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- 2026-04-03 21:38:51
- Policy
- H1 Pharma exports amounted to $5.38B
- by Lee, Hye-Kyung Aug 07, 2025 06:05am
- In the first half of this year, healthcare industry exports increased by 13.2% compared to the same period last year, reaching $13.79 billion, an all-time high for a half-year period. By sector, exports were led by cosmetics at $5.51 billion (+14.9%), pharmaceuticals at $5.38 billion (+20.5%), and medical devices at $2.91 billion (△0.6%). The Korea Health Industry Development Institute (KHIDI, President: Soon-do Cha) announced these export figures for pharmaceuticals, medical devices, and cosmetics for the first half of 2025 on August 6. Exports of pharmaceuticals increased by 20.5% year-over-year to $5.38 billion, driven by a surge in biopharmaceutical and vaccine exports. Biopharmaceutical exports (accounting for approximately 63.4% of total pharmaceutical exports) recorded $3.41 billion, a 27.4% increase year-over-year. Notably, exports saw a significant increase to the United States ($980 million, +41.4%), Hungary ($520 million, +26.8%), Germany ($470 million, +66.7%), Switzerland ($460 million, +76.9%), and the Netherlands ($250 million, +719.8%). H1 2025 Healthcare Industry Exports (unit: $1 million, %) Vaccine exports ($170 million, +53.3%) grew significantly in Sudan ($20 million, +397.3%), South Sudan (from $0 in H1 2024 to $10 million in H1 2025), and Congo (from $0 in H1 2024 to $10 million in H1 2025). According to Lee Byung-kwan, head of KHIDI's Biohealth Innovation Planning Division, "In the first half of 2025, healthcare industry exports were driven by all-time high half-year performances in the cosmetics and pharmaceutical sectors," and added, "In the second half, export growth is also expected to continue, driven by the expanding global demand for key products like biopharmaceuticals and basic cosmetics." Lee emphasized, "As external uncertainties such as changes in the U.S. tariff policy persist, it is crucial to monitor market trends and respond with caution and strategy carefully."
- Company
- 'Brintellix', stable position in antidepressant drugs mkt
- by Eo, Yun-Ho Aug 07, 2025 06:05am
- Product photo of Brintellix 'Brintellix' has established a stable presence in the antidepressant drugs market over the past 10 years. Its presence has not been disturbed by issues such as generic entries. According to industry sources, Lundbeck Korea's Brintellix (vortioxetine) has been growing in the market for antidepressant drugs for the past 10 years. In Q1 20125, Brintellix ranked No.2 in sales in the antidepressant market, based on the IQVIA data. Brintellix, first introduced in Korea in 2015, is differentiated from existing antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), which work by blocking the reuptake of serotonin or norepinephrine to produce an antidepressant effect. Brintellix is a new antidepressant with a mechanism that acts on various serotonin receptors while also inhibiting serotonin reuptake. Through this, it not only balances various neurotransmitters in addition to serotonin but also shows an effect in improving depressive symptoms and cognitive symptoms (such as concentration, attention, learning ability, and executive function) in patients with Major Depressive Disorder (MDD). Brintellix has been proven to significantly improve cognitive symptoms such as reduced attention, lack of concentration, and memory impairment that are observed in MDD patients. Furthermore, this drug was confirmed to significantly improve symptoms of reduced motivation and lack of energy in depressed patients, and it also statistically and meaningfully improved emotional blunting. These improvements in cognitive and emotional symptoms were not limited to short-term treatment. Brintellix demonstrated sustained antidepressant effects through a long-term study lasting 52 weeks and was reported to reduce the relapse rate in MDD patients by approximately 50% compared to placebo. Additionally, efforts to enhance the administration convenience for Brintellix are underway. Lundbeck is currently conducting clinical trials to compare the safety and pharmacokinetic properties of a salt-changed product of Brintellix upon administration. An official of Lundbeck stated, "As we celebrate the 10th year of Brintellix launch in Korea, Lundbeck has a variety of plans to help more patients based on its years of clinical experience and reliable products. We plan to contribute to treating depression with a patient-centered treatment option."
