharmacist services to provide counseling for patients with mild symptoms and guarantee access to medicines. On the 9th, the Ministry of Health and Welfare announced a plan to promote health and welfare regulatory reform in 2023. This year, the Ministry of Health and Welfare will promote regulatory improvement in seven key areas, focusing on the regulatory innovation plan for the new health industry. They are innovative medical devices, innovative and essential medicines, digital healthcare, advanced regenerative medicine and advanced biopharmaceuticals, genetic testing, BMI, and infrastructure. In addition, we will continue to discover regulatory improvement tasks such as rapid registration of new drugs. In the health and welfare sector, regulations are improved to allow new industries to enter the market by supporting innovation in the private sector, as population aging and increased demand for health care are expected. Although leasing was prohibited after the sale of land to companies in the high-tech medical complex, various forms of occupancy opportunities were provided, such as allowing leasing only to resident companies in need of leasing, such as conducting joint research with a common goal. We plan to revitalize the complex and improve space utilization. When a pharmaceutical company requests an expansion of reimbursement standards for pharmaceuticals, the process of reviewing reimbursement standards is made transparent and predictability is increased by enabling the information system to check the progress of each evaluation task. When evaluating drugs that are life-threatening and have sufficient improvement effects, a policy to promptly list new drugs is also implemented. A pilot project will be conducted to strengthen patient accessibility by concurrently proceeding with permission from the Ministry of Food and Drug Safety, benefits evaluation by the Health Insurance Review and Assessment Service, and drug price negotiations with the National Health Insurance Corporation. By legalizing public late-night pharmacies that provide counseling for patients with mild symptoms that occur at night and provide pharmacist services to ensure access to medicines, the public health blind spot is eliminated by providing medication counseling and drug use guidance to patients with mild symptoms during night time. Despite changes in the environment of the pharmaceutical industry, the innovative pharmaceutical company certification system maintains its original form when introduced (2012). Minister of Health and Welfare Cho Kyu-hong said, "In accordance with the strong regulatory innovation direction of the Yoon Seok-yeol government, we will continue to create results of regulatory innovation in the health and welfare sector to revitalize new industries and resolve difficulties and public inconvenience while putting top priority on the lives and safety of the people." revealed
Company
HPV vaccination for males a necessity rather than an option
by
Whang, byung-woo
Mar 14, 2023 05:51am
Whether the national immunization program (NIP) for the human papillomavirus (HPV) vaccine should be extended to cover males remains a hot issue in Korea. With the NIP applied for its use in girls aged 12 years or older, the government extended the program to include those aged 13 to 17 (born between 2004 to 2008) and low-income women aged 18 to 26. In countries such as the US, male HPV vaccination is also covered through NIP, but the agenda is still under discussion in Korea. However, as President Yoon Suk-Yeol had announced vaccination to males aged 12 years older using NIP as an election pledge, whether this will really be implemented is gathering attention. For this, the Korea Disease Control and Prevention Agency was found to have been carrying out a research project to analyze the cost-effectiveness of extending NIP to HPV vaccinations in adolescent males on the 3rd. Director Geun-Yong Kwon, Division of Immunization, Bureau of Healthcare Safety and Immunization at KDCA, said, “The new government fully agrees on the need for male HPV vaccinations, and we are in the process of securing evidentiary material to support this. We plan to reflect its inclusion in the budget by early next year." However, the conclusion may not be so easily drawn as it would cost a considerable amount. Due to its characteristics and the NIP, HPV vaccines are better known in Korea as a cervical cancer vaccines. However, men also do get infected with HPV, and the most common clinical manifestation is genital warts in men. At a media session that was held by MSD on the 3rd on the 'A to Z of HPV,’ Seung-Ju Lee, President of the Korean Association of Urogenital Tract Infection and Inflammation (Urology, St. Vincent Hospital) stressed the need for male HPV vaccinations. According to Lee, the prevalence of genital warts in Korea had increased threefold over the past decade, from 25,208 patients in 2010 to 65,203 patients in 2019 prior to the pandemic. Also, although the prevalence of genital warts was higher in women than men, it was highest in men 25-29 years of age. In Korea, genital warts occur mainly in the younger age group, and its incidence tended to be higher in men than in women. Also, there were views that it is important to vaccinate men to prevent cervical cancer, for which the NIP is currently applied to HPV vaccinations for women only. With the yearly rise in the HPV vaccination rate, the prevalence of HPV infections are expected to be decline, however, when considering the time required to achieve herd immunity, Lee explained that it would be more effective if both women and men are vaccinated at the same time. According to MSD, its predictive modeling study in Europe and Belgium showed that allowing HPV vaccination for both men and women was expected to be cost-effective in most countries. while allowing the high vaccination rate to be maintained among girls. Lee said, “Although the domestic HPV vaccination rate exceeded 80% for initial vaccinations, the rate becomes lower when taking into account the second vaccinations. Korea is quite new to applying NIP to HPV vaccines yet, therefore, to create herd immunity, it would be much more effective and also better for preventing male diseases to concurrently allow HPV vaccinations for men under NIP as well.” Among the 110 countries that are conducting HPV vaccinations under NIP, 52 countries including the US, UK, Canada, Australia, Switzerland, Italy, and Austria have extended its vaccinated subjects from girls to boys (as of March 2022), therefore, it is not unusual that this discussion is being made in Korea. As the government has also been selected extending eligibility for HPV vaccinations using NIP as its national task, it is true that there are positive forces underway supporting the implementation of the system. However, the issue mentioned above is its cost-effectiveness. The KDCA estimates that a budget of approximately KRW 19 billion won will be required every year if HPV vaccination is expanded to boys. In this sense, the results of KDCA’s research project that will be disclosed in the first half of this year may determine the direction of whether the NIP will be expanded to male HPV vaccination in Korea.