- Company
- COVID-19 vaccines transitioned to NIP
- by Whang, byung-woo Aug 06, 2025 06:10am
- COVID-19 vaccines, which were previously contracted through a pre-purchase model with pharmaceutical companies, will transition to the National Immunization Program (NIP) system. The Korea Disease Control and Prevention Agency (KDCA) announced on August 5 that it has signed a procurement contract for the supply of vaccines for the 2025-2026 seasonal COVID-19 immunization program. Unlike the previous method (2020-2024), where contracts were signed through a pre-purchase model with pharmaceutical companies using full government funding, this COVID-19 vaccine contract was signed through a government procurement model, transitioning it to a local government-subsidyzed project (matching local government funds), which is the same as the existing NIP system. The COVID-19 vaccines to be supplied to Korea for the 2025-2026 season are vaccines with the LP.8.1 strain, which have been recommended for use by the WHO (World Health Organization), EMA (European Medicines Agency) on May 16, and FDA (U.S. Food and Drug Administration). The decision was made by the Korea Expert Committee on Immunization Practices (KECIP). The total vaccine volume to be procured is 5.3 million doses (3.28 million from Pfizer and 2.02 million from Moderna), and contracts were signed through their respective COVID-19 vaccine distributors (companies with exclusive sales rights) in Korea. The domestic distributor for the Pfizer vaccine is HK inno.N, and Boryung Biopharma is the domestic distributor for Moderna. Regarding this contract, the KDCA explained, "The COVID-19 vaccine supply contract in Korea was signed using a private contract method, rather than a competitive bid, to ensure stable supply. However, based on a survey of local government demand, we incorporated price competitiveness elements and an additional reserve volume (5%) for each pharmaceutical company, aiming for both stable vaccine supply and budget savings." To minimize vaccine waste, vaccines nearing their expiration date during the project period can be exchanged to ensure continuous use throughout the vaccination period. After the project concludes, remaining vaccines can be returned within a 5% limit of the contracted volume. To minimize vaccine waste, vaccines nearing their expiration date during the project period can be exchanged to ensure continuous use throughout the vaccination period. After the project concludes, remaining vaccines can be returned within a 5% limit of the contracted volume. Meanwhile, Moderna announced that it will strive to protect high-risk groups aged 65 and over in Korea through the 2025-2026 seasonal NIP. Moderna's COVID-19 vaccine has accumulated extensive real-world vaccination data in Korea, with approximately 29.18 million doses administered from the beginning of the pandemic until now, confirming its efficacy and safety. According to a study conducted by the KDCA, the Moderna vaccine was found to have the lowest breakthrough infection rate among the vaccines used in Korea during the early stages of the pandemic. Since 2021, Moderna has collaborated with Samsung Biologics to produce the only mRNA COVID-19 vaccine in Korea. In addition, Moderna is making efforts to strengthen mRNA technology capabilities through various collaborations, including joint research on a vaccine candidate for Severe Fever with Thrombocytopenia Syndrome (SFTS) with the National Institute of Infectious Diseases under the KDCA, and a partnership with KAIST and Yonsei University K-NIBRT for training mRNA research talent. Kim Sang-pyo, General Manager of Moderna Korea, said, "We are deeply grateful and find it meaningful that Moderna's efforts over the past few years to protect high-risk groups from the COVID-19 can continue through this year's NIP," and added, "As COVID-19 remains an infectious disease with a high severity rate, especially in adults aged 65 and over, we will put utmost efforts to protect more high-risk individuals in line with the government's vaccination plan."
- Company
- Imfinzi wins nod as pre- and post-operative adjuvant therapy
- by Whang, byung-woo Aug 06, 2025 06:10am
- Product photo of Imfinzi AstraZeneca announced on August 4 that it has received approval for its Imfinzi (durvalumab) as pre- and post-operative adjuvant therapy for patients with muscle-invasive bladder cancer from the Ministry of Food and Drug Safety on July 30. With this approval, Imfinzi has become the first and only immunotherapy in Korea to be approved for pre- and post-operative adjuvant therapy in the treatment of muscle-invasive bladder cancer. Imfinzi's specific approved indication is for 'the treatment of patients with muscle-invasive bladder cancer as a neoadjuvant combination therapy with cisplatin and gemcitabine or as Imfinzi monotherapy as adjuvant therapy after radical cystectomy.' Imfinzi's specific approved indication is for 'the treatment of patients with muscle-invasive bladder cancer as a neoadjuvant combination therapy with cisplatin and gemcitabine or as Imfinzi monotherapy as adjuvant therapy after radical cystectomy.' The previous standard therapy was neoadjuvant chemotherapy followed by radical cystectomy. However, this left an unmet need due to high recurrence rates and poor prognosis even after treatment. It is known that approximately 50% of muscle-invasive bladder cancer patients experience recurrence within three years. The expanded indication is based on the Phase 3 NIAGARA clinical study, which evaluated the clinical efficacy and safety of Imfinzi as a pre- and post-operative adjuvant therapy for muscle-invasive bladder cancer. In this study, patients were divided into two groups. The experimental group received Imfinzi and chemotherapy (gemcitabine-cisplatin) in combination as neoadjuvant therapy for 4 cycles at 3-week intervals, followed by surgery and then Imfinzi monotherapy as adjuvant therapy for 8 cycles at 4-week intervals. The control group underwent chemotherapy (gemcitabine-cisplatin) as neoadjuvant therapy, followed by surgery only. The study results showed that Imfinzi's pre- and post-operative adjuvant therapy significantly improved one of the key primary endpoints, event-free survival (EFS), compared to the control group. The 2-year event-free survival rate was 67.8% for the Imfinzi pre- and post-operative adjuvant therapy group and 59.8% for the control group. The Imfinzi pre- and post-operative adjuvant therapy reduced the risk of disease progression, recurrence, failure to undergo radical cystectomy (surgery), and death from all causes by 32%. In terms of the safety profile, Imfinzi's results were consistent with the individual safety profiles of previously confirmed Imfinzi and chemotherapy (gemcitabine-cisplatin). Based on these clinical benefits, Imfinzi is a Category 1 preferred recommendation for pre- and post-operative adjuvant therapy for patients with muscle-invasive bladder cancer in the National Comprehensive Cancer Network (NCCN) guidelines. Furthermore, the European Society for Medical Oncology (ESMO) has rated it with an A-grade, the highest rating in their Magnitude of Clinical Benefit Scale (MCBS) framework. Professor Byong Chang Jeong of the Department of Urology at Samsung Medical Center (President of the Korean Urological Oncology Society) explained, "The previous standard therapy for muscle-invasive bladder cancer had limitations in improving patient survival due to high recurrence rates," and added, "The newest approval of an immunotherapy as a pre- and post-operative adjuvant therapy is a favorable change in the clinical field." Jeong added, "By administering Imfinzi, we can expect to increase the success rate of surgery through neoadjuvant therapy and reduce the recurrence rate through adjuvant therapy, ultimately improving the survival rate of patients with muscle-invasive bladder cancer in Korea."