Company
The erectile dysfunction tx market sales are at an all-time
by
Chon, Seung-Hyun
Mar 14, 2023 05:51am
Hanmi Pharmaceutical PalPal Leads for 7 Consecutive Years. Continuation of Dominant System Last year, the domestic erectile dysfunction treatment market grew to the largest ever. Domestic companies' generic products dominated the market, accounting for nearly 90% of the market. According to IQVIA, a drug research institute on the 8th, the size of the erectile dysfunction treatment market last year was 129.1 billion won, up 9.1% from the previous year. Following 2021, it broke the record for the second consecutive year. After recording 113.9 billion won in 2019, the erectile dysfunction treatment market recorded a downward trend to 112.4 billion won the following year. At the time, it was evaluated that growth was dampened as patients' visits to hospitals and clinics decreased due to the prolonged Corona 19 and restrictions were placed on sales marketing activities. It succeeded in rebounding by 5.2% from the previous year to 118.3 billion won in 2021 and continued to grow last year. Products released by domestic pharmaceutical companies dominated the erectile dysfunction treatment market. Last year, sales of erectile dysfunction treatments by domestic companies totaled 114.7 billion won, up 10.8% from the previous year. It increased by 26.6% over four years from 90.6 billion won in 2018, showing a steady rise. Last year, domestic companies accounted for 88.9% of the erectile dysfunction treatment market. It continued to rise every year from 83.8% in 2018. The multinational pharmaceutical company's erectile dysfunction treatment products are Viagra and Cialis. Generic products released by domestic pharmaceutical companies overwhelm original products. Looking at the sales of major products, Hanmi Pharmaceutical's PalPal still showed off its unrivaled prestige in the market. PalPal is a generic product of Viagra. Last year, PalPal's sales increased by 6.3% year-on-year to 21.8 billion won. PalPal's market share in the entire erectile dysfunction treatment market reached 16.9%, so it was influential in the market. PalPal overtook Viagra in the second quarter of 2013, one year after its release, and surpassed Cialis in the fourth quarter of 2015, becoming the leader in erectile dysfunction treatment sales. PalPal has never fallen from the leading position for seven years from the fourth quarter of 2015 to last year. PalPal more than doubled the sales of the original product Viagra (8.7 billion won). Considering that the price of PalPal is significantly lower than that of Viagra, it is possible to calculate that the prescription volume gap is much larger. Chong Kun Dang's Cendom ranked second with sales of 11.4 billion won last year, up 6.1% from the previous year. Hanmi Pharm's Gugu recorded sales of 11.4 billion won, up 18.5% from the previous year, exceeding 10 billion won in annual sales for the first time. Cendom and Gugu are generics of Cialis. Among all erectile dysfunction drugs, only three products (PalPal, Cendom, and Gugu) exceeded 10 billion won in sales. Released after Cialis' patent expired in September 2015, Cendom gradually expanded its market share, surpassing the original product Cialis in the fourth quarter of 2017. In the fourth quarter of 2018, it maintained its second place since surpassing Viagra. Gugu surpassed Cialis in the second quarter of 2019 and also surpassed Viagra in the second quarter of 2021. Sales of Viagra and Cialis, which had built the two major mountain ranges of erectile dysfunction treatments in the past, have gradually decreased. Viagra's sales last year were 8.7 billion won, down 1.1 percent from the previous year. It decreased by 12.3% in 4 years from 9.9 billion won in 2018. Last year, sales of Cialis recorded 5.7 billion won, down 5.2% from the previous year. It fell 22.8% over four years from 7.4 billion won in 2018.