- Company
- US drug price 3.9 times higher than in Korea
- by Kim, Jin-Gu Aug 06, 2025 06:09am
- With the US government pushing forward the introduction of a Most Favored Nation (MFN) policy to lower drug prices, an analysis has revealed that US drug prices are 3.9 times higher than those in South Korea. The Korea Biotechnology Industry Organization cited an analysis by the US public policy research institute Rand Corporation on the 4th on this finding. The data was released in February 2024 and is based on drug prices in 33 OECD countries, including the United States. According to the data, the overall drug price level in the United States is 2.8 times higher than the average of 32 OECD countries. Compared to South Korea, it is 3.9 times higher. In other words, drug prices in South Korea are equivalent to 25.6% of those in the United States. In addition, US drug prices are 3.5 times higher than Japan’s, 3.3 times higher than France’s, 2.9 times higher than Germany’s, and 2.7 times higher than the United Kingdom’s. Among OECD countries, Turkey has the largest price disparity, with prices 10.3 times higher than those in the United States. Also, a significant price difference was observed between brand-name (original) drugs and generic drugs. The price of brand-name drugs was 4.2 times higher in the US than the OECD average. In particular, the top 60 drugs in terms of sales in the US are 5.0 times higher than the OECD average. Among brand-name drugs, biopharmaceuticals are 3.6 times higher than the OECD average. On the other hand, the price of generic drugs in the US is lower – around 66.8% of the OECD average. The US President Donald Trump has been strengthening trade pressure on pharmaceuticals by imposing tariffs and most-favored-nation (MFN) policies. While announcing plans to impose tariffs on pharmaceuticals, he is also targeting drug prices in other countries as a means of exerting trade pressure. As part of this effort, President Trump signed an executive order in May to lower prescription drug prices in the U.S. to the lowest prices among major developed countries (MFN). The main point of the order is to compare drug prices in OECD countries with a per capita GDP of 60% or more than that of the US, and lower US drug prices to the lowest among them. The most-favored-nation treatment policy applies only to products that do not have biosimilars or generics. The US Department of Health and Human Services plans to first encourage pharmaceutical companies to voluntarily lower drug prices and then force them to do so. If the policy is fully implemented, the prices of new drugs entering the US market are expected to be set lower than those in other countries, such as the EU and Canada. It is speculated that this may automatically lower the prices of domestic pharmaceutical companies' drugs in the US. In particular, new drug development companies are expected to be affected. If drug prices in the US drop to European or Canadian levels, pharmaceutical companies' expected sales are likely to decrease, and the value of their new drug licenses is expected to decline. On the other hand, biosimilars and generics are not expected to be directly affected, as the policy targets products without existing biosimilars or generics. However, these products may still face pressure on profitability in the future. If the prices of original drugs decrease, the benchmark prices for generics and biosimilars could also decline, reducing sales incentives.
- Opinion
- [Reporter's View] Can NA resolve the drug shortage issue?
- by Kim, Jin-Gu Aug 06, 2025 06:09am
- Whether the four bills presented for amendments to the Pharmaceutical Affairs Act aimed at resolving the shortage of medicines will be discussed at the National Assembly's Health and Welfare Committee in August is gaining attention. The amendments to the Pharmaceutical Affairs Act were proposed by Rep. Jeong-ae Han, Rep. Yoon Kim, and Rep. Mi-hwa Seo of the Democratic Party of Korea, and Rep. Sun-min Kim of the Rebuilding Korea Party. Rep Jeong-ae Han’s bill proposes the establishment of a supply management committee involving both the public and private sectors, as well as the designation of “medicines with unstable supply” and the establishment of regulations for emergency production and import orders. Rep Yoon Kim's bill includes medicines with temporary supply shortages or sudden increases in demand as “medicines subject to stable supply management,” and allows medical professionals and relevant institutions, and organizations to participate in the National Essential Medicines Supply Stability Council. Rep. Mi-hwa Seo's bill focuses on including medications without alternatives as National Essential Medicines and implementing constant monitoring. Rep. Sun-min Kim’s bill includes medications with temporary supply shortages or sudden increases in demand in the “stable supply management targets” category and seeks to allow medical professionals and institutions/organizations to participate in the National Essential Medications Supply Stability Council. All four amendments were positively received as they presented their own solutions to stabilize the supply of medicines. Considering the repeated medicine shortages and supply disruptions that arose over the past few years, they were also deemed timely. If the bills are submitted and pass the Health and Welfare Committee review, they are likely to be processed through the Legislative and Judiciary Committee and handled during the September regular session of the National Assembly. If this process is realized, it is expected to provide a significant boost to resolving the medicine supply shortage that has been recurring for several years. Resolving the medicine supply shortage was a common campaign pledge made by both the ruling and opposition parties in the last presidential election. Furthermore, except for the extent to which the international nonproprietary name prescriptions should be allowed, there does not seem to be much disagreement between the parties. This means that now is the optimal time to discuss measures to resolve the medicine supply shortage. However, it is necessary to carefully review whether there are any aspects that have not been included in the revised bill. In particular, the pharmaceutical industry has consistently demanded fundamental solutions for increasing the self-sufficiency rate of domestically produced raw materials for pharmaceuticals and strengthening incentives for the production of low-profit essential drugs, which require urgent attention. There are calls for the need to establish practical supply chain strengthening policies that go beyond simply expanding the scope of items subject to supply instability and forming a consultative body. Fundamental measures are needed to overcome low productivity and a weak supply structure. The government should also consider expanding public reserves and establishing a digital-based real-time monitoring system. Overseas cases are also worth noting. The United States operates a Drug Shortage Task Force to maintain an early warning and supply substitution system. The European Union (EU) operates a system to jointly manage and stockpile about 200 essential drugs. Japan is known to operate a system to reevaluate the prices of low-profit products that cause deficits, focusing on essential drugs. These countries share the common feature of active government intervention to expand supply and promote corporate participation. The current parliamentary discussion presents an opportunity to address critical issues that can no longer be postponed. It must serve as the starting point for developing practical solutions. This rare opportunity must not be wasted. Instead of half-hearted measures, a clear direction that ensures supply stability that both citizens and the pharmaceutical industry can feel must be presented this time.
- Company
- GIST drug Qinlock receives orphan drug designation in KOR
- by Eo, Yun-Ho Aug 06, 2025 06:09am
- The GIST treatment Qinlock has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety announced the news through a public notice on the 4th. Ono Pharmaceutical's gastrointestinal stromal tumor (GIST) treatment Qinlock (ripreitinib) had previously been designated as a Global Innovative Products on Fast Track (GIFT) drug last month. Qinlock is used to treat patients with advanced GIST who have a history of treatment with three or more kinase inhibitors, including Gleevec (imatinib). Qinlock has also been designated as an orphan drug by the US FDA and the European EMA. It was selected for Fast Track review and received the Breakthrough Therapy Designation (BTD) from the FDA and received approval in 2020, and was approved by the EMA in 2021. Qinlock demonstrated efficacy in the Phase III INVICTUS trial for GIST patients. In the study, which enrolled 129 patients, the median progression-free survival (PFS) in the ripreitinib group was 6.3 months, a significant improvement compared to 1.0 months in the placebo group. Additionally, Qinlock reduced the risk of disease progression or death by approximately 85% compared to placebo, demonstrating a statistically significant effect. Meanwhile, GIST is a type of cancer that can occur anywhere in the gastrointestinal tract. It typically develops in the submucosal or muscularis mucosa, not the mucosal layer that is visible through endoscopy. This makes early detection difficult. While most tumors are benign, 20-30% are malignant. Symptoms appear as the tumor grows or cancer cells penetrate the submucosal layer or muscle layer and invade the mucosa. As gastrointestinal stromal tumors grow, they can cause abdominal pain and even intestinal obstruction. In addition to the first-line drug Gleevec, later-line options approved include the second-line treatment Sutent (sunitinib) and third-line treatments Stivarga (regorafenib). Qinlock has been approved as a fourth-line treatment.