Policy
SGLT2 + DPP4 combi benefit expansion has increased
by
Lee, Tak-Sun
Mar 14, 2023 05:50am
As the insurance authorities decided to expand the combined coverage of major diabetes drugs from April, applications for reimbursement for related complex drugs are continuing. MSD Stegluzan's application for benefits was recently confirmed, and Dong-A ST Sugadapa, which was approved on the 13th, plans to apply for benefits this month. Accordingly, it is understood that a total of five items will be applied for benefits within this month. According to the industry on the 13th, two-dose items of MSD Stegluzan were applied for and the HIRA was calculated. Stegluzan is a combination of the SGLT-2 inhibitory ingredient Ertugliflozin L-pyroglutamic acid and DPP-4 inhibitory ingredient Sitagliptin Phosphate Hydrate. For Ertugliflozin, the original single drug product is Steglatro, and the ingredient Sitagliptin is Januvia. All of these items are owned by MSD and are listed on the list. Stegluzan will be calculated based on the upper limit of Steglatro and Januvia. Prior to this, Boehringer Ingelheim Esglito and AstraZeneca Qtern were also known to have applied for benefits. Since the company that owns the original single drug is launching it on the market as a combination product that combines the single drug, there is no possibility that the market launch will be delayed due to patents. LG Chem is also said to have applied for Zemidapa benefits. Gemigliptin is a DPP-4 inhibitory ingredient developed by LG Chem, and its brand name is Zemiglo. Accordingly, among the SGLT-2+DPP-4 combination drugs, 3 items from foreign companies and 2 items from domestic companies are expected to be reimbursed within the first half of the year. Since the upper limit of the single system is voluntarily lowered according to the April benefit expansion, the upper limit of the combined system is set based on this. LG Chem and Dong-A ST's combination drugs are paying close attention to the voluntary reduction rate of the original Forxiga because Dapagliflozin is combined. Meanwhile, the insurance authorities plan to expand reimbursement for the combined use of drugs between classes, such as Metformin + DPP-4 + SGLT-2, from April.
Company
Will the new prostate cancer drug Erleada be reimb in April?
by
Eo, Yun-Ho
Mar 14, 2023 05:50am
Whether the new prostate cancer drug ‘Erleada’ will be listed for reimbursement is gaining industry attention. The drug pricing negotiation period for Janssen Korea’s metastatic hormone-sensitive prostate cancer (mHSPC) treatment Erleada (apalutamide) with the National Health Insurance Service is about to expire this month (March). Erleada had passed deliberation by the NHIS Cancer Disease Deliberation Committee in February and then that of the Drug Reimbursement Evaluation Committee in December of the same year and has started the drug pricing negotiation process for its reimbursement earlier this year. If the pricing negotiations are completed within the set period, the agenda may be presented for review by the Health Insurance Policy Deliberation Committee in March. And if the agenda passes HIPDC review, the drug may be listed for reimbursement in April at the earliest. Erleada is an androgen receptor targeted agent (ARTA) and is a latecomer in the same class of drug as ‘Zytiga (abiraterone),’ or ‘Xtandi (enzalutamide).’ The drug’s efficacy was demonstrated through the Phase III TITAN trial that was conducted on 1,052 patients with mHSPC. Although 40% of the patients that were allocated to the placebo arm continued treatment with Erleada, the risk of death in the Erleada arm was 35% lower than that in the placebo arm. At 48 weeks, overall survival (OS) was 65% in the Erleada arm and 52% in the placebo arm. Also, when excluding the effect of patients who switched from the placebo to Erleada in the placebo arm, the risk of death in the Erleada arm was 48% lower than that of the placebo arm. According to data from the Cancer registration· Statistics Program, 16,815 patients in Korea were diagnosed with prostate cancer in 2020. Among men, prostate cancer is the third most common cancer in Korea, only headed by lung cancer with 19,657 patients and stomach cancer with 17,869 patients and followed by colorectal cancer, which has 16,485 patients. Moreover, among the five most common cancers in men (lung cancer, gastric cancer, prostate cancer, colorectal cancer, liver cancer), only the prevalence of prostate cancer has been increasing at an annual rate that exceeds 5%.
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