- Company
- COVID-19 vaccination system has been included in the NIP
- by Whang, byung-woo Aug 06, 2025 06:09am
- As COVID-19 vaccination has been included in the National Immunization Program (NIP), changes to the operational system is anticipated. Previously, government provided COVID-19 immunization service for high-risk groups. Whereas the previous service had been temporary, the current vaccination system is expected to become more established. The Korea Disease Control and Prevention Agency (KDCA) announced that it will procure a total of 5.3 million doses of vaccine for the 2025-2026 season's COVID-19 NIP project through a private contract. The suppliers have been determined as ▲Pfizer (3.28 million doses) ▲Moderna (2.02 million doses), with HK inno.N and Boryung Biopharma, respectively, serving as the domestic distributors (companies with exclusive sales rights) for the COVID-19 vaccines. The vaccination will target high-risk groups, including the elderly aged 65 and over and immunocompromised individuals aged 6 months and older. Vaccinations are scheduled to begin in mid-October. The Korea Disease Control and Prevention Agency (KDCA) announced changes to a procurement system for COVID-19 vaccines. From 2025, the government will procure vaccines through a private contract. This transition of the COVID-19 vaccination program to the NIP is analyzed as an effort to increase the efficiency and predictability of the vaccination system, as the demand for vaccination among high-risk groups persists. The key to this transition is the establishment of a 'seasonal vaccination system'. Previously, vaccination plans were adjusted as needed based on the COVID-19 epidemic situation and vaccine supply conditions. However, after the NIP transition, it is expected that routine vaccinations will be standardized, like the flu vaccine. Accordingly, the vaccination implementation guidelines, recommendation criteria, and vaccine distribution are also expected to be managed solely within the government system. For the 2024-2025 seasonal COVID-19 vaccine, vaccinations were administered from October 11th to April 30th. However, as the incidence of COVID-19 increased not only in winter but also in summer, the vaccination period was extended from late April to June 30 of this year. The financial structure will also change. Unlike the previous system of full state funding, a 'national+local government matching fund' model will be introduced for this NIP project. The funding will consist of 30% national and 70% local government funds for Seoul, and 50% national and 50% local government funds for other regions. Since each local government will be responsible for executing the budget and managing vaccination rates, there is a possibility of differences in campaign intensity and implementation between regions. For the 2024-2025 seasonal COVID-19 vaccine, the vaccination period was extended from the regular schedule. Less Uncertainty for Pharmaceutical Suppliers...Expectations for Future Expansion of Vaccination Targets For vaccine suppliers Pfizer and Moderna, the latest structural change is expected to be a favorable shift in terms of supply stability and business predictability. Previously, COVID-19 vaccinations were based on government pre-purchase, with storage and delivery handled by government-commissioned companies. Such a system had possibility that the project could be terminated at any time based on the government's will. Now that it is included in the NIP, a stable volume of vaccines will be secured, and production and supply plans can be formulated based on an annual procurement cycle. From the government's perspective, even though the procurement is based on a private contract, price competitiveness and supply capabilities are included as evaluation factors, ensuring transparency in the supplier selection process. However, the responsibilities of pharmaceutical companies are also expected to increase. Since manufacturers will be directly responsible for storage and delivery, the company's logistical capabilities, including maintaining the cold chain, handling returns, and managing product exchanges, will be a critical variable. Although NIP vaccines have relatively fewer marketing elements, the availability of two vaccine options, along with the allowance for exchanges of vaccines nearing their expiration date and returns of up to 5%, means there is a high possibility of future competition between pharmaceutical companies. The COVID-19 epidemic situation for 2022-2025. The incidence of COVID-19 increased not only in winter but also in summer. In the clinical field, there is an expectation for a unified system, along with a focus on whether the target population will be expanded in the future. Currently, the program targets only high-risk groups, but it could be extended to the general population, similar to the flu (influenza), as the vaccination program becomes more established. First, experts advise that a practical strategy is needed to improve vaccination rates alongside the implementation of the NIP. Professor Woo Joo Kim of Korea University Guro Hospital's Department of Infectious Diseases stated in a meeting with DailyPharm, "High-risk groups, such as the elderly and those with underlying diseases, must be aware of their risk of infection and proactively get vaccinated. If they have symptoms, they must seek diagnosis and treatment quickly." Kim added, "At a societal level, a 'culture of resting when sick' needs to be established, and at a government level, an independent surveillance system for COVID-19 alone needs to be built." Kim also added, "Data on the latest COVID-19 epidemic trends, disease burden, and vaccine efficacy and safety must be understood to formulate vaccination timing and public relations strategies swiftly."
- Company
- Organon-KSCRH implements Implanon NTX Certificate Program
- by Whang, byung-woo Aug 05, 2025 06:08am
- 임플라논엔엑스티 이식제 제품사진 The Implanon NXT Certificate Program, jointly implemented by Organon Korea and the Korean Society of Contraception and Reproductive Health, is yielding positive results. Organon Korea announced on the 4th that 172 medical professionals have received certification through the ‘Implanon NTX Certificate Program,’ which has been in operation since 2024. The certification program aims to provide opportunities to enhance proficiency in the insertion and removal procedures of Implanon NXT (etonogestrel, hereinafter referred to as ‘Implanon’), a subdermal implantable contraceptive. Medical professionals seeking certification must complete four courses—Product Overview, Insertion Procedure, Removal and Replacement, and Patient Counseling—through the medical professional portal Organon Pro, followed by participation in an Implanon insertion and removal practical training session hosted by Organon Korea. Implanon is a subdermal contraceptive implant inserted under the skin on the inner side of the arm, providing up to 99% effectiveness for up to three years with a single procedure. It is a long-acting reversible contraceptive (LARC) method, with fertility returning within a few days to one week after removal. It does not require daily administration, making it independent of medication adherence, and can be used by women who have never given birth. Due to its structural characteristics, which prevent users from manipulating it themselves, insertion and removal must be performed by a qualified healthcare professional. Accordingly, the approval guidelines strongly recommend that healthcare professionals participate in the procedure training. The World Health Organization (WHO) also recommends in its Family Planning Handbook that implantable contraceptives must be administered by healthcare professionals who have received appropriate training. In line with these standards, Organon Korea has been implementing a procedure certification system linked to healthcare professional education and certification since 2024. After submitting a practical training certificate, the Korean Society of Contraception and Reproductive Health issues an Implanon procedure certification. As of 2024, a total of 172 medical professionals have been certified, and the program will continue to operate in the second half of the year. Ji-young Lee, President of the Korean Society of Contraception and Reproductive Health, said, “With growing patient interest in modern contraceptive methods like Implanon, there is a consensus among medical professionals that safer and more consistent procedures must be provided. Accordingly, we have introduced a certification program that combines education and practical training.” Sori Lee, Marketing Lead of the Women's Health Division at Organon Korea, said, “Since Implanon is a contraceptive that works continuously for up to three years inside the body, it must be inserted at the correct location and depth. We are implementing the certification program in collaboration with the society to further enhance the professionalism and consistency of the procedure. Going forward, we will continue to create an environment where women can choose contraceptive procedures with confidence and support more women in taking an active role in designing their health and lives.”
- Company
- Generic companies challenge Xtandi’s patent in KOR
- by Kim, Jin-Gu Aug 05, 2025 06:08am
- Astellas' prostate cancer treatment ‘Xtandi (enzalutamide)’ has become the target of a patent challenge by a generic drug company. According to industry sources on the 4th, Alvogen Korea recently filed a request for invalidation trial (passive scope confirmation trial) of the composition patent for Xtandi against Astellas. This is the first patent challenge ever filed against Xtandi in Korea. Xtandi is Astellas' prostate cancer treatment. The drug is protected by two patents: a substance patent expiring in June 2026 and a composition patent expiring in September 2033. Alvogen Korea plans to avoid the composition patent expiring in 2033 and launch a generic version in time for the expiration of the substance patent in 2026. What is interesting is that Alvogen Korea has already received approval for a generic version of Xtandi. In February of this year, Alvogen Korea received approval to import Anamide from the Ministry of Food and Drug Safety. At the time of approval, the composition patent for Xtandi had not yet been registered by the original company. In addition, Alvogen Korea is developing a generic version of another prostate cancer treatment, “Zytiga (abiraterone).” The company received approval for a bioequivalence study for “AK-D311” in October last year. Prior to Alvogen Korea, Hanmi Pharmaceutical, and Ace Pharma had already launched generic versions of Zytiga. Xtandi is competing with Janssen's ‘Erleada (apalutamide)’ and Zytiga in the first-line treatment market for prostate cancer. Recently, a new first-line treatment, ‘Akeega,’ has entered the competition as well. Akeega is a combination of Zytiga and Takeda's Zejula (niraparib). Recent trends show that Zytiga’s sales have been declining since the release of the generic version. On the other hand, sales of Xtandi and Erleada are on the rise. According to pharmaceutical market research institution IQVIA, Xtandi's sales increased by 1.9 times over four years, from KRW 23 billion in 2019 to KRW 43.2 billion in 2023. It is estimated that its sales last year alone were around KRW 50 billion.